The aim of the study was to determine the effects of a simulated communication training course on nurses ' communication competence , self-efficacy , communication performance , myocardial infarction knowledge , and general satisfaction with their learning experience .


A randomized controlled trial was conducted with a pre-test and two post-tests .


The experimental group underwent simulated communication training course and the control group received a case-based communication training course .


The experimental group made more significant improvement in competence and self-efficacy in communication from pre-test to the second post-test than the control group .


Although both groups ' satisfaction with their learning experience significantly increased from the first post-test to the second post-test , the experimental group was found to be more satisfied with their learning experience than the control group .


No significant differences in communication performance and myocardial infarction knowledge between the two groups were identified .


Scenario-based communication training can be more fully incorporated into in-service education for nurses to boost their competence and self-efficacy in communication and enhance their communication performance in myocardial infarction patient care .


Introduction of real-life communication scenarios through multimedia in communication education could make learners more motivated to practice communication , hence leading to improved communication capacity .


Postoperative breathing exercises are recommended to cardiac surgery patients .


Instructions concerning how long patients should continue exercises after discharge vary , and the significance of treatment needs to be determined .


Our aim was to assess the effects of home-based deep breathing exercises performed with a positive expiratory pressure device for @ months following cardiac surgery .


The study design was a prospective , single-blinded , parallel-group , randomized trial .


Patients performing breathing exercises @ months after cardiac surgery ( n = @ ) were compared with a control group ( n = @ ) performing no breathing exercises after discharge .


The intervention consisted of @ slow deep breaths performed with a positive expiratory pressure device ( @-@ cm H@O ) , @ times a day , during the first @ months after surgery .


The outcomes were lung function measurements , oxygen saturation , thoracic excursion mobility , subjective perception of breathing and pain , patient-perceived quality of recovery ( @-Item Quality of Recovery score ) , health-related quality of life ( @-Item Short Form Health Survey ) , and self-reported respiratory tract infection/pneumonia and antibiotic treatment .


Two months postoperatively , the patients had significantly reduced lung function , with a mean decrease in forced expiratory volume in @ second to @ @ % ( P < @ ) of preoperative values .


Oxygenation had returned to preoperative values , and @ of @ aspects in the @-Item Short Form Health Survey were improved compared with preoperative values ( P < @ ) .


There were no significant differences between the groups in any of the measured outcomes .


No significant differences in lung function , subjective perceptions , or quality of life were found between patients performing home-based deep breathing exercises and control patients @ months after cardiac surgery .


Maraviroc is unique among approved antiretroviral drugs in targeting the host-cell chemokine coreceptor type-@ receptor .


With its novel mechanism of action , we sought to describe the @-year safety profile of maraviroc .


Two large phase @ studies of maraviroc enrolled HIV-infected treatment-experienced patients and followed them up for @ or more years .


Survival and selected clinical end points were identified and assessed .


A total of @ enrolled patients received maraviroc-containing regimens .


Rates of death and selected clinical events ( eg , hepatic failure , malignancy , and myocardial infarction ) were low during follow-up .


Maraviroc was generally safe in treatment-experienced participants for > @ years .


To investigate the feasibility and effectiveness of the modified traction arch of skull ( crossbar traction arch ) for skull traction in treating cervical spine injury by comparing with traditional traction arch of skull .


Between June @ and June @ , @ patients with cervical vertebrae fractures or dislocation were treated with modified skull traction surgery ( trial group , n = @ ) and traditional skull traction surgery ( control group , n = @ ) .


There was no significant difference in gender , age , injury types , injury level , the interval between injury and admission , and Frankel grading of spinal injury between @ groups ( P > @ ) .


The clinical efficacy was evaluated after operation by the indexes such as traction arch slippage times , operation time , the infection incidence of the pin hole , incidence of skull perforation , visual analogue scale ( VAS ) , and reduction status of cervical dislocation .


The traction arch slippage times , the infection incidence of the pin hole , operation time , blood loss , and postoperative VAS score in trial group were significantly lower than those in control group ( P < @ ) .


There was no significant difference in the incidence of skull perforation caused by clamp crooks of traction arch between @ groups ( P = @ ) .


At @ weeks after operation , the patients had no headaches , infections , or other complications in @ groups .


In patients with cervical dislocation , @ of the trial group and @ of the control group failed to be reset , the reduction rate was @ % ( @/@ ) and @ % ( @/@ ) respectively , showing no significant difference ( @ = @ , P = @ ) .


The operation with modified traction arch of skull has significant advantages to reduce postoperative complication compared with tradition traction arch of skull .


Many smokers find currently available nicotine replacement therapies unsatisfactory .


The pharmacokinetics of nicotine delivered via a novel inhaler device , and its effect on craving satiation and smoking urges , were compared with the Nicorette Inhalator ( @ mg ) .


Results are reported for Parts B ( N = @ ) and D ( N = @ ) of a @-part Phase I study .


Participants ( @-@ years , @ cigarettes/day within @ hr of waking , expired carbon monoxide > @ ppm on screening ) received single doses of nicotine on consecutive days ( @ and @ mg -LSB- Part B -RSB- and @ mg -LSB- Part D -RSB- via the novel device ; @ mg via Nicorette -LSB- Parts B and D -RSB- ) .


Venous pharmacokinetics , craving , and tolerability were assessed .


In Part B , the novel device @ and @ mg produced significantly lower C max , AUClast , and AUCall than Nicorette ( all p @ ) , higher AUC@-@ and significantly shorter T max ( @ and @ min vs. @ min , respectively , p @ ) .


Craving score AUC was lower for the novel device @ mg than for Nicorette in Part B ( @ vs. @ , p = @ ) and approached statistical significance in Part D ( @ vs. @ -LSB- p = @ -RSB- ) .


Mean craving scores were lower for the novel device @ mg than Nicorette at @/@ postdose timepoints in Part B ( p @ at @ and @ min ) and at all timepoints in Part D ( p @ at @ , @ , and @ min ) .


The novel device was at least as effective as the Nicorette Inhalator ( @mg ) in relieving craving and smoking urges and was statistically superior at certain timepoints and in an overall craving AUC analysis , despite lower total nicotine exposure .


To describe and compare the structure and relative severity of symptoms in clinical trial patients diagnosed with Post Traumatic Stress Disorder ( PTSD ) or schizophrenia using the Positive and Negative Syndrome Scale ( PANSS ) , developed originally to evaluate symptoms of schizophrenia .


This secondary data analysis used baseline PANSS symptom ratings ( n = @ ) from a six-month multicenter randomized placebo-controlled trial of adjunctive risperidone in patients with chronic military-related PTSD .


First , using a split-half design , Exploratory Factor Analysis ( EFA ) was employed to identify independent factors which were then compared to published factor structures for schizophrenia .


Next , Confirmatory Factor Analysis ( CFA ) was applied to the second half of the sample to compare the results of the EFA and published factor structures .


Finally , T-tests were used to compare the severity of factor scores between the PTSD sample and the baseline PANSS ratings from the Clinical Antipsychotic Trial for Intervention Effectiveness ( CATIE ) schizophrenia sample ( n = @ ) .


EFA suggested five factors similar to those identified in a summary of @ schizophrenia studies by Wallwork ( Schizophrenia Research , @:@ -@ ) .


CFA showed that the five factor Wallwork model fit the data better than the EFA , although both had relatively high goodness of fit .


T-tests showed that the PTSD sample had more severe symptoms on the Depressive factor , and the schizophrenia sample on the Positive , Negative , and Disorganized factors , with no significant difference on the Excited factor .


Veterans with PTSD had similar symptom structure to patients with schizophrenia on the PANSS , but were less symptomatic on psychosis-related factors and more symptomatic on depression .


Dimensional symptom factors can be virtually the same across diagnoses .


In hypertensive persons aged @ years or below , visit-to-visit SBP variability is directly associated with cardiovascular events , especially stroke .


It is unclear whether such a relationship exists for older persons .


We investigated whether there is a relationship between visit-to-visit SBP variability and cardiovascular events in an elderly population , and identified the factors associated with increased SBP variability .


Information from @ visits of @ patients aged at least @ years being treated for hypertension in the Second Australian National Blood Pressure study was used .


Patients were followed for @ ( median ) years and had eight ( median ) doctor visits during the study .


SBP variability was defined as within-individual SD of SBP across study follow-up visits .


Increased visit-to-visit SBP variability was found to be a strong predictor for future cardiovascular events in this elderly population .


The hazard ratio ( @ % confidence interval ) for any first fatal/nonfatal cardiovascular event for highest decile compared with lowest decile of SBP variability was @ ( @-@ @ ) after adjusting for sex , age , treatment including other baseline variables , and average on-treatment SBP .


A similar effect was observed for stroke ( hazard ratio @ , @-@ @ ) , myocardial infarction ( hazard ratio @ , @-@ @ ) , and heart failure ( hazard ratio @ , @-@ @ ) .


Highest SBP variability was also a predictor of post-trial fatal cardiovascular events .


Increased visit-to-visit SBP variability was related to age , pulse pressure , changing physicians , smoking , treatment allocation , and the use of multiple BP-lowering drugs .


These findings suggest that reducing visit-to-visit SBP variability might be an important objective in addition to conventional blood pressure-lowering in elderly hypertensive patients .


Oral aprepitant , a neurokinin-@ receptor antagonist , is recommended in combination with other anti-emetic agents for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy in adults , but its efficacy and safety in paediatric patients are unknown .


We did this phase @ trial to examine the safety and efficacy of such treatment in children .


In this final analysis of a phase @ , randomised , multicentre , double-blind study , patients aged @ months to @ years with a documented malignancy who were scheduled to receive either moderately or highly emetogenic chemotherapy were randomly assigned with an interactive voice response system to an age-based and weight-based blinded regimen of aprepitant ( @ mg for ages @-@ years ; @ mg/kg up to @ mg for ages @ months to < @ years ) plus ondansetron on day @ , followed by aprepitant ( @ mg for ages @-@ years ; @ mg/kg up to @ mg for ages @ months to < @ years ) on days @ and @ , or placebo plus ondansetron on day @ followed by placebo on days @ and @ ; addition of dexamethasone was allowed .


Randomisation was stratified according to patient age , planned use of chemotherapy associated with very high risk of emetogenicity , and planned use of dexamethasone as an anti-emetic .


Ondansetron was dosed per the product label for paediatric use or local standard of care .


The primary efficacy endpoint was the proportion of patients who achieved complete response ( defined as no vomiting , no retching , and no use of rescue medication ) during the @-@ h ( delayed phase ) after initiation of emetogenic chemotherapy .


Efficacy and safety analyses were done with all randomly assigned patients who received at least one dose of study treatment .


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


Between Sept @ , @ , and Aug @ , @ , @ patients were randomly assigned at @ sites in @ countries to either the aprepitant group ( @ patients ) or to the control group ( @ patients ) .


Three patients in the aprepitant group and two in the control group did not receive study medication , and thus were excluded from analyses .


@ ( @ % ) of @ patients in the aprepitant group and @ ( @ % ) of @ in the control group achieved a complete response in the delayed phase ( p < @ ) .


The most common grade @-@ adverse events were febrile neutropenia ( @ -LSB- @ % -RSB- of @ in the aprepitant group vs @ -LSB- @ % -RSB- of @ in the control group ) , anaemia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and decreased neutrophil count ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


The most common serious adverse event was febrile neutropenia ( @ -LSB- @ % -RSB- patients in the aprepitant group vs @ -LSB- @ % -RSB- in the control group ) .


Addition of aprepitant to ondansetron with or without dexamethasone is effective for the prevention of chemotherapy-induced nausea and vomiting in paediatric patients being treated with moderately or highly emetogenic chemotherapy .


To investigate potential drug-drug interactions between topiramate and metformin and pioglitazone at steady state .


Two open-label studies were performed in healthy adult men and women .


In Study @ , eligible participants were given metformin alone for @ days ( @ mg twice daily -LSB- BID -RSB- ) followed by concomitant metformin and topiramate ( titrated to @mg BID ) from days @ to @ .


In Study @ , eligible participants were randomly assigned to treatment with pioglitazone @ mg once daily ( QD ) alone for @ days followed by concomitant pioglitazone and topiramate ( titrated to @ mg BID ) from days @ to @ ( Group @ ) or to topiramate ( titrated to @ mg BID ) alone for @ days followed by concomitant pioglitazone @ mg QD and topiramate @ mg BID from days @ to @ ( Group @ ) .


An analysis of variance was used to evaluate differences in pharmacokinetics with and without concomitant treatment ; @ % confidence intervals ( CI ) for the ratio of the geometric least squares mean ( LSM ) estimates for maximum plasma concentration ( Cmax ) , area under concentration-time curve for dosing interval ( AUC@ or AUC@ ) , and oral clearance ( CL/F ) with and without concomitant treatment were used to assess a drug interaction .


A comparison to historical data suggested a modest increase in topiramate oral clearance when given concomitantly with metformin .


Coadministration with topiramate reduced metformin oral clearance at steady state , resulting in a modest increase in systemic metformin exposure .


Geometric LSM ratios and @ % CI for metformin CL/F and AUC@ were @ % ( @ % , @ % ) and @ % ( @ % , @ % ) , respectively .


Pioglitazone had no effect on topiramate pharmacokinetics at steady state .


Concomitant topiramate resulted in decreased systemic exposure to pioglitazone and its active metabolites , with geometric LSM ratios and @ % CI for AUC@ of @ % ( @ % , @ % ) for pioglitazone , @ % ( @ % , @ % ) for M-III , and @ % ( @ % , @ % ) for M-IV , respectively .


This effect appeared more pronounced in women than in men .


Coadministration of topiramate with metformin or pioglitazone was generally well tolerated by healthy participants in these studies .


A modest increase in metformin exposure and decrease in topiramate exposure was observed at steady state following coadministration of metformin @ mg BID and topiramate @mg BID .


The clinical significance of the observed interaction is unclear but is not likely to require a dose adjustment of either agent .


Pioglitazone @ mg QD did not affect the pharmacokinetics of topiramate at steady state , while coadministration of topiramate @ mg BID with pioglitazone decreased steady-state systemic exposure to pioglitazone , M-III , and M-IV .


While the clinical consequence of this interaction is unknown , careful attention should be given to the routine monitoring for adequate glycemic control of patients receiving this concomitant therapy .


Concomitant administration of topiramate with metformin or pioglitazone was generally well tolerated and no new safety concerns were observed .


Pneumonia poses a significant risk in patients with moderate to severe chronic obstructive pulmonary disease but data are limited on the disease phenotypes most susceptible to pneumonia .


Cluster analysis using a data-driven recursive partitioning algorithm was employed using baseline data from two pooled one-year randomized exacerbation trials ( n = @,@ ) of fluticasone furoate/vilanterol or vilanterol alone to identify distinct patient groups at greatest risk of pneumonia or serious ( hospitalization or death ) pneumonia .


Five clusters were identified .


Patients at greater risk of first pneumonia had more severe obstruction ( forced expiratory volume in one second/forced vital capacity < @ % ) and either a body mass index < @ kg/m ( @ ) ( hazard ratio @ , @ % confidence interval @-@ @ ; n = @ ) or a pneumonia history and greater comorbidities ( hazard ratio @ , @ % confidence interval @-@ @ ; n = @ ) relative to the cluster with the lowest pneumonia risk ( reference ; n = @ ) .


Multiple comorbidities and use of psychoanaleptics also contributed to an increased risk of pneumonia in more obstructed patients .


Independent of cluster , use of inhaled corticosteroids was associated with pneumonia ( hazard ratio @ , @ % confidence interval @-@ @ ) and serious pneumonia ( hazard ratio @ , @ % confidence interval @-@ @ ) .


Cluster analysis can identify patient populations at risk for serious safety outcomes and inform risk management strategies to optimize patient management .


The greatest risk for pneumonia was in subjects with multiple pneumonia risk factors .


In this study , effects of pregabaline on postoperative pain and opioid consumption used perioperatively in patients undergoing modified radical mastectomy ( MRM ) were investigated .


Sixty ASA @-@ patients scheduled for MRM were included .


Patients were randomly divided into two and @ patients were allocated into each group .


Group Pregabaline was given pregabaline @ mg @ hr before operation and Group Placebo empty capsule .


In both groups , anesthesia induction was obtained by penthotal , fentanyl and rocuronium and maintainence by sevoflurane , N@O and O@ .


Twelve hr after operation , Group Pregabaline was administered pregabaline @ mg while Placebo group received empty capsule again .


All patients received lornoxicam @ mg iv @ hr before end of surgery and ondansetrone @ mg @ min before .


Patient-controlled analgesia device prepared with morphine was connected to both groups for postoperative analgesia .


Postoperative VAS pain scores , hemodynamic parameters , morphine consumption , side-effects like nausea-vomiting , sedation and dizziness were followed and recorded .


Demographic parameters were similar .


VAS scores were significantly lower in Group Pregabaline at @ , @ min , @,@,@ and @ hr ( p < @ ) .


There was no significant difference in postoperative morphine consumption and need for additional dose , although they were higher in Placebo group .


The patients in Placebo group had higher bothersome scores for side-effects .


Hemodynamic parameters and other side-effects were similar .


In our study , we showed that pregabalin administered perioperatively increased postoperative analgesic efficacy in MRM operations without making significant side effect , but did not change opioid consumption .


We think that further studies about this topic must be held with different dose and patient groups .


To explore the acute toxic effects and early curative efficacy of concurrent chemotherapy with different doses of cisplatin for Chinese nasopharyngeal carcinoma ( NPC ) patients using intensity-modulated radiation therapy ( IMRT ) .


Eighty-eight untreated stage II/III nasopharyngeal cancer patients receiving IMRT and concurrent cisplatin were randomized into two groups receiving different doses of cisplatin .


The standard group ( DDP @ mg/m q@w , n = @ ) and the study group ( DDP @ mg/m q@w , n = @ ) .


The acute toxic effects and @-month therapeutic efficacy ( early curative efficacy ) in patients of the two groups who completed treatment were compared and analyzed .


During the treatment , grade III-IV acute toxic effects were observed in more patients of the standard group compared with that in the study group ( @ % vs. @ % ) , but the difference was statistically not significant ( P = @ ) .


Significant difference was only seen in upper gastrointestinal reaction ( P = @ ) and anemia ( P = @ ) among the non-hematological and hematological adverse events .


No significant differences in other adverse events were found between the two groups ( P < @ ) .


Three months after the completion of radiotherapy , @ cases of the whole group achieved complete remission ( CR ) in the nasopharynx and neck MRI .


In both the standard group and study group , @ patients had CR and @ patients had residual disease , respectively , showing a non-significant difference ( P = @ ) between the two groups .


During the IMRT course , patients received cisplatin @ mg/m q@w , experienced less grade III-IV acute toxic effects .


Concurrent chemoradiotherapy with cisplatin @ mg/m q@w or @ mg/m q@w , demonstrate similar early curative efficacy in II/III stage NPC patients in endemic regions of China .


While physical activity , energy restriction and weight loss are the cornerstone of type @ diabetes management , less emphasis is placed on optimizing skeletal muscle mass .


As muscle is the largest mass of insulin-sensitive tissue and the predominant reservoir for glucose disposal , there is a need to develop safe and effective evidence-based , lifestyle management strategies that optimize muscle mass as well as improve glycaemic control and cardiometabolic risk factors in people with this disease , particularly older adults who experience accelerated muscle loss .


Using a two-arm randomized controlled trial , this @-month study builds upon the community-based progressive resistance training ( PRT ) programme Lift for Life to evaluate whether ingestion of a whey-protein drink combined with vitamin D supplementation can enhance the effects of PRT on glycaemic control , body composition and cardiometabolic health in older adults with type @ diabetes .


Approximately @ adults aged @ to @ years with type @ diabetes , treated with either diet alone or oral hypoglycaemic agents ( not insulin ) , will be recruited .


All participants will be asked to participate in a structured , supervised PRT programme based on the Lift for Life programme structure , and randomly allocated to receive a whey-protein drink ( @ g daily of whey-protein plus @ g after each PRT session ) plus vitamin D supplements ( @ IU/day ) , or no additional powder and supplements .


The primary outcome measures to be collected at baseline , @ and @ months will be glycated haemoglobin ( HbA@c ) and insulin sensitivity ( homeostatic model assessment ) .


Secondary outcomes will include changes in : muscle mass , size and intramuscular fat ; fat mass ; muscle strength and function ; blood pressure ; levels of lipids , adipokines and inflammatory markers , serum insulin-like growth factor-@ and @-hydroxyvitamin D ; renal function ; diabetes medication ; health-related quality of life , and cognitive function .


The findings from this study will provide new evidence on whether increased dietary protein achieved through the ingestion of a whey-protein drink combined with vitamin D supplementation can enhance the effects of PRT on glycaemic control , muscle mass and size , and cardiometabolic risk factors in older adults with type @ diabetes .


To evaluate the effectiveness of the ` Healthy Dads , Healthy Kids ( HDHK ) ' program when delivered by trained facilitators in community settings .


A two-arm randomized controlled trial of @ overweight/obese fathers ( mean -LSB- SD -RSB- age = @ -LSB- @ -RSB- years ; BMI = @ -LSB- @ -RSB- kg/m ( @ ) ) and their primary school-aged children ( n = @ ) from the Hunter Region , Australia .


In @-@ , families were randomized to either : ( i ) HDHK intervention ( n = @ fathers , n = @ children ) or ( ii ) wait-list control group .


The @-week intervention included seven sessions and resources ( booklets , pedometers ) .


Assessments were held at baseline and @-weeks with fathers ' weight ( kg ) as the primary outcome .


Secondary outcomes for fathers and children included waist , BMI , blood pressure , resting heart rate , physical activity ( pedometry ) , and self-reported dietary intake and sedentary behaviors .


Linear mixed models ( intention-to-treat ) revealed significant between-group differences for fathers ' weight ( P < @ , d = @ ) , with HDHK fathers losing more weight ( -@ kg ; @ % CI , -@ , -@ ) than control fathers ( @ kg ; @ % CI , -@,@ ) .


Significant treatment effects ( P < @ ) were also found for fathers ' waist ( d = @ ) , BMI ( d = @ ) , resting heart rate ( d = @ ) , energy intake ( d = @ ) and physical activity ( d = @ ) and for children 's physical activity ( d = @ ) and adiposity ( d = @ ) .


HDHK significantly improved health outcomes and behaviors in fathers and children , providing evidence for program effectiveness when delivered in a community setting .


Pipelle is a silastic curette which does not require a tenaculum or straightening of the cervical fundus axis because of its flexibility and does not require general anaesthesia , whereas Dilatation and curettage ( D&C ) requires hospitalization and general anaesthesia along with the problem of postoperative pain .


The objective of the study was to assess the effectiveness of Pipelle sampling in terms of adequate specimen collection and patients ' knowledge and perception about Pipelle and compare it D&C .


In this randomized control trial , @ women presenting with abnormal uterine bleeding were enrolled .


The patients were randomly assigned to one of the two procedures .


In group A @ patients were subjected to Pipelle endometrial sampling and in group B @ patients were enrolled for D&C .


Frequencies of adequacy of histopathology reports and cost effectiveness of both groups were compared .


Patient 's knowledge , perception , pain and acceptability of the procedure of both groups were also assessed and compared .


The mean age of the patients was @ @ years .


Tissue obtained for histopathology was @ % adequate when the procedure was D&C while it was @ % in Pipelle group .


In group-A @ % patients experienced no discomfort , with only @ % experiencing severe pain and @ % mild pain .


On the other hand in group-B , @ % patients experienced moderate and @ % experienced severe pain up to @ on visual analogue scale ( VAS ) postoperatively arid requiring post-operative analgesia .


The acceptability for the Pipelle suction curette was @ % and for the D&C group was @ % .


Regarding previous knowledge of procedure none of patients ( @ % ) knew about Pipelle procedure but @ % patients were aware of D&C procedure .


Pipelle was eight times more cost effective as compared to D&C .


The results of obtained by endometrial sample by Pipelle and D&C are compareable .


Pipelle significantly produced less pain than D&C .


Previous studies have indicated that persons with co-occurring mental health and substance use problems can benefit by attending dual-focus mutual aid groups .


However , to date , a trial to test the efficacy of these groups has not been published .


This study randomly assigned @ substance misusing clients attending a mental health or dual-diagnosis facility to either a dual-focus @-step group ( Double Trouble in Recovery ; DTR ) or a waiting list control group .


Participants were followed for @-@ months .


The primary outcome was substance use ( days used in the past @ with saliva testing to detect under-reporting ) ; secondary outcomes included psychiatric medication adherence , attendance at traditional ( single-focus ) @-step meetings ( e.g. , AA/NA ) ; and improvement in mental health and substance use problems ( quality of life ) .


Multilevel model ( MLM ) regression was used to analyze the nested effect of participants within @ facilities ( @ in New York City and @ in Michigan ) .


Regression imputation was used to adjust for drug use under-reporting .


At follow-up @ % of the subjects were interviewed .


In intent to treat analysis , DTR subjects compared with control subjects used alcohol ( p = @ ) and any substances ( p = @ ) on fewer days .


DTR compared with control subjects were also more likely to rate themselves as experiencing better mental health and fewer substance use problems ( p = @ ) .


There were no effects for DTR on drug use only , medication adherence or NA/AA attendance .


Findings reported in previous studies on the association between exposure to DTR and reductions in substance use were partially supported in this efficacy trial .


Intimate partner violence ( IPV ) is associated with HIV infection .


We aimed to assess whether provision of a combination of IPV prevention and HIV services would reduce IPV and HIV incidence in individuals enrolled in the Rakai Community Cohort Study ( RCCS ) , Rakai , Uganda .


We used pre-existing clusters of communities randomised as part of a previous family planning trial in this cohort .


Four intervention group clusters from the previous trial were provided standard of care HIV services plus a community-level mobilisation intervention to change attitudes , social norms , and behaviours related to IPV , and a screening and brief intervention to promote safe HIV disclosure and risk reduction in women seeking HIV counselling and testing services ( the Safe Homes and Respect for Everyone -LSB- SHARE -RSB- Project ) .


Seven control group clusters ( including two intervention groups from the original trial ) received only standard of care HIV services .


Investigators for the RCCS did a baseline survey between February , @ , and June , @ , and two follow-up surveys between August , @ , and April , @ , and June , @ , and December , @ .


Our primary endpoints were self-reported experience and perpetration of past year IPV ( emotional , physical , and sexual ) and laboratory-based diagnosis of HIV incidence in the study population .


We used Poisson multivariable regression to estimate adjusted prevalence risk ratios ( aPRR ) of IPV , and adjusted incidence rate ratios ( aIRR ) of HIV acquisition .


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


Between Feb @ , @ , and June @ , @ , we enrolled @ individuals aged @-@ years .


@ individuals ( in four intervention clusters ) were allocated into the SHARE plus HIV services group and @ individuals ( in seven control clusters ) were allocated into the HIV services only group .


Compared with control groups , individuals in the SHARE intervention groups had fewer self-reports of past-year physical IPV ( @ -LSB- @ % -RSB- of @ responders in control groups vs @ -LSB- @ % -RSB- of @ responders in intervention groups ; aPRR @ , @ % CI @-@ ) and sexual IPV ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ; @ , @-@ ) .


Incidence of emotional IPV did not differ ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ; @ , @-@ ) .


SHARE had no effect on male-reported IPV perpetration .


At follow-up @ ( after about @ months ) the intervention was associated with a reduction in HIV incidence ( @ cases per @ person-years in control vs @ cases per @ person-years in intervention group ; aIRR @ , @ % CI @-@ , p = @ ) .


SHARE could reduce some forms of IPV towards women and overall HIV incidence , possibly through a reduction in forced sex and increased disclosure of HIV results .


Findings from this study should inform future work toward HIV prevention , treatment , and care , and SHARE 's ecological approach could be adopted , at least partly , as a standard of care for other HIV programmes in sub-Saharan Africa .


Pediatric rheumatic diseases have a significant impact on children 's quality of life and family functioning .


Disease control and management of the symptoms are important to minimize disability and pain .


Specialist clinical nurses play a key role in supporting medical teams , recognizing poor disease control and the need for treatment changes , providing a resource to patients on treatment options and access to additional support and advice , and identifying best practices to achieve optimal outcomes for patients and their families .


This highlights the importance of investigating follow-up telenursing ( TN ) consultations with experienced , specialist clinical nurses in rheumatology to provide this support to children and their families .


This randomized crossover , experimental longitudinal study will compare the effects of standard care against a novel telenursing consultation on children 's and family outcomes .


It will examine children below @ years old , recently diagnosed with inflammatory rheumatic diseases , who attend the pediatric rheumatology outpatient clinic of a tertiary referral hospital in western Switzerland , and one of their parents .


The telenursing consultation , at least once a month , by a qualified , experienced , specialist nurse in pediatric rheumatology will consist of providing affective support , health information , and aid to decision-making .


Cox 's Interaction Model of Client Health Behavior serves as the theoretical framework for this study .


The primary outcome measure is satisfaction and this will be assessed using mixed methods ( quantitative and qualitative data ) .


Secondary outcome measures include disease activity , quality of life , adherence to treatment , use of the telenursing service , and cost .


We plan to enroll @ children .


The telenursing consultation is designed to support parents and children/adolescents during the course of the disease with regular follow-up .


This project is novel because it is based on a theoretical standardized intervention , yet it allows for individualized care .


We expect this trial to confirm the importance of support by a clinical specialist nurse in improving outcomes for children and adolescents with inflammatory rheumatisms .


The use of domiciliary noninvasive positive pressure ventilation ( NPPV ) in stable chronic obstructive pulmonary disease ( COPD ) with chronic hypercapnic respiratory failure has yielded variable effects on survival , quality of life , and dyspnea .


We hypothesized that use of NPPV in stable COPD and partial pressure of carbon dioxide ( PaCO@ ) < @ mmHg might result in improvement in quality of life and dyspnea .


Thirty patients with stable COPD ( forced expiratory volume in the first second < @ % predicted and PaCO@ < @ mmHg ) were prospectively randomized to receive domiciliary NPPV ( bilevel positive airway pressure , @/@ cm H@O ) or usual therapy for @ months .


Measurements were made at baseline , @ weeks , @ months , and @ months .


Primary outcomes were quality of life as assessed by the Chronic Respiratory Disease Questionnaire ( CRQ ) , and dyspnea as measured by the Transitional Dyspnea Index ( TDI ) .


Fifteen subjects in the NPPV arm and @ controls completed all the study visits .


At @ weeks and @ months , the NPPV arm showed significant improvement in TDI total score .


However , this effect persisted only in the TDI-Task at @ months ( P = @ ) .


NPPV use was associated with a small improvement in the CRQ-Mastery domain ( @ versus -@ , P = @ ) .


The arterial partial pressure of oxygen ( PaO@ ) in the control arm worsened over the period of the study , whereas it remained stable in the NPPV arm ( change -@ mmHg versus +@ mmHg , respectively , P = @ ) .


NPPV resulted in a small improvement in quality of life indices in stable COPD patients with PaCO@ < @ mmHg .


Future larger studies will clarify the role of NPPV in this stable subgroup of patients with COPD .


To evaluate the impact of a senior early assessment model of care on performance measures in a single ED .


A pragmatic single-blinded randomised control trial with day of ED presentation randomised to one of three study arms : senior work-up assessment and treatment ( SWAT ) model of care intervention , non-SWAT control or control .


The primary outcomes were the proportion of patients meeting National Emergency Access Target ( NEAT ) criteria ( ED length of stay less than @h ) and ED length of stay .


Secondary outcome measured was time to decision to admit in the subgroup of admitted patients .


A total of @ patients were analysed .


There was no overall difference in NEAT performance ( @ % -LSB- @ % CI @ , @ -RSB- vs @ % ( -LSB- @ % CI @ , @ -RSB- vs @ % -LSB- @ % CI @ , @ -RSB- , P = @ ) or ED length of stay ( P = @ ) between SWAT , non-SWAT and standard of care control groups , respectively .


In the subgroup of patients discharged from ED ( non-admitted ) , the SWAT intervention group was associated with higher NEAT performance ( P = @ ) compared with non-SWAT and control .


A senior early assessment model of care was not associated with improved overall NEAT performance and ED length of stay .


However , there is evidence that improvements were made in the subgroup of discharged patients .


There was no difference in overall NEAT performance among the three study groups .


To determine whether exercise on alternative terrain affects the development of the digital cushion and bony structures of the bovine foot .


@ weaned bull calves .


Two-month-old calves were randomly allocated to an exercise or control group .


For @ months , the control group was maintained in grass paddocks , and the exercise group was maintained in a @-km lane with a mixed terrain of dirt , stones ( @ - to @-cm pea gravel and @-cm crusher run ) , and grass .


Water and food for the exercise group were located at opposite ends of the lane ; calves were fed twice daily , which ensured they walked @ km/d .


Pedometers were applied to all calves to measure distance traveled .


All calves were slaughtered at @ months of age .


The right forefeet and hind feet were harvested for MRI and CT evaluation .


Control calves walked a mean of @ km daily , whereas the exercised calves walked a mean of @ km daily .


Mean digital cushion volume and surface area were @,@ mm ( @ ) and @,@ mm ( @ ) , respectively , for the exercised calves and @,@ mm ( @ ) and @,@ mm ( @ ) , respectively , for the control calves .


When weight was controlled , mean digital cushion volume and surface area for the exercise group were increased by @ % and @ % , respectively , from those for the control group .


Results indicated that exercise on alternative terrain increased the volume and surface area of the digital cushion of the feet of dairy calves , which should make them less susceptible to lameness .


A secondary objective of this head-to-head study of lisdexamfetamine dimesylate ( LDX ) and atomoxetine ( ATX ) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder ( ADHD ) and an inadequate response to methylphenidate ( MPH ) .


The primary efficacy and safety outcomes of the study , SPD@-@ ( ClinicalTrials.gov NCT@ ) , have been published previously .


In this @-week , double-blind , active-controlled study , patients aged @-@ years with a previous inadequate response to MPH were randomized ( @:@ ) to dose-optimized LDX ( @ , @ or @ mg/day ) or ATX ( patients < @ kg : @-@ @ mg/kg/day , not to exceed @ mg/kg/day ; patients @ kg : @ , @ or @ mg/day ) .


Treatment response was a secondary efficacy outcome and was predefined as a reduction from baseline in ADHD Rating Scale IV ( ADHD-RS-IV ) total score of at least @ , @ or @ % .


Sustained response was predefined as a reduction from baseline in ADHD-RS-IV total score ( @ , @ or @ % ) or a Clinical Global Impressions ( CGI ) - Improvement ( CGI-I ) score of @ or @ throughout weeks @-@ .


CGI-Severity ( CGI-S ) scores were also assessed , as an indicator of remission .


A total of @ patients were enrolled ( LDX , n = @ ; ATX , n = @ ) and @ completed the study ( LDX , n = @ ; ATX , n = @ ) .


By week @ , significantly ( p < @ ) greater proportions of patients receiving LDX than ATX met the response criteria of a reduction from baseline in ADHD-RS-IV total score of at least @ % ( @ vs. @ % ) , @ % ( @ vs. @ % ) or @ % ( @ vs. @ % ) .


Sustained response rates were also significantly ( p < @ ) higher among LDX-treated patients ( ADHD-RS-IV @ , @ % ; ADHD-RS-IV @ , @ % ; ADHD-RS-IV @ , @ % ; CGI-I , @ % ) than among ATX-treated individuals ( ADHD-RS-IV @ , @ % ; ADHD-RS-IV @ , @ % ; ADHD-RS-IV @ , @ % ; CGI-I , @ % ) .


Finally , by week @ , @ % of patients receiving LDX and @ % of those receiving ATX had a CGI-S score of @ ( normal , not at all ill ) or @ ( borderline mentally ill ) , and greater proportions of patients in the LDX group than the ATX group experienced a reduction from baseline of at least one CGI-S category .


Both LDX and ATX treatment were associated with high levels of treatment response in children and adolescents with ADHD and a previous inadequate response to MPH .


However , within the parameters of the study , LDX was associated with significantly higher treatment response rates than ATX across all response criteria examined .


In addition , higher proportions of patients in the LDX group than the ATX group had a CGI-S score of @ or @ by week @ , indicating remission of symptoms .


Both treatments were generally well tolerated , with safety profiles consistent with those observed in previous studies .


To compare the efficacy differences in the treatment of somatoform pain disorder between resuscitation and tranquilization acupuncture technique and oral administration of deanxit .


Forty cases of somatoform pain disorder ( complicated with mild and moderate depression ) were randomized into an acupuncture group and a western medication group , @ cases in each one .


In the acupuncture group .


acupuncture was applied to Shenting ( GV @ ) .


Shuigou ( V @ ) .


Sishencong ( EX HN I ) to Baihui ( ( V @ ) ( penetrating technique ) .


Feng-chi ( GB @ ) .


etc. .


The treatment was given once every day .


@ times a week .


In the western medication group .


the anti depression drug .


deanxit was prescribed for oral administration , @ tablet in every morning and lunchtime each day .


In @ weeks of continuous treatment , the visual analogue scale ( VAS ) and Hamilton depression scale @ items ( HAMD ) were used to evaluate the efficacy in the patients of the two groups , the adverse reactions were observed and the recurrence rate was followed up in @ months .


After treatment .


VAS and HIIAMD scores were all apparently reduced as compared with those before treatment in the patients of the two groups ( all P < @ ) .


The reducing amplitude of VAS score in the acupuncture group was greater than that in the western medication group ( P < @ ) and that of HAM ) score was not different significantly as compared with that in the western mnedica tion group ( P > @ ) .


There was no adverse reaction in the acupuncture group and were @ cases as dizziness , trembling .


dry mouth and constipation in the western medication group .


The curative and remarkably effective rate was @ ( @ ( @ ) ) in the acupuncture group , better than @ % ( @/@ ) in the western medication group ( P < @ ) .


The recurrence rate was @ ( @/@ ) in the acupuncture group .


lower than @ % ( @/@ ) in the western medication group ( P < @ ) .


The resuscitation and tranquilization acupuncture technique achieves the definite efficacy on somatoform pain disorder , relieves depression symptoms of patients , especially pain and reduces adverse reactions and recurrence rate .


The effects of this therapy are advanced as compared with deanxit .


The purpose of this study was to investigate the effect of mild-to - moderate ( m-mod ) traumatic brain injury ( TBI ) on spontaneous object ( SO ) recognition and temporal order ( TO ) memory in male Wistar rats and to compare the effects of environmental enrichment ( EE ) and simvastatin ( Sim ) on SO and TO memory post-injury .


A randomized repeated measure experimental design was used .


Seven days after arrival , animals received the injury or sham surgery .


Using a Y-shaped maze , SO and TO memory was assessed in the two groups of animals at @ , @ , @ , @ hours and @ , @ , @ and @ days post-surgery .


Total time exploring each object and discrimination ratio were calculated and analysed .


Then SO and TO memory were compared between two groups that received either Sim or EE for @ hours daily starting @ hours post-injury and a sham group that received saline for @ days post-injury .


The results showed that the injury impaired SO and TO memory compared to the sham up to @ days post-trauma .


Injured animals exhibited familiarity preference , novelty aversion and impaired TO performance .


EE improved the animals ' SO recognition deficits @ days post-injury after a shorter delay ( @ minute ) only and Sim reversed TO memory deficits @ days post-injury after a longer delay ( @ minutes ) .


Persistent SO and TO memory deficits follow TBI in animals ; Simv and EE seem to be promising therapies of TBI memory deficits .


Currently , most ESRD patients are treated with open surgical technique or with laparoscopic technique .


In this study , we examined the role of the ureteroscope-assisted `` Mini-Perc '' technique versus the modified open surgery in the treatment of ESRD in a prospective randomized manner .


A total of @ patients with chronic renal failure were prospectively randomized for the ureteroscope-assisted `` Mini-Perc '' technique or modified open surgery .


Intraoperative and postoperative morbidity , incision size , dose of local anesthesia , operative time , hospital stay , and initial catheter survival and follow-up were compared for both methods .


`` Mini-Perc '' group was associated with shorter incision size , operative time , and hospital stay , with lower dose of local anesthesia and incidence of bloody ascites .


Two of five patients with the history of abdominal surgery in `` Mini-Perc '' group required adhesiolysis under direct vision of telescope .


All adhesions were easily dissected .


All complications of leakage ( @ % ) and incisional hernia ( @ % ) occurred in the open surgery group , but a difference of no significant value with `` Mini-Perc '' group ( p = @ , p = @ ) .


There was no any other significant difference in common complications between two groups .


After @ years of follow-up , @ patients ( @ % ) survived with their initial PD catheter .


The overall death was @ ( @ % ) .


Compared to modified open surgical technique , the ureteroscope-assisted `` Mini-Perc '' technique can be used to achieve the same clinical efficacy for placement of peritoneal dialysis catheters in ESRD patients , and it carries minimal morbidity .


Craniotomy patients have a high incidence of postoperative nausea and vomiting ( PONV ) .


This prospective , randomized , double-blind , multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients .


A total of @ American Society of Anesthesiologists physical status I-II patients aged @-@ years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study .


All patients received total intravenous anesthesia ( TIVA ) with propofol and remifentanil .


Patients were randomly allocated into three groups to receive ondansetron ( @mg ; group A , n = @ ) , ondansetron ( @mg ; group B , n = @ ) , or ramosetron ( @ mg ; group C , n = @ ) intravenously at the time of dural closure .


The incidence of PONV , the need for rescue antiemetics , pain score , patient-controlled analgesia ( PCA ) consumption , and adverse events were recorded @h postoperatively .


Among the initial @ patients , @ completed the study and were included in the final analysis .


The incidences of PONV were lower ( nausea , @ % vs. @ % and @ % , respectively ; P < @ ; vomiting , P = @ ) and the incidence of complete response was higher ( @ % vs. @ % and @ % , respectively ; P < @ ) in group C than in groups A and B at @h postoperatively .


There were no significant differences in the incidence of PONV or need for rescue antiemetics @-@h postoperatively , but significant differences were observed in the incidence of PONV and complete response among the three groups @-@h postoperatively .


No statistically significant intergroup differences were observed in postoperative pain , PCA consumption , or adverse events .


Intravenous administration of ramosetron at @ mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients .


Ramosetron at @ mg was more effective than ondansetron at @ or @mg for preventing PONV in adult craniotomy patients .


Many patients with stroke receive integrative medicine in China , which includes the basic treatment of Western medicine and routine rehabilitation , in conjunction with acupuncture and Chinese medicine .


The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition .


Consequently , we will conduct a multicentre , randomised , controlled , assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation .


@ participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation ( IMR ) group and the conventional rehabilitation ( CR ) group in a @:@ ratio .


Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment .


The CR group will not receive acupuncture and Chinese herbal medicine .


The assessment data will be collected at baseline , @ and @ weeks postrandomisation , and then at @ weeks ' follow-up .


The primary outcome is measured by the Modified Barthel Index .


The secondary outcomes are the National Institutes of Health Stroke Scale ( NIHSS ) , Fugl-Meyer Assessment , the mini-mental state examination and Montreal Cognitive , Hamilton 's Depression Scale and Self-Rating Depression Scale , and the incidence of adverse events .


In contrast to conventional breast imaging techniques , one major diagnostic benefit of breast magnetic resonance imaging ( MRI ) is the simultaneous acquisition of morphologic and dynamic enhancement characteristics , which are based on angiogenesis and therefore provide insights into tumor pathophysiology .


The aim of this investigation was to intraindividually compare @ macrocyclic MRI contrast agents , with low risk for nephrogenic systemic fibrosis , in the morphologic and dynamic characterization of histologically verified mass breast lesions , analyzed by blinded human evaluation and a fully automatic computer-assisted diagnosis ( CAD ) technique .


Institutional review board approval and patient informed consent were obtained .


In this prospective , single-center study , @ women with @ histopathologically verified ( @ malignant , @ benign ) mass lesions underwent @ identical examinations at @ T ( mean time interval , @ days ) with @-mmol kg doses of gadoteric acid and gadobutrol .


All magnetic resonance images were visually evaluated by @ experienced , blinded breast radiologists in consensus and by an automatic CAD system , whereas the morphologic and dynamic characterization as well as the final human classification of lesions were performed based on the categories of the Breast imaging reporting and data system MRI atlas .


Lesions were also classified by defining their probability of malignancy ( morpho-dynamic index ; @ % -@ % ) by the CAD system .


Imaging results were correlated with histopathology as gold standard .


The CAD system coded @ of @ lesions with gadoteric acid and gadobutrol ( detection rate , @ % ) ; initial signal increase was significantly higher for gadobutrol than for gadoteric acid for all and the malignant coded lesions ( P < @ ) .


Gadoteric acid resulted in more postinitial washout curves and fewer continuous increases of all and the malignant lesions compared with gadobutrol ( CAD hot spot regions , P < @ ) .


Morphologically , the margins of the malignancies were different between the @ agents , whereas gadobutrol demonstrated more spiculated and fewer smooth margins ( P < @ ) .


Lesion classifications by the human observers and by the morpho-dynamic index compared with the histopathologic results did not significantly differ between gadoteric acid and gadobutrol .


Macrocyclic contrast media can be reliably used for breast dynamic contrast-enhanced MRI .


However , gadoteric acid and gadobutrol differed in some dynamic and morphologic characterization of histologically verified breast lesions in an intraindividual , comparison .


Besides the standardization of technical parameters and imaging evaluation of breast MRI , the standardization of the applied contrast medium seems to be important to receive best comparable MRI interpretation .


Left ventricular hypertrophy ( LVH ; high LV mass -LSB- LVM -RSB- ) is traditionally classified as concentric or eccentric based on LV relative wall thickness .


We evaluated the prediction of subsequent adverse events in a new @-group LVH classification based on LV dilatation ( high LV end-diastolic volume -LSB- EDV -RSB- index ) and concentricity ( mass/end-diastolic volume -LSB- M/EDV -RSB- ( @/@ ) ) in hypertensive patients .


In the Losartan Intervention for Endpoint Reduction ( LIFE ) echocardiography substudy , @ hypertensive patients with measurable LVM at baseline were randomized to a mean of @ years of losartan - or atenolol-based treatment .


Patients with LVH ( LVM/body surface area @ and @ g/m ( @ ) in men and woman , respectively ) were divided into @ groups-concentric nondilated ( increased M/EDV , normal EDV ) , eccentric dilated ( increased EDV , normal M/EDV ) , concentric dilated ( increased M/EDV and EDV ) , and eccentric nondilated ( normal M/EDV and EDV ) - and compared with patients with normal LVM .


Time-varying LVH classes were tested for association with all-cause and cardiovascular mortality and a composite end point of myocardial infarction , stroke , heart failure , and cardiovascular death in multivariable Cox analyses .


At baseline , the LVs were categorized as eccentric nondilated in @ % , eccentric dilated in @ % , concentric nondilated in @ % , concentric dilated in @ % , and normal LVM in @ % .


Treatment changed the prevalence of @ LVH groups to @ % , @ % , @ % , and @ % ; @ % had normal LVM after @ years .


In time-varying Cox analyses , compared with normal LVM , those with eccentric dilated and both concentric nondilated and dilated LVH had increased risks of all-cause or cardiovascular mortality or the composite end point , whereas the eccentric nondilated group did not .


Hypertensive patients with relatively mild LVH without either increased LV volume or concentricity have similar risk of all-cause mortality or cardiovascular events because hypertensive patients with normal LVM seem to be a low-risk group .


The purpose of this study was to evaluate the clinical success of three fissure sealants ( FSs ) with different contents on primary teeth .


Three FSs were used to seal @ primary molars in @ children aged @-@ years .


All FSs were placed on occlusal surfaces in a split-mouth and randomized clinical trial .


For patients in Group@ , amorphous calcium phosphate ( ACP ) containing resin-based sealant ( RBS ) ( Aegis ) was applied to a primary molar tooth on one side , and non-fluoride RBS ( Helioseal ) FS was applied to symmetrical molar tooth .


For patients in Group@ , fluoride-containing RBS ( Helioseal F ) was applied to a primary molar tooth on one side , and Helioseal FS was applied to symmetrical molar tooth .


For patients in Group@ , Helioseal FS was applied to a primary molar tooth on one side , and Aegis FS was applied to symmetrical molar tooth .


Clinical evaluation of FSs was carried out to assess retention , marginal discoloration , marginal adaptation , and the presence of caries in months @,@,@,@,@ and @ after FS application .


There were no significant differences for all criteria in groups @ and @ ( p@ @ ) .


In group @ , cumulative success rates according to @ months ' follow-up were statistically insignificant during the comparisons performed in terms of retention , marginal adaptation , and presence of caries ( p@ @ ) .


Marginal discoloration was found to be statistically significant ( p < @ ) .


RBS containing ACP or fluoride may be more effective than conventional RBS for caries prevention .


To observe the efficacy on primary osteoporosis treated with spreading moxibustion for warming yang and activating blood circulation so as to provide the effective clinical therapeutic methods for osteoporosis .


Sixty cases of primary osteoporosis were randomized into a spreading moxibustion group ( @ cases ) and a calcium tablet group ( @ cases ) .


In the calcium tablet group , caltrate was prescribed for oral administration , @ mg per day .


In the spreading moxibustion group , on the basis of the treatment as the calcium tablet group , the spreading moxibustion was applied at Dazhui ( GV @ ) to Yaoshu ( GV @ ) for warming yang and activating blood circulation .


The duration of treatment was @ weeks .


Visual analogue scale ( VAS ) score , TCM clinical symptom score and bone mineral density ( BMD ) were observed and compared before and after treatment in the patients between the two groups .


VAS scores were reduced apparently after treatment in the two groups ( both P < @ ) and the results in the spreading moxibustion group were obviously superior to that in the calcium tablet group ( @ + / - @ vs @ + / - @ , P < @ ) .


BMD were all increased in the two groups ( P < @ , P < @ ) and the results in the spreading moxibustion group were superior to those in the calcium tablet group ( both P < @ ) .


The total clinical effective rate was @ % ( @/@ ) in the spreading moxibustion group , apparently better than @ % ( @/@ ) in the calcium tablet group ( P < @ ) .


TCM clinical symptom scores after treatment were all reduced apparently in the two groups ( both P < @ ) , and the result in the spreading moxibustion group was obviously superior to that in the calcium tablet group ( @ + / - @ vs @ + / - @ , P < @ ) .


The total effective rate of TCM symptoms was @ % ( @/@ ) in the spreading moxibustion group , apparently better than @ % ( @/@ ) in the calcium tablet group ( P < @ ) .


The combined therapy of spreading moxibustion for warming yang and activating blood circulation and the oral administration of caltrate apparently relieves pain and TCM clinical symptoms , improves BMD in the patients of osteoporosis and achieves definite clinical efficacy in the patients of osteoporosis .


In oral and maxillofacial outpatient surgery , sedation techniques are an important component in patient management for a wide variety of surgical procedures .


Fentanyl and midazolam are commonly used sedatives with different mechanisms of action and specific analgesic or amnestic properties .


This study examined whether the order of their administration would affect a patient 's pain perception or procedural vital signs .


After institutional review board approval and written informed consent , a prospective , randomized , parallel-group clinical trial was conducted in patients who planned to undergo removal of at least @ third molars under intravenous moderate sedation .


Patients were randomly assigned to @ of @ groups .


The fentanyl-first group received fentanyl and then midazolam ; the midazolam-first group received midazolam and then fentanyl .


Recollection of the intraoperative pain score was assessed @ hours after surgery using the Wong-Baker FACES pain scale .


The Mann-Whitney U test was used to assess for the presence of a statistically significant difference between the @ groups .


Statistically significant differences in procedural vital sign fluctuations were examined using the t test .


Patients ' satisfaction with the procedure was assessed and intergroup comparisons were made .


Sixty-six patients were enrolled , @ of whom did not complete the study .


Recollected procedural pain scores at @ hours after surgery were not statistically different between groups .


Median scores on the Wong-Baker FACES pain scale for the @ groups were @ ( interquartile range , @ ) for the fentanyl-first group and @ ( interquartile range , @ ) for the midazolam-first group ( P = @ ) .


There was no statistical difference in the change in vital signs from baseline to @ surgical end points in the @ groups .


In addition , patient satisfaction with the procedure did not statistically differ between the @ groups .


In this study , selective sequencing of midazolam or fentanyl during an intravenous moderate-sedation procedure did not result in a measurable difference of recollected procedural pain scores at @ hours after third molar extraction .


The choice of the sedation agents and the order of their administration should be tailored to the patient 's needs , type of surgical procedure , and surgeon preference .


To explore the effect of compound qizhu granule ( CQG ) on cellular immunity of chronic hepatitis B ( CHB ) patients .


Totally @ CHB patients treated with lamivudin ( LAM ) for @ months , who had partial virological response ( HBeAg positive ) were randomly assigned to two groups , @ in the treatment group and @ in the control group .


All patients took LAM @ mg ( once a day ) plus ADV @ mg ( once a day ) .


Patients in the treatment group additionally took CQG , one dose per day .


After one-year treatment hepatitis B virus ( HBV ) DNA negative rates , HBeAg seroconversion , levels of HBV specific cytotoxic T lymphocyte ( CTL ) , non-specific CTL and natural killing ( NK ) cells were compared between the two groups .


After @-year treatment , HBV DNA negative rate of the treatment group was @ : @ % in @ cases , slightly higher than that of the control group ( @ cases , @ % ) , but with no statistical difference ( P > @ ) .


HBeAg seroconversion of the treatment group was @ % in @ cases , higher than that of the control group ( @ cases , @ % ) , with statistical difference ( P < @ ) .


Levels of HBV specific CTL ( @ % @ % ) , non-specific CTL ( @ % @ % ) and NK cells ( @ % @ % ) of the treatment group were higher than those of the control group ( @ % @ % , @ % @ % , and @ % @ % , respectively ; allP < @ ) .


Treating CHB patients with partial virological response by ADV plus CQG could improve specific and non-specific cellular immunity , thereby elevating HBeAg seroconversion rate .


Stroke is often associated with cognitive decline which can be evaluated by event-related potentials ( ERP ) .


So far , only little is known about the impact of stroke on ERP .


The aim of this prospective study was to follow-up ERP latencies in stroke patients and to evaluate the influence of sex , vascular territory of stroke , reinfarction , and secondary prevention ( acetylsalicylic acid versus piracetam ) .


Visually evoked ERP were recorded in @ stroke patients at baseline ( i.e. , within four weeks after stroke ) , after @ months , and after @ months .


The latencies of the P@ , N@ , and P@ components were assessed and compared between different subgroups .


The P@ latency is initially more increased in female stroke patients , but shows a better recovery in women compared to men .


A secondary prevention with piracetam leads to a significantly better recovery of ERP latencies than a treatment with acetylsalicylic acid .


Data suggests a better recovery of left hemispheric infarction compared to right hemispheric infarction .


Patients , who suffered another stroke during the follow-up period , showed a prolongation of P@ latency , suggesting an increased P@ latency to be associated with reinfarction .


Our results suggest that ERP measurement is an appropriate method for diagnosis and follow-up of cognitive changes after ischemic stroke .


In particular the P@ component is an indicator for patients at risk for reinfarction .


The reduction in acquired infections ( AI ) due to methicillin-resistant Staphylococcus aureus ( MRSA ) with the mupirocin/chlorhexidine ( M/C ) decontamination regimen has not been well studied in intubated patients .


We performed post hoc analysis of a prior trial to assess the impact of M/C on MRSA AI and colonization .


We conducted a multicenter , placebo-controlled , randomized , double-blind study with the primary aim to reduce all-cause AI .


The two regimens used -LSB- topical polymyxin and tobramycin ( P/T ) , nasal mupirocin with chlorhexidine body wash ( M/C ) , or corresponding placebos for each regimen -RSB- were administered according to a @ @ factorial design .


Participants were intubated patients in the intensive care units of three French university hospitals .


The patients enrolled in the study ( n = @ ) received either active P/T ( n = @ ) , active M/C ( n = @ ) , both active regimens ( n = @ ) , or placebos only ( n = @ ) for the period of intubation and an additional @ h.


The incidence and incidence rates ( per @,@ study days ) of MRSA AI were assessed .


Due to the absence of a statistically significant interaction between the two regimens , analysis was performed at the margins by comparing all patient receiving M/C ( n = @ ) to all patients not receiving M/C ( n = @ ) , and all patients receiving P/T ( n = @ ) to all patients not receiving P/T ( n = @ ) .


Incidence -LSB- odds ratio ( OR ) @ , @ % confidence interval ( CI ) ( @-@ @ ) , P = @ -RSB- and incidence rates -LSB- incidence rate ratio ( IRR ) @ , @ % CI @-@ @ , P = @ -RSB- of MRSA AI were significantly lower with the use of M/C .


We also observed an increase in the incidence ( OR @ , @ % CI @-@ @ , P = @ ) and the incidence rate ( IRR @ , @ % CI @-@ @ , P = @ ) of MRSA AI with the use of P/T .


Among our study cohort of intubated patients , the use of M/C significantly reduced MRSA AI .


In patients with type @ diabetes , improving adherence to medication is important in order to maintain favourable glycaemic control during long-term treatment and , thus , prevent the onset or aggravation of complications .


SYR-@ is a novel once-weekly oral DPP-@ inhibitor for type @ diabetes , which could be a treatment option when clinicians seek to improve medication adherence by reducing the number of required administrations .


In this study , we assessed the efficacy and safety of SYR-@ in patients with type @ diabetes .


In this phase @ , multicentre , randomised , double-blind , parallel-group , placebo-controlled , dose-ranging study , we included Japanese patients with inadequately controlled type @ diabetes despite diet and exercise treatment .


Patients were randomly assigned ( allocation ratio @:@:@:@:@:@ ) to receive either placebo or SYR-@ at five different doses ( @ mg , @ mg , @ mg , @ mg , or @ mg ) .


Randomisation was done with a permuted block schedule .


All investigators and patients were unaware of the treatment assignment .


Treatment drug was given orally once weekly for @ weeks .


The primary efficacy variable was the change in HbA@c concentration from baseline to the end of treatment .


This study has been registered at the Japan Pharmaceutical Information Center ( JAPIC ) Clinical Trials Information : Japic CTI-@ .


@ patients were randomly assigned to receive placebo ( @ patients ) or SYR-@ at @ mg ( @ patients ) , @ mg ( @ patients ) , @ mg ( @ patients ) , @ mg ( @ patients ) or @ mg ( @ patients ) .


The least square ( LS ) mean change in HbA@c concentration from baseline was @ % ( SE @ ; -@ mmol/mol ) for the placebo group , -@ % ( @ ; -@ mmol/mol ) for the @ mg group , -@ % ( @ ; -@ mmol/mol ) for the @ mg group , -@ % ( @ ; -@ mmol/mol ) for the @ mg group , -@ % ( @ ; -@ mmol/mol ) for the @ mg group , and -@ % ( @ ; -@ mmol/mol ) for the @ mg group .


In general , HbA@c concentration decreased in a dose-dependent manner ( trend test using contrast coefficients p < @ ) and the reduction was significantly greater for all SYR-@ doses ( p < @ for each group ) than for placebo .


The incidence of treatment-emergent adverse events in each SYR-@ group was similar to that in the placebo group .


The most common adverse event was nasopharyngitis in all groups .


No episodes of hypoglycaemia defined by investigator occurred with any treatment during the study .


Once-weekly SYR-@ treatment produced clinically and statistically significant improvements in glycaemic control in patients with type @ diabetes .


It was well tolerated and might be a new treatment option for patients with this disease .


There is a lack of trials of psychodynamic treatments of depression in breast cancer patients .


The purpose of this trial was to determine the efficacy of short-term psychodynamic psychotherapy ( STPP ) in non-metastatic breast cancer patients diagnosed with depression , one of the most frequent mental comorbidities of breast cancer .


In a multicenter prospective trial , @ breast cancer patients with comorbid depression were randomized to either individual STPP ( intervention group , N = @ ) or ` treatment as usual ' ( control group , TAU , N = @ ) .


As our primary outcome measure , we hypothesized a higher rate of remission defined as no diagnosis of depression ( Structured Clinical Interview for DSM-IV ) and reduction in depression score by at least @ points ( Hospital Anxiety and Depression Scale , HADS-D ) in STPP versus TAU at treatment termination .


Secondary outcomes mainly refer to quality of life ( QoL ) .


In the intention to treat ( ITT ) analysis , @ % of the STPP group achieved highly significantly more remission than TAU ( @ % ) .


STPP treatment ( OR = @ ; P < @ ) was the strongest predictor for remission post-treatment ; time was also significant ( OR = @ ; P < @ ) .


A high effect favoring STPP ( d = @ ) was observed for the HADS-D score post-treatment ( secondary outcome ) .


Regarding further secondary outcomes ( QoL ) , analyses of covariance yielded main effects for group ( favoring STPP with an effect size of at least d = @ ) for global QoL , role , emotional and social functioning , pain , treatment side-effects , breast symptoms and upset by hair loss .


STPP is an effective treatment of a broad range of depressive conditions in breast cancer patients improving depression and functional QoL .


Findings are limited by the drop-out rate ( @/@ ) and delayed post-treatment assessments .


Future trials may consider stepped-care approaches , tailored to patients ' needs and requirements in the acute treatment phase .


Two strategies to interrogate the insulin growth factor @ receptor ( IGF-@R ) pathway were investigated : vertical inhibition with dalotuzumab and MK-@ or ridaforolimus to potentiate PI@K pathway targeting and horizontal cross-talk inhibition with dalotuzumab and MK-@ to exert effects against cellular proliferation , angiogenesis , and stem cell propagation .


A phase I , multi-cohort dose escalation study was conducted in patients with advanced solid tumours .


Patients received dalotuzumab ( @mgkg ( -@ ) ) and escalating doses of MK-@ ( @-@mg ) or escalating doses of dalotuzumab ( @-@mgkg ( -@ ) ) and MK-@ ( @mg ) weekly .


Upon maximum tolerated dose determination , patients with low-RAS signature , high-IGF@ expression ovarian cancer were randomised to dalotuzumab/MK -@ versus dalotuzumab/ridaforolimus , whereas patients with high IGF@/low IGF@ expression colorectal cancer received dalotuzumab/MK -@ .


A total of @ patients were enrolled : @ in part A ( @ in the dalotuzumab/MK -@ arm and @ in the dalotuzumab/MK -@ arm ) and @ in part B ( @ in each arm ) .


Dose-limiting toxicities ( DLTs ) for dalotuzumab/MK -@ included grade @ neutropenia and grade @ serum sickness-like reaction , maculopapular rash , and gastrointestinal inflammation .


For dalotuzumab/MK -@ , DLTs included grade @ dehydration , rash , and diarrhoea .


Seven patients remained on study for > @ cycles .


Dalotuzumab/MK -@ and dalotuzumab/MK -@ combinations were tolerable .


Further developments of prospectively validated predictive biomarkers to aid in patient selection for anti-IGF-@R therapies are needed .


The aim of this study was to evaluate clinical success of primary teeth class II lesions restored with different restorative materials -LSB- Hybrid Composite Resin ( HCR ) , Resin Modified Glass Ionomer Cement ( RMGIC ) , compomer , and Giomer Composite Resin ( GCR ) -RSB- followed up for @ months .


This study was carried out on @ primary molars of @ children in the age range of @-@ years .


The class II lesions in primary molars of a patient were restored using different restorative materials .


Restorations were evaluated according to FDI-criteria and their survival rates were determined .


Data were analysed with Pearson chi-square , Kaplan-Meier and Wilcoxon ( Breslow ) tests ( = @ ) .


The failure rates of restorative materials were as follows : compomer @ % , RMGIC @ % , HCR @ % and GCR @ % .


While the functional failure was the most important factor in restorative material failure , RMGIC was the most successful material in terms of biological evaluation criterion and GCR had the longest survival rate .


Cetuximab and bevacizumab have both been shown to improve outcomes in patients with metastatic colorectal cancer when added to chemotherapy regimens ; however , their comparative effectiveness when partnered with first-line fluorouracil , folinic acid , and irinotecan ( FOLFIRI ) is unknown .


We aimed to compare these agents in patients with KRAS ( exon @ ) codon @/@ wild-type metastatic colorectal cancer .


In this open-label , randomised , phase @ trial , we recruited patients aged @-@ years with stage IV , histologically confirmed colorectal cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status of @-@ , an estimated life expectancy of greater than @ months , and adequate organ function , from centres in Germany and Austria .


Patients were centrally randomised by fax ( @:@ ) to FOLFIRI plus cetuximab or FOLFIRI plus bevacizumab ( using permuted blocks of randomly varying size ) , stratified according to ECOG performance status , number of metastatic sites , white blood cell count , and alkaline phosphatase concentration .


The primary endpoint was objective response analysed by intention to treat .


The study has completed recruitment , but follow-up of participants is ongoing .


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


Between Jan @ , @ , and Sept @ , @ , @ patients with KRAS exon @ wild-type tumours were randomly assigned and received treatment ( @ in the FOLFIRI plus cetuximab group and @ in the FOLFIRI plus bevacizumab group ) .


@ ( @ % , @ % CI @-@ ) patients in the cetuximab group achieved an objective response compared with @ ( @ % , @-@ ) in the bevacizumab group ( odds ratio @ , @ % CI @-@ ; p = @ ) .


Median progression-free survival was @ months ( @ % CI @-@ ) in the cetuximab group and @ months ( @-@ ) in the bevacizumab group ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p = @ ) ; however , median overall survival was @ months ( @ % CI @-@ ) in the cetuximab group compared with @ months ( @-@ ) in the bevacizumab group ( HR @ , @ % CI @-@ ; p = @ ) .


Safety profiles were consistent with the known side-effects of the study drugs .


The most common grade @ or worse adverse events in both treatment groups were haematotoxicity ( @ -LSB- @ % -RSB- of @ patients in the cetuximab group vs @ -LSB- @ % -RSB- of @ patients in the bevacizumab group ) , skin reactions ( @ -LSB- @ % -RSB- vs six -LSB- @ % -RSB- ) , and diarrhoea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Although the proportion of patients who achieved an objective response did not significantly differ between the FOLFIRI plus cetuximab and FOLFIRI plus bevacizumab groups , the association with longer overall survival suggests that FOLFIRI plus cetuximab could be the preferred first-line regimen for patients with KRAS exon @ wild-type metastatic colorectal cancer .


Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment .


Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression , insomnia , obesity , diabetes , cardiovascular disease , and cancer .


Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes .


Although some observational studies have shown improvement of depression and insomnia after cataract surgery , randomized controlled trials are lacking .


We will conduct a parallel-group , assessor-blinded , simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms , sleep quality , body mass regulation , and glucose and lipid metabolism .


We will recruit patients who are aged @ years and over , scheduled to receive their first cataract surgery , and have grade @ or higher nuclear opacification as defined by the lens opacities classification system III .


Exclusion criteria will be patients with major depression , severe corneal opacity , severe glaucoma , vitreous haemorrhage , proliferative diabetic retinopathy , macular oedema , age-related macular degeneration , and patients needing immediate or combined cataract surgery .


After baseline participants will be randomized to two groups .


Outcomes will be measured at three months after surgery among the intervention group , and three months after baseline among the control group .


We will assess depressive symptoms as a primary outcome , using the short version geriatric depression scale ( GDS-@ ) .


Secondary outcomes will be subjective and actigraph-measured sleep quality , sleepiness , glycated haemoglobin , fasting plasma glucose and triglyceride , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , body mass index , abdominal circumference , circadian rhythms of physical activity and wrist skin temperature , and urinary melatonin metabolite .


Chronotype and visual function will be assessed using the ` morningness-eveningness ' questionnaire , the Munich chronotype questionnaire , and the National Eye Institute Visual Function Questionnaire .


Although there are potential limitations due to the difference in duration from baseline survey to outcome measurements between two groups , any seasonal effect on the outcome measurement will be balanced as a result of continuous inclusion of participants through the year , and outcomes will be adjusted for day length at outcome measurements at analysis .


The objective of this study was to evaluate the safety and efficacy of the surgical versus transcatheter approach to correct perimembranous ventricular septal defects ( pmVSDs ) in a prospective , randomized , controlled clinical trial .


pmVSD is a common congenital heart disease in children .


Surgical closure of pmVSD is a well-established therapy but requires open-heart surgery with cardiopulmonary bypass .


Although the transcatheter approach is associated with significant incidence of complete atrioventricular block , it may provide a less invasive alternative .


Critical comparison of the safety and efficacy of the @ interventions necessitates a prospective , randomized , controlled trial .


Between January @ and July @ , @ children with pmVSD were randomly assigned to surgical or transcatheter intervention .


Clinical , laboratory , procedural , and follow-up data over a @-year period were compared .


Neither group had mortality or major complications .


However , statistical analysis of the @ groups demonstrated significant differences ( p < @ ) in minor adverse events ( @ vs. @ ) , quantity of blood transfused , duration of the procedure , median hospital stay , median intensive care unit stay , median hospitalization cost , and median blood loss .


During a median follow-up of @ years , the left ventricular end-diastolic dimension of both groups returned to normal and there was no difference in closure rate , adverse events , and complications between groups .


Transcatheter device closure and surgical repair are effective interventions with excellent midterm results for treating pmVSD in children .


Transcatheter device closure has a lower incidence of myocardial injury , less blood transfused , faster recovery , shorter hospital stay , and lower medical expenses .


( Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects ; NCT@ ) .


Sepsis sequelae include critical illness polyneuropathy , myopathy , wasting , neurocognitive deficits , post-traumatic stress disorder , depression and chronic pain .


Little is known howlong-term sequelae following hospital discharge are treated .


The aim of our study is to determine the effect of a primary care-based , long-term program on health-related quality of life in sepsis survivors .


In a two-armed randomized multicenter interventional study , patients after sepsis ( n = @ ) will be assessed at @ , @ and @months .


Patients are eligible if severe sepsis or septic shock ( ICD-@ ) , at least two criteria of systemic inflammatory response syndrome ( SIRS ) , at least one organ dysfunction and sufficient cognitive capacity are present .


The intervention comprises @ ) discharge management , @ ) training of general practitioners and patients in evidence-based care for sepsis sequelae and @ ) telephone monitoring of patients .


At six months , we expect an improved primary outcome ( health-related quality of life/SF -@ ) and improved secondary outcomes such as costs , mortality , clinical - , psycho-social - and process-of-care measures in the intervention group compared to the control group .


This study evaluates a primary care-based , long-term program for patients after severe sepsis .


Study results may add evidence for improved sepsis care management .


General practitioners may contribute efficiently to sepsis aftercare .


The aim of this study was to determine if ablation that targets patient-specific atrial fibrillation ( AF ) - sustaining substrates ( rotors or focal sources ) is more durable than trigger ablation alone at preventing late AF recurrence .


Late recurrence substantially limits the efficacy of pulmonary vein isolation for AF and is associated with pulmonary vein reconnection and the emergence of new triggers .


Three-year follow-up was performed of the CONFIRM ( Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation ) trial , in which @ consecutive patients with AF ( @ % persistent ) underwent novel computational mapping .


Ablation comprised source ( focal impulse and rotor modulation -LSB- FIRM -RSB- ) and then conventional ablation in @ patients ( FIRM guided ) and conventional ablation alone in @ patients ( FIRM blinded ) .


Patients were followed with implanted electrocardiographic monitors when possible ( @ % of FIRM-guided patients , @ % of FIRM-blinded patients ) .


FIRM mapping revealed a median of @ ( interquartile range : @ to @ ) rotors or focal sources in @ % of patients during AF .


During a median follow-up period of @ days ( interquartile range : @ to @,@ days ) , compared to FIRM-blinded therapy , patients receiving FIRM-guided ablation maintained higher freedom from AF after @ @ procedures ( median @ ; interquartile range : @ to @ ) ( @ % vs. @ % , p = @ ) and a single procedure ( p < @ ) and higher freedom from all atrial arrhythmias ( p = @ ) .


Freedom from AF was higher when ablation directly or coincidentally passed through sources than when it missed sources ( p < @ ) .


FIRM-guided ablation is more durable than conventional trigger-based ablation in preventing @-year AF recurrence .


Future studies should investigate how ablation of patient-specific AF-sustaining rotors and focal sources alters the natural history of arrhythmia recurrence .


( The Dynamics of Human Atrial Fibrillation ; NCT@ ) .


Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm .


However , verapamil may have side effects and is contraindicated in some clinical settings .


During an investigator-initiated , randomized , double-blind trial , we evaluated the need for preventive verapamil administration .


After vascular access was established , patients received either @ mg verapamil ( n = @ ) or placebo ( n = @ ) .


We compared the rate of access site conversions as primary end point using a superiority margin of @ % .


Occurrence of code breaks ( composite of conversions and unplanned use of verapamil ) , overall verapamil use , procedural and fluoroscopic times , contrast volume , and subjective pain were investigated as secondary end points .


The rate of access site conversions was not different in the @ arms ( placebo @ % versus verapamil @ % , P = @ , difference @ % , @ % CI for the difference -@ % to @ % ) .


Proportion of code breaks was similar in the @ groups ( @ % versus @ % , P = @ ) , whereas overall verapamil use was markedly lower in the placebo arm ( @ % versus @ % , P < @ ) .


Procedural time ( median -LSB- IQR -RSB- @ minutes -LSB- @ to @ minutes -RSB- versus @ minutes -LSB- @ to @ minutes -RSB- , P = @ ) , fluoroscopic time ( @ minutes -LSB- @ to @ minutes -RSB- versus @ minutes -LSB- @ to @ minutes -RSB- , P = @ ) , contrast volume ( @ mL -LSB- @ to @ mL -RSB- versus @ mL -LSB- @ to @ mL -RSB- , P = @ ) , and pain score ( P for trend = @ ) were comparable in the @ groups .


The preventive use of verapamil may be unnecessary for transradial procedures .


The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil .


Although occult metastasis to lymph node in the lateral neck compartment is common in papillary thyroid carcinoma ( PTC ) , the clinical impact of these metastasis is unknown .


We hypothesized that sentinel lymph node biopsy ( SLNB ) of the lateral neck compartment with radioisotopes may detect occult metastasis , which could prevent recurrence .


This randomized , controlled study was conducted from June @ to January @ and included @ patients with PTC who were receiving treatment at the Samsung Medical Center .


Of the @ patients enrolled in the study , @ were randomized to a lateral SLNB ( LSLNB ) group and @ patients were to the control group .


Lateral sentinel lymph nodes ( LSLNs ) were identified in @ of the @ patients ( @ % ) for whom stimulated thyroglobulin ( sTg ) levels were available .


Among the @ patients with LSLNs , @ ( @ % ) had metastases and underwent an ipsilateral modified radical neck dissection .


Among the @ patients for whom repeated sTg test results were available , the first median level of sTg in the LSLNB study group was less compared with the control group ( P = @ , adjusted for duration ) .


However , the second sTg level ( after the first radioactive iodine ablation ) was not different between the @ groups .


Moreover , the sTg levels were not significantly different between the LSLN-positive ( n = @ ) and other patients ( n = @ ) after the first and second ablations .


During patient follow-up ( median , @months ; range , @-@ ) , @ cases of recurrence were observed in the control group and @ case in the study group ( a LSLN had not been detected in this case ) .


Although LSLNB was able to remove occult metastasis in PTC , this procedure had no effect on either sTg levels or on recurrence rates at a mean follow-up of @months .


Additional long-term studies are needed to explore fully the clinical usefulness of LSLNB in the prevention of PTC recurrence .


We aimed to compare overall survival after standard-dose versus high-dose conformal radiotherapy with concurrent chemotherapy and the addition of cetuximab to concurrent chemoradiation for patients with inoperable stage III non-small-cell lung cancer .


In this open-label randomised , two-by-two factorial phase @ study in @ institutions in the USA and Canada , we enrolled patients ( aged @ years ) with unresectable stage III non-small-cell lung cancer , a Zubrod performance status of @-@ , adequate pulmonary function , and no evidence of supraclavicular or contralateral hilar adenopathy .


We randomly assigned ( @:@:@:@ ) patients to receive either @ Gy ( standard dose ) , @ Gy ( high dose ) , @ Gy plus cetuximab , or @ Gy plus cetuximab .


All patients also received concurrent chemotherapy with @ mg/m ( @ ) paclitaxel and carboplatin once a week ( AUC @ ) ; @ weeks after chemoradiation , two cycles of consolidation chemotherapy separated by @ weeks were given consisting of paclitaxel ( @ mg/m ( @ ) ) and carboplatin ( AUC @ ) .


Randomisation was done with permuted block randomisation methods , stratified by radiotherapy technique , Zubrod performance status , use of PET during staging , and histology ; treatment group assignments were not masked .


Radiation dose was prescribed to the planning target volume and was given in @ Gy daily fractions with either intensity-modulated radiation therapy or three-dimensional conformal radiation therapy .


The use of four-dimensional CT and image-guided radiation therapy were encouraged but not necessary .


For patients assigned to receive cetuximab , @ mg/m ( @ ) cetuximab was given on day @ followed by weekly doses of @ mg/m ( @ ) , and was continued through consolidation therapy .


The primary endpoint was overall survival .


All analyses were done by modified intention-to-treat .


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


Between Nov @ , @ , and Nov @ , @ , @ patients were randomly assigned to receive standard-dose chemoradiotherapy , @ to high-dose chemoradiotherapy , @ to standard-dose chemoradiotherapy and cetuximab , and @ to high-dose chemoradiotherapy and cetuximab .


Median follow-up for the radiotherapy comparison was @ months ( IQR @-@ @ ) .


Median overall survival was @ months ( @ % CI @-@ @ ) for patients who received standard-dose radiotherapy and @ months ( @-@ @ ) for those who received high-dose radiotherapy ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ @ ; p = @ ) .


Median follow-up for the cetuximab comparison was @ months ( IQR @-@ @ ) .


Median overall survival in patients who received cetuximab was @ months ( @ % CI @-@ @ ) compared with @ months ( @-@ @ ) in those who did not ( HR @ , @ % CI @-@ @ ; p = @ ) .


Both the radiation-dose and cetuximab results crossed protocol-specified futility boundaries .


We recorded no statistical differences in grade @ or worse toxic effects between radiotherapy groups .


By contrast , the use of cetuximab was associated with a higher rate of grade @ or worse toxic effects ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ patients ; p < @ ) .


There were more treatment-related deaths in the high-dose chemoradiotherapy and cetuximab groups ( radiotherapy comparison : eight vs three patients ; cetuximab comparison : ten vs five patients ) .


There were no differences in severe pulmonary events between treatment groups .


Severe oesophagitis was more common in patients who received high-dose chemoradiotherapy than in those who received standard-dose treatment ( @ -LSB- @ % -RSB- of @ patients vs @ -LSB- @ % -RSB- of @ patients ; p < @ ) .


@ Gy radiation given in @ Gy fractions with concurrent chemotherapy was not better than @ Gy plus concurrent chemotherapy for patients with stage III non-small-cell lung cancer , and might be potentially harmful .


Addition of cetuximab to concurrent chemoradiation and consolidation treatment provided no benefit in overall survival for these patients .


The authors evaluated the potential of methylphenidate to improve antidepressant response to citalopram , as assessed by clinical and cognitive outcomes , in elderly depressed patients .


The authors conducted a @-week randomized double-blind placebo-controlled trial for geriatric depression in @ older outpatients diagnosed with major depression comparing treatment response in three treatment groups : methylphenidate plus placebo ( N = @ ) , citalopram plus placebo ( N = @ ) , and citalopram plus methylphenidate ( N = @ ) .


The primary outcome measure was change in depression severity .


Remission was defined as a score of @ or less on the Hamilton Depression Rating Scale .


Secondary outcomes included measures of anxiety , apathy , quality of life , and cognition .


Daily doses ranged from @ mg to @ mg for citalopram ( mean = @ mg ) and from @ mg to @ mg for methylphenidate ( mean = @ mg ) .


All groups showed significant improvement in depression severity and in cognitive performance .


However , the improvement in depression severity and the Clinical Global Impressions improvement score was more prominent in the citalopram plus methylphenidate group compared with the other two groups .


Additionally , the rate of improvement in the citalopram plus methylphenidate group was significantly higher than that in the citalopram plus placebo group in the first @ weeks of the trial .


The groups did not differ in cognitive improvement or number of side effects .


Combined treatment with citalopram and methylphenidate demonstrated an enhanced clinical response profile in mood and well-being , as well as a higher rate of remission , compared with either drug alone .


All treatments led to an improvement in cognitive functioning , although augmentation with methylphenidate did not offer additional benefits .


We evaluated an alternative administration route , reduced schedule priming series , and increased intervals between booster doses for anthrax vaccine adsorbed ( AVA ) .


AVA 's originally licensed schedule was @ subcutaneous ( SQ ) priming injections administered at months ( m ) @ , @ , @ , @ , @ and @ with annual boosters ; a simpler schedule is desired .


Through a multicenter randomized , double blind , non-inferiority Phase IV human clinical trial , the originally licensed schedule was compared to four alternative and two placebo schedules .


@-SQ group participants received @ SQ injections with m@ and m@ `` annual '' boosters ; participants in the @-IM group received intramuscular ( IM ) injections according to the same schedule .


Reduced schedule groups ( @-IM , @-IM , @-IM ) received IM injections at m@ , m@ , m@ ; at least one of the m@ @ , m@ , m@ , m@ vaccine doses were replaced with saline .


All reduced schedule groups received a m@ booster .


Post-injection blood draws were taken two to four weeks following injection .


Non-inferiority of the alternative schedules was compared to the @-SQ group at m@ , m@ , and m@ .


Reactogenicity outcomes were proportions of injection site and systemic adverse events ( AEs ) .


The @-IM group 's m@ response was non-inferior to the @-SQ group for the three primary endpoints of anti-protective antigen IgG geometric mean concentration ( GMC ) , geometric mean titer , and proportion of responders with a @-fold rise in titer .


At m@ anti-PA IgG GMCs for the three reduced dosage groups were non-inferior to the @-SQ group GMCs .


At m@ , @-IM , @-IM , and @-IM group GMCs were superior to the @-SQ group .


Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. .


Route of administration did not influence the occurrence of systemic AEs .


A @ dose IM priming schedule with doses administered at m@ , m@ , and m@ elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at @ months .


A priming series of @ intramuscular doses administered at m@ , m@ , and m@ with a triennial booster was non-inferior to more complex schedules for achieving antibody response .


To compare acute normovolemic hemodilution versus low central venous pressure strategy versus conventional fluid management in reducing intraoperative estimated blood loss , hematocrit drop and need for blood transfusion in patients undergoing radical retropubic prostatectomy under general anesthesia .


Patients undergoing radical retropubic prostatectomy under general anesthesia were randomized to conventional fluid management , acute normovolemic hemodilution or low central venous pressure ( @mmHg ) .


Treatment effects on estimated blood loss and hematocrit change were tested in multivariable regression models accounting for surgeon , prostate size , and all two-way interactions .


Ninety-two patients completed the study .


Estimated blood loss ( meanSD ) was significantly lower with low central venous pressure ( @ml ) compared to acute normovolemic hemodilution ( @ml ) and conventional ( @ml ) groups ( p = @ ) .


There was no difference between the groups in need for blood transfusion , or hematocrit drop from preoperative values .


The multivariate model predicting estimated blood loss showed a significant effect of treatment ( p = @ ) and prostate size ( p = @ ) , accounting for surgeon ( p = @ ) .


In the model predicting hematocrit change , accounting for surgeon difference ( p = @ ) , the treatment effect depended on prostate size ( p = @ ) with the slope of low central venous pressure differing from the other two groups .


Hematocrit was predicted to drop more with increased prostate size in acute normovolemic hemodilution and conventional groups but not with low central venous pressure .