To date , however , the potential of Souvenaid to improve cognitive functioning in subjects with other neurodegenerative conditions also characterized by synaptic loss has not been explored .


To evaluate the impact of Souvenaid on executive functions , social cognition and behavioral disturbances in subjects with the behavioral variant of frontotemporal dementia ( bv-FTD ) .


Twenty-six subjects with bv-FTD were enrolled in the study and randomized to Souvenaid ( @ ml/day ) or placebo groups .


After @ weeks , subjects were switched between the two groups .


All subjects , blinded to treatment , underwent clinical and cognitive evaluations at enrollment , after @ weeks and after @ weeks .


Treatment with Souvenaid was associated with a significant reduction of behavioral symptoms and an increase in Theory of Mind skills compared to placebo , which both returned to baseline when Souvenaid was discontinued .


Souvenaid did not have an effect on executive functions .


Our results provide evidence of the potential of Souvenaid therapy for the treatment of behavioral disturbances and social cognition skills in FTD .


Intracranial-pressure ( ICP ) monitoring is considered standard care for severe traumatic brain injury and is used frequently , but the efficacy of treatment based on monitoring in patients with hemorrhagic stroke has not been rigorously assessed .


In this study , we investigated the clinical value of ICP monitoring in patients with hemorrhagic stroke .


We conducted a randomized , unblinded , controlled trial in which @ patients with hemorrhagic stroke were randomly assigned to ICP monitoring or a control group .


The primary outcome was a composite of incidence rate of hematoma enlargement and secondary brain herniation .


The secondary outcome was neurological status assessed using the Glasgow Outcome Scale scores at @months post-onset .


Characteristics of the patients at baseline and outcome measurements were also compared between the two groups .


There was no significant between-group difference in the incidence of hematoma enlargement ( control group , @ % vs. ICP monitoring group , @ % ; P > @ ) .


The incidence rate of secondary brain herniation in the ICP monitoring group was significantly lower compared with the control group ( @ % vs. @ % , P = @ ) .


Six-month mortality was @ % in the ICP group and @ % in the control group ( P < @ ) , and neurological outcome was better in the ICP group compared with the control group ( P < @ ) .


The dynamic ICP value may be more sensitive and effective in preventing secondary brain herniation in patients with hemorrhagic stroke compared with guidance directed by clinical signs and radiological indicators .


To explore the pain control effect of lornoxicam on patients after nasal packing .


A total of @ patients undergoing nasal packing between January @ and August @ were randomly divided into the treatment group and control group .


( @ ) Treatment group : routinely given lornoxicam for injection @ mg ( @ ml ) , intravenous injection , twice a day ; ( @ ) CONTROL GROUP : given saline @ ml , intravenous injection , twice a day , other treatments are the same with the treatment group .


Visual analog scale was used to record the painful severity of nose and head at @ , @ , @ , @ and @ h , and record the sleep quality score at @ and @ h.


The pain in nose and head and night sleeping in treatment group were all significantly better than that in control group .


The analgesic effect of lornoxicam in nasal packing is good , with no evident adverse reactions .


Noninvasive brain stimulation , including repetitive transcranial magnetic stimulation ( rTMS ) and transcranial direct current stimulation ( tDCS ) , have gained popularity in the stroke rehabilitation literature .


Little is known about the time course and duration of effects of noninvasive brain stimulation on corticospinal excitability in individuals with stroke .


We examined the aftereffects of a single session of high-frequency rTMS ( @ Hz ) and anodal tDCS on corticospinal excitability in the same sample of participants with chronic stroke .


Ten individuals with chronic stroke participated in this randomized cross-over study .


Participants received @ session of rTMS and @ session of tDCS , with @ week between sessions .


During the rTMS session , @-Hz rTMS ( total of @ stimuli ) was administered to the ipsilesional primary motor cortex ( M@ ) .


For anodal tDCS , @ mA of direct current was delivered to the ipsilesional M@ for @ minutes .


Motor evoked potentials were measured before and after ( immediately , @ minutes , @ minutes , and @ minutes ) each stimulation session .


Both @-Hz rTMS and anodal tDCS significantly increased corticospinal excitability for @ to @ minutes after stimulation .


There was no statistically significant difference between the @ stimulation techniques in their effects on motor evoked potentials .


No changes in measures of motor or cognitive performance were observed .


Both @-Hz rTMS and anodal tDCS induced effects on corticospinal excitability in persons with chronic stroke lasting at least @ hour after stimulation .


In the absence of concurrent motor practice , neither form of stimulation applied in a single session was associated the changes in motor performance .


These approaches to increased cortical excitability may be of value as adjuncts to training .


Postoperative infection after breast reduction surgery is a common complication , with the most commonly involved pathogen being Staphylococcus aureus .


Previous studies of antibiotic prophylaxis in breast reduction surgery have been inconclusive .


The aim of the present study was to clarify the role of prophylactic antibiotics in breast reduction surgery .


In total , @ women were randomized to antibiotic prophylaxis -LSB- with @ g of cloxacillin intravenously ( IV ) or @ mg of clindamycin IV -RSB- ( intervention group ) or no antibiotic prophylaxis ( control group ) .


Follow-up was conducted at @ and @ weeks postoperatively .


Patients with signs of infections or other complications were followed up until resolution .


Patients who received antibiotic treatment within @ days from surgery ( cloxacillin @ mg or clindamycin @ mg orally ) were considered having an infection and this was the main outcome variable .


All postoperative infections were also judged according to a graded scale .


In the intervention group , @ ( @ % ) patients were treated with antibiotic ; and in the control group , @ ( @ % ) patients were treated with antibiotics .


No difference was found between the groups ( relative risk , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Twenty-two ( @ % ) patients in the intervention group were classified to have a possible infection according to the scale compared to @ ( @ % ) in the control group .


No statistical difference was found ( relative risk , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Prophylactic cloxacillin as a single-dose IV in breast reduction surgery does not reduce the incidence of postoperative infections .


Personalized medicine is the holy grail of medicine .


The EULAR recommendations for the management of rheumatoid arthritis ( RA ) support differential treatment between patients with baseline characteristics suggestive of a non-poor prognosis ( non-PP ) or poor prognosis ( PP ) ( presence of autoantibodies , a high inflammatory activity and damage on radiographs ) .


We aimed to determine which prognostic risk groups benefit more from initial monotherapy or initial combination therapy .


@ patients were randomized to initial monotherapy ( iMono ) or initial combination therapy ( iCombo ) .


Disease outcomes of iMono and iCombo were compared within non-PP or PP groups as determined on baseline characteristics


PP patients treated with iCombo after three months more often achieved ACR@ ( @ % vs @ % , P < @ ) , ACR@ ( @ % vs @ % , P < @ ) and ACR@ response ( @ % vs @ % , P < @ ) than those treated with iMono , and had more improvement in HAQ ( median decrease @ vs @ , P < @ ) .


After @ year , differences in ACR@ response and DAS-remission remained ; PP patients treated with iCombo ( vs iMono ) had less radiographic progression ( median @ vs @ , P = @ ) .


Since PP and non-PP patients benefit equally from iCombo through earlier clinical response and functional improvement than with iMono , we conclude that personalized medicine as suggested in the guidelines is not yet feasible .


The choice of treatment strategy should depend more on rapid relief of symptoms than on prognostic factors .


The aim of this study was to evaluate the effect of knee position during wound closure ( flexed vs. extended ) in total knee arthroplasty on knee strength and function , as determined by knee society scores and isokinetic testing of extensor and flexor muscle groups .


In a prospective , randomized , double-blind trial , @ patients were divided in two groups : for Group @ patients , surgical closing was performed with the knee extended , and for Group @ patients , the knee flexed at @ .


All the patients were treated with the same anaesthesia method , surgical team , surgical technique , prosthesis type , and rehabilitation process .


American Knee Society Score values and knee flexion degrees were recorded .


Isokinetic muscle strength measurements of both knees in flexion and extension were taken using @ and @/s angular velocity .


The peak torque and total work values , isokinetic muscle strength differences , and total work difference values were calculated for surgically repaired and healthy knees .


No significant difference in the mean American Knee Society Score values and knee flexion degrees was observed between the two groups .


However , using isokinetic evaluation , a significant difference was found in the isokinetic muscle strength differences and total work difference of the flexor muscle between the two groups when patients were tested at @/s .


Less loss of strength was detected in the isokinetic muscle strength differences of the flexor muscle in Group @ ( -@ % ) than in Group @ ( -@ % ) .


For patients undergoing total knee arthroplasty , post-operative flexor muscle strength is improved if the knee is flexed during wound closure .


Patients with diabetes mellitus inject insulin in different regions of the body .


This study investigated the pharmacokinetic and pharmacodynamic properties of insulin degludec ( IDeg ) , a new-generation once-daily basal insulin with an ultra-long duration of action , after subcutaneous ( SC ) administration in different injection regions .


In this study , @ healthy subjects received single SC doses of IDeg ( @ U/kg ; separated by @-@days ) in the thigh , abdomen and deltoid in a randomised , open-label , single-centre , single-dose , complete crossover trial .


Each dose was followed by a @-h euglycaemic clamp and @-h pharmacokinetic blood sampling .


The obtained pharmacokinetic/pharmacodynamic profiles were extrapolated to steady state by simulation using a pharmacokinetic/pharmacodynamic model .


Total IDeg exposure -LSB- area under the IDeg serum concentration-time curve @-@h after a single dose ( AUCIDeg,@-@h , SD ) -RSB- and maximum serum concentration -LSB- maximum IDeg serum concentration after a single dose ( C max , IDeg , SD ) -RSB- were higher ( @-@ and @-@ % , respectively ) following a single SC dose in the deltoid or abdomen , compared with the thigh , as also observed with other insulin preparations .


No statistical difference was observed in these measures between deltoid and abdominal administration .


No pronounced differences were observed in the glucose-lowering effect of IDeg -LSB- area under the glucose infusion rate ( GIR ) curve @-@h after a single dose ( AUCGIR,@-@h , SD ) and maximum GIR after a single dose ( GIRmax , SD ) -RSB- when injected in the thigh , abdomen or deltoid ( AUCGIR,@-@h , SD @,@ , @,@ and @,@ mg/kg , respectively ) .


Simulated mean steady-state pharmacokinetic and pharmacodynamic profiles supported a flat and stable IDeg exposure and effect regardless of injection region , with comparable total glucose-lowering effects -LSB- area under the GIR curve at steady state ( AUCGIR , , SS ) -RSB- between the thigh , abdomen and deltoid .


These findings support administering IDeg SC in the thigh , upper arm or abdominal wall without affecting IDeg absorption or effect at steady state .


FVC outcomes in clinical trials on idiopathic pulmonary fibrosis ( IPF ) can be substantially influenced by the analytic methodology and the handling of missing data .


We conducted a series of sensitivity analyses to assess the robustness of the statistical finding and the stability of the estimate of the magnitude of treatment effect on the primary end point of FVC change in a phase @ trial evaluating pirfenidone in adults with IPF .


Source data included all @ study participants randomized to treatment with pirfenidone or placebo in the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis ( ASCEND ) study .


Sensitivity analyses were conducted to assess whether alternative statistical tests and methods for handling missing data influenced the observed magnitude of treatment effect on the primary end point of change from baseline to week @ in FVC .


The distribution of FVC change at week @ was systematically different between the two treatment groups and favored pirfenidone in each analysis .


The method used to impute missing data due to death had a marked effect on the magnitude of change in FVC in both treatment groups ; however , the magnitude of treatment benefit was generally consistent on a relative basis , with an approximate @ % reduction in FVC decline observed in the pirfenidone group in each analysis .


Our results confirm the robustness of the statistical finding on the primary end point of change in FVC in the ASCEND trial and corroborate the estimated magnitude of the pirfenidone treatment effect in patients with IPF .


Children whose mothers had low thyroid hormone levels during pregnancy have been reported to have decreased cognitive function .


The reported research is part of the follow-on study of the Controlled Antenatal Thyroid Screening Study ( CATS I ) , a randomised controlled trial which investigated the impact of treated vs. untreated low thyroid hormone level in women during pregnancy with the primary outcome being the child 's IQ at age @ .


No significant differences in IQ were found between the treated and untreated groups .


These children are now aged between @ and @ years and aspects of their cognitive functioning including their IQ are being reassessed as part of CATS II .


Cognitive assessments generate an IQ score and further tests administered will investigate long term memory function and motor coordination .


The aim is to complete the assessments with @ % of the children born to mothers either in the treated or untreated low thyroid hormone groups ( n = @ per group ) .


Also children born to mothers who had normal thyroid functioning during CATS I are being assessed for the first time ( n = @ ) to provide a comparison .


Assessments are conducted either in the research facility or the participant 's home .


The study is designed to assess the cognitive functioning of children born to mothers with low thyroid hormone levels and normal thyroid functioning during pregnancy .


This is the largest study of its type and also is distinguishable in its longitudinal design .


The research has the potential to have a significant impact on public health policy in the UK ; universal screening of thyroid hormone levels in pregnancy may be the recommendation .


Unnecessary ventricular pacing in sinus node disease ( SND ) must be avoided .


To test the hypothesis that in SND , with or without @st degree atrioventricular ( AV ) block , cumulative percent ventricular pacing ( cum % VP ) can be limited by low right atrial septal ( LRAS ) instead of right atrial appendage ( RAA ) pacing .


We studied @ dual-chamber pacemaker recipients with SND .


The PQ interval on @-lead electrocardiogram and the atrial paced to ventricular sensed interval ( Ap-Vs ) during LRAS and RAA pacing were measured and compared at implantation , @ months and @ year of follow-up .


Group @ included @ patients with baseline PQ interval < @milliseconds during LRAS ( n = @ ) versus RAA ( n = @ ) pacing .


Group @ included @ patients with baseline PQ @ milliseconds during LRAS ( n = @ ) versus RAA ( n = @ ) pacing .


cum % VP were measured at @ months and @ year .


The characteristics and AV conduction properties were similar and the Ap-Vs interval was significantly shorter in the LRAS than in the RAA pacing group up to @ year ( @ @ milliseconds vs. @ @ milliseconds in Group @ ; P = @ , @ @ milliseconds vs. @ @ milliseconds in Group @ ; P < @ ) .


While cumulative percent atrial pacing was consistently similar , cum % VP was significantly smaller during LRAS than RAA pacing ( @ @ % vs. @ @ % in Group @ ; P = @ , @ @ % vs. @ @ % in Group @ ; P < @ ) .


Similar observations were made with or without left atrial ( LA ) enlargement .


Compared with RAA , LRAS pacing showed shorter AV interval in SND patients with or without @st degree AV block and LA enlargement .


This beneficial effect persisted through @-year follow-up , and decreased cum % VP significantly .


While prior preliminary studies have broadened our understanding of how repetitive transcranial magnetic stimulation ( rTMS ) improves language outcomes in stroke patients with nonfluent aphasia , the evidence base of the effectiveness of this method remains inadequate .


In this study , we aimed to strengthen the evidence that this approach improves language performance and to identify characteristics of patients predisposed to benefit most from this treatment .


Fifty-six stroke patients with nonfluent aphasia were randomly allocated to a real or a sham stimulation group : Group A ( n = @ ) , who underwent @ sessions of @-Hz rTMS over the contralesional pars triangularis ( PTr ) , and Group B ( n = @ ) , who received sham @-Hz stimulation .


We performed the Picture Naming Test and the Concise Chinese Aphasia Test ( CCAT ) at the baseline , post-rTMS intervention , and at @-month follow-up .


Group A showed significantly greater improvement than Group B in CCAT scoring ( P < @ ) , object-naming accuracy ( P = @ ) , and naming reaction time ( P = @ ) .


The CCAT scoring and naming testing changes for Group A were persistent at @ months following intervention ( P = @ ) .


Patients who had a lower contralesional rest motor threshold ( rMT ) were predisposed to a favorable therapeutic outcome ( P = @ ) , independent of aphasia type , severity , and duration .


The results of this study provide evidence that inhibitory rTMS , through downregulating the circuitry of the right pars triangularis ( PTr ) , achieves a persistent and broadly modulating effect , irrespective of aphasia severity and subtype .


Patients who show lower rMT in the right motor system would seem to benefit the most from inhibitory rTMS .


The aim of this study was to determine the pharmacokinetic profile of metronidazole ( Mtz ) tablet and to compare Mtz gel and tablet concentrations in both blood plasma and saliva .


In this randomized cross-over study with a @-week washout period , @ volunteers randomly received one ( a single oral dose of @ mg Mtz ( Flagyl -- tablet ) and @ ) @ g of @ % Mtz benzoate gel ( applied by using a dental tray ) .


The HPLC with ultraviolet detection was used to quantify plasma and saliva concentrations of Mtz .


The pharmacokinetic parameters ( PPs ) areas under the curves from @ to @ h ( AUC@-@ ) and from @ to infinity ( AUC@ - ) , the maximum plasma concentration ( C ( max ) ) , the time to C ( max ) , volume of distribution and renal clearance were determined for Mtz tablet .


Considering the Mtz tablet , plasma showed higher Mtz concentration from @ to @ h after drug administration and the highest values concerning AUC@-@ h and AUC@ - than those obtained in saliva ( P < @ ) .


No significant differences were observed between plasma and saliva concentrations for Mtz gel .


The study showed that some PPs were higher in plasma ( P < @ ) than in saliva concerning Mtz tablet .


Gel formulation had similar Mtz bioavailability in plasma and saliva resulting in systemic absorption .


Therapy with tenofovir is associated with lower bone mineral density ( BMD ) , higher markers of bone turnover and increased fracture risk in HIV-infected adults .


Bone structural parameters generated by hip structural analysis may represent a separate measure of bone strength , but have not been assessed in HIV .


Dual-energy X-ray absorptiometry ( DXA ) scans from @ HIV-infected adults randomised to simplify their existing dual nucleoside analogue reverse transcriptase inhibitor therapy to coformulated tenofovir-emtricitabine or abacavir-lamivudine were analysed using DXA-derived hip structural analysis software .


Hip structural parameters included femoral strength index , section modulus , cross-sectional area , and cross-sectional moment of inertia .


We used one-way ANOVA to test the relationship between nucleoside analogue type at baseline and structural parameters , multivariable analysis to assess baseline covariates associated with femoral strength index , and t-tests to compare mean change in structural parameters over @ weeks between randomised groups .


Participants taking tenofovir at baseline had lower section modulus ( -@ mm@ , p = @ ) , lower cross-sectional area ( -@ mm@ , p = @ ) , and lower cross-sectional moment of inertia ( -@,@ mm@ , p = @ ) than those receiving other nucleoside analogues .


After adjustment for baseline risk factors , the association remained significant for section modulus ( p = @ ) and cross-sectional area ( p = @ ) .


Baseline covariates significantly associated with higher femoral strength index were higher spine T-score ( p = @ ) , lower body fat mass ( p < @ ) , lower bone alkaline phosphatase ( p = @ ) , and higher osteoprotegerin ( p = @ ) .


Hip structural parameters did not change significantly over @ weeks and none was significantly affected by treatment simplification to tenofovir-emtricitabine or abacavir-lamivudine .


In this population , tenofovir use was associated with reduced composite indices of bone strength as measured by hip structural analysis , but none of the structural parameters improved significantly over @ weeks with tenofovir cessation .


We examined narrative discourse in amyotrophic lateral sclerosis ( ALS ) to assess the role of executive functioning in support of language and the neuroanatomical basis for such support .


We analyzed a semistructured speech sample in @ patients with ALS and @ healthy seniors for narrative discourse features of coherence .


Regression analyses related a measure of discourse coherence ( `` local connectedness '' ) to gray matter atrophy and reduced white matter fractional anisotropy .


Patients with ALS were impaired relative to controls on measures of discourse adequacy , including local connectedness and maintenance of the theme .


These discourse measures were related to measures of executive functioning but not to motor functioning .


Regressions related local connectedness to gray matter atrophy in ventral and dorsal prefrontal regions and to reduced fractional anisotropy in white matter tracts mediating projections between prefrontal regions .


Patients with ALS exhibit deficits in their ability to organize narrative discourse .


These deficits appear to be related in part to executive limitations .


Consistent with the hypothesis that ALS is a multisystem disorder , this deficit is related to disease in prefrontal regions .


In spite of the high occurrence of migraine headaches in school-age children , there are currently no approved and widely accepted pharmacologic agents for migraine prophylaxis in children .


Our previous open-label study in children revealed the efficacy of cinnarizine , a calcium channel blocker , in migraine prophylaxis .


A placebo-controlled trial was conducted to demonstrate the efficacy and safety of cinnarizine in the prophylaxis of migraine in children .


A double-blind , placebo-controlled , parallel-group study conducted in a tertiary medical center in Tehran , Iran .


Children ( @-@ years ) who experienced migraines with and without aura , as defined on the basis of @ International Headache Society criteria , were recruited into the study .


Children were excluded if they had complicated migraine , epilepsy , or a history of use of migraine prophylactic agents .


Each participant was randomly assigned to receive cinnarizine ( a single @ mg/kg/day dose in children weighing less than @ kg and a single @ mg dose in children weighing more than @ kg , administered at bedtime ) or placebo .


The frequency , severity , and duration of headaches over the trial period were assessed and adverse effects were monitored .


A total of @ children ( @ in each group ) with migraine were enrolled and @ participants completed the study .


After @ months of taking cinnarizine or placebo , children in both groups experienced significantly reduced frequency , severity , and duration of headaches compared with baseline measurements ( P < @ ) .


However , compared with @ % of children in the placebo group , @ % of children in the cinnarizine group reported more than @ % reduction in monthly headache frequency ( P = @ ) , suggesting that cinnarizine was significantly more effective than placebo in reducing the frequency of headaches .


No serious adverse effects of the medications were observed in the treated children , including no abnormal weight gain or extrapyramidal signs .


Our results indicate that the use of cinnarizine at doses administered in this study is effective and safe for prophylaxis of migraine headaches in children .


Among patients with HIV infection , changes in the kidney filtration marker cystatin C after initiation of antiretroviral therapy ( ART ) may be related to changes in body composition or biomarkers of inflammation .


ACTG A@s was a substudy of A@ , which randomly assigned ART-naive HIV-infected subjects to blinded abacavir/lamivudine ( ABC/@TC ) or tenofovir/emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or ritonavir-boosted atazanavir .


This analysis explored changes in cystatin C from @ to @ weeks .


Of the @ subjects , @ % were male and @ % white non-Hispanics ; baseline mean CD@ count was @ cells per cubic millimeter and cystatin C was @ mg/L .


Cystatin C decreased significantly within each arm ; however , ritonavir-boosted atazanavir attenuated the beneficial effects of ART on cystatin C compared to EFV .


Compared to ABC/@TC , TDF/FTC led to a marginally significant attenuation for percent change analyses only .


Higher baseline body mass index and HIV RNA were associated with larger reductions in cystatin C in multivariable models .


At baseline , cystatin C was positively correlated with high-sensitivity C-reactive protein ( Spearman r = @ ) , interleukin @ ( r = @ ) , soluble intercellular adhesion molecule ( r = @ ) , soluble vascular cell adhesion molecule ( r = @ ) , tumor necrosis factor ( r = @ ) , and soluble TNF - receptor I ( r = @ , all P < @ ) .


Reductions in cystatin C from @ to @ weeks correlated with reductions in all inflammatory biomarkers ( r = @-@ @ , P < @ ) except for high-sensitivity C-reactive protein ( r = @ , P = @ ) and IL-@ ( r = @ , P = @ ) .


The beneficial effect of ART on cystatin C concentrations is attenuated by boosted ATV when compared to EFV .


Reductions in cystatin C after ART are associated with reductions in systemic inflammation .


We aimed to assess the effect of afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma through an analysis of data from two open-label , randomised , phase @ trials .


Previously untreated patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma were enrolled in LUX-Lung @ ( n = @ ) and LUX-Lung @ ( n = @ ) .


These patients were randomly assigned in a @:@ ratio to receive afatinib or chemotherapy ( pemetrexed-cisplatin -LSB- LUX-Lung @ -RSB- or gemcitabine-cisplatin -LSB- LUX-Lung @ -RSB- ) , stratified by EGFR mutation ( exon @ deletion -LSB- del@ -RSB- , Leu@Arg , or other ) and ethnic origin ( LUX-Lung @ only ) .


We planned analyses of mature overall survival data in the intention-to-treat population after @ ( LUX-Lung @ ) and @ ( LUX-Lung @ ) deaths .


These ongoing studies are registered with ClinicalTrials.gov , numbers NCT@ and NCT@ .


Median follow-up in LUX-Lung @ was @ months ( IQR @-@ ) ; @ ( @ % ) of @ patients had died .


In LUX-Lung @ , median overall survival was @ months ( @ % CI @-@ @ ) in the afatinib group and @ months ( @-@ @ ) in the pemetrexed-cisplatin group ( HR @ , @ % CI @-@ @ , p = @ ) .


In LUX-Lung @ , median overall survival was @ months ( @ % CI @-@ @ ) in the afatinib group and @ months ( @-@ @ ) in the gemcitabine-cisplatin group ( HR @ , @ % CI @-@ @ , p = @ ) .


However , in preplanned analyses , overall survival was significantly longer for patients with del@-positive tumours in the afatinib group than in the chemotherapy group in both trials : in LUX-Lung @ , median overall survival was @ months ( @ % CI @-@ @ ) in the afatinib group versus @ months ( @-@ @ ) in the chemotherapy group ( HR @ , @ % CI @-@ @ , p = @ ) ; in LUX-Lung @ , it was @ months ( @ % CI @-@ @ ) versus @ months ( @-@ @ ) , respectively ( HR @ , @ % CI @-@ @ , p = @ ) .


By contrast , there were no significant differences by treatment group for patients with EGFR Leu@Arg-positive tumours in either trial : in LUX-Lung @ , median overall survival was @ months ( @-@ @ ) in the afatinib group versus @ months ( @-not estimable ) in the chemotherapy group ( HR @ , @ % CI @-@ @ , p = @ ) ; in LUX-Lung @ , it was @ months ( @ % CI @-@ @ ) versus @ months ( @-@ @ ) , respectively ( HR @ , @ % CI @-@ @ , p = @ ) .


In both trials , the most common afatinib-related grade @-@ adverse events were rash or acne ( @ -LSB- @ % -RSB- of @ patients in LUX-Lung @ and @ -LSB- @ % -RSB- of @ patients in LUX-Lung @ ) , diarrhoea ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- ) , paronychia ( @ -LSB- @ % -RSB- in LUX-Lung @ only ) , and stomatitis or mucositis ( @ -LSB- @ % -RSB- in LUX-Lung @ only ) .


In LUX-Lung @ , neutropenia ( @ -LSB- @ % -RSB- of @ patients ) , fatigue ( @ -LSB- @ % -RSB- ) and leucopenia ( nine -LSB- @ % -RSB- ) were the most common chemotherapy-related grade @-@ adverse events , while in LUX-Lung @ , the most common chemotherapy-related grade @-@ adverse events were neutropenia ( @ -LSB- @ % -RSB- of @ patients ) , vomiting ( @ -LSB- @ % -RSB- ) , and leucopenia ( @ -LSB- @ % -RSB- ) .


Although afatinib did not improve overall survival in the whole population of either trial , overall survival was improved with the drug for patients with del@ EGFR mutations .


The absence of an effect in patients with Leu@Arg EGFR mutations suggests that EGFR del@-positive disease might be distinct from Leu@Arg-positive disease and that these subgroups should be analysed separately in future trials .


This study was to evaluate the characteristics of selective spinal anesthesia using @ mg of bupivacaine combined with fentanyl or sufentanil in elderly patients undergoing transurethral resection of prostate .


Fifty-six patients were randomized into two groups .


The Fentanyl group received @ % hyperbaric bupivacaine @ mL + fentanyl @ g +@ % dextrose @ mL , and the Sufentanil group received @ % hyperbaric bupivacaine @ mL + sufentanil @ g +@ % dextrose @ mL intrathecally .


Intraoperative and postoperative characteristics were evaluated .


Patient satisfaction was assessed postoperatively .


Twenty-six patients in each group completed the study .


The median peak sensory block level was similar between two groups , but sensory regression time was longer in the Sufentanil group than the Fentanyl group ( p = @ ) .


All patients were able to move themselves to the bed without any aid when they arrived at the admission room .


Pain scores were lower in the Sufentanil group than the Fentanyl group at postoperative @ , @ , and @ hours ( p = @ ) .


Compared to the Fentanyl group , the Sufentanil group required less postoperative analgesia ( p = @ ) and the time to the first analgesic request was longer ( p = @ ) .


Twenty-four of @ patients ( @ % ) in each group showed `` good '' satisfaction level .


Selective spinal anesthesia using @ mg of bupivacaine with fentanyl or sufentanil provided appropriate sensory block level with spared motor function for transurethral resection of the prostate in elderly patients .


Intrathecal sufentanil was superior to fentanyl in postoperative analgesic quality .


Angina pectoris ( Angina ) is a medical condition related to myocardial ischemia .


Although acupuncture has been widely accepted as a clinical approach for angina , there is no sufficient evidence of its effectiveness against this syndrome , and its mechanisms have not yet been well elucidated .


We develop this protocol to confirm the clinical efficacy of electro-acupuncture on stable angina pectoris by needling on acupoint Neiguan ( PC@ ) .


Furthermore , we employ high-throughput sequencing technology to investigate the gene expression profiling and determine involvement of histone modifications in the regulation of genes after electro-acupuncture treatment .


A randomized , controlled , double-blinded ( assessor and patients ) trial will be carried out .


Sixty participants will be randomly assigned to two acupuncture treatment groups and one control group in a @:@:@ ratio .


Participants in acupuncture groups will receive @ sessions of electro-acupuncture treatment across @ weeks , followed by a @-week randomization period .


The acupuncture groups are divided into Neiguan ( PC@ ) on Pericardium Meridian of Hand-jueyin or a non-acupoint .


The primary clinical measure of effect is the frequency of angina attacks between these groups for four weeks after randomization .


RNAs are extracted from peripheral neutrophils collected from all participants on day @ , day @ , and week @ , and are processed to RNA-Seq .


We then investigate profiles of histone modifications by ChIP-Seq , for H@ Lysine @ ( H@K@me ) and acetylation of H@ Lysine @ ( H@K@ac ) , in the presence or absence of acupuncture treatment .


This study determines the efficacy and mechanisms of electro-acupuncture on stable angina pectoris .


We focus on effectiveness of acupuncture on alleviating symptoms of myocardial ischemia and the gene regulation and the chromatin remodeling marks , including H@K@me@ , H@K@me@ , and H@K@ac , which could be key factors for regulating gene expressions caused by electro-acupuncture treatment at Neiguan .


This is the first genome-wide study of electro-acupuncture treatment in angina patients , and will provide valuable information for future studies in the fields of acupuncture and its underlying mechanisms .


Fourteen patients have been recruited since recruitment opened in November of @ .


This study is scheduled to end in November of @ .


Despite prompt revascularization of acute myocardial infarction ( AMI ) , substantial myocardial injury may occur , in part a consequence of ischaemia reperfusion injury ( IRI ) .


There has been considerable interest in therapies that may reduce IRI .


In experimental models of AMI , sodium nitrite substantially reduces IRI .


In this double-blind randomized placebo controlled parallel-group trial , we investigated the effects of sodium nitrite administered immediately prior to reperfusion in patients with acute ST-elevation myocardial infarction ( STEMI ) .


A total of @ patients presenting with acute STEMI were randomized to receive either an i.v. infusion of @ mol sodium nitrite ( n = @ ) or matching placebo ( n = @ ) over @ min immediately before primary percutaneous intervention ( PPCI ) .


Patients underwent cardiac magnetic resonance imaging ( CMR ) at @-@ days and at @ months and serial blood sampling was performed over @ h for the measurement of plasma creatine kinase ( CK ) and Troponin I. Myocardial infarct size ( extent of late gadolinium enhancement at @-@ days by CMR-the primary endpoint ) did not differ between nitrite and placebo groups after adjustment for area at risk , diabetes status , and centre ( effect size -@ % @ % CI : -@ % , +@ % ; P = @ ) .


There were no significant differences in any of the secondary endpoints , including plasma troponin I and CK area under the curve , left ventricular volumes ( LV ) , and ejection fraction ( EF ) measured at @-@ days and at @ months and final infarct size ( FIS ) measured at @ months .


Sodium nitrite administered intravenously immediately prior to reperfusion in patients with acute STEMI does not reduce infarct size .


The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals , general practitioners and municipalities .


The disease management programmes assign a central role to general practice ; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice .


The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention .


The study was a stepped-wedge , randomised , controlled trial among general practices in the Capital Region of Denmark .


The intervention group was offered three one-hour visits by a facilitator .


The intervention was semi-tailored to the perceived needs as defined by each general practice , and the practices could choose from a list of possible topics .


The control group was a delayed intervention group .


The primary outcome was change in the number of annual chronic disease check-ups .


Secondary outcomes were : changes in the number of annual check-ups for type @ diabetes ( DM@ ) and chronic obstructive pulmonary disease ( COPD ) ; changes in the number of spirometry tests , changes in the use of ICPC diagnosis coding and patient stratification ; sign-up for a software program for patient overview ; and reduction in number of practices with few annual chronic disease check-ups .


We randomised @ general practices : @ practices were allocated to the intervention group and @ to the delayed intervention group .


For the primary outcome , @ and @ practices were analysed .


Almost every outcome improved from baseline to follow-up in both allocation groups .


At follow-up there was no difference between allocation groups for the primary outcome ( p = @ ) .


However , some secondary outcomes favoured the intervention : a higher reported use of ICPC diagnosis coding for DM@ and COPD ( p = @ , p = @ respectively ) , stratification for COPD ( p = @ ) and a faster initial sign-up rate for the software program .


The mixed results from this study indicate that a semi-tailored facilitator-based intervention of relatively low intensity is unlikely to add substantially to the implementation of disease management programmes for DM@ and COPD in a context marked by important concurrent initiatives ( including financial incentives and mandatory registry participation ) aimed at moving all practices towards changes in chronic care .


To compare the incidence of infection after minor surgery conducted using non-sterile clean boxed gloves with surgery conducted using sterile gloves .


Prospective randomised controlled single-centre trial testing for non-inferiority in infection rates .


Primary care regional centre , Queensland , Australia .


Consecutive patients presenting to participating general practitioners for a minor skin excision , between @ June @ and @ March @ , were eligible to participate .


The use of non-sterile clean boxed gloves was compared with normal treatment using sterile gloves in the control group .


Wound infection , assessed at the time of removal of sutures , and other adverse events .


Four hundred and ninety-three consecutive patients presenting for minor skin excisions were randomly allocated to the two treatment groups : non-sterile clean boxed gloves ( n = @ ) or sterile gloves ( n = @ ) .


Four hundred and seventy-eight patients contributed data for analysis ( @ non-sterile , @ sterile gloves ) .


The incidence of infection in the non-sterile gloves group ( @ % ; @ % CI , @ % -@ % ) was significantly non-inferior compared with the incidence in the control group ( @ % ; @ % CI , @ % -@ % ) .


The two-sided @ % CI for the difference in infection rate ( - @ % ) was - @ % to @ % , and did not reach the predetermined margin of @ % which had been assumed as the non-inferiority limit .


RESULTS of the intention-to-treat analysis were confirmed by per-protocol and sensitivity analyses .


There were no important adverse effects .


Our study suggests that in regard to wound infection , non-sterile clean boxed gloves are not inferior to sterile gloves for minor skin excisions in general practice .


Reports of the accuracy of existing neuromonitoring methods for detecting or preventing medial malpositioning of thoracic pedicle screws have varied widely in their claimed effectiveness .


The object of this study was to develop , test , and validate a novel neuromonitoring method for preventing medial malpositioning of pedicle screws in the thoracic spine during surgery .


This is a prospective , blinded and randomized study using a novel combination of input ( @-pulse stimulus trains delivered within the pedicle track ) and output ( evoked electromyography from leg muscles ) to detect pedicle track trajectories that-once implanted with a screw-would cause that screw to breach the pedicle 's medial wall and encroach upon the spinal canal .


For comparison , the authors also used screw stimulation as an input and evoked electromyogram from intercostal and abdominal muscles as output measures .


Intraoperative electrophysiological findings were compared with postoperative CT scans by multiple reviewers blinded to patient identity or intraoperative findings .


Data were collected from @ patients , in whom @ screws were implanted between the T-@ and L-@ vertebral levels .


A total of @ screws ended up with screw threads encroaching on the spinal canal by at least @ mm .


Pulse-train stimulation within the pedicle track using a ball-tipped probe and electromyography from lower limb muscles correctly predicted all @ ( @ % ) of these medially malpositioned screws .


The combination of pedicle track stimulation and electromyogram response from leg muscles proved to be far more effective in predicting these medially malpositioned screws than was direct screw stimulation and any of the target muscles ( intercostal , abdominal , or lower limb muscles ) we monitored .


Based on receiver operating characteristic analysis , the combination of @-mA ( lower alarm ) and @-mA stimulation intensities proved most effective for detection of pedicle tracks that ultimately gave rise to medially malpositioned screws .


Additional results pertaining to the impact of feedback of these test results on surgical decision making are provided in the companion report .


This novel neuromonitoring approach accurately predicts medially malpositioned thoracic screws .


The approach could be readily implemented within any surgical program that is already using contemporary neuromonitoring methods that include transcranial stimulation for monitoring motor evoked potentials .


Oxidative stress is involved in lead toxicity .


This suggests that some antioxidants may play a role in the treatment of lead poisoning .


In the light of this , the aim of the study was to determine whether beta-carotene administration reduces oxidative stress and homocysteine level in workers chronically exposed to lead .


The exposed population included healthy male workers exposed to lead who were randomly divided into @ groups ( mean blood lead level ca. @ microg/dl ) .


Workers in the @st group ( N = @ , reference group ) had no antioxidants , drugs , vitamins or dietary supplements administered , while workers in the @nd group ( N = @ ) had beta-carotene administered in a dose of @ mg per day for @ weeks .


Biochemical analysis included markers of lead-exposure and the level of malondialdehyde ( MDA ) , an oxidative stress biomarker .


We also measured the level of homocysteine ( Hcy ) and thiol groups as well as the activity of superoxide dismutase ( SOD ) and its isoenzyme EC-SOD in serum .


After supplementation , the level of MDA significantly decreased , compared to baseline , by @ % , and to the reference group .


When compared to the reference group , Hcy level was also significantly decreased .


However , the level of thiol groups was significantly higher after supplementation with beta-carotene compared to the reference group .


Analogically , the activity of SOD and EC-SOD was significantly higher compared to the baseline and to the reference group .


Despite some controversies over antioxidant properties of beta-carotene , our results indicate that its antioxidant action could provide some beneficial effects in lead poisoning independent of chelation .


Public-health guidelines recommend patients with congenital heart disease to exercise .


Studies have shown that patients with congenital heart disease can improve physical exercise capacity .


The effect of training on regional ventricular performance has hardly been studied .


We performed a pilot study to assess whether an exercise training program would result in adverse changes of regional ventricular performance in patients with corrected tetralogy of Fallot .


Multicenter prospective randomized controlled pilot study in patients with tetralogy of Fallot aged @ to @ years .


A @-week standardized aerobic dynamic exercise training program ( @ one-hour sessions per week ) was used .


Pre - and post-training cardiopulmonary exercise tests , MRI , and echocardiography , including tissue-Doppler imaging , were performed .


Patients were randomized to the exercise group ( n = @ ) or control group ( n = @ ) .


One patient in the exercise group dropped out .


Change in tissue-Doppler imaging parameters was similar in the exercise group and control group ( change in right ventricle free wall peak velocity E ' exercise group , @ cm/s ; control group , @ ; peak velocity A ' exercise group , @ m/s ; control group @ cm/s ) .


This randomized controlled pilot study provides preliminary data suggesting that regional ventricular performance is well maintained during @-month aerobic dynamic exercise training in children and young adults with repaired tetralogy of Fallot .


This information might help patients adhere to current public-health guidelines .


Incident syphilis infections continue to be especially prevalent among a core group of HIV-infected men who have sex with men ( MSM ) .


Because of synergy between syphilis and HIV infections , innovative means for controlling incident syphilis infections are needed .


Thirty MSM who had syphilis twice or more since their HIV diagnosis were randomized to receive either daily doxycycline prophylaxis or contingency management ( CM ) with incentive payments for remaining free of sexually transmitted diseases ( STDs ) .


Participants were tested for the bacterial STDs gonorrhea ( Neisseria gonorrhoeae ) , chlamydia ( Chlamydia trachomatis ) and syphilis at weeks @ , @ , @ , and @ and completed a behavioral risk questionnaire during each visit to assess number of partners , condom use , and drug use since the last visit .


Generalized linear mixed models were used to analyze differences between arms in STD incidence and risk behaviors at follow-up .


Doxycycline arm participants were significantly less likely to test positive for any selected bacterial STD during @ weeks of follow-up ( odds ratio , @ ; confidence interval , @-@ @ ) compared with CM arm participants ( P = @ ) .


There were no significant self-reported risk behavior differences between the doxycycline and CM arms at follow-up .


Daily doxycycline taken prophylactically was associated with a decreased incidence of N. gonorrhoeae , C. trachomatis , or syphilis incident infections among a core group of HIV-infected MSM at high risk for these infections .


Safe and effective biomedical tools should be included in the efforts to control transmission of syphilis , especially in this population .


A randomized clinical trial should be conducted to confirm and extend these findings .


The individual placement and support ( IPS ) model of supported employment has been implemented throughout North America and Europe , with multiple randomized controlled trials documenting its effectiveness , but it has not been widely implemented in Asia .


To date , no rigorous evaluations of IPS have been conducted in Japan .


We sought to evaluate whether IPS could be implemented in Japan and produce superior competitive employment outcomes compared with conventional vocational services .


We employed a randomized controlled trial with a @-month follow-up ; @ participants were randomly assigned to IPS and @ to conventional vocational services .


We assessed competitive employment rates , hours and weeks worked , and wages earned .


Over the @-month follow-up period , IPS participants were more likely than those in usual care to work competitively ( @ % for IPS vs. @ % for controls , p = @ ) , work more hours ( mean of @ hr for IPS vs. @ hr for controls , p = @ ) , and work more weeks ( mean of @ weeks for IPS vs. @ weeks for controls , p = @ ) .


IPS can be implemented in Japan and yield better competitive employment outcomes than conventional vocational services .


Adoption of the IPS model might have a dramatic impact on the mental health service system in Japan where psychiatric hospitals play a central role in mental health care .


Procalcitonin-guided antibiotic therapy for community-acquired pneumonia is effective and safe .


However , the usefulness of procalcitonin for aspiration pneumonia and its nutrition-related outcomes are unknown .


We conducted a noninferiority randomized controlled study in patients with aspiration pneumonia who were admitted to our hospital between September @ and January @ .


We randomly assigned @ patients to groups with different durations of antibiotic therapy based on the procalcitonin levels upon admission ( procalcitonin group ) or according to the standard guidelines ( control group ) .


The primary endpoints were relapse of aspiration pneumonia and death within @ days , with a predefined noninferiority boundary of @ % .


Secondary endpoints included duration of antibiotic exposure .


Furthermore , we conducted a retrospective analysis of the prognostic factors that determined continuation of oral nutritional intake , relapse of pneumonia , and in-hospital death .


The rate of relapse and death within @ days were similar in the procalcitonin and control groups ( @ % versus @ % ; difference , -@ % ; @ % confidence interval , -@ % to @ % ) .


Procalcitonin-guided antibiotic therapy significantly shortened the median duration of antibiotic exposure ( @ versus @ days ; p < @ ) ; however , the continuation of oral intake was not increased ( @ % versus @ % ; p = @ ) .


A multivariable analysis showed a significant association between the continuation of oral nutritional intake and the body mass index upon admission .


Procalcitonin-guided antibiotic therapy for aspiration pneumonia can shorten the duration of antibiotic exposure , but it does not increase the continuation of oral intake ( UMIN@ ) .


To evaluate the clinical efficacy of acupuncture for treatment of diarrhea-predominant irritable bowel syndrome and discuss its action mechanism .


Fifty-seven cases were randomly divided into two groups .


The acupuncture group ( @ cases ) was treated with acupuncture at Taichong ( LR @ ) , Zusanli ( ST @ ) and Sanyinjiao ( SP @ ) etc. , once a day and @ times per week .


The medication group ( @ cases ) was treated with oral administration of pinaverium ( @ mg each time , @ times a day ) and live combined bifidobacterium and lactobacillus tablet ( @ tablets each time , @ times a day ) .


Four weeks were taken as a treatment course in both groups .


Before and after treatment ELISA method was applied to measure the level of serum @-HT of the patients in two groups .


The scores of clinical symptoms were observed before treatment , after one and four weeks of treatment and @ months after treatment , respectively .


The level of serum @-HT was significantly reduced in the acupuncture group and medication group ( P < @ , P < @ ) , which had no statistical difference between two groups ( P > @ ) .


Compared with the medication group , the scores of clinical symptoms were obviously improved in the acupuncture group after one and four weeks of treatment and @ months after treatment ( P < @ , P < @ ) .


The total effective rate was @ % ( @/@ ) in the acupuncture group , which was superior to @ % ( @/@ ) in the medication group ( P < @ ) .


The efficacy of acupuncture is superior to that of medicine in the treatment of diarrhea-predominant irritable bowel syndrome .


The acupuncture treatment could reduce the visceral sensitivity , improve the intestinal motility and regulate the imbalance of brain-intestine interactive function .


Recurrent Clostridium difficile infection ( CDI ) with poor response to standard antimicrobial therapy is a growing medical concern .


We aimed to investigate the outcomes of fecal microbiota transplant ( FMT ) for relapsing CDI using a frozen suspension from unrelated donors , comparing colonoscopic and nasogastric tube ( NGT ) administration .


Healthy volunteer donors were screened and a frozen fecal suspension was generated .


Patients with relapsing/refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT .


The primary endpoint was clinical resolution of diarrhea without relapse after @ weeks .


The secondary endpoint was self-reported health score using standardized questionnaires .


A total of @ patients were enrolled , @ in each treatment arm .


Patients had a median of @ ( range , @-@ ) relapses prior to study enrollment , with @ ( range , @-@ ) antibiotic treatment failures .


Resolution of diarrhea was achieved in @ patients ( @ % ) after a single FMT ( @ of @ in the colonoscopy group and @ of @ in the NGT group ) .


Five patients were retreated , with @ obtaining cure , resulting in an overall cure rate of @ % .


Daily number of bowel movements changed from a median of @ ( interquartile range -LSB- IQR -RSB- , @-@ ) the day prior to FMT to @ ( IQR , @-@ ) after the infusion .


Self-ranked health score improved significantly , from a median of @ ( IQR , @-@ ) before transplant to @ ( IQR , @-@ ) after transplant .


No serious or unexpected adverse events occurred .


In our initial feasibility study , FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI .


NGT administration appears to be as effective as colonoscopic administration .


To observe the effect of catgut implantation at acupoint on the content of tumor necrosis factor alpha ( TNF-alpha ) , and to explore its mechanism for treatment of ankylosing spondylitis ( AS ) .


Seventy-four AS patients were randomly assigned to the observation group and the control group by digit random table , @ in each group .


Patients in the control group took Sulfasalazine Enteric-coated Tablet ( SECT ) , @ g each time , three times daily for @ months .


Those in the observation group additionally received catgut implantation at acupoint for @ months .


Changes of visual analogue scale ( VAS ) , Schober test , pillow wall distance , thoracic activity , erythrocyte sedimentation rate ( ESR ) , C reactive protein ( CRP ) , and TNF-alpha were compared after @ months of treatment .


There was obvious change in VAS , Schober test , pillow wall distance , thoracic activity , ESR , CRP , and TNF-alpha after treatment in the both groups , showing statistical difference when compared with before treatment ( P < @ , P < @ ) .


The aforesaid indices were obviously improved after treatment in the observation group ( P < @ , P < @ ) .


Catgut implantation at acupoint , as an assistant therapy , could significantly improve clinical symptoms and signs , decrease the level of TNF-alpha , and its effect was superior to that of oral SECT administration alone .


In Scotland most women get emergency contraception ( EC ) from pharmacies .


Pharmacists currently can not provide effective ongoing contraception after EC .


In this pilot study , we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC .


This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh , UK , in @ .


Pharmacies were cluster randomized to provide either standard care or one of two interventions : ( a ) one packet of progestogen-only pills ( POPs ) , giving women @ month to arrange ongoing contraception ; ( b ) invitation to present the empty EC packet to a family planning clinic ( FPC ) for contraceptive advice ( rapid access ) .


One hundred sixty-eight women were recruited from @ pharmacies to POP ( n = @ ) , rapid access ( n = @ ) and standard care ( N = @ ) groups , respectively .


Telephone follow-up was conducted successfully in @ women ( @ % ) @-@ weeks later to determine current contraceptive use .


In the POP arm , @/@ ( @ % ) women used the pills provided , and @/@ women ( @ % ) in the rapid access arm attended the FPC .


The proportion of women using effective contraception at follow-up was significantly greater in both POP -LSB- @ % ( @/@ ) , p = < @ -RSB- and rapid access -LSB- @ % ( @/@ ) , p = @ -RSB- groups compared to standard care -LSB- @ % ( @/@ ) -RSB- .


The relative probability of a woman using an effective method of contraception versus barrier/no method , after use of EC , was @ -LSB- @ % confidence interval ( CI ) , @-@ @ -RSB- in the POP group and @ ( @ % CI , @-@ @ ) in the rapid access group .


This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC .


A larger study is required to provide further validation of these findings .


For women obtaining EC from a pharmacy , simple interventions such as supplying @ month of a POP , or offering rapid access to a FPC , hold promise as strategies to increase the uptake of effective contraception after EC .


Dietary triacylglycerols ( TAGs ) containing palmitic acid in the sn-@ position might impair insulin release and increase plasma glucose .


We tested this hypothesis by comparing postprandial responses to fats with varying proportions of palmitic acid in the sn-@ position .


Using a crossover-designed randomized controlled trial in healthy men ( n = @ ) and women ( n = @ ) , we compared four meals on postprandial changes in glucose ( primary outcome ) , insulin , C-peptide , glucose , glucose-dependent insulinotropic polypeptide ( GIP ) and polypeptide YY ( PYY ) concentrations .


The meals provided @g protein , @g carbohydrate and @g test fat , supplied as high oleic sunflower ( HOS ) oil ( control ) , palm olein ( PO ) , interesterified palm olein ( IPO ) and lard containing @ , @ , @ and @ mol % palmitic acid at sn-@ , respectively .


No differences in plasma glucose , insulin and C-peptide response between meals were found .


GIP release was lower ( P < @ ) for IPO and lard compared with HOS and PO meals ; the maximal increments ( geometric mean and @ % confidence interval ) for HOS , PO , IPO and lard were @ ( @ , @ ) , @ ( @ , @ ) , @ ( @ , @ ) and @ ( @ , @ ) ng/l , respectively .


There was a trend for the postprandial increase in PYY to be lower in women on the IPO and lard meals than those on the HOS and PO meals .


Dietary TAGs with an increased proportion of palmitic acid in the sn-@ position do not have acute adverse effects on the insulin and glucose response to meals in healthy men and women , but they decrease GIP release .


Although recent studies have documented high-risk drinking occurring during Spring Break ( SB ) , particularly on SB trips with friends , published intervention studies are few .


In the present study , we evaluated the efficacy of event specific prevention strategies for reducing SB drinking among college students , compared to general prevention strategies and an assessment-only control group , as well as evaluated inclusion of peers in interventions and mode of intervention delivery ( in-person vs. web ) .


Participants included @ undergraduates ( @ % women ; average age = @ years ) intending to go on a SB trip with friends as well as to drink heavily on at least @ day of SB .


Participants completed assessments prior to SB and were randomized to @ of @ intervention conditions : SB in-person Brief Alcohol Screening and Intervention for College Students ( BASICS ; Dimeff , Baer , Kivlahan , & Marlatt , @ ) , SB web BASICS , SB in-person BASICS with friend , SB web BASICS with friend , general BASICS , or an attention control condition .


Follow-up assessment was completed @ week after SB .


Although the SB web BASICS ( with and without friends ) and general BASICS interventions were not effective at reducing SB drinking , results indicated significant intervention effects for SB in-person BASICS in reducing SB drinking , particularly on trip days .


Follow-up analyses indicated that change in descriptive norms mediated treatment effect and reductions in drinking , whereas SB drinking intentions and positive expectancies did not .


Overall , results suggest that an in-person SB-specific intervention is effective at reducing SB drinking , especially during trips .


In contrast , interventions that contain non-SB-related content , are web-based , or seek to involve friends may be less effective at reducing SB drinking .


This study aimed to improve our understanding of static and dynamic lower extremity sensory perception and the impact of sensory impairments on the control of walking in stroke survivors .


Using a custom , real-time unloading system , we tested load perception at heel strike , mid stance and push off in @ stroke survivors and compared their performance to @ age-matched and @ young adult control subjects .


Dynamic load perception was based on a judgment of which leg was bearing more load , which was altered on a step by step basis .


We also examined lower extremity static load perception , coordination , proprioception , balance , and gait symmetry .


The stroke survivors performed significantly worse than the control subjects in dynamic load perception , coordination , proprioception , balance and gait symmetry .


Gait symmetry correlated with static and dynamic load perception measures but not with age , proprioception , coordination , and balance .


Sensory deficits related to load detection in the impaired limb could result in an increased uncertainty of limb load and a gait strategy in which stroke survivors minimize loading of the impaired limb .


This new method of measuring lower extremity dynamic load perception provides a framework for understanding gait-related sensory impairments in stroke survivors .


To investigate the impact of respiratory muscle endurance training ( RMET ) on lung function and exercise performance in athletes with high lesion level paraplegia .


This was a case-control intervention study .


Sport and exercise science laboratories and bike path .


Twelve competitive handbike athletes with high lesion level paraplegia matched by lesion and fitness level in training ( T ) group ( @ ) and control ( C ) group ( @ ) .


The T group performed @ RMET training sessions over a @-week period using a SpiroTiger .


Each session lasted for @ minutes .


The C group did not perform any RMET .


Resting lung function , respiratory muscle endurance , and exercise performance ( arm cranking maximal incremental test and simulated handbike time trial ) .


Resting lung function was not different between groups and did not change with the intervention .


After RMET , the respiratory muscle endurance was significantly increased by @ % in the T group but did not alter in the C group .


Final minute ventilation was increased from @ @ L/min to @ @ L/min after RMET in the T group and the sensation of dyspnea decreased ( P < @ ) .


Peak oxygen consumption , peak mechanical power output , and handbike time trial performance were not different between groups and did not change with the RMET intervention .


A short-term RMET intervention in handbike athletes with high lesion level paraplegia improved respiratory muscle endurance but had little impact on overall exercise performance .


To assess the effectiveness of pilates method on patients with chronic non-specific low back pain ( LBP ) .


A randomized controlled trial was carried out in sixty patients with a diagnosis of chronic non-specific LBP .


Patients were randomly assigned to one of two groups : Experimental Group ( EG ) that maintained medication treatment with use of NSAID and underwent treatment with the pilates method and Control Group ( CG ) that continue medication treatment with use of NSAID and did not undergo any other intervention .


A blinded assessor performed all evaluations at baseline ( T@ ) , after @ , @ , and @ days ( T@ , T@ and T@ ) for : pain ( VAS ) , function ( Roland Morris questionnaire ) , quality of life ( SF-@ ) , satisfaction with treatment ( Likert scale ) , flexibility ( sit and reach test ) and NSAID intake .


The groups were homogeneous at baseline .


Statistical differences favoring the EG were found with regard to pain ( P < @ ) , function ( P < @ ) and the quality of life domains of functional capacity ( P < @ ) , pain ( P < @ ) and vitality ( P < @ ) .


Statistical differences were also found between groups regarding the use of pain medication at T@ , T@ and T@ ( P < @ ) , with the EG taking fewer NSAIDs than the CG .


The pilates method can be used by patients with LBP to improve pain , function and aspects related to quality of life ( functional capacity , pain and vitality ) .


Moreover , this method has no harmful effects on such patients .


Obese children tend to consume less dietary folate , which is an important cofactor in remethylation of homocysteine to methionine .


The deficiency of folate can lead to hyperhomocysteinemia .


To determine whether folic acid supplementation could reduce plasma homocysteine in obese children .


Obese children , aged @-@ years with body mass index > median plus @ SD according to WHO reference , were randomly assigned to @ groups : receiving either @ mg folic acid or placebo for @ months .


Fasting homocysteine , creatinine , folate , vitamin B@ , insulin , glucose and lipid profiles were taken at baseline and the end of the study .


Dietary vitamin B@ , folate intake and physical activity were assessed using validated questionnaires .


Fifty obese children ( @ boys and @ girls ) took part in the study .


Their mean age was @ @ years and mean BMI Z-score was @ @ .


After the intervention , plasma homocysteine decreased by @ % and @ % in the folic acid and placebo group , respectively ( mean difference @ % ; @ % CI : @ % , @ % , p = @ ) .


This divergence was more pronounced in boys and it remained significant after adjusting for baseline homocysteine and other confounders .


Subgroup analysis showed a larger magnitude of plasma homocysteine reduction in the low folate group ( mean difference @ % ; @ % CI : @ % , @ % ) .


The homocysteine lowering effect of folic acid supplementation was found in obese children , especially in boys and those with low serum folate .


Further long-term interventional studies are needed to determine the effects of the lowered plasma homocysteine on the cardiovascular outcomes of obese children .


This trial was registered on clinicaltrials.gov ( NCT@ ) .


The purpose of this study was to evaluate whether simple bone cysts ( SBC ) resolve with age .


Twenty four subjects with SBC who participated in a prior randomized clinical trial but had not healed at trial conclusion were evaluated for cyst healing .


The following clinical and radiographic data were evaluated : age , sex , pain ( Visual Analogue Scale ) , functional health ( Short Form @ ) , subsequent fracture , involved bone , cyst area ( cm ) , distance from physis ( cm ) , endosteal thickening ( yes/no ) , scalloping ( no new scalloping/new scalloping ) , opacity/radiolucency ( as is ) , loculation ( yes/no ) , trabeculation ( yes/no ) , tubulation ( yes/no ) , transition zone ( sharp/wide ) , geographic borders ( geographic nonpermeative/nongeographic permeative ) , radiodense rim ( > @ % / no rim ) , and growth plate status ( open/closed ) .


Cyst healing was graded as : @-cyst clearly visible ; @-cyst visible but multilocular and opaque ; @-sclerosis around or within a partially visible cyst ; or @-complete healing with obliteration of cyst .


Healing was defined as grade @ .


Of @ subjects , @ ( @ % ) were male , @ ( @ % ) cysts were located in the humerus , and @ ( @ % ) in the femur .


Patients were followed for @ years following initial treatment with a mean age at follow-up of @ years and @ ( @ % ) of growth plates were closed .


Pain was minimal ( @ / @ ) , function was high ( @/@ ) , and none of the patients had experienced subsequent fractures .


Although distance from physeal scar had increased ( P < @ ) , cyst area reduction ( P < @ ) and overall cyst healing ( P < @ ) had not changed .


Of the @ subjects , none were graded as healed at time of follow-up .


Of the remaining radiographic variables , only decreased loculation ( P < @ ) and increased endosteal thickening ( P < @ ) showed significant changes .


Despite the assumption that most SBC will resolve with skeletal maturity , this study indicates that none of the cysts were graded as completely healed although @ % of growth plates were closed .


Growth plate closure may not signify healing of SBC and although symptoms and fractures are rare , further studies are needed to follow patients with SBC through early adulthood .


Lifestyle interventions among people with impaired glucose tolerance reduce the incidence of diabetes , but their effect on all-cause and cardiovascular disease mortality is unclear .


We assessed the long-term effect of lifestyle intervention on long-term outcomes among adults with impaired glucose tolerance who participated in the Da Qing Diabetes Prevention Study .


The study was a cluster randomised trial in which @ clinics in Da Qing , China-serving @ adults with impaired glucose tolerance-were randomised ( @:@:@:@ ) to a control group or lifestyle intervention groups ( diet or exercise or both ) .


Patients were enrolled in @ and the intervention phase lasted for @ years .


In @ , we followed up participants to assess the primary outcomes of cardiovascular mortality , all-cause mortality , and incidence of diabetes in the intention-to-treat population .


Of the @ patients , @ were assigned to the intervention group and @ were assigned to the control group ( one refused baseline examination ) .


@ ( @ % ) of @ participants had complete data for mortality and @ ( @ % ) contributed data to the analysis .


@ participants died during the @ years of follow-up ( @ in the intervention group vs @ in the control group ) .


Cumulative incidence of cardiovascular disease mortality was @ % ( @ % CI @-@ @ ) in the intervention group versus @ % ( @-@ @ ) in the control group ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ @ ; p = @ ) .


All-cause mortality was @ % ( @ % CI @-@ @ ) versus @ % ( @-@ @ ; HR @ , @ % CI @-@ @ ; p = @ ) .


Incidence of diabetes was @ % ( @-@ @ ) versus @ % ( @-@ @ ; HR @ , @ % CI @-@ @ ; p = @ ) .


A @-year lifestyle intervention programme for Chinese people with impaired glucose tolerance can reduce incidence of cardiovascular and all-cause mortality and diabetes .


These findings emphasise the long-term clinical benefits of lifestyle intervention for patients with impaired glucose tolerance and provide further justification for adoption of lifestyle interventions as public health measures to control the consequences of diabetes .


To our knowledge , prior research has not examined the effects of magnesium supplementation on metabolic status and pregnancy outcomes in maternal-child dyads affected by gestational diabetes ( GDM ) .


This study was designed to assess the effects of magnesium supplementation on metabolic status and pregnancy outcomes in magnesium-deficient pregnant women with GDM .


A randomized , double-blind , placebo-controlled clinical trial was performed in @ women with GDM .


Patients were randomly assigned to receive either @ mg magnesium oxide ( n = @ ) or a placebo ( n = @ ) for @ wk .


Fasting blood samples were taken at baseline and after a @-wk intervention .


The change in serum magnesium concentration was greater in women consuming magnesium than in the placebo group ( +@ @ vs. -@ @ mg/dL , P = @ ) .


However , after controlling for baseline magnesium concentrations , the changes in serum magnesium concentrations were not significantly different between the groups .


Changes in fasting plasma glucose ( -@ @ vs. +@ @ mg/dL , P < @ ) , serum insulin concentration ( -@ @ vs. +@ @ IU/mL , P = @ ) , homeostasis model of assessment-estimated insulin resistance ( -@ @ vs. +@ @ , P < @ ) , homeostasis model of assessment-estimated - cell function ( -@ @ vs. +@ @ , P = @ ) , and the quantitative insulin sensitivity check index ( +@ @ vs. -@ @ , P = @ ) in supplemented women were significantly different from those in women in the placebo group .


Changes in serum triglycerides ( +@ @ vs. +@ @ mg/dL , P = @ ) , high sensitivity C-reactive protein ( -@ @ vs. +@ @ ng/mL , P = @ ) , and plasma malondialdehyde concentrations ( -@ @ vs. +@ @ mol/L , P = @ ) were significantly different between the supplemented women and placebo group .


Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia ( @ % vs. @ % , P = @ ) and newborn hospitalization ( @ % vs. @ % , P = @ ) .


Magnesium supplementation among women with GDM had beneficial effects on metabolic status and pregnancy outcomes .


This trial was registered at www.irct.ir as IRCT@N@ .


Physical performances and cognition are positively related in cognitively healthy people .


The aim of this study was to examine whether physical performances are related to specific cognitive functioning in older people with mild to severe cognitive impairment .


This cross-sectional study included @ people with a mild to severe cognitive impairment ( mean age @ years ) .


Multiple linear regression was performed , after controlling for covariates and the level of global cognition , with the performances on mobility , strength , aerobic fitness , and balance as predictors and working memory and episodic memory as dependent variables .


The full models explain @-@ % of the variance in working memory and @-@ % of episodic memory .


Strength , aerobic fitness , and balance are significantly associated with working memory , explaining @-@ % of its variance , irrespective of the severity of the cognitive impairment .


Physical performance is not related to episodic memory in older people with mild to severe cognitive impairment .


Physical performance is associated with working memory in older people with cognitive impairment .


Future studies should investigate whether physical exercise for increased physical performance can improve cognitive functioning .


This trial is registered with ClinicalTrials.gov NTR@ .


Different types of modified ultrafiltration ( MUF ) systems evaluated showed that none of the MUF techniques adhered to the normal venous to arterial blood flow dynamics .


This study compared a conventional arteriovenous modified ultrafiltration ( AVMUF ) system to a custom - designed venoarterial modified ultrafiltration ( VAMUF ) system .


Randomized , controlled clinical study conducted at the Northwest Armed Forces Military hospital in Tabuk , Saudi Arabia .


Sixty patients who underwent MUF during the years @ and @ were divided into @ groups : the AVMUF ( n = @ ) and the VAMUF ( n = @ ) groups .


MUF was performed for a mean time of @ minutes in both groups .


In AVMUF , blood was removed from the aorta , hemoconcentrated , and infused into the right atrium ( RA ) .


In VAMUF , blood flow was from the RA through a hemoconcentrator and re-infused into the aorta .


Results of the study showed that the VAMUF group required a shorter ventilation time ( P < @ ) , in.tensive care unit ( ICU ) ( P = @ ) , and hospital stay ( P = @ ) than the AVMUF group .


Results also demonstrated a lower percentage of fluid balance ( P = @ ) in the VAMUF group .


The systolic ( P < @ ) and mean blood pres.sures ( P < @ ) were significantly higher after VAMUF , with a decrease in heart rate ( P < @ ) and central venous pressure ( P = @ ) .


The VAMUF group showed a significantly greater decrease of creatinine ( P < @ ) , serum lactacte ( P < @ ) , and uric acid ( P < @ ) over time with no significant differences in oximetry .


Results prove that VAMUF is a more physiological technique than AVMUF .


Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis ( LSS ) unresponsive to conservative care .


The purpose of this prospective , multicenter , randomized , controlled trial was to compare @-year clinical outcomes in patients with moderate LSS treated with the Superion ( ) ( Experimental ) or the X-Stop ( ) , a FDA-approved interspinous spacer ( Control ) .


A total of @ patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental ( n = @ ) or Control ( n = @ ) interspinous spacer and followed through @ years post-treatment .


Complication data were available for all patients and patient-reported outcomes were available for @ patients ( @ Experimental , @ Control ) at @ years .


Zurich Claudication Questionnaire ( ZCQ ) Symptom Severity and Physical Function scores improved @ % to @ % in both groups through @ years ( all p < @ ) .


Patient Satisfaction scores at @ years were @ @ with Experimental and @ @ with Control .


Axial pain decreased from @ @ mm at baseline to @ @ mm at @ years with Experimental and from @ @ mm to @ @ mm with Control ( both p < @ ) .


Extremity pain decreased from @ @ mm to @ @ mm at @ years with Experimental and from @ @ mm to @ @ mm with Control ( both p < @ ) .


Back function assessed with the Oswestry Disability Index similarly improved with Experimental ( @ @ % to @ @ % ) and Control ( @ @ % to @ @ % ) ( both p < @ ) .


Freedom from reoperation at the index level was @ % for Experimental and @ % for Control ( log-rank : p = @ ) at @ years .


Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through @ years in patients with moderate LSS who were unresponsive to conservative care .


Sacrococcygeal pilonidal sinus is common in young men and may recur over time after surgery .


We investigated whether a factor exists that can aid in the determination of the preferred technique between the early Limberg flap and Karydakis flap techniques for treating recurrent pilonidal sinus .


This prospective and randomized study enrolled @ patients with recurrent pilonidal sinus in whom the Limberg flap or Karydakis flap techniques were applied for reconstruction after excision .


Patients were divided into two groups as follows : @ patients were treated with the Limberg flap technique and @ patients were treated with the Karydakis flap technique .


Fluid collection , wound infection , flap edema , hematoma , partial wound separation , return to daily activities , pain score , complete healing time , painless seating and patient satisfaction were compared between the groups .


ClinicalTrial.gov : NCT@ .


The development rates of total fluid collection , wound infection , flap edema , hematoma , and partial wound separation were @ % , @ % , @ % , @ % and @ % , respectively ; total flap necrosis was not observed in any patient ( p < @ ) .


During the average follow-up of @ months , no patients ( @ % ) developed recurrent disease .


The two groups differed with respect to early surgical complications ( p < @ ) .


In this study , use of the Limberg flap was associated with lower complication rates , shorter length of hospital stay , early return to work , low pain score , high patient satisfaction and better complete healing duration .


Therefore , we recommend the Limberg flap for treatment of recurrent pilonidal sinus .


Hyperbaric @ % prilocaine produces a faster onset and shorter duration of spinal anesthesia than a plain solution .


The anesthetic profile could be improved by restricting the block to the operative side .


We compared unilateral versus conventional bilateral spinal anesthesia with hyperbaric @ % prilocaine in day-case patients undergoing unilateral inguinal herniorrhaphy .


Eighty patients were randomly assigned to receive either conventional bilateral ( N. = @ ) or unilateral ( N. = @ ) spinal anesthesia with @ mg hyperbaric prilocaine @ % .


In the unilateral group , lateral decubitus was maintained for @ minutes .


Sensory and motor block courses , time to first micturition , and side effects were recorded .


On the operated side , the highest sensory block was T@ ( T@-T@ ) in the unilateral and T@ ( T@-T@ ) in the bilateral group ( P = @ ) ; the time to motor ( @ @ min in the unilateral and @ @ min in the bilateral groups , P = @ ) and sensory ( @ @ min in the unilateral and @ @ min in the bilateral groups , P = @ ) block resolution was similar in both groups .


On the non-operated side , the unilateral group had a faster motor ( @ @ , P < @ ) and sensory ( @ @ , P < @ ) time to block resolution than the conventional group .


Restricted unilateral motor and sensory block was achieved in @ % and @ % of patients , respectively .


Time to voiding was shorter in the unilateral than in the conventional group ( @ @ vs. @ @ min , respectively , P = @ ) .


There were no significant differences in adequacy for surgery and side effects between the groups .


In day-case inguinal herniorrhaphy , attempting unilateral spinal anesthesia with @ mg hyperbaric @ % prilocaine produced faster time to voiding .


Eslicarbazepine acetate ( ESL ) is an anticonvulsant approved as an adjunctive therapy in adults with partial-onset seizures .


To evaluate the efficacy , safety and tolerability of ESL in the treatment of acute mania and prevention of recurrence in bipolar disorder I.


Two @-week multicentre , double-blind , randomised , placebo-controlled studies in acute mania ( study BIA-@-@ : dose titrated by response , ESL @-@mg or @-@mg , once-daily ; study BIA-@-@ : fixed doses of @ , @ and @mg , once-daily ) were followed by a recurrence prevention study consisting of a @-week open-label period ( @mg , once-daily ) continued by a double-blind , parallel-group , fixed dose ( @ , @ and @mg , once-daily ) period for a minimum of @ months .


The primary endpoint was changed from baseline until the end of the @-week treatment period in Young Mania Rating Scale ( YMRS ) in studies BIA-@-@ and BIA-@-@ , and the proportion of patients showing no worsening according to the Clinical Global Impressions - Bipolar Version ( CGI-BP ) over Part II in study BIA-@-@ .


In study BIA-@-@ ( n = @ , ITT ) , neither dose group was statistically different from placebo in the primary endpoint , though the ESL @-@mg showed a greater reduction in YMRS score ( p = @ ) .


CGI-BP score changes for mania and overall bipolar illness indicate a significant improvement in patient symptomatology for the ESL @-@mg group ( from preceding and worst phase ) and for ESL @-@mg group ( from worst phase only ) when compared to placebo .


Study BIA-@-@ ( n = @ ) results were inconclusive due to premature termination caused by recruitment difficulties .


In study BIA-@-@ ( n = @ , ITT ) , at least @ % of patients showed no worsening in all treatment groups ( p = @ ) .


ESL adverse events were mostly of mild and moderate intensities and consistent with previously reported observations for ESL .


ESL treatment was not significantly different from placebo in manic patients in the primary outcome , but secondary outcomes may be suggestive of efficacy .


The recurrence prevention study provides preliminary support for efficacy of ESL in patients recovered from an acute manic episode .


A previously published proof of principle phase IIa trial with @ patients from Kabul showed that bipolar high-frequency ( HF ) electro-cauterization ( EC ) of cutaneous leishmaniasis ( CL ) ulcers and subsequent moist wound treatment ( MWT ) closed @ % of all Leishmania ( L. ) tropica lesions within @days .


A three-armed phase IIb , randomized and controlled clinical trial was performed in Mazar-e-Sharif .


L. tropica - or L. major-infected CL patients received intradermal sodium stibogluconate ( SSG ) ( Group I ) ; HF-EC followed by MWT with @ % DAC N-@ ( Group II ) ; or MWT with @ % DAC N-@ in basic crme alone ( Group III ) .


The primary outcome was complete epithelialisation before day @ after treatment start .


@ patients enrolled in the trial were randomized into group I ( n = @ ) , II ( n = @ ) and III ( n = @ ) .


The per-protocol analysis of @ ( @ % ) patients revealed complete epithelialisation before day @ in @ ( of @ ; @ % ) patients of Group I , in @ ( of @ ; @ % ) patients of Group II , and in @ ( of @ ; @ % ) patients of Group III ( p = @ , Fisher 's Exact Test ) .


In the per-protocol analysis , wound closure times were significantly different between all regimens in a pair-wise comparison ( p = @ , Log-Rank ( Mantel-Cox ) test ) .


In the intention-to-treat analysis wound survival times in Group II were significantly different from those in Group I ( p = @ , Log-Rank ( Mantel-Cox ) test ) .


Re-ulcerations occurred in four ( @ % ) , three ( @ % ) and seven ( @ % ) patients of Group I , II or III , respectively ( p = @ , Pearson Chi-Square Test ) .


Treatment of CL ulcers with bipolar HF-EC followed by MWT with @ % DAC N-@ or with DAC N-@ alone showed shorter wound closure times than with the standard SSG therapy .


The results merit further exploration in larger trials in the light of our current knowledge of in vitro and in vivo activities of chlorite .


Clinicaltrials.gov ID : NCT@ .


Registered : @th October @ .


The primary objective of this prospective controlled study was to investigate the impact of standardized injection-site warming on prandial rapid acting insulin dose and glycemic control when studied under real-world conditions .


All @ participating patients ( @ female , @ male , @ type @ and @ type @ patients , age : @ yrs , HbA@c : @ % ) were treated with intensive insulin glargine and short-acting insulin analog therapy .


After a @week treatment optimization run-in period , patients were randomized to continue therapy for three months without ( control ) or with a local injection-site warming device ( InsuPad * ) .


Observation parameters included HbA@c , insulin dose , frequency of hypoglycemia , body weight and adverse events .


HbA@c improved in both arms until study end ( control group : @ % ; injection-site warming device : @ % ; both p < @ vs. baseline ) .


To achieve this good control , patients in the control group needed to increase the daily prandial insulin dose by @ % ( from @U to @U , p < @ ) with stable basal insulin requirements .


Patients who used the injection-site warming device required less prandial insulin ( @U to @U ; -@ % , p < @ ) and slightly more basal insulin ( +@ % ) .


Total daily insulin dose increased in the control group ( +@ % ) and decreased with warming device use ( -@ % , p < @ ) .


The number of hypoglycemic events ( < @mg/dL ) during the observation period was higher in the control group ( @ / patient vs. injection-site warming device : @ / patient , p < @ ) .


Main study limitations can be seen in the open label design reliability of the collected dose information and the very obese patient cohort .


When treating obese patients to target with insulin therapy , use of an injection-site warming device for @months resulted in a lower frequency of hypoglycemic events and a reduction in prandial insulin analog requirements .


If these results are confirmed in other patient populations , an injection-site warming device may be useful in achieving treatment targets with a safer and more efficient basal bolus therapy in insulin-treated patients with type @ and type @ diabetes .


To examine whether an acute bout of active or dynamic hamstring-stretching exercises would reduce the amount of muscle damage observed after a strenuous eccentric task and to determine whether the stretching protocols elicit similar responses .


A randomized controlled clinical trial .


Thirty-six young male students performed @ min of jogging as a warm-up and were allocated to @ of @ groups : @ min of static active stretching ( SAS ) , @ min of dynamic active stretching ( DAS ) , or control ( CON ) .


All subjects performed eccentric exercise immediately after stretching .


Heart rate , core temperature , maximal voluntary isometric contraction , passive hip flexion , passive hamstring stiffness ( PHS ) , plasma creatine kinase activity , and myoglobin were recorded at prestretching , at poststretching , and every day after the eccentric exercises for @ d.


After stretching , the change in hip flexion was significantly higher in the SAS ( @ ) and DAS ( @ ) groups than in the CON ( -@ ) group .


The change in PHS was significantly higher in the DAS ( @ % ) group than in the CON ( -@ % ) and SAS ( -@ % ) groups .


Furthermore , changes in muscle-damage markers were smaller in the SAS group than in the DAS and CON groups .


Prior active stretching could be useful for attenuating the symptoms of muscle damage after eccentric exercise .


SAS is recommended over DAS as a stretching protocol in terms of strength , hamstring range of motion , and damage markers .


To develop and validate a predictive model for glucose change and risk for new-onset impaired fasting glucose in hypertensive participants following treatment with atenolol or hydrochlorothiazide ( HCTZ ) .


Randomized multicenter clinical trial .


A total of @ white or African-American men and women with uncomplicated hypertension .


Pharmacogenomic Evaluation of Antihypertensive Responses ( PEAR ) is a randomized clinical trial to assess the genetic and nongenetic predictors of blood pressure response and adverse metabolic effects following treatment with atenolol or HCTZ .


To develop and validate predictive models for glucose change , PEAR participants were randomly divided into a derivation cohort of @ and a validation cohort of @ .


Linear and logistic regression modeling were used to build models of drug-associated glucose change and impaired fasting glucose ( IFG ) , respectively , in the derivation cohorts .


These models were then evaluated in the validation cohorts .


For glucose change after atenolol or HCTZ treatment , baseline glucose was a significant ( p < @ ) predictor , explaining @ % of the variability in glucose change after atenolol and @ % of the variability in glucose change after HCTZ .


Baseline glucose was also the strongest and most consistent predictor ( p < @ ) for development of IFG after atenolol or HCTZ monotherapy .


The area under the receiver operating curve was @ for IFG after atenolol and @ after HCTZ treatment , respectively .


Baseline glucose is the primary predictor of atenolol or HCTZ-associated glucose increase and development of IFG after treatment with either drug .


To compare the benefits of a thermal cure and non-thermal rehabilitation in treatment of knee osteoarthritis ( KOA ) .


Randomized therapeutic trial including patients with knee osteoarthritis ( American College of Rheumatology criteria ) .


Patients were randomly divided into two groups .


Spa treatment consisted of underwater shower , massage-jet showers , hydromassage , pool rehabilitation and peloid therapy .


Non-thermal rehabilitation consisted of analgesic physiotherapy , muscle strengthening and group physical rehabilitation .


A blinded evaluation was carried out at day @ and @months following treatment .


It was based on the visual analogic scale of pain ( VAS ) , which represented the primary endpoint .


Two hundred and forty patients were included ( February-June @ ) .


The spa treatment and non-thermal rehabilitation groups included @ and @patients respectively .


Two hundred and thirty-three patients completed their treatments .


Significant improvement of the visual analogic scale of pain was noted in the thermal cure group ( @ at day @ versus @ at @months , P < @ ) , but not in the non-thermal group ( @ at day @ versus @ at @months , P = @ ) .


At day @ , comparison of the two groups revealed no significant difference on the VAS ( P = @ ) .


However , at @months , the thermal cure group was significantly more improved ( P = @ ) .


In our study , crenobalneotherapy had resulted , at @months , in more pronounced long-term improvement of the painful symptoms of KOA than had non-thermal rehabilitation .


To assess the effects of maintenance therapy with aripiprazole once-monthly @mg on personal and social functioning .


Data were analyzed from @ randomized , double-blind trials of patients with schizophrenia requiring chronic antipsychotic treatment .


One study was a @-week trial of aripiprazole once-monthly @mg versus placebo ; the other was a @-week trial of aripiprazole once-monthly @mg , oral aripiprazole ( @-@ mg daily ) , and aripiprazole once-monthly @mg ( subtherapeutic dose to test assay sensitivity ) .


Functioning was assessed using the Personal and Social Performance ( PSP ) scale , comprising @ domain subscales .


In the @-week study , @ patients stabilized on aripiprazole once-monthly @mg were randomized to receive aripiprazole once-monthly @mg ( n = @ ) or placebo ( n = @ ) .


In the @-week study , @ patients stabilized on oral aripiprazole were randomized to receive aripiprazole once-monthly @mg ( n = @ ) , oral aripiprazole ( n = @ ) , or aripiprazole once-monthly @mg ( subtherapeutic dose ; n = @ ) .


In the @-week study , mean changes from baseline were significantly worsened with placebo compared with aripiprazole once-monthly @mg for PSP total score ( P < @ ) and domain scores for Personal and Social Relationships ( P < @ ) , Self-Care ( P < @ ) , and Disturbing and Aggressive Behavior ( P < @ ) .


In the @-week study , mean changes from baseline were significantly worsened with aripiprazole once-monthly @mg compared with aripiprazole once-monthly @mg for PSP total score ( P < @ ) and the Personal and Social Relationships domain score ( P < @ ) .


Patient functioning , assessed using the PSP scale , was maintained in stabilized patients treated with aripiprazole once-monthly in @ pivotal relapse studies .


To ( @ ) determine diabetes patients ' acceptance of Internet-based interventions ( IBIs ) for depression , to ( @ ) examine the effectiveness of an acceptance facilitating intervention ( AFI ) and to ( @ ) explore subgroup specific effects .


@ diabetes patients from two inpatient rehabilitation units and one outpatient clinic in Germany were randomly allocated to an intervention ( IG ) and a no-intervention control group ( CG ) .


The IG received an AFI consisting of a personal information session before filling-out a questionnaire on patients ' acceptance of IBIs , predictors of acceptance ( performance expectancy , effort expectancy , social influence , facilitating conditions , and Internet anxiety ) as well as sociodemographic , depression-related and diabetes-related variables .


The CG filled out the questionnaire immediately .


Patients ' acceptance of IBIs was measured with a four-item scale ( sum-score ranging from @ to @ ) .


The CG showed a low ( @ % ) to medium ( @ % ) acceptance with only @ % of all diabetes patients reporting a high acceptance of IBIs for depression .


The AFI had no significant effect on acceptance ( IG : M = @ , SD = @ , n = @ ; KG : M = @ , SD = @ , n = @ ; d = @ -LSB- @ % - CI : -@ ; @ -RSB- ) and the predictors of acceptance .


Yet , subgroup analyses yielded a trend for depressed , diabetes-related distressed , female and younger ( < @ ) participants and for those who do not frequently use the Internet to profit from the AFI .


Diabetes patients show a rather low acceptance toward IBIs for depression .


Findings indicate that the AFI is likely to be effective in the subgroup of depressed , diabetes-related distressed , female or younger diabetes patients , but not in the whole target population .


Hence , AFIs might need to be tailored to the specific needs of subpopulations .


To compare the use of ropivacaine versus bupivacaine for @-in-@ block during total knee arthroplasty ( TKA ) in terms of efficacy and safety ( lack of toxicity ) .


@ men and @ women aged @ to @ ( median , @ ) years who had the American Society of Anesthesiologists ( ASA ) grades I to III physical status were randomised to receive ropivacaine ( n = @ ) or bupivacaine ( n = @ ) of a concentration of @ % for @-in-@ block during TKA .


The dosage was @ ml/kg .


In addition , a sciatic nerve block ( @ ml of prilocaine @ % ) was used .


The onset of the block , duration of postoperative analgesia , level of motor block , and any side-effects were compared .


The median time to onset of block was significantly shorter in those receiving ropivacaine than bupivacaine ( @ vs. @ minutes , p < @ ) , but the levels of motor blockade were not significantly different ( p = @ ) .


Complete analgesia was achieved throughout the procedure .


There was no significant difference between the ropivacaine and bupivacaine groups in terms of the mean duration of analgesia ( @ vs. @ minutes , p = @ ) , the mean VAS scores at all time points , and the mean total morphine consumption .


One patient in the ropivacaine group developed a joint haematoma and @ patients in the bupivacaine group had excessive wound drainage .


Both conditions resolved after antibiotic use .


Ropivacaine and bupivacaine showed similar anesthetic and analgesic effects , but the former had a significantly faster onset time .


Many of the approximately @ million people with a migration background living in Germany ( @ % of the population ) are inadequately reached by existing healthcare provision .