In a multivariable regression model , the risk of being nonadherent ( MAQ < @ ) was associated with younger age , depression , being on a complex medication regimen , poorer health insurance coverage , and a lower level of social support , with consistent findings across countries .


In Phase @ , the polypill group showed improved adherence compared with the group receiving separate medications after @ months of follow-up : @ % versus @ % ( p = @ ; intention-to-treat population ) and @ % versus @ % ( p = @ ; per protocol population ) when using the primary endpoint , attending the final visit with MAQ = @ and high pill count ( @ % to @ % ) combined , to assess adherence .


Adherence also was higher in the FDC group when measured by MAQ alone ( @ % vs. @ % , p = @ ) .


No treatment difference was found at follow-up in mean systolic blood pressure ( @ mmHg vs. @ mmHg ) , mean low-density lipoprotein cholesterol levels ( @ mg/dl vs. @ mg/dl ) , serious adverse events ( @ vs. @ ) , or death ( @ , @ % in each group ) .


For secondary prevention following acute MI , younger age , depression , and a complex drug treatment plan are associated with lower medication adherence .


Meanwhile , adherence is increased in patients with higher insurance coverage levels and social support .


Compared with the @ drugs given separately , the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an acute MI .


( Fixed Dose Combination Drug -LSB- Polypill -RSB- for Secondary Cardiovascular Prevention -LSB- FOCUS -RSB- ; NCT@ ) .


The presence of entrapped lung changes the appropriate management of malignant pleural effusion from pleurodesis to insertion of an indwelling pleural catheter .


No methods currently exist to identify entrapped lung prior to effusion drainage .


Our objectives were to develop a method to identify entrapped lung using tissue movement and deformation ( strain ) analysis with ultrasonography and compare it to the existing technique of pleural elastance ( PEL ) .


Prior to drainage , @ patients with suspected malignant pleural effusion underwent thoracic ultrasound using an echocardiogram machine .


Images of the atelectatic lower lobe were acquired during breath hold , allowing motion and strain related to the cardiac impulse to be analyzed using motion mode ( M mode ) and speckle-tracking imaging , respectively .


PEL was measured during effusion drainage .


The gold-standard diagnosis of entrapped lung was the consensus opinion of two interventional pulmonologists according to postdrainage imaging .


Participants were randomly divided into development and validation sets .


Both total movement and strain were significantly reduced in entrapped lung .


Using data from the development set , the area under the receiver-operating curves for the diagnosis of entrapped lung was @ ( speckle tracking ) , @ ( M mode ) , and @ ( PEL ) .


Using respective cutoffs of @ % , @ mm , and @ cm H@O on the validation set , the sensitivity/specificity was @ % / @ % ( speckle tracking ) , @ % / @ % ( M mode ) , and @ % / @ % ( PEL ) .


This novel ultrasound technique can identify entrapped lung prior to effusion drainage , which could allow appropriate choice of definitive management ( pleurodesis vs indwelling catheter ) , reducing the number of interventions required to treat malignant pleural effusion .


Oral care is important for oral and systemic health , especially for elderly institutionalized individuals and compromised patients .


However , conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration .


Although antimicrobial photodynamic therapy ( aPDT ) , which is considered an alternative or adjunct to mechanical approaches , has potential application as a less stressful method of daily plaque control , no clinical application of this technique has been reported .


We investigated the inhibitory effect of a combination of toluidine blue O ( TBO ) , and a red light-emitting diode ( LED ) on dental plaque formation in healthy volunteers .


The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells .


To survey the mechanism of TBO-mediated aPDT , the quality and quantity of reactive oxygen species ( ROS ) generated during aPDT were also examined using electron spin resonance ( ESR ) spectroscopy .


Subsequently , the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study .


The right or left mandibular premolars were randomly assigned to the treatment ( with aPDT ) or control ( without aPDT ) groups .


In total , aPDT was applied six times ( twice per day ) to the teeth in the test group over a period of four days .


On the fourth day , the study concluded and the analyses were performed .


A combination of @ or @ g/ml TBO and LED irradiation for @ s significantly decreased the number of colony forming units of Streptococcus oralis .


The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity .


Hydroxyl radicals were detected by ESR analysis , but singlet oxygen was not .


A randomized controlled trial demonstrated that aPDT with @ g/ml TBO and red LED irradiation significantly suppressed dental plaque formation without harming teeth or the surrounding tissues .


aPDT has the potential to be a promising novel technical modality for dental plaque control .


Familial amyloid polyneuropathy , a lethal genetic disease caused by aggregation of variant transthyretin , induces progressive peripheral nerve deficits and disability .


Diflunisal , a nonsteroidal anti-inflammatory agent , stabilizes transthyretin tetramers and prevents amyloid fibril formation in vitro .


To determine the effect of diflunisal on polyneuropathy progression in patients with familial amyloid polyneuropathy .


International randomized , double-blind , placebo-controlled study conducted among @ patients with familial amyloid polyneuropathy exhibiting clinically detectable peripheral or autonomic neuropathy at amyloid centers in Sweden ( Ume ) , Italy ( Pavia ) , Japan ( Matsumoto and Kumamoto ) , England ( London ) , and the United States ( Boston , Massachusetts ; New York , New York ; and Rochester , Minnesota ) from @ through @ .


Participants were randomly assigned to receive diflunisal , @ mg ( n = @ ) , or placebo ( n = @ ) twice daily for @ years .


The primary end point , the difference in polyneuropathy progression between treatments , was measured by the Neuropathy Impairment Score plus @ nerve tests ( NIS +@ ) which ranges from @ ( no neurological deficits ) to @ points ( no detectable peripheral nerve function ) .


Secondary outcomes included a quality-of-life questionnaire ( @-Item Short-Form Health Survey -LSB- SF-@ -RSB- ) and modified body mass index .


Because of attrition , we used likelihood-based modeling and multiple imputation analysis of baseline to @-year data .


By multiple imputation , the NIS +@ score increased by @ ( @ % CI , @-@ @ ) points in the placebo group and by @ ( @ % CI , @-@ @ ) points in the diflunisal group , a difference of @ points ( @ % CI , @-@ @ points ; P < @ ) .


Mean SF-@ physical scores decreased by @ ( @ % CI , -@ to -@ ) points in the placebo group and increased by @ ( @ % CI , -@ to @ ) points in the diflunisal group ( P < @ ) .


Mean SF-@ mental scores declined by @ ( @ % CI , -@ to @ ) points in the placebo group while increasing by @ ( @ % CI , @-@ @ ) points in the diflunisal group ( P = @ ) .


By responder analysis , @ % of the diflunisal group and @ % of the placebo group exhibited neurological stability at @ years ( < @-point increase in NIS +@ score ; P = @ ) .


Among patients with familial amyloid polyneuropathy , the use of diflunisal compared with placebo for @ years reduced the rate of progression of neurological impairment and preserved quality of life .


Although longer-term follow-up studies are needed , these findings suggest benefit of this treatment for familial amyloid polyneuropathy .


It has been known that ADH@B * @ allele has a protective effect against the development of alcohol dependence .


However , the protection mechanism is still unknown .


We investigated whether ADH@B gene polymorphism affects ethanol ( EtOH ) metabolism .


In a parent study , we conducted a randomized crossover trials on @ healthy male subjects who were selected by genotyping : @ with ALDH@ * @ / * @ ( active form ) and @ with ALDH@ * @ / * @ ( inactive form ) .


In the present study , the @ subjects were reclassified into @ groups of @ with ADH@B * @ / * @ and @ with ADH@B * @ / * @ according to the ADH@B genotypes .


Each subject was administered @ of @ doses of EtOH ( @ , @ , @ g/kg ) or a placebo in @ trials .


After the administration of alcohol , blood EtOH and acetaldehyde concentrations were measured @ times over @ hours .


In the case of EtOH , the area under the concentration-time curve from @ to @ hours ( AUC@-@ ) and the peak blood concentration of EtOH ( Cmax ) in subjects with ADH@B * @ / * @ were significantly higher than those in subjects with ADH@B * @ / * @ at all @ dosages before stratifying by ALDH@ genotype .


However , after stratifying by ALDH@ genotype , a statistically significant difference between ADH@B * @ / * @ and ADH@B * @ / * @ was found only at the @ g/kg dosage regardless of ALDH@ genotype .


In the case of acetaldehyde , the AUC@-@ and Cmax of acetaldehyde of ADH@B * @ / * @ after administration of @ g/kg alcohol and the AUC@-@ of acetaldehyde of ADH@B * @ / * @ at @ g/kg were significantly higher than corresponding values of ADH@B * @ / * @ only in the group of ALDH@ * @ / * @ .


Our findings indicate that the blood EtOH concentrations of ADH@B * @ / * @ group are higher than those of ADH@B * @ / * @ group regardless of ALDH@ genotype , and the blood acetaldehyde concentrations of ADH@B * @ / * @ are also higher than those of ADH@B * @ / * @ only in the ALDH@ * @ / * @ group .


To our knowledge , this is the first report to demonstrate the association of ADH@B * @ allele with blood EtOH and acetaldehyde levels in humans , and these results suggest that higher blood EtOH and acetaldehyde concentrations in ADH@B * @ / * @ may constitute the mechanism of protection against alcoholism by ADH@B * @ / * @ .


Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition .


The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital .


However , the majority of patients with chronic kidney disease are managed by their general practitioners in the community .


It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting .


The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage @ chronic kidney disease in the primary care setting .


STOP-CKD is a multicentre , prospective , randomized , double-blind , placebo-controlled pilot trial of @ adult patients with stage @ chronic kidney disease recruited from up to @ general practices in South Birmingham , England .


Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone @mg once daily or a matching inactive placebo for @weeks , followed by a wash-out period of @weeks .


Investigators , outcome assessors , data analysts and participants will all be blinded to the treatment allocation .


The primary endpoint is improved arterial stiffness , as measured by carotid-femoral pulse wave velocity between baseline and @weeks .


The secondary endpoints are incidence of hyperkalaemia , change in estimated glomerular filtration rate , change in urine albumin : creatinine ratio , change in brachial blood pressure , change in pulse waveform characteristics and overall tolerability of spironolactone .


An additional quality control study , aiming to compare the laboratory serum potassium results of samples processed via two methods ( utilizing routine transport or centrifugation on site before rapid transport to the laboratory ) for @ participants and a qualitative research study exploring patients ' and general practitioners ' attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study .


Herpes simplex virus type @ ( HSV-@ ) biomarkers are often used in adolescent sub-Saharan HIV prevention studies , but evaluations of test performance and disclosure outcomes are rare in the published literature .


Therefore , we investigated the proportion of ELISA-positive and indeterminate samples confirmed by western blot ( WB ) , the psychosocial response to disclosure and whether reports of sexual behaviour and HSV-@ symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya .


In @ , @ Kenyan orphan youth in grades @ and @ enrolled in an HIV prevention clinical trial with HSV-@ biomarker outcomes .


We used a modified algorithm for the Kalon HSV-@ ELISA to improve specificity ; positive and indeterminate results were WB tested .


We developed culturally sensitive protocols for disclosing positive results , and documented psychosocial responses , reports of sexual contact and HSV-@ symptoms .


@ adolescents ( @ % ) were identified as HSV-@ seropositive , six as indeterminate .


Of these , @ positive and all indeterminates were WB tested ; @ and @ , respectively , were confirmed positive .


Most youth reported moderate brief stress after disclosure ; @ % reported longer and more severe distress .


Boys were more likely to be in the latter category .


Self-reported virginity was highly inconsistent with WB-confirmed positives .


The higher than manufacturer 's cut-off for Kalon ELISA modestly reduced the rate of false-positive test results , but also increased false negatives .


Investigators should consider the risk : benefit ratio in deciding whether or not to disclose HSV-@ results to adolescent participants under specific field conditions .


We investigated and compared the effects of @ different types of upper extremity exercise training on upper extremity function , strength , endurance , and ambulation in patients with early-stage Duchenne muscular dystrophy ( DMD ) .


The study group ( n = @ ) exercised with an arm ergometer under the supervision of a physiotherapist , whereas the control group ( n = @ ) underwent a strengthening range-of-motion ( ROM ) exercise program under the supervision of their families at home for @ weeks .


Upper extremity functional performance , strength , endurance , and ambulatory status were assessed before and after the training .


Ambulation scores , endurance , and arm functions , as well as proximal muscle strength , were improved after the training in the study group ( P < @ ) .


These results demonstrate that upper extremity training with an arm ergometer is more effective in preserving and improving the functional level of early-stage DMD patients compared to ROM exercises alone .


To evaluate whether follow-up of patients with obstructive sleep apnoea ( OSA ) undergoing CPAP treatment could be performed in primary care ( PC ) settings .


Non-inferiority , randomised , prospective controlled study .


Sleep unit ( SU ) at the University Hospital and in @ PC units in Lleida , Spain .


Patients with OSA were randomised to be followed up at the SU or PC units over a @-month period .


The primary outcome was CPAP compliance at @months .


The secondary outcomes were Epworth Sleep Scale ( ESS ) score , EuroQoL , patient satisfaction , body mass index ( BMI ) , blood pressure and cost-effectiveness .


We included @ patients in PC ( ( meanSD ) apnoea-hypopnoea index ( AHI ) @ / h , age @ years , @ % male ) and @ in the SU ( AHI @ / h , age @ years , @ % male ) ) .


The CPAP compliance was ( mean ( @ % CI ) @ ( @ to @ ) vs @ ( @ to @ ) h , p = @ ) in PC and SU groups , respectively .


In the SU group , there were greater improvements in ESS scores ( mean change @ , @ % CI +@ to +@ , p = @ ) and patient satisfaction ( -@ , @ % CI -@ to -@ ) ; there was a significant mean difference in BMI between the groups ( @ , @ % CI +@ to +@ , p = @ ) .


In the PC setting , there was a cost saving of @ % , with similar effectiveness , as well as a decrease in systolic blood pressure ( -@ ; @ % CI -@ to +@ , p = @ ) .


For patients with OSA , treatment provided in a PC setting did not result in worse CPAP compliance compared with a specialist model and was shown to be a cost-effective alternative .


Japanese encephalitis ( JE ) is a vaccine-preventable acute disease .


We report the results of a phase @/@ trial of JENVAC , a Vero cell-derived vaccine developed using an Indian strain of JE virus ( JEV ) .


JENVAC was administered in @ doses @ days apart , and immunogenicity was compared to that from a single dose of SA-@-@-@ , the only approved JE vaccine and regimen at the time in India .


After both the doses , seroconversion and seroprotection were > @ % for JENVAC .


For SA-@-@-@ , seroconversion and seroprotection were @ % and @ % , respectively , on day @ and @ % and @ % , respectively , on day @ .


The geometric mean titers at day @ and day @ were @ and @ , respectively , for JENVAC and @ and @ , respectively , for SA-@-@-@ .


With a single dose of JENVAC , seroprotection titers lasted at least @ months in > @ % of the subjects .


Following receipt of @ doses , @ % of subjects retained seroprotection titers at @ months , and immunogenicity criteria were higher than that for SA-@-@-@ at @ , @ , and @ months each .


Sera from JENVAC subjects neutralized JEV genotypes I , II , III , and IV equally well .


Adverse events were not significantly different between the @ vaccines .


JENVAC elicits long-lasting , broadly protective immunity .


Experimental studies suggest that pretreatment with - agonists might prevent acute lung injury ( ALI ) .


To determine if in adult patients undergoing elective esophagectomy , perioperative treatment with inhaled - agonists effects the development of early ALI .


We conducted a randomized placebo-controlled trial in @ UK centers ( @-@ ) .


Adult patients undergoing elective esophagectomy were allocated to prerandomized , sequentially numbered treatment packs containing inhaled salmeterol ( @ g twice daily ) or a matching placebo .


Patients , clinicians , and researchers were masked to treatment allocation .


The primary outcome was development of ALI within @ hours of surgery .


Secondary outcomes were ALI within @ days , organ failure , adverse events , survival , and health-related quality of life .


An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury .


A total of @ patients were randomized to salmeterol and @ to placebo .


Baseline characteristics were similar .


Treatment with salmeterol did not prevent early lung injury ( @ -LSB- @ % -RSB- of @ vs. @ -LSB- @ % -RSB- of @ ; odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) .


There was no difference in organ failure , survival , or health-related quality of life .


Adverse events were less frequent in the salmeterol group ( @ vs. @ ; OR , @ ; @ % CI , @-@ @ ) , predominantly because of a lower number of pneumonia ( @ vs. @ ; OR , @ ; @ % CI , @-@ @ ) .


Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury .


Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI .


Clinical trial registered with International Standard Randomized Controlled Trial Register ( ISRCTN@ ) and European Union database of randomized Controlled Trials ( EudraCT @-@-@ ) .


To evaluate the clinical outcome of sonic endo-instruments in combination with Mtwo Ni-Ti files in root canal preparation of molars .


One hundred patients ( @ first molars , @ root canals ) were included in this study , they were randomly assigned into @ groups ( n = @ ) .


Group @ was shaped with sonic endo-instruments in combination with Mtwo Ni-Ti files , while group @ was treated with stainless-steel files , both groups were obturated with lateral condensation technique .


The time of root canal shaping , acute post-operative pain , the quality of the root canal filling and the success rate after @ year were recorded and analyzed using SPSS @ software package .


The average preparation time in group @ was ( @ ) min/canal and ( @ ) min/canal in group @ ( t = @ , P < @ ) .


The rate of acute postoperative pain was significantly lower X ( @ ) = @ , P < @ , in group @ ( @ % ) than in group @ ( @ % ) ; in group @ , @ % root canals were filled adequately while only @ % in group @ , the difference was significant ( X ( @ ) = @ , P < @ ) ; higher success rate ( X ( @ ) = @ , P < @ ) after @ year was achieved in group @ ( @ % ) compared with group @ ( @ % ) .


Compared with stainless-steel files , sonic endo instruments in combination with Mtwo Ni-Ti files in root canal preparation of molars seem more effective , cause less postoperative pain and offer higher success rates .


To determine which patients respond best to stereotactic radiotherapy ( SRT ) for neovascular age-related macular degeneration .


Participants ( n = @ ) receiving intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration enrolled in a randomized , double-masked sham-controlled trial comparing @ Gray , @ Gray , or Sham SRT .


In a post hoc analysis , participants were grouped according to their baseline characteristics , to determine if these influenced SRT efficacy .


At @ weeks , SRT was most effective for lesions @ mm in greatest linear dimension and with a macular volume greater than the median value of @ mm .


For @ % of the participants with both these characteristics , SRT resulted in @ % fewer ranibizumab injections ( @ vs. @ ; P = @ ) , a mean visual acuity change that was @ letters superior to sham ( +@ vs. -@ letters ; P = @ ) , and a @-m greater reduction in mean central subfield thickness ( -@ vs. -@ m ; P = @ ) .


Other features associated with a positive response to SRT included pigment epithelial detachment and the absence of fibrosis .


Stereotactic radiotherapy is most effective for neovascular age-related macular degeneration lesions that are actively leaking at the time of treatment , and no larger than the @-mm treatment zone .


To evaluate the efficacy of a stand-alone personalized normative feedback ( PNF ) intervention targeting misperceptions of gambling among college students .


Undergraduates ( N = @ ; @ % male ) who reported gambling in the past @ days were recruited between September @ and March @ .


Using a randomized clinical trial design , participants were assigned to receive either PNF or an attention control task .


In addition to self-report , this study used @ computer-based risk tasks framed as `` gambling opportunities '' to assess cognitive and behavioral change at @ week post intervention .


After @ week , participants receiving PNF showed a marked decrease in perception of other students ' gambling , and evinced lower risk-taking performance on @ analog measures of gambling .


Changes in both self-reported perceived norms and analog gambling behavior suggest that a single , stand-alone PNF intervention may modify gambling among college students .


Whether it can impact gambling outside of the laboratory remains untested .


To evaluate interobserver agreement and time-trend in chest CT assessment of emphysema , airways , and interstitial abnormalities in a lung cancer screening cohort .


Visual assessment of baseline and fifth-year examination of @ participants was performed independently by two observers .


Results were standardised by means of an electronic score sheet ; kappa and time-trend analyses were performed .


Interobserver agreement was substantial in early emphysema diagnosis ; highly significant ( p < @ ) time-trends in both emphysema presence and grading were found ( higher prevalence and grade of emphysema in late CT examinations ) .


Significant progression in emphysema was seen in continuous smokers , but not in former smokers .


Agreement on centrilobular emphysema subtype was substantial ; agreement on paraseptal subtype , moderate .


Agreement on panlobular and mixed subtypes was only fair .


Agreement was fair regarding airway analysis .


Interstitial abnormalities were infrequent in the cohort , and agreement on these was fair to moderate .


A highly significant time-trend was found regarding interstitial abnormalities , which were more frequent in late examinations .


Visual scoring of chest CT is able to characterise the presence , pattern , and progression of early emphysema .


Continuous smokers progress ; former smokers do not .


Substantial interobserver consistency in determining early-stage emphysema in low-dose CT. .


Longitudinal analyses show clear time-trends for emphysema presence and grading .


For continuous smokers , progression of emphysema was seen in all lung zones .


For former smokers , progression of emphysema was undetectable by visual assessment .


Onset and progression of interstitial abnormalities are visually detectable .


Aortic root management in type A acute aortic dissection is controversial .


This study compared outcomes of root replacement ( RR ) interventions versus more conservative root ( CR ) management .


Of @,@ type A acute aortic dissection patients enrolled in the International Registry of Acute Aortic Dissection , @ ( @ % ) underwent RR interventions and @,@ ( @ % ) underwent CR management .


Independent predictors of hospital and @-year survival were identified using multivariable logistic and Cox regression models .


Compared with CR patients , RR patients were younger ( @ versus @ years ; p = @ ) and more likely to present with larger root diameter ( @ cm versus @ cm ; p < @ ) , Marfan syndrome ( @ % versus @ % ; p < @ ) , aortic insufficiency ( @ % versus @ % ; p < @ ) , and hypotension , shock , or tamponade ( @ % versus @ % ; p = @ ) .


Root replacement management did not increase hospital mortality ( propensity score-adjusted odds ratio , @ ; p = @ ) .


On Kaplan-Meier analysis , @-year survival ( RR , @ % @ % versus CR , @ % @ % ; log-rank p = @ ) and freedom from aortic root reintervention ( RR , @ % @ % versus CR ,@ % @ % ; log-rank p = @ ) were similar .


Only @ patients ( @ per group ) underwent follow-up root reintervention .


Propensity score-adjusted Cox regression excluded a relationship between root treatment and follow-up survival ( hazard ratio , @ ; @ % confidence interval , @ to @ ; p = @ ) .


In type A acute aortic dissection patients more-extensive RR interventions are not associated withincreased hospital mortality .


This supports such anapproach in young patients and patients with connective tissue diseases and bicuspid aortic valves .


Excellent midterm survival and freedom from root reintervention in both groups suggest stable behavior of the nonreplaced aortic sinuses at @ years .


Thus , pending studies with longer follow-up , the use of aggressive RR techniques can be determined by patient-specific and dissection-related factors .


To identify clinical conditions associated with a large increase ( spike ) in the heart rate characteristics index in very low birth weight ( VLBW ) infants .


Retrospective medical record review within a day of all large heart rate characteristics index spikes ( increase of @ from the previous @-day average ) in VLBW infants at a single center enrolled from @ to @ in a multicenter trial of heart rate characteristics monitoring .


In the trial , infants were randomized to having their heart rate characteristics index displayed to clinicians or not displayed .


Of @ eligible infants , @ large heart rate characteristics spikes occurred in @ infants .


Thirty-three spikes were associated with surgery or procedures requiring anesthetic or anticholinergic medications , and infection-related conditions were the most common clinical association with the other spikes .


Of the first spikes in @ infants randomized to conventional monitoring ( heart rate characteristics index not displayed to clinicians ) , @ % were associated with suspected or proven infection .


Respiratory deterioration without suspected infection occurred with @ % , and no association was identified in @ % .


Infants randomized to having their heart rate characteristics index displayed were more likely to have antibiotics initiated around the time of a large heart rate characteristics index spike .


Sepsis , other infectious or systemic inflammatory conditions , respiratory deterioration , and surgical procedures are the most common clinical associations with a large increase in the heart rate characteristics index in VLBW infants .


This information may improve use of heart rate characteristics monitors in patients in the neonatal intensive care unit .


Small studies suggest peanut oral immunotherapy ( OIT ) might be effective in the treatment of peanut allergy .


We aimed to establish the efficacy of OIT for the desensitisation of children with allergy to peanuts .


We did a randomised controlled crossover trial to compare the efficacy of active OIT ( using characterised peanut flour ; protein doses of @-@ mg/day ) with control ( peanut avoidance , the present standard of care ) at the NIHR/Wellcome Trust Cambridge Clinical Research Facility ( Cambridge , UK ) .


Randomisation ( @:@ ) was by use of an audited online system ; group allocation was not masked .


Eligible participants were aged @-@ years with an immediate hypersensitivity reaction after peanut ingestion , positive skin prick test to peanuts , and positive by double-blind placebo-controlled food challenge ( DBPCFC ) .


We excluded participants if they had a major chronic illness , if the care provider or a present household member had suspected or diagnosed allergy to peanuts , or if there was an unwillingness or inability to comply with study procedures .


Our primary outcome was desensitisation , defined as negative peanut challenge ( @ mg protein in DBPCFC ) at @ months ( first phase ) .


Control participants underwent OIT during the second phase , with subsequent DBPCFC .


Immunological parameters and disease-specific quality-of-life scores were measured .


Analysis was by intention to treat .


Fisher 's exact test was used to compare the proportion of those with desensitisation to peanut after @ months between the active and control group at the end of the first phase .


This trial is registered with Current Controlled Trials , number ISRCTN@ .


The primary outcome , desensitisation , was recorded for @ % ( @ of @ participants ; @ % CI @-@ ) in the active group and none of the control group after the first phase ( @ of @ ; @ % CI @-@ ; p < @ ) .


@ % ( @ % CI @-@ ) of the active group tolerated daily ingestion of @ mg protein ( equivalent to roughly five peanuts ) .


Median increase in peanut threshold after OIT was @ mg ( range @-@ ; p < @ ) or @ times ( range @-@ ; p < @ ) .


After the second phase , @ % ( @ % CI @-@ ) tolerated @ mg challenge ( equivalent to roughly ten peanuts ) and @ % ( @-@ ) tolerated daily ingestion of @ mg protein .


Quality-of-life scores improved ( decreased ) after OIT ( median change -@ ; p < @ ) .


Side-effects were mild in most participants .


Gastrointestinal symptoms were , collectively , most common ( @ participants with nausea , @ with vomiting , and one with diarrhoea ) , then oral pruritus after @ % of doses ( @ participants ) and wheeze after @ % of doses ( @ participants ) .


Intramuscular adrenaline was used after @ % of doses ( one participant ) .


OIT successfully induced desensitisation in most children within the study population with peanut allergy of any severity , with a clinically meaningful increase in peanut threshold .


Quality of life improved after intervention and there was a good safety profile .


Immunological changes corresponded with clinical desensitisation .


Further studies in wider populations are recommended ; peanut OIT should not be done in non-specialist settings , but it is effective and well tolerated in the studied age group .


Surgery in the beach chair position ( BCP ) may reduce cerebral blood flow and oxygenation , resulting in neurological injuries .


The authors tested the hypothesis that a ventilation strategy designed to achieve end-tidal carbon dioxide ( E ' ( CO ) ) values of @-@ mm Hg would increase cerebral oxygenation ( Sct ( O ) ) during BCP shoulder surgery compared with a ventilation strategy designed to achieve E ' ( CO ) values of @-@ mm Hg .


Seventy patients undergoing shoulder surgery in the BCP with general anaesthesia were enrolled in this randomized controlled trial .


Mechanical ventilation was adjusted to maintain an E ' ( CO ) of @-@ mm Hg in the control group and an E ' ( CO ) of @-@ mm Hg in the study group .


Cerebral oxygenation was monitored continuously in the operating theatre using near-infrared spectroscopy .


Baseline haemodynamics and Sct ( O ) were obtained before induction of anaesthesia , and these values were then measured and recorded continuously from induction of anaesthesia until tracheal extubation .


The number of cerebral desaturation events ( CDEs ) ( defined as a @ % reduction in Sct ( O ) from baseline values ) was recorded .


No significant differences between the groups were observed in haemodynamic variables or phenylephrine interventions during the surgical procedure .


Sct ( O ) values were significantly higher in the study @-@ group throughout the intraoperative period ( P < @ ) .


In addition , the incidence of CDEs was lower in the study @-@ group ( @ % ) compared with the control @-@ group ( @ % , P < @ ) .


Cerebral oxygenation is significantly improved during BCP surgery when ventilation is adjusted to maintain E ' ( CO ) at @-@ mm Hg compared with @-@ mm Hg .


Prognosis of unresectable glioblastoma ( GB ) remains poor , despite temozolomide ( TMZ ) - based chemoradiation .


Activity of bevacizumab ( BEV ) and irinotecan ( IRI ) has been reported in recurrent disease .


We evaluated BEV and IRI as neo-adjuvant and adjuvant treatment combined with TMZ-based chemoradiation for unresectable GB .


Patients with unresectable GB , age @-@ , IK @ were eligible .


The experimental arm ( BEV/IRI ) consisted of neo-adjuvant intravenous BEV , @ mg/kg , and IRI , @ mg/m ( @ ) , every @ weeks for four cycles before radiotherapy ( RT ) ( @ Gy ) , concomitant oral TMZ , @ mg/m ( @ ) / day , and BEV , @ mg/kg every @ weeks .


Adjuvant BEV and IRI were given every @ weeks for @ months .


The control arm consisted of concomitant oral TMZ , @ mg/m ( @ ) / day during RT , and @-@ mg/m ( @ ) for @ days every @ days for @ months .


The use of BEV was allowed at progression in the control arm .


Patients ( @ ) were included from April @ to January @ .


The working hypothesis was that treatment would increase the progression-free survival at @ month ( PFS-@ ) from @ % to @ % .


The primary objective was not achieved , and only @ out of @ patients were alive without progression at @ months ( @ % -LSB- IC@ % ( @ ; @ ) -RSB- in the BEV/IRI arm when @ out of @ patients were required according to the Fleming decision rules .


PFS-@ was @ months in BEV/IRI versus @ months in the control arm .


The median overall survival was not different between the two arms ( @ months ) .


Main toxicities were three fatal intracranial bleedings , three bile duct or digestive perforations/infections ( @ fatal ) , and six thrombotic episodes in the BEV/IRI arm , whereas there was one intracranial bleeding , two bile duct or digestive perforations/infections ( @ fatal ) , and one thrombotic episode in the control arm .


Neo-adjuvant and adjuvant BEV/IRI , combined with TMZ-radiation , is not recommended for further evaluation in the first-line treatment of unresectable GB .


Physical therapists are well established as providers of treatments for common , painful , and disabling conditions , such as knee osteoarthritis ( OA ) .


Thus , they are well placed to deliver treatments that integrate physical and psychosocial elements .


Attention is usually given to outcomes of such programs , but few studies have examined the processes and outcomes of training physical therapists to deliver such treatments .


The aim of this study was to describe the processes in training physical therapists : ( @ ) to deliver a standardized pain coping skills treatment and ( @ ) to evaluate the effectiveness of that training .


This study was an analysis of data relating to therapist performance in a randomized clinical trial .


Eleven physical therapists were trained to deliver a @-session pain coping skills training program for people with knee OA as part of a randomized controlled trial ( N = @ ) .


The initial training was provided in a workshop format and included extensive , ongoing supervision by a psychologist and rigorous use of well-defined performance criteria to assess competence .


Adherence to the program , ratings of performance , and use of advanced skills were all measured against these criteria in a sample ( n = @ , @ % ) of the audio recordings of the intervention sessions .


Overall , the physical therapists achieved a very high standard of treatment delivery , with @ % adherence to the program and mean performance ratings all in the satisfactory range .


These results were maintained throughout the intervention and across all sessions .


Only @ % of the delivered sessions were analyzed , and the physical therapists who took part in the study were a self-selected group .


This study demonstrated that a systematic approach to training and accrediting physical therapists to deliver a standardized pain coping skills program can result in high and sustained levels of adherence to the program .


Training fidelity was achieved in this group of motivated clinicians , but the supervision provided was time intensive .


The data provide a promising indicator of greater potential for psychologically informed practice to be a feature of effective health care .


Venous thromboembolism ( VTE ) prophylaxis remains debated following trauma , and recommendations have not been established .


Although hyperfibrinogenemia is a marker of proinflammatory states , it also contributes to thrombus formation .


Postinjury hyperfibrinogenemia is common , but the effect of hyperfibrinogenemia on VTE prophylaxis has not been fully elucidated .


Therefore , we hypothesized that heparin is less effective for VTE prophylaxis following severe injury due to hyperfibrinogenemia .


In vitro studies evaluated thromboelastography ( TEG ) parameters in @ healthy volunteers after the addition of fibrinogen concentrate and heparin .


Data from a recent randomized controlled trial , conducted at an academic level I trauma center surgical intensive care unit , were reviewed .


Critically injured patients were randomized to standard VTE prophylaxis ( @,@ U low-molecular-weight heparin daily ) or TEG-guided prophylaxis ( up to @,@ U low-molecular-weight heparin daily ) and were followed up for @ days .


Analysis was performed to evaluate the relationship between fibrinogen levels , measures of anticoagulation , and TEG parameters .


In vitro studies revealed increased fibrinogen reversed the effects of heparin as measured by TEG .


Fifty patients were enrolled in the clinical study with @ in each arm .


Thromboelastography parameters , fibrinogen , platelet count , and anti-Xa levels did not differ between groups despite treatment provided .


Fibrinogen levels increased over the @-day study period ( @ @ to @ @ ) , as well as clot strength ( @ @ to @ @ ) , which had a significant correlation coefficient ( P < @ ) .


Moreover , there was a moderate inverse correlation between fibrinogen level and the effect of heparin ( RF ) , which was significant on study days @ and @ , implicating hyperfibrinogenemia in heparin resistance .


Hypercoagulability and heparin resistance are common following trauma .


The preclinical and clinical relationships between fibrinogen levels and hypercoagulability implicate hyperfibrinogenemia as a potential factor in heparin resistance .


( Primary ) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use .


Multi-method randomised control trial ( RCT ) .


Three NHS Trusts .


Nulliparous women not planning elective caesarean , without medication for hypertension and without psychological illness .


Randomisation at @-@ weeks ' gestation to usual care , or to usual care plus brief self-hypnosis training ( two @-minute groups at around @ and @ weeks ' gestation ; daily audio self-hypnosis CD ) .


Follow up at @ and @ weeks postnatal .


Primary : epidural analgesia .


Secondary : associated clinical and psychological outcomes ; cost analysis .


Six hundred and eighty women were randomised .


There was no statistically significant difference in epidural use : @ % ( intervention ) , @ % ( control ) , odds ratio ( OR ) @ -LSB- @ % confidence interval ( CI ) : @-@ @ -RSB- , or in @ of @ pre-specified secondary clinical and psychological outcomes .


Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and @ weeks post natal ( anxiety : mean difference -@ , @ % CI -@ to -@ , P = @ ) ; fear ( mean difference -@ , @ % CI -@ to -@ , P = @ ) -LSB- Correction added on @ July @ , after first online publication : ` Mean difference ' replaced ` Odds ratio ( OR ) ' in the preceding sentence . -RSB-


Postnatal response rates were @ % overall at @ weeks .


The additional cost in the intervention arm per woman was @ ( CI -@ to @ ) .


Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables .


The impact of women 's anxiety and fear about childbirth needs further investigation .


The aim of this prospective randomized trial was to test the null hypothesis that there was no difference in the percentage of the fracture line of scaphoid waist fractures that demonstrated bridging bone on computed tomography ( CT ) @ weeks after injury between patients treated in a below-elbow cast including or excluding the thumb .


A total of @ patients with a CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fracture of the scaphoid were enrolled in a prospective , multicenter , randomized trial comparing treatment in a below-elbow cast including or excluding the thumb .


There were @ waist and @ distal fractures ( owing to a miscommunication at @ of the centers ) .


We adhered to intention-to-treat principles .


The primary outcome was the extent of union on CT performed after @ weeks of cast treatment , expressed as a percentage of the fracture line that had bridging bone , determined by musculoskeletal radiologists blinded to treatment .


Secondary study outcomes included wrist motion ; grip strength ; the Mayo Modified Wrist Score ; the Disabilities of the Arm , Shoulder and Hand score ; a visual analog scale for pain ; and radiographic union at @ months after injury .


There was a significant difference in the average extent of union on CT at @ weeks ( @ % vs @ % ) favoring treatment with a cast excluding the thumb .


The overall union rate was @ % .


The @ exception was a patient in the thumb immobilization group who elected operative treatment @ week after enrollment , used crutches , and failed to heal .


There were no significant differences between groups for wrist motion ; grip strength ; Mayo Modified Wrist Score ; Disabilities of the Arm , Shoulder , and Hand score ; or pain intensity .


Immobilization of the thumb appears unnecessary for CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fractures of the waist of the scaphoid .


This study will evaluate hypoxia , as a novel concept in the pathogenesis of diabetic macular oedema ( DMO ) .


As the oxygen demand of the eye is maximum during dark-adaptation , we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO .


The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis .


This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO .


Three hundred patients with non-centre-involving DMO in at least one eye will be randomised @:@ to light-masks and control masks ( with no light ) to be used during sleep at night for a period of @ months .


The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography ( SD-OCT ) .


Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula , macular volume , refracted visual acuity and level of retinopathy .


Safety parameters will include sleep disturbance .


Adverse events and measures of compliance will be assessed over @ months .


Participants recruited to the mechanistic sub-study will have additional retinal oximetry , multifocal electroretinography ( ERG ) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at @ months .


The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple , non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes .


Pain is the primary complaint and the main reason for prolonged recovery after laparoscopic cholecystectomy .


The authors hypothesized that patients undergoing laparoscopic cholecystectomy will have less pain four hours after surgery when receiving maintenance of anesthesia with propofol when compared to isoflurane , desflurane , or sevoflurane .


In this prospective , randomized trial , @ patients scheduled for laparoscopic cholecystectomy were assigned to propofol , isoflurane , desflurane , or sevoflurane for the maintenance of anesthesia .


Our primary outcome was pain measured on the numeric analog scale four hours after surgery .


We also recorded intraoperative use of opioids as well as analgesic consumption during the first @h after surgery .


There was no statistically significant difference in pain scores four hours after surgery ( p = @ ) .


There were also no statistically significant differences in pain scores between treatment groups during the @h after surgery ( p = @ ) .


Intraoperative use of fentanyl and morphine did not vary significantly among the groups ( p = @ and @ , respectively ) .


There were no differences in total morphine and hydrocodone/APAP use during the first @h ( p = @ and @ , respectively ) .


Patients receiving maintenance of general anesthesia with propofol do not have less pain after laparoscopic cholecystectomy when compared to isoflurane , desflurane , or sevoflurane .


The aim of this study was twofold : First , to assess the personality profile of treatment-seeking adult outpatients with pathological gambling compared to a matched control group under the Alternative Five Factor Model perspective , and second , to determine which personality variables would predict treatment outcome .


The final total sample consisted of @ consecutive treatment-seeking pathological gamblers ( PGs ) and @ controls paired by age and sex who completed the Zuckerman-Kuhlman Personality Questionnaire ( ZKPQ ) .


Twelve months after starting an open program of individual cognitive-behavioral therapy , PGs were categorized as abstinent or treatment failure .


PGs scored significantly higher on Neuroticism-Anxiety .


Those who had relapsed or dropped out showed higher Impulsivity and Sensation Seeking scores .


Impulsivity emerged as a significant predictor of treatment failure .


Treatment-seeking PGs scored higher on Neuroticism-Anxiety and Impulsivity appeared as a risk factor of relapsing or dropping out .


Our findings support the importance of individual differences in personality on therapy outcomes .


The ZKPQ may constitute a useful tool to identify these individual differences that might be considered when making personalized treatment decisions to improve the effectiveness and quality of treatment interventions .


The purpose of this study was to determine whether a difference exists in learner performance and the type and frequency of diagnostic reasoning skills used , based on the method of case presentation .


Faculty can select from a variety of methods for presenting cases when teaching diagnostic reasoning , but little evidence exists with regard to how students use these skills while interacting with the cases .


A total of @ nursing students participated in two case analyses using human patient and computer-based simulations .


Participant performance and diagnostic reasoning skills were analyzed .


Performance was significantly better with the human patient simulation case .


All diagnostic reasoning skills were used during both methods of case presentation , with greater performance variation in the computer-based simulation .


Both human patient and computer-based simulations are beneficial for practicing diagnostic reasoning skills ; however , these findings support the use of human patient simulations for improving student performance in case synthesis .


Given the limitations of prostate specific antigen and standard biopsies for detecting prostate cancer , we evaluated the cancer detection rate and external validity of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system used at the National Institutes of Health .


We performed a phase III trial of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system with participants enrolled between @ and @ .


A total of @ men consented to the study and underwent @ Tesla multiparametric magnetic resonance imaging with an endorectal coil for clinical suspicion of prostate cancer .


Lesions were classified as low or moderate/high risk for prostate cancer .


Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and standard @-core prostate biopsy were performed and @ men were eligible for analysis .


Mean patient age was @ years and mean prostate specific antigen was @ ng/ml .


The overall cancer detection rate was @ % ( @ of @ patients ) .


The cancer detection rate in those with moderate/high risk on imaging was @ % ( @ of @ ) vs @ % ( @ of @ ) in those classified as low risk for prostate cancer ( p < @ ) .


Mean tumor core length was @ and @ mm for fusion biopsy and standard @-core biopsy , respectively ( p < @ ) .


Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy detected prostate cancer that was missed by standard @-core biopsy in @ % of cases ( @ of @ ) , of which @ % ( @ of @ ) were clinically significant .


This biopsy upgraded @ % of cancers ( @ of @ ) deemed clinically insignificant on @-core biopsy to clinically significant prostate cancer necessitating treatment .


Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy can improve prostate cancer detection .


The results of this trial support the external validity of this platform and may be the next step in the evolution of prostate cancer management .


Febuxostat , a novel non-purine selective inhibitor of xanthine oxidase , has been identified as a potential alternative to allopurinol in patients with hyperuricemia .


The purpose of this study was to compare the urate-lowering ( UL ) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia .


Gout patients ( n = @ ) with serum uric acid ( sUA ) concentrations of at least @ mg/dL were randomized to receive daily febuxostat @mg or @mg or allopurinol @mg for @weeks .


Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks @ through @ .


The primary endpoint was the percentage of subjects achieving a sUA concentration of < @ mg/dL at the last three monthly measurements .


The primary endpoint was reached in @ % of patients receiving @mg of febuxostat , @ % of those receiving @mg of febuxostat , and @ % of those receiving allopurinol .


The UL efficacy in the febuxostat @mg group was higher than in the allopurinol ( P < @ ) and febuxostat @mg ( P = @ ) groups .


The UL efficacy of the febuxostat @mg group was statistically non-inferior to that of the allopurinol group .


No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group .


The rate of gout flares requiring treatment from weeks @ through @ and the incidence of adverse events was similar among treatment groups .


The UL efficacy of daily febuxostat @mg was greater than that of febuxostat @mg and allopurinol @mg , which exhibited comparable UL efficacy .


Safety of febuxostat and allopurinol was comparable at the doses tested .


Effective functioning of the neurotransmitter serotonin is important for optimal cognitive and emotional function .


Dietary supplements able to increase availability to the brain of the precursor amino acid , tryptophan ( TRP ) , and thereby enhance serotonin synthesis , can have measurable impact on these psychological processes .


This study involves a randomised controlled trial of a TRP-rich egg-white protein hydrolysate ( DSM Nutritional Products Ltd. , Switzerland ) on plasma amino acids , cognition , mood and emotional processing in older women .


Following a baseline test day without treatment , @ healthy women aged @-@ years received drinks containing either @ or @ g of TRP-rich protein hydrolysate product or @ g casein hydrolysate as a control .


One hour later , they undertook a @-h battery of cognitive and emotional tests .


The TRP-rich protein hydrolysate produced the expected dose-dependent increase in the ratio of plasma TRP to competing large neutral amino acids .


TRP-rich protein hydrolysate ( @ g only ) prevented both the decline in wellbeing and increase in fatigue seen over the test session in the control group .


This treatment dose resulted in a significant shift in emotional processing towards positive words and reduced negative bias in assessing negative facial expressions .


Effects on cognition were small and not statistically reliable and are not reported here .


However , there was no evidence for any adverse effects .


Consumption of a low dose of TRP-rich protein hydrolysate may have beneficial effects on emotional function that could promote feelings of wellbeing , possibly conferring resistance to deterioration in mood in healthy subjects or depressive episodes .


There is concern that combining energy drinks with alcohol may ` mask ' subjective intoxication leading to greater alcohol consumption .


This study examines the effects of alcohol alone and combined with energy drink on objective and subjective intoxication and mood over the course of @h .


Using a double-blind , placebo-controlled , balanced , crossover design , @ participants ( mean age @ years ) were administered with double placebo , @ g/kg alcohol ( mean peak blood alcohol content of @ % ) , @ml energy drink and alcohol/energy drink , according to a Latin square design , with a washout of > @h .


On each visit , they were breathalysed and rated themselves on a comprehensive battery of mood items at baseline and then at @ , @ and @min post-drink .


Blood alcohol and subjective intoxication were significantly increased following both alcohol alone and alcohol/energy drink .


Both measures were statistically indistinguishable between alcohol conditions .


In keeping with its ( @mg ) caffeine content , the energy drink alone significantly increased self-rated ` alertness ' and reduced ` depression-dejection ' scores compared with the combined alcohol/energy drink .


The alcohol/energy drink increased ` vigor ' and ` contentment ' at @min and decreased ` contentment ' at @min .


The co-ingestion of an energy drink with alcohol does not differently influence blood alcohol content recordings or subjective intoxication compared with alcohol alone , although some mood items are differentially affected .


Simethicone and N-acetylcysteine have been widely used in improving endoscopic visibility .


However , the optimal dose , volume , and dosing time for the premedication regimen are still unclear .


Our aim was to assess the efficacy of premedication in improving endoscopic visibility and determine the contributions of dose , volume , and premedication time .


A total of @ patients were prospectively treated in three groups : group A : @-mg simethicone suspension in @ mL water ; group B : @-mg simethicone suspension in @ mL water ; and group C : @-mg simethicone suspension in @ mL water containing @ mg N-acetylcysteine .


Mucosa visibility was assessed at seven sites of upper gastrointestinal tract .


The sum of scores was considered as total mucosal visibility score ( TMVS ) .


The upper body of stomach had the worst visibility score for all groups .


TMVS of groups B and C were significantly lower than those of group A. Group C had a significantly fewer patients requiring endoscopic flushing than groups A and B.


The TMVS for groups B and C were significantly lower than for group A within @ min of beginning premedication .


Beyond @ min of premedication , there was no significant difference in the TMVS among groups .


Premedication using @ mg simethicone in @ mL of water improves endoscopic visibility .


Addition of N-acetylcysteine to simethicone in @ mL of water reduces the need for endoscopic flushing .


For patients unable to tolerate a large fluid volume , a @-mL simethicone suspension administered more than @ min prior to upper endoscopy is suggested .


The aim of this study was to evaluate the remineralization effect of Casein Phosphopeptid Amorphous Calcium Phosphate ( CPP-ACP ) on white spot lesions ( WSL ) and its inhibitory effect on Streptococcus mutans colonization .


The study group consisted of @ children exhibiting at least @-WSL .


Subjects were randomly divided into @ groups : a test group of using CPP-ACP cream ( Tooth Mousse , GC Europe N.V. , Leuven , Belgium ) and a control group using only fluoride containing toothpaste for a period of @-months .


Baseline WSLs were scored using DIAGNOdent device ( KaVo Germany ) and the saliva samples were collected to measure S. mutans counts .


After the @-month period the WSLs were again recorded and the saliva sample collection was repeated .


Wilcoxon Signed Ranks Test was used for statistical analysis .


DIAGNOdent measurements were increased by time ( p = @ ) in control group and no statistically significant diference ( p = @ ) was found in test group by the @-month period .


In both groups , the mutans counts were decreased in @-month experimental period .


These clinical and laboratory results suggested that CPP-ACP containing cream had a slight remineralization effect on the WSL in the @-month evaluation period however longer observation is recommended to confirm whether the greater change in WSLs is maintained .


The endomyocardial biopsy ( EMB ) is considered the gold standard in rejection surveillance post cardiac transplant , but is invasive , with risk of complications .


A previous trial suggested that the gene expression profiling ( GEP ) blood test was noninferior to EMB between @ and @ months post transplant .


As most rejections occur in the first @ months , we conducted a single-center randomized trial of GEP versus EMB starting at @ days post transplant ( when GEP is valid ) .


Sixty heart transplant patients meeting inclusion criteria were randomized beginning at @ days post transplant to either GEP or EMB arms .


A positive GEP @ between @ and @ months , or @ after @ months , prompted a follow-up biopsy .


The primary end point included a composite of death/retransplant , rejection with hemodynamic compromise or graft dysfunction at @ months post transplant .


A coprimary end point included change in first-year maximal intimal thickness by intravascular ultrasound , a recognized surrogate for long-term outcome .


Corticosteroid weaning was assessed in both the groups .


The composite end point was similar between the GEP and EMB groups ( @ % versus @ % ; log-rank P = @ ) .


The coprimary end point of first-year intravascular ultrasound change demonstrated no difference in mean maximal intimal thickness ( @ versus @ mm ; P = @ ) .


Steroid weaning was successful in both the groups ( @ % versus @ % ) .


In this pilot study , GEP starting at @ days post transplant seems comparable with EMB for rejection surveillance in selected heart transplant patients and does not result in increased adverse outcomes .


GEP also seems useful to guide corticosteroid weaning .


Larger randomized trials are required to confirm these findings .


Short-term advantages to laparoscopic surgery are well described .


This study compared medium - to long-term outcomes of a randomized clinical trial comparing laparoscopic and open colonic resection for cancer .


The case notes of patients included in the LAFA study ( perioperative strategy in colonic surgery ; LAparoscopy and/or FAst track multimodal management versus standard care ) were reviewed @-@years after randomization for incisional hernia , adhesional small bowel obstruction ( SBO ) , overall survival , cancer recurrence and quality of life ( QoL ) .


The laparoscopic and open groups were compared irrespective of fast-track or standard perioperative care .


Data on incisional hernias , SBO , survival and recurrence were available for @ of @ patients : @ laparoscopic and @ open resections .


These outcomes were corrected for duration of follow-up .


Median follow-up was @ ( i.q.r. @-@ ) years .


Multivariable regression analysis showed that open resection was a risk factor for incisional hernia ( odds ratio ( OR ) @ , @ per cent confidence interval ( c.i. ) @ to @ ; P = @ ) and SBO ( OR @ , @ to @ ; P = @ ) .


There were no differences in overall survival ( hazard ratio @ , @ per cent c.i. @ to @ ; P = @ ) or in cumulative incidence of recurrence ( P = @ ) between the laparoscopic and open groups .


There were no measured differences in QoL in @ respondents ( P > @ for all scales ) .


Laparoscopic colonic surgery led to fewer incisional hernia and adhesional SBO events .


Past studies that demonstrated that sexual dysfunction is common among women receiving chronic hemodialysis did not distinguish sexual dysfunction/difficulty from sexual inactivity .


This study sought to differentiate these in order to elucidate the prevalence of true `` sexual dysfunction '' in this population .


As part of a clinical trial of symptom management strategies in patients receiving chronic hemodialysis , female sexual function was prospectively assessed monthly for @ months and quarterly thereafter using the Female Sexual Function Index , to which questions were added differentiating sexual dysfunction/difficulty from sexual inactivity .


Beginning in month @ , patients were asked three questions about sexual activity , difficulty , and satisfaction monthly .


Of the women enrolled in the clinical trial ,@ participants completed @ assessments between @ and @ .


Scores on @ of @ ( @ % ) quarterly Female Sexual Function Index assessments were consistent with sexual dysfunction , due largely to sexual inactivity , which was reported on @ ( @ % ) quarterly assessments .


When reported ( n = @ ) , the most frequently described reasons for sexual inactivity were lack of interest in sex ( n = @ ; @ % ) and lack of a partner ( n = @ ; @ % ) , but rarely sexual difficulty ( n = @ ; @ % ) .


When reported ( n = @ ) , women were moderately to very satisfied with their sexual life on @ ( @ % ) assessments and on @ of @ ( @ % ) assessments in which lack of interest was cited as a reason for sexual inactivity .


Women indicated an interest in learning about the causes of and treatment for sexual dysfunction on just @ % of all assessments .


Although many women receiving chronic hemodialysis are sexually inactive , few describe sexual difficulty .


Most , including those with a lack of interest in sex , are satisfied with their sexual life and few wish to learn about treatment options .


These findings suggest that true sexual dysfunction is uncommon in this population and that treatment opportunities are rare .


To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease ( COPD ) compared with usual care .


@ month , multicentre , pragmatic cluster randomised controlled trial


@ general practices in the western part of the Netherlands


Patients with COPD according to GOLD ( Global Initiative for COPD ) criteria .


Exclusion criteria were terminal illness , cognitive impairment , alcohol or drug misuse , and inability to fill in Dutch questionnaires .


Practices were included if they were willing to create a multidisciplinary COPD team .


General practitioners , practice nurses , and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice , including early recognition of exacerbations and self management , smoking cessation , physiotherapeutic reactivation , optimal diagnosis , and drug adherence .


Additionally , the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice .


The control group continued usual care ( based on international guidelines ) .


The primary outcome was difference in health status at @ months , measured by the Clinical COPD Questionnaire ( CCQ ) ; quality of life , Medical Research Council dyspnoea , exacerbation related outcomes , self management , physical activity , and level of integrated care ( PACIC ) were also assessed as secondary outcomes .


Of a total of @ patients from @ clusters , @ practices ( @ patients ) were randomly assigned to the intervention group and @ clusters ( @ patients ) to the usual care group .


No difference was seen between groups in the CCQ at @ months ( mean difference -@ , @ % confidence interval -@ to @ ; P = @ ) .


After @ months , no differences were seen in secondary outcomes between groups , except for the PACIC domain `` follow-up/coordination '' ( indicating improved integration of care ) and proportion of physically active patients .


Exacerbation rates as well as number of days in hospital did not differ between groups .


After @ months , no differences were seen in outcomes , except for the PACIC follow-up/coordination domain .


In this pragmatic study , an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care , except improved level of integrated care and a self reported higher degree of daily activities .


The contradictory findings to earlier positive studies could be explained by differences between interventions ( provider versus patient targeted ) , selective reporting of positive trials , or little room for improvement in the already well developed Dutch healthcare system .


Malaria is a leading cause of morbidity and mortality among young children and is estimated to cause at least @ million deaths each year especially among pregnant women and young children under the age of five years .


Vitamin A supplementation is known to reduce morbidity and mortality in young children .


Zinc is required for growth and immunity and we sought to replicate the study by Zeba et al. which showed @ % lower cases of clinical malaria in children on a combination of zinc and a large dose of vitamin A compared with children on vitamin A alone based on the hypothesis that combined vitamin A and zinc reduced symptomatic malaria compared to vitamin A alone .


The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria and other anthropometric indices .


It also sought to assess the effects on the incidence of anaemia , diarrhoea and pneumonia .


The study was community-based and @ children between the ages of @-@ months were randomised to receive either vitamin A ( @,@ IU for infants less than @ months & @,@ IU for children greater than @ months and @ mg daily zinc in the intervention group or vitamin A and zinc placebo for @ months in the control group .


The number of children who were diagnosed with uncomplicated malaria in the intervention group was @ % significantly lower compared with the children in the control group ( p = @ ) .


There were , however , no effects on severe malaria , pneumonia , anaemia and diarrhea .


Our study confirms a significant role of vitamin A and zinc in reducing malaria morbidity .


Preventing and rehabilitating gait disorders in people with dementia during early disease stage is of high importance for staying independent and ambulating safely .


However , the evidence gathered in randomized controlled trials ( RCTs ) on the effectiveness of exercise training for improving spatio-temporal gait parameters in people with dementia is scarce .


The aim of the present study was to determine whether a specific , standardized training regimen can improve gait characteristics in people with dementia .


Sixty-one individuals ( mean age : @ years ) with confirmed mild to moderate stage dementia took part in a @-month double-blinded outpatient RCT .


Subjects in the intervention group ( IG ) received supervised , progressive resistance and functional group training for @ months ( @ times per week for two hours ) specifically developed for people with dementia .


Subjects in the control group ( CG ) conducted a low-intensity motor placebo activity program .


Gait characteristics were measured before and after the intervention period using a computerized gait analysis system ( GAITRite ) .


Adherence to the intervention was excellent , averaging @ % in the IG and @ % in the CG .


The exercise training significantly improved gait speed ( P < @ ) , cadence ( P = @ ) , stride length ( P = @ ) , stride time ( P = @ ) , and double support ( P = @ ) in the IG compared to the CG .


Effect sizes were large for all gait parameters that improved significantly ( Cohen 's d : @-@ @ ) .


No improvements were found for step width ( P = @ ) , step time variability ( P = @ ) and Walk-Ratio ( P = @ ) .


Interestingly , low baseline motor status , but not cognitive status , predicted positive training response ( relative change in gait speed from baseline ) .


The intensive , dementia-adjusted training was feasible and improved clinically meaningful gait variables in people with dementia .


The exercise program may represent a model for preventing and rehabilitating gait deficits in the target group .


Further research is required for improving specific gait characteristics such as gait variability in people with dementia .


Palliative care patients and their family caregivers may have a foreshortened perspective of the time left to live , or the expectation of the patient 's death in the near future .


Patients and caregivers may report distress in physical , psychological , or existential/spiritual realms .


To conduct a randomized controlled trial examining the effectiveness of retired senior volunteers ( RSVs ) in delivering a reminiscence and creative activity intervention aimed at alleviating palliative care patient and caregiver distress .


Of the @ dyads that completed baseline assessments , @ completed postintervention and @ completed follow-up assessments .


The intervention group received three home visits by RSVs ; control group families received three supportive telephone calls by the research staff .


Measures included symptom assessment and associated burden , depression , religiousness/spirituality , and meaning in life .


Patients in the intervention group reported a significantly greater reduction in frequency of emotional symptoms ( P = @ ) and emotional symptom bother ( P = @ ) than the control group , as well as improved spiritual functioning .


Family caregivers in the intervention group were more likely than control caregivers to endorse items on the Meaning of Life Scale ( P = @ ) .


Only improvement in intervention patients ' emotional symptom bother maintained at follow-up after discontinuing RSV contact ( P = @ ) .


Delivery of the intervention by RSVs had a positive impact on palliative care patients ' emotional symptoms and burden and caregivers ' meaning in life .


Meaningful prolonged engagement with palliative care patients and caregivers , possibly through alternative modes of treatment delivery such as continued RSV contact , may be necessary for maintenance of therapeutic effects .


Postoperative pancreatic fistula is a major contributor to complications and death associated with pancreatic resection .


Pasireotide , a somatostatin analogue that has a longer half-life than octreotide and a broader binding profile , decreases pancreatic exocrine secretions and may prevent postoperative pancreatic fistula .


We conducted a single-center , randomized , double-blind trial of perioperative subcutaneous pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy .


We randomly assigned @ patients to receive @ g of subcutaneous pasireotide ( @ patients ) or placebo ( @ patients ) twice daily beginning preoperatively on the morning of the operation and continuing for @ days ( @ doses ) .


Randomization was stratified according to the type of resection and whether the pancreatic duct was dilated at the site of transection .


The primary end point was the development of pancreatic fistula , leak , or abscess of grade @ or higher ( i.e. , requiring drainage ) .


The primary end point occurred in @ of the @ patients ( @ % ) .


The rate of grade @ or higher postoperative pancreatic fistula , leak , or abscess was significantly lower among patients who received pasireotide than among patients who received placebo ( @ % vs. @ % ; relative risk , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


This finding was consistent among @ patients who underwent pancreaticoduodenectomy ( @ % vs. @ % ; relative risk , @ ; @ % CI , @ to @ ) and @ patients who underwent distal pancreatectomy ( @ % vs. @ % ; relative risk , @ ; @ % CI , @ to @ ) , as well as among @ patients with a dilated pancreatic duct ( @ % vs. @ % ; relative risk , @ ; @ % CI , @ to @ ) and @ patients with a nondilated pancreatic duct ( @ % vs. @ % ; relative risk , @ ; @ % CI , @ to @ ) .


Perioperative treatment with pasireotide decreased the rate of clinically significant postoperative pancreatic fistula , leak , or abscess .


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


On the basis of phase II trials , we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke .


We studied transcranial laser therapy in a double-blind , sham-controlled randomized clinical trial intended to enroll @ patients with acute ischemic stroke treated @ hours after stroke onset and who did not undergo thrombolytic therapy .


The primary efficacy measure was the @-day functional outcome as assessed by the modified Rankin Scale , with hierarchical Bayesian analysis incorporating relevant previous data .


Interim analyses were planned after @ and @ patients included .


The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of @ completed patients found no difference in the primary end point ( transcranial laser therapy @/@ -LSB- @ % -RSB- versus sham @/@ -LSB- @ % -RSB- for good functional outcome ; modified Rankin Scale , @-@ ) .


The results remained stable after inclusion of all @ randomized patients ( adjusted odds ratio , @ ; @ % confidence interval , @-@ @ ) .


Once the results of the interim futility analysis became available , all study support was immediately withdrawn by the capital firms behind PhotoThera , and the company was dissolved .


Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera , the CRO Parexel and members of the steering and the safety committees .


We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within @ hours after stroke onset .


The frailty syndrome is as a well-established condition of risk for disability .


Aim of the study is to explore whether a physical activity ( PA ) intervention can reduce prevalence and severity of frailty in a community-dwelling elders at risk of disability .


Exploratory analyses from the Lifestyle Interventions and Independence for Elders pilot , a randomized controlled trial enrolling @ community-dwelling persons ( mean age = @ years ) with sedentary lifestyle and at risk of mobility disability .


Participants were randomized to a @-month PA intervention versus a successful aging education group .


The frailty phenotype ( ie , @ of the following defining criteria : involuntary weight loss , exhaustion , sedentary behavior , slow gait speed , poor handgrip strength ) was measured at baseline , @ months , and @ months .


Repeated measures generalized linear models were conducted .


A significant ( p = @ ) difference in frailty prevalence was observed at @ months in the PA intervention group ( @ % ; @ % confidence interval = @ % , @ % ) , relative to the successful aging group ( @ % ; @ % confidence interval = @ % ,@ % ) .


Over follow-up , in comparison to successful aging participants , the mean number of frailty criteria in the PA group was notably reduced for younger subjects , blacks , participants with frailty , and those with multimorbidity .


Among the frailty criteria , the sedentary behavior was the one most affected by the intervention .


Regular PA may reduce frailty , especially in individuals at higher risk of disability .


Future studies should be aimed at testing the possible benefits produced by multidomain interventions on frailty .


Past traumatic events have been associated with poorer clinical outcomes in people with bipolar disorder .


However , the impact of these events in the early stages of the illness remains unclear .


The aim of this study was to investigate whether prior traumatic events were related to poorer outcomes @ months following a first episode of psychotic mania .


Traumatic events were retrospectively evaluated from patient files in a sample of @ participants who had experienced first episode psychotic mania .


Participants were aged between @ and @ years and were treated at a specialised early psychosis service .


Clinical outcomes were measured by a variety of symptomatic and functioning scales at the @-month time-point .


Direct-personal traumatic experiences prior to the onset of psychotic mania were reported by @ % of the sample .


Participants with past direct-personal trauma had significantly higher symptoms of mania ( p = @ ) , depression ( p = @ ) and psychopathology ( p = @ ) @ months following their first episode compared to participants without past direct-personal trauma , with medium to large effects observed .


After adjusting for baseline scores , differences in global functioning ( as measured by the Global Assessment of Functioning scale ) were non-significant ( p = @ ) ; however , participants with past direct-personal trauma had significantly poorer social and occupational functioning ( p = @ ) at the @-month assessment with medium effect .


Past direct-personal trauma may predict poorer symptomatic and functional outcomes after first episode psychotic mania .


Limitations include that the findings represent individuals treated at a specialist early intervention centre for youth and the retrospective assessment of traumatic events may have been underestimated .


Saline ( @ % sodium chloride ) is the most commonly administered intravenous fluid ; however , its use may be associated with acute kidney injury ( AKI ) and increased mortality .


To determine the effect of a buffered crystalloid compared with saline on renal complications in patients admitted to the intensive care unit ( ICU ) .


Double-blind , cluster randomized , double-crossover trial conducted in @ ICUs in New Zealand from April @ through October @ .


Three ICUs were general medical and surgical ICUs ; @ ICU had a predominance of cardiothoracic and vascular surgical patients .


All patients admitted to the ICU requiring crystalloid fluid therapy were eligible for inclusion .


Patients with established AKI requiring renal replacement therapy ( RRT ) were excluded .


All @ eligible patients were enrolled ; @ of @ patients ( @ % ) receiving buffered crystalloid and @ of @ patients ( @ % ) receiving saline were analyzed .


Participating ICUs were assigned a masked study fluid , either saline or a buffered crystalloid , for alternating @-week treatment blocks .


Two ICUs commenced using @ fluid and the other @ commenced using the alternative fluid .


Two crossovers occurred so that each ICU used each fluid twice over the @ weeks of the study .


The treating clinician determined the rate and frequency of fluid administration .


The primary outcome was proportion of patients with AKI ( defined as a rise in serum creatinine level of at least @-fold or a serum creatinine level of @ mg/dL with an increase of @ mg/dL ) ; main secondary outcomes were incidence of RRT use and in-hospital mortality .


In the buffered crystalloid group , @ of @ patients ( @ % ) developed AKI within @ days after enrollment compared with @ of @ patients ( @ % ) in the saline group ( absolute difference , @ % -LSB- @ % CI , -@ % to @ % -RSB- ; relative risk -LSB- RR -RSB- , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) .


In the buffered crystalloid group , RRT was used in @ of @ patients ( @ % ) compared with @ of @ patients ( @ % ) in the saline group ( absolute difference , -@ % -LSB- @ % CI , -@ % to @ % -RSB- ; RR , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) .


Overall , @ of @ patients ( @ % ) in the buffered crystalloid group and @ of @ patients ( @ % ) in the saline group died in the hospital ( absolute difference , -@ % -LSB- @ % CI , -@ % to @ % -RSB- ; RR , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) .


Among patients receiving crystalloid fluid therapy in the ICU , use of a buffered crystalloid compared with saline did not reduce the risk of AKI .


Further large randomized clinical trials are needed to assess efficacy in higher-risk populations and to measure clinical outcomes such as mortality .


To observe the clinical effect of Lingtong Capsule ( LC ) in treating primary dysmenorrhea ( PD ) .


Totally @ PD patients took LC , while @ patients in the placebo group took placebo capsule , two pills immediately when they felt dysmenorrhea .


Their pain levels were quantitatively classified .


The pain score was assessed at an interval of @ min using visual analogue scale/score ( VAS ) while taking medicine and within two h after taking medicine .


It was assessed as effective when the pain level was reduced by more than or equal to @ % within @ h.


The total effective rate was @ % ( @ / @ ) in the LC group and @ % ( @/@ ) in the placebo group ( P < @ ) .


The analgesia effect was obviously superior in the LC group @ min after taking medicine ( P < @ ) .


LC showed better effect in treating mild , moderate , and severe PD ( P < @ ) .


LC showed obvious analgesia effect on PD .


Increased risk of osteoporosis and its clinical significance in patients with diabetes is controversial .


We analyze osteoporosis prevalence and determinants of bone mineral density ( BMD ) in patients with type @ and @ diabetes .


Three hundred and ninety-eight consecutive diabetic patients from a single outpatient clinic received a standardized questionnaire on osteoporosis risk factors , and were evaluated for diabetes-related complications , HbA@c levels , and lumbar spine ( LS ) and femoral neck ( FN ) BMD .


Of these , @ ( @ men , @ women ) type @ and @ ( @ men , @ women ) type @ diabetes patients were included in the study .


BMD ( T-scores and values adjusted for age , BMI and duration of disease ) was compared between patient groups and between patients with type @ diabetes and population-based controls ( @ men , @ women ) .


For both genders , adjusted BMD was not different between the type @ and type @ diabetes groups but was higher in the type @ group compared with controls ( p < @ ) .


Osteoporosis prevalence ( BMD T-score < -@ SD ) at FN and LS was equivalent in the type @ and type @ diabetes groups , but lower in type @ patients compared with controls ( FN : @ % vs @ % , LS : @ % vs @ % men ; FN : @ % vs @ % , LS : @ % vs @ % women ) .


Osteoporosis prevalence was higher at FN-BMD than at LS-BMD .


BMD was positively correlated with BMI and negatively correlated with age , but not correlated with diabetes-specific parameters ( therapy , HbBA@c , micro - and macrovascular complications ) in all subgroups .


Fragility fracture prevalence was low ( @ % ) and not different between diabetes groups .


Fracture patients had lower BMDs compared with those without fractures ; however , BMD T-score was above -@ SD in most patients .


Diabetes-specific parameters did not predict BMD .


Fracture occurrence was similar in both diabetes groups and related to lower BMD , but seems unrelated to the threshold T-score , < -@ SD .


These results suggest that osteoporosis , and related fractures , is a clinically significant and commonly underestimated problem in diabetes patients .


Lumbar punctures are frequently performed in pediatric leukemia for central nervous system leukemic prophylaxis .


The contribution of local anesthetic with deep sedation is unknown .


The objective was to evaluate EMLA ( eutectic mixture of local anesthetics ) cream as a pain reliever in conjunction with propofol in the setting of routine lumbar punctures .


We included patients with acute lymphoblastic leukemia aged @-@ years requiring at least two routine lumbar punctures .


Patients were randomly assigned to receive EMLA or placebo cream and the alternate treatment with the second procedure .


Patients , personnel and outcome assessors were blinded to allocation .


The primary outcome included three indirect measures of pain : total median propofol doses , patient movement and heart rate changes at the time of skin puncture in both treatment groups .


Twenty-six patients were enrolled and @ were analyzed .


With EMLA cream , @ mg/kg ( median ) of propofol was required ( @ % CI @-@ @ ) .


With placebo , @ mg/kg of propofol was needed ( @ % CI @-@ @ ; P = @ ) .


When EMLA cream was applied , @ % of patients moved , whereas @ % moved with placebo cream ( P < @ ) .


There was a lower average heart rate by seven beats in the EMLA treatment compared to placebo ( @ % CI -@ -@ ; @-@ @ ; P = @ ) .


There were no adverse events in either treatment group .


This study demonstrated that the combination of EMLA cream with propofol is beneficial .


Topical analgesics are at the discretion of the oncologist , allowing us to advocate for patients by providing safe and efficacious pain management for lumbar punctures .


We aimed to investigate effects of superoxide dismutase ( SOD ) - melon concentrate supplementation on psychological stress , physical and mental fatigue in healthy people .


A randomized , double-blind , placebo-controlled trial was performed on @ people divided in two groups : active supplement ( n = @ ) and placebo ( n = @ ) for @ weeks .


Volunteers were given one small hard capsule per day .


One capsule contained @ mg of SOD-melon concentrate ( @ U of SOD ) and starch for the active supplement and starch only for the placebo .


Stress and fatigue were evaluated using four psychometric scales : PSS-@ ; SF-@ ; Stroop tests and Prevost scale .


The supplementation with SOD-melon concentrate significantly decreased perceived stress , compared to placebo .


Moreover , quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation .


SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue .


No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction .


We aimed to assess whether changes in the fetal ductus venosus Doppler waveform ( DV ) could be used as indications for delivery instead of cardiotocography short-term variation ( STV ) .


In this prospective , European multicentre , unblinded , randomised study , we included women with singleton fetuses at @-@ weeks of gestation who had very preterm fetal growth restriction ( ie , low abdominal circumference -LSB- < @th percentile -RSB- and a high umbilical artery Doppler pulsatility index -LSB- > @th percentile -RSB- ) .


We randomly allocated women @:@:@ , with randomly sized blocks and stratified by participating centre and gestational age ( < @ weeks vs @ weeks ) , to three timing of delivery plans , which differed according to antenatal monitoring strategies : reduced cardiotocograph fetal heart rate STV ( CTG STV ) , early DV changes ( pulsatility index > @th percentile ; DV p@ ) , or late DV changes ( A wave -LSB- the deflection within the venous waveform signifying atrial contraction -RSB- at or below baseline ; DV no A ) .


The primary outcome was survival without cerebral palsy or neurosensory impairment , or a Bayley III developmental score of less than @ , at @ years of age .


We assessed outcomes in surviving infants with known outcomes at @ years .


We did an intention to treat study for all participants for whom we had data .


Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women .


This study is registered with ISRCTN , number @ .


Between Jan @ , @ and Oct @ , @ , @ of @ eligible women were randomly allocated to monitoring groups ( @ to CTG STV , @ to DV p@ , and @ to DV no A ) .


The median gestational age at delivery was @ weeks ( IQR @-@ ) and mean birthweight was @ g ( SD @ ) .


The proportion of infants surviving without neuroimpairment did not differ between the CTG STV ( @ -LSB- @ % -RSB- of @ infants with known outcome ) , DV p@ ( @ -LSB- @ % -RSB- of @ ) , and DV no A ( @ -LSB- @ % -RSB- of @ ) groups ( ptrend = @ ) .


@ fetuses ( @ % ) died in utero and @ ( @ % ) neonatal deaths occurred .


Of survivors , more infants where women were randomly assigned to delivery according to late ductus changes ( @ -LSB- @ % -RSB- of @ , @ % , @ % CI @-@ ) were free of neuroimpairment when compared with those randomly assigned to CTG ( @ -LSB- @ % -RSB- of @ , @ % CI @-@ ; p = @ ) , but this was accompanied by a non-significant increase in perinatal and infant mortality .


Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint , timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at @ years of age .


To compare corneal stromal and endothelial cells after photorefractive keratectomy with intraoperative mitomycin C in alcohol-assisted versus mechanical epithelial debridement using confocal microscopy .


This prospective randomized comparative study was performed on @ eyes ( @ patients ) with myopia up to -@ diopters .


The right eye of each patient was randomly assigned to either mechanical or alcohol-assisted groups , and the left eye was assigned to the alternate group .


Confocal microscopy was performed preoperatively and at @ months postoperatively .


The main outcome measures were epithelial thickness ; number of keratocytes in the anterior , mid - , and posterior stroma ; and characteristics of the central corneal endothelial cells in terms of density , mean cell area , and polymegathism and hexagonality .


Three months after surgery , no statistically significant difference was noted between the study groups in terms of epithelial thickness .


We also found no statistically significant difference in central corneal endothelial cells regarding cell density , mean cell area , hexagonality , or polymegathism .


Compared with baseline values , the density of mid - and posterior stromal keratocytes showed no significant change in either group , whereas it decreased significantly in the anterior stroma in both groups @ months after surgery .


We found that the adverse effects of photorefractive keratectomy with mitomycin C on central corneal endothelial cells were comparable between the mechanical and alcohol-assisted epithelial debridement groups and the significant decrease in postoperative keratocyte density in anterior stroma was comparable between the two groups .


The choice of their application could be left to the discretion of the ophthalmologist .


The transition from pediatric to nephrology care is not yet a standardized procedure .


The result is an increased risk of deteriorating transplant function , with the potential for premature transplant failure .


In phase I of this study , we shall evaluate the current patient transition situation in all existing German pediatric and nephrology departments ( n = @ ) , including an evaluation of the views of physicians , nurses , and psychosocial support staff regarding transition .


Phase II will be a prospective , randomized study in which we compare current unstructured transition ( control group ) to structured transition ( intervention group ) .


The structured transition approach integrates the core elements of the Berliner TransitionsProgramm in combination with two facilitating smartphone apps .


The primary endpoint of this study will be therapy adherence , as reflected by group variation coefficients of immunosuppressive agent levels .


As a secondary outcome , we will compare patients ' self-reported quality of life , satisfaction of patients and their parents with each transition model , and how patient-centered healthcare components are utilized .


These secondary parameters will be assessed with established instruments or with instruments developed ( and pilot tested ) in phase I of the project .


The long-term goal of this work is to provide a model of structured transition from pediatric to adult care for adolescent nephrology patients , in order to improve transplant survival and patient wellbeing .


To explore the clinical efficacy of radiotherapy combined with concurrent combination chemotherapy in the treatment of patients with advanced nasopharyngeal carcinoma ( NPC ) .


Two hundred patients with stage III/IV NPC were randomly allocated into the treatment group ( N = @ ) and the control group ( N = @ ) .


Patients in the control group received conventional fractionated radiotherapy , while patients in the treatment group received conventional fractionated radiotherapy combined with concurrent combination chemotherapy with cisplatin and @-fluorouracil ( @-FU ) .


Short-term efficacy , radiotherapy toxicity , shortand long-term survival were compared .


The short-term response rate of the treatment group was @ % , which was significantly higher than that of the control group ( @ % , p < @ ) .


The local radiation toxicity of the treatment group was similar to that of the control group p > @ ) , but the hematological and gastrointestinal toxicities were significantly higher in the treatment group p < @ ) .


The @ - , @ - and @-year overall survival rates were @ , @ , and @ % , respectively , in the treatment group and @ , @ , and @ % , respectively , in the control group , significantly favoring the treatment group p < @ ) .


Radiotherapy with concurrent combination chemotherapy can improve the prognosis of patients with advanced NPC but at the cost of significant toxicity .


To determine the induction doses , then minimum infusion rates of alfaxalone for total intravenous anaesthesia ( TIVA ) , and subsequent , cardiopulmonary effects , recovery characteristics and alfaxalone plasma concentrations in cats undergoing ovariohysterectomy after premedication with butorphanol-acepromazine or butorphanol-medetomidine .


Prospective randomized blinded clinical study .


Twenty-eight healthy cats .


Cats undergoing ovariohysterectomy were assigned into two groups : together with butorphanol -LSB- @ mgkg ( -@ ) intramuscularly ( IM ) -RSB- , group AA ( n = @ ) received acepromazine ( @ mgkg ( -@ ) IM ) and group MA ( n = @ ) medetomidine ( @gkg ( -@ ) IM ) .


Anaesthesia was induced with alfaxalone to effect -LSB- @ mgkg ( -@ ) intravenously ( IV ) every @seconds -RSB- , initially maintained with @mgkg ( -@ ) hour ( -@ ) alfaxalone IV and infusion adjusted ( @ mg kg ( -@ ) hour ( -@ ) ) every five minutes according to alterations in heart rate ( HR ) , respiratory rate ( fR ) , Doppler blood pressure ( DBP ) and presence of palpebral reflex .


Additional alfaxalone boli were administered IV if cats moved/swallowed ( @ mgkg ( -@ ) ) or if fR > @ breaths minute ( -@ ) ( @ mgkg ( -@ ) ) .


Venous blood samples were obtained to determine plasma alfaxalone concentrations .


Meloxicam ( @ mgkg ( -@ ) IV ) was administered postoperatively .


Data were analysed using linear mixed models , Chi-squared , Fishers exact and t-tests .


Alfaxalone anaesthesia induction dose ( meanSD ) , was lower in group MA ( @ ; group AA : @ mgkg ( -@ ) ) .


No cats became apnoeic .


Intraoperative bolus requirements and TIVA rates ( group AA : @ , group MA : @ mgkg ( -@ ) hour ( -@ ) ) did not differ significantly between groups .


Plasma concentrations ranged between @ and @ gmL ( -@ ) .


In group MA , fR , end-tidal carbon dioxide , temperature and DBP were significantly higher and HR lower .


Alfaxalone TIVA in cats after medetomidine or acepromazine sedation provided suitable anaesthesia with no need for ventilatory support .


After these premedications , the authors recommend initial alfaxalone TIVA rates of @mg kg ( -@ ) hour ( -@ ) .