The mean ( SD ) duration to reach full enteral feed was @ ( @ ) days in glycerin suppository group and was not significantly different ( P = @ ) from control group , -LSB- @ ( @ ) days -RSB- .


Glycerin suppository group regained birth weight @ days earlier than control group but this difference was not significant ( P = @ ) .


There was no significant difference in duration of hospital stay or occurrence of necrotizing enterocolitis amongst the two study groups .


Once daily application of glycerin suppository does not accelerate the achievement of full feeds in preterm very-low-birthweight neonates .


Hypokalaemia is frequently encountered in the daily clinical practices of a paediatric cardiac intensive care unit ( PCICU ) .


It is a strong independent predictor of mortality in patients with heart failure .


Thus , prompt potassium replacement therapy holds pivotal importance in therapy for hypokalaemia .


Although intravenous potassium replacement ( IVPR ) in hypokalaemia is the preferred route in most intensive care settings , it is associated with known safety risks and can lead to arrhythmias , cardiac arrest and death if inappropriately administered .


Enteral potassium replacement ( EPR ) , with its superior safety profile , may be a better alternative to IVPR .


Primary outcome To compare the efficacy EPR and IVPR for treatment of hypokalaemia .


Secondary outcome measures include a comparison of adverse effects ( hyperkalaemia , diarrhoea , gastrointestinal bleeds , nausea and vomiting ) after EPR and IVPR and a comparison of the number of dose/s required to achieve resolution of hypokalaemia for each episode of hypokalaemia .


The Enteral Versus Intravenous Potassium Supplementation trial is designed as a randomised , controlled , non-blinded trial with two arms .


Intervention arms will be block randomised on alternate weeks for IVPR and EPR .


Recruited patients will receive treatment accordingly .


For analysis , the percentage change in serum potassium levels in mEq/L after each event of potassium replacement in both arms will be used as an end point to compare the efficacy EPR and IVPR for treatment of hypokalaemia .


The study will be conducted at the PCICU at the Aga Khan University Hospital , Karachi .


Low-intensity exercise applied in anorexia nervosa patients has been shown to have a harmless effect on body composition and to effect short-term improvements in muscular strength and agility .


The aim of this study was to determine the effects of a high-intensity resistance training program designed for adolescents to improve strength and agility in anorexia nervosa restricting-type patients ( AN-R ) .


From a total of @ female patients with AN-R , one group ( intervention , n = @ ) underwent a supervised high-intensity resistance training program lasting @ weeks , and the other group with no exercise ( control , n = @ ) .


Body weight , body mass index , whole-body muscular strength , and agility were assessed before , after , and @ weeks after training ( detraining ) .


Leg-press , bench-press , and lateral row tests improved significantly ( p < @ ) after @ weeks of training compared with controls .


Improvements were maintained after the detraining period .


The training program also showed beneficial effects on agility .


A high-intensity resistance training program adapted to the recommendations for adolescents in AN-R patients was effective and safe , improving muscular strength in the whole body and the ability to perform daily tasks .


However , long-term maintenance of gains seems to be linked to the continuance of training or the use of a maintenance program .


Depression is highly prevalent within individuals diagnosed with schizophrenia , and is associated with an increased risk of suicide .


There are no current evidence based treatments for low mood within this group .


The specific targeting of co-morbid conditions within complex mental health problems lends itself to the development of short-term structured interventions which are relatively easy to disseminate within health services .


A brief cognitive intervention based on a competitive memory theory of depression , is being evaluated in terms of its effectiveness in reducing depression within this group .


This is a single blind , intention-to-treat , multi-site , randomized controlled trial comparing Positive Memory Training plus Treatment as Usual with Treatment as Usual alone .


Participants will be recruited from two NHS Trusts in Southern England .


In order to be eligible , participants must have a DSM-V diagnosis of schizophrenia or schizo-affective disorder and exhibit at least a mild level of depression .


Following baseline assessment eligible participants will be randomly allocated to either the Positive Memory Training plus Treatment as Usual group or the Treatment as Usual group .


Outcome will be assessed at the end of treatment ( @-months ) and at @-month and @-month post randomization by assessors blind to group allocation .


The primary outcome will be levels of depression and secondary outcomes will be severity of psychotic symptoms and cost-effectiveness .


Semi-structured interviews will be conducted with all participants who are allocated to the treatment group so as to explore the acceptability of the intervention .


Cognitive behaviour therapy is recommended for individuals diagnosed with schizophrenia .


However , the number of sessions and length of training required to deliver this intervention has caused a limit in availability .


The current trial will evaluate a short-term structured protocol which targets a co-morbid condition often considered of primary importance by service users .


If successful the intervention will be an important addition to current initiatives aimed at increasing access to psychological therapies for people diagnosed with severe mental health problems .


Manual thrombus aspiration ( TA ) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction .


The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention .


Population of the EXAMINATION trial ( n = @ ) was divided into @ groups according to the use of TA .


Immediate angiographic results , primary patient-oriented end point ( combination of all-cause death , myocardial infarction , and any revascularization ) and secondary device-oriented end point ( combination of cardiac death , target vessel myocardial infarction , and clinically driven target lesion revascularization ) , definite/probable stent thrombosis , and major/minor bleeding were evaluated at @ years .


A total of @ ( @ % ) patients were classified into TA group and @ ( @ % ) patients into nonthrombus aspiration group .


Manual TA was most frequently used in patients with worse initial thrombolysis in myocardial infarction flow .


The TA group received less number of stents implanted ( @ @ versus @ @ , P = @ ) with bigger size ( @ @ versus @ @ mm , P < @ ) compared with the nonthrombus aspiration group .


A higher rate of direct stenting ( @ % versus @ % , P < @ ) with lower rate of postdilatation ( @ % versus @ % , P < @ ) was also present in the TA group compared with the nonthrombus aspiration group .


At @-year follow-up , no differences in clinical end point were observed between groups .


Manual TA during primary percutaneous coronary intervention is associated with a higher rate of direct stenting , a lower rate of postdilatation , and larger and less stents in comparison with conventional primary percutaneous coronary intervention .


Conversely , manual TA had no apparent impact on clinical outcomes at long-term follow-up .


Subclinical doses of propofol produce anterograde amnesia , characterized by an early failure of memory consolidation .


It is unknown how propofol affects the amygdala-dependent emotional memory system , which modulates consolidation in the hippocampus in response to emotional arousal and neurohumoral stress .


We present an event-related functional magnetic resonance imaging study of the effects of propofol on the emotional memory system in human subjects .


Thirty-five healthy subjects were randomized to receive propofol , at an estimated brain concentration of @ g ml ( -@ ) , or placebo .


During drug infusion , emotionally arousing and neutral images were presented in a continuous recognition task , while blood-oxygen-level-dependent activation responses were acquired .


After a drug-free interval of @ h , subsequent memory for successfully encoded items was assessed .


Imaging analysis was performed using statistical parametric mapping and behavioural analysis using signal detection models .


Propofol had no effect on the stereotypical amygdalar response to emotional arousal , but caused marked suppression of the hippocampal response .


Propofol caused memory performance to become uncoupled from amygdalar activation , but it remained correlated with activation in the posterior hippocampus , which decreased in proportion to amnesia .


Propofol is relatively ineffective at suppressing amygdalar activation at sedative doses , but abolishes emotional modulation and causes amnesia via mechanisms that commonly involve hyporesponsiveness of the hippocampus .


These findings raise the possibility that amygdala-dependent fear systems may remain intact even when a patient has diminished memory of events .


This may be of clinical importance in the perioperative development of fear-based psychopathologies , such as post-traumatic stress disorder .


Four randomized studies show that adjuvant radiotherapy ( RT ) lowers the risk of subsequent ipsilateral breast events ( IBEs ) after breast-conserving surgery ( BCS ) for ductal carcinoma in situ ( DCIS ) by approximately @ % after @ to @ years .


We present @ years of follow-up data for the SweDCIS trial .


Between @ and @ @,@ women were randomly assigned to RT or not after BCS for primary DCIS .


Results up to @ have been published , and we now add another @ years of follow-up .


All breast cancer events and causes of death were registered .


There were @ in situ and @ invasive IBEs .


Absolute risk reduction in the RT arm was @ % at @ years ( @ % CI , @ to @ ) , with a relative risk reduction of @ % .


Absolute reduction was @ % ( @ % CI , @ to @ ) for in situ and @ % ( @ % CI , -@ to @ ) for invasive IBEs .


There was a nonstatistically significantly increased number of contralateral events in the RT arm ( @ v @ events ; hazard ratio , @ ; @ % CI , @ to @ ) .


Breast cancer-specific death and overall survival were not influenced .


Younger women experienced a relatively higher risk of invasive IBE and lower effect of RT. .


The hazard over time looked different for in situ and invasive IBEs .


Use of adjuvant RT is supported by @-year follow-up .


Modest protection against invasive recurrences and a possible increase in contralateral cancers still call for a need to find groups of patients for whom RT could be avoided or mastectomy with breast reconstruction is indicated .


Surgical incision closure , as well as total joint replacement itself , plays a key role in the overall outcome of an arthroplasty procedure .


Uncomplicated wound healing is the essential condition of successful rehabilitation and the patient 's return to normal activities .


Although there are many innovative suturing techniques which offer advantages , their safety is still being discussed .


The aim of this prospective non-blind randomised study was to evaluate wound healing and complications in relation to skin incision closure with either conventional suture or metal staples .


A total of @ patients , @ men and @ women , who underwent a standard primary total knee arthroplasty ( TKA ) at our department in the period from January till June @ , were evaluated .


They were allocated to two groups by random assignment based on the patient 's date of birth ( even or odd day of birth ) .


In group @ ( n = @ ) skin was closed using metal staples ( Leukosan Skin Stapler ) , in group @ ( n = @ ) , conventional continuous Donati suture was used .


The groups , previously assessed as independent and comparable in terms of age , gender and BMI , were compared in the following criteria : suturing time , duration of wound drainage , wound healing , complications , resuturing when necessary , and their relation to the body mass index , skin plica thickness and co-morbidities potentially complicating soft tissue healing .


The differences were statistically evaluated by parametric and non-parametric tests , i.e. , the median test , ( @ ) - test , Student 's t-test , Fisher 's exact test and Pearson 's correlation coefficient .


The statistical significance of differences was set at a level of @ .


A significant difference ( p < @ ) between the groups was found in suturing time ; the median time for staples was @ sec in comparison with @ sec for conventional suture .


In both groups , staples or sutures were removed on the @ th postoperative day and there was no difference in wound drainage ( median time , @ days ; p = @ for both ) .


Treatment for late discharge was required in two sutured wounds ( @ % ) and in three stapled wounds ( @ % ) .


One of the latter was due to early deep wound infection , which later resulted in revision TKA .


The groups did not differ in the values of either BMI or plica thickness ( Pearson 's r ) .


Views on alternative suture techniques for skin closure in orthopaedic surgery vary .


In this study , the use of metal staples or conventional suture is compared between two groups of patients undergoing TKA , i.e. , the same type of procedure .


The advantage of staples involves a quick and simple application but , as reported , removal may be more painful with staples than with stitches , and much depends on the technique of staple application .


The continuous suture technique may produce skin strangulation at wound margins , which will complicate healing .


Staples minimise this risk and are therefore commonly used in TKA surgery .


However , only very few studies comparing these two suture techniques in TKA patients have been published .


Correctly performed skin suturing by means of metal staples is not associated with a higher complication rate and is therefore a simple , rapid , efficient and economical alternative to the conventional suture technique .


Fluid overload in infants can result from inappropriate volume expansion ( VE ) .


The aim of this work was to evaluate the beneficial values of Transoesophageal Doppler TED in intraoperative fluid guidance versus standard clinical monitoring parameters in infants undergoing Kasai operation .


Forty infants scheduled for Kasai procedure were randomly allocated into two groups ( Doppler and clinical group ) .


In Doppler group decided to provide VE ( @-@ m@/kg of Hydroxyethyl starches HES ) when the index stroke volume decreased by @ % from the baseline value , in clinical group , hemodynamic variables triggering colloid administration mean arterial blood pressure ( MAP ) less than @ % below baseline or central venous pressure ( CVP ) < @ cmH@O in both groups : Ringer 's acetate was infused at constant rate ( @ m @/kg/h ) .


Standard and TED-derived data were recorded before and after VE .


Follow up the postoperative outcome and hospital stay .


There were significantly lower mean volume of HES ( @ @ versus @ @ ml ) and percent of infants required it ( @ % versus @ % ) associated with earlier tolerance to oral feeding ( @ @ versus @ @ ) , shorter hospital stay ( @ @ versus @ -LSB- symbols : see text -RSB- days ) and lower rate of chest infection ( @ % versus @ % ) in Doppler group than clinical group .


There was no difference between the two studied groups regarding heart rate , MAP .


TED guided intraoperative fluid intake in infants undergoing Kasai operation optimize fluid consumption and improve outcome associated with shorter hospital stay .


High sodium intake during infancy and early childhood can change salt preference and blood pressure trajectories across life , representing a modifiable cardiovascular risk factor .


Describing young children 's sodium intake is important for informing effective targets for sodium reduction .


This study aimed to describe food sources and demographic and behavioral correlates of sodium intake in @ young Australian children using three unscheduled @-hour recalls ( when children were @ and then @ months of age ) with mothers participating within an existing randomized controlled trial , the Melbourne Infant Feeding Activity and Nutrition Trial ( InFANT ) Program .


Differences in individual-level and family-level demographic and behavioral variables were assessed across tertiles of sodium density ( mg/@ ,@ kcal ) .


Descriptive statistics were used to describe food-group contributions to total energy and sodium intakes at both ages .


Mean sodium intake was @ mg ( standard deviation = @ mg ) at @ months and had more than doubled to @,@ mg ( standard deviation = @ mg ) at @ months of age .


Fifty-four percent of children at @ months exceeded the Recommended Daily Upper Level for sodium intake , with bread , cheese , breakfast cereal , soup , and mixed dishes all important sources of sodium at both ages .


Yeast extracts , processed meats , and bread products became important additional sources at @ months .


A greater proportion of children in the highest sodium-density tertile had ceased breastfeeding and had commenced solids at an earlier age .


The key food sources of sodium for children younger than @ years are those that contribute to the whole population 's high salt burden and highlight the essential role governments and food industry must play to reduce salt in commonly consumed foods .


Delirium is a common complication in patients with hip fractures and is associated with an increased risk of subsequent dementia .


The aim of this trial was to evaluate the effect of a pre - and postoperative orthogeriatric service on the prevention of delirium and longer-term cognitive decline .


This was a single-center , prospective , randomized controlled trial in which patients with hip fracture were randomized to treatment in an acute geriatric ward or standard orthopedic ward .


Inclusion and randomization took place in the Emergency Department at Oslo University hospital .


The key intervention in the acute geriatric ward was Comprehensive Geriatric Assessment including daily interdisciplinary meetings .


Primary outcome was cognitive function four months after surgery measured using a composite outcome incorporating the Clinical Dementia Rating Scale ( CDR ) and the @ words learning and recalls tasks from the Consortium to Establish a Registry for Alzheimer 's Disease battery ( CERAD ) .


Secondary outcomes were pre - and postoperative delirium , delirium severity and duration , mortality and mobility ( measured by the Short Physical Performance Battery ( SPPB ) ) .


Patients were assessed four and twelve months after surgery by evaluators blind to allocation .


A total of @ patients were included .


There was no significant difference in cognitive function four months after surgery between patients treated in the acute geriatric and the orthopedic wards ( mean @ versus @ , @ % confidence interval for the difference -@ to @ ; P = @ ) .


There was also no significant difference in delirium rates ( @ % versus @ % , P = @ ) or four month mortality ( @ % versus @ % , P = @ ) between the intervention and the control group .


In a pre-planned sub-group analysis , participants living in their own home at baseline who were randomized to orthogeriatric care had better mobility four months after surgery compared with patients randomized to the orthopedic ward , measured with SPPB ( median @ versus @ , @ % confidence interval for the median difference @ to @ ; P = @ ) .


Pre - and postoperative orthogeriatric care given in an acute geriatric ward was not effective in reducing delirium or long-term cognitive impairment in patients with hip fracture .


The intervention had , however , a positive effect on mobility in patients not admitted from nursing homes .


Shockwave was shown to enhance the healing of anterior cruciate ligament ( ACL ) reconstruction in rabbits .


This study evaluated the effect of extracorporeal shockwave therapy ( ESWT ) on ACL reconstruction in human subjects .


We hypothesized that ESWT may improve human ACL reconstruction .


Fifty-three patients were randomized into two groups with @ patients in ESWT group and @ patients in control group .


The ESWT group underwent single-bundle hamstring autograft ACL reconstruction and received ESWT immediately after surgery .


The control group underwent ACL surgery without ESWT .


Both groups received the same rehabilitation postoperatively .


The evaluations included Lysholm score , IKDC score and KT-@ , radiograph , bone mineral density , and magnetic resonance imaging .


ESWT group showed significantly better Lysholm score than control group at @ and @y postoperatively ( P < @ and @ , respectively ) .


No significant difference was noted in IKDC score between the two groups ( P = @ and @ , respectively ) .


The KT-@ values were significantly better in ESWT group than control group at @y postoperatively ( P = @ ) .


The tibia tunnel on X-ray was significantly smaller in ESWT group compared with control group at @y ( P = @ ) .


The bone mineral density values showed no discernable difference between the two groups at @mo and @y ( P = @ and @ , respectively ) .


On magnetic resonance imaging , ESWT group showed significant decrease in tibia tunnel enlargement at @mo and @y compared with the control group ( P = @ and < @ , respectively ) .


ESWT significantly improves the subjective Lysholm score and decreases the middle @/@ tibia tunnel enlargement after single hamstring autograft ACL reconstruction .


The objective was to compare the effectiveness of repositioning every @ or @ h for preventing pressure ulcer development in patients in intensive care unit under mechanical ventilation ( MV ) .


This was a pragmatic , open-label randomized clinical trial in consecutive patients on an alternating pressure air mattress ( APAM ) requiring invasive MV for at least @ h in a university hospital in Spain .


Eligible participants were randomly assigned to groups for repositioning every @ ( n = @ ) or @ ( n = @ ) h.


The primary outcome was the incidence of a pressure ulcer of at least grade II during ICU stay .


A pressure ulcer of at least grade II developed in @ % ( @/@ ) of patients turned every @ h versus @ % ( @/@ ) of those turned every @ h ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ , P = @ ) .


The composite end point of device-related adverse events was recorded in @ versus @ % ( HR @ , CI @ % @-@ @ , P = @ ) , unplanned extubation in @ versus @ % ( HR @ , @ % CI @-@ @ , P = @ ) , and endotracheal tube obstruction in @ versus @ % , respectively ( HR @ , @ % CI @-@ @ , P = @ ) .


The median ( interquartile range ) daily nursing workload for manual repositioning was @ ( @-@ ) versus @ min/patient ( @-@ ) ( P < @ ) .


A strategy aimed at increasing repositioning frequency ( @ versus @ h ) in patients under MV and on an APAM did not reduce the incidence of pressure ulcers .


However , it did increase device-related adverse events and daily nursing workload .


To compare the bond strength to human primary dentin of a self-adhesive light-curing resin composite , a self-etch adhesive and a glass-ionomer cement by means of microshear bond strength ( pSBS ) test and scanning electron microscopic ( SEM ) observations .


@ human primary molars were sectioned to obtain a @ mm-thick slab of mid-coronal dentin , randomly divided into three groups ( n = @ ) .


Nine conical frustum-shaped buildups were constructed on the occlusal surface of each dentin slab using a self-adhesive light-curing resin composite ( Vertise Flow ; Group @ ) , bonding agent ( Optibond All-in-One ; Group @ ) combined with resin composite ( Premise Flow ) and a glass-ionomer cement ( Ketac-Fil ; Group @ ) .


After thermocycling , specimens were subjected to microSBS test .


All debonded specimens were observed at SEM .


Data were analyzed by a mixed model and chi-square test .


The bond strength measured in Group @ ( @ + / - @ MPa ) was significantly lower than that one recorded in Group @ ( @ + / -@ MPa ) although it was significantly higher than the one recorded in Group @ ( @ + / - @ MPa ) .


Failures were mainly adhesive in all groups .


This study examined potential predictors of nurses ' intentions to work during the @ influenza A ( H@N@ ) pandemic .


A questionnaire was mailed to a random sample of @,@ nurses chosen from all RNs and LPNs registered with the Maine State Board of Nursing during the second wave of the flu pandemic .


Of the @ respondents , @ % initially indicated that they intended to work during a flu pandemic .


Respondents were significantly more likely to work if provided with adequate personal protective equipment ( PPE ) but significantly less likely without adequate PPE or if they feared family members could become ill with pandemic flu .


They were also significantly less likely to work if assigned to direct care of a flu patient ; if a colleague were quarantined for or died of pandemic flu ; if they feared their own family members might die of pandemic flu ; if they themselves were ill for any reason ; if a family member or loved one were sick at home and needed care ; if they lacked a written family protection plan ; or if certain incentives were offered : antiviral medication or vaccine for nurse and family , double pay , or free room and board at work .


About @ % of RNs reported that they would not be willing to work during a flu pandemic , regardless of incentives or other factors .


An inverse relationship was found between the perceived level of threat posed by a flu pandemic and nurses ' willingness to work .


To maintain an adequate nursing workforce during a flu pandemic , employers should ensure that policies and procedures include providing adequate PPE for nurses and safeguarding the health of nurses and their families .


The level of perceived threat is likely to affect the proportion of nurses willing to work .


Some nurses will not work during a flu pandemic no matter what protections and incentives are offered ; efforts intended to force or entice all nurses to work are unlikely to succeed .


Psychological treatments for posttraumatic stress disorder ( PTSD ) are usually delivered once or twice a week over several months .


It is unclear whether they can be successfully delivered over a shorter period of time .


This clinical trial had two goals : to investigate the acceptability and efficacy of a @-day intensive version of cognitive therapy for PTSD and to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment .


Patients with chronic PTSD ( N = @ ) were randomly allocated to @-day intensive cognitive therapy for PTSD , @ months of standard weekly cognitive therapy , @ months of weekly emotion-focused supportive therapy , or a @-week waiting list condition .


The primary outcomes were change in PTSD symptoms and diagnosis as measured by independent assessor ratings and self-report .


The secondary outcomes were change in disability , anxiety , depression , and quality of life .


Evaluations were conducted at the baseline assessment and at @ and @ weeks ( the posttreatment/wait assessment ) .


For groups receiving treatment , evaluations were also conducted at @ weeks and follow-up assessments at @ and @ weeks after randomization .


All analyses were intent-to-treat .


At the posttreatment/wait assessment , @ % of the intensive cognitive therapy group , @ % of the standard cognitive therapy group , @ % of the supportive therapy group , and @ % of the waiting list group had recovered from PTSD .


All treatments were well tolerated and were superior to waiting list on nearly all outcome measures ; no difference was observed between supportive therapy and waiting list on quality of life .


For primary outcomes , disability , and general anxiety , intensive and standard cognitive therapy were superior to supportive therapy .


Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy .


Cognitive therapy for PTSD delivered intensively over little more than a week was as effective as cognitive therapy delivered over @ months .


Both had specific effects and were superior to supportive therapy .


Intensive cognitive therapy for PTSD is a feasible and promising alternative to traditional weekly treatment .


Modafinil is a medication licensed for the treatment of narcolepsy .


However , it has been reported that healthy individuals without wakefulness disorders are using modafinil off-label to enhance cognitive functioning .


Although some studies have reported that modafinil improves cognitive task performance in healthy volunteers , numerous other studies have failed to detect cognitive enhancing effects of modafinil on several well-established neuropsychological tasks .


Interestingly , several clinical and preclinical studies have found that improved cognitive task performance by modafinil is accompanied by slower response times .


This observation raises the question as to whether this slowing of response time in healthy volunteers is a necessary and sufficient condition for cognitive enhancement with modafinil .


The aim of the current experiment was to explore this question by investigating the effects of modafinil on the Hayling Sentence Completion Test ( HSCT ) .


Sixty-four healthy volunteers received either a single dose ( @ mg ) of modafinil ( n = @ ) or placebo ( n = @ ) in a randomized , double-blind , placebo-controlled , parallel group study in which the principal outcome measures were response latencies on the response initiation and response inhibition sections of the HSCT .


Participants dosed with modafinil had significantly longer mean response latencies on the HSCT for both the response initiation and response inhibition compared to participants dosed with placebo .


However , participants in both groups made a similar number of errors on each of these measures , indicating that modafinil did not enhance the accuracy of performance of the task relative to placebo .


This study demonstrated that administration of single @ mg doses of modafinil to healthy individuals increased the latency of responses in the performance of the HSCT , a task that is highly sensitive to prefrontal executive function , without enhancing accuracy of performance .


This finding may provide important clues to defining the limitations of modafinil as a putative cognitive enhancer .


Subjects with diabetes mellitus ( DM ) develop gait dysfunction contributing to falls , reluctance to perform activities and injuries .


Neuropathic pain ( NeP ) related to diabetic peripheral neuropathy ( DPN ) is associated with increased gait variability that may contribute to gait dysfunction .


We used a portable device ( GaitMeter ) and related gait and balance measures to measure gait parameters in painful DPN ( PDPN ) subjects prior to and during analgesia .


Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP .


DPN subjects with at least moderate NeP were assessed in a randomized , double-blind crossover study of pregabalin versus placebo .


The outcome measure was variability in step length and step velocity .


Testing for Timed Get-Up-and-Go Test , Tinetti Mobility Scales , Sway Testing , a Physiological Profile Approach , and fall-related surveys were also performed .


DPN severity was quantified using the Utah Early Neuropathy Score .


PDPN subjects developed increased , rather than decreased , step length and step velocity variability during pregabalin treatment .


There were no significant differences between cohorts for other physiological gait and balance testing .


Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo .


There was a negative relationship for step length with pain severity .


Analgesia did not decrease gait variability in PDPN patients , and in fact , increased gait variability was seen during pregabalin treatment .


Other important relationships of gait dysfunction with PDPN should be sought .


It has been suggested that off-pump coronary artery bypass grafting ( CABG ) surgery reduces myocardial ischemia-reperfusion injury , postoperative systemic inflammatory response , and oxidative stress .


The aim of this study was to measure serum malondialdehyde ( MDA ) , high-sensitivity C-reactive protein ( hs-CRP ) , M@ , and M@ levels and to investigate the relationship between M@ levels and oxidative stress and inflammation in patients undergoing on-and off-pump CABG surgery .


Fifty patients were randomly assigned to on-pump or off-pump CABG surgery ( @ patients off-pump and @ on-pump CABG surgery ) , and blood samples were collected prior to surgery , and @ minutes , @ minutes , @ hours , and @ hours after CABG surgery .


Compared to the on-pump group , serum MDA levels at @ minutes , @ minutes , @ hours , and @ hours after the CABG surgery were significantly lower in the off-pump group ( P = @ , P = @ , P = @ , and P = @ , respectively ) .


Serum M@ levels were found to be elevated in both groups , returning to baseline at @ hours .


When compared to baseline , the hs-CRP level reached its peak at @ hours at @ mg/dL in the on-pump group , and @ mg/dL in the off-pump group .


CABG surgery is associated with an increase in inflammatory markers and serum M@ levels , indicating epithelial/endothelial apoptosis in the early period .


To determine the efficacy of a @-day regimen of esomeprazole @ mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider .


Adults with frequent heartburn @ days per week in the past @ weeks were randomly assigned to @-day double-blind treatment with esomeprazole @ mg once daily or placebo in @ identical multicenter studies ( ClinicalTrials.gov identifiers : NCT@ , NCT@ ) .


The primary efficacy outcome was percentage of heartburn-free @-hour days across @ days .


Secondary efficacy outcomes included heartburn resolution , defined as heartburn @ days over @ days , and percentages of subjects reporting @ day with heartburn in the first and final weeks of treatment .


Subjects recorded data in daily self-assessment diaries .


The percentage of heartburn-free @-hour days over @ days was significantly higher ( P < @ ) in subjects receiving esomeprazole @ mg compared with placebo in study @ ( N = @ ; @ % vs. @ % , respectively ) and study @ ( N = @ ; @ % vs @ % , respectively ) .


Significantly more subjects treated with esomeprazole @ mg had heartburn resolution over @ days and in the first and final weeks compared with placebo .


Within the first @ days , the proportion of subjects with heartburn-free days was significantly greater with esomeprazole @ mg versus placebo .


Treatment was generally well tolerated , with a safety pattern consistent with the known profile for esomeprazole .


A @-day regimen of esomeprazole @ mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications .


In @ , the Danish Cancer Society opened a rehabilitation centre in which cancer patients were offered a free , six-day , multidimensional residential course .


Our previous studies of the effects of this course at one and six months of follow-up showed no positive effect on distress .


We investigated long-term effects at @ months of follow-up and whether subgroups with fewer psychosocial resources received more benefit from the intervention than patients with better resources .


In two Danish counties , @ patients with breast , prostate , colon or rectum cancer diagnosed within the past two years who had completed primary treatment were randomised to a six-day , multidimensional residential rehabilitation course or to standard care .


Of these , @ patients received the allocated intervention and @ received the allocated control condition and were included in the analyses .


Patients in both groups completed questionnaires at baseline and at one , six and @ months of follow-up , including the ` Profile of Mood States short form ' , the ` General Self-efficacy ' scale and a question on emotional support .


At @ months of follow-up , @ participants in the intervention group and @ in the control group provided data .


No effect of the intervention was found on distress at @ months of follow-up , even in subgroups with fewer psychosocial resources at baseline , i.e. greater baseline distress , poorer self-efficacy and less emotional support .


Multidimensional rehabilitation programmes may not be effective in the treatment of distress .


During the past few decades , studies of psychotherapy or psycho-education in cancer patients have shown small to moderate effects .


More focused rehabilitation programmes may be more effective .


To verify the technical feasibility of low contrast volume ( @ mL ) run-off CT angiography ( run-off CTA ) with the individual scan time optimization based on double-level test bolus technique .


A prospective study of @ consecutive patients who underwent run-off CTA performed with @ mL of contrast medium ( injection rate of @ mL/s ) and optimized scan times on a second generation of dual-source CT. .


Individual optimized scan times were calculated from aortopopliteal transit times obtained on the basis of double-level test bolus technique -- the single injection of @ mL test bolus and dynamic acquisitions in two levels ( abdominal aorta and popliteal arteries ) .


Intraluminal attenuation ( HU ) was measured in @ levels ( aorta , iliac , femoral and popliteal arteries , middle and distal lower-legs ) and subjective quality ( @-point score ) was assessed .


Relations of image quality , test bolus parameters and arterial circulation involvement were analyzed .


High mean attenuation ( HU ) values ( @ ; @ ; @ ; @ ; @ ; @ ) and quality score in all monitored levels was achieved .


In @ patients ( @ ) the sufficient diagnostic quality ( score @-@ ) in aorta , iliac and femoral arteries was determined .


A total of @ patients ( @ ) were not evaluable in distal lower-legs .


Only the weak indirect correlation of image quality and test-bolus parameters was proved in iliac , femoral and popliteal levels ( r values : -@ , -@ and -@ ) .


The statistically significant difference of the test-bolus parameters and image quality was proved in patients with occlusive and aneurysmal disease .


We proved the technical feasibility and sufficient quality of run-off CTA with low volume of contrast medium and optimized scan time according to aortopopliteal transit time calculated from double-level test bolus .


Clopidogrel therapy has recently been shown to reduce cardiovascular events in patients with stable vascular disease .


This benefit may be due to effects not exclusively related to platelet aggregation .


The aim of this study was to evaluate the effect of clopidogrel therapy on microvascular endothelial function in subjects with stable coronary artery disease ( CAD ) .


Forty subjects with stable CAD were randomised to clopidogrel therapy ( @mg/day ) or control .


Blood and endothelial function testing occurred at baseline , one week and three months following randomisation .


Microvascular endothelial function was assessed via reactive hyperaemic index ( RHI ) .


Platelet function was assessed by adenosine diphosphate ( ADP ) - induced whole blood aggregation and the VerifyNow system .


Plasma markers of endothelial function ( asymmetric dimethylarginine , ADMA ) and oxidative stress ( myeloperoxidase , MPO ) were also tested .


The primary endpoint was endothelial function assessment ( RHI ) at three months .


At one week RHI increased by @ % in the clopidogrel group ; this effect was maintained at three months ( @ % increase from baseline ; P < @ ) .


A significant decrease in ADP-induced platelet aggregation and P@Y@ reaction units was observed in the clopidogrel therapy group ( P < @ ) .


There was no correlation between endothelial function and platelet function testing in the clopidogrel therapy group .


Clopidogrel therapy is associated with improved microvascular endothelial function in patients with stable CAD .


This effect is independent of its effects on ADP-induced platelet reactivity .


To investigate if adding Caphosol ( ) , a mouthwash solution , to oral cryotherapy ( OC ) further protects against oral mucositis ( OM ) , a toxic painful complication to high dose chemotherapy .


The study was a randomised , controlled , study design .


Patients @ years scheduled for allogeneic stem cell transplantation were included consecutively and randomised to experimental group receiving OC combined with Caphosol ( ) ( n = @ ) or control group receiving OC only ( n = @ ) .


OC was given from start to end of HDCT .


Caphosol ( ) , from day @ to day @ .


There were no significant differences regarding age or gender between the groups .


Mucositis was assessed with the World Health Organisation ( WHO ) grading scale .


Pain was assessed with a @ cm visual analogue scale ( VAS ) from @ = no pain to @ = worst imaginable pain .


Start and duration of therapy with pain relieving drugs , serum C-reactive protein values , and number of days of hospitalisation were collected from the medical records .


Data on OM , oral pain , use of i.v. opioids and total parenteral nutrition were collected during @ days .


There was no significant difference between the groups on OM , oral pain , use of i.v. opioids or TPN between the groups .


The study showed no additional effect of combining Caphosol ( ) with OC .


The health benefits of exercise are well established .


However , the relationship between exercise volume and intensity and health benefits remains unclear , particularly the benefits of low-volume and intensity exercise .


The primary purpose of this investigation was , therefore , to examine the dose-response relationship between exercise volume and intensity with derived health benefits including volumes and intensity of activity well below international recommendations .


Generally healthy , active participants ( n = @ ; age = @ @ years ) were assigned randomly to control ( n = @ ) or one of five @-week exercise programs : ( @ ) @-min brisk walking @/week ( n = @ ) , ( @ ) @-min brisk walking @/week ( n = @ ) , ( @ ) @-min brisk walking @/week ( n = @ ) , ( @ ) @-min brisk walking @/week ( n = @ ) , and ( @ ) @-min running @/week ( n = @ ) , in addition to their regular physical activity .


Health measures evaluated pre - and post-training including blood pressure , body composition , fasting lipids and glucose , and maximal aerobic power ( VO@max ) .


Health improvements were observed among programs at least @ min in duration , including body composition and VO@max : @-min walking @-@ @ mL kg ( -@ ) min ( -@ ) , @-min walking @-@ @ mL kg ( -@ ) min ( -@ ) , and @-min running @-@ @ mL kg ( -@ ) min ( -@ ) .


The greater intensity running program also demonstrated improvements in triglycerides .


In healthy active individuals , a physical activity program of at least @ min in duration for three sessions/per week is associated with consistent improvements in health status .


Obesity-related comorbidities frequently contribute to acute illness .


Obesity interventions during hospitalization are not often utilized but may be effective .


To examine whether inpatient weight loss intervention with postdischarge follow-up results in weight loss at @ months when compared to control .


Prospective , randomized controlled trial .


Academic medical center in Chicago , Illinois .


Obese adult inpatients .


Intervention subjects viewed a weight education video , underwent personalized counseling , and set specific weight loss , dietary , and fitness goals prior to discharge .


All participants were followed by phone over the subsequent @ months .


The trial was unblinded to participants , physicians , and investigators .


Primary outcome was weight change between groups at @ months .


Weight change from baseline and waist-to-hip ratios ( WHR ) were also assessed .


For @ participants in the intention-to-treat analysis , mean baseline weight for the intervention group was @ kg ( standard deviation -LSB- SD -RSB- = @ ) and @ kg ( SD = @ ) for controls .


Mean weight loss at @ months was @ kg ( SD = @ ) for intervention subjects and @ kg ( SD = @ ) among controls .


There was no significant difference in weight loss between groups at @ months ( P = @ ) .


As-treated analysis yielded similar results .


There were no differences in WHRs between the intervention and control at @ months ( @ vs @ , P = @ ) .


We found no difference in weight loss between the intervention and control groups at @ months .


The purpose of this study was to determine the acceptability of peer - and health-professional-led self-management education using the Stanford Program with Australian veterans and their partners .


The @-week program taught problem-solving and decision-making skills to activate healthful behaviors , including action-planning and goal-setting .


The evaluation included a participant and facilitator postprogram questionnaire ; group interview ; and alcohol , posttraumatic stress disorder , anxiety , depression , anger , relationship , and quality-of-life measures as part of a randomized controlled study .


Participants included @ male veterans with comorbid alcohol dependency , psychiatric and medical conditions , and @ female partners ( n = @ ) , @ % of who reported a chronic condition .


The primary outcome was a self-reported improvement in self-management of their conditions in @ % of participants , with another @ % reporting that their confidence to self-manage had improved .


There was an improvement in all measures at @ months .


The program resulted in improvements in lifestyle and confidence in self-management for Vietnam veterans , a cohort difficult to engage in healthy behaviors .


Most participants were also accompanied by their partners .


The program is a valuable resource for providing self-management education to veterans with alcohol dependency and various chronic conditions and needs to be considered in the suite of rehabilitation programs available to Defense Force personnel , veterans , and their partners .


The objectives of the studies reported here were to determine the relative bioavailability of linagliptin and metformin when administered in a fixed-dose combination ( FDC ) tablet with and without food , and to investigate the relative bioavailability of linagliptin and metformin FDC tablets from two treatment batches with different dissolution behavior .


These studies were open-label , single-dose , randomized , two-way crossover trials .


After an overnight fast , healthy volunteers received an FDC tablet once ( with/without food in the food-effect study ; or from one of two batches with differing dissolution behavior in the tablet-dissolution study ) .


On a separate visit , following a washout period of @ days , participants received the alternative treatment .


In the food-effect study the primary endpoints were maximum measured concentration in plasma ( C ( max ) ) for linagliptin and metformin , area under the plasma concentration-time curve from @ to @ hours ( AUC ( @-@ ) ) for linagliptin and from @ to infinity ( AUC ( @-inf ) ) for metformin .


In the tablet-dissolution study the primary endpoints were Cmax for both analytes , AUC ( @-@ ) for linagliptin , and from @ to the time of the last quantifiable data point ( AUC ( @-t ) ) for metformin .


The administration of the FDC tablet with food had no influence on the relative bioavailability of linagliptin and metformin with regard to the extent of exposure as determined by AUC ( @-@ ) ( linagliptin ) and AUC ( @-inf ) ( metformin ) compared with FDC tablet administration while fasting .


After food intake , peak plasma concentrations of linagliptin were slightly lowered ( from @ to @ nmol L ) , but the @ % confidence interval ( CI ) of the geometric mean test/reference ratio was still located within the generally applied bioequivalence acceptance limits of @ - @ % .


The median time from dosing to the maximum concentration of linagliptin in plasma ( t ( max ) ) was similar under both conditions .


Administration with food reduced the rate of absorption of metformin indicated by a prolongation in median tmax ( from @ to @ hours ) and a decrease in Cmax by ~ @ % .


There were no notable differences between the two treatment groups with respect to safety and tolerability .


In the tablet-dissolution study , bioequivalence was demonstrated between linagliptin/metformin FDC tablets with normal and slower dissolution characteristics .


For both linagliptin and metformin , the @ % CI of all pharmacokinetic ( PK ) parameters were well within the bioequivalence acceptance limits of @ - @ % .


Tablets from both batches were well tolerated with no unexpected adverse events .


Food did not have a relevant impact on the bioavailability of linagliptin from the FDC tablet .


The effect of food on the metformin component was comparable to that previously demonstrated .


Furthermore , differences in tablet-dissolution characteristics did not have an impact on the bioavailability of linagliptin or metformin from the FDC tablet .


Social factors play an important role in quitting smoking in the general population , but relatively little is known about social influences on smoking cessation efforts among individuals with serious mental illness who suffer disproportionately high rates of smoking .


This study examined social factors as predictors of using smoking cessation treatment among adults with serious mental illness .


We conducted a secondary analysis of data from a randomized study comparing two versions of a motivational decision support system for smoking cessation treatment including @ smokers with schizophrenia or severe mood disorders .


Hierarchical logistic regression with blocked entry of theoretically linked predictor variables was used to model two types of social influences ( explicit and implicit ) as predictors of using cessation group therapy or smoking cessation medication .


Approximately @ % of participants initiated smoking cessation treatment during the @-month follow-up .


Hierarchical logistic regression analyses revealed that over and above demographic and personal factors , implicit social influences ( others ' approval of treatment ) significantly predicted use of smoking cessation medication , while explicit social influences ( smoking with others ) significantly predicted use of cessation group therapy .


For people with serious mental illness , social factors appear to influence use of smoking cessation treatment above and beyond personal factors and may be specific to the type of treatment .


These data support the need to further explore the role of social factors as potential leverage points for engagement in smoking cessation treatments in this population .


To evaluate @-year weight losses achieved with intensive lifestyle intervention ( ILI ) in the Look AHEAD ( Action for Health in Diabetes ) study .


Look AHEAD assessed the effects of intentional weight loss on cardiovascular morbidity and mortality in @,@ overweight/obese adults with type @ diabetes , randomly assigned to ILI or usual care ( i.e. , diabetes support and education -LSB- DSE -RSB- ) .


The ILI provided comprehensive behavioral weight loss counseling over @ years ; DSE participants received periodic group education only .


All participants had the opportunity to complete @ years of intervention before Look AHEAD was halted in September @ ; @ % of both groups completed the @-year outcomes assessment .


ILI and DSE participants lost ( mean SE ) @ % @ % and @ @ % of initial weight , respectively ( P < @ ) at year @ ; @ % and @ % , respectively , lost @ % ( P < @ ) , and @ % and @ % , respectively , lost @ % ( P < @ ) .


Across the @ years ILI participants , compared with DSE , reported greater practice of several key weight-control behaviors .


These behaviors also distinguished ILI participants who lost @ % and kept it off from those who lost but regained .


Look AHEAD 's ILI produced clinically meaningful weight loss ( @ % ) at year @ in @ % of patients with type @ diabetes and can be used to manage other obesity-related co-morbid conditions .


Intraocular pressure is increased during laparoscopic surgeries performed in a steep Trendelenburg position .


This study compared the effects of propofol with those of sevoflurane on intraocular pressure in patients undergoing robot-assisted laparoscopic radical prostatectomy in a @ Trendelenburg position .


Sixty-six patients were randomly allocated to a maintenance anesthetic consisting of remifentanil and sevoflurane ( Sevoflurane Group ) or remifentanil and propofol ( Propofol Group ) .


Intraocular pressure ( IOP ) was measured at nine predefined time points , including baseline ( T@ ) , five minutes after establishing pneumoperitoneum ( T@ ) , @min after establishing the Trendelenburg position with pneumoperitoneum ( T@ ) , five minutes after returning to the horizontal position ( T@ ) , and immediately after tracheal extubation ( T@ ) .


The primary outcome was the change in intraocular pressure from T@ to T@ .


The results of linear mixed model analysis showed that intraocular pressure differed between the two groups ( P = @ ) .


At T@ , the mean ( SD ) IOP was greater in the Sevoflurane Group -LSB- @ ( @ ) mmHg -RSB- than in the Propofol Group -LSB- @ ( @ ) mmHg -RSB- ( P = @ ) .


At T@ and T@ , IOP was also greater in the Sevoflurane Group than in the Propofol Group ( P = @ and P = @ , respectively ) .


There was a statistically significant increase in intraocular pressure from baseline to T@ ( pneumoperitoneum and steep Trendelenberg ) in the Sevoflurane Group -LSB- @ ( @ ) mmHg ; P < @ -RSB- but not in the Propofol Group -LSB- @ ( @ ) mmHg ; P = @ -RSB- .


None of the patients experienced ocular complications .


Intraocular pressure increases after pneumoperitoneum and the steep Trendelenburg position are established .


This increase is less with propofol than with sevoflurane anesthesia .


This trial was registered at ClinicalTrials.gov : NCT@ .


Enhancing exercise adherence over the longer term is an important goal in self-management of knee osteoarthritis ( OA ) .


Following an initial period of more intensive exercise supervision , this study investigated whether @ additional physiotherapy visits improved outcomes with continued home exercise over a subsequent @-week period .


A total of @ people with medial knee OA ( mean SD age @ @ years , mean SD body mass index @ @ kg/m ( @ ) , and radiographic disease severity @ % mild , @ % moderate , and @ % severe ) who completed a @-week physiotherapist-supervised exercise trial were randomly allocated to @ @-minute physiotherapy booster sessions ( delivered by @ physiotherapists in private clinics ) or no booster sessions for the subsequent @ weeks .


All participants were asked to continue home exercises @ times weekly .


Primary outcomes were change in pain , using a @-mm visual analog scale , and self-reported physical function , measured using the Western Ontario McMaster Universities Osteoarthritis Index .


Participants and physiotherapists were unblinded to group allocation , although participants were blinded to the study hypothesis .


A total of @ participants ( @ % ) completed the trial .


There was no significant difference between groups for change in pain ( mean difference -LSB- @ % confidence interval ( @ % CI ) -RSB- @ mm -LSB- -@ , @ -RSB- ; P = @ ) or physical function ( -@ units -LSB- @ % CI -@ , @ -RSB- ; P = @ ) .


The mean SD percentage of home exercise sessions completed was @ % @ % in the booster group and @ % @ % in the control group ( P > @ ) .


Two booster sessions with a physiotherapist did not influence pain or physical function outcomes , or measures of home exercise adherence .


These findings suggest other more effective strategies are needed to maximize longer-term adherence with the aim to achieve greater improvements in clinical outcomes from exercise in this patient population .


Heart failure is a prevalent health problem associated with costly hospital readmissions .


Transitional care programs have been shown to reduce readmissions but are costly to implement .


Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed .


The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause @-day hospital readmissions for older adults hospitalized with heart failure .


A multi-center , randomized controlled trial is being conducted at six academic health systems in California .


A total of @,@ patients aged @years and older will be enrolled during a hospitalization for treatment of heart failure .


Patients in the intervention group will receive intensive patient education using the ` teach-back ' method and receive instruction in using the telemonitoring equipment .


Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over @months from nurses located in a centralized call center .


The nurses also will call patients and patients ' physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters .


The primary outcome is readmission for any cause within @days .


Secondary outcomes include @-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life .


BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring .


The study population also includes patients with a wide range of demographic and socioeconomic characteristics .


Once completed , the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure .


Chemosaturation with percutaneous hepatic perfusion ( PHP ; Hepatic CHEMOSAT ( ) Delivery System ; Delcath Systems Inc , USA ) is a minimally invasive , repeatable regional therapy for unresectable hepatic metastases .


It uses a system of catheters and filters to isolate hepatic venous blood from the systemic circulation , allowing delivery of high-dose chemotherapy to the hepatic artery .


Effluent hepatic venous blood is filtered before being returned to the systemic circulation , thereby reducing exposure to chemotherapy .


We describe our experiences with chemosaturation-PHP at @ European centers .


@ patients presented unresectable hepatic metastases from solid tumors ; @ received @-@ sessions of chemosaturation-PHP .


Melphalan @ ( n = @ ) or @ ( n = @ ) mg/kg was given as a @-minute infusion into the hepatic artery .


@ patients were evaluable for tumor response .


One complete ( cholangiocarcinoma , n = @ ) and @ partial responses ( ocular , n = @ or cutaneous melanoma , n = @ ) were observed , @ patients had stable disease ( ocular melanoma , n = @ ; breast cancer , n = @ ; gastric cancer , n = @ ) .


Mild to moderate filter-related toxicity ( i.e. thrombocytopenia , anemia ) was observed immediately post-procedure .


Grade @/@ melphalan-related pancytopenia developed after @-@ weeks .


All hematological events were managed effectively with transfusions and/or other supportive measures .


The new high-efficiency filter showed milder toxicity and faster recovery .


In one case , chemosaturation-PHP was abandoned prematurely due to heparin-induced vaginal bleeding , and one patient died due to retroperitoneal hemorrhage from heparin anti-coagulation .


Chemosaturation-PHP for non-resectable liver metastases is a feasible treatment option when performed by an experienced multi-disciplinary team .


It may be a promising regional therapy for patients with no effective treatment options .


The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment , adherence to trial protocols and support given to future staff .


We interviewed staff working on a type @ diabetes trial in order to aid interpretation of trial findings , inform recommendations for the rollout of the treatments investigated and provide recommendations for the conduct of future trials .


However , our interviews uncovered aspects of trial work erstwhile unrecognised or underreported in the trials literature , and it is these which form the focus of this paper .


In-depth interviews were conducted with ( n = @ ) staff , recruited from seven centres , who were involved in recruitment and trial delivery .


Data were analysed thematically .


Alongside logistical and practical issues which made trial work challenging , staff often talked spontaneously and at length about how trial work had affected them emotionally .


Staff not only described the emotional stresses arising from having to meet recruitment targets and from balancing research roles with clinical responsibilities , they also discussed having to emotionally manage patients and their colleagues .


The emotional aspects of trial work particularly came to the fore when staff notified patients about their treatment allocation .


On such occasions , staff described having to employ emotional strategies to pre-empt and manage potential patient disappointment and anger .


Staff also described having to manage their own emotions when patients withdrew from the trial or were not randomised to the treatment arm which , in their clinical judgment , would have been in their best interests .


To help address the emotional challenges they encountered , staff highlighted a need for more practical , emotional and specialist psychological support .


More attention should be paid to the emotional aspects of trial work to help ensure trial staff are adequately supported .


Such support could comprise : increased training for staff to improve their own and patients ' understandings of randomization , role-play to develop techniques to manage patient anger and disappointment , sharing of good practice , formalised team support with psychological input and access to specialist psychological support to troubleshoot complex emotional and ethical issues .


Motion sickness is an unpleasant physiological state that may be controlled via nonpharmacological methods .


Controlled breathing has been shown to maximize parasympathetic nervous system ( PNS ) tone and may have the ability to decrease motion sickness symptoms .


The effects of slow diaphragmatic breathing ( DB ) in a motion sickness-inducing environment were examined within motion sickness susceptible individuals .


Subjects ( N = @ ) were assigned randomly to either an experimental group trained in slow DB or a control group breathing naturally at a normal pace .


The experimental group was trained using a digital video that helped them pace their diaphragmatic breathing at six breaths/min .


During the study , subjects viewed a virtual reality ( VR ) experience of a boat in rough seas for @ min .


Motion sickness ratings along with heart rate and respiration rate were collected before , during , and after the VR experience .


Results indicated that the experimental group was able to decrease their breathing to eight breaths/min during the VR experience .


This breathing rate was significantly slower than those in the control group .


We found that DB subjects , compared to those in the control group , displayed significantly greater heart rate variability and reported feeling less motion sickness during exposure to the VR experience than those in the control group .


Results indicate possible benefits of using slow DB techniques in a motion sickness inducing environment .


The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials .


The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at @ mg .


Adults ( n = @ ) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment ( TPA ) were randomly assigned to use either flurbiprofen @ mg lozenges ( n = @ ) or matching placebo lozenges ( n = @ ) under double-blind conditions .


Patients sucked one lozenge every three to six hours as needed , up to five lozenges per day , and rated symptoms on @-mm scales : the Sore Throat Pain Intensity Scale ( STPIS ) , the Difficulty Swallowing Scale ( DSS ) , and the Swollen Throat Scale ( SwoTS ) .


Reductions in pain ( lasting for three hours ) and in difficulty swallowing and throat swelling ( for four hours ) were observed after a single dose of the flurbiprofen @ mg lozenge ( P < @ compared with placebo ) .


After using multiple doses over @ hours , flurbiprofen-treated patients experienced a @ % greater reduction in throat pain , @ % less difficulty swallowing , and @ % less throat swelling than placebo-treated patients ( all P < @ ) .


There were no serious adverse events .


Utilizing the sore throat pain model with multiple doses over @ hours , flurbiprofen @ mg lozenges were shown to be an effective , well-tolerated treatment for sore throat pain .


Other pharmacologic actions ( reduced difficulty swallowing and reduced throat swelling ) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model .


The aim of this randomized trial was to compare short-term postoperative complications of laparoscopic transabdominal preperitoneal ( TAPP ) and Lichtenstein tension free hernia repair .


A total of @ patients who went inguinal hernia repair at Shahid Sadoughi university training hospital from April @ to August @ were randomized into two TAPP ( N. = @ ) and Lichtenstein ( N. = @ ) repair group .


Follow-up occurred within @ weeks .


The postoperative assessments included pain score ( VAS ) , hematoma/seroma , urinary retention , wound infection incidence , and duration of hospital stay .


Pain was the most common symptoms in both groups .


The TAPP group patients significantly had experienced less postoperative pain than the Lichtenstein group in all moments ( P < @ ) .


TAPP group had lower incidence of hematoma ( TAPP , @ % vs. Lichtenstein @ % ; P = @ ) , seroma ( TAPP @ % vs. Lichtenstein @ % ; P = @ ) , and infection ( TAPP @ vs. Lichtenstein @ % ; P = @ ) .


However , no differences between the @ groups were found in terms of postoperative complications .


In TAPP group mean of hospital stay significantly was less than Lichtenstein group ( TAPP , @ vs. Lichtenstein , @ days ; P < @ ) .


The laparoscopic TAPP repair is safer and less complicated approach to inguinal hernia repair .


The two main short-term advantages of the laparoscopic TAPP repair with the tension free Lichtenstein repair were less postoperative pain and earlier return to the normal life activities .


No difference was seen in overall complications .


To assess whether bipolar transurethral resection of the prostate ( B-TURP ) using the TURis system has a similar level of efficacy and safety to that of the traditional monopolar transurethral resection of the prostate ( M-TURP ) , and to evaluate the impact of the TURis system on postoperative urethral stricture rates over a @-month follow-up period .


A total of @ patients with benign prostatic obstruction were randomised to undergo either B-TURP using the TURis system or conventional M-TURP , and were regularly followed for @ months after surgery .


The primary endpoint was safety , which included the long-term complication rates of postoperative urethral stricture .


The secondary endpoint was the follow-up measurement of efficacy .


In peri-operative findings , no patient in either treatment group presented with transurethral resection syndrome , and the decline in levels of haemoglobin and hematocrit were similar .


The mean operation time was significantly extended in the TURis treatment group compared with the M-TURP group ( @ vs @ min ; P = @ ) and postoperative clot retention was more likely to be seen after M-TURP ( P = @ ) .


Similar efficacy findings were maintained throughout @ months , but a significant difference in postoperative urethral stricture rates between groups was detected ( @ % in M-TURP vs @ % in TURis ; P = @ ) .


After stratifying patients according to prostate volume , there was no significant difference between the two treatment groups with regard to urethral stricture rates in patients with a prostate volume @mL ( @ % in M-TURP vs @ % in TURis ) , but in the TURis group there was a significantly higher urethral stricture rate compared with the M-TURP group in patients with a prostate volume > @mL ( @ % in TURis vs @ % in M-TURP ; P = @ ) .


Furthermore , the mean operation time for TURis was significantly longer than for M-TURP for the subgroup of patients with a prostate volume > @mL ( @ vs @ min ; P = @ ) , but not for the subgroup of patients with a prostate volume @mL .


The TURis system seems to be as efficacious and safe as conventional M-TURP except that there was a higher incidence of urethral stricture in patients with larger preoperative prostate volumes .


The gadolinium-based MRI contrast agent gadobenate dimeglumine has nearly twice the MR relaxivity of gadopentetate dimeglumine at @ T.


The purpose of this study was to determine whether a lower dose ( @ mmol/kg ) of gadobenate dimeglumine can be used to obtain delayed-enhancement MR images comparable to those obtained with a standard dose ( @ mmol/kg ) of gadopentetate dimeglumine .


In this blinded randomized crossover study , @ patients with known myocardial infarction underwent two separate delayed-enhancement MRI examinations after receiving @ mmol/kg gadobenate dimeglumine and @ mmol/kg gadopentetate dimeglumine ( random administration ) .


The conspicuity of lesion enhancement @ , @ , and @ minutes after contrast administration was quantified as relative enhancement ratio ( RER ) .


With either gadolinium-based contrast agent , damaged myocardium had higher signal intensity than normal remote myocardium ( RER > @ ) on delayed-enhancement MR images , and the blood RER declined over time after contrast administration .


The blood RER was not significantly higher for gadobenate dimeglumine than for gadopentetate dimeglumine at @ and @ minutes .


Nevertheless , there was a larger reduction in blood RER for gadobenate dimeglumine than for gadopentetate dimeglumine between @ and @ minutes and between @ and @ minutes .


The volumes of enhancement were similar for gadobenate dimeglumine ( @ @ cm ( @ ) ) and gadopentetate dimeglumine ( @ @ cm ( @ ) ) ( p = @ ) .


The mean difference in Bland-Altman analysis for delayed-enhancement volume between the agents was @ cm ( @ ) .


Qualitatively and quantitatively , delayed-enhancement MR images of ischemic myocardium obtained with @ mmol/kg gadobenate dimeglumine are comparable to those obtained with @ mmol/kg gadopentetate dimeglumine @ , @ , and @ minutes after contrast administration .


The ocular vestibular-evoked myogenic potential ( oVEMP ) test yields the same information as the rotational test in sleep-deprived subjects as evidenced by increased vestibulo-ocular reflex ( VOR ) asymmetry .


However , the duration of sleep deprivation ( @ h ) and testing time required for the oVEMP test are shorter than for the rotational test .


This study utilized the oVEMP test in sleep-deprived subjects to investigate the effect of short-duration sleep deprivation on the VOR system .


Twenty healthy resident physicians underwent oVEMP and cervical VEMP ( cVEMP ) tests twice in a randomized order ; one test battery was performed after a normal sleep , and the other was performed after a night duty at the emergency service , which meant a state of @ h sleep deprivation .


All @ subjects had clear oVEMPs regardless of whether testing was performed after a normal sleep or @ h sleep deprivation condition .


Significant differences were not identified between the two sleep conditions in terms of characteristic parameters , i.e. latencies and amplitude of oVEMPs .


However , the mean asymmetry ratio after sleep deprivation ( @ @ % ) was significantly larger than that after normal sleep ( @ @ % ) .


Conversely , the cVEMP parameters did not differ significantly between the two sleep conditions .


Peer-led interventions to improve chronic disease self-management can improve health outcomes but are not widely used .


Therefore , we tested a peer-led hypertension self-management intervention delivered at regular meetings of community veterans ' organizations .


We randomized @ organizational units ( `` posts '' ) of veterans ' organizations in southeast Wisconsin to peer-led vs. professionally delivered self-management education .


Volunteer peer leaders at peer-led posts delivered monthly presentations regarding hypertension self-management during regular post meetings .


Volunteer post representatives at seminar posts encouraged post members to attend @ didactic seminars delivered by health professionals at a time separate from the post meeting .


Volunteers in both groups encouraged members to self-monitor using blood pressure cuffs , weight scales , and pedometers .


Our primary outcome was change in systolic blood pressure ( SBP ) at @ months .


We measured SBP in @ participants at baseline and in @ participants at @ months .


SBP decreased significantly ( @ mm Hg ; P < @ ) overall ; the decrease was similar in peer-led and seminar posts ( @ mm Hg vs. @ mm Hg ; P = @ ) .


Among participants with uncontrolled BP at baseline , SBP decreased by @ mm Hg from baseline to @ months but was again similar in the @ groups .


This pattern was also seen at @ months and with diastolic blood pressure .


Our peer-led educational intervention was not more effective than didactic seminars for SBP control .


Although peer-led educational programs have had important impacts in a number of studies , we did not find our intervention superior to a similar intervention delivered by healthcare professionals .


Pritelivir , an inhibitor of the viral helicase-primase complex , exhibits antiviral activity in vitro and in animal models of herpes simplex virus ( HSV ) infection .


We tested the efficacy and safety of pritelivir in otherwise healthy persons with genital HSV-@ infection .


We randomly assigned @ HSV-@-positive persons with a history of genital herpes to receive one of four doses of oral pritelivir ( @ , @ , or @ mg daily , or @ mg weekly ) or placebo for @ days .


Participants obtained daily swabs from the genital area for HSV-@ testing , which was performed with a polymerase-chain-reaction assay .


Participants also maintained a diary of genital signs and symptoms .


The primary end point was the rate of genital HSV shedding .


HSV shedding among placebo recipients was detected on @ % of days ; shedding among pritelivir recipients was detected on @ % of days among those receiving @ mg daily , @ % of days among those receiving @ mg daily , @ % of days among those receiving @ mg daily , and @ % of days among those receiving @ mg weekly .


The relative risk of viral shedding with pritelivir , as compared with placebo , was @ ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) with the @-mg daily dose , @ ( @ % CI , @ to @ ) with the @-mg daily dose , @ ( @ % CI , @ to @ ) with the @-mg daily dose , and @ ( @ % CI , @ to @ ) with the @-mg weekly dose .


The percentage of days with genital lesions was also significantly reduced , from @ % in the placebo group to @ % in both the group receiving @ mg of pritelivir daily ( relative risk , @ ; @ % CI , @ to @ ) and the group receiving @ mg weekly ( relative risk , @ ; @ % CI , @ to @ ) .


The rate of adverse events was similar in all groups .


Pritelivir reduced the rates of genital HSV shedding and days with lesions in a dose-dependent manner in otherwise healthy men and women with genital herpes .


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


To test the hypothesis that the simultaneous administration of GLP-@ and insulin may increase their vasodilatory , antiinflammatory , and antioxidant action in type @ diabetes .


In two groups of persons with type @ diabetes , two sets of experiments were performed .


The first group had two normoglycemic-normoinsulinemic clamps with or without GLP-@ and two normoglycemic-hyperinsulinemic clamps with or without GLP-@ .


The second group had two hyperglycemic-normoinsulinemic clamps and two hyperglycemic-hyperinsulinemic clamps with or without GLP-@ .


During the normoglycemic-hyperinsulinemic clamp , flow-mediated dilatation ( FMD ) increased , while soluble intercellular adhesion molecule ( sICAM-@ ) , plasma @-iso-prostaglandin F@ ( @-iso-PGF@ ) , nitrotyrosine , and interleukin ( IL ) -@ decreased compared with normoglycemic-normoinsulinemic clamp .


Similar results were obtained with the infusion of GLP-@ during the normoglycemic-normoinsulinemic clamp .


The combination of hyperinsulinemia and GLP-@ in normoglycemia was accompanied by a further FMD increase and sICAM-@ , @-iso-PGF@ , nitrotyrosine , and IL-@ decrease .


During the hyperglycemic-normoinsulinemic clamp , FMD significantly decreased , while sICAM-@ , @-iso-PGF@ , nitrotyrosine , and IL-@ significantly increased .


When hyperglycemia was accompanied by hyperinsulinemia or by the simultaneous infusion of GLP-@ , these phenomena were attenuated .


The simultaneous presence of hyperinsulinemia and GLP-@ had an increased beneficial effect .


Our results show that the combination of insulin and GLP-@ is more effective than insulin or GLP-@ alone in improving endothelial dysfunction , inflammation , and oxidative stress in type @ diabetes .


Examine the effect of an early intervention programme on cognitive outcome at @ and @years in children with birth weight ( BW ) < @g .


A randomised controlled trial of a modified version of the Mother-Infant Transaction Program .


A single tertiary neonatal unit .


@ infants were randomised into a preterm control group ( @ ) or a preterm intervention group ( @ ) .


The intervention consisted of eight sessions shortly before discharge and four home visits by specially trained nurses focusing on the infants ' unique characteristics , temperament , developmental potential and the interaction between infants and parents .


Outcomes were assessed with the Wechsler Intelligence Scale for Children ( WISC-III ) .


Mean BWs were @ ( @ ) g in the intervention group and @ ( @ ) g in the control group .


After adjusting for the possible clustering effects of twin pairs and maternal education , there were no significant differences in WISC-III scores at age @ or @ .


The mean difference was @ points ( @ % CI -@ to @ points ) in favour of the intervention group at @years and @ points ( @ % CI -@ to @ points ) at @years .


At @years , a @ points difference in the Verbal Comprehension Index ( @ % CI @ to @ points ) was found in favour of the intervention group .


Loss to follow-up at age @ and @ was @ % and @ % , respectively .


This intervention programme did not have a sustained significant effect on overall cognitive outcomes in preterm children at age @ and @ .


Local analgesia through wound catheters is used as a part of multimodal analgesia .


The efficacy of continuous subfascial wound infusion compared to epidural analgesia is unknown for abdominal hysterectomy and bilateral salpingo-oophorectomy ( TAH-BSO ) via Pfannenstiel incision .


The aim of this study was to compare the aforementioned two methods in this type of surgery for postoperative morphine consumption , acute and persistent postsurgical pain .


Fifty patients enrolled in the study were randomly allocated to receive continuous @ mL/h levobupivacaine either via subfascial ( Group S ) or epidural ( Group E ) catheter for @ h postoperatively .


In Group S @ % levobupivacaine was used for the first six hours and @ % thereafter , whereas Group E received @ % levobupivacaine throughout the study period .


Cumulative morphine consumption , static and dynamic pain , gastrointestinal recovery , ambulation , patient satisfaction , hospital stay , as well as pain at @nd and @th months were evaluated .


Group S was superior to Group E regarding cumulative morphine consumption ( @ mg and @ mg respectively , P < @ ; mean difference -@ with @ % CI of the difference -@ to -@ ) and pain relief .


Patient satisfaction was higher in Group S compared to Group E ( P = @ ) .


Less postoperative vomiting was observed in Group S. No difference was detected in length of hospital stay and persistent postsurgical pain incidence .


Wound analgesia via subfascial catheter with continuous levobupivacaine infusion decreases postoperative morphine consumption and increases patient satisfaction compared to epidural analgesia with no difference in persistent postsurgical pain following TAH-BSO via Pfannenstiel incision .


This study evaluates the effects of an intervention performed by youth health care professionals on child health behaviors .


The intervention consisted of offering healthy lifestyle counseling to parents of overweight ( not obese ) @-year-old children .


Effects of the intervention on the child having breakfast , drinking sweet beverages , watching television and playing outside were evaluated .


Data were collected with the ` Be active , eat right ' study , a cluster randomized controlled trial among nine youth health care centers in the Netherlands .


Parents of overweight children received lifestyle counseling according to the intervention protocol in the intervention condition ( n = @ ) and usual care in the control condition ( n = @ ) .


Parents completed questionnaires regarding demographic characteristics , health behaviors and the home environment at baseline and at @-year follow-up .


Cluster adjusted regression models were applied ; interaction terms were explored .


The population for analysis consisted of @ % boys ; mean age @ -LSB- sd @ -RSB- years ; mean BMI SDS @ -LSB- sd @ -RSB- .


There were no significant differences in the number of minutes of outside play or television viewing a day between children in the intervention and the control condition .


Also , the odds ratio for having breakfast daily or drinking two or less glasses of sweet beverages a day showed no significant differences between the two conditions .


Additional analyses showed that the odds ratio for drinking less than two glasses of sweet beverages at follow-up compared with baseline was significantly higher for children in both the intervention ( p < @ ) and the control condition ( p = @ ) .


Comparison of the children in the two conditions showed that the intervention does not contribute to a change in health behaviors .


Further studies are needed to investigate opportunities to adjust the intervention protocol , such as integration of elements in the regular well-child visit .


The intervention protocol for youth health care may become part of a broader approach to tackle childhood overweight and obesity .


Current practice in the delivery of caloric intake ( DCI ) in patients with severe acute kidney injury ( AKI ) receiving renal replacement therapy ( RRT ) is unknown .


We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy ( RENAL ) study and to assess the association between DCI and clinical outcomes .


We performed a secondary analysis in @ patients from the RENAL trial .


We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression , Cox proportional hazards models , and time adjusted models .


Overall , mean DCI during treatment in ICU was low at only @ Kcal/kg/day for non-survivors and @ Kcal/kg/day for survivors .


Among patients with a lower DCI ( below the median ) @ of @ ( @ % ) had died at @-days after randomization compared with @ of @ ( @ % ) patients with a higher DCI ( above the median ) ( P = @ ) .


On multivariable logistic regression analysis , mean DCI carried an odds ratio of @ ( @ % confidence interval ( CI ) : @-@ @ ; P = @ ) per @ Kcal increase for @-day mortality .


DCI was not associated with significant differences in renal replacement ( RRT ) free days , mechanical ventilation free days , ICU free days and hospital free days .


These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling .


In the RENAL study , mean DCI was low .


Within the limits of such low caloric intake , greater DCI was not associated with improved clinical outcomes .


To develop a clinically valid interactive level @ screening assessment for autism spectrum disorders ( ASD ) in toddlers that is brief , easily administered , and scored by clinicians .


We describe the development , training , standardization , and validation of the Rapid Interactive Screening Test for Autism in Toddlers ( RITA-T ) with ASD-specific diagnostic instruments .


The RITA-T can be administered and scored in @ minutes .


We studied the validity of the RITA-T to distinguish between toddlers with ASD from toddlers with developmental delay ( DD ) / non-ASD in an early childhood clinic .


We also evaluated the test 's performance in toddlers with no developmental concerns .


We identified a cutoff score based on sensitivity , specificity , and positive predictive value of the RITA-T that best differentiates between ASD and DD/non-ASD .


A total of @ toddlers were enrolled .


RITA-T scores were correlated with ASD-specific diagnostic tools ( r = @ ; P < @ ) and ASD clinical diagnoses ( r = @ ; P < @ ) .


Mean scores were significantly different in subjects with ASD , those with DD/non-ASD , and those with no developmental concerns ( @ vs @ vs @ , respectively ; P < @ ) .


At a cutoff score of > @ , the RITA-T had a sensitivity of @ , specificity of @ , and positive predictive value of @ for identifying ASD risk in a high-risk group .


The RITA-T is a promising new level @ interactive screening tool for improving the early identification of ASD in toddlers in general pediatric and early intervention settings and allowing access to treatment .


Despite the great variety of mammaplasty techniques , outcome assessment remains a challenging issue .


The authors devised an objective method to evaluate mammary symmetry based on statistical analysis of objective manual breast measurements and validated the method by applying it to results of a randomized controlled trial on the correction of breast asymmetry .


Sixty consecutive patients with hypoplastic breasts and small-volume asymmetry were enrolled in the study and randomly assigned to @ of @ groups .


One group received a fixed-volume implant in @ breast and an adjustable-volume implant in the other .


The other group received @ fixed-volume implants of different sizes .


The differences in specific breast and chest measurements , obtained before surgery and during follow-up , were analyzed statistically with the Wilcoxon signed rank test .


Correction of the asymmetry resulted in the reduction of the differences between left and right values for each specific breast measurement .


Placement of an adjustable implant on @ side yielded better symmetry than placement of @ fixed-volume prostheses of different sizes .


Patient and physician satisfaction was high for both groups .


This objective analysis of clinical parameters enables comparing results for different patients in large clinical trials and for the same patient at different follow-up periods .


The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions .


In two random-order , crossover studies with similar but distinct designs , we compared glycemic control with a wearable , bihormonal , automated , `` bionic '' pancreas ( bionic-pancreas period ) with glycemic control with an insulin pump ( control period ) for @ days in @ adults and @ adolescents with type @ diabetes mellitus .


The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon .


Among the adults , the mean plasma glucose level over the @-day bionic-pancreas period was @ mg per deciliter ( @ mmol per liter ) , and the mean percentage of time with a low glucose level ( < @ mg per deciliter -LSB- @ mmol per liter -RSB- ) was @ % .


After @ day of automatic adaptation by the bionic pancreas , the mean ( SD ) glucose level on continuous monitoring was lower than the mean level during the control period ( @ vs. @ mg per deciliter -LSB- @ vs. @ mmol per liter -RSB- , P < @ ) and the percentage of time with a low glucose reading was lower ( @ % vs. @ % , P = @ ) .


Among the adolescents , the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period ( @ vs. @ mg per deciliter -LSB- @ vs. @ mmol per liter -RSB- , P = @ ) , but the percentage of time with a low plasma glucose reading was similar during the two periods ( @ % and @ % , respectively ; P = @ ) .


The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period ( one per @ days vs. one per @ days , P < @ ) .


As compared with an insulin pump , a wearable , automated , bihormonal , bionic pancreas improved mean glycemic levels , with less frequent hypoglycemic episodes , among both adults and adolescents with type @ diabetes mellitus .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; ClinicalTrials.gov numbers , NCT@ and NCT@ . )


The study aim was to establish the threshold of stretching volume for flexibility enhancement during physical education lessons in secondary school children .


Subjects were @ tenth grade children randomly assigned to four groups ( boys @ , girls @ , mean age @ @ ) .


Children involved in after-school sports were not included in the study .


Physical education lessons were performed twice a week for @ minutes in duration .


The intervention lasted for five weeks comprising @ physical education lessons .


Flexibility was determined from sit and reach test before and after intervention .


Subjects in group @ performed standard `` sit and reach '' test of four trials in every physical education lesson ; in group @ received one stretching exercise of four repetitions ; group @ received four stretching exercises of four repetitions ; in group @ no stretching was performed .


Flexibility improvement in group @ were the greatest ( @ % ; P < @ ) , smaller in group @ ( @ % , P < @ ) and smallest in @ group ( @ % , P < @ ) , while control group changes were insignificant ( @ % , P > @ ) .


The main finding was that single flexibility test performed twice a week for five weeks was sufficient stimulus to increase range of motion in secondary school children .


Stretching exercises provides exceptional prospects to achieve youths ' improvement since schoolchildren are very sensitive to flexibility training .


In this phase II study , patients with stage IIIB/IV non-small-cell lung cancer were randomly assigned ( @:@:@ ) to receive LY@ ( @ mg twice daily -LSB- @ LY@ -RSB- or @ mg twice daily -LSB- @ LY@ -RSB- ) or placebo for @ days , followed by concurrent cisplatin ( @ mg/m@ ; day @ ) and gemcitabine ( @ mg/m@ ; days @ and @ ) , every @ days.The primary endpoint was progression-free survival , ( PFS ) , with @ % power to detect @ % improvement compared with placebo ( @ months ) .


Of @ randomized patients , @ were treated .


Demographics were well balanced across treatment arms : @ % of the patients were men ; median age was @ years ; @ % had stage IV disease ; and patients had an Eastern Cooperative Oncology Group performance status of @ ( @ % ) or @ ( @ % ) .


The most frequent study drug-related toxicities were nausea , vomiting , and fatigue .


Response rates were similar across treatment arms ( @ LY@ : @ % ; @ LY@ : @ % ; placebo : @ % ) .


Median PFS ( @ % confidence interval ) was not significantly different across treatment arms ( @ LY@ : @ months -LSB- @-@ @ -RSB- ; @ LY@ : @ months -LSB- @-@ @ -RSB- ; placebo : @ months -LSB- @-@ @ -RSB- ) .


LY@ combined with gemcitabine-cisplatin did not increase median PFS compared with placebo plus gemcitabine-cisplatin in patients with non-small-cell lung cancer .


The alginate-antacid , Gaviscon Double Action ( Gaviscon DA ; Reckitt Benckiser , Slough , UK ) suppresses reflux after meals by creating a gel-like barrier that caps and displaces the acid pocket distal to the oesophago-gastric junction .


The effect of Gaviscon DA on reflux and dyspepsia symptoms has not yet been demonstrated with a modern trial design .


A pilot study to assess the efficacy and safety of Gaviscon DA compared with matched placebo for decreasing upper gastrointestinal symptoms in symptomatic gastro-oesophageal reflux disease ( GERD ) patients .


A randomised , double-blind , parallel group study was performed in @ patients with symptoms of GERD .


Patients received Gaviscon DA or placebo tablets for @ consecutive days .


The primary endpoint compared the change in overall Reflux Disease Questionnaire ( RDQ ) symptom score ( combined heartburn/regurgitation/dyspepsia ) .


Secondary endpoints assessed individual dimensions , GERD dimension ( heartburn and regurgitation ) and overall treatment evaluation ( OTE ) .


There was a greater decrease in overall RDQ symptom score in the Gaviscon DA group compared with the placebo group ( Least Squares Mean difference -@ ; P = @ ) , and for each of the dimensions independently .


Patients in the Gaviscon DA group evaluated their overall treatment response higher than patients in the placebo group -LSB- mean ( standard deviation ) OTE @ ( @ ) vs. @ ( @ ) ; P = @ -RSB- .


No differences in the incidence of adverse events were observed between treatment groups .


Gaviscon DA decreases reflux and dyspeptic symptoms in GERD patients compared with matched placebo and has a favourable benefit-risk balance .


Larger scale clinical investigations of medications targeting the acid pocket are warranted .


( EudraCT , @-@-@ ) .


Polysomnography defines the pathophysiology of obstructive sleep apnea syndrome ( OSAS ) but does not predict some important comorbidities or their response to adenotonsillectomy .


We assessed whether OSAS symptoms , as reflected on the Sleep-Related Breathing Disorders Scale of the Pediatric Sleep Questionnaire ( PSQ ) , may offer clinical predictive value .


Baseline and @-month follow-up data were analyzed from @ participants ( aged @-@ years with polysomnographically confirmed OSAS ) in the surgical treatment arm of the multicenter Childhood Adenotonsillectomy Trial .


Associations were assessed between baseline PSQ or polysomnographic data and baseline morbidity ( executive dysfunction , behavior , quality of life , sleepiness ) or postsurgical improvement .


At baseline , each @-SD increase in baseline PSQ score was associated with an adjusted odds ratio that was @ to @ times higher for behavioral morbidity , @ times higher for reduced global quality of life , @ times higher for reduced disease-specific quality of life , and @ times higher for sleepiness .


Higher baseline PSQ scores ( greater symptom burden ) also predicted postsurgical improvement in parent ratings of executive functioning , behavior , quality of life , and sleepiness .


In contrast , baseline polysomnographic data did not independently predict these morbidities or their postsurgical improvement .


Neither PSQ nor polysomnographic data were associated with objectively assessed executive dysfunction or improvement at follow-up .


PSQ symptom items , in contrast to polysomnographic results , reflect subjective measures of OSAS-related impairment of behavior , quality of life , and sleepiness and predict their improvement after adenotonsillectomy .


Although objective polysomnography is needed to diagnose OSAS , the symptoms obtained during an office visit can offer adjunctive insight into important comorbidities and likely surgical responses .


Adherence to evidence-based cardiovascular ( CV ) medications after an acute myocardial infarction ( MI ) is low after the first @ months .


The use of fixed-dose combinations ( FDC ) has been shown to improve treatment adherence and risk factor control .


However , no previous randomized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients .


The cross-sectional FOCUS ( Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention ) study ( Phase @ ) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI .


Additionally , @ patients from Phase @ were randomized into a controlled trial ( Phase @ ) to test the effect of a polypill ( containing aspirin @ mg , simvastatin @ mg , and ramipril @ , @ , or @ mg ) compared with the @ drugs given separately on adherence , blood pressure , and low-density lipoprotein cholesterol , as well as safety and tolerability over a period of @ months of follow-up .


In Phase @ , a @-country cohort of @,@ patients was analyzed .


Patients were randomized to either the polypill or @ drugs separately for Phase @ .


Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire ( MAQ ) and pill count ( patients had to meet both criteria for adherence at the in-person visit to be considered adherent ) .


In Phase @ , overall CV medication adherence , defined as an MAQ score of @ , was @ % .