Those in the control group underwent regular treatment , which included a daycare rehabilitation program .


Assessments included the @-item Resilience Scale ( RS ) , Positive and Negative Syndrome Scale ( PANSS ) , plasma and salivary BDNF level , and SAA activity .


Fifty patients participated ( @ in each group ; mean agestandard deviation , @ years ; mean duration of illness , @ years ; mean total PANSS score , @ ) .


No significant differences in changes in any variable from baseline to week @ were found between the two groups ( changes in the yoga group versus the control group : RS score , -@ versus @ ; PANSS score , @ versus @ ; plasma BDNF , @ pg/dl versus @ pg/dl ; SAA , -@ kU/l versus -@ kU/l , respectively ) .


Adjunct yoga therapy showed no positive changes in resilience level or stress markers .


Duration and intensity of yoga sessions and the focus on patients with chronic illness may explain the negative observations in light of past positive evidence regarding yoga therapy .


The purpose of this study was to determine the impact of psychotherapy on cognitive functioning in older adults with late-life depression ( LLD ) and executive dysfunction .


Two hundred twenty-one adults aged @ years and older participated in a randomized clinical trial comparing the efficacy of Problem Solving Therapy ( PST ) and Supportive Therapy ( ST ) for LLD .


Cognitive performance on seven tests of executive functioning , verbal learning , and memory was evaluated at baseline , after @ weeks of treatment , and at @ weeks after the completion of treatment .


Performance on a measure of executive functioning with a significant information processing speed component ( Stroop Color and Word Test ) improved after treatment , F ( @ , @ ) = @ , p = @ , and improved performance was associated with a reduction in depressive symptoms but not treatment type .


Performance on other measures of executive functioning , verbal learning , and memory did not change significantly after @ weeks of psychotherapy treatment .


Our results suggest that improvements in cognitive functioning after psychotherapy treatment for depression in older adults with executive dysfunction are likely focal and not distributed across all cognitive domains .


Although previous analyses reported that PST was superior to ST in the treatment of depression , this analysis indicated no difference between the two treatments with regard to improvements in cognitive functioning .


To determine whether exposure to a peer-led intervention focused on colorectal cancer ( CRC ) screening , physical activity , and multi-vitamin intake can lead to increased intentions to be screened for CRC once age eligible among adults under the age of @ .


Participants were residents of low-income housing sites , and CRC screening intentions were assessed at baseline and at follow-up ( approximately @ years later ) to determine changes in screening intentions and factors associated with changes in intentions .


Participants ( n = @ ) were @ % female , @ % Hispanic and @ % black .


At follow-up , @ % maintained their intention to be screened and @ % newly intended to get screened .


Individuals newly intending to get screened were more likely to have participated in the intervention , be older , male , and born in Puerto Rico or the United States compared to those who maintained their intention not to get screened ( p < @ ) .


Exposure to CRC prevention messages before the age of @ can increase screening intentions among individuals who did not initially intend to get screened .


Peer-led interventions to promote CRC screening should include individual less than @ years of age , as this may contribute to increased screening at the recommended age threshold .


Men who have sex with men ( MSM ) often face socially sanctioned disapproval of sexual deviance from the heterosexual `` normal . ''


Such sexual stigma can be internalized producing a painful affective state ( i.e. , shame ) .


Although shame ( e.g. , addiction ) can predict risk-taking ( e.g. , alcohol abuse ) , sexual shame 's link to sexual risk-taking is unclear .


Socially Optimized Learning in Virtual Environments ( SOLVE ) was designed to reduce MSM 's sexual shame , but whether it does so , and if that reduction predicts HIV risk reduction , is unclear .


To test if at baseline , MSM 's reported past unprotected anal intercourse ( UAI ) is related to shame ; MSM 's exposure to SOLVE compared to a wait-list control ( WLC ) condition reduces MSM 's shame ; and shame-reduction mediates the link between WLC condition and UAI risk reduction .


HIV-negative , self-identified African American , Latino or White MSM , aged @-@ years , who had had UAI with a non-primary/casual partner in the past three months were recruited for a national online study .


Eligible MSM were computer randomized to either WLC or a web-delivered SOLVE .


Retained MSM completed baseline measures ( e.g. , UAI in the past three months ; current level of shame ) and , in the SOLVE group , viewed at least one level of the game .


At the end of the first session , shame was measured again .


MSM completed follow-up UAI measures three months later .


All data from @ retained MSM ( WLC condition , @ ; SOLVE condition , @ ) were analyzed , with missing data multiply imputed .


At baseline , MSM reporting more risky sexual behaviour reported more shame ( r s = @ ; p < @ ) .


MSM in the SOLVE intervention reported more shame reduction ( M = -@ ) than MSM in the control condition ( M = @ ; t ( @ ) = @ ; p < @ ) .


As predicted , the indirect effect was significant ( point estimate -@ , @ % bias-corrected CI -LSB- -@ to -@ -RSB- such that participants in the SOLVE treatment condition reported greater reductions in shame , which in turn predicted reductions in risky sexual behaviour at follow-up .


The direct effect , however , was not significant .


SOLVE is the first intervention to : ( @ ) significantly reduce shame for MSM ; and ( @ ) demonstrate that shame-reduction , due to an intervention , is predictive of risk ( UAI ) reduction over time .


It is unclear whether the effect of video-assisted thoracoscopic surgery ablation is better than catheter ablation on paroxysmal atrial fibrillation ( PAF ) or not .


This study aimed to compare the effects of catheter ablation and video-assisted thoracoscopic surgery ablation on PAF .


From March @ to March @ , @ consecutive patients with PAF were randomly assigned to receive either video-assisted thoracoscopic surgery ablation ( thoracoscopy group , n = @ ) or the traditional catheter ablation ( catheter group , n = @ ) .


No patient died during the study and all were successfully followed and included in analysis .


There were no significant differences in clinical and echocardiographic characteristics between the two groups .


All patients were evaluated at @ week , @ month , @ months , @ months , and @ months after discharge by physical examination and related laboratory tests .


Preoperative left atrium dimensions ( LADs ) of the recurrent AF were ( @ @ ) mm in the thoracoscopy group and ( @ @ ) mm in the catheter group , whereas the LADs were ( @ @ ) and ( @ @ ) mm , respectively , in non-recurrent PAF .


The short-term outcome of video-assisted thoracoscopic surgery ablation is safe and effective ; and the indications are wider than those for catheter ablation .


The larger left atrium diameter is related to the recurrence of atrial fibrillation .


The objective was to determine if use of ultrasound ( US ) by emergency physicians ( EPs ) to localize spinal landmarks improves the performance of lumbar puncture ( LP ) .


This was a prospective , randomized , controlled study conducted in a county teaching hospital .


Subjects , adults @years of age or older who were to receive LPs for routine clinical care in the emergency department ( ED ) , were randomized either to undergo US localization of the puncture site or to have the puncture site determined by palpation of spinal landmarks .


Primary outcomes were the number of needle insertion attempts and success of the procedure .


Secondary outcomes were pain associated with the procedure , time to perform the procedure , number of traumatic taps , and patient satisfaction with the procedure .


One-hundred patients were enrolled in the study , with @ in each study group .


There were no significant differences between the two groups in terms of age , sex , body mass index ( BMI ) , indication for LP , or ease of palpation of landmarks .


For both primary outcomes and secondary outcomes there were no significant differences between those undergoing US localization and those with palpation alone .


These data do not suggest any advantage to the routine use of US localization for LP insertion , although further study may be warranted to look for benefit in the difficult to palpate or obese patient subgroups .


One of the most common joint dislocations presented to the emergency department ( ED ) is anterior shoulder dislocation ( ASD ) .


Various techniques for the treatment of this abnormality have been suggested .


In this study , we evaluated the efficacy and success rate of modified scapular manipulation ( MSM ) as a painless procedure compared to traction-countertraction ( TCT ) for reduction of ASD .


Patients with ASD who were presented to ED of Baqiyatallah Hospital , Tehran during @ were included .


They were randomly divided into MSM group or TCT group and then pain at reduction , time of reduction , duration of hospitalization , and success rate were compared .


In TCT group , reduction was performed using sedative and antipain medications .


Ninety seven patients ( @ % male ) with a mean age of @ years@ @ years were studied .


The reduction time between both groups showed a significant difference ( @ seconds@ @ seconds for TCT group , @ seconds@ @ seconds for MSM group , P < @ ) .


The success rate in MSM group in the first and second effort were @ % and @ % whereas @ % and @ % in the TCT group respectively ( P < @ ) .


It seems that the manipulation technique can be more successful than the TCT method at the first effort whilst the second effort has the opposite results .


Also MSM can be safer , cheaper and more acceptable for patients than TCT as a standard traditional method .


The purpose of this clinical study was to compare the chair time and degree of patient satisfaction after use of the Isolite system ( IS ) versus rubber dam ( RD ) during the application of pit and fissure sealants .


The patients included in this study ranged from seven to @ years old .


In each subject , pit and fissure sealants were applied to one permanent molar in each quadrant .


IS dental isolation was used on one side ; RD isolation was used on the other side .


Chair time was assessed using a stopwatch , and patient acceptance was evaluated using a questionnaire .


Forty-two subjects ( @ females and @ males ) were enrolled in the study .


The average chair time was @ minutes for the application of pit and fissure sealants on the RD side ; average chair time was @ minutes for the IS side ( P < @ ) .


Sixty-nine percent of the subjects were more comfortable using IS , while @ percent found RD to be more comfortable ( P = @ ) .


Isolite is a viable alternative to the conventional rubber dam .


The use of Isolite is associated with reduced chair time and greater patient satisfaction .


The objective of this study was to determine the Hounsfield unit ( HU ) changes in the alveolar bone and root surfaces during controlled canine retractions .


Eighteen maxillary canine retraction patients were selected for this split-mouth design clinical trial .


The canines in each patient were randomly assigned to receive either translation or controlled tipping treatment .


Pretreatment and posttreatment cone-beam computed tomography scans of each patient were used to determine tooth movement direction and HU changes .


The alveolar bone and root surface were divided into @ divisions , respectively .


The HUs in each division were measured .


Mixed-model analysis of variance was applied to test the HU change distribution at the P < @ significance level .


The HU changes varied with the directions relative to the canine movement .


The HU reductions occurred at the root surfaces .


Larger reductions occurred in the divisions that were perpendicular to the moving direction .


However , HUs decreased in the alveolar bone in the moving direction .


The highest HU reduction was at the coronal level .


HU reduction occurs on the root surface in the direction perpendicular to tooth movement and in the alveolar bone in the direction of tooth movement when a canine is retracted .


Over fifty percent of stroke patients experience chronic arm hand performance problems , compromising independence in daily life activities and quality of life .


Task-oriented training may improve arm hand performance after stroke , whereby augmented therapy may lead to a better treatment outcome .


Technology-supported training holds opportunities for increasing training intensity .


However , the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date .


The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients .


In a single-blind randomized controlled trial , @ chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training ( experimental group ) or task-oriented non-robotic arm-hand training ( control group ) .


For training , the T-TOAT ( Technology-supported Task-Oriented Arm Training ) method was applied .


Training was provided during @ weeks , @ times/week , @ @ min/day .


A significant improvement after training on the Action Research Arm Test ( ARAT ) was demonstrated in the experimental group ( p = @ ) .


Results were maintained until @ months after cessation of the training .


On the perceived performance measure ( Motor Activity Log ( MAL ) ) , both , the experimental and control group improved significantly after training ( control group p = @ ; experimental group p = @ ) .


The improvements on MAL in both groups were maintained until @ months after cessation of the training .


With regard to quality of life , only in the control group a significant improvement after training was found ( EuroQol-@D p = @ , SF-@ physical p = @ ) .


However , the improvement on SF-@ in the control group was not maintained ( p = @ ) .


No between-group differences could be demonstrated on any of the outcome measures .


Arm hand performance improved in chronic stroke patients , after eight weeks of task oriented training .


The use of a Haptic Master robot in support of task-oriented arm training did not show additional value over the video-instructed task-oriented exercises in highly functional stroke patients .


To compare the clinical and radiological outcomes of two implant designs with different prosthetic interfaces and neck configurations .


Thirty-four partially edentate patients randomly received at least one NobelActive implant ( Nobel Biocare , Gteborg , Sweden ) with back-tapered collar , internal conical connection and platform shifting design , and one NobelSpeedy implant ( Nobel Biocare ) with external hexagon and flat-to-flat implant-abutment interface according to a split-mouth design .


Follow-up continued to @ years post-loading .


The primary outcome measures were the success rates of the implants and prostheses , and the occurrence of any surgical and prosthetic complications during the entire follow-up .


Secondary outcome measures were : horizontal and vertical peri-implant marginal bone level ( MBL ) changes , resonance frequency analysis values at implant placement and loading ( @ months ) , sulcus bleeding index ( SBI ) and plaque score ( PS ) .


No drop-out occurred .


No implants and prostheses failures were observed to the @-year follow-up .


MBL changes were statistically significant different with better results for the NobelActive implants for both horizontal and vertical measurements ( P = @ ) .


After @ years post-loading , the NobelActive implants underwent a mean vertical bone resorption of @ mm , compared with @ mm for the NobelSpeedy Groovy implants ( P = @ ) ; the mean horizontal bone resorption was @ mm for the NobelActive implants and @ mm for the NobelSpeedy Groovy implants ( P = @ ) .


A high ISQ value was found for both implants , and no statistically significant difference was found for ISQ mean values between interventions ( P = @ at baseline ; P = @ at implantabutment connection ; P = @ at prosthesis delivery ) .


All implants showed good periodontal health at the @-year-in-function visit , with no significant differences between groups .


The results of this research suggest that in well-maintained patients , the MBL changes could be affected by the different implant design .


After @ months of unloaded healing , as well as after @ years in function , both implants provided good results , however vertical and horizontal bone loss had statistically significant differences between the two groups ( difference of @ @ mm for the vertical MBL , and @ @ mm for the horizontal MBL ) , with lower values in the Nobel Active implants , compared to the NobelSpeedy Groovy implants .


Unopposed estrogen has a central role in development of endometrial benign , premalignant and malignant lesions .


The aim of this study was to evaluate the anti-estrogenic effect of metformin on endometrial histology in comparison with progesterone .


A total of @ patients who were referred to our center for abnormal uterine bleeding and had a histologic diagnosis were disordered proliferative endometrium or simple endometrial hyperplasia were included and randomly distributed in two groups treated with metformin ( @mg Bid ) or megestrol ( @mg daily ) , respectively , for three months .


After this period the patients were evaluated by another endometrial biopsy to assess the impact of the two drugs in restoring normal endometrial histology .


Our findings revealed that metformin could induce endometrial atrophy in @ out of @ patients ( @ % ) while this positive response was achieved in only @ out of @ patients ( @ % ) in the megstrol group .


In addition two low grade endometrial carcinomas in the metformin group responded very well .


We conclude that metformin could be used as an effective antiestrogenic agent in control of abnormal endometrial proliferative disorders .


Thiazolidinediones are associated with increased fractures in type @ diabetes mellitus ( T@D ) .


One explanation is that activation of peroxisome proliferator-activated receptor - expression alters bone remodeling cells .


To investigate whether osteoclast and osteogenic precursor cells are altered by rosiglitazone ( RSG ) treatment in T@D as compared to metformin ( MET ) treatment .


A randomized controlled trial of RSG or MET for @ weeks , followed by @ weeks of MET .


Data were generated at a tertiary care center .


Seventy-three T@D postmenopausal women participated .


Peripheral blood mononuclear cells were isolated and cultured with receptor activator of nuclear factor B ligand and stained for tartrate-resistant acid phosphatase to measure circulating osteoclast precursors .


Peripheral blood mononuclear cells were also characterized for osteogenic , endothelial , and calcification markers by flow cytometry with the ligands osteocalcin ( OCN ) , CD@ , and CD @ .


Tartrate-resistant acid phosphatase-positive cells increased between weeks @ and @ ( RSG , @ @ to @ @ U/L , P = @ ; MET , @ @ to @ @ U/L , P = @ ) , increasing further in the RSG group after changing to MET ( to @ @ U/L , P = @ vs wk @ ) .


With RSG , OCN + cells with CD@ but without CD@ fell from weeks @ to @ ( @ @ % to @ @ % ; P = @ ) , remaining stable through week @ .


The OCN + cells lacking both CD@ and CD@ increased from weeks @ to @ ( @ @ to @ @ % ; P = @ ) , but returned to baseline after switching to MET .


In postmenopausal women with T@D , circulating osteoclast precursor cells increase with both RSG and MET , and increase further when switching from RSG to MET .


Subpopulations of cells that may be involved in the osteogenic lineage pathway are also altered with RSG .


Further work is necessary to elucidate how these changes may relate to fracture risk .


This study was designed to assess the knowledge acquired by very young children ( < @ years ) trained by their own teachers at nursery school .


This comparative study assessed the effect of training before the age of @ years compared with a group of age-matched untrained children .


Some schoolteachers were trained by emergency medical teams to perform basic first aid .


Eighteen classes comprising @ pupils were randomly selected : nine classes of trained pupils ( cohort C@ ) and nine classes of untrained pupils ( cohort C@ ) .


The test involved observing and describing three pictures and using the phone to call the medical emergency centre .


Assessment of each child was based on nine criteria , and was performed by the teacher @ months after completion of first aid training .


This study concerned @ pupils : @ trained and @ untrained .


The majority of trained pupils gave the expected answers for all criteria and reacted appropriately by assessing the situation and alerting emergency services ( @-@ @ % according to the questions ) .


Comparison of the two groups revealed a significantly greater ability of trained pupils to describe an emergency situation ( p < @ ) and raise the alert ( p < @ ) .


This study shows the ability of very young children to assimilate basic skills as taught by their own schoolteachers .


Existing studies of risk factors for physical impairments in acute lung injury ( ALI ) survivors were potentially limited by single-center design or relatively small sample size .


To evaluate risk factors for three measures of physical impairments commonly experienced by survivors of ALI in the first year after hospitalization .


A prospective , longitudinal study of @ - and @-month physical outcomes ( muscle strength , @-minute-walk distance , and Short Form -LSB- SF -RSB- -@ Physical Function score ) for @ survivors of ALI enrolled from @ hospitals participating in the ARDS Network randomized trials .


Multivariable regression analyses evaluated the independent association of critical illness-related variables and intensive care interventions with impairments in each physical outcome measure , after adjusting for patient demographics , comorbidities , and baseline functional status .


At @ and @ months , respectively , mean ( SD ) values for strength ( presented as proportion of maximum strength score evaluated using manual muscle testing ) was @ % ( @ % ) and @ % ( @ % ) , @-minute-walk distance ( as percent-predicted ) was @ % ( @ % ) and @ % ( @ % ) , and SF-@ Physical Function score ( as percent-predicted ) was @ % ( @ % ) and @ % ( @ % ) .


After accounting for patient baseline status , there was significant association and statistical interaction of mean daily dose of corticosteroids and intensive care unit length of stay with impairments in physical outcomes .


Patients had substantial impairments , from predicted values , for @-minute-walk distance and SF-@ Physical Function outcome measures .


Minimizing corticosteroid dose and implementing existing evidence-based methods to reduce duration of intensive care unit stay and associated patient immobilization may be important interventions for improving ALI survivors ' physical outcomes .


Aortic valve stenosis is one of the most common heart diseases in older patients .


Nowadays , surgical aortic valve replacement is the ` gold standard ' treatment for this pathology and the most implanted prostheses are biological ones .


The three most implanted bovine bioprostheses are the Trifecta valve ( St. Jude Medical , Minneapolis , MN , USA ) , the Mitroflow valve ( Sorin Group , Saluggia , Italy ) , and the Carpentier-Edwards Magna Ease valve ( Edwards Lifesciences , Irvine , CA , USA ) .


We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses .


First , we will measure the aortic annulus diameter using CT-scan , echocardiography and by direct sizing in the operating room after native aortic valve resection .


The accuracy of information , in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers , will be checked .


Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery .


This prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses .


The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient 's morphological characteristics .


Polio eradication efforts have been hampered by low responses to trivalent oral poliovirus vaccine ( tOPV ) in some developing countries .


Since stomach acidity may neutralize vaccine viruses , we assessed whether administration of a buffer solution could improve the immunogenicity of tOPV .


Healthy infants @-@ weeks old in Sylhet , Bangladesh , were randomized to receive tOPV with or without a sodium bicarbonate and sodium citrate buffer at age @ , @ , and @ weeks .


Levels of serum neutralizing antibodies for poliovirus types @ , @ , and @ were measured before and after vaccination , at @ and @ weeks of age , respectively .


Serologic response rates following @ doses of tOPV for buffer recipients and control infants were @ % and @ % ( P = @ ) , respectively , for type @ poliovirus ; @ % and @ % ( P = @ ) , respectively , for type @ poliovirus ; and @ % and @ % ( P = @ ) , respectively , for type @ poliovirus .


Administration of a buffer solution prior to vaccination was not associated with statistically significant increases in the immune response to tOPV ; however , a marginal @ % increase ( P = @ ) in serologic response to poliovirus type @ was observed .


Data on the effect of initial combination therapy with ambrisentan and tadalafil on long-term outcomes in patients with pulmonary arterial hypertension are scarce .


In this event-driven , double-blind study , we randomly assigned , in a @:@:@ ratio , participants with World Health Organization functional class II or III symptoms of pulmonary arterial hypertension who had not previously received treatment to receive initial combination therapy with @ mg of ambrisentan plus @ mg of tadalafil ( combination-therapy group ) , @ mg of ambrisentan plus placebo ( ambrisentan-monotherapy group ) , or @ mg of tadalafil plus placebo ( tadalafil-monotherapy group ) , all administered once daily .


The primary end point in a time-to-event analysis was the first event of clinical failure , which was defined as the first occurrence of a composite of death , hospitalization for worsening pulmonary arterial hypertension , disease progression , or unsatisfactory long-term clinical response .


The primary analysis included @ participants ; @ were assigned to the combination-therapy group , @ to the ambrisentan-monotherapy group , and @ to the tadalafil-monotherapy group .


A primary end-point event occurred in @ % , @ % , and @ % of the participants in these groups , respectively , and in @ % of the pooled-monotherapy group ( the two monotherapy groups combined ) .


The hazard ratio for the primary end point in the combination-therapy group versus the pooled-monotherapy group was @ ( @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


At week @ , the combination-therapy group had greater reductions from baseline in N-terminal pro-brain natriuretic peptide levels than did the pooled-monotherapy group ( mean change , -@ % vs. -@ % ; P < @ ) , as well as a higher percentage of patients with a satisfactory clinical response ( @ % vs. @ % ; odds ratio , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) and a greater improvement in the @-minute walk distance ( median change from baseline , @ m vs. @ m ; P < @ ) .


The adverse events that occurred more frequently in the combination-therapy group than in either monotherapy group included peripheral edema , headache , nasal congestion , and anemia .


Among participants with pulmonary arterial hypertension who had not received previous treatment , initial combination therapy with ambrisentan and tadalafil resulted in a significantly lower risk of clinical-failure events than the risk with ambrisentan or tadalafil monotherapy .


( Funded by Gilead Sciences and GlaxoSmithKline ; AMBITION ClinicalTrials.gov number , NCT@ . )


With the rise in the ageing population and absence of a cure for dementia , cost-effective prevention strategies for those ` at risk ' of dementia including those with depression and/or mild cognitive impairment are urgently required .


This study evaluated the efficacy of a multifaceted Healthy Brain Ageing Cognitive Training ( HBA-CT ) program for older adults ` at risk ' of dementia .


Using a single-blinded design , @ participants ( mean age = @ years , SD = @ ) were randomized to an immediate treatment ( HBA-CT ) or treatment-as-usual control arm .


The HBA-CT intervention was conducted twice-weekly for seven weeks and comprised group-based psychoeducation about cognitive strategies and modifiable lifestyle factors pertaining to healthy brain ageing , and computerized cognitive training .


In comparison to the treatment-as-usual control arm , the HBA-CT program was associated with improvements in verbal memory ( p = @ ) , self-reported memory ( p = @ ) , mood ( p = @ ) , and sleep ( p = @ ) .


While the improvements in memory ( p = @ ) and sleep ( p = @ ) remained after controlling for improvements in mood , only a trend in verbal memory improvement was apparent after controlling for sleep .


The HBA-CT program improves cognitive , mood , and sleep functions in older adults ` at risk ' of dementia , and therefore offers promise as a secondary prevention strategy .


A recombinant cysteine proteinase from Leishmania ( Leishmania ) infantum chagasi ( rLdccys@ ) was previously shown to induce protective immune responses against murine and canine visceral leishmaniasis .


These findings encouraged us to use rLdccys@ in the immunotherapy of naturally infected dogs from Teresina , Piau , a region of high incidence of visceral leishmaniasis in Brazil .


Thirty naturally infected mongrel dogs displaying clinical signs of visceral leishmaniasis were randomly divided in three groups : one group received three doses of rLdccys@ in combination with the adjuvant Propionibacterium acnes at one month interval between each dose ; a second group received three doses of P. acnes alone ; a third group received saline .


The main findings were : @ ) dogs that received rLdccys@ with P. acnes did not display increase of the following clinical signs : weight loss , alopecia , onychogryphosis , cachexia , anorexia , apathy , skin lesions , hyperkeratosis , ocular secretion , and enlarged lymph nodes ; they also exhibited a significant reduction in the spleen parasite load in comparison to the control dogs ; @ ) rLdccys@-treated dogs exhibited a significant delayed type cutaneous hypersensitivity elicited by the recombinant antigen , as well as high IgG@ serum titers and low IgG@ serum titers ; sera from rLdccys@-treated dogs also contained high IFN - and low IL-@ concentrations ; @ ) control dogs exhibited all of the clinical signs of visceral leishmaniasis and had low serum IgG@ and IFN - levels and high concentrations of IgG@ and IL-@ ; @ ) all of the dogs treated with rLdccys@ were alive @ months after treatment , whereas dogs which received either saline or P. acnes alone died within @ to @ months .


These findings illustrate the potential use of rLdccys@ as an additional tool for the immunotherapy of canine visceral leishmaniasis and support further studies designed to improve the efficacy of this recombinant antigen for the treatment of this neglected disease .


To evaluate the safety and immunogenicity of the thiomersal-free ( TF ) and thiomersal-containing ( TC ) formulations of Hepavax-Gene in healthy Vietnamese neonates .


A single-blind , randomized , controlled study in Ho Chi Minh City , Vietnam .


Healthy infants , born after a normal gestational period ( @-@ weeks ) to hepatitis B surface antigen-negative mothers , participated in the study .


Subjects were randomly allocated in a @:@ ratio to receive either Hepavax-Gene TC or Hepavax-Gene TF using a standard @-@-@-month administration schedule .


Postvaccination blood samples were taken at months @ , @ and @ .


Parents/legal guardians recorded solicited local and systemic adverse events up to @ weeks after each vaccination .


Very high proportions of subjects were seroprotected .


Seroprotection rates at @ , @ and @ months were all above @ % using a @ IU/L cutoff , and were mostly above @ % using a @ IU/L cutoff .


Seroprotection rates between the @ formulations were equivalent within a @ % margin for either cutoff titer both after @ and @ months .


There were no significant differences in the number of adverse events reported between the @ formulations .


Safety results were in line with previous reports for Hepavax-Gene .


Both formulations of Hepavax-Gene were well tolerated .


There were no local adverse events reported in the TF group .


No serious adverse events were reported during the study .


The thiomersal-free formulation of Hepavax-Gene was noninferior to the thiomersal-containing formulation of Hepavax-Gene in terms of immunogenicity .


There was evidence that the thiomersal-free vaccine was associated with fewer local adverse events .


To investigate the dynamics of lipid metabolism , C-reactive protein ( CRP ) , lipid peroxidation and antioxidant system in lacunar infarction ( LI ) in chronic cerebral ischemia .


Two groups of patients were studied .


The main group included @ patients who received intravenous laser irradiation of blood ( ILIB ) with semiconductor laser ( wavelength - @ microns , the power output - @-@ mW ) in addition to standard treatment .


Patients of the control group ( n = @ ) received only standard treatment .


A statistically significant decrease in total cholesterol levels to normal values due to the significant reduction of the content of antiatherogenic fraction of cholesterol ( high-density lipoprotein and atherogenic low-density lipoprotein cholesterol ) was found in the main group after treatment .


The reduction in atherogenic cholesterol fractions in both groups was associated with the decrease in apolipoprotein B level .


The level of CRP was higher than normal in the main and control groups of patients before and after treatment , which indicated the risk of vascular diseases in patients with LI .


After treatment , superoxide dismutase activity returned to normal values .


In patients of the main group , the catalase activity increased while the level of reduced glutathione did not change and lipid peroxidation products remained on the high level .


Additional antioxidant therapy is needed for these patients .


Clinical trials have shown the effectiveness of systemic and local insulin therapy in improving wound healing .


Diabetic wounds remain a challenge for healthcare providers .


Impaired angiogenesis and reduced granulation tissue formation contribute to inadequate wound healing .


The aim of this study was to investigate the effect of local insulin administration in acute and chronic diabetic wounds .


Eight diabetic patients presenting with full-thickness wounds , of different causes , were included in this study .


Five wounds were due to necrobiosis , one to trauma , and two to postneoplasm resection .


All wounds were treated with regular bedside treatment .


In addition , half of the wound surface was treated with insulin and the other half did not receive insulin .


Thermographic and biopsy specimens of the two sides were obtained on days @ and @ .


The presence of fibrosis , change in temperature , and amount of blood were evaluated .


Significant differences in the number of vessels were observed on the insulin-treated side ( @ @ ) when compared with the no-insulin side ( @ @ ) ( p < @ ) .


The percentage of fibrosis ( insulin : @ @ percent versus no insulin : @ @ percent ; p < @ ) and the mean temperature ( insulin : @ @ C versus no-insulin : @ @ C ; p < @ ) were also significantly different between sides .


No adverse events related to the study occurred .


The use of local insulin improves the formation of new blood vessels , increases fibrosis , and correlates with increased temperature .


Therapeutic , II .


The prevalence of peanut allergy among children in Western countries has doubled in the past @ years , and peanut allergy is becoming apparent in Africa and Asia .


We evaluated strategies of peanut consumption and avoidance to determine which strategy is most effective in preventing the development of peanut allergy in infants at high risk for the allergy .


We randomly assigned @ infants with severe eczema , egg allergy , or both to consume or avoid peanuts until @ months of age .


Participants , who were at least @ months but younger than @ months of age at randomization , were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract , which was determined with the use of a skin-prick test -- one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring @ to @ mm in diameter .


The primary outcome , which was assessed independently in each cohort , was the proportion of participants with peanut allergy at @ months of age .


Among the @ infants in the intention-to-treat population who initially had negative results on the skin-prick test , the prevalence of peanut allergy at @ months of age was @ % in the avoidance group and @ % in the consumption group ( P < @ ) .


Among the @ participants in the intention-to-treat population who initially had positive test results , the prevalence of peanut allergy was @ % in the avoidance group and @ % in the consumption group ( P = @ ) .


There was no significant between-group difference in the incidence of serious adverse events .


Increases in levels of peanut-specific IgG@ antibody occurred predominantly in the consumption group ; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody .


A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG@ : IgE were associated with peanut allergy .


The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts .


( Funded by the National Institute of Allergy and Infectious Diseases and others ; ClinicalTrials.gov number , NCT@ . )


Health care professionals in several countries are searching for alternatives to acute hospitalization .


In Hallingdal , Norway , selected acute patients are admitted to a community hospital .


The aim of this study was to analyse whether acute admission to a community hospital as an alternative to a general hospital had any positive or negative health consequences for the patients .


Patients intended for acute admission to the local community hospital were asked to join a randomized controlled trial .


One group of the enrolled patients was admitted as planned ( group @ , n = @ ) , while another group was admitted to the general hospital ( group @ , n = @ ) .


Health outcomes were measured by the Nottingham Extended Activity of Daily Living Questionnaire and by collection of data concerning specialist and community health care services in a follow-up year .


After one year , no statistical significant differences in the level of daily function was found between group @ ( admissions to the community hospital ) and group @ ( admissions to the general hospital ) .


Group @ had recorded fewer in-patient days at hospitals and nursing homes , as well as lower use of home nursing , than group @ .


For outpatient referrals , the trend was the opposite .


However , the differences between the two groups were not at a @ % level of statistical significance .


No statistical significant differences at a @ % level were found related to health consequences between the two randomized groups .


The study however , indicates a consistent trend of health benefits rather than risk from acute admissions to a community hospital , as compared to the general hospital .


Emergency admission and treatment at a lower-level facility than the hospital thus appears to be a feasible solution for a selected group of patients .


Obesity in pregnancy is associated with fetal macrosomia , a raised neonatal fat mass and an increased risk of obesity and poor metabolic health in childhood which persists into adulthood .


The offspring of obese women are more likely to be obese than the offspring of lean women when they become pregnant themselves , perpetuating a cycle of obesity and its associated negative metabolic consequences .


Increasing physical activity during pregnancy could improve insulin sensitivity and reduce the risk of maternal and offspring adverse outcomes .


The UK Pregnancy Better Eating and Activity Trial ( UPBEAT ) is a trial of a complex intervention designed to improve pregnancy outcomes through dietary changes and physical activity .


Data from the pilot trial of @ women were available for analysis .


The relationship between the time spent at different physical activity levels and maternal and infant pregnancy outcomes was examined .


Strong evidence exists that physical activity improves insulin sensitivity in non-pregnant populations , and lifestyle interventions of proven effectiveness in non-pregnant populations have been developed .


Women who are active in pregnancy demonstrate better glucose control and favourable pregnancy outcomes .


There is a lack of effective interventions to support obese pregnant women to be physically active .


No difference was detected in objectively measured physical activity between women randomised to the intervention and control arms of the UPBEAT pilot trial .


Light-intensity physical activity was lower in early pregnancy in women who delivered macrosomic infants .


Maternal sedentary time at @-@ weeks ' gestation was positively associated and moderate-intensity physical activity was inversely associated with neonatal abdominal circumference .


Maternal physical activity is associated with infant birth weight and abdominal circumference and is an appropriate target for intervention to improve infant outcomes .


The challenge remains to develop an effective intervention to support obese pregnant women to be physically active .


In type @ diabetes mellitus , fixed-dose combination ( FDC ) can provide the complementary benefits of correction of multiple pathophysiologic defects such as dysfunctions in glycemic or metabolic control while improving compliance compared with separate tablets taken together .


The objective of the study reported here was to compare the pharmacodynamic ( PD ) , pharmacokinetic ( PK ) , and tolerability profiles of gemigliptin and extended-release metformin ( metformin XR ) between FDC and separate tablets .


A randomized , open-label , single-dose , two-way , two-period , crossover study was conducted in @ healthy male volunteers .


Two FDC tablets of gemigliptin/metformin @/@ mg or separate tablets of gemigliptin ( @ mg @ ) and metformin XR ( @ mg @ ) were orally administered in each period .


Serial blood samples were collected up to @ hours post-dose to determine dipeptidyl peptidase @ ( DPP-@ ) activity using spectrophotometric assay and concentrations of gemigliptin and metformin using tandem mass spectrometry .


Geometric mean ratios ( GMRs ) of FDC to separate tablet formulations and their @ % confidence intervals ( CIs ) were calculated to compare the PD and PK parameters between the two formulations .


Tolerability was assessed throughout the study .


The plasma DPP-@ activity-time curves of the FDC and the separate tablets almost overlapped , leading to a GMR ( @ % CI ) of the FDC to separate tablets for the plasma DPP-@ activity and its maximum inhibition of @ ( @-@ @ ) and @ ( @-@ @ ) , respectively .


Likewise , all of the GMRs ( @ % CIs ) of FDC to separate tablets for the area under the plasma concentration-time curve and maximum plasma concentration of gemigliptin and metformin fell entirely within the conventional bioequivalence range of @-@ @ .


Both the FDC and separate tablets were well tolerated .


The PD , PK , and tolerability profiles of gemigliptin and metformin XR in FDC and separate tablets were found to be comparable .


The FDC tablet of gemigliptin and metformin sustained release can be a convenient therapeutic option in patients with type @ diabetes mellitus requiring a combination approach .


To compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation ( RFVTA ) of fibroids and laparoscopic myomectomy ( LM ) .


The present postmarket , randomized , prospective , single-center , longitudinal , comparative study , conducted in Tbingen , Germany , evaluated the outcomes of RFVTA and the current standard of care ( LM ) for symptomatic uterine fibroids in women who desired uterine conservation .


The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound .


The mean hospitalization times were @ @ ( median @ -LSB- range @-@ @ -RSB- ) hours for the RFVTA group and @ @ ( median @ -LSB- range @-@ @ -RSB- ) hours for the LM group ( P < @ , Wilcoxon test ) .


Intraoperative blood loss was @ @ ( median @ -LSB- range : @-@ -RSB- ) mL for the RFVTA procedures and @ @ ( median @ -LSB- range @-@ -RSB- ) mL for the LM procedures .


The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was @ % for RFVTA and @ % for LM .


Two complications were reported : vertigo ( n = @ ; RFVTA ) and port site hematoma ( n = @ ; LM ) .


Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids , a significantly shorter hospital stay , and less intraoperative blood loss than laparoscopic myomectomy .


ClinicalTrials.gov : NCT@ .


To quantify the coupled motion of the wrist during selected functional tasks and to determine the effects of constraining this coupled motion using a radial-ulnar deviation blocking splint on performance of these tasks .


Ten healthy , right-handed men performed @ trials during selected functional tasks with and without a splint , blocking radial and ulnar deviation .


The following tasks were performed : dart throwing , hammering , basketball free-throw , overhand baseball and football throwing , clubbing , and pouring .


Kinematic coupling parameters ( coupling , kinematic path length , flexion-extension range of motion , radial-ulnar deviation range of motion , flexion-extension offset , and radial-ulnar deviation offset ) and performance were determined for each functional task .


A generalized estimation equation model was used to determine whether each kinematic coupling parameter was significantly different across tasks .


A repeated-measures generalized estimation equation model was used to test for differences in performance and kinematic coupling parameters between the free and splinted conditions .


Wrist motion exhibited linear coupling between flexion-extension and radial-ulnar deviation , demonstrated by R ( @ ) values from @ to @ .


Average wrist coupling and kinematic path lengths were significantly different among tasks .


Coupling means and kinematic path lengths were different between free and splinted conditions across all tasks other than pouring .


Performance was different between wrist conditions for dart throwing , hammering , basketball shooting , and pouring .


Wrist kinematic coupling parameters are task specific in healthy individuals .


Functional performance is decreased when wrist coupling is constrained by an external splint .


Surgical procedures that restrict wrist coupling may have a detrimental effect on functional performance as defined in the study .


Patients may benefit from surgical reconstructive procedures and wrist rehabilitation protocols designed to restore kinematic coupling .


This open randomized study compares the effects of @-week-long treatment with rosuvastatin and with atorvastatin coadministered with ezetimibe on the parameters of carbohydrate metabolism and the plasma levels of adipokynes in patients with coronary artery disease and type @ diabetes mellitus or impaired glucose tolerance ( IGT ) .


A total of @ patients with coronary artery disease and type @ diabetes mellitus or IGT were recruited in the study .


Patients were randomized into two groups : group @ included patients who received rosuvastatin therapy in an average dose of @ mg/day ( n = @ ) ; group @ included patients who received combination treatment with atorvastatin in an average dose of @ mg/day and ezetimibe ( @ mg ) ( n = @ ) .


Plasma levels of lipids , apoB , apoA@ , glucose , insulin , leptin , and adiponectin were evaluated ; HOMA-IR index ( an empty stomach insulin , mu/l x fasting glucose , mmol/l ) / @ ) was calculated .


During the therapy , the LDL-C and apoB levels decreased by @ % and @ % in group @ and by @ % and @ % in group @ , respectively .


Reduction in the triglyceride levels was significantly more pronounced in group @ than in group @ : @ % vs @ % ( p < @ ) , whereas we did not observed significant changes of HDL-C and apoA@ in either group .


The increases in basal glycemia , basal insulinemia , HbA@c levels ( from @ % -LSB- @-@ @ % -RSB- to @ % @-@ @ % -RSB- ) , and HOMA-IR ( from @ -LSB- @-@ @ -RSB- to @ -LSB- @-@ @ -RSB- ) were found only in group @ ( p < @ for all ) .


These changes were observed in @ % of patients of group @ independently of the presence of diabetic state or IGT , but the changes were more pronounced in patients with disturbed carbohydrate metabolism .


Changes of leptin levels during the therapy were diverse : @ % patients of group @ demonstrated decrease in the leptin levels , whereas @ % of patients in group @ experienced @ % - increase in the leptin concentrations .


Degree of increased basal glycemia was associated with increase in the leptin levels ( r = @ , p = @ ) in the entire group of patients ( n = @ ) .


Furthermore , changes in leptin levels were negatively associated with decreased adiponectin levels ( r = -@ , p = @ ) .


In case of equivalent degree of the decrease in LDL-C levels , @-week combination therapy with atorvastatin and ezetimibe , unlike rosuvastatin treatment , induced increases in basal glycemia , insulinemia , HbA@c , and HOMA-IR index irrespective of the presence of carbohydrate metabolism disturbances before treatment .


Our data suggest that adiponectin and leptin are involved in the mechanisms of adverse metabolic effects of the combination of atorvastatin and ezetimibe .


Mild traumatic brain injury ( mTBI ) and postconcussion syndrome ( PCS ) are common among military combatants .


Hyperbaric oxygen ( HBO@ ) is a proposed treatment for these conditions , but it has not been rigorously studied .


The objective of this study was to determine the effects of HBO@ by @ months post compression at @ commonly employed dosing levels to treat PCS ; whether specific subgroups may have benefited ; and if no overall effect was found , whether benefit is masked by other conditions .


This randomized , double-blind , sham-controlled study was conducted at the Naval Air Station in Pensacola , Florida on @ male Marines with a history of mTBI and PCS .


Intervention consisted of @ once daily @-minute hyperbaric chamber compressions at @ atmospheres absolute ( ATA ) at @ of @ randomly preassigned oxygen fractions , resulting in respective blinded groups with an oxygen-breathing exposure equivalent to ( @ ) surface air ( sham ) , ( @ ) @ % oxygen at @ ATA , or ( @ ) @ % oxygen at @ ATA .


The main outcome measure was the Rivermead Post-Concussion Questionnaire-@ ( RPQ-@ ) collected before compressions and at @ later points .


The interaction of time by intervention group was not significant for improvement on the RPQ-@ .


Nor was there evidence of efficacy on the RPQ-@ for any subgroup .


No significant time by intervention interaction was found for any functional , cognitive , or psychomotor secondary outcome measure at an unadjusted @ significance level .


Using a randomized control trial design and analysis including a sham , results showed no evidence of efficacy by @ months post-compression to treat the symptomatic , cognitive , or behavioral sequelae of PCS after combat-related mTBI .


To assess and compare the safety and efficacy of allapinine and quinidine bisulphate in the treatment of patients with persistent atrial fibrillation after cardioversion .


Design -- Prospective , randomised , open study .


Patients -- @ consecutive patients ( men only , mean age @ @ years ) with persisnent atrial fibrillation and flutter .


Interventions -- @ patients were randomised to allapinine ( ALP ) ( @ mg/kg/d ) , @ to quinidine bisulphate ( QUIN ) ( @ mg/kg/d ) with subsequent successful pharmacological or electrical cardioversion .


Main outcome measures -- Recurrence of atrial fibrillation or side effects .


In the ALP group @ of the @ patients developed atrial fibrillation up to @ month of follow-up , while in the QUIN group @ patients developed atrial fibrillation and @ experienced significant side effects .


Relative risk ( RR ) ( ALP vs QUIN ) @ ( @ % CI @-@ @ , p < @ ) .


The number needed to treat ( NNT ) was ( -@ ) ( @-@ @ harm ) .


When @ patients with significant side effects were excluded from the analysis RR was @ ( @ % CI @-@ @ , p = @ ) and NNT -- ( -@ ) ( @-@ @ harm ) but power of the study was too low -- @ % .


Allapinine is as effective as quinidine bisulphate in the long term treatment of patients with persistent atrial fibrillation after successful cardioversion but causes significantly less side effects .


Bovine herpesvirus type @ ( BoHV-@ ) is the causative agent of respiratory and genital tract infections ; causing a high economic loss in all continents .


Use of marker vaccines in IBR eradication programs is widely accepted since it allows for protection of the animals against the disease while adding the possibility of differentiating vaccinated from infected animals.The aim of the present study was the development and evaluation of safety and efficacy of a glycoprotein E-deleted ( gE - ) BoHV-@ marker vaccine strain ( BoHV-@gEgal ) generated by homologous recombination , replacing the viral gE gene with the - galactosidase ( gal ) gene .


In vitro growth kinetics of the BoHV-@gEgal virus was similar to BoHV-@ LA. .


The immune response triggered by the new recombinant strain in cattle was characterized both as live attenuated vaccine ( LAV ) and as an inactivated vaccine .


BoHV-@gEgal was highly immunogenic in both formulations , inducing specific humoral and cellular immune responses .


Antibody titers found in animals vaccinated with the inactivated vaccine based on BoHV-@gEgal was similar to the titers found for the control vaccine ( BoHV-@ LA ) .


In the same way , titers of inactivated vaccine groups were significantly higher than any of the LAV immunized groups , independently of the inoculation route ( p < @ ) .


Levels of IFN - were significantly higher ( p < @ ) in those animals that received the LAV compared to those that received the inactivated vaccine .


BoHV-@gEgal exhibited an evident attenuation when administered as a LAV ; no virus was detected in nasal secretions of vaccinated or sentinel animals during the post-vaccination period .


BoHV-@gEgal , when used in either formulation , elicited an efficient immune response that protected animals against challenge with virulent wild-type BoHV-@ .


Also , the deletion of the gE gene served as an immunological marker to differentiate vaccinated animals from infected animals .


All animals vaccinated with the BoHV-@gE gal strain were protected against disease after challenge and shed significantly less virus than control calves , regardless of the route and formulation they were inoculated .


Based on its attenuation , immunogenicity and protective effect after challenge , BoHV-@gEgal virus is an efficient and safe vaccine candidate when used either as inactivated or as live attenuated forms .


To evaluate the clinical efficacy and safety of Qiangji Recipe ( QR ) in ad - junctive treatment of axial undifferentiated spondyloarthritis ( axuSpA ) through a four-week open study .


Fifty-four axuSpA patients of Shen-deficiency Du-channel cold syndrome ( SDDCS ) in line with inclusive criteria were recruited and assigned to the treatment group and the control group according to random digit table , @ in each group .


Patients in the control group took Celecoxib Capsule ( @ g each time , twice per day ) .


Patients in the treatment group additionally took QR ( consisting of Herba Epimedii @ g , antler glue @ g , Cibotium Barometz @ g , eucommia bark @ g , dipsacus asper @ g , two toothed achyranthes root @ g , drynaria @ g , Taxillus Chinensis @ g , ground beetle @ g , scorpion @ g , wild celery @ g , notopterygium incisium @ g , cow-fat seed @ g , white mustard seed @ g , and licorice root @ g , one dose per day , twice daily ) .


The therapeutic course for all was @ weeks .


The Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , the Bath Ankylosing Spondylitis Functional Index ( BASFI ) , the Bath AS Metrology Index ( BASMI ) , total body pain and spinal pain , patient and physician global assessment on a four-point scale , the Ankylosing Spondylitis Quality of Life ( ASQoL ) , erythrocyte sedimentation rate ( ESR ) and C-reactive protein ( CRP ) were measured before and after @ weeks of treatment .


The primary end point in this study was the proportion of patients with a @ % improvement response accord - ing to the ASAS International Working Group Criteria ( ASAS @ responders ) at week @ .


Totally @ patients completed this trial , @ in the treatment group and @ in the control group .


Improvement of BASDAI , BASFI , BASMI , ASQoL , ESR , and CRP was shown in both groups after treatment .


Better effect was shown in the treatment group in all indices except ESR and BASMI after treatment ( P < @ , P < @ ) .


Twenty cases ( accounting for @ % ) in the treatment group achieved ASAS @ response at week @ , while @ cases ( accounting for @ % ) in the control group achieved ASAS @ response at week @ ( P < @ ) .


No obvious adverse reaction occurred in the two groups .


QR combined Celecoxib Capsule showed better effect in treating axuSpA patients than using Celecoxib Capsule alone .


The ` Supporting Teachers And childRen in Schools ' ( STARS ) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management ( TCM ) programme as a public health intervention .


TCM is a @ day training course delivered to groups of @-@ teachers .


The STARS trial will investigate whether TCM can improve children 's behaviour , attainment and wellbeing , reduce teachers ' stress and improve their self-efficacy .


This protocol describes the methodology of the process evaluation embedded within the main trial , which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes .


The STARS trial will work with eighty teachers of children aged @-@ years from eighty schools .


Teachers will be randomised to attend the TCM course ( intervention arm ) or to `` teach as normal '' ( control arm ) and attend the course a year later .


The process evaluation will use quantitative and qualitative approaches to assess fidelity to model , as well as explore headteachers ' and teachers ' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice .


Four of the eight groups of teachers ( n = @ ) will be invited to participate in focus groups within one month of completing the TCM course , and again a year later , while @ of the @ headteachers will be invited to take part in telephone interviews .


Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model .


Teachers will also complete standardised session evaluations .


This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term .


The process evaluation will provide valuable insights into factors that may facilitate or impede any impact .


The Quality Initiative in Rectal Cancer ( QIRC ) trial targeted surgeon intraoperative technique and not radiation therapy ( RT ) use .


We performed a post hoc analysis of RT use among patients in the QIRC trial , not by arm of trial but rather for the entire group .


We wished to identify associations between local recurrence risk and use of preoperative , postoperative or no RT. .


We compared demographic , tumour and process of care measures among patients receiving preoperative , postoperative or no RT. .


A multivariable Cox regression model assessed local recurrence risk .


The QIRC trial enrolled @ patients at @ hospitals between @ and @ .


Radiation therapy use did not differ between trial arms , and median follow-up was @ years .


For the preoperative , postoperative and no RT groups , respectively , the percentage of patients was @ % , @ % and @ % ; the percentage of stage II/III tumours was @ % , @ % and @ % ; and the local recurrence rate was @ % , @ % and @ % ( p = @ ) .


After controlling for patient and tumour characteristics , including tumour stage , the hazard ratio ( HR ) for local recurrence was increased in the postoperative RT versus the no RT group ( HR @ , @ % confidence interval @-@ @ , p = @ ) .


Use of preoperative RT was low ; most patients with stage II/III disease did not receive RT and , as expected , the postoperative RT group had the highest risk of local recurrence .


Our results suggest opportunities to improve rectal cancer RT use in Ontario .


Levels of platelet reactivity in patients on dual antiplatelet therapy ( DAPT ) can be influenced by concomitant treatment with statins .


We verified if the pharmacodynamic effects of CYP@A@-metabolized statins ( atorvastatin ) and non-CYP@A@-metabolized statins ( pitavastatin ) differ in patients with coronary artery disease ( CAD ) treated with DAPT .


A total of @ CAD patients receiving DAPT ( clopidogrel @mg plus aspirin @mg ) entered the PORTO trial .


Patients were randomly assigned to atorvastatin ( @mg day ) or pitavastatin ( @mg day ) for @ days , and then switched to the other drug for @ days .


Platelet reactivity was expressed as VerifyNow P@Y@ platelet response units ( PRU ) before and after each @-day treatment period .


High platelet reactivity was defined as PRU > @ .


As compared with pretreatment ( @ ) , PRU was significantly higher after @-day atorvastatin ( @ ; P = @ ) , but was unchanged after @-day pitavastatin ( @ PRU , NS ) .


In the @ patients with PRU > @ at baseline ( @ ) , PRU increased significantly after @-day atorvastatin ( @ , P = @ ) , but not after @-day pitavastatin ( @ , NS ) .


In the @ patients with PRU < @ at baseline ( @ ) , PRU did not change significantly with respect to baseline either after @-day atorvastatin ( @ , NS ) or after @-day pitavastatin ( @ , NS ) .


Pitavastatin , a non-CYP@A@-metabolized statin , does not affect clopidogrel 's response as compared with atorvastatin in patients who are borderline or poor responders to DAPT .


With accumulating knowledge on osteoarthritis development , the next step is to focus on possibilities for primary prevention .


In a @ @ factorial design , the effects of a diet-and-exercise program and of oral glucosamine sulfate ( double blind and placebo-controlled ) on the incidence of knee osteoarthritis were evaluated in a high-risk group of @ middle-aged women with a body mass index @ kg/m ( @ ) without clinical signs of knee osteoarthritis at baseline ( ISRCTN @ ) .


Primary outcome was the incidence of knee osteoarthritis , defined as Kellgren & Lawrence grade @ , joint space narrowing of @ mm , or clinical knee osteoarthritis ( clinical and radiographic American College of Rheumatology criteria ) after @ years .


After @ years , only @ % of all subjects were lost to follow-up , and @ % of all knees showed incident knee osteoarthritis .


Accounting for the significant interaction between the interventions , no significant main effect of either intervention was found .


Independently , both interventions alone showed indications of reduced knee osteoarthritis incidence ( odds ratio -LSB- OR -RSB- @ ; @ % CI , @-@ @ for the diet-and-exercise program and OR @ ; @ % CI , @-@ @ for the glucosamine intervention ) .


These effects were neutralized in subjects receiving both interventions ( OR @ ; @ % CI , @-@ @ ) .


No significant main effects of the diet-and-exercise program and of glucosamine sulfate were found on incident knee osteoarthritis .


Nevertheless , this trial provides valuable insights for future trial design for preventive osteoarthritis studies .


Sleep disturbances are most prevalent among older adults and often go untreated .


Treatment options for sleep disturbances remain limited , and there is a need for community-accessible programs that can improve sleep .


To determine the efficacy of a mind-body medicine intervention , called mindfulness meditation , to promote sleep quality in older adults with moderate sleep disturbances .


Randomized clinical trial with @ parallel groups conducted from January @ to December @ , @ , at a medical research center among an older adult sample ( mean -LSB- SD -RSB- age , @ -LSB- @ -RSB- years ) with moderate sleep disturbances ( Pittsburgh Sleep Quality Index -LSB- PSQI -RSB- > @ ) .


A standardized mindful awareness practices ( MAPs ) intervention ( n = @ ) or a sleep hygiene education ( SHE ) intervention ( n = @ ) was randomized to participants , who received a @-week intervention ( @ hours per week ) with assigned homework .


The study was powered to detect between-group differences in moderate sleep disturbance measured via the PSQI at postintervention .


Secondary outcomes pertained to sleep-related daytime impairment and included validated measures of insomnia symptoms , depression , anxiety , stress , and fatigue , as well as inflammatory signaling via nuclear factor ( NF ) - B.


Using an intent-to-treat analysis , participants in the MAPs group showed significant improvement relative to those in the SHE group on the PSQI .


With the MAPs intervention , the mean ( SD ) PSQIs were @ ( @ ) at baseline and @ ( @ ) at postintervention .


With the SHE intervention , the mean ( SD ) PSQIs were @ ( @ ) at baseline and @ ( @ ) at postintervention .


The between-group mean difference was @ ( @ % CI , @-@ @ ) , with an effect size of @ .


The MAPs group showed significant improvement relative to the SHE group on secondary health outcomes of insomnia symptoms , depression symptoms , fatigue interference , and fatigue severity ( P < @ for all ) .


Between-group differences were not observed for anxiety , stress , or NF-B , although NF-B concentrations significantly declined over time in both groups ( P < @ ) .


The use of a community-accessible MAPs intervention resulted in improvements in sleep quality at immediate postintervention , which was superior to a highly structured SHE intervention .


Formalized mindfulness-based interventions have clinical importance by possibly serving to remediate sleep problems among older adults in the short term , and this effect appears to carry over into reducing sleep-related daytime impairment that has implications for quality of life .


While emergency room ( ER ) studies have documented a strong association of alcohol with injury , these studies are not necessarily representative of the general population .


To evaluate comparative risk of injury from drinking for those treated in the ER with non-ER-treated injuries ( those treated elsewhere or those not treated ) , data on alcohol and injury are analyzed in the U.S. general population by type of injury treatment .


Relative risk ( RR ) of injury from drinking within @ hours prior to the event was analyzed using case-crossover analysis based on respondents ' usual frequency of drinking in @ ( @ to @ ) National Alcohol Surveys ( n = @,@ ) .


RR was @ for the total injured and significantly elevated for ER-treated injured ( @ ) , but not for those treated elsewhere ( @ ) and those not treated ( @ ) .


RR was significantly elevated for those aged @ to @ years ( @ ; @ , @ ) , Blacks ( @ ; @ , @ ) and Hispanics ( @ ; @ , @ ) , those positive on the Rapid Alcohol Problems Screen ( RAPS@ ) as a measure of alcohol dependence ( @ ; @ , @ ) , and for motor vehicle injuries ( @ ; @ , @ ) or cutting/piercing injuries ( @ , @ , @ ) .


For those reporting ER-treated injuries , significant effect modification was found for those aged @ to @ years ( RR = @ ) , Blacks ( RR = @ ) and Hispanics ( RR = @ ) , high risk-taking ( RR = @ ) , positive RAPS@ ( RR = @ ) , and for motor vehicle ( RR = @ ) and cutting/piercing injuries ( RR = @ ) .


Data suggest alcohol plays a larger role in injuries for which ER treatment is sought than for other injuries , and estimates for injury from drinking derived from ER studies may be elevated .


Future general population studies should take into account intensity of exposure to alcohol prior to injury , potential recall bias ( by eliciting data on the proximity of injury to time of the respondent interview ) and severity of injury , for improving estimates of the attributable burden of alcohol to injury in society .


To compare the astigmatism-reducing effect of an aspheric toric intraocular lens ( IOL ) and an aspheric nontoric IOL with an opposite clear corneal incision ( OCCI ) in cataract surgery .


Vienna Institute for Research in Ocular Surgery , Hanusch Hospital , Vienna , Austria .


Prospective randomized clinical study .


Patients with low to moderate corneal astigmatism scheduled for cataract surgery received an aspheric toric IOL ( Lentis L-@T ) or an aspheric nontoric IOL ( Lentis L-@ ) combined with an OCCI .


Keratometry and corneal tomography were performed @ hour , @ week , @ months and @ months postoperatively .


Postoperative residual astigmatism was measured using an autorefractor .


Rotational toric IOL stability was analyzed using retroillumination photography .


Fifty-five patients were included .


Three months postoperatively , the mean reduction in corneal astigmatism was @ diopter ( D ) @ ( SD ) in the toric group and @ @ D in the nontoric-OCCI group .


The mean uncorrected distance visual acuity was @ @ logMAR and @ @ logMAR , respectively ( P = @ ) .


The mean refractive astigmatism was @ @ D and @ @ D , respectively ( P = @ ) .


One hour , @ months , and @ months postoperatively , the mean absolute IOL misalignment of toric IOLs was @ @ degrees , @ @ degrees , and @ @ degrees , respectively .


The toric IOL tended to rotate significantly postoperatively .


Visual acuity was good in both groups .


Residual refractive cylinder was significantly lower in the toric IOL group .


Randomized , double-blind , crossover , sham-controlled trial .


Repetitive transcranial magnetic stimulation ( rTMS ) over the primary motor cortex ( M@ ) leads to a significant reduction of spasticity in subjects with spinal cord injury ( SCI ) , but the physiological basis of this effect is still not well understood .


The purpose of this study was to evaluate the disynaptic reciprocal Ia inhibition of soleus motoneurons in SCI patients .


Department of Neurology , Merano , Italy and TMS Laboratory , Paracelsus Medical University , Salzburg , Austria .


Nine subjects with incomplete cervical or thoracic SCI received @ days of daily sessions of real or sham rTMS applied over the contralateral M@ .


We compared the reciprocal inhibition , the Modified Ashworth Scale and the Spinal Cord Injury Assessment Tool for Spasticity at baseline , after the last session and @ week later in the real rTMS and sham stimulation groups .


We found that real rTMS significantly reduced lower limb spasticity and restored the impaired excitability in the disynaptic reciprocal inhibitory pathway .


In a small proof-of-concept study , rTMS strengthened descending projections between the motor cortex and inhibitory spinal interneuronal circuits .


This reversed a defect in reciprocal inhibition after SCI , and reduced leg spasticity .


A controlled , clinical , double-blind study was conducted to assess the efficacy of sugar-free tablets containing zinc lactate and magnolia bark extract ( MBE ) on oral volatile sulfur-containing compounds ( VSC ) versus placebo tablets for two hours .


In order to join the study , subjects had to have at least @ teeth , no report of oral and systemic diseases , and no removable dentures .


All @ eligible participants had to avoid any professional oral hygiene , refrain from taking medicines for two weeks , be not menstruating , and not brush their teeth and tongue , smoke , drink alcohol , coffee or tea , eat onion , garlic , or licorice for a six-hour period before the visit and during the test .


Moreover , to join the protocol , they had to show a VSC score of @ ppb at the baseline measurement .


Each qualified subject was placed in the test or the control group using a table of random numbers .


The test tablet ( @ g ) contained @ mg of zinc , in the form of zinc lactate , and @ mg magnolia bark extract ; the control tablet was identical , but without these active agents .


The OralChroma@ device was utilized to evaluate total oral VSC .


Their levels were recorded at baseline , after eight minutes of sucking two tablets in succession , after one hour , and after two hours .


Data were analyzed with SPSS software and the level of significance was set at = @ .


One hundred subjects completed the trial ( @ in the control group and @ in the test group ) ; @ men and @ women , mean age @ .


None reported problems linked to zinc lactate or magnolia bark extract .


The mean percentage reduction from baseline at the end of eight minutes of tablet sucking was @ % in the control group ( p < @ ) and @ % in the test group ( p < @ ) ; one hour later it was @ % in the control group and @ % in the test group ( p < @ ) , and two hours later it was @ % in the control group and @ % in the test group ( p < @ ) .


The comparisons between the two groups after baseline adjustment showed a statistically significant difference in reductions of VSC between the test and the control tablets at the end of the sucking period ( p < @ ) , after one hour ( p < @ ) , and after two hours ( p < @ ) .


Tablets containing zinc lactate and magnolia bark extract can statistically significantly reduce the oral VSC levels for over two hours and were statistically significantly more effective than a control tablet .


Cognitive impairment is integral to many neurological illnesses .


Specific enhancement of glutamatergic transmission may improve memory and learning .


Org @ increases the synaptic availability of glycine , an obligate co-agonist with glutamate at N-methyl-D-aspartate receptors .


We hypothesised that Org @ would acutely improve the learning and memory of healthy volunteers .


A randomised , double-blind , parallel-group , single-dose study of Org @ and placebo was carried out .


Thirty-two healthy male volunteers took either @-mg Org @ or matching placebo and were later assessed with the manikin task , digit span and verbal memory tests .


Systematic assessments of cardiovascular and adverse events were also taken .


There was no effect of Org @ on reaction time , number of correct responses or learning ( greater or slower improvement over successive tasks ) compared with placebo .


Org @ caused significantly more dizziness and drowsiness compared with placebo ; these side effects were mainly mild .


A single dose of Org @ does not improve learning or memory in healthy male individuals .


However , the drug was well tolerated , and it remains to be seen whether it would have a positive effect on cognition in patient groups with pre-existing cognitive deficits .


The American College of Emergency Physicians and the American Society of Clinical Oncology recommend early palliative care consultation for patients with advanced , life-limiting illnesses , such as metastatic cancer .


The objectives were to assess the process of early referral from the emergency department ( ED ) to palliative care for patients with advanced , incurable cancer as part of a randomized controlled trial and to compare the proportion and timing of consultation to a care as usual group .


A single-blind randomized controlled trial ( ClinicalTrials.gov ID NCT@ ) compared early , ED-based referrals to palliative care for patients admitted with advanced , incurable cancer to physician-driven consultation ( i.e. , care as usual ) .


Participants had to speak English or Spanish and have no history of palliative care consultation .


They were randomized via balanced block randomization to the intervention or control group .


Each intervention subject was referred by a research staff member to the palliative care team for consultation .


The usual care group received palliative care only if requested by the admitting physician .


Analysis was based on intention to treat .


A chart review was performed to assess proportion and timing of palliative care consults during the index admission , defined as : ( @ ) completed palliative care consult documented in the chart and ( @ ) days from admission to palliative care consult .


A total of @ participants were enrolled and randomized .


For patients in the intervention group , @ % ( @ of @ ) had documented palliative care consultations during their index admissions ( @ % confidence interval -LSB- CI -RSB- = @ to @ ) , compared to @ % ( @ of @ ) in the control group ( @ % CI = @ to @ ; p < @ ) .


The @ intervention patients received palliative care consultations on average @ days from admission ( @ % CI = @ to @ ) , compared to @ days from admission in the @ control patients ( @ % CI = @ to @ ; p = @ ) .


This study documented a low baseline rate of palliative care involvement as part of usual care in patients with advanced cancer being admitted from the ED .


Early referral to palliative care in the context of a research study significantly increased the likelihood that patients received a consult , thus meriting further investigation of how to generalize this approach .


Brief postsurgical electrical stimulation ( ES ) has been shown to enhance peripheral nerve regeneration in animal models following axotomy and crush injury .


However , whether this treatment is beneficial in humans with sensory nerve injury has not been tested .


The goal of this study was to test the hypothesis that ES would enhance sensory nerve regeneration following digital nerve transection compared to surgery alone .


Patients with complete digital nerve transection underwent epineurial nerve repair .


After coaptation of the severed nerve ends , fine wire electrodes were implanted before skin closure .


Postoperatively , patients were randomized to receiving either @ hour of @Hz continuous ES or sham stimulation in a double-blinded manner .


Patients were followed monthly for @ months by a blinded evaluator to monitor physiological recovery of spatial discrimination , pressure threshold , and quantitative small fiber sensory testing .


Functional disability was measured using the Disability of Arm , Shoulder , and Hand questionnaire .


A total of @ patients were recruited , with @ in each group .


Those in the ES group showed consistently greater improvements in all sensory modalities by @ to @ months postoperatively compared to the controls .


Although there was a trend of greater functional improvements in the ES group , it was not statistically significant ( p > @ ) .


Postsurgical ES enhanced sensory reinnervation in patients who sustained complete digital nerve transection .


The conferred benefits apply to a wide range of sensory functions .


A ready-to-use betamethasone valerate @ % ( BMV ) dressing was found to be superior to placebo dressing and a reference @ % BMV cream in the treatment of patients with chronic plaque psoriasis ( CPP ) .


This multicentre , prospective , randomized , investigator-blinded , controlled , non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate ( CBD ) ointment during a @-week treatment of patients with mild to moderate CPP .


The primary efficacy endpoint was the @-item psoriasis total severity score ( TSS-@ ) at week @ , and the associated non-inferiority margin was @ point .


Secondary outcome measures included the psoriasis global assessment ( PGA ) score and patients ' quality of life ( QoL ) .


Safety was assessed through adverse events ( AE ) reporting in each treatment group .


Of @ screened patients , @ were randomized to BMV ( N = @ ) or CBD ( N = @ ) , and were considered evaluable for the safety and intention-to-treat ( ITT ) efficacy analyses .


Per protocol ( PP ) populations included @ and @ patients in the BMV and CBD groups respectively .


The mean adjusted TSS-@ significantly decreased through the study from baseline in both groups .


The PP ( primary ) analysis of week @ data revealed a -@ ( @ % CI : -@ to @ ) not significant between-group difference in adjusted means , demonstrating non-inferiority of BMV to CBD .


Non-inferiority was also demonstrated in the ITT analysis .


The PGA and other secondary outcomes were significantly improved from baseline in both groups at week @ .


The QoL score was slightly better in the CBD group at week @ , but no difference was observed at follow-up .


No safety or tolerability concerns were observed in either group .


BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP .


Both treatments significantly improve patients ' psoriasis and QoL .


Camera eye in the McGrath video-laryngoscope blade is located closer to the larynx , which may allow reduction of the head-neck movement during laryngoscopy compared with a conventional laryngoscope .


We compared the degree of head extension during laryngoscopy with McGrath laryngoscope and that with Macintosh laryngoscope .


Fifty patients without cervical spine abnormality were randomized into two groups : laryngoscopies with Macintosh laryngoscope and that with McGrath laryngoscope .


Each patient wearing goggles mounted with a goniometer lay supine with the head in the neutral position .


After general anesthesia and muscle relaxation were obtained an experienced anesthesiologist obtained the best glottic view using either laryngoscope , and change in the angle of goggles ( head extension angle ) during laryngoscopy was measured .


In addition , we compared the head extension angle with extension angle of the cervical spine between the occiput and the fourth cervical vertebra ( C@-@ ) measured radiologically in @ healthy volunteers .


Head extension angles with Macintosh and McGrath laryngoscopes were @ @ degrees and @ @ degrees , respectively ( P < @ ) .


There was a strong relationship between head extension angle and C@-@ extension angle measured radiologically in the volunteers ( r = @ , P < @ ) .


The McGrath laryngoscope may be a reasonable technique of choice for intubation when minimal cervical spine movement is indispensable because of reduction of head extension during laryngoscopy compared with the conventional laryngoscopy .


To assess short-term efficacy and safety of desvenlafaxine @ and @ mg/d versus placebo for treating major depressive disorder ( MDD ) .


Assessment of sexual function was a secondary objective .


Outpatients ( @ years ) who met criteria for MDD from the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision and had screening and baseline @-item Hamilton Depression Rating Scale ( HDRS@ ) total scores @ were randomly assigned to placebo or desvenlafaxine @ or @ mg/d in an @-week study conducted from October @ to August @ .


The primary efficacy end point was change from baseline in HDRS@ total score at week @ , analyzed using a mixed-effects model for repeated measures .


Sexual function was assessed using the Arizona Sexual Experiences Scale ( ASEX ) .


The safety population included @ patients ( intent-to-treat population , n = @ ) .


Significantly greater improvement in adjusted mean HDRS@ total score from baseline to week @ was observed for desvenlafaxine @ mg ( -@ ; P = @ ) and desvenlafaxine @ mg ( -@ ; P < @ ) compared with placebo ( -@ ) , with adjustment for multiplicity .


In the ASEX total score analysis ( n = @ ) , the treatment by gender interaction was not significant ; thus , genders were combined for subsequent analyses .


Comparisons for desvenlafaxine versus placebo for change from baseline in ASEX total and all item scores found P > @ , with no adjustment for multiplicity .


Rates of sexual dysfunction based on ASEX were comparable among treatment groups .


These results support previous findings demonstrating antidepressant efficacy , safety , and tolerability of desvenlafaxine @ and @ mg/d versus placebo .


Sexual function was comparable between desvenlafaxine and placebo .


Rapid and early virological responses to peginterferon-alpha and ribavirin are predictive of sustained virological response ( SVR ) in hepatitis C virus ( HCV ) infection .


We aimed at finding a simple rule to determine the shortest duration of dual therapy for all HCV genotypes , obtained by multiplying time to Initial Viral Response , IVR ( first undetectable HCV-RNA ) by @ ( Tailored Therapy-@ , or TT@ ) .


@ nave HCV-infected patients with compensated liver disease were randomized ( @:@ ) to the TT@ ( n = @ ) or current standard-of-care ( SoC , n = @ ) and received peginterferon-alpha plus ribavirin .


Patients with HCV-RNA decrease @log@ at week @ or detectable HCV-RNA at week @ discontinued treatment .


Both groups had comparable baseline characteristics , SVR rates were similar in the whole population ( @ % vs. @ % ) and within each genotype subgroup ( G@ : @ % vs. @ % ; G@ : @ % vs. @ % ; G@ : @ % vs. @ % ; G@ : @ % vs. @ % ) .


Relapse rate was higher in G@-TT@ than G@-SoC .


Treatment duration in SVR patients was shorter in TT@ compared to SoC , both overall -LSB- @ vs. @ weeks -RSB- , and for subgroups : G@ -LSB- @ vs. @ weeks -RSB- , G@ -LSB- @ vs. @ weeks -RSB- , G@ -LSB- @ vs. @ weeks -RSB- and G@ -LSB- @ vs. @ weeks -RSB- .


In HCV-naive patients , TT@-rule treatment yields similar SVR rates compared to SoC but with shorter treatment duration and remarkable cost reduction .


To determine the efficacy of stress urinary incontinence treatments adding pelvic floor muscle training to vaginal electrical stimulation .


Forty-eight women with stress urinary incontinence were randomized into @ groups : @ underwent isolated vaginal electrical stimulation , and @ vaginal electrical stimulation plus pelvic floor muscle training .


History , physical examination , voiding diary , perineum strength test , and urodynamic study were assessed .


Comparisons were made for adherence to treatment , muscle strength improvement , urinary symptoms , and degree of satisfaction immediately , @ and @ months after treatment .


Patients ' degree of satisfaction on vaginal electrical stimulation , and on vaginal electrical stimulation plus pelvic floor muscle training immediately , @ and @ months post treatment , were , respectively : @ % versus @ % @ % versus @ % and @ % versus @ % ( p > @ ) .


Vaginal electrical stimulation associated to pelvic floor muscle training did not show better results than vaginal electrical stimulation alone .


To evaluate and compare the efficacy of vaginal misoprostol and a rectal nonsteroidal anti-inflammatory drug ( NSAID ) on pain relief during Pipelle endometrial biopsies in a placebo-controlled randomized study .


One hundred and fifty-one women who had an indication for a Pipelle endometrial biopsy were randomized into three groups as follows : group @ , vaginal misoprostol ; group @ , rectal NSAID , and group @ , control .


After the procedure , the women were asked to record their pain severity on a visual analog scale .


The secondary outcome of the study was patient acceptability , and vasovagal symptoms and analgesic requirements after the procedure were also recorded .


There were no statistically significant differences in the demographic characteristics of the patients .


The primary study outcome was the comparison of the median visual analog scale pain scores of groups @ and @ versus group @ ( controls ) ; no statistically significant differences were found ( p = @ ) .


In addition , the patient acceptability ( Likert scale ) , vasovagal symptoms and analgesic requirements after the procedure were similar among the groups ( p = @ , @ and @ , respectively ) .


Our study did not demonstrate a reduction in pain relief during Pipelle endometrial biopsies for patients receiving vaginal misoprostol or a rectal NSAID when compared to patients receiving placebo treatment .


Bronchiolitis is a public health problem in the word and in Tunisia .


Nebulized hypertonic saline seems to have some benefits in bronchiolitis .


The aim of this study is to evaluate the efficacy of nebulized @ % hypertonic saline alone or mixed with epinephrine in bronchiolitis as measured by improvement in clinical score , oxygen saturation or reduction in duration of hospitalization .


This prospective , double blind , placebo controlled , randomized clinical trial was performed at Children 's Hospital of Tunis from February @ to Mars @ .


A total of @ patients less than @ months of age with diagnosis of moderately severe bronchiolitis were enrolled and assigned to receive @ % nebulized hypertonic saline , mixed @ % hypertonic saline with standard epinephrine @,@ % or normal saline ( placebo ) at admission and every @ hours during hospitalization .


There were no significant difference between nebulized @ % hypertonic saline , mixed @ % hypertonic saline with epinephrine or normal saline at baseline , T@ min , T@ min , and T@ min after start study in Wang severity score , oxygen saturation in room air , rate respiratory and heart rate .


There was no difference in duration of hospitalization .


Nebulized @ % hypertonic saline or mixed @ % hypertonic saline with epinephrine are safety but does not appear effective in treating moderately ill infants with the first acute bronchiolitis .


Physical exercise and a Mediterranean diet improve serum lipid profile .


The present work studied whether red wine has an effect on top of a lipid-lowering lifestyle in patients with carotid atherosclerosis .


A prospective randomised unblinded trial was performed from @ to @ in @ patients with carotid atherosclerosis , @ % of whom were already on statin therapy with a low mean LDL of @ mg/dl .


Half of them were advised to follow a modified Mediterranean diet and to perform moderate physical exercise during @ min/day ( lifestyle changes ) for @ weeks .


Within these two groups half of the patients were randomised either to avoid any alcohol or to drink @ ml of red wine ( women ) or @ ml of red wine ( men ) daily .


LDL was significantly lowered by @ % in the lifestyle-changes group compared to the no-lifestyle-changes group ( p = @ ) after @ weeks .


Lifestyle changes lowered the LDL/HDL ratio after @ weeks by @ % ( p = @ ) and red wine independently by @ % ( p = @ ) .


The effect on LDL/HDL ratio after @ weeks was , however , more pronounced in the non-LC group .


Total cholesterol ( -@ % ; p = @ ) and triglycerides ( -@ % ; p = @ ) were lowered significantly by lifestyle changes after @ weeks compared to the no-lifestyle-changes group .


Lipoprotein ( a ) was not significantly affected by any intervention .


The given results are per ITT analysis .


Lifestyle changes including a modified Mediterranean diet and physical exercise as well as a glass of red wine daily improve independently the LDL/HDL ratio in patients with carotid arteriosclerosis even though the vast majority of them was already on statin therapy .


Patients with non-small-cell lung cancer ( NSCLC ) and ALK rearrangements generally have a progression-free survival of @-@ months while on treatment with the ALK inhibitor crizotinib .


However , resistance inevitably develops , with the brain a common site of progression .


More potent ALK inhibitors with consistently demonstrable CNS activity and good tolerability are needed urgently .


Alectinib is a novel , highly selective , and potent ALK inhibitor that has shown clinical activity in patients with crizotinib-naive ALK-rearranged NSCLC .


We did a phase @/@ study of alectinib to establish the recommended phase @ dose of the drug and examine its activity in patients resistant or intolerant to crizotinib .


We enrolled patients with ALK-rearranged NSCLC who progressed on or were intolerant to crizotinib .


We administered various oral doses of alectinib ( @-@ mg twice a day ) during the dose-escalation portion of the study ( phase @ ) , to ascertain the recommended dose for phase @ .


We used Response Evaluation Criteria in Solid Tumors criteria ( version @ ) to investigate the activity of alectinib in all patients with a baseline scan and at least one post-treatment scan ( CT or MRI ) , with central radiological review of individuals with brain metastases .


We assessed safety in all patients who received at least one dose of alectinib .


Here , we present data for the phase @ portion of the study , the primary objective of which was to establish the recommended phase @ dose ; phase @ is ongoing .


This trial is registered at ClinicalTrials.gov , number NCT@ .


@ patients were enrolled .


Alectinib was well tolerated , with the most common adverse events being fatigue ( @ -LSB- @ % -RSB- ; all grade @-@ ) , myalgia ( eight -LSB- @ % -RSB- ; all grade @-@ ) , and peripheral oedema ( seven -LSB- @ % -RSB- grade @-@ , one -LSB- @ % -RSB- grade @ ) .


Dose-limiting toxic effects were recorded in two patients in the cohort receiving alectinib @ mg twice a day ; one individual had grade @ headache and the other had grade @ neutropenia .


The most common grade @-@ adverse events were increased levels of - glutamyl transpeptidase ( two -LSB- @ % -RSB- ) , a reduction in the number of neutrophils ( two -LSB- @ % -RSB- ) , and hypophosphataemia ( two -LSB- @ % -RSB- ) .


Three patients reported four grade @ serious adverse events that were deemed unrelated to alectinib : acute renal failure ; pleural effusion and pericardial effusion ; and brain metastasis .


At data cut-off ( median follow-up @ days -LSB- IQR @-@ -RSB- ) , @ patients could be assessed for activity .


Investigator-assessed objective responses were noted in @ ( @ % ) patients , with a confirmed complete response in one ( @ % ) , a confirmed partial response in @ ( @ % ) , and an unconfirmed partial response in nine ( @ % ) .


@ ( @ % ) patients had stable disease ; the remaining four ( @ % ) had progressive disease .


Of @ patients with CNS metastases at baseline , @ ( @ % ) had an objective response ; six ( @ % ) had a complete response ( three unconfirmed ) and five ( @ % ) had a partial response ( one unconfirmed ) ; eight ( @ % ) patients had stable disease and the remaining two ( @ % ) had progressive disease .


Pharmacokinetic data indicated that mean exposure ( AUC@-@ ) after multiple doses of alectinib ( @-@ mg twice a day ) was dose-dependent .


Alectinib was well tolerated , with promising antitumour activity in patients with ALK-rearranged NSCLC resistant to crizotinib , including those with CNS metastases .


On the basis of activity , tolerability , and pharmacokinetic data , we chose alectinib @ mg twice a day as the recommended dose for phase @ .


We assessed long-term mortality and hospitalisation in patients with severe sepsis resuscitated with hydroxyethyl starch ( HES ) or Ringer 's acetate .


This was an investigator-initiated , parallel-grouped , blinded randomised trial using computer-generated allocation sequence and centralised allocation data that included @ patients with severe sepsis needing fluid resuscitation in @ general intensive care units ( ICUs ) in Scandinavia .


Patients were allocated to fluid resuscitation using either @ % HES @/@ @ or Ringer 's acetate during ICU admission .


We assessed mortality rates at @ months , @ year and at the time of longest follow-up and days alive and out of hospital at @ year .


The vital status of all patients was obtained at a median of @ ( range @-@ ) months after randomisation .


Mortality rates in the HES versus Ringer 's groups at @ months were @ ( @/@ patients ) versus @ % ( @/@ ) -LSB- relative risk @ ; @ % confidence interval ( CI ) @-@ @ ; P = @ -RSB- , respectively ; at @ year , @ ( @/@ ) versus @ % ( @/@ ) ( @ ; @ % CI @-@ @ ; P = @ ) , respectively ; at the time of longest follow-up , @ ( @/@ ) versus @ % ( @/@ ) ( @ ; @ % CI @-@ @ ; P = @ ) , respectively .


Percentage of days alive and out of hospital at @ year in the HES versus Ringer 's groups was @ ( @-@ days ) versus @ % ( @-@ ) ( P = @ ) .


The long-term mortality rates did not differ in patients with severe sepsis assigned to HES @/@ @ versus Ringer 's acetate , but we could not reject a @ % relative increased or a @ % relative decreased mortality at @ year with HES at the @ % confidence level .


Titrating the dosage of growth hormone ( GH ) to serum levels of insulin-like growth factor-I ( IGF-I ) is a feasible treatment strategy in children with GH deficiency ( GHD ) and idiopathic short stature ( ISS ) .


The objective was to assess the dose-sparing effect and theoretical safety of IGF-I-based GH therapy .


This was a post hoc analysis of a previously described @-year , multicenter , open-label , randomized , outpatient , controlled clinical trial in @ prepubertal short children -LSB- age @ @ years ; height standard deviation score ( HSDS ) -@ @ -RSB- classified by baseline peak GH levels as GHD ( < @ ng/ml ) or ISS ( @ ng/ml ) .


Conventional weight-based dosing of GH ( @ mg/kg/day ) ( n = @ ) or GH dosing titrated to an IGF-I target of @ SDS ( IGF@T ; n = @ ) or an IGF-I target of +@ SDS ( IGF@T ; n = @ ) .