Based on these data , the laser method represents a simple , yet effective tool for continuous intraoperative evaluation of lower extremity alignment .


The objective of this study was to evaluate the protective effects of a new device for reducing perineal tears during vaginal childbirth .


A multicenter open randomized controlled trial ( RCT ) was performed in Helsingborg , Lund and Malm , Sweden consisting of @ women .


Women anticipating a vaginal delivery were either randomized to the intervention group ( n = @ in which the perineal protection device was used , or a control group ( n = @ ) , in which the perineal protection device was not used .


The main outcome measurements were incidence of vaginal and perineal tears ( @st to @th degree tears ) and adverse effects on the parturient and newborn .


The incidences of first - and second-degree tears of the vagina ( p = @ ) and perineum ( p = @ ) were significantly reduced in the intervention group compared with the controls .


In the intervention - and control group , @ women ( @ % ) and @ ( @ % ) showed no perineal tearing , respectively ( p = @ ) .


Numbers needed to treat to avoid any perianal tearing was @ .


The incidence of anal sphincter rupture ( ASR ) was the same in both groups ( n = @ ; @ % ) .


No negative effects on mother or child from using the device were observed .


The perineal protective device significantly reduced the incidence of first - and second-degree tears in the vagina and perineum during vaginal birth and also significantly increased the number of parturients with a fully intact posterior commissure .


No significant reduction of ASR and no negative effects of the device were observed .


DNA methylation has been linked to many important biological phenomena .


Researchers have recently begun to sequence bisulfite treated DNA to determine its pattern of methylation .


However , sequencing reads from bisulfite-converted DNA can vary significantly from the reference genome because of incomplete bisulfite conversion , genome variation , sequencing errors , and poor quality bases .


Therefore , it is often difficult to align reads to the correct locations in the reference genome .


Furthermore , bisulfite sequencing experiments have the additional complexity of having to estimate the DNA methylation levels within the sample .


Here , we present a highly accurate probabilistic algorithm , which is an extension of the Genomic Next-generation Universal MAPper to accommodate bisulfite sequencing data ( GNUMAP-bs ) , that addresses the computational problems associated with aligning bisulfite sequencing data to a reference genome .


GNUMAP-bs integrates uncertainty from read and mapping qualities to help resolve the difference between poor quality bases and the ambiguity inherent in bisulfite conversion .


We tested GNUMAP-bs and other commonly-used bisulfite alignment methods using both simulated and real bisulfite reads and found that GNUMAP-bs and other dynamic programming methods were more accurate than the more heuristic methods .


The GNUMAP-bs aligner is a highly accurate alignment approach for processing the data from bisulfite sequencing experiments .


The GNUMAP-bs algorithm is freely available for download at : http://dna.cs.byu.edu/gnumap .


The software runs on multiple threads and multiple processors to increase the alignment speed .


This study is an analysis of the pre-trial quality assurance ( QA ) exercises submitted by clinicians from radiotherapy ( RT ) centres across Europe and Canada to qualify for participation in the CONVERT trial .


QA exercises submitted by @ clinicians at @ RT centres were included in this analysis .


The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan , for both trial arms , for a patient fitting the eligibility criteria of the trial .


This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol .


Patient eligibility , disease and critical structure outlining and treatment planning technique were assessed .


Results from QA trial-specific questionnaires received between February @ and September @ , returned as part of the QA exercise , indicated that the majority of centres ( @ % ) were using @-MV photons and type B treatment planning system algorithms ( @ % ) .


@ % of clinicians assessed submitted data for patients who fitted the eligibility criteria for the trial .


There were inconsistencies in outlining of gross tumour volume ( GTV ) and organs at risk , mainly heart and oesophagus , and in the use of margins around the GTV .


Such a QA programme helps to ensure that centres conform to trial protocol and should reduce inconsistencies in RT planning that may confound the results of the CONVERT trial .


Few studies reporting pre-trial QA have been published to date .


This article outlines the importance of such a QA programme in the context of multicentre Phase III studies .


Pelvic floor muscle exercises ( PFME ) are commonly recommended during pregnancy and after birth for both prevention and treatment of lower urinary tract symptoms ( LUTS ) .


Stress urinary incontinence has long been presumed to be associated with urethral hypermobility .


Pregnancy and delivery are known cause of increasing bladder neck descent ( BND ) .


The present study aimed to determine the effect of antenatal PFME on bladder neck descent in nulliparous pregnancy .


@ nulliparous women pregnant between @-@ weeks were interviewed and then underwent transperineal ultrasound .


Of the total , @ women were randomly assigned to a PFMT group , while @ women to a control group .


The latter group received routine antenatal care .


For the intervention group , patients were taught about PFMT using visual biofeedback by transperineal ultrasound .


The PFMT regimen comprised a series of @ contractions , and each contraction was heldfor @ seconds , with @ seconds rest between each contraction .


Patients were asked to repeat this regimen for @ times after each meal .


At second trimester , third trimester , @-month postpartum and @-month postpartum , the subjects in both groups were interviewed and then underwent another ultrasound assessment .


Transperineal ultrasound was performed after bladder emptying , with the patient in the supine position .


Bladder neck position was measured at rest and on maximal valsava , and the differences yielded a numerical valueforBND .


The sample size was calculated with apower of@ % p < @ was considered significant .


SPSS @ .


Ofor windows ( SPSS Inc. , Chicago , Illinois ) was used for statistical analyses .


Demographic characteristics did not differ significantly between PFMT and control groups , showing effective randomization .


Mean age was @ and @ years for PFMT and control group , respectively ( p = @ ) .


There were no significant differences in bladder symptoms between the two groups at the first visit .


In the first trimester , the average BND of the PFMT group was slightly higher than BND of the control group ( @ mm and @ mm respectively ( p = @ ) ) .


When comparing delivery mode by using Pearson 's Chi-square test , there was no statistically significant difference between two groups ( p = @ ) .


The mean fetal birth weight of women in the PFMTgroup was @,@ grams and in the control group was @,@ grams ( p = @ ) .


At @ monthspostpartum , @ women of the PFMT group and @ women of the control group returned for follow-up .


There were no differences regarding the prevalence ofL UTS between the groups at @ months after delivery .


Women in the control group had a higher BND ( @ mm ) than those in the PFMT group ( @ mm , p = @ ) .


This difference was also found in the subgroup of the women who delivered vaginally ( BND = @ mm in the control group and @ mm in the PFMTgroup , p = @ ) .


Although postpartum prevalence of LUTS was no different between groups , this study has demonstrated that antenatal pelvic floor muscle exercises may reduce bladder neck mobility at @ months after childbirth .


The significance of such an effect remains to be determined .


To investigate the clinical response of gastro-esophageal reflux disease ( GERD ) symptoms to exclusion diets based on food intolerance tests .


A double blind , randomized , controlled pilot trial was performed in @ GERD patients partially or completely non-responders to proton pump inhibitors ( PPI ) treatment .


Fasting blood samples from each patients were obtained ; leukocytotoxic test was performed by incubating the blood with a panel of @ food items to be tested .


The reaction of leukocytes ( rounding , vacuolization , lack of movement , flattening , fragmentation or disintegration of cell wall ) was then evaluated by optical microscopy and rated as follows : level @ = negative , level @ = slightly positive , level @ = moderately positive , and level @ = highly positive .


A `` true '' diet excluding food items inducing moderate-severe reactions , and a `` control '' diet including them was developed for each patient .


Then , twenty patients received the `` true '' diet and @ the `` control '' diet ; after one month ( T@ ) symptoms severity was scored by the GERD impact scale ( GIS ) .


Hence , patients in the `` control '' group were switched to the `` true '' diet , and symptom severity was re-assessed after three months ( T@ ) .


At baseline ( T@ ) the mean GIS global score was @ ( range : @-@ ) with no difference between `` true '' and control group ( @ @ vs @ @ ) .


All patients reacted moderately/severely to at least @ food ( range : @-@ ) , with a significantly greater number of food substances inducing reaction in controls compared with the `` true '' diet group ( @ vs @ , P < @ ) .


Food items more frequently involved were milk , lettuce , brewer 's yeast , pork , coffee , rice , sole asparagus , and tuna , followed by eggs , tomato , grain , shrimps , and chemical yeast .


At T@ both groups displayed a reduction of GIS score ( `` true '' group @ @ , -@ % , P = @ ; control group @ @ , -@ % , P = @ ) , although the GIS score was significantly lower in `` true '' vs `` control '' group ( P = @ ) .


At T@ , after the diet switch , the `` control '' group showed a further reduction in GIS score ( @ @ , -@ % , P = @ ) , while the `` true '' group did not ( @ @ , -@ % , P = @ ) , so that the GIS scores did n't differ between the two groups .


Our results suggest that food intolerance may play a role in GERD symptoms development , and leucocytotoxic test-based exclusion diets may be a possible therapeutic approach when PPI are not effective or indicated .


Pediatric traumatic brain injury ( TBI ) contributes to impairments in functioning in everyday settings .


Evidence suggests that online family problem-solving therapy ( FPST ) may be effective in reducing adolescent behavioral morbidity .


This article examines the efficacy of Counselor-Assisted Problem Solving ( CAPS ) , a form of online FPST in improving long-term functional outcomes of adolescents with TBI relative to Internet resources only .


Children , aged @ to @ years , who were hospitalized in the previous @ months for TBI were enrolled in a multisite , assessor-blinded randomized controlled trial .


Consented participants were randomly assigned to CAPS or an Internet resource comparison ( IRC ) condition .


Outcomes were assessed at baseline and at follow-ups @ , @ , and @ months postbaseline .


The Child and Functional Assessment Scale and the Iowa Family Interaction Rating Scale ( IFIRS ) served as primary outcomes of child and family functioning respectively .


For the Child and Functional Assessment Scale total , we found a significant group time interaction , with less impaired functioning for the CAPS group than for the IRC group at the final follow-up .


Parent education moderated the efficacy of CAPS on overall rates of impairment and school/work functioning , with the advantage of CAPS over IRC evident at the final follow-up only for participants with less-educated parents .


Neither group differences nor group time interactions were found for the IFIRS .


Relatively brief , online treatment shortly after injury may result in long-term improvements in child functioning , particularly among families of lower socioeconomic status .


Clinical implementation of CAPS during the initial months postinjury should be considered .


The Troms Intervention Study on Preterms evaluates an early , sensitizing intervention given to parents of prematurely born children ( birth-weight < @g ) .


The current study investigated the potential influence of the intervention on children 's self-reported and parental proxy-reported quality of life ( QoL ) at children 's age of nine .


Participants were randomized to either intervention ( PI , n = @ ) or preterm control ( PC , n = @ ) in the neonatal care unit , while healthy term-born infants were recruited to a term reference group ( TR , n = @ ) .


The intervention was a modified version of the Mother-Infant Transaction Program , and comprised eight one-hour sessions during the last week before discharge and four home visits at @ , @ , @ and @weeks post-discharge .


The two control groups received care in accordance with written guidelines drawn up at the hospital .


Participants and parents reported QoL independently on the Kinder Lebensqualitt Fragebogen ( KINDL ) questionnaire .


Differences between groups were analyzed by SPSS ; Linear Mixed Models and parent-child agreement were analyzed and compared by intra-class correlations within each group .


On average , children in all groups reported high levels of well-being .


The PI children reported better physical well-being than the PC children ( p = @ ) .


In all other aspects of QoL both the PI and the PC children reported at similar levels as the term reference group .


PI parents reported better emotional wellbeing ( p = @ ) and a higher level of contentment in school ( p = @ ) compared with PC parents .


Parent-child agreement was significantly weaker in the PI group than in the PC group on dimensions such as emotional well-being and relationships with friends ( p < @ ) .


PI parents reported QoL similar to parents of terms on all aspects except the subscale self-esteem , while PC parents generally reported moderately lower QoL than TR parents .


This early intervention appears to have generated long-lasting positive effects , improving perceived physical well-being among prematurely born children and parent 's perception of these children 's QoL in middle childhood .


Colorectal cancer is an important public health problem in Spain .


Over the last decade , several regions have carried out screening programmes , but population participation rates remain below recommended European goals .


Reminders on electronic medical records have been identified as a low-cost and high-reach strategy to increase participation .


Further knowledge is needed about their effect in a population-based screening programme .


The main aim of this study is to evaluate the effectiveness of an electronic reminder to promote the participation in a population-based colorectal cancer screening programme .


Secondary aims are to learn population 's reasons for refusing to take part in the screening programme and to find out the health professionals ' opinion about the official programme implementation and on the new computerised tool .


This is a parallel randomised trial with a cross-sectional second stage .


all the invited subjects to participate in the public colorectal cancer screening programme that includes men and women aged between @-@ , allocated to the eleven primary care centres of the study and all their health professionals .


The randomisation unit will be the primary care physician .


The intervention will consist of activating an electronic reminder , in the patient 's electronic medical record , in order to promote colorectal cancer screening , during a synchronous medical appointment , throughout the year that the intervention takes place .


A comparison of the screening rates will then take place , using the faecal occult blood test of the patients from the control and the intervention groups .


We will also take a questionnaire to know the opinions of the health professionals .


The main outcome is the screening status at the end of the study .


Data will be analysed with an intention-to-treat approach .


We expect that the introduction of specific reminders in electronic medical records , as a tool to facilitate and encourage direct referral by physicians and nurse practitioners to perform colorectal cancer screening will mean an increase in participation of the target population .


The introduction of this new software tool will have good acceptance and increase compliance with recommendations from health professionals .


In order to assess relationships between thyroid hormone status and findings on brain MRI , a subset of babies was recruited to a multi-centre randomised , placebo-controlled trial of levothyroxine ( LT@ ) supplementation for babies born before @ weeks ' gestation ( known as the TIPIT study , for Thyroxine supplementation In Preterm InfanTs ) .


These infants were imaged at term-equivalence .


Forty-five TIPIT participants had brain MRI using diffusion tensor imaging ( DTI ) to estimate white matter development by apparent diffusion coefficient ( ADC ) , fractional anisotropy ( FA ) and tractography metrics of number and length of streamlines .


We made comparisons between babies with the lowest and highest plasma FT@ concentrations during the initial @ weeks after birth .


There were no differences in DTI metrics between babies who had received LT@ supplementation and those who had received a placebo .


Among recipients of a placebo , babies in the lowest quartile of plasma-free thyroxine ( FT@ ) concentrations had significantly higher apparent diffusion coefficient measurements in the posterior corpus callosum and streamlines that were shorter and less numerous in the right internal capsule .


Among LT@-supplemented babies , those who had plasma FT@ concentrations in the highest quartile had significantly lower apparent diffusion coefficient values in the left occipital lobe , higher fractional anisotropy in the anterior corpus callosum and longer and more numerous streamlines in the anterior corpus callosum .


DTI variables were not associated with allocation of placebo or thyroid supplementation .


Markers of poorly organised brain microstructure were associated with low plasma FT@ concentrations after birth .


The findings suggest that plasma FT@ concentrations affect brain development in very immature infants and that the effect of LT@ supplementation for immature babies with low FT@ plasma concentrations warrants further study .


Periodontitis is an inflammatory process in response to dental biofilm and leads to periodontal tissue destruction .


The aim of this study was the comparison of outcomes using either an enamel matrix derivative ( EMD ) or a nanocrystalline hydroxyapatite ( NHA ) in regenerative periodontal therapy after @ and @ months .


Using a parallel group , prospective randomized study design , we enrolled @ patients in each group .


The primary outcome was bone fill after @ months .


Attachment gain , probing pocket depth ( PPD ) reduction , and recession were secondary variables .


Additionally , early wound healing and adverse events were assessed .


Data analysis included test of noninferiority of NHA group ( test ) compared to EMD group ( reference ) in bone fill .


Differences in means of secondary variables were compared by paired t-test , frequency data by exact ( @ ) test .


Both groups showed significant bone fill , reduction of PPD , increase in recession , and gain of attachment after @ and @ months .


No significant differences between groups were found at any time point .


Adverse events were comparable between both groups with a tendency of more complaints in the NHA group .


The clinical outcomes were similar in both groups .


EMD could have some advantage compared to NHA regarding patients comfort and adverse events .


The trial is registered with ClinicalTrials.gov NCT@ .


Recent neuroimaging studies on poststroke aphasia revealed maladaptive cortical changes in both hemispheres , yet their functional contribution in language recovery remains elusive .


The aim of this study was to evaluate the long-term efficacy of dual-hemisphere repetitive transcranial magnetic stimulation ( rTMS ) on poststroke aphasia .


Thirty patients with subacute poststroke nonfluent aphasia were randomly allocated to receive real or sham rTMS .


Each patient received @ rTMS pulses ( @ Hz at @ % of resting motor threshold -LSB- rMT -RSB- over the right unaffected Broca 's area and @ pulses ( @ Hz at @ % rMT ) over the left affected Broca 's area for @ consecutive days followed by speech/language training .


The language section of the Hemispheric Stroke Scale ( HSS ) , the Stroke Aphasic Depression Questionnaire-Hospital Version ( SADQ-H ) , and the National Institutes of Health Stroke Scale ( NIHSS ) were measured before , immediately after the @ sessions , and @ and @ months after the last session .


At baseline , there were no significant differences between groups in demographic and clinical rating scales .


However , there was a significantly greater improvement in the HSS language score as well as in the SADQ-H after real rTMS compared with sham rTMS , which remained significant @ months after the end of the treatment sessions .


This is the first clinical study of dual-hemisphere rTMS in poststroke aphasia .


Combining dual-hemisphere rTMS with language training might be a feasible treatment for nonfluent aphasia ; further multicenter studies are needed to confirm this result .


The randomized , phase III AVAPERL trial evaluated the safety and efficacy of bevacizumab maintenance with or without pemetrexed in nonsquamous nonsmall-cell lung cancer ( nsNSCLC ) .


Progression-free survival ( PFS ) was significantly prolonged with bevacizumab-pemetrexed , but overall survival ( OS ) data were immature .


In this article , we report an independent , updated analysis of survival outcomes in AVAPERL .


Patients with advanced nsNSCLC received first-line bevacizumab ( @ mg/kg ) , cisplatin ( @ mg/m ( @ ) ) , and pemetrexed ( @ mg/m ( @ ) ) every @ weeks ( q@w ) for four cycles .


Nonprogressing patients were randomized to maintenance bevacizumab ( @ mg/kg ) or bevacizumab-pemetrexed ( @ mg/m ( @ ) ) q@w until progression or consent withdrawal .


The primary end point of the trial was PFS ; in this independent OS analysis , participating study centers were contacted to collect survival data on patients still alive at the time of the first analysis .


A total of @ patients received induction treatment .


Disease control was confirmed in @ % of patients ; @ patients were randomized to maintenance treatment with bevacizumab ( n = @ ) or bevacizumab-pemetrexed ( n = @ ) .


At a median follow-up of @ months , patients allocated to bevacizumab-pemetrexed had significantly improved PFS versus those on bevacizumab when measured from randomization -LSB- @ versus @ months , hazard ratio ( HR ) , @ , @ % confidence interval ( CI ) @-@ @ ) ; P < @ -RSB- .


OS events occurred in @ % of all patients .


OS was numerically longer with bevacizumab-pemetrexed versus bevacizumab when measured from randomization -LSB- @ versus @ months , HR @ ( @-@ @ ) ; P = @ -RSB- .


Second-line therapy was administered in @ % and @ % of patients in the bevacizumab and bevacizumab-pemetrexed arms , respectively .


No new adverse events were reported during this updated analysis .


In an unselected population of nsNSCLC patients achieving disease control on platinum-based induction therapy , maintenance with bevacizumab-pemetrexed was associated with a nonsignificant increase in OS over bevacizumab alone .


Preoperative airway assessment in Denmark is based on a non-specific clinical assessment left to the discretion of the responsible anesthesiologist .


The DIFFICAIR trial compares the effect of using a systematic and consistent airway assessment versus a non-specific clinical assessment on the frequency of unanticipated difficult airway management.To prevent outcome bias and selective reporting , we hereby present a detailed statistical analysis plan as an amendment ( update ) to the previously published protocol for the DIFFICAIR trial .


The DIFFICAIR trial is a stratified , parallel group , cluster ( cluster = department ) randomized multicenter trial involving @ departments of anesthesia in Denmark randomized to airway assessment either by the Simplified Airway Risk Index ( SARI ) or by a usual non-specific assessment .


Data from patients ' preoperative airway assessment are registered in the Danish Anesthesia Database .


An objective score for intubation grading the severity , that is the severity of the intubations , as well as the frequency of unanticipated difficult intubation , is measured for each group.Primary outcome measures are the fraction of unanticipated difficult and easy intubations.The database is programmed so that the registration of the SARI is mandatory for the intervention group but invisible to controls.Data recruitment was commenced in October @ and ended in ultimo December @ .


We intend to increase the transparency of the data analyses regarding the DIFFICAIR trial by an a priori publication of a statistical analysis plan .


To assess the effect of an electronic health record-based transitional care intervention involving automated alerts to primary care providers and staff when older adults were discharged from the hospital .


Randomized controlled trial .


Large multispecialty group practice .


Individuals aged @ and older discharged from hospital to home .


In addition to notifying primary care providers about the individual 's recent discharge , the system provided information about new drugs added during the inpatient stay , warnings about drug-drug interactions , recommendations for dose changes and laboratory monitoring of high-risk medications , and alerts to the primary care provider 's support staff to schedule a posthospitalization office visit .


An outpatient office visit with a primary care provider after discharge and rehospitalization within @ days after discharge .


Of the @,@ discharges in the intervention group , @ % had an office visit with a primary care provider within @ days of discharge .


Of the @,@ discharges in the control group , @ % had an office visit with a primary care provider within @ days of discharge .


In the intervention group , @ % experienced a rehospitalization within the @-day period after discharge , compared with @ % in the control group .


The hazard ratio for an office visit with a primary care physician did not significantly differ between the intervention and control groups .


The hazard ratio for rehospitalization in the @-day period after hospital discharge in the intervention versus the control group was @ ( @ % confidence interval = @-@ @ ) .


This electronic health record-based intervention did not have a significant effect on the timeliness of office visits to primary care providers after hospitalization or risk of rehospitalization .


Psychological stress may alter immune function by activating physiological stress pathways .


Building on our previous study , in which we report that stress management training led to an altered self-reported and cortisol response to psychological stress in patients with rheumatoid arthritis ( RA ) , we explored the effects of this stress management intervention on the immune response to a psychological stress task in patients with RA .


In this study , @ patients with RA , who were randomly assigned to either a control group or a group that received short stress management training , performed the Trier Social Stress Test ( TSST ) @ week after the intervention and at a @-week follow-up .


Stress-induced changes in levels of key cytokines involved in stress and inflammatory processes ( for example , interleukin ( IL ) -@ and IL-@ ) were assessed .


Basal and stress-induced cytokine levels were not significantly different in patients in the intervention and control groups one week after treatment , but stress-induced IL-@ levels were lower in patients in the intervention group than in the control group at the follow-up assessment .


In line with our previous findings of lower stress-induced cortisol levels at the follow-up of stress management intervention , this is the first study to show that relatively short stress management training might also alter stress-induced IL-@ levels in patients with RA .


These results might help to determine the role of immunological mediators in stress and disease .


The use of intravenous regional anesthesia ( IVRA ) is limited by pain resulting from the application of tourniquets and postoperative pain .


To assess the efficacy of low-level laser therapy added to IVRA for improving pain related to surgical fixation of distal radius fractures .


The present double-blinded , placebo-controlled , randomized clinical trial involved @ patients who were undergoing surgical fixation of distal radius fractures .


Participants were randomly assigned to either an intervention group ( n = @ ) , who received @ nm laser irradiation as @ Jpoint for @ s over ipsilateral three nerve roots in the cervical region corresponding to C@-C@ vertebrae , and @ nm laser irradiation as @ Jcm@ for @ min in a tangential scanning mode over the affected extremity ; or a control group ( n = @ ) , who underwent the same protocol and timing of laser probe application with the laser switched off .


Both groups received the same IVRA protocol using @ % lidocaine .


The mean visual analogue scale scores were significantly lower in the laser-assisted group than in the lidocaine-only group on all measurements during and after operation ( P < @ ) .


The mean time to the first need for fentanyl administration during the operation was longer in the laser group ( P = @ ) .


The total amount of fentanyl administered to patients was significantly lower in the laser-assisted group ( P = @ ) .


The laser group needed significantly less pethidine for pain relief ( P = @ ) and at a later time ( P = @ ) compared with the lidocaine-only group .


There was no difference between the groups in terms of mean arterial pressure and heart rate .


The addition of gallium-aluminum-arsenide laser irradiation to intravenous regional anesthesia is safe , and reduces pain during and after the operation .


Physical activity ( PA ) is not only an important marker of physical impairment , but also a pathway to improve quality of life and enhance cognitive and social functioning of old individuals .


Yet , making interventional use of PA training as a means for prevention and enhancement of quality of life of nursing home residents has found very limited attention worldwide so far .


That said , the project ` Long-term Care in Motion ' ( LTCMo ) as a part of the INNOVAGE consortium ( funded by the European Commission ) has the following aims : Overall : Install and assess a socially innovative intervention in the nursing home ecology .


Concrete : ( a ) Conceptualization of a multidimensional intervention program ( resident and staff oriented ) with the potential to promote PA in nursing home residents ; ( b ) Mixed-methods assessment of the program based on automated recording as well as questionnaire data .


LTCMo 's PA-related intervention has several components which are applied in parallel manner : ( @ ) Residents are engaged in a physical exercise program that is based on multiple approaches : supervised group sessions , a serious games approach , and specific training in severely impaired persons ; ( @ ) Staff members will receive a competence training with a focus on PA motivation and facilitation of residents ' PA engagement .


Primary outcome assessment ( movement-related behavior of residents ) is completely conducted by means of automated data collection strategies ( accelerometer-based activity recording , sensor-based life space recording ) .


This is enriched by a broad range of secondary outcomes ( e.g. , cognitive performance , depression of residents ; behavioral and attitudinal components of staff ) .


Pre - , post - and @-month follow-up assessment will take place in the target intervention setting as well as in a waiting control condition in which we will also replicate the training and its assessment in a later step .


Although we are faced with methodological challenges ( e.g. , rather small sample size ; no randomized control trial ) , we believe that our approach has something to offer and indeed has some unique characteristics that may have the potential to contribute to the enhancement of nursing home residents ' quality of life and at the same time further PA-related research with vulnerable populations at large .


A prospective , randomized study wias performed to compare two anesthetic methods .


To evaluate the effect of epidural analgesia on postoperative pain , endocrine - metabolic and inflammatory stress response and cellular inmmune responses during major corrective spine surgetry .


The study included @ patients aged @ to @ who were randomly allocated to two equal groups .


Group I ( n = @ ) had continuous epidural analgesia ( E@ ) and sevoflurane anesthesia during surgety and continuous epidural analgesia with ropivacaine and fentanil after surgery ; Group @ ( n = @ ) had general anesthesia with sevoflurane and fentanil and systemic administration of opioids after surgery .


Patient pain , PONV syndrome , mobility , and satisfaction were measured after surgery along with plasma levels ofcortisol , ghmcose , interleukins IL-@ , IL-@ , and IL-@ during and after surgemy C-reactive protein ( CRP ) , and cell-surface receptor expression of immune cells ( cluster of differentiation ) HLA-DR + / CD@ - , HLA-DR + / CD@ + , HILA-DR , CD@ , CD@ , CD@ , CD@ , CD@ CD@/@ + , and CD@/@ + / CD@ + ) were measured perioperatively .


In group @ , there were significantly less pain , less nausea , earlier mobility , and higher satisfaction than those in group @ .


Group I has also demonstrated significantly less plasma levels of glucose , cortisol , CRP , IL-l , IL-@ , IL-@ at various stages .


The ratio of CD@/CD@ ( p = @ ) and B cells ( p = @ ) have increased by postoperative day @ in group @ .


NK-cells ( CD@/@ + ) have decreased significantly by day @ after surgery ( p = @ ) compared to the group @ .


T-lymphocytes , ( CD@ ) have decreased in all patients , but they were significantly lower in patients receiving opioids , compared wiith EA .


Polerfulr afferent stimulation in major corrective spine surgery accompanied by immunosuppression for at least a wieek after surgery .


EA reduces the surgical stress response , prevents postoperative lymphocyte apoptosis and thus , increases stress and infectious resistance .


Central obesity in polycystic ovary syndrome ( PCOS ) is associated with increased inflammatory markers and increased risk for type @ diabetes .


To evaluate if improved body composition during treatment with metformin ( M ) vs. oral contraceptive pills ( OCP ) was associated with changes in circulating adiponectin , interleukin ( IL ) -@ , and monocyte chemoattractant protein ( MCP ) -@ .


Ninety patients with PCOS were randomized to @-month treatment with M ( @ g/day ) , M + OCP ( @ mg desogestrel + @ microgram ethinylestradiol ) or OCP .


Adiponectin , IL-@ , MCP-@ , whole body DXA scans , and clinical evaluations were performed before and after the intervention period in the @ study completers .


Changes in inflammatory markers and changes in total and regional fat mass estimates .


Adiponectin , IL-@ , and MCP-@ levels were unchanged during the three types of medical intervention .


Treatment with M and M + OCP was superior to OCP regarding decreased regional fat mass .


Baseline adiponectin and IL-@ were associated with BMI , waist , and trunk fat mass .


Changes in trunk fat were significantly associated with changes in IL-@ and MCP-@ during M + OCP .


Long-term treatment with M alone or in combination with OCP was associated with improved body composition compared to OCP , whereas inflammatory markers were unchanged .


OCP was not associated with increased inflammatory markers despite a small but significant weight gain .


To compare the effects of bupivacaine , lidocaine and saline injections in alleviating post tonsillectomy pain .


We recruited @ patients into the study .


All subjects were randomly allocated into @ groups .


Group @ received @ % sodium chloride ( saline group ) , group @ received @ % bupivacaine ( bupivacaine group ) and group @ received @ % lidocaine ( lidocaine group ) , infiltrated around each tonsil .


Pain was evaluated with McGrath 's face scale .


The postoperative pain scores at @ and @ hours were similar among the groups ( P > @ ) .


The pain scores in the bupivacaine group were lower than those in the saline group at @ h ( P < @ ) .


The pain scores in the bupivacaine and lidocaine groups were significantly lower than those in the saline group from @ to @ hours until day @ ( P < @ ) .


There was no difference between the bupivacaine and lidocaine groups ( P > @ ) .


Local infiltration of bupivacaine is a relatively and safe effective method and is equivalent to use of lidocaine for post tonsillectomy pain .


The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi ( a specific and compound sensation during the acupuncture ) , which is necessary to achieve the best therapeutic effect .


However , the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence .


This study aims to compare the efficacy of acupuncture with either strong ( intended to elicit de qi ) or weak stimulation among patients with allergic rhinitis .


This study compares real versus sham acupuncture in @ patients with a history of persistent allergic rhinitis ( PER ) or intermittent allergic rhinitis ( IAR ) and with a positive skin prick test ( SPT ) .


The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine ( China ) .


In the study , patients will be randomly assigned into two groups by computer-generated randomization and assessed prior to treatment .


They will then receive @ sessions of treatments for @ consecutive weeks and have a follow-up phase lasting @ weeks .


The main outcome measures include the primary and secondary indicators .


Primary indicators are subjective symptoms scores as evaluated by visual analogue scales ( VAS ) , rhinoconjunctivitis quality of life questionnaires ( RQLQ ) , and the Modified Massachusetts General Hospital acupuncture sensation scale , Chinese version ( C-MMASS ) .


The secondary indicators are the results of laboratory examinations , such as serum allergen-specific immunoglobulin E ( sIgE ) nasal inflammatory cells counts ( mast cells , eosinophils , and T cells ) , and nitric oxide concentration in nasal excretion .


The use of anti-allergic medication will also be recorded as one of the secondary indicators .


Furthermore , adverse events will be recorded and analyzed .


Intention-to-treat analysis ( ITT ) and per-protocol ( PP ) analysis will be performed to test and verify the results in this trial .


The results of this trial will demonstrate the efficacy of using acupuncture to treat allergic rhinitis and verify whether the effectiveness of acupuncture is related to the needle sensation de qi .


The two-operator technique for colonoscopy , with the endoscopy assistant actively advancing and withdrawing the scope , is still commonly practiced in Europe .


As uncontrolled data has suggested that the one-operator technique is associated with a higher adenoma detection rate , we tested the hypothesis that the two-operator-technique can achieve comparable performances in terms of adenoma detection .


Non-inferiority trial in which consecutive adult outpatients were randomised to undergo colonoscopy by one ( one-operator ) or by four endoscopists .


Each performed half the procedures by one-operator and half by two-operator technique independently of routine clinical practice .


Main outcome measure was adenoma detection rate .


@ subjects ( @ % males , mean age @ @ years ) were randomised to one ( n = @ ) or to two-operator technique ( n = @ ) colonoscopy .


No significant differences were found in adenoma detection ( @ % vs. @ % , p = @ ) , or cecal intubation rate , procedure times , and patient tolerability .


No differences were found in the subgroup analysis according to routinely adopted colonoscopy technique .


This study does not confirm a higher adenoma detection rate for one-operator technique colonoscopy .


Changing current practice to improve adenoma detection rate for endoscopists routinely using two-operator technique is not warranted .


The aim of this case-control study was to compare the efficacy of ethinyl estradiol/drospirenone and Fructus agni casti in women with severe primary dysmenorrhea measuring uterine artery blood flow via Doppler ultrasonography .


A total of @ women with severe primary dysmenorrhea and @ healthy women ( control ) were included in this study .


Thirty patients were treated with ethinyl estradiol @ mg/drospirenone ( group @ ) and another @ were treated with Fructus agni casti ( group @ ) during three menstrual cycles .


Before and at the end of third month of therapy visual analog scale ( VAS ) scores , pulsatility index ( PI ) , resistance index ( RI ) of uterine artery were recorded before and after receiving therapy on the first day of the menstrual cycle .


Mean PI and RI values in patients with severe primary dysmenorrhea were significantly higher than in the control groups on the first day of the menstrual cycle ( P < @ ) .


Mean PI and RI values were significantly lower after the treatment in both groups compared to before values ( P < @ for both ) .


After using the drugs for three menstrual cycles , VAS scores were significantly dropped in both groups compared to before treatment values ( P < @ for both ) ; however , there were no significant differences in terms of Doppler findings between group @ and @ .


The effectiveness of Fructus agni casti was similar to that of ethinyl estradiol/drospirenone in patients with primary dysmenorrhea .


Dyspnea and exercise intolerance are the symptoms that most affect the quality of life of children and adolescents with respiratory disorders resulting from cystic fibrosis ( CF ) .


To evaluate the effect of noninvasive ventilation ( NIV ) on treadmill @-min walk distance and regional chest wall volumes in cystic fibrosis patients .


Crossover clinical trial , randomized , controlled and open with @ children and adolescents with CF , aged @-@ years , with pulmonary impairment ( NTC@ ) .


The patients performed a treadmill walking test ( TWT ) during @min , with and without NIV on a BiLEVEL mode , an interval of @-@hbetween tests .


Before and after each test , patients were assessed by spirometry and optoelectronic plethysmography .


Walking distance in TWT with NIV was significantly higher that without ventilatory support ( meansd : @ vs. @ km , p = @ ) .


TWT with NIV increase forced expiratory volume on @s ( FEV@ ; p = @ ) , tidal volume ( Vt ; p = @ ) , minute ventilation ( MV ; p = @ ) , pulmonary rib cage volume ( Vrcp ; p = @ ) , and decrease the abdominal volume ( Vab ; p = @ ) after test .


There was a significant reduction in oxygen saturation ( p = @ ) and permanent increase in respiratory rate after @min ( p = @ ) after the end test without NIV .


During the walking test on the treadmill , the NIV change thoracoabdominal kinematics and lung function in order to optimized ventilation and tissue oxygenation , with improvement of walk distance .


Consequently , NIV is an effective tool to increase functional capacity in children and adolescents with cystic fibrosis .


This study aimed to compare three-dimensional conformal radiotherapy ( @D CRT ) and intensity-modulated radiotherapy ( IMRT ) combined with concurrent chemotherapy for cervical cancer .


A total of @ patients with Grades IIa-IIIb cervical cancer were randomly divided into two groups , namely , the IMRT group for IMRT plan ( primary lesion , @ Gy/@ ; the pelvic wall lymphatic drainage area , @ Gy/@ ) , and the @D CRT group ( conformal pelvic radiotherapy , @ Gy/@ ; subsequent supplement of pelvic wall , @ Gy/@ ) .


Both groups received concurrent chemotherapy of nedaplatin @ mg/m@ weekly for six cycles , with an after-loading therapy of @ Gy/@ each time .


In the IMRT group , the grade III diarrhea rate was @ % and the rate in the @D CRT group was @ % ; both groups significantly differed .


No significant difference was observed between the overall survival and disease-free survival in first , second , and third years in both groups .


Cervical cancer IMRT can significantly reduce the incidence of acute enteritis .


For standard @D CRT , no significant difference was observed in overall survival and disease-free survival .


The Helicobacter pylori eradication rate with standard triple therapy is very low .


H. pylori is known to require the nickel-containing metalloenzymes urease and NiFe-hydrogenase to survive at the low pH environment in the stomach .


To compare the H. pylori eradication rate of a nickel free-diet associated with standard triple therapy and standard triple therapy alone as the first-line regimen .


Fifty-two sex - and age-matched patients at the first diagnosis of H. pylori infection were randomized @:@ into two different therapeutic schemes : ( @ ) standard LCA ( @ patients ) : lansoprazole @ mg bid , clarithromycin @ mg bid and amoxicillin @,@ mg bid for @ days with a common diet ; ( @ ) standard LCA plus a nickel free-diet ( NFD-LCA ) ( @ patients ) .


Patients followed @ days of a nickel-free diet plus a week of lansoprazole @ mg bid , clarithromycin @ mg bid and amoxicillin @,@ mg bid starting from day @ of the diet .


All patients completed the study .


A significantly higher eradication rate was observed in the NFD-LCA group ( @/@ ) versus LCA group ( @/@ ) ( p < @ ) .


Only a few patients ( @ of @ ) reported the occurrence of mild therapy-related side effects , without any significant differences between the two groups .


The addition of a nickel-free diet to standard triple therapy significantly increases the H. pylori eradication rate .


The reduction of H. pylori urease activity due to the nickel-free diet could expose the bacterium to gastric acid and increase H. pylori 's susceptibility to amoxicillin .


Further studies are necessary to confirm this preliminary result .


The majority of adults are not meeting the guidelines for physical activity despite activity being linked with numerous improvements to long-term health .


In light of this , researchers have called for more community-level interventions .


The main objective of the present study was to evaluate whether a community-level physical activity intervention increased the activity levels of rural communities .


@ rural villages ( clusters ) were randomised to receive the intervention in one of four time periods between April @ and December @ .


The Devon Active Villages intervention provided villages with @ weeks of physical activity opportunities for all age groups , including at least three different types of activities per village .


Each village received an individually tailored intervention , incorporating a local needs-led approach .


Support was provided for a further @ months following the intervention .


The evaluation study used a stepped wedge cluster randomised controlled trial design .


All @ villages were measured at each of five data collection periods using a postal survey .


The primary outcome of interest was the proportion of adults reporting sufficient physical activity to meet internationally recognised guidelines .


Minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome .


To compare between intervention and control modes , random effects linear regression and marginal logistic regression models were implemented for continuous and binary outcomes respectively .


@,@ adults ( @ intervention , @ control ) completed the postal survey ( response rate @ % ) .


The intervention did not increase the odds of adults meeting the physical activity guideline ( adjusted OR @ , @ % CI : @ to @ ; P = @ ) , although there was weak evidence of an increase in minutes of moderate-and-vigorous-intensity activity per week ( adjusted mean difference = @ , @ % CI : -@ to @ ; P = @ ) .


The ineffectiveness of the intervention may have been due to its low penetration-only @ % of intervention mode participants reported awareness of the intervention and just @ % reported participating in intervention events .


A community-level physical activity intervention providing tailored physical activity opportunities to rural villages did not improve physical activity levels in adults .


Greater penetration of such interventions must be achieved if they are to increase physical activity prevalence at the community level .


Patients with a recent myocardial infarction ( MI ) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption ( Vo@ peak ) .


The impact of a Tai Chi Chuan ( TCC ) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed .


Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI .


A single-blind randomized clinical trial was conducted .


The researchers who performed the tests were blinded to group allocation .


Between the @th and @st days after hospital discharge , all patients performed a cardiopulmonary exercise testing and a laboratory blood workup .


Mean age was similar ( @ years in the TCC group and @ years in the control group ) .


Patients allocated to the intervention group performed @ weekly sessions of TCC Beijin style for @ weeks ( n = @ ) .


The control group participated in @ weekly sessions of full-body stretching exercises ( n = @ ) .


After the @-week study period , participants in the TCC group experienced a significant @ % increase in Vo@ peak from baseline ( @ @ to @ @ mL/kg per minute ) , whereas control participants had a nonsignificant @ % decline in Vo@ peak ( @ @ to @ @ mL/kg per minute ) .


There was a significant difference between the @ groups ( P < @ ) .


Tai Chi Chuan practice was associated with an increase in Vo@ peak in patients with a recent MI and may constitute an effective form of cardiac rehabilitation in this patient population .


To evaluate the in vitro and in vivo effects of three treatment regimens on dentin permeability and reduction of dentin hypersensitivity ( DH ) .


The desensitization treatments were : Gluma Desensitizer PowerGel ( GLU ) , MS Coat One ( MSC ) , and dentin burnishing with fiber-resin burs ( STB ) .


A split-chamber device was used to determine the permeability of dentin slices cut from human molars in vitro .


Fluid flow through dentin was recorded with a photochemical method after EDTA cleaning , albumin soaking and desensitization treatment ( n = @ ) .


@ study participants with three severely hypersensitive teeth each were enrolled .


Sensitivity was determined with an air stimulus before , immediately after treatment , and after @ , @ and @ months , using a verbal rating scale .


From the @ study participants enrolled , @ completed the trial .


Permeability at baseline and after albumin soaking was not significantly different .


All treatments produced reduced fluid flow through dentin ( P > @ ) .


All treatments reduced DH significantly ( no or moderate sensitivity ) .


Statistical results revealed significant differences among the treatments ( P = @ ) .


Mann-Whitney comparisons showed GLU , STB < MSC .


Isotretinoin has been frequently used for acne therapy .


However , it has limitation in acceptance because of its adverse effects .


Although antihistamine recently revealed to decrease the lipogenesis , evidence is lacking regarding the clinical relevance of antihistamine in the treatment of acne .


To evaluate the clinical efficacy and tolerability of antihistamine as an adjuvant treatment of isotretinoin .


Forty patients with moderate acne were included in this randomized , controlled comparative study .


Twenty patients were treated with isotretinoin and @ patients were treated with additional antihistamine , desloratadine .


Assessment was made at baseline , after @ , @ , @ and @ weeks of treatment .


At week @ , compared with isotretinoin only group , isotretinoin with additional antihistamine group showed more statistically significant decrease in acne lesion counts ( non-inflammatory lesions : @ % vs. @ % ; inflammatory lesions : @ % vs. @ % ; total lesions : @ % vs. @ % ; all P < @ ) .


Significant decrease was also observed in the score of global acne grading system and the measured value of sebum and erythema .


Moreover , acne flare during the treatment occurred less frequently and adverse events of isotretinoin were more tolerable in additional antihistamine group .


This results provide early evidence that antihistamine has a synergic effect with minimizing the side-effect of isotretinoin , and may be used as an adjuvant treatment of moderate acne .


Ospemifene is a new oral estrogen receptor agonist/antagonist with tissue-selective effects approved for the treatment of moderate to severe dyspareunia , a symptom of postmenopausal vulvar and vaginal atrophy ( VVA ) .


The aim of the study is to assess ospemifene or lubricant use on the clinical signs of VVA .


Subjects in three double-blind , placebo-controlled clinical trials were randomized to ospemifene or placebo .


In two of the trials , women were provided nonhormonal lubricants for use as needed , and a preplanned evaluation of the frequency of lubricant use was performed .


Additionally , a post hoc placebo group analysis for impact of lubricant use or nonuse on physiologic effects of the percentage of superficial and parabasal cells ( maturation index ) and vaginal pH was conducted .


A secondary preplanned end point included visual examination of the vagina ( clinical signs of vaginal dryness , petechiae , pallor , friability , and redness of the mucosa ) comparing change from baseline to end of treatment for the ospemifene @-mg/day group and vs. placebo .


The primary end points in the phase @ clinical trials included the percentage of superficial cells , parabasal cells , vaginal pH , and most bothersome symptoms compared with placebo .


There was no significant difference in physiologic effects between placebo lubricant users vs. nonusers in either @-week study .


Compared with baseline , substantially more subjects receiving ospemifene @mg/day than placebo showed complete resolution of clinical signs of VVA after @ and @ weeks of treatment .


Ospemifene substantially improved clinical signs of VVA .


Within the placebo group , there was no difference in physiologic effects in lubricant users vs. nonusers .


Based on gynecologic evaluation of the vagina , benefits were apparent at @ weeks and sustained for @ weeks in the ospemifene-treated subjects with significant improvement over placebo .


In these three clinical trials , in contrast to ospemifene-treated women , placebo subjects who utilized lubricants had no improvement in their underlying vaginal physiology .


BCG vaccination prevents disseminated tuberculosis in children , but it is contraindicated for persons with human immunodeficiency virus ( HIV ) infection because it can result in severe disease in this population .


In tuberculosis-endemic regions , BCG vaccine is administered soon after birth , before in utero and peripartum HIV infection is excluded .


We therefore assessed the immunogenicity of BCG vaccine in HIV-exposed infants who received BCG at birth or at @ weeks of age .


HIV-exposed , uninfected infants were randomly assigned to receive BCG vaccination at birth ( the early vaccination arm ) or @ weeks of age ( the delayed vaccination arm ) .


BCG-specific proliferative and intracellular cytokine responses were assessed in @ infants per arm at @ , @ , and @ weeks of life .


There was no difference in BCG-specific T-cell proliferation between the study arms @ weeks after vaccination .


However , at @ weeks of age , the frequency of interferon - expressing CD@ ( + ) T cells and multifunctional BCG-specific responses in the delayed vaccinated arm were significantly higher than those in the early vaccination arm ( P = @ and P = @ , respectively ) .


The immunogenicity of BCG vaccination in HIV-exposed , uninfected infants is not compromised when delayed until @ weeks of age and results in robust BCG-specific T-cell responses at @ weeks of age .


These findings support further evaluation of this modified BCG vaccination strategy for HIV-exposed infants .


To characterize the association between clinical symptoms and anatomical and functional cerebral deficits in codeine-containing cough syrups ( CCS ) users using voxel-based morphometry and resting state functional connectivity analysis .


Participants were @ CCS users and @ matched controls .


Both groups were scanned using a volumetric three-dimensional fast field echo sequence and a gradient-echo echo-planar imaging sequence .


Impulsivity traits of both groups were evaluated with the Barratt Impulsiveness Scale @ ( BIS @ ) .


Voxel-based morphometry was used to characterize gray matter ( GM ) deficits in CCS users .


The clinical significance of regional volume reduction was investigated by evaluating its association with impulsivity in CCS users and with alterations in resting state functional connectivity when brain regions with GM volume reduction were used as seed areas .


Significantly decreased GM volume was observed in CCS users in bilateral ventral medial prefrontal cortex ( vmPFC ) which was related to greater impulsivity in CCS users .


Significantly decreased integration was found in CCS users between the vmPFC and the default mode network .


Also , significantly enhanced functional connectivity was found between the vmPFC and the right insula , and the right dorsal lateral PFC. Negative correlation was observed between BIS total scores , scores for attentional impulsivity and vmPFC-inferior parietal lobe connectivity in CCS users .


The findings revealed volume loss and aberrant functional organization in vmPFC among CCS users .


In addition , the decreased vmPFC GM volume and attenuated functional connectivity of the vmPFC-inferior parietal lobe network were associated with clinical higher impulsivity trait in CCS users .


To observe the differences in the clinical efficacy on menopausal irritability between acupuncture and medication .


Sixty cases of menopausal irritability were randomized into an acupuncture group ( @ cases ) and a medication group ( @ cases ) .


In the acupuncture group , the warming needling manipulation was applied at the key acupoints such as Hegu ( LI @ ) and Taichong ( LR @ ) , once a day , @ treatments made one session .


Totally , @ sessions were required .


In the medication group , @ mg diazepam tablets were prescribed , three times a day , for @ days totally .


The clinical efficacy , the modified Kupperman score and self-rated health measurement scale ( SRHMS ) were compared before and after treatment in the two groups .


RESULTS The total effective rate was @ % ( @/@ ) in the acupuncture group and @ % ( @/@ ) in the medication group .


The difference in the clinical efficacy was not significant between the two groups ( P > @ ) .


The modified Kupperman score and SRHMS score were both reduced obviously after treatment in the two groups , indicating the significant difference ( all P < @ ) .


The reduction of two scores in the acupuncture group was more obvious than those in the medication group ( Kupperman : @ + / - @ vs @ + / - @ ; SRHMS : @ + / - @ vs @ + / - @ , both P < @ ) .


The acupuncture and medication are effective in the treatment of menopausal irritability , but the efficacy of warming needling manipulation is better than that of diazepam tablets .


Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects .


The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known .


We conducted a randomized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in @,@ patients with moderate-to-high-risk atrial fibrillation ( median follow-up , @ years ) .


The primary efficacy end point was stroke or systemic embolism .


Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period .


The principal safety end point was major bleeding .


The annualized rate of the primary end point during treatment was @ % with warfarin ( median time in the therapeutic range , @ % ) , as compared with @ % with high-dose edoxaban ( hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ for noninferiority ) and @ % with low-dose edoxaban ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ for noninferiority ) .


In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


The annualized rate of major bleeding was @ % with warfarin versus @ % with high-dose edoxaban ( hazard ratio , @ ; @ % CI , @ to @ ; P < @ ) and @ % with low-dose edoxaban ( hazard ratio , @ ; @ % CI , @ to @ ; P < @ ) .


The corresponding annualized rates of death from cardiovascular causes were @ % versus @ % ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , and @ % ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were @ % versus @ % ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , and @ % ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes .


( Funded by Daiichi Sankyo Pharma Development ; ENGAGE AF-TIMI @ ClinicalTrials.gov number , NCT@ . )


Interface choice is crucial for non-invasive ventilation ( NIV ) success .


We compared a new interface , the helmet next ( HN ) , with the facial mask ( FM ) and the standard helmet ( HS ) in twelve healthy volunteers .


In this study , five NIV trials were randomly applied , preceded and followed by a trial of unassisted spontaneous breathing ( SB ) .


Baseline settings , for example , @ cmH@O of both inspiratory pressure support ( PS ) and positive end-expiratory pressure ( PEEP ) , were applied through FM , HS and HN , while increased settings ( PS and PEEP of @ cmH@O ) were only applied through HS and HN .


We measured flow , airway , esophageal and gastric pressures , and calculated inspiratory effort indexes and trigger delays .


Comfort was assessed with a visual-analog-scale .


We found that FM , HS and HN at baseline settings were not significantly different with respect to inspiratory effort indexes and comfort .


Inspiratory trigger delay and time of synchrony ( TI , synchrony ) were significantly improved by FM compared to both helmets , whereas expiratory trigger delay was shorter with FM , as opposed to HS only .


HN at increased settings performed better than FM in decreasing inspiratory effort measured by pressure-time product of transdiaphragmatic pressure ( PTPdi ) / breath ( @ versus @ cmH@Os ) , and PTPdi/min ( @ versus @ cmH@Os/min ) , and PTPdi/L ( @ versus @ cmH@Os/L ) .


TI , synchrony was inferior between HN and HS at increased settings and FM .


HN might hold some advantages with respect to interaction and synchrony between subject and ventilator , but studies on patients are needed to confirm these findings .


The benefits of prophylactic central compartment lymph node dissection ( pCCND ) in papillary thyroid cancer ( PTC ) are still under investigation .


This treatment seems to reduce PTC recurrence/mortality rates but has a higher risk of surgical complications .


The lack of prospective randomized trials does not allow definitive recommendations .


The aim of this prospective randomized controlled study was to evaluate the clinical advantages and disadvantages of pCCND .


A total of @ patients with PTC without evidence of preoperative/intraoperative lymph node metastases ( cN@ ) were randomly assigned to either Group A ( n = @ ) and treated with total thyroidectomy ( TTx ) or Group B ( n = @ ) and treated with TTx + pCCND .


After @ years of followup , no difference was observed in the outcome of the two groups .


However , a higher percentage of Group A were treated with a higher number of ( @ ) I courses ( P = @ ) , whereas a higher prevalence of permanent hypoparathyroidism was observed in Group B ( P = @ ) .


No preoperative predictors of central compartment lymph node metastases ( N@a ) were identified .


Only three patients were upstaged , and the therapeutic strategy changed in only one case .


cN@ patients with PTC treated either with TTx or TTx + pCCND showed a similar outcome .


One advantage of TTx + pCCND was a reduced necessity to repeat ( @ ) I treatments , but the disadvantage was a higher prevalence of permanent hypoparathyroidism .


Almost @ % of patients with PTC had micrometastatic lymph nodes in the central compartment , but none of the presurgical features analyzed , including BRAF mutation , was able to predict their presence ; moreover , to be aware of their presence does not seem to have any effect on the outcome .


The cause of death in patients with chronic kidney disease ( CKD ) varies with CKD severity , but variation has not been quantified .


Retrospective analysis of prospective randomized clinical trial .


We analyzed @,@ individuals with anemia and diabetic CKD from TREAT , a randomized trial comparing darbepoetin alfa and placebo .


Baseline estimated glomerular filtration rate ( eGFR ) and protein-creatinine ratio ( PCR ) .


Cause of death as adjudicated by a blinded committee .


Median eGFR and PCR ranged from @ mL/min/@ @ m ( @ ) and @ g/g in quartile @ ( Q@ ) to @ mL/min/@ @ m ( @ ) and @ g/g in Q@ ( P < @ ) .


Of @ deaths , @ , @ , and @ were due to cardiovascular ( CV ) , non-CV , and unknown causes , respectively .


Cumulative CV mortality at @ years was higher with lower eGFR ( Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; P < @ ) or higher PCR ( Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; P < @ ) .


Similarly , non-CV mortality was higher with lower eGFR ( Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; P < @ ) or higher PCR ( Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; Q@ , @ % ; P = @ ) .


Sudden death was @-fold higher with lower eGFR ( P = @ ) and @-fold higher with higher PCR ( P < @ ) .


Infection-related mortality was @-fold higher in the lowest eGFR quartile ( P < @ ) and @-fold higher in the highest PCR quartile ( P < @ ) .


The overall proportion of CV and non-CV deaths was not significantly different across eGFR or PCR quartiles .


Results may not be generalizable to nondiabetic CKD or diabetic CKD in the absence of anemia .


Measured GFR was not available .


In diabetic CKD , both lower baseline GFR and higher PCR are associated with higher CV and non-CV mortality rates , particularly from sudden death and infection .


Efforts to improve outcomes should focus on CV disease and early diagnosis and treatment of infection .


A culturally focused psychiatric ( CFP ) consultation service was implemented to increase engagement in mental health care and reduce depressive symptoms among adult Latino primary care patients .


The aim of this study was to assess preliminary efficacy of the CFP consultation service to reduce depressive symptoms .


In a randomized controlled study , primary care clinics were randomly selected to provide either the two-session CFP intervention or enhanced usual care .


For CFP intervention participants , study clinicians ( psychologists or psychiatrists ) provided a psychiatric assessment , psychoeducation , cognitive-behavioral tools , and tailored treatment recommendations ; primary care providers were provided a consultation summary .


Depressive symptoms ( as measured by the Quick Inventory of Depressive Symptomatology-Self Rated -LSB- QIDS-SR -RSB- ) were assessed at baseline and six-month follow-up .


Multiple regression analysis was conducted to evaluate whether CFP intervention participants showed greater improvement in depressive symptoms at follow-up , with control for baseline depression , clinic site , and significant covariates .


Participants ( N = @ ) were primarily Spanish-monolingual speakers ( @ % ) .


Although depressive symptoms remained in the moderate range for both groups from baseline to six months , symptom reduction was greater among CFP intervention participants ( meanSD change in QIDS-SR score = @ ) than those in usual care ( change = @ ) .


The final multiple regression model indicated that participation in the CFP intervention predicted lower depressive symptoms at follow-up ( unstandardized beta = -@ , p = @ ) , independent of baseline depressive symptoms , clinic site , age , gender , and employment status .


Results suggest that Latinos experiencing depressive symptoms may benefit from a short-term CFP consultation .


Findings also support the integration of psychiatric interventions for Latinos in the primary care setting .


Sentinel-node biopsy , a minimally invasive procedure for regional melanoma staging , was evaluated in a phase @ trial .


We evaluated outcomes in @ patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation , with lymphadenectomy for nodal relapse ( observation group ) , or wide excision and sentinel-node biopsy , with immediate lymphadenectomy for nodal metastases detected on biopsy ( biopsy group ) .


Results No significant treatment-related difference in the @-year melanoma-specific survival rate was seen in the overall study population ( @ % with and @ % without nodal metastases ) .


Mean ( SE ) @-year disease-free survival rates were significantly improved in the biopsy group , as compared with the observation group , among patients with intermediate-thickness melanomas , defined as @ to @ mm ( @ @ % vs. @ @ % ; hazard ratio for recurrence or metastasis , @ ; P = @ ) , and those with thick melanomas , defined as > @ mm ( @ @ % vs. @ @ % ; hazard ratio , @ ; P = @ ) .


Among patients with intermediate-thickness melanomas , the @-year melanoma-specific survival rate was @ @ % among those with metastasis versus @ @ % for those without metastasis ( hazard ratio for death from melanoma , @ ; P < @ ) ; among patients with thick melanomas , the respective rates were @ @ % and @ @ % ( hazard ratio , @ ; P = @ ) .


Biopsy-based management improved the @-year rate of distant disease-free survival ( hazard ratio for distant metastasis , @ ; P = @ ) and the @-year rate of melanoma-specific survival ( hazard ratio for death from melanoma , @ ; P = @ ) for patients with intermediate-thickness melanomas and nodal metastases .


Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group , and a significant treatment benefit persisted .


Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy .


Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas .


( Funded by the National Cancer Institute , National Institutes of Health , and the Australia and New Zealand Melanoma Trials Group ; ClinicalTrials.gov number , NCT@ . )


Few studies have evaluated the effects of rabeprazole on low-dose aspirin ( LDA ) - induced gastroduodenal injuries .


To conduct a randomised , double-blind , triple-dummy , active-controlled , multicentre trial , named the PLANETARIUM study , to assess the efficacy , dose-response relationship and safety of rabeprazole for peptic ulcer recurrence in Japanese patients on long-term LDA therapy .


Eligible patients had a history of endoscopically confirmed peptic ulcers and were receiving long-term LDA ( @ or @ mg/day ) therapy for cardiovascular or cerebrovascular protection .


Subjects were randomly segregated into three groups receiving rabeprazole @ mg once daily ( standard dose in Japan ) , rabeprazole @ mg once daily , or teprenone ( geranylgeranylacetone ; mucosal protective agent commercially available in Japan ) @ mg three times per day as an active control .


The primary endpoint was recurrence of peptic ulcers over @ weeks .


Among @ randomised subjects , @ subjects ( n = @ , @ , @ , respectively ) constituted the full analysis set .


The cumulative recurrence rates of peptic ulcers over @ weeks in the @ - and @-mg rabeprazole groups were @ % and @ % , respectively , both of which were significantly lower than that in the teprenone group ( @ % ) .


The cumulative occurrence rate of bleeding ulcers over @ weeks in the teprenone group was @ % , while bleeding ulcers were not observed in the @ - or @-mg rabeprazole groups .


Rabeprazole was well tolerated at both doses .


Rabeprazole prevents the recurrence of peptic ulcers with no evidence of a major dose-response effect in subjects on low-dose aspirin therapy .


Nintedanib ( formerly known as BIBF @ ) is an intracellular inhibitor that targets multiple tyrosine kinases .


A phase @ trial suggested that treatment with @ mg of nintedanib twice daily reduced lung-function decline and acute exacerbations in patients with idiopathic pulmonary fibrosis .


We conducted two replicate @-week , randomized , double-blind , phase @ trials ( INPULSIS-@ and INPULSIS-@ ) to evaluate the efficacy and safety of @ mg of nintedanib twice daily as compared with placebo in patients with idiopathic pulmonary fibrosis .


The primary end point was the annual rate of decline in forced vital capacity ( FVC ) .


Key secondary end points were the time to the first acute exacerbation and the change from baseline in the total score on the St. George 's Respiratory Questionnaire , both assessed over a @-week period .


A total of @ patients were randomly assigned in a @:@ ratio to receive nintedanib or placebo .


The adjusted annual rate of change in FVC was -@ ml with nintedanib versus -@ ml with placebo ( difference , @ ml ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) in INPULSIS-@ and -@ ml with nintedanib versus -@ ml with placebo ( difference , @ ml ; @ % CI , @ to @ ; P < @ ) in INPULSIS-@ .


In INPULSIS-@ , there was no significant difference between the nintedanib and placebo groups in the time to the first acute exacerbation ( hazard ratio with nintedanib , @ ; @ % CI , @ to @ ; P = @ ) ; in INPULSIS-@ , there was a significant benefit with nintedanib versus placebo ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


The most frequent adverse event in the nintedanib groups was diarrhea , with rates of @ % and @ % in the nintedanib and placebo groups , respectively , in INPULSIS-@ and @ % and @ % in the two groups , respectively , in INPULSIS-@ .


In patients with idiopathic pulmonary fibrosis , nintedanib reduced the decline in FVC , which is consistent with a slowing of disease progression ; nintedanib was frequently associated with diarrhea , which led to discontinuation of the study medication in less than @ % of patients .


( Funded by Boehringer Ingelheim ; INPULSIS-@ and INPULSIS-@ ClinicalTrials.gov numbers , NCT@ and NCT@ . )


Approximately @ % of children younger than @ years experience at least @ episode of wheezing .


Antiasthmatic medication is routinely prescribed , but its effectiveness remains unclear .


Our study was aimed to evaluate the effect of anti-inflammatory treatment on frequency and severity of preschool wheeze episodes ( PWEs ) .


Children aged @ to @ months with the first up to the third PWE were randomly assigned to receive montelukast , fluticasone , or no treatment for @ weeks .


The outcome measures were the number of PWEs , the number of hospitalizations due to PWE , and the severity of respiratory symptoms .


results : There were no significant differences in outcome measures between the groups .


However , tobacco-exposed children treated with fluticasone had significantly fewer PWEs ( P = @ ) .


Neither montelukast nor fluticasone has proven effective in the prevention of PWE recurrence .


Children of smoking parents may benefit from fluticasone treatment after PWE .


This observation requires confirmation in larger studies .


The efficacy of antibiotic prophylaxis for the prevention of surgical-site infection ( SSI ) after open tension-free inguinal hernia repair remains controversial .


A double-blind , randomized , placebo-controlled trial was conducted .


Patients who underwent elective open mesh-plug hernia repair were eligible for randomization .


In the antibiotic prophylaxis group , @ g cefazolin was intravenously administrated @ minutes before the incision .


In the placebo group , an equal volume of sterile saline was administered .


The primary end point was the incidence of SSI .


A total of @ patients were enrolled .


SSI developed in @ of @ patients ( @ % ) in the antibiotic prophylaxis group and @ of @ patients ( @ % ) in the placebo group , indicating a significant difference between the @ groups ( relative risk ratio , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Other complications occurred in @ patients : @ ( @ % ) in the antibiotic prophylaxis group and @ ( @ % ) in the placebo group ( P = @ ) .


This study indicates that antibiotic prophylaxis is effective for the prevention of SSI after open mesh-plug hernia repair .


Postoperative radiation therapy for stage I endometrial cancer improves locoregional control but is without survival benefit .


To facilitate treatment decision support for individual patients , accurate statistical models to predict locoregional relapse ( LRR ) , distant relapse ( DR ) , overall survival ( OS ) , and disease-free survival ( DFS ) are required .


Clinical trial data from the randomized Post Operative Radiation Therapy for Endometrial Cancer ( PORTEC-@ ; N = @ patients ) and PORTEC-@ ( N = @ patients ) trials and registered group ( grade @ and deep invasion , n = @ ) were pooled for analysis ( N = @ ) .


For most patients ( @ % ) pathology review data were available ; otherwise original pathology data were used .


Trial variables which were clinically relevant and eligible according to data constraints were age , stage , given treatment ( pelvic external beam radiation therapy ( EBRT ) , vaginal brachytherapy ( VBT ) , or no adjuvant treatment , FIGO histological grade , depth of invasion , and lymph-vascular invasion ( LVSI ) .


Multivariate analyses were based on Cox proportional hazards regression model .


Predictors were selected based on a backward elimination scheme .


Model results were expressed by the c-index ( @-@ @ ; random to perfect prediction ) .


Two validation sets ( n = @ and @ patients ) were used .


Accuracy of the developed models was good , with training accuracies between @ and @ .


The nomograms validated well for DR ( @ ) , DFS ( @ ) , and OS ( @ ) , but validation was only fair for LRR ( @ ) .


Ranking of variables as to their predictive power showed that age , tumor grade , and LVSI were highly predictive for all outcomes , and given treatment for LRR and DFS .


The nomograms were able to significantly distinguish low - from high-probability patients for these outcomes .


The nomograms are internally validated and able to accurately predict long-term outcome for endometrial cancer patients with observation , pelvic EBRT , or VBT after surgery .


These models facilitate decision support in daily clinical practice and can be used for patient counseling and shared decision making , selecting patients who benefit most from adjuvant treatment , and generating new hypotheses .


The detailed mechanism of plaque stabilization by statin therapy is not fully understood .


The aim of this study was to assess the effect of lipid-lowering therapy with @ mg/day of atorvastatin versus @ mg/day of atorvastatin on fibrous cap thickness in coronary atherosclerotic plaques by using optical coherence tomography ( OCT ) .


Seventy patients with unstable angina pectoris and untreated dyslipidemia were randomized to either @mg/day or @ mg/day of atorvastatin therapy .


OCT was performed to assess intermediate nonculprit lesions at baseline and @-month follow-up .


Serum low-density lipoprotein cholesterol level was significantly lower during therapy with @ mg/day compared with @ mg/day of atorvastatin ( @ mg/dl vs. @ mg/dl ; p = @ ) .


The increase in fibrous cap thickness was significantly greater with @ mg/day compared with @ mg/day of atorvastatin ( @ % vs. @ % ; p < @ ) .


The increase in fibrous cap thickness correlated with the decrease in serum levels of low-density lipoprotein cholesterol ( R = -@ ; p < @ ) , malondialdehyde-modified low-density lipoprotein ( R = -@ ; p = @ ) , high-sensitivity C-reactive protein ( R = -@ ; p = @ ) , and matrix metalloproteinase-@ ( R = -@ ; p < @ ) , and the decrease in grade of OCT-derived macrophages ( R = -@ ; p = @ ) .


Atorvastatin therapy at @ mg/day provided a greater increase in fibrous cap thickness in coronary plaques compared with @ mg/day of atorvastatin .


The increase of fibrous cap was associated with the decrease in serum atherogenic lipoproteins and inflammatory biomarkers during atorvastatin therapy .


( Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography : The EASY-FIT Study ; NCT@ ) .


In patients treated with oral anticoagulants , subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding , although the effectiveness of the vaccine has only been proven for intramuscular injection .


The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants .


We present a prospective , double blinded , clinical trial comparing two groups of patients with oral anticoagulants : one group was administered tetanus-diphtheria vaccine by intramuscular injection , while the other was administered the same vaccine by subcutaneous injection .


Allocation to each group was randomized and the duration of the study was six years .


all patients treated with oral anticoagulants , who had been administered with at least one dose of vaccine , at @ Health Centres in Vigo ( Spain ) , and who agreed to participate in the study .


The sample size was @ patients in each group .


The main variables for the safety analysis were the measurement of the brachial diameter , the appearance of basic injuries at the vaccine administration site , the appearance of pain and systemic reactions .


The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed .


Details will be classified according to the administration route , while within each group a @-tiered stratification will be defined by the administered number of doses .


As a measure of association , relative risk will be estimated ; the reduction of relative risk will also measured .


For safety and to control the confounder effect , a logistic regression analysis will be carried out .


As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT @ guidelines were applied for reporting parallel group randomised trials .


The most significant difficulties on the project are related to the large number of participating centres , required to obtain a viable study population sample size , and the coordination given the scattering of the centres and researchers .


Insulin regulates the GH-IGF@ axis .


Insulin analogs differ from human insulin in receptor affinity and possibly liver accessibility .


Therefore , we compared the GH-IGF@ axis response with human NPH insulin , insulin detemir , and insulin glargine in patients with type @ diabetes ( T@D ) .


A total of @ patients ( seven were women ) with T@D ( age of @ ( @-@ ) years ( mean and range ) , BMI of @ ( @-@ @ ) kg/m ( @ ) , HbA@c of @ ( @-@ @ ) % ( @ ( @-@ ) mmol/mol ) , T@D duration of @ ( @-@ ) years ) were studied using a randomized , three-period crossover design .


Patients received s.c. injections of equal , individual doses of NPH , detemir , and glargine at @h .


Plasma glucose , serum total IGF@ , bioactive IGF , IGF-binding protein ( IGFBPs ) , and GH were measured hourly for @h post-injection .


When compared with the area under the curve ( AUC ) following NPH and glargine , detemir resulted in the lowest @-@h AUC ( mean and range ) of IGFBP@ ( @ ( @-@ ) ) vs @ ( @-@ ) vs @ ( @-@ ) g/lh ) and GH ( @ ( @-@ @ ) vs @ ( @-@ @ ) vs @ ( @-@ @ ) g/lh ) , but in the highest AUC of bioactive IGF ( @ ( @-@ @ ) vs @ ( @-@ @ ) vs @ ( @-@ @ ) g/lh ) ( all P < @ ) .


These differences were unrelated to plasma glucose .


By contrast , profiles of total IGF@ , IGFBP@ , and IGFBP@ were comparable .


Independent of plasma glucose , a single dose of detemir caused larger suppression in serum IGFBP@ than NPH and glargine , whereas bioactive IGF was higher , thereby explaining the lower GH levels .


Thus , detemir appears to be more liver specific than NPH insulin and glargine .


Nivolumab was associated with higher rates of objective response than chemotherapy in a phase @ study involving patients with ipilimumab-refractory metastatic melanoma .


The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase @ controlled study .


We randomly assigned @ previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab ( at a dose of @ mg per kilogram of body weight every @ weeks and dacarbazine-matched placebo every @ weeks ) or dacarbazine ( at a dose of @ mg per square meter of body-surface area every @ weeks and nivolumab-matched placebo every @ weeks ) .


The primary end point was overall survival .


At @ year , the overall rate of survival was @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) in the nivolumab group , as compared with @ % ( @ % CI , @ to @ ) in the dacarbazine group ( hazard ratio for death , @ ; @ % CI , @ to @ ; P < @ ) .


The median progression-free survival was @ months in the nivolumab group versus @ months in the dacarbazine group ( hazard ratio for death or progression of disease , @ ; @ % CI , @ to @ ; P < @ ) .


The objective response rate was @ % ( @ % CI , @ to @ ) in the nivolumab group versus @ % ( @ % CI , @ to @ ) in the dacarbazine group ( odds ratio , @ ; P < @ ) .


The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups , including subgroups defined by status regarding the programmed death ligand @ ( PD-L@ ) .


Common adverse events associated with nivolumab included fatigue , pruritus , and nausea .


Drug-related adverse events of grade @ or @ occurred in @ % of the patients treated with nivolumab and @ % of those treated with dacarbazine .


Nivolumab was associated with significant improvements in overall survival and progression-free survival , as compared with dacarbazine , among previously untreated patients who had metastatic melanoma without a BRAF mutation .


( Funded by Bristol-Myers Squibb ; CheckMate @ ClinicalTrials.gov number , NCT@ . )


Maaori are the Indigenous people of New Zealand and do not enjoy the same oral health status as the non-Indigenous majority .


To overcome oral health disparities , the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants .


The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child .


This study seeks to determine whether implementing a kaupapa Maaori ( Maaori philosophical viewpoint ) in an early childhood caries ( ECC ) intervention reduces dental disease burden among Maaori children .


The intervention consists of four approaches to prevent early childhood caries : dental care provided during pregnancy , fluoride varnish application to the teeth of children , motivational interviewing , and anticipatory guidance .


The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui .


This randomised-control trial will be undertaken utilising the principles of kaupapa Maaori research , which encompasses Maaori leadership , Maaori relationships , Maaori customary practices , etiquette and protocol .


Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention .


Self-report information will be collected in a baseline questionnaire during pregnancy and when children are aged @ and @ months .


Clinical oral health data will be collected during standardised examinations at ages @ and @ months by calibrated dental professionals .


All participants receive the ECC intervention benefits , with the intervention delayed by @ months for participants who are randomised to the control-delayed arm .


The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa Maaori research in the research processes .


This study will assess an ECC intervention which could provide a meaningful approach for Maaori for the protection and maintenance of oral health for Maaori children and their family , thus reducing oral health disparities .


The surgical Apgar score ( SAS ) can predict @-day major complications or death after surgery .


Studies have validated the score in different patient populations and suggest it should be used to objectively guide postoperative care .


We aimed to see whether using the SAS in a decisive approach in a future randomised controlled trial ( RCT ) would be likely to demonstrate an effect on postoperative care and clinical outcome .


A total of @ adults undergoing general/vascular surgery in @ National Health Service hospitals were recruited to a pilot single blinded RCT and the data for @ of these were analysed .


Participants were randomised to a control group with standard postoperative care or to an intervention group with care influenced ( but not mandated ) by the SAS ( decisive approach ) .


The notional primary outcome was @-day major complications or death .


Incidence of major complications was similar in both groups ( control : @/@ -LSB- @ % -RSB- , intervention : @/@ -LSB- @ % -RSB- , p = @ ) .


Immediate admissions to the critical care unit was higher in the intervention group , especially in the SAS @-@ subgroup ( @/@ vs @/@ ) although this was not statistically significant ( p = @ ) .


Validity was also confirmed in area under the curve ( AUC ) analysis ( AUC : @ ) .


This pilot study found that a future RCT to investigate the effect of using the SAS in a decisive approach may demonstrate a difference in postoperative care .


However , significant changes to the design are needed if differences in clinical outcome are to be achieved reliably .


These would include a wider array of postoperative interventions implemented using a quality improvement approach in a stepped wedge cluster design with blinded collection of outcome data .


To investigate if patients with thyroid carcinoma having N@a disease are at the same risk with N@b using the collective of the well-defined European prospective Multicentre Study Differentiated Thyroid Cancer ( MSDS ) .


Overall ( OS ) and event free survival ( EFS ) were calculated .


Cox multivariable regression analysis was performed in order to calculate Hazard ratios ( HR ) .


EFS was significantly decreased only in patients with N@b metastasis as compared to N@ patients and became worse when N@a was concomitantly affected .


A superior survival in favor of N@a patients as compared to N@b patients with regard to EFS was also observed .


The patients having N@a disease showed no differences in the EFS as compared to N@ .


OS did not differ significantly in any of the groups .


There was an increased HR for events with regards to histology , T-stage , tumor size , UICC stage and cervical lymph node metastasis .


Tumor size showed a significantly increased risk for OS .


Patients with pT@b and pT@a tumors with N@b are of higher risk for relapse , albeit not affecting overall survival .


Patients with N@a are of no higher risk .


The risk stratification of these patients may be adapted accordingly .


A single randomized trial established lobectomy as the standard of care for the surgical treatment of early-stage non-small cell lung cancer .


Recent advances in imaging/staging modalities and detection of smaller tumors have once again rekindled interest in sublobar resection for early-stage disease .


The objective of this study was to compare lung cancer survival in patients with non-small cell lung cancer with a diameter of @ mm or less with clinical stage @ disease who underwent lobectomy or sublobar resection .


We identified @ patients diagnosed with lung cancer who underwent lobectomy ( n = @ ) or sublobar resection ( n = @ ) for non-small cell lung cancer manifesting as a solid nodule in the International Early Lung Cancer Action Program from @ to @ .


Differences in the distribution of the presurgical covariates between sublobar resection and lobectomy were assessed using unadjusted P values determined by logistic regression analysis .


Propensity scoring was performed using the same covariates .


Differences in the distribution of the same covariates between sublobar resection and lobectomy were assessed using adjusted P values determined by logistic regression analysis with adjustment for the propensity scores .


Lung cancer-specific survival was determined by the Kaplan-Meier method .


Cox survival regression analysis was used to compare sublobar resection with lobectomy , adjusted for the propensity scores , surgical , and pathology findings , when adjusted and stratified by propensity quintiles .


Among @ patients , @-year Kaplan-Meier for @ patients treated by sublobar resection compared with @ patients treated by lobectomy was @ % ( @ % confidence interval , @-@ ) versus @ % ( confidence interval , @-@ ) ( P = @ ) .


Cox survival analysis showed no significant difference between sublobar resection and lobectomy when adjusted for propensity scores or when using propensity quintiles ( P = @ and P = @ , respectively ) .


For those with cancers @ mm or less in diameter , the @-year rates were @ % ( @ % confidence interval , @-@ ) versus @ % ( @ % confidence interval , @-@ ) ( P = @ ) , and Cox survival analysis showed no significant difference between sublobar resection and lobectomy using either approach ( P = @ and P = @ , respectively ) .


Sublobar resection and lobectomy have equivalent survival for patients with clinical stage IA non-small cell lung cancer in the context of computed tomography screening for lung cancer .


To assess the effects of postural rehabilitation ( PR ) on trunk asymmetry and balance , with and without Kinesio taping ( KT ) of the back muscles as additional treatment , in patients with Parkinson 's disease ( PD ) who have postural disorders .


Single-blind , randomized controlled trial with @-month follow-up .


Ambulatory care in referral center .


Patients ( N = @ ) with PD showing postural abnormalities of the trunk , in the sagittal and/or coronal plane .


Four weeks of patient-tailored proprioceptive and tactile stimulation , combined with stretching and postural reeducation , was provided to @ subjects ( PR group ) , while @ received no treatment ( control group ) .


Six of the @ subjects receiving PR also had KT strips applied to their trunk muscles , according to the features of their postural abnormalities .


Berg Balance Scale , Timed Up and Go , and degrees of trunk bending in the sagittal and coronal planes were assessed at the enrollment ( t@ ) , @ month later ( t@ ) , and @ months later ( t@ ) .


At t@ , all treated patients showed a significant improvement in trunk posture in both the sagittal ( P = @ ) and coronal planes ( P = @ ) , compared with baseline .


Moreover , they showed an improvement in measures of gait and balance ( P < @ ) .


Benefits persisted at t@ for all measures , except lateral trunk bend .


No differences were found when comparing the PR and KT groups .


The combination of active posture correction and trunk movements , muscle stretching , and proprioceptive stimulation may usefully impact PD axial symptoms .


Repeated training is advocated to avoid waning of the effect .


To study the effect of a countermovement on the lower limb force-velocity ( F-v ) mechanical profile and to experimentally test the influence of F-v mechanical profile on countermovement jump ( CMJ ) performance , independently from the effect of maximal power output ( P max ) .


Fifty-four high-level sprinters and jumpers performed vertical maximal CMJ and squat jump ( SJ ) against five to eight additional loads ranging from @ to @ kg .


Vertical ground reaction force data were recorded ( @,@ Hz ) and used to compute center of mass vertical displacement .


For each condition , mean force , velocity , and power output were determined over the entire push-off phase of the best trial , and used to determine individual linear F-v relationships and P max .


From a previously validated biomechanical model , the optimal F-v profile maximizing jumping performance was determined for each subject and used to compute the individual mechanical F-v imbalance ( Fv IMB ) as the difference between actual and optimal F-v profiles .