A randomized controlled trial tested a telephone and mailed print intervention among @ older , overweight , long-term survivors of breast , prostate , and colorectal cancer .


Dietary and exercise behaviors were assessed at @ time points throughout the year-long intervention ; health outcomes were examined postintervention .


Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior .


Attendance showed positive indirect relationships with physical function ( = @ , p < @ ) , basic and advanced lower extremity function ( = @ , p < @ / = @ , p < @ ) , and mental health ( = @ , p < @ ) , and a negative indirect relationship with body mass index ( = -@ , p < @ ) .


Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes ( Clinicaltrials.gov number NCT@ ) .


To investigate the putative modifying effect of dual antiplatelet therapy ( DAPT ) use on the incidence of stent thrombosis at @ years in patients randomized to Endeavor zotarolimus-eluting stent ( E-ZES ) or Cypher sirolimus-eluting stent ( C-SES ) .


Of @ patients in PROTECT , @ were randomized to E-ZES and @ to C-SES .


Aspirin was to be given indefinitely , and clopidogrel/ticlopidine for @ months or up to @ months after implantation .


Main outcome measures were definite or probable stent thrombosis at @ years .


Multivariable Cox regression analysis was applied , with stent type , DAPT , and their interaction as the main outcome determinants .


Dual antiplatelet therapy adherence remained the same in the E-ZES and C-SES groups ( @ % at @ year , @ % at @ years , and @ % at @ years ) .


We observed a statistically significant ( P = @ ) heterogeneity in treatment effect of stent type in relation to DAPT .


In the absence of DAPT , stent thrombosis was lower with E-ZES vs. C-SES ( adjusted hazard ratio @ , @ % confidence interval @ , @ ; P = @ ) .


In the presence of DAPT , no difference was found ( @ ; @ , @ ; P = @ ) .


A strong interaction was observed between drug-eluting stent type and DAPT use , most likely prompted by the vascular healing response induced by the implanted DES system .


These results suggest that the incidence of stent thrombosis in DES trials should not be evaluated independently of DAPT use , and the optimal duration of DAPT will likely depend upon stent type ( Clinicaltrials.gov number NCT@ ) .


Safe venepuncture technique is a critical skill for health care professionals , to avoid accidental occupational injury .


This study investigates whether watching an instructional video improves medical students ' ability to perform venepuncture safely .


This was a randomised , controlled , assessor-blinded trial that evaluated the utility of an instructional video , with the primary outcome of the ability to perform venepuncture safely .


Forty-two second-year medical students were recruited and randomised to receive either video instruction ( group A , n = @ ) or no intervention ( group B , n = @ ) .


Prior to the study , all students attended an instructor-led workshop on venepuncture .


During the study , students were paired and instructed to perform venepuncture on a partner .


Performance was assessed using a points-based checklist .


Pre - and post-study surveys were conducted to assess confidence with technique .


The mean total checklist score was higher in group A than in group B , with values of @ and @ , respectively ( p < @ , maximum @ points ) .


Mean scores were also higher in group A than in group B among students who performed first ( p = @ ) and students who performed second ( p = @ ) within the pair .


From the post-procedure survey , only group A rated increased confidence in performing venepuncture after the study ( p = @ ) .


Students who watched an instructional video performed venepuncture more effectively and reported greater confidence with the technique .


Medical students can benefit from having access to an instructional video on venepuncture as an adjunct to the standard curriculum .


Safe venepuncture technique is a critical skill for health care professionals .


Hospital admissions may provide an opportunity to discontinue potentially inappropriate medications ( PIMs ) in older patients .


Little is known about the effect of using the Screening Tool of Older People 's potentially inappropriate Prescriptions ( STOPP ) in this context .


This study aimed to test the hypothesis that specific STOPP recommendations from an inpatient geriatric consultation team ( IGCT ) to the hospital physician leads to reductions in PIMs for patients at discharge .


This was a randomised controlled study in @ frail inpatients ( in @ ) .


The intervention consisted of STOPP recommendations made by the IGCT to ward physicians to discontinue PIMs , in addition to the standard geriatric advice .


Intervention ( n = @ ) and control ( n = @ ) groups were similar in terms of patient characteristics ( median age @years ; median number of daily drugs , seven ) and PIM distribution ( @ and @ PIMs in @ and @ % of patients , respectively ) .


At discharge , the reduction in PIMs was twice as high for the intervention group as for the control group ( @ and @ % , respectively ; p = @ ) .


The proportion of patients who still had one or more PIM at discharge did not differ between groups .


In the @ patients followed-up a year later , the majority of PIMs that had been stopped during hospitalisation had not been restarted after discharge ( @/@ ; @ % ) .


The clinical relevance of PIMs identified at baseline in those patients was considered major ( @ % ) , moderate ( @ % ) , minor ( @ % ) , deleterious ( @ % ) , or not assessed ( @ % ) .


Discontinuation rate was not associated with clinical importance .


Specific STOPP recommendations provided to hospital physicians doubled the reduction of PIMs at discharge in frail older inpatients .


To further improve the appropriateness of prescribing in older patients , clinicians should focus on the STOPP criteria that are of major clinical importance , and general practitioners should be actively involved .


We investigated induction of - secretase A disintegrin and metalloprotease @ ( ADAM@ ) by the synthetic retinoid acitretin ( Neotigason ; Actavis , Mnchen-Riem , Germany ) in patients with mild to moderate Alzheimer disease ( AD ) via measurement of CSF content of - secretase-derived amyloid precursor protein ( APPs - ) .


Twenty-one patients clinically diagnosed with mild to moderate AD received acitretin ( @ mg per day ) or placebo in a @-week double-blind study .


Primary endpoint was the difference of CSF APPs - ratios calculated from the APPs - levels after treatment and at baseline .


We monitored safety and tolerability of the treatment .


In addition , we assessed biomarkers such as - amyloid @ ( A@ ) under treatment conditions .


The acitretin group showed a significant increase in CSF APPs - levels compared with the placebo group ( difference @ , @ % confidence interval @-@ @ , p = @ ) within this rather short treatment period .


The synthetic retinoid acitretin was overall safe and well tolerated .


Our pilot study highlights that acitretin is able to enhance the nonamyloidogenic APP processing in human patients .


Clinical consequences of this regulation should be investigated in larger and longer trials in patients with AD to evaluate acitretin 's potential to serve as a novel therapeutic drug .


This study provides Class III evidence that in patients with AD , oral acitretin increases CSF APPs - levels .


H.P. Acthar ( ) Gel is currently the only Food and Drug Administration therapy approved for the treatment of nephrotic syndrome .


Active drug ingredients include structurally related melanocortin peptides that bind to cell surface G-protein-coupled receptors known as melanocortin receptors , which are expressed in glomerular podocytes .


In animal models of membranous nephropathy , stimulation has been demonstrated to reduce podocyte injury and loss .


We hypothesized that H.P. Acthar ( ) Gel would improve symptoms of the nephrotic syndrome in patients with idiopathic membranous nephropathy .


Twenty patients received a subcutaneous dose of @ or @ IU twice weekly .


Changes in proteinuria , albumin , cholesterol profile , estimated glomerular filtration rate and serum anti-PLA@R antibodies were assessed at baseline and in response to treatment along with tolerance and safety .


Baseline characteristics included mean proteinuria ( @ @ g/day ) , albumin ( @ @ g/dL ) , estimated glomerular filtration rate ( @ @ mL/min ) along with elevated total and low-density lipoprotein ( LDL ) cholesterol .


By @ months of follow-up , there was a significant improvement in proteinuria in the entire cohort , decreasing to @ @ g/day ( P < @ ) with significant improvements in serum albumin , total and LDL cholesterol .


A > @ % decrease in proteinuria was noted in @ % of the patients with a trend toward better outcomes among patients who received greater cumulative doses .


No significant adverse effects were documented .


Clearing of serum anti-PLA@R antibodies prior to or in parallel with proteinuria improvement was noted in some , but not all patients .


H.P. Acthar ( ) Gel is a potential therapy for nephrotic syndrome secondary to idiopathic membranous nephropathy that deserves further study .


The capsular polysaccharide of Salmonella enterica serovar Typhi , Vi antigen , is an essential virulence factor and a protective antigen .


Similar to other polysaccharide vaccines , the protective action of Vi , both to the polysaccharide alone or when presented as a conjugate , is mediated by serum IgG Vi antibodies .


The evaluation of Vi capsular polysaccharide based vaccines to prevent typhoid fever would be significantly facilitated by the identification of a `` protective level '' of serum antibodies to Vi antigen .


The protective level of anti-Vi IgG against typhoid fever was derived from the protective efficacy and immune response of a Vi-rEPA conjugate vaccine efficacy trial .


The estimation was derived by two methods : correlation of the percent efficacy and the antibody distribution profile in the vaccine group at a given period of observation , and use of the relative ratio of anti-Vi IgG levels between the vaccine and placebo groups greater or equal to the Relative Risk of typhoid fever used in the efficacy determination .


Both methods predicted a similar range of a minimum protective level of anti-Vi IgG between @ and @ g/ml ( short term threshold ) .


When applying a protective threshold of @g/ml at @ months post immunization , an IgG level in excess of @ g/ml was achieved by @ % of children at @ months post immunization , consistent with an @ % level of protection over the duration of the study .


We thus suggest that the proportion of children with Vi IgG > @g/ml ( long term threshold ) @ months after immunization may reflect the proportion protected over at least a @ year period .


The current assignment of an anti-Vi IgG protective level may be of value when evaluating vaccine performance of future Vi conjugate vaccines .


Reducing LDL cholesterol ( LDL-C ) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD , including dialysis patients , but the effect of lowering LDL-C on vascular access patency is unclear .


The Study of Heart and Renal Protection ( SHARP ) randomized patients with CKD to @ mg simvastatin plus @ mg ezetimibe daily versus matching placebo .


This study aimed to explore the effects of treatment on vascular access occlusive events , defined as any access revision procedure , access thrombosis , removal of an old dialysis access , or formation of new permanent dialysis access .


Among @ SHARP participants who had functioning vascular access at randomization , allocation to simvastatin plus ezetimibe resulted in a @ % proportional reduction in vascular access occlusive events ( @ -LSB- @ % -RSB- for simvastatin/ezetimibe versus @ -LSB- @ % -RSB- for placebo ; risk ratio -LSB- RR -RSB- , @ ; @ % confidence interval -LSB- @ % CI -RSB- , @ to @ ; P = @ ) .


There was no evidence that the effects of treatment differed for any of the separate components of this outcome .


To test the hypothesis raised by SHARP , comparable analyses were performed using the AURORA ( A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis : An Assessment of Survival and Cardiovascular Events ) trial cohort .


AURORA did not provide independent confirmation ( vascular access occlusive events : @ -LSB- @ % -RSB- for rosuvastatin versus @ -LSB- @ % -RSB- for placebo ; RR , @ , @ % CI , @ to @ ; P = @ ) .


After combining the two trials , the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant ( @ -LSB- @ % -RSB- with any LDL-C-lowering therapy versus @ -LSB- @ % -RSB- with placebo ; RR , @ , @ % CI , @ to @ ; P = @ ) .


Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency , but there was no evidence of benefit in AURORA .


Taken together , the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest .


Mobile smartphones are rapidly emerging as an effective means of communicating with many Americans .


Using mobile applications ( apps ) , they can access remote databases , track time and location , and integrate user input to provide tailored health information .


A smartphone mobile app providing personalized , real-time sun protection advice was evaluated in a randomized clinical trial .


The trial was conducted in @ and had a randomized pretest-posttest controlled design with a @-week follow-up .


Data were collected from a nationwide population-based survey panel .


A sample of @ non-Hispanic and Hispanic adults from the Knowledge Panel @ years or older who owned an Android smartphone were enrolled .


The mobile app provided advice on sun protection ( ie , protection practices and risk of sunburn ) and alerts ( to apply or reapply sunscreen and get out of the sun ) , hourly UV Index , and vitamin D production based on the forecast UV Index , the phone 's time and location , and user input .


Percentage of days using sun protection and time spent outdoors ( days and minutes ) in the midday sun and number of sunburns in the past @ months were collected .


Individuals in the treatment group reported more shade use ( mean days staying in the shade , @ % vs @ % ; P = @ ) but less sunscreen use ( mean days , @ % vs @ % ; P = @ ) than controls .


There was no significant difference in number of sunburns in the past @ months ( mean , @ in the treatment group vs @ for controls ; P = @ ) .


Those who used the mobile app reported spending less time in the sun ( mean days keeping time in the sun to a minimum , @ % for app users vs @ % for nonusers ; P = @ ) and using all protection behaviors combined more ( mean days , @ % vs @ % ; P = @ ) .


The mobile app improved some sun protection .


Use of the mobile app was lower than expected but associated with increased sun protection .


Providing personalized advice when and where people are in the sun may help reduce sun exposure .


This study was carried out to examine the difference in effects between rosuvastatin and pravastatin on neointimal formation after the placement of a drug-eluting stent ( DES ) .


Forty patients who underwent placement of a DES in our hospital were prospectively randomized to receive rosuvastatin ( n = @ ) or pravastatin ( n = @ ) , and analyzed by optical coherence tomography at the chronic stage .


The main outcome measure was comparison of neointimal coverage analyzed at a strut level .


A significant reduction in total cholesterol , low-density lipoprotein , and white blood cell count was observed during the study in the rosuvastatin group ( total cholesterol , from @ to @ mmol/l , P = @ ; low-density lipoprotein , from @ to @ mmol/l , P = @ ; white blood cell count , from @ to @/l , P = @ ) , but not in the pravastatin group .


Although not statistically significant , C-reactive protein was lower in the rosuvastatin than in the pravastatin group at the chronic stage ( @ vs. @ mg/l , P = @ ) .


Malapposed and uncovered struts were significantly less frequent in the rosuvastatin group than in the pravastatin group ( malapposed , @ vs. @ % , P < @ ; uncovered , @ vs. @ % , P < @ ) .


The difference in uncovered struts was maintained even when stent types were analyzed separately ( everolimus-eluting stent , @ vs. @ % , P = @ ; sirolimus-eluting stent , @ vs. @ % , P < @ ) .


Comparison of neointimal thickness between the rosuvastatin and the pravastatin groups showed inconsistent results depending on the stent types analyzed .


Compared with pravastatin , the use of rosuvastatin resulted in lower frequency of uncovered and malapposed struts after the placement of a DES , which might be mediated through improved inflammatory and lipid profiles .


The purpose of this study was to describe the unique characteristics of informal hospice cancer caregiving .


Researchers conducted a secondary analysis of data drawn from a randomized clinical trial of an informal hospice caregiving intervention ( N = @ ) .


Demographic characteristics and measures of the informal caregiving experience of hospice patients and their informal caregivers were compared based on the patient 's diagnosis using chi-square tests for association of categorical variables and t tests for continuous variables .


Informal caregivers of cancer patients differed from their non-cancer counterparts in a number of respects including patient age , caregiver age , patient residence , relationship between patient and caregiver , amount and duration of care provided , likelihood to incur out-of-pocket expenses related to patient care , caregiver problem-solving style , and impact on caregiver daily schedule .


There were no statistically significant differences between cancer and non-cancer caregivers in terms of gender , race , employment status , anxiety , and quality of life .


While cancer and non-cancer caregivers are similar in many respects , a number of unique features characterize the informal hospice cancer caregiving experience .


Attention to these unique features will allow hospice providers to tailor supportive care interventions to better address cancer caregivers ' needs .


Interest in improving care for the growing number of individuals with chronic conditions is rising .


However , access to care is limited by distance , disability , and distribution of doctors .


Small-scale studies in Parkinson disease , a prototypical chronic condition , have suggested that delivering care using video house calls is feasible , offers similar clinical outcomes to in-person care , and reduces travel burden .


We are conducting a randomized comparative effectiveness study ( Connect.Parkinson ) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist .


Recruitment is completed centrally using online advertisements and emails and by contacting physicians , support groups , and allied health professionals .


Efforts target areas with a high proportion of individuals not receiving care from neurologists .


Approximately @ individuals with Parkinson disease and their care partners will be enrolled at @ centers throughout the United States and followed for one year .


Participants receive educational materials , then are randomized in a @:@ ratio to continue their usual care ( control arm ) or usual care and specialty care delivered virtually ( intervention arm ) .


Care partners are surveyed about their time and travel burden and their perceived caregiver burden .


Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at @ months .


All study activities are completed remotely.The primary outcomes are : ( @ ) feasibility , as measured by the proportion of visits completed , and ( @ ) quality of life , as measured by the @-item Parkinson 's Disease Questionnaire .


Secondary outcomes include measures of clinical benefit , quality of care , time and travel burden , and caregiver burden .


Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease .


The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions .


Nitrous oxide anesthesia increases postoperative homocysteine concentrations .


Renal transplantation candidates present with higher homocysteine levels than patients with no renal disease .


We designed this study to investigate if homocysteine levels are higher in subjects receiving nitrous oxide for renal transplantation compared with subjects undergoing nitrous oxide free anesthesia .


Data from @ patients scheduled for living-related donor renal transplantation surgery were analyzed in this randomized , controlled , blinded , parallel-group , longitudinal trial .


Patients were assigned to receive general anesthesia with ( flowmeter was set at @ L/min nitrous oxide and @ L/min oxygen ) or without nitrous oxide ( @ L/min air and @ L/min oxygen ) .


We evaluated levels of total homocysteine and known determinants , including creatinine , folate , vitamin B@ , albumin , and lipids .


We evaluated factor V and von Willebrand factor ( vWF ) to determine endothelial dysfunction and creatinine kinase myocardial band ( CKMB ) - mass , troponin T to show myocardial ischemia preoperatively in the holding area ( T@ ) , after discontinuation of anesthetic gases ( T@ ) , and @ hours after induction ( T@ ) .


Compared with baseline , homocysteine concentrations significantly decreased both in the nitrous oxide ( @ @ vs @ @ ; P < @ ) and nitrous oxide-free groups ( @ @ vs @ @ ; P < @ ) at postoperative hour @ .


The nitrous oxide group had significantly higher mean plasma homocysteine concentrations than the nitrous oxide-free group ( P = @ ) .


The actual homocysteine difference between groups was @ mol/L .


This study shows that homocysteine levels markedly decrease within @ hours after living-related donor kidney transplantation .


Patients receiving nitrous oxide have a lesser reduction , but this finding is unlikely to have a clinical relevance .


The effect of tranexamic acid ( TXA ) on bleeding and improvement of surgical field during functional endoscopic sinus surgery ( FESS ) is not clear yet .


This study was conducted to answer this question .


This trial was conducted on @ patients with chronic sinusitis at Beasat Hospital , Hamadan , Iran , from April to November @ .


Thirty patients in the intervention group received three pledgets soaked with TXA @ % and phenylephrine @ % for @ minutes in each nasal cavity before surgery .


Thirty patients in the control group received phenylephrine @ % with the same way .


The amount of bleeding and the quality of surgical field were evaluated at @ , @ , and @ minutes after the start of surgery using Boezaart grading .


The quality of the surgical field in the intervention group compared to the control group was significantly better in the first quarter ( P = @ ) and the second quarter ( P = @ ) but not in the third quarter ( P = @ ) .


Furthermore , the amount of bleeding was much less during all periods in the intervention group than in the control group ( P = @ ) .


Topical TXA can efficiently reduce bleeding and improve the surgical field in FESS in patients with rhinosinusitis .


Based on these findings , topical TXA may be a useful method for providing a suitable surgical field during the first @ minutes after use .


The authors have reported in Part @ of this study on a novel neuromonitoring test for the prevention of medial malpositioning of thoracic pedicle screws .


In the present paper they examine the impact of providing the results of the test as intraoperative feedback to the surgical team .


This is the second part of a @-part report of a prospective , blinded and randomized neuromonitoring study designed to lower the incidence of medially malpositioned thoracic pedicle screws .


Details of the neuromonitoring technique and data supporting the alarm criteria used are contained in the companion article ( Part @ ) .


For the majority of pedicle screw placements , intraoperative test results were withheld from the study team ( that is , the team members were blinded to the test results ) .


However , for a limited number of pedicle sites the authors provided one of @ forms of testing feedback to the surgical team : @ ) `` break the blind '' feedback , if testing suggested that screw placement would result in direct contact between screw and the dura mater ; and @ ) `` planned '' feedback , beginning during the later stages of the study and provided for @ % of pedicle sites .


Feedback gave the surgeon the opportunity to adjust the trajectory that the screw would ultimately take within the pedicle .


The final screw position relative to the pedicle 's medial wall for all sites in which feedback was withheld from the surgical team was compared with the screw position for those sites in which either form of feedback ( `` break the blind '' or `` planned '' ) was provided to and acted upon by the surgical team .


Of the @ pedicle tracks tested among the @ surgical cases included in this study , a total of @ were operated upon without any form of feedback .


Planned feedback was provided for an additional @ pedicle tracks , of which @ triggered an intraoperative alarm ( evoked electromyogram response in leg muscles to stimulus intensity @ mA ) leading to a warning to the surgical team of a medially biased pedicle track .


Finally , the blind was broken @ times , in each case when testing revealed a particularly low threshold ( @ mA ) for evoked responses in leg muscles when stimulating along the pedicle track with the ball-tipped probe .


As detailed in the companion paper to this one , there were @ screws with threads lying at least @ mm medial to the pedicle wall .


In all @ instances ( @ % ) , either these screws were in the `` no feedback '' category ( n = @ ) or they were in a feedback category but the surgeon elected to not revise the pedicle-track trajectory .


Two patients returned to the operating room for revision of screw placements because the screws were encroaching upon the central canal ; the pedicle tracks for these screws had been in the `` no feedback '' category .


This is the first blinded and randomized study to prove that implementing a novel neuromonitoring strategy during placement of thoracic pedicle screws can significantly reduce the incidence of clinically relevant thoracic pedicle screw medial malpositioning .


The aim of the present study was twofold : @ .


to compare the efficacy of three antipsychotics ( ziprasidone , olanzapine and perazine ) in schizophrenia @ .


to compare the improvement in cognitive functioning between groups treated with the three different neuroleptics .


A total of @ Caucasian patients diagnosed with paranoid schizophrenia were recruited into the study group .


We used the Polish version of the CIDI ( Composite International Diagnostic Interview ) to obtain ICD-@ diagnoses .


The intensity of psychopathological symptoms was examined using the PANSS .


The patients were randomly assigned to treatment with perazine , olanzapine or ziprasidone administered as monotherapy for @ months .


The treatment efficacy was measured as a change in the PANSS ( Positive and Negative Syndrome Scale ) total score from baseline ( T@ ) to @ months ( T@ ) .


The WCST ( The Wisconsin Card Sorting Test ) was used to measure working memory and executive functions in the evaluated patients .


Wilcoxon 's and Kruskal-Wallis tests were applied to compare changes in the PANSS scores between the treatment groups .


To analyze the cognitive functions , Kruskal-Wallis test for the WCST parameters was used .


The three antipsychotics similarly reduced the total PANSS score .


The WCST parameters in the @ groups of examined patients using the Kruskal-Wallis test revealed some differences between the three administered antipsychotics .


Results suggest that the short-term efficacy of the atypical ( olanzapine , ziprasidone ) and typical ( perazine ) antipsychotic drugs did not differ .


Based on the analysis , a conclusion can be drawn that the three neuroleptics provided similar improvements in cognitive functioning .


Contextual factors , including the gender of researchers , influence experimental and patient pain reports .


It is currently not known how social stimuli influence pain percepts , nor which types of sensory modalities of communication , such as auditory , visual or olfactory cues associated with person perception and gender processing , produce these effects .


To determine whether exposure to two forms of social stimuli ( audio and visual ) from a virtual male or female stranger modulates cold pressor task ( CPT ) pain reports .


Participants with similar demographic characteristics conducted a CPT in solitude , without the physical presence of an experimenter or another person .


During the CPT , participants were exposed to the voice and image of a virtual male or female stranger .


The voices had analogous vocal prosody , provided no semantic information ( spoken in a foreign language ) and differed only in pitch ; the images depicted a middle-age male or female health care practitioner .


Male participants , but not females , showed higher CPT pain intensity when they were exposed to the female stimuli compared with the male stimuli .


Follow-up analyses showed that the association between the social stimuli and variability in pain sensitivity was not moderated by individual differences in subjective ( eg , self-image ) or objective measurements of one 's physical stature .


The findings show that exposure to virtual , gender-based auditory and visual social stimuli influences exogenous pain sensitivity .


Further research on how contextual factors , such as the vocal properties of health care examiners and exposure to background voices , may influence momentary pain perception is necessary for creating more standardized methods for measuring patient pain reports in clinical settings .


To compare early induction and expectant management regarding delivery outcomes and the experience of delivery in nulliparous women with prolonged latent phases .


Randomized controlled trial .


One delivery unit in a Swedish hospital .


Nulliparous women at term experiencing continuous contractions impeding rest ( women 's report ) and exceeding @ h , a cervical dilation of less than @ cm , intact membranes and with a singleton fetus in cephalic presentation .


The women were randomly allocated to either early induction ( n = @ ) or expectant management ( n = @ ) .


All participants received medication for therapeutic rest .


The early induction group was induced five hours after medication , and the expectant group awaited spontaneous onset of labor .


The Wijma Delivery Experience Questionnaire ( W-DEQ version B ) was filled in after delivery .


The primary outcome was mode of delivery .


Secondary outcomes included birth experience , duration of labor , postpartum hemorrhage , and neonatal outcomes .


The cesarean section rate was @ of @ ( @ % ) in the early induction group and @ of @ ( @ % ) in the expectant group ( p = @ , OR @ , @ % CI @-@ @ ) .


No significant differences were shown regarding delivery , neonatal outcomes or birth experience .


No significant differences were shown between the two groups in the rate of cesarean sections or the experience of delivery .


According to the actual results , the power to detect a difference was only @ % .


The cesarean section rate was high in both groups , regardless of intervention .


A double blind , randomized , unsupervised , parallel-group clinical trial was conducted on over @,@ children in Sichuan Province , China .


This clinical trial compared the anti-caries efficacy of two test dentifrices to that of a control dentifrice .


The test dentifrices contained @ % arginine , @ ppm fluoride as sodium monofluorophosphate ( MFP ) , and an insoluble calcium compound ( either dicalcium phosphate or calcium carbonate ) .


The positive control dentifrice contained @ ppm fluoride as sodium fluoride ( NaF ) , in a silica base .


The children were randomly assigned one of the toothpastes , and children residing in the same household were assigned the same dentifrice to use at home , twice a day .


Three calibrated dentists examined the children at baseline , as well as after one and two years of product use .


After one year of product use , there were no statistically significant differences among the three groups with respect to decayed , missing , and filled teeth ( DMFT ) or to decayed , missing , and filled surfaces ( DMFS ) .


After two years of product use , subjects in the two test groups using the dentifrices containing @ % arginine , @ ppm fluoride as MFP , and an insoluble calcium compound had a statistically significant reduction in DMFT increments of @ % and in DMFS increments of @ % when compared to subjects in the group using the positive control dentifrice .


After two years , there were no statistically significant differences with respect to DMFT or DMFS between the two groups using the dentifrices containing @ % arginine , @ ppm fluoride as MFP , and an insoluble calcium compound .


The use of the two test dentifrices demonstrated significant reductions in decayed , missing , and filled teeth and surfaces , however there was no statistically significant different between the two test dentifrices clinically after two years of using the toothpastes .


The results of this two-year clinical investigation support the conclusion that dentifrices containing @ % arginine , an insoluble calcium compound , and @ ppm fluoride as MFP provide superior protection against caries lesion cavitation compared to a positive control dentifrice containing only @ ppm fluoride as NaF .


Although practice nurses are increasingly involved in hypertension management , there is little robust evidence of effectiveness .


To evaluate the effect of a specialist nurse-led hypertension clinic with consultant backup on change in systolic blood pressure .


Randomized trial .


Two inner city general practices .


Participants .


Three hundred and fifty-three patients , mean age @ years ( range @-@ ) , with last recorded blood pressure British Hypertension Society audit standard were randomly allocated to the nurse-led clinic or usual care .


Intervention .


Patients received a letter informing them that their last blood pressure was over target and inviting them to the clinic .


After assessment at the clinic , the nurse discussed any changes in anti-hypertensive treatment with a visiting consultant and the patient 's GP , and followed up the patient over @ months until blood pressure targets were achieved .


Reduction in systolic blood pressure , assessed using two audits of the practices ' computerized records where blood pressure was measured independently by practice staff before and after the intervention period .


Follow-up was @ % ( @/@ ) .


There was greater reduction in systolic blood pressure in the clinic group ( n = @ ) than usual care group ( n = @ , adjusted difference @ mmHg ; @ % CI @ to @ ) .


Of @ patients randomly selected for the clinic , @ ( @ % ) attended , @ had blood pressure above target when measured according to protocol and @ had their anti-hypertensive treatment intensified by their GP .


Invitation to a specialist nurse-led hypertension clinic with consultant back up was associated with reduced systolic blood pressure .


To evaluate the difference between a single preoperative dose versus an additional two-day postoperative course of oral amoxicillin in patients undergoing conventional dental implant placement .


Two dentists in two different private practices conducted this study .


One hour prior to surgery , patients had to take a single prophylactic antibiotic dose , consisting of @ g of amoxicillin orally ; after implant placement , patients were randomly allocated to two different groups : protocol A ( no other antibiotic administration ) and protocol B , ( @ g of amoxicillin in the evening of the day of surgery and @ g twice a day for the @ days after ) .


Outcome measures were prosthetic and implant failures , adverse events and early postoperative complications .


Patients were followed up to @ months after functional loading .


Three hundred and sixty patients were randomised and treated ( @ patients in one centre and @ in the other ) .


Five hundred and sixty-seven implants were placed .


Protocol A was applied to @ patients ( @ implants ) and protocol B also to @ patients ( @ implants ) .


Data for @ patients , @ from protocol A and three from protocol B , were not available .


No statistically significant differences were found for the reported outcomes .


Two patients of protocol B experienced a prosthetic failure , losing four implants , while no prosthetic failures were reported for protocol A ( P = @ ; difference in proportions = -@ ; @ % CI : -@ to @ ) .


Five patients ( @ % ) of protocol A lost five implants versus @ patients ( @ % ) who lost eight implants in protocol B ( P = @ ; difference in proportions = @ ; @ % CI : -@ to @ ) .


Three adverse events were observed in the total population , all occurring in protocol B ( @ % ) , with no statistically significant differences between the two groups ( P = @ ; difference in proportions = -@ ; @ % CI : -@ to @ ) .


However , one patient experienced a severe allergic reaction requiring therapy discontinuation and hospital admission .


Early postoperative complications occurred in six patients of protocol A and in four patients of protocol B , with no statistically significant differences ( P = @ ; difference in proportions = @ ; @ % CI : -@ to @ ) .


No statistically significant differences were observed between @ g of preoperative amoxicillin and an additional @-day postoperative course , although adverse events were reported only in the additional @-day postoperative group .


Based on these findings , it might be sufficient to routinely administer preoperatively @ g of amoxicillin to patients undergoing routine dental implant placement procedures rather than administering additional postoperative doses .


Abnormal levels of CD@ T-cell activation persist in HIV-@-infected patients on suppressive antiretroviral therapy ( ART ) and may be deleterious .


CD@ T-cell activation ( % coexpressing CD@/HLA-DR ) was analyzed on blood specimens from @ HIV-@-infected patients on ART for @ weeks with concurrent plasma HIV RNA ( vRNA ) @ copies per milliliter .


Factors associated with CD@ T-cell activation were assessed using generalized estimating equations to incorporate longitudinal measurements ( median @/participant ) .


Participants were @ % men , @ % white , @ % black , and @ % Hispanic , with median pre-ART age @ years and median ART exposure @ weeks .


CD@ T-cell activation was higher at timepoints when vRNA was @-@ versus @ copies per milliliter -LSB- mean CD@ T-cell activation @ % vs. @ % ; adjusted difference : @ % ( @ % confidence interval : @ to @ ) , P = @ -RSB- .


Restricting to vRNA @ copies per milliliter , multivariable models showed the following factors associated with higher CD@ T-cell activation : older age -LSB- @ vs. @ years : @ % ( @ to @ ) , P = @ -RSB- , hepatitis C virus antibody positivity -LSB- @ % ( @ to @ ) , P = @ -RSB- , Hispanic vs. white -LSB- @ % ( @ to @ ) , P < @ -RSB- , lower concurrent CD@ count -LSB- @ vs. > @ cells/mm : @ % ( @ to @ ) , P < @ -RSB- , lower concurrent CD@/CD@ ratio -LSB- -@ % ( -@ to -@ ) per @ unit increase , P < @ -RSB- , and higher pre-ART CD@ T-cell activation -LSB- @ % ( @ to @ ) per @ % higher , P < @ -RSB- .


In participants included in our analysis , residual low-level viremia between @ and @ copies per milliliter during ART was shown to be associated with greater CD@ T-cell activation than full suppression to < @ copies per milliliter .


Older age , hepatitis C virus antibody positivity , race/ethnicity , higher pre-ART CD@ T-cell activation , and lower concurrent CD@/CD@ ratio and CD@ T-cell count also contribute to greater CD@ T-cell activation during suppressive ART .


Antiretroviral therapy ( ART ) is associated with improved kidney function ; however , the nucleotide reverse transcriptase inhibitor ( NRTI ) tenofovir disoproxil fumarate ( TDF ) has been associated with decreased kidney function and proteinuria .


We examined changes in urine protein : creatinine ( UPCR ) and urine albumin : creatinine ( UACR ) ratios in @ ART-naive participants in A@ randomized in a substudy to blinded NRTI ( abacavir/lamivudine , ABC/@TC , n = @ or TDF/emtricitabine , TDF/FTC , n = @ ) with open-label protease inhibitor ( PI ) atazanavir/ritonavir or nonnucleoside reverse transcriptase inhibitor ( NNRTI ) efavirenz .


At baseline , @ % of participants had clinically significant proteinuria ( UPCR @ mg/g ) , and @ % had clinically significant albuminuria ( UACR @ mg/g ) .


The prevalence of clinically significant proteinuria and albuminuria decreased from baseline to week @ in all treatment groups .


In intention-to-treat analyses , there was a significant effect of NRTI component on fold change in UPCR ( P = @ ) and UACR ( P = @ ) from baseline to week @ , with greater improvements in participants randomized to ABC/@TC .


There was no significant effect of NNRTI/PI component on fold change in UPCR ( P = @ ) or UACR ( P = @ ) , and no significant interactions between NRTI and NNRTI/PI components .


In this prespecified secondary analysis , ART initiation was associated with improvements in proteinuria and albuminuria , with significantly greater improvements in participants randomized to ABC/@TC versus TDF/FTC .


These are the first data from a randomized trial to suggest that initiation of TDF/FTC may not be associated with the same degree of improvement in proteinuria and albuminuria that have been reported with other regimens .


Future studies should consider the long-term clinical significance of these findings .


This open-label , randomized study evaluated efficacy and safety of artemether-lumefantrine ( AL ) and dihydroartemisinin-piperaquine ( DP ) in treatment of uncomplicated falciparum malaria in children below five years of age , to build evidence on use of AL as first-line treatment and DP as second-line treatment in Kenya .


A total of @ children aged six to @ months with uncomplicated falciparum malaria were randomized ( @:@ ) to receive AL dispersible or DP paediatric tablets and followed up for @ days .


Primary efficacy variable was corrected adequate clinical and parasitological response ( ACPR ) rate on day @ .


Secondary variables included corrected ( day @ , @ and @ ) , uncorrected ( day @ , @ , @ and @ ) cure rates , parasitological failure at days @ , @ and @ .


Acceptability and tolerability of both drugs were assessed by caregiver questionnaire .


On day @ , corrected ACPR rates for AL dispersible and DP paediatric were @ % ( @ % CI : @-@ @ ) and @ % ( @ % CI : @-@ @ ) , respectively , in intention-to-treat population , with no significant treatment differences noted between AL dispersible and DP paediatric arms .


Additionally , no significant differences were observed for PCR corrected cure rates on days @ and ACPR on day @ for AL dispersible ( @ % ; @ % ) and DP paediatric ( @ % ; @ % ) .


Similarly , for PCR uncorrected cure rates , no significant differences were seen on days @ , @ , @ , and @ for AL dispersible ( @ % ; @ % ; @ % ; @ % ) and DP paediatric ( @ % ; @ % ; @ % ; @ % ) .


Parasite clearance was rapid , with approximately @ % clearance achieved in @ hours in both treatment arms .


Incidence of adverse events was related to underlying disease ; malaria being reported in both treatment arms .


One serious adverse event was noted in AL dispersible ( @ % ) arm , not related to study drug .


Adherence to treatment regimen was higher for children treated with AL dispersible ( @ % ) compared to DP paediatric ( @ % ) .


Acceptability of AL dispersible regimen was assessed as being significantly better than DP paediatric .


AL and DP were both efficacious and well tolerated , and had similar effects at day @ on risk of recurrent malaria .


No signs of Plasmodium falciparum tolerance to artemisinins were noted .


Tracheostomy facilitates respiratory care and the process of weaning from mechanical ventilatory support .


To compare the complications found in percutaneous dilatational tracheostomy ( PDT ) and surgical tracheostomy ( ST ) techniques .


This was a prospective randomized study to evaluate the complications of PDT and ST procedures in patients admitted to ICU unit of a teaching hospital during @ to @ .


We studied @ patients in each group .


PDTs were performed with blue rhino technique at the bedside by a skilled clinician and all cases of STs performed by Charles G Durbin technique in operating room under general anesthesia .


Bronchoscopic examination through tracheostomy tube was performed to ensure the correct position of tracheostomy tube in the trachea lumen .


The duration of procedures and pre - and post-interventional complications were recorded .


The most common complications observed in the PDT group were minor bleeding ( n = @ ) , hypoxemia , and cardiac dysrhythmias ( n = @ ) whereas in the ST group , the most frequent complications were minor bleeding ( n = @ ) and endotracheal tube puncture ( n = @ ) .


The difference in overall complications between the two groups was insignificant ( P = @ ) .


PDT with blue rhino technique is a safe , quick , and effective method while the overall complications in both groups were comparable .


To assess the influence of the surgical removal of partially impacted third molars ( @Ms ) and compare the effects of a @-cornered laterally rotated flap ( LRF ) with primary closure ( flap @ ) and an envelope flap with secondary closure ( flap @ ) on the short-term periodontal status of the adjacent second molars ( @Ms ) .


We also assessed the postoperative complications after removal of the partially impacted @M .


A split mouth , randomized clinical study was designed .


The study sample included patients with bilateral partially impacted @Ms .


The primary predictor variable was the type of flap design ( flaps @ and @ ) .


The primary outcome variable was periodontal status ( gingival recession -LSB- GR -RSB- , probing depth -LSB- PD -RSB- , plaque index -LSB- PI -RSB- , and gingival index ) of the @Ms measured preoperatively and @ days postoperatively .


The secondary outcome variables were postoperative complications , including pain , facial swelling , alveolitis , and local wound infection .


The other variables included gender , position of the @Ms , and surgical difficulty .


We performed descriptive , comparative , correlation , and multivariate analyses .


The sample included @ patients aged @ to @ years .


The GR , PD , and PI values with the flap @ design were greater than those with the flap @ design ( P < @ ) .


Facial swelling with the flap @ design was significantly greater than with the flap @ design on the second postoperative day ( P < @ ) .


The pain levels with the flap @ design were significantly greater than those with the flap @ design on the first and second postoperative days ( P < @ ) .


According to the multivariate regression analyses , flap design was closely related to the periodontal status of the @Ms and postoperative discomfort .


The results of the present clinical study have shown that the flap design in partially impacted @M surgery considerably influences the early periodontal health of the @Ms and postoperative discomfort .


However , although the @-cornered LRF design might cause more pain and swelling , it could be the method of choice for partially impacted @M surgery because of the early periodontal healing .


Recent data suggest that intraoperative ( Phase I ) colloid ( human serum albumin -LSB- HSA -RSB- ) and a high fresh frozen plasma ( FFP ) / red blood cell ( RBC ) resuscitation will reduce postoperative ( Phase II ) fluid uptake .


This study compares a noncolloid ( balanced electrolyte solution -LSB- BES -RSB- ) plus low ( @ ) FFP/RBC resuscitation ( Group A ) with an HSA plus high ( > @ ) FFP/RBC resuscitation .


A previous randomized study of @ patients included @ BES patients and @ HSA patients .


A Subgroup A of @ BES patients with low FFP/RBC was compared with a Subgroup D of @ HSA patients with high FFP/RBC .


Parameters monitored included Phase I vital signs and resuscitation needs ; Phase II duration , BES needs , weight gain , and hourly urine output ; and postoperative plasma volume ( PV ) by radioiodinated serum albumin ( RISA ) , extracellular fluid ( ECF ) volume by inulin space , and interstitial volume by ECF-PV .


Admission pulse ( @ for A vs. @ for D ) , systolic blood pressure ( SBP ) ( @ for A vs. @ for D ) and Phase I shock time ( SBP < @ Torr ; @ for A vs. @ for D ) were similar .


Phase I RBC needs ( @ @ for A vs. @ @ for D ) and BES needs ( @ @ L for A vs. @ @ L for D ) were similar .


During Phase II , D patients had more RBC , comparable BES , and weight gain , with lower hourly urine output compared with Group A patients .


HSA with high FFP/RBC does not prevent Phase II fluid uptake and causes lower urine output despite increased PV .


Colloid reduces glomerular filtration , increases tubular reabsorption , and increases ECF , thus , prolonging Phase II .


Therapeutic study , level IV .


To compare two self-titration algorithms for initiating and escalating prandial insulin lispro in patients with type @ diabetes inadequately controlled on basal insulin .


The trial was designed as two independent , multinational , parallel , open-label studies ( A and B ) , identical in design , to provide substantial evidence of efficacy and safety in endocrine and generalist settings .


Subjects were @-@ years old ( study A : N = @ ; study B : N = @ ) , on basal insulin plus oral antidiabetic drugs for @ months , and had an HbA@c @ % to @ % ( > @ to @ mmol/mol ) .


Once optimized on insulin glargine , subjects were randomized to one of two self-titration algorithm groups adjusting lispro either every day ( Q@D ) or every @ days ( Q@D ) for @ weeks .


The primary outcome was the change in HbA@c from baseline .


The primary and secondary objectives were evaluated for the overall population and subjects @ years old .


Baseline HbA@c was similar ( study A : Q@D @ % -LSB- @ mmol/mol -RSB- vs. Q@D @ % -LSB- @ mmol/mol -RSB- , P = @ ; study B : Q@D @ % -LSB- @ mmol/mol -RSB- vs. Q@D @ % -LSB- @ mmol/mol -RSB- , P = @ ) .


Both algorithms had significant and equivalent reductions in HbA@c from baseline ( study A : Q@D -@ % -LSB- -@ mmol/mol -RSB- , Q@D -@ % -LSB- -@ mmol/mol -RSB- , Q@D-Q@D @ % -LSB- @ mmol/mol -RSB- -LSB- @ % CI -@ to @ ( -@ to @ ) -RSB- ; study B : Q@D -@ % -LSB- -@ mmol/mol -RSB- , Q@D -@ % -LSB- -@ mmol/mol -RSB- , Q@D-Q@D @ % -LSB- @ mmol/mol -RSB- -LSB- @ % CI -@ to @ ( -@ to @ ) -RSB- ) .


The incidence and rate of hypoglycemia were similar for Q@D and Q@D in both studies .


In general , no clinically relevant differences were found between the two algorithms in subjects @ years old in either study .


Prandial insulin lispro can effectively and safely be initiated , by either of two self-titrated algorithms , in a variety of practice settings .


Interferon-free regimens are needed to treat hepatitis C virus ( HCV ) infections .


We investigated the efficacy of combined simeprevir and sofosbuvir .


We enrolled patients with chronic HCV genotype @ infections who had previously not responded to pegylated interferon ( peginterferon ) and ribavirin or were treatment naive .


Patients were randomly assigned in a @:@:@:@ ratio to receive @ mg simeprevir and @ mg sofosbuvir daily for @ weeks with ( group @ ) or without ( group @ ) ribavirin or for @ weeks with ( group @ ) or without ( group @ ) ribavirin , in two cohorts : previous non-responders with METAVIR scores F@-F@ ( cohort @ ) and previous non-responders and treatment-naive patients with METAVIR scores F@-F@ ( cohort @ ) .


The primary endpoint was sustained virological response @ weeks after stopping treatment ( SVR@ ) .


Analysis was done by intention to treat .


Safety data from cohorts @ and @ were pooled for analysis .


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


@ patients were enrolled and randomised , and @ started treatment ( n = @ in cohort @ and n = @ in cohort @ ) .


SVR@ was achieved in @ ( @ % ) patients ( n = @ -LSB- @ % , @ % CI @-@ -RSB- in cohort @ and n = @ -LSB- @ % , @-@ -RSB- in cohort @ ) .


The most common adverse events in the pooled groups were fatigue ( n = @ -LSB- @ % -RSB- ) , headache ( n = @ -LSB- @ % -RSB- ) , and nausea ( n = @ -LSB- @ % -RSB- ) .


Grade @ adverse events were seen in one ( @ % ) of @ patients in each of groups @ and @ and in three ( @ % ) of @ patients in group @ , whereas grade @-@ events were reported in less than @ % of all patients , except increased blood amylase concentration .


Serious adverse events were seen in four ( @ % ) patients , all in groups @ and @ .


Four ( @ % ) patients discontinued all study treatment because of adverse events , three before week @ .


Combined simeprevir and sofosbuvir was efficacious and well tolerated .


We investigated the influences of the inner retinal sublayers and analytical areas in macular scans by spectral-domain optical coherence tomography ( OCT ) on the diagnostic ability of early glaucoma .


A total of @ early ( including @ preperimetric ) glaucomatous and @ normal eyes underwent macular and peripapillary retinal nerve fiber layer ( pRNFL ) scans ( @D-OCT-@ ) .


The area under the receiver operating characteristics ( AUC ) for glaucoma diagnosis was determined from the average thickness of the total @ grids ( @ @ mm ) , central @ grids ( @ @ mm ) , and peripheral @ grids ( outside of the @ grids ) , and for each macular sublayer : macular RNFL ( mRNFL ) , ganglion cell layer plus inner plexiform layer ( GCL/IPL ) , and mRNFL plus GCL/IPL ( ganglion cell complex -LSB- GCC -RSB- ) .


Correlation of OCT parameters with visual field parameters was evaluated by Spearman 's rank correlation coefficients ( rs ) .


The GCC-related parameters had a significantly larger AUC ( @-@ @ ) than GCL/IPL ( @-@ @ ) , mRNFL-related parameters ( @-@ @ ) , or average pRNFL ( @ ) in more than half of all comparisons .


The central @ grids had a significantly lower AUC than other analytical areas in GCC and mRNFL thickness .


Conversely , the peripheral @ grids had a significantly lower AUC than the @ grids in GCL/IPL inferior thickness .


Inferior thickness of GCC ( rs , @-@ @ ) and mRNFL ( rs , @-@ @ ) showed comparably high correlations with central visual field parameters to average pRNFL thickness ( rs , @ , @ ) even in the central @ grids .


The diagnostic ability of macular OCT parameters for early glaucoma differed by inner retinal sublayers and also by the analytical areas studied .


Use of an injection site modulation device ( InsuPad ) in intensive insulin treatment reduces frequency of hypoglycemia and prandial insulin requirements by enhancing subcutaneous microcirculation .


This meal tolerance test ( MTT ) investigation was performed as a sub-study during the real-world BARMER study to demonstrate non-inferiority of the reduced insulin doses observed in this study with respect to metabolic control .


The MTT was performed at baseline and after @ months in insulin treated diabetes patients using the modulation device vs. a control group without device .


The dose used for the MTT was individually calculated based on the prandial insulin records from the patient diaries before the test .


Blood was drawn for determination of glucose , insulin , C-peptide , proinsulin , triglycerides , free fatty acids , nitrotyrosine , and asymmetric dimethyl-arginine ( ADMA ) at multiple time-points from @ to @min .


A total of @ patients from one site were included into this MTT study ( @ female , @ type @ diabetes , age : @ yrs , HbA@c : @ % ) .


During the BARMER study , mean HbA@c was treated to target ( < @ % ) in both groups .


The prandial insulin dose decreased in the MTT modulation device group by -@ % , but remained unchanged in the control group ( -@ % , p < @ ) .


No change was seen for the basal insulin dose in both treatment arms .


There were no differences between the groups with respect to the postprandial curves for glucose , C-peptide , intact proinsulin , free fatty acids , and triglycerides .


Insulin absorption was faster with the modulation device ( Tmax : @min vs. @min , p < @ ) .


Key limitations are the small patient sample size and impossibility to determine the short-term effects of device use .


The results of this meal tolerance sub-study confirm that the observed prandial insulin dose reduction when using the injection site modulation device has no negative impact on postprandial metabolism .


This is the final report of a phase III randomized study to evaluate whole-brain radiotherapy ( WBRT ) in primary therapy of primary CNS lymphoma ( PCNSL ) after a median follow-up of @ months .


Patients with newly diagnosed PCNSL were randomized to high-dose methotrexate ( HDMTX ) - based chemotherapy alone or followed by WBRT .


We hypothesized that the omission of WBRT would not compromise overall survival ( OS ; primary endpoint ) , using a noninferiority design with a margin of @ .


In the per-protocol population ( n = @ ) , WBRT nonsignificantly prolonged progression-free survival ( PFS ) ( median @ vs @ months , hazard ratio -LSB- HR -RSB- @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- , p = @ ) and significantly PFS from last HDMTX ( @ vs @ months , HR @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) , but without OS prolongation ( @ vs @ months , HR @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) .


In the intent-to-treat population ( n = @ ) , there was a prolongation by WBRT of both PFS ( @ vs @ months , HR @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) and PFS from last HDMTX ( @ vs @ months , HR @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) , but not of OS ( @ vs @ months , HR @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) .


Although the statistical proof of noninferiority regarding OS was not given , our results suggest no worsening of OS without WBRT in primary therapy of PCNSL .


This study provides Class II evidence that in PCNSL HDMTX-based chemotherapy followed by WBRT does not significantly increase survival compared to chemotherapy alone .


The study lacked the precision to exclude an important survival benefit or harm from WBRT .


The antimetabolite @-fluorouracil ( @-FU ) is used for topical treatment of actinic keratosis .


Overall improvement in the skin is also observed .


Additionally , @-FU was reported to be used for superficial peels .


To evaluate the efficacy and safety of @ % @-FU cream compared with peels for photodamaged forearms .


This interventional , randomized , comparative , evaluator-blind study included @ patients with severe photoaging of forearms .


The regimens comprised either application of @ % @-FU cream everyday for @ weeks on @ forearm and @ weekly peels on the other .


Efficacy assessment included : clinical photodamage scores , opinion of patients and investigators , and blind photographic evaluation by independent observers .


Skin biopsies were performed for histologic and immunohistochemical analysis .


Safety evaluation comprised observation of adverse events .


Clinical and histologic findings confirmed the benefits of topical @ % @-FU , in cream or peels , which improved skin appearance and decreased the dermal elastotic material .


Immunohistochemistry showed reduced levels of epidermal p@ and increase in the level of procollagen I. Results were maintained after @ months .


Predictable adverse events occurred , with no differences between treatments .


Patients reported better tolerability to peels .


Five percent @-FU cream or peels was safe and effective for the treatment of photodamaged forearms .


Decreased epidermal p@ levels and new dermal collagen were confirmed .


We evaluate whether lifestyle and metformin interventions used to prevent diabetes have durable effects on markers of inflammation and coagulation and whether the effects are influenced by the development of diabetes .


The Diabetes Prevention Program was a controlled clinical trial of @,@ subjects at high risk for diabetes who were randomized to lifestyle , metformin , or placebo interventions for @ years .


Diabetes was diagnosed semiannually by fasting glucose and annually by oral glucose tolerance testing .


In addition to baseline testing , anthropometry was performed every @ months ; fasting insulin yearly ; and hs-CRP , tissue plasminogen activator ( tPA ) , and fibrinogen at @ year and end of study ( EOS ) .


CRP and tPA levels were unchanged in the placebo group but fell in the lifestyle and metformin groups at @ year and remained lower at EOS .


These reductions were not seen in those who developed diabetes over the course of the study despite intervention .


Fibrinogen was lower at @ year in the lifestyle group .


Differences in weight and weight change explained most of the influence of diabetes on the CRP response in the lifestyle group , but only partly in the placebo and metformin groups .


Weight , insulin sensitivity , and hyperglycemia differences each accounted for the influence of diabetes on the tPA response .


Lifestyle and metformin interventions have durable effects to lower hs-CRP and tPA .


Incident diabetes prevented these improvements , and this was accounted for by differences in weight , insulin resistance , and glucose levels .


A single-agent , extended-release formulation of hydrocodone ( HC ) has been developed for treatment of chronic moderate-to-severe pain .


This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain ( CLBP ) .


This multicenter , enriched enrollment , randomized withdrawal study comprised an open-label conversion/titration phase ( @ weeks ) followed by placebo-controlled , double-blind treatment ( @ weeks ) .


During the conversion/titration phase , subjects ( N = @ ) converted from their current opioid and were titrated to a stabilized dose of HC extended release ( @-@mg every @ hours ) .


During treatment , subjects ( N = @ per group ) received HC extended release or placebo ; rescue medication was permitted .


The primary efficacy end point was mean change in average pain intensity from baseline to day @ .


Response rates ( @ % pain improvement ) and satisfaction ( Subject Global Assessment of Medication ) were assessed .


Demographic and baseline characteristics were similar between groups .


MeanSD change in average pain intensity score from baseline to day @ was significantly lower in the HC extended-release treatment group vs placebo ( @ vs @ ; P = @ ) .


Significantly more responders were in the treatment group ( @ % vs @ % ; P < @ ) .


Mean Subject Global Assessment of Medication scores increased significantly ( @ vs @ ; P < @ ) , indicating greater satisfaction with HC extended release .


The adverse event profile was consistent with other opioids .


Extended-release HC is well tolerated and effective , without acetaminophen-associated risks of liver toxicity , for treatment of CLBP .


Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration .


To evaluate the safety and efficacy of ixmyelocel-T in @ prospective randomized phase @A Trials administered via minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy ( DCM ) stratified by ischemic or nonischemic status .


In IMPACT-DCM , patients were randomized to either ixmyelocel-T or standard-of-care control in a @:@ ratio ( n = @ ) ; ixmyelocel-T was administered intramyocardially via minithoracotomy .


In Catheter-DCM , patients were randomized to either ixmyelocel-T or standard of care control in a @:@ ratio ( n = @ ) ; ixmyelocel-T was administered intramyocardially using the NOGA Myostar catheter .


Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections .


In the @ studies , a total of @ patients were randomized , and @ were treated or received standard of care .


Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event during follow-up when compared with control patients .


A similar benefit was not seen in the nonischemic patients .


Heart failure exacerbation was the most common major adverse cardiovascular event .


Ixmyelocel-T treatment was associated with improved New York Heart Association class , @-minute walk distance , and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control ; a similar trend was not observed in the nonischemic population .


Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM .


To assess the effectiveness of OMT on chronic migraineurs using HIT-@ questionnaire , drug consumption , days of migraine , pain intensity and functional disability .


@-Armed randomized controlled trial setting : all patients admitted in the Department of Neurology of Ancona 's United Hospitals , Italy , with a diagnosis of migraine and without chronic illness , were considered eligible for the study .


Patients were randomly divided into three groups : ( @ ) OMT + medication therapy , ( @ ) sham + medication therapy and ( @ ) medication therapy only .


Patients received @ treatments in a study period of @ months .


Changing from baseline HIT-@ score .


@ subjects were included .


At the end of the study , ANOVA showed that OMT significantly reduced HIT-@ score ( mean change scores OMT-conventional care : -@ ; @ % confidence interval ( CI ) -@ to -@ ; p < @ and OMT-sham : -@ ; @ % CI -@ to -@ ; p < @ ) , drug consumption ( OMT-sham : RR = @ , @ % CI @-@ @ ; OMT-control : RR = @ , @ % CI @-@ @ ) , days of migraine ( OMT-conventional care : M = -@ ; @ % CI -@ to -@ ; p < @ and OMT-sham : -@ ; @ % CI -@ to -@ ; p < @ ) , pain intensity ( OMT-sham : RR = @ , @ % CI @-@ @ ; OMT-control : RR = @ , @ % CI @-@ @ ) and functional disability ( p < @ ) .


These findings suggest that OMT may be considered a valid procedure for the management of migraineurs .


The present trial was registered on www.ClinicalTrials.gov ( identifier : NCT@ ) .


The aim of this study was to assess the efficacy of strontium ranelate in improving symptoms in knee OA .


Symptoms were assessed over @ years in patients with primary knee OA receiving strontium ranelate @ g/day ( n = @ ) , @ g/day ( n = @ ) or placebo ( n = @ ) in the Strontium Ranelate Efficacy in Knee Osteoarthritis Trial .


Clinical response was evaluated using WOMAC subscores , minimal perceptible clinical improvement ( MPCI ) , minimal clinically important improvement ( MCII ) and a modified OMERACT-Osteoarthritis Research Society International ( OARSI ) responder definition .


Patients who withdrew prematurely from the study were considered non-responders .


There was no significant effect on symptoms for strontium ranelate @ g/day .


At the dosage of @ g/day , strontium ranelate was associated with greater response than placebo in terms of @ % improvement in WOMAC pain from baseline to the last visit ( @ % vs @ % , P = @ ) and @ % improvement in WOMAC pain ( @ % vs @ % , P = @ ) .


Significant differences were found in MPCI response for WOMAC pain ( @ % vs @ % , P < @ ) , stiffness ( @ % vs @ % , P = @ ) and physical function ( @ % vs @ % , P = @ ) and in MCII response for WOMAC physical function ( @ % vs @ % , P = @ ) .


There were also more OMERACT-OARSI-like responders with strontium ranelate ( @ % vs @ % , P = @ ) .


The treatment-placebo difference in MPCI response for WOMAC pain was significant after @ months ( P = @ ) , while that in MPCI and MCII response for WOMAC physical function reached significance after @ months ( P = @ and P = @ , respectively ) .


Treatment with strontium ranelate @ g/day over @ years is associated with a clinically meaningful improvement in pain from @ months as well as physical function and stiffness as assessed by the number of responders above thresholds of clinical relevance .


Eighty-five percent of institutionalized elderly people have osteoporosis and bone fracture rates @ to @ times higher than rates observed among community-dwelling elderly people .


Nevertheless , most of these persons are left untreated and are excluded from pivotal osteoporosis trials .


To determine the efficacy and safety of zoledronic acid to treat osteoporosis in frail elderly women in long-term care facilities .


We conducted a @-year , randomized , placebo-controlled , double-blinded study from December @ through March @ .


Included were @ women @ or older with osteoporosis , including those with cognitive impairment , immobility , and multimorbidity , who were living in nursing homes and assisted-living facilities .


One @-mg dose of zoledronic acid or placebo intravenously and daily calcium and vitamin D supplementation .


Hip and spine bone mineral density ( BMD ) at @ and @ months and adverse events .


There were no baseline differences in mean ( SE ) age ( @ -LSB- @ -RSB- years ) , BMD , or functional or cognitive status , but the treatment group included more participants with frailty , falls history , diabetes , and anticonvulsant medication use .


Values for BMD were available for @ % of participants at @ months and @ % at @ months .


Mean ( SE ) BMD changes were greater in the treatment group : @ ( @ ) and @ ( @ ) percentage-point differences in the total hip at @ and @ months , respectively ( P < @ for both comparisons ) , and @ ( @ ) and @ ( @ ) percentage-point differences at the spine ( P < @ ) ; adjusted analyses were similar .


The treatment and placebo groups ' fracture rates were @ % and @ % , respectively ( OR , @ ; @ % CI , @-@ @ ) ; mortality rates were @ % and @ % ( OR , @ ; @ % CI , @-@ @ ) .


Groups did not differ in the proportion of single fallers ( @ % vs @ % ; OR , @ ; @ % CI , @-@ @ ; P = @ ) , but more participants in the treatment group had multiple falls ( @ % vs @ % ; OR , @ ; @ % CI , @-@ @ ; P = @ ) ; however , this difference was no longer significant when adjusted for baseline frailty .


In this group of frail elderly women with osteoporosis , @ dose of zoledronic acid improved BMD over @ years .


The clinical importance of nonsignificant increases in fracture and mortality rates in the treatment group needs further study .


Since it is not known whether such therapy reduces the risk of fracture in this cohort , any change in nursing home practice must await results of larger trials powered to assess fracture rates .


Nutrition is an important aspect in the care of very low birth weight ( VLBW ) preterm infants .


Human milk fortified with human milk fortifiers ( HMF ) is best for enteral feeding of premature infants .


HMF is expensive and not easily available in Thailand .


Post discharge formula ( PDF ) has been routinely used to fortify human milk at Queen Sirikit National Institute of Child Health ( QSNICH ) but there is lack of supportive data regarding efficacy and safety .


To study and compare anthropometrics , biochemical markers and complications in VLBW infants fed human milk fortified with either HMF or PDF .


This was a prospective , randomized pilot study conducted in the neonatal unit of QSNICH from @ March @ to @ February @ .


Very low birth weight neonates , whose mothers had adequate breast milk within @ hours of birth , were enrolled in the study and received parenteral nutrition and enteral feeding as per protocol .


Once the babies were feeding @ cc/kg/day of human milk , they were randomly divided into two groups : the human milk fortified group ( HMF group ) and the post discharge formula fortified group ( PDF group ) .


Body weight was recorded daily while head circumference and length were recorded weekly .


Hematocrit , Blood Urea Nitrogen ( BUN ) , creatinine , electrolytes ( including phosphorus and calcium ) , alkaline phosphatase and albumin were checked at the beginning of the study ( feeding @ cc/kg/day ) , @ weeks later and when on full oral breast feeding or reached a weight of @,@ grams , which ever came first .


Thirty-eight infants were enrolled in the study but eventually only @ remained ( @ in HMF group , @ in PDF group ) .


Both groups had similar baseline demographic data , nutritional management , postnatal morbidities and length of stay .


There were no statistically significant differences in growth parameters and serum biochemical markers between the groups .


Definite NEC was not different between the groups .


Other complications of prematurity including osteopenia of prematurity were similar in both the groups .


The cost of breast milk fortification per person in the PDF and HMF group was @ and @,@ baht , respectively .


Human milk fortifiers are best for fortification of human milk in VLBW babies but using PDF as a fortifier may be considered as an alternative for VLBW infant in resource limited , developing countries .


However , it should always be additionally supplemented with multivitamins especially vitamin D , iron , calcium and phosphorus .


Complications like feeding intolerances and suspected NEC should be monitored closely .


Larger studies focusing on short and long-term outcomes are needed in the future .


Based on current evidence , there is a little agreement on the best timing for after birth umbilical cord clamping .


This study was designed to compare the impact of using two different times for cord clamping on hematocrit concentration and Apgar scores of the neonate .


Fifty-six healthy full-term vaginally born neonates were allocated to early ( @ seconds after delivery ) and late ( @ minutes after delivery ) umbilical cord clamping groups in this randomized clinical trial .


We recorded the length of the @rd stage of labor and Apgar score at @ minutes .


Infant 's hematocrit was measured at @ and @ hours of age .


Neonatal hematocrit differed between the two groups .


Late cord clamping group had greater hematocrit at @ hours ( @ @ vs. @ @ , P = @ ) and @ hours ( @ @ vs. @ @ , P = @ ) .


Apgar scores at @ minutes ( @ @ vs. @ @ , p = @ ) and duration of delivery @rd stage ( @ @ min vs. @ @ min , P = @ ) did not differ between early and late cord clamping groups respectively .


Late cord clamping leads to a significant increase in the hematocrit of the neonate but it does not have effects on Apgar score and duration of the @rd stage of labor .


Unintentional injury is a leading cause of infant mortality .


To examine the role of caregiver health literacy in infant injury prevention behaviors .


A cross-sectional analysis of data collected in @-@ from a randomized trial at four pediatric clinics was performed in @-@ .


Caregiver health literacy was assessed with the Short Test of Functional Health Literacy in Adults .


Caregiver-reported adherence to American Academy of Pediatrics-recommended injury prevention behaviors was assessed across seven domains : ( @ ) car seat position ; ( @ ) car seat use ; ( @ ) sleeping safety ; ( @ ) fire safety ; ( @ ) hot water safety ; ( @ ) fall prevention ; and ( @ ) firearm safety .


Data were analyzed from @ English - and Spanish-speaking caregivers of @-month-old children .


Many caregivers were non-adherent with injury prevention guidelines , regardless of health literacy .


Notably , @ % inappropriately placed their children in the prone position to sleep , and @ % did not have their hot water heater set < @F .


Eleven percent of caregivers were categorized as having low health literacy .


Low caregiver health literacy , compared to adequate health literacy , was significantly associated with increased odds of caregiver non-adherence with recommended behaviors for car seat position ( AOR = @ , @ % CI = @ , @ ) and fire safety ( AOR = @ , @ % CI = @ , @ ) recommendations .


Caregivers with low health literacy were less likely to be non-adherent to fall prevention recommendations ( AOR = @ , @ % CI = @ , @ ) .


Non-adherence to injury prevention guidelines was common .


Low caregiver health literacy was significantly associated with some injury prevention behaviors .


Future interventions should consider the role of health literacy in promoting injury prevention .


During primary percutaneous coronary intervention ( PCI ) , manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion .


Small trials have suggested that thrombectomy improves surrogate and clinical outcomes , but a larger trial has reported conflicting results .


We randomly assigned @,@ patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone .


The primary outcome was a composite of death from cardiovascular causes , recurrent myocardial infarction , cardiogenic shock , or New York Heart Association ( NYHA ) class IV heart failure within @ days .


The key safety outcome was stroke within @ days .


The primary outcome occurred in @ of @ patients ( @ % ) in the thrombectomy group versus @ of @ patients ( @ % ) in the PCI-alone group ( hazard ratio in the thrombectomy group , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


The rates of cardiovascular death ( @ % with thrombectomy vs. @ % with PCI alone ; hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) and the primary outcome plus stent thrombosis or target-vessel revascularization ( @ % vs. @ % ; hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) were also similar .


Stroke within @ days occurred in @ patients ( @ % ) in the thrombectomy group versus @ patients ( @ % ) in the PCI-alone group ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


In patients with STEMI who were undergoing primary PCI , routine manual thrombectomy , as compared with PCI alone , did not reduce the risk of cardiovascular death , recurrent myocardial infarction , cardiogenic shock , or NYHA class IV heart failure within @ days but was associated with an increased rate of stroke within @ days .


( Funded by Medtronic and the Canadian Institutes of Health Research ; TOTAL ClinicalTrials.gov number , NCT@ . )


Expert consensus guidelines recommend low-density lipoprotein cholesterol as the primary serum lipid target for recurrent stroke risk reduction .


However , mounting evidence suggests that other lipid parameters might be additional therapeutic targets or at least also predict cardiovascular risk .


Little is known about the effects of nontraditional lipid variables on recurrent stroke risk .


We analyzed the Vitamin Intervention for Stroke Prevention study database comprising @ recent ( < @ days ) noncardioembolic stroke patients followed up for @ years .


Independent associations of baseline serum lipid variables with recurrent ischemic stroke ( primary outcome ) and the composite end point of ischemic stroke/coronary heart disease/vascular death ( secondary outcomes ) were assessed .


Of all variables evaluated , only triglycerides/high-density lipoprotein cholesterol ( HDL-C ) ratio was consistently and independently related to both outcomes : compared with the lowest quintile , the highest triglycerides/HDL-C ratio quintile was associated with stroke ( adjusted hazard ratio , @ ; @ % confidence interval , @-@ @ ) and stroke/coronary heart disease/vascular death ( @ ; @-@ @ ) , including adjustment for lipid modifier use .


Compared with the lowest quintile , the highest total cholesterol/HDL-C ratio quintile was associated with stroke/coronary heart disease/vascular death ( @ ; @-@ @ ) .


Low-density lipoprotein cholesterol/HDL-C ratio , non-HDL-C , elevated triglycerides alone , and low HDL-C alone were not independently linked to either outcome .


Of various nontraditional lipid variables , elevated baseline triglycerides/HDL-C and total cholesterol/HDL-C ratios predict future vascular risk after a stroke , but only elevated triglycerides/HDL-C ratio is related to risk of recurrent stroke .


Future studies should assess the role of triglycerides/HDL-C as a potential therapeutic target for global vascular risk reduction after stroke .


There are no randomized clinical trials regarding efficacy of trazodone in the treatment of sleep disturbances ( SD ) in patients with Alzheimer disease ( AD ) .


We tested the efficacy and safety of trazodone to treat SD in patients with AD .


We conducted a double-blind , randomized and controlled trial during periods of @-@ days at baseline and @ weeks of treatment .


Geriatric medical center of the university 's general hospital .


Individuals with probable AD and SD .


The complete analysis comprised @ patients assigned to either the active treatment group ( N = @ ) or the placebo group ( N = @ ) .


Patients received @ mg of trazodone once daily at @:@ P.M. or placebo in a @:@ ratio for @ weeks .


Patients were evaluated using actigraphy and structured scales before and after intervention .


Compared with the placebo group , trazodone users slept @ more minutes per night and had their nighttime percent sleep increased @ percentage points according to actigraphic data post-treatment .


Neither trazodone nor placebo induced significant daytime sleepiness or naps .


The treatments with trazodone or placebo did not show any effects either on cognition ( Mini-Mental State Examination , forward/backward digit span task , letter-number sequencing , arithmetic , digit symbol-coding , and symbol search ) or functionality ( Katz index ) .


There were no differences in frequency or severity rating of adverse events between the groups .


This study shows significant therapeutic effects of trazodone @ mg in community-dwelling AD patients with SD .


Despite rising international rates of obesity , men remain reluctant to participate in weight loss research .


There is a lack of evidence to guide the development of effective weight loss interventions that engage men .


The objective of this study was to provide a comprehensive process evaluation of the SHED-IT ( Self-Help , Exercise and Diet using Information Technology ) weight loss program for men , as delivered in the SHED-IT community weight loss trial , and to identify key components associated with success .


In an assessor-blinded randomised controlled trial , @ overweight and obese men ( BMI @-@ @ kg/m@ ) were randomised to one of two gender-tailored weight loss interventions with no face-to-face contact , or a control group .


The interventions were informed by Bandura 's Social Cognitive Theory ( SCT ) with men encouraged to complete a Support Book containing SCT-based tasks including goal setting , reward setting , creation of social support strategies and self-monitoring of : i ) weight , ii ) physical activity , and iii ) diet .


At post-test , compliance with SCT tasks was examined and men also completed a process evaluation questionnaire .


Both SHED-IT intervention groups demonstrated greater weight loss during the intervention compared to the control , with no difference between intervention groups .


Most men engaged with the SCT tasks although compliance declined over time and utilisation of social support networks and reward selection was poor .


In a multiple regression model , the number of goals set ( -LSB- @ % CI -RSB- = -@ -LSB- -@ , -@ -RSB- , p = @ ) and the number of weight records documented ( -LSB- @ % CI -RSB- = -@ -LSB- -@ , -@ -RSB- , p = @ ) independently predicted weight loss .


The process evaluation indicated that men found the programs to be supportive , enjoyable and beneficial .


This process evaluation provides valuable information to inform the development of obesity treatment strategies that engage men .


Future studies with men should include a strong focus on self-monitoring and goal setting to enhance behaviour change and improve treatment effects .


Hepatocellular carcinoma ( HCC ) risk-scores may predict HCC in Asian entecavir ( ETV ) - treated patients .


We aimed to study risk factors and performance of risk scores during ETV treatment in an ethnically diverse Western population .


We studied all HBV monoinfected patients treated with ETV from @ European referral centres within the VIRGIL Network .


A total of @ patients were included ; @ % Caucasian , @ % Asian , @ % other , @ % unknown .


At baseline , @ patients ( @ % ) had cirrhosis .


During a median follow-up of @ ( IQR @-@ ) weeks , @ patients developed HCC of whom nine ( @ % ) had cirrhosis at baseline .


The @-year cumulative incidence rate of HCC was @ % for non-cirrhotic and @ % for cirrhotic patients ( p < @ ) .


HCC incidence was higher in older patients ( p < @ ) and patients with lower baseline platelet counts ( p = @ ) .


Twelve patients who developed HCC achieved virologic response ( HBV DNA < @IU/mL ) before HCC .


At baseline , higher CU-HCC and GAG-HCC , but not REACH-B scores were associated with development of HCC .


Discriminatory performance of HCC risk scores was low , with sensitivity ranging from @ % to @ % , and c-statistics from @ to @ .


Performance was further reduced in Caucasians with c-statistics from @ to @ .


Predicted risk of HCC based on risk-scores declined during ETV therapy ( all p < @ ) , but predictive performances after @year were comparable to those at baseline .


Cumulative incidence of HCC is low in patients treated with ETV , but ETV does not eliminate the risk of HCC .


Discriminatory performance of HCC risk scores was limited , particularly in Caucasians , at baseline and during therapy .


To measure the effects of an HIV-Care-Program , focusing on nutrition and lifestyle , which can be provided at scale to HIV-infected patients , on clinical and anthropometrical parameters , and health status .


A cluster-randomized trial , including @ health facilities randomized to intervention n = @ ( HIV-Care-Program ) or control n = @ ( Usual-Care ) .


The HIV-Care-Program consisted of counseling lessons for @ months , on : nutrition , hygiene , coping with stigma and discrimination , embedded in practical activities .


Outcome variables were CD@ count after @ months and time to antiretroviral therapy ( ARV ) initiation , using analysis of covariance and Kaplan-Meier method , respectively .


After @ months , CD@ count dropped by @ cells ( @ % ) ( intervention ) and @ ( @ % ) ( control ) ( p = @ ) .


Mean time to ARV ; @ months @ % CI ( @ , @ ) ( intervention ) ; @ months @ % CI ( @ , @ ) ( control ) ( p < @ ) .


There was a partial correlation between CD@ count and initial viral load ( r = -@ , p = @ ) .


The intervention provides a low-cost alternative improving health status , slowing down CD@ cell decline , delaying initiation of ARV and thus freeing local ARV capacities for patients in urgent need .


To test the association between docosahexaenoic acid ( DHA ) supplementation and perceived stress and cortisol response to a stressor during pregnancy in a sample of African American women living in low-income environments .


Sixty-four African American women were enrolled at @-@ weeks of gestation .


Power calculations were computed using published standard deviations for the Perceived Stress Scale and the Trier Social Stress Test .


Participants were randomized to either @ mg per day of DHA ( n = @ ) or placebo ( n = @ ) .


At baseline and at @ and @ weeks of gestation , perceived stress was assessed by self-report .


Cortisol response to a controlled stressor , the Trier Social Stress Test was measured from saliva samples collected upon arrival to the laboratory and after the completion of the Trier Social Stress Test .


Women in the DHA supplementation group reported lower levels of perceived stress at @ weeks of gestation , controlling for depression and negative life events ( mean @ compared with @ , F -LSB- @ , @ -RSB- @ , P = @ , Cohen 's d = @ ) .


Women in the DHA supplementation had lower cortisol output in response to arriving to the laboratory and a more modulated response to the stressor ( F -LSB- @ , @ -RSB- @ , P = @ , Cohen 's d = @ ) .


Pregnant women living in urban low-income environments who received DHA reported reduced perceived stress and lower levels of stress hormones in the third trimester .


Docosahexaenoic acid supplementation may be a method for attenuating the effects of maternal stress during late pregnancy and improving the uterine environment with regard to fetal exposure to glucocorticoids .


The objective of this study was to evaluate the performance of digital subtraction angiography ( DSA ) - like bone subtraction with @ different registration methods for the identification of bone marrow edema pattern ( BMEP ) in patients with lytic bone lesions , using magnetic resonance imaging as the criterion standard .


Fifty-five patients with a lytic bone lesion were included in this prospective study with approval from the ethics committee .


All patients underwent magnetic resonance imaging and low-dose computed tomographic ( CT ) perfusion after signing an informed consent .


Two CT volumes were used for bone subtraction , which was performed with @ different algorithms ( rigid and nonrigid ) .


Enhancement at the nonlytic bone marrow was considered as a sign of BMEP .


Two readers evaluated the images blindly .


The presence of BMEP on bone-subtracted CT images was evaluated subjectively and quantitatively .


Image quality was assessed .


Magnetic resonance imaging was used as the criterion standard .


Using a rigid registration method , the sensitivity , specificity , positive predictive value , negative predictive value , and accuracy of CT with DSA-like bone subtraction BMEP was @ % , @ % , @ % , @ % , and @ % , respectively .


The interobserver agreement was good ( , @ ) .


Image quality was better using a nonrigid registration .


With this algorithm , artifacts interfered with image interpretation in only @ % of cases .


However , there was a noticeable drop in sensitivity and negative predictive value when a nonrigid algorithm was used : @ % and @ % , respectively .


The interobserver agreement was average with a nonrigid subtraction algorithm .


Computed tomography with DSA-like bone subtraction is sensitive and highly specific for the identification of BMEP associated with lytic bone lesions .


Rigid registering should be preferred , but nonrigid algorithms can be used as a second option when artifacts interfere with image interpretation .


Tadalafil is used to treat erectile dysfunction after prostate cancer treatment , but its role as a preventive agent is undefined .


To determine primarily whether tadalafil preserved erectile function in men treated with radiotherapy for prostate cancer , and secondarily to determine whether participant - or partner-reported overall sexual function and sexual and marital satisfaction were affected .


Stratified , placebo-controlled , double-blind , parallel-group study with @:@ randomization at @ community-based and tertiary medical sites in the United States and Canada .


Two hundred forty-two participants with intact erectile function scheduled to receive radiotherapy for prostate cancer were recruited between November @ and February @ with follow-up through March @ .


One hundred twenty-one participants were assigned @ mg of tadalafil daily and @ were assigned placebo for @ weeks starting with external radiotherapy ( @ % ) or brachytherapy ( @ % ) .


Participant-reported International Index of Erectile Function response before radiotherapy and at weeks @ and @ , between weeks @ and @ , between weeks @ and @ , and @ year thereafter .


Participants and partners could respond also to the Sexual Adjustment Questionnaire and to the Locke Marital Adjustment Test before radiotherapy , between weeks @ and @ and weeks @ and @ , and at @ year .


Primary outcome was off-drug spontaneous erectile function @ to @ weeks after radiotherapy started .


Secondary end points were spontaneous erection at @ year ; overall sexual function and satisfaction ; marital adjustment ; and partner-reported satisfaction and marital adjustment at @ to @ weeks and @ year , predictors of tadalafil response ; and adverse events .


Among @ evaluable participants , @ ( @ % ; @ % CI , @ % -@ % ) assigned to receive tadalafil retained erectile function between weeks @ and @ compared with @ ( @ % ; @ % CI , @ % -@ % ) assigned to receive placebo ( P = @ ) ; an absolute difference of @ % ( @ % CI , -@ % to @ % ) .


A significant difference was also not observed at @ year ( @ % ; @ % CI , @ % -@ % vs @ % ; @ % CI , @ % -@ % ; P = @ ) .


Tadalafil was not associated with significantly improved overall sexual function or satisfaction ; a significant difference was not observed in any domain subscale .


Partners of men assigned tadalafil noted no significant effect on sexual satisfaction , and marital adjustment was not significantly improved in participants or partners .


Among men undergoing radiotherapy for prostate cancer , daily use of tadalafil compared with placebo did not result in improved erectile function .


These findings do not support daily use of tadalafil to prevent erectile dysfunction in these patients .


This study investigated the effect of a re-wetting agent on the microtensile bond strengths ( mTBS ) of primary and permanent dentin after acid or laser etching .


Twelve permanent and @ primary molar teeth were ground to expose an occlusal dentin surface .


Each group teeth were randomly divided into groups ; I-II : @ % phosphoric acid etching with/without re-wetting agent , III-IV : Erbium : Yttrium aluminium garnet laser etching with/without re-wetting agent .


An etch-and-rinse adhesive was used , and vertical sticks were obtained for the microtensile test .


mTBS of permanent teeth was higher than that of primary teeth ( P < @ ) .


Re-wetting agent groups were similar with control groups in both etching groups in the permanent teeth ( P > @ ) .


Re-wetting agent group was similar with the control group in acid etch group ( P > @ ) and lower than the control group in laser etch group in primary teeth ( P < @ ) .


Acid etching in permanent teeth ; laser etching in primary teeth was found more successful .


The use of re-wetting agent did not provide an advance on bond strength of the adhesive in both primary and permanent teeth after acid-etch or laser-etch .


Evidence based practice ( EBP ) requires that health professionals are competent in integrating the best evidence in their decision making .


Being ` evidence-based ' requires skills and knowledge in epidemiology , biostatistics and information literacy .


EBP is commonly taught in medical and health sciences degrees , yet there is little evidence to guide educators as to the best teaching modality to increase learner competency in EBP .


This study is mixed methods in design .


A randomised controlled trial will examine the effectiveness of blended learning versus didactic approach of teaching EBP to medical students .


The primary outcome of the RCT is EBP competency as assessed by the Berlin tool .


Focus groups will be conducted to explore student perceptions and attitudes towards implementing a blended learning approach in teaching EBP .


A concurrent triangulation design will be implemented , permitting quantitative data to inform the effectiveness of the intervention and qualitative data to contextualise the results .


This study will provide novel evidence on the effectiveness of blended learning in teaching EBP to a cohort of undergraduate and graduate-entry medical students .


There is currently little evidence regarding the selection of patients for clinical trials in Parkinson 's Disease ( PD ) , especially those involving experimental therapies delivered using invasive techniques .


Understanding which patients are recruited will increase awareness of issues regarding parity of access to clinical trials and have an impact on the wider applicability of results , as well as provoking discussion regarding future improvements in the enrolment process .


TRANSEURO is an open label multi-centre surgical transplant trial which seeks to investigate the feasibility and efficacy of grafts of human foetal ventral mesencephalic tissue in patients with PD .


The Cambridge based cohort of TRANSEURO participants ( n = @ ) was compared with a population representative sample of patients with PD eligible for , but not enrolled in , TRANSEURO ( n = @ ) .


Measurements were available in both populations for demographics , neuropsychological tests , tests of motor and non-motor function and quality of life .


Patients enrolled in TRANSEURO were younger and had significantly more years of education with higher scores on the revised Addenbrooke 's Cognitive Examination .


This difference was accounted for by memory , fluency and visuospatial subscores .


There were significant differences in the Movement Disorder Society Unified PD Rating Scale scores with better motor function but more motor complications in the enrolled group .


Those enrolled were also more likely to be under the care of the principal investigator of the study .


In this trial our population was younger and more educated with higher cognitive scores and better motor function than eligible PD patients not enrolled .


This raises interesting questions about the parity of access to clinical trials of this nature amongst patients with PD .


Little is known about the type of care older people of different ages receive at the end of life .


The goal of treatment is an important parameter of the quality of end-of-life care .


This study aims to provide an evaluation of the main goal of treatment in the last week of life of people aged @ and older compared with those between @ and @ and to examine how treatment goals are associated with age .


Population - based cross sectional survey in Flanders , Belgium .


A stratified random sample of death certificates was drawn of people who died between @ June and @ November @ .


The effective study sample included @,@ deaths ( response rate : @ % ) .


Non-sudden deaths of patients aged @ years and older were selected ( N = @ ) .


Main outcome was the main goal of treatment in the last week of life ( palliative care or life-prolonging/curative treatment ) .