To assess treatment outcomes via acoustic voice laboratory measurements before and after intervention in patients with common voice problems and Determine if outcome sensitivity of certain voice laboratory measures varies with disorder type .


Retrospective and single-blinded .


In this study , @ patients with a single voice disorder diagnosis of either benign vocal fold lesions ( lesions ) , primary muscle tension dysphonia ( MTD-@ ) , vocal fold atrophy ( atrophy ) or unilateral vocal fold paralysis ( UVFP ) underwent baseline testing , a single intervention-type ( phonosurgery/voice therapy ) , and follow-up testing at uniform time points .


Ten patients per diagnosis group were analyzed before and after treatment .


Time - and frequency-based acoustic measures taken from vowels and sentences as well as patient-perceptual analysis ( Voice Handicap Index-@ ) were reviewed .


Statistically significant improvements were observed for three of four groups .


Patients with muscle tension dysphonia displayed an improvement in Cepstral Spectral Index of Dysphonia speech ( CSID ) ( P < @ ) .


Patients with lesions had improved Voice Handicap Index-@ ( P < @ ) , cepstral peak prominence ( CPP ) vowel standard deviation ( P < @ ) , and CPP speech ( P < @ ) .


Patients with atrophy did not demonstrate significant improvement in any measure .


Patients with unilateral vocal fold paralysis showed an improvement in CSID speech ( P < @ ) and CPP speech ( P < @ ) .


In addition , strong effect sizes were observed for many of the acoustic parameters studied .


For all groups except atrophy , treatment was successful in improving patient perception of voice handicap and/or some acoustic voice parameters .


A disorder-specific response to frequency-based acoustic measures was found .


Breakthrough cancer pain ( BTcP ) is recognized as a clinically significant complication of chronic cancer pain with most BTcP episodes peaking in intensity within a few minutes and lasting for approximately @min .


Although a number of rapid-onset fentanyl preparations have been developed in the last decade , BTcP is still typically managed through the use of rescue doses of oral morphine but a comparative study of sublingual fentanyl and oral morphine is still lacking .


The aim of this study was to determine the efficacy , tolerability , and patient satisfaction of sublingual fentanyl citrate ( SLF ) and oral morphine solution ( OM ) in the treatment of BTcP .


In this prospective , longitudinal , controlled-study , @ patients with BTcP were allocated to receive oral morphine ( OM ) or sublingual fentanyl ( SLF ) .


Pain intensity level on a @-@ numerical rating visual analog scale ( VAS ) , frequency of BTcP throughout the day , onset of relief ( @-@ , @-@ , @-@ , or over @min ) , time required for dose titration , patient satisfaction and adverse effects were assessed at @ , @ , @ , and @days after starting the treatment .


Mean doses of opioids for BTcP were @ g ( SLF ) and @ mg ( OM ) .


The mean pain intensity levels were significantly lower with SLF than OM at @days ( @ vs. @ ; p = @,@ ) , @days ( @ vs. @ , p < @ ) , @days ( @ vs. @ , p < @ ) , and @days ( @ vs. @ , p < @ ) .


SLF provided significantly faster relief for BTcP than OM ( p < @ ) with a shorter dose titration period ( mean @ vs. @ days ; p < @ ) and better satisfaction scores and with a very good safety profile .


Administration of SLF might provide a more effective treatment option than oral morphine for BTcP .


Four cycles of etoposide plus cisplatin and accelerated hyperfractionated thoracic radiotherapy ( AHTRT ) is the standard of care for limited-stage small-cell lung cancer ( SCLC ) .


Irinotecan plus cisplatin significantly improved overall survival compared with etoposide plus cisplatin for extensive-stage SCLC .


We compared these regimens for overall survival of patients with limited-stage SCLC .


We did this phase @ study in @ institutions in Japan .


Eligibility criteria included age @-@ years , Eastern Cooperative Oncology Group ( ECOG ) performance status of @-@ , and adequate organ functions .


Eligible patients with previously untreated limited-stage SCLC received one cycle of etoposide plus cisplatin ( intravenous etoposide @ mg/m ( @ ) on days @-@ ; intravenous cisplatin @ mg/m ( @ ) on day @ ) plus AHTRT ( @ Gy twice daily , @ days a week , total @ Gy over @ weeks ) .


Patients without progressive disease following induction therapy were randomised ( @:@ ratio , using a minimisation method with biased-coin assignment balancing on ECOG performance status -LSB- @ vs @ -RSB- , response to induction chemoradiotherapy -LSB- complete response plus near complete response vs partial response and stable disease -RSB- , and institution ) to receive either three further cycles of consolidation etoposide plus cisplatin or irinotecan plus cisplatin ( intravenous irinotecan @ mg/m ( @ ) on days @ , @ , @ ; intravenous cisplatin @ mg/m ( @ ) on day @ ) .


Patients , physicians , and investigators were aware of allocation .


The primary endpoint was overall survival after randomisation ; primary analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT@ , and the UMIN Clinical Trials Registry , number C@ .


@ patients were enrolled between Sept @ , @ , and Oct @ , @ .


After induction etoposide plus cisplatin and AHTRT , @ patients were randomised to consolidation etoposide plus cisplatin ( n = @ ) or irinotecan plus cisplatin ( n = @ ) .


In the etoposide plus cisplatin group , median overall survival was @ years ( @ % CI @-@ @ ) .


In the irinotecan and cisplatin group , median overall survival was @ years ( @ % CI @-@ @ ) ; overall survival did not differ between the two groups ( hazard ratio @ -LSB- @ % CI @-@ @ -RSB- , one-sided stratified log-rank p = @ ) .


The most common adverse events of grade @ or @ were neutropenia ( @ -LSB- @ % -RSB- in the etoposide plus cisplatin group vs @ -LSB- @ % -RSB- in the irinotecan plus cisplatin group ) , anaemia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , thrombocytopenia ( @ -LSB- @ % -RSB- vs six -LSB- @ % -RSB- ) , febrile neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and diarrhoea ( two -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


There was one treatment-related adverse event leading to death in each group ( radiation pneumonitis in the etoposide plus cisplatin group ; brain infarction in the irinotecan plus cisplatin group ) .


Four cycles of etoposide plus cisplatin and AHTRT should continue to be the standard of care for limited-stage SCLC .


To compare the response with synthetic human parathyroid hormone ( PTH ) @-@ delivered by twice-daily injection vs insulin pump in children with severe congenital hypoparathyroidism due to calcium receptor mutation or autoimmune polyglandular syndrome type @ .


Children and young adults aged @-@ years with congenital hypoparathyroidism ( N = @ ) were randomized to receive PTH @-@ , delivered either by twice-daily subcutaneous injection or insulin pump for @ weeks , followed by crossover to the opposite delivery method .


The principal outcome measures were serum and urine calcium levels .


Secondary outcomes included serum and urine magnesium and phosphate levels and bone turnover markers .


PTH @-@ delivered via pump produced near normalization of mean serum calcium ( @ @ -LSB- pump -RSB- vs @ @ -LSB- injection -RSB- mmol/L , P < @ , normal @-@ @ mmol/L ) , normalized mean urine calcium excretion ( @ @ -LSB- pump -RSB- vs @ @ mmol/@ h/@ @ m ( @ ) , P = @ ) , and significantly reduced markers of bone turnover ( P < @ ) .


Serum and urine calcium and magnesium showed a biphasic pattern during twice-daily injection vs minimal fluctuation during pump delivery .


The PTH @-@ dosage was markedly reduced during pump delivery ( @ @ vs @ @ g/kg/d , P < @ ) , and magnesium supplements were also reduced ( P < @ ) .


Compared with twice-daily delivery , pump delivery of PTH @-@ provides more physiologic calcium homeostasis and bone turnover in children with severe congenital hypoparathyroidism .


Whole-body ischemia during out-of-hospital cardiac arrest triggers immediate activation of inflammatory systems leading to a sepsis-like syndrome .


The aim was to investigate the association between level of systemic inflammation and mortality in survivors after out-of-hospital cardiac arrest treated with targeted temperature management .


Post hoc analysis .


Single-center study of a prospective multicenter randomized study .


One hundred sixty-nine patients ( @ % ) with available blood samples out of @ patients included in the Target Temperature Management trial , randomly assigning patients to targeted temperature management at @C or @C .


None .


At baseline and @ , @ , and @ hours after out-of-hospital cardiac arrest , blood samples were obtained and screened for a battery of inflammatory markers .


Level of interleukin-@ , interleukin-@ , interleukin-@ , interleukin-@ , interleukin-@ , interleukin-@ , interleukin-@ , interleukin-@ , interleukin-@ , tumor necrosis factor - , interferon - , C-reactive protein , and procalcitonin were measured .


Mortality at @ days was evaluated by Cox analysis , and the predictive capability of inflammatory markers was evaluated by area under the curve .


Level of all inflammatory markers changed significantly within @ hours after out-of-hospital cardiac arrest ( all p values < @ ) , but only procalcitonin levels showed overall differences between nonsurvivors and survivors ( p = @ ) .


At baseline , interleukin-@ was independently associated with mortality , whereas both interleukin-@ levels ( hazard ratio = @ -LSB- @-@ @ -RSB- ; p = @ ) and procalcitonin levels ( hazard ratio = @ -LSB- @-@ @ -RSB- ; p = @ ) @ hours after out-of-hospital cardiac arrest were associated with @-day mortality with no interactions between targeted temperature management group and levels of interleukin-@ ( p = @ ) or procalcitonin ( p = @ ) .


None of the other inflammatory markers were independently associated with mortality .


Area under the curve for procalcitonin and interleukin-@ , @ hours after out-of-hospital cardiac arrest , were @ and @ , respectively .


Level of inflammation , assessed by interleukin-@ and procalcitonin , was independently associated with increased mortality with the highest discriminative value obtained @ hours after out-of-hospital cardiac arrest .


Interventions aiming at decreasing level of inflammation as a way to improve outcome may be investigated in future studies .


Candida spp .


are frequently recovered from endotracheal secretions in critically ill patients suspected of having ventilator-associated pneumonia .


Observational studies reported an association with worse clinical outcomes but the effect of antifungal therapy in these patients remains unclear .


We designed this pilot study to assess the feasibility of a larger trial and to evaluate inflammatory profiles and clinical outcomes in these patients .


We conducted a double-blind , placebo-controlled , multicenter pilot randomized trial of antifungal therapy in critically ill patients with a clinical suspicion of ventilator-associated pneumonia with positive airway secretion specimens for Candida spp .


We also included an observational group without Candida spp .


in their airway secretions .


We measured recruitment rate , inflammatory and innate immune function profiles over time , and clinical outcomes .


We recruited @ patients into the randomized trial and @ patients into the observational study .


Markers of inflammation and all clinical outcomes were comparable between placebo and antifungal treatment group at baseline and over time .


At baseline , plasma TNF - levels were higher in patients with VAP and Candida compared to the observational group ( mean SD ) ( @ @ versus @ @ pg/ml , p = @ ) and these patients had lower innate immune function as evidenced by reduced whole blood ex vivo LPS-induced TNF - production capacity ( @ @ versus @,@ @,@ pg/ml , p = @ ) .


This study does not provide evidence to support a larger trial examining the efficacy of empiric antifungal treatment in patients with a clinical suspicion of ventilator-associated pneumonia and Candida in the endotracheal secretions .


The presence of Candida in the lung may be associated with persistent inflammation and immunosuppression .


The purpose of the current study was to investigate whether an informative Web site is effective at producing higher scores for an individual 's knowledge of Alzheimer 's disease ( AD ) relative to those who do not visit a Web site .


A total of @ participants completed the study on Amazon 's Mechanical Turk ; half were randomly assigned to visit alz.org , while a control group did not .


Both groups were given the AD Knowledge Scale ( ADKS ) to assess their knowledge of AD .


Participants who visited alz.org scored significantly higher on the ADKS than those in the control group .


Participants who were health care workers demonstrated higher scores than others in the experimental condition .


Findings indicate that the Alzheimer 's Association Web site is effective at producing higher scores for AD knowledge relative to no Web site at all and that it is especially helpful for health care workers compared to those who are not health care workers .


This study aimed to examine the relationship between respiratory health of Malaysian adolescents with secondhand smoke ( SHS ) exposure and smoke-free legislation ( SFL ) implementation .


A total of @ students from @ schools across comprehensive - and partial-SFL states were recruited .


SHS exposures and respiratory symptoms were assessed via questionnaire .


Prenatal and postnatal SHS exposure information was obtained from parental-completed questionnaire .


The prevalence of respiratory symptoms was : @ % ever wheeze , @ % current wheeze , @ % exercise-induced wheeze , @ % nocturnal cough , and @ % self-reported asthma .


SHS exposure was most frequently reported in restaurants .


Hierarchical logistic regression indicates living in a comprehensive-SFL state was not associated with a lower risk of reporting asthma symptoms .


SHS exposure in public transport was linked to increased risk for wheeze ( Adjusted Odds Ratio ( AOR ) @ ; @ % confidence interval ( CI ) , @-@ @ ) and current wheezing ( AOR @ ; @ % CI , @-@ @ ) .


Adolescents continue to be exposed to SHS in a range of public venues in both comprehensive - and partial-SFL states .


Respiratory symptoms are common among those reporting SHS exposure on public transportation .


Non-compliance with SFL appears to be frequent in many venues across Malaysia and enforcement should be given priority in order to reduce exposure .


The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic .


Well structured , IT-based educational programmes ( eLearning ) often ensure quality and may make training more affordable and accessible .


The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients .


In a cluster-randomized intervention trial , the nursing personnel on @ wards were randomly assigned to eLearning ( intervention ) or training-as-usual ( control ) groups .


The eLearning course comprised six modules with specific topics ( legal and ethical issues , behaviour-related factors , therapeutic relationship and self-awareness , teamwork and integrating knowledge with practice ) and specific learning methods .


The rates ( incidents per @ occupied bed days ) and durations of the coercion incidents were examined before and after the course .


A total of @ coercion incidents ( @ seclusions -LSB- @ % -RSB- and @ incidents involving the use of mechanical restraints -LSB- @ % -RSB- ) were recorded on the study wards during the data collection period .


On the intervention wards , there were no statistically significant changes in the rates of seclusion and mechanical restraint .


However , the duration of incidents involving mechanical restraints shortened from @ to @ h ( median ) ( P < @ ) .


No statistically significant changes occurred on the control wards .


After our eLearning course , the duration of incidents involving the use of mechanical restraints decreased .


However , more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements .


The eLearning course deserves further development and further studies .


The duration of coercion incidents merits attention in future research .


To evaluate whether pretreatment dehydroepiandrosterone ( DHEA ) supplementation improves ovarian response markers , ovarian response to standard low-dose gonadotropin stimulation , and in vitro fertilization ( IVF ) outcomes in poor responders .


Randomized , double-blind , placebo-controlled pilot study .


Tertiary reproductive medicine unit .


Thirty-two women with anticipated poor ovarian response .


Randomization into DHEA group ( n = @ ) receiving GNC ( @ mg three times a day ) or placebo ( n = @ ) starting from at least @ weeks before the scheduled IVF treatment according to a computer-generated randomization list .


Measurement of monthly ovarian response markers , including antral follicle count ( AFC ) , serum antimllerian hormone ( AMH ) , and follicle-stimulating hormone ( FSH ) levels ; comparison of ovarian response to a standard dose of gonadotropin stimulation at week @ and IVF outcomes ; and AFC after @ weeks ( primary outcome ) .


The DHEA supplementation resulted in statistically significantly higher serum DHEA-S , free androgen index , and follicular DHEA-S levels .


No statistically significant differences in the ovarian response markers ( AFC , AMH , or FSH ) , the ovarian response to standard-dose gonadotropin stimulation , or IVF outcomes were found between the two groups .


No statistically significant improvement in ovarian response markers , ovarian response to standard dose gonadotropin stimulation , or IVF outcomes was found in poor responders receiving pretreatment DHEA .


To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women .


A randomised double-blind placebo-controlled trial was conducted .


Four hundred and sixty five participants ( @ males ; age @ @ y ( mean SD ) and @ females ; age @ @ y ) were assigned to one of three groups : Group @ - Bifidobacterium animalis subsp .


lactis Bl-@ ( Bl-@ ) @ @ ( @ ) colony forming units per day , CFU per day , Group @ - Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp .


lactis Bi-@ ( NCFM & Bi-@ ) @ @ ( @ ) CFU each per day ) or Group @ - placebo mixed in a drink .


The risk of an upper respiratory illness episode was significantly lower in the Bl-@ group ( hazard ratio @ ; @ % confidence interval @-@ @ ; P = @ ) compared to placebo .


There was no significant difference in illness risk between the NCFM & Bi-@ group ( hazard ratio @ ; @-@ @ ; P = @ ) and the placebo group .


There was a @ and @ month delay in the median time to an illness episode in the Bl-@ and NCFM & Bi-@ groups respectively compared to placebo ( placebo @ months ; Bl-@ @ months ; NCFM & Bi-@ @ months ) .


There were insufficient GI illness episodes for analysis .


The NCFM & Bi-@ group but not the Bl-@ group undertook significantly more physical activity ( @ % ; @ % -@ % ; P < @ ) than the placebo group .


The probiotic Bl-@ appears to be a useful nutritional supplement in reducing the risk of URTI in healthy physically-active adults .


Hot flushes and night sweats ( vasomotor symptoms ) are common menopausal symptoms , often causing distress , sleep deprivation and reduced quality of life .


Although hormone replacement therapy is an effective treatment , there are concerns about serious adverse events .


Non-hormonal pharmacological therapies are less effective and can also cause adverse effects .


Complementary therapies , including acupuncture , are commonly used for menopausal vasomotor symptoms .


While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive , acupuncture has a low risk of adverse effects , and two small studies suggest it may be more effective than non-insertive sham acupuncture .


Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women .


Our current study design is informed by methods tested in a pilot study .


This is a stratified , parallel , randomised sham-controlled trial with equal allocation of participants to two trial groups .


We are recruiting @ menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency .


Exclusion criteria include breast cancer , surgical menopause , and current hormone replacement therapy use .


Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive ( blunt ) needles for ten treatments over eight weeks .


Participants are blinded to treatment allocation .


Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures .


The primary outcome measure is hot flush score , assessed using the validated Hot Flush Diary .


Secondary outcome measures include health-related quality of life , anxiety and depression symptoms , credibility of the sham treatment , expectancy and beliefs about acupuncture , and adverse events .


Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy .


Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms .


If found to be effective and safe , acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms .


Insertion of a ventriculoperitoneal shunt ( VPS ) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK , but failures caused by infection occur in approximately @ % of primary cases .


VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service .


Antibiotic-impregnated ( rifampicin and clindamycin ) and silver-impregnated VPS have been developed to reduce infection rates .


Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection , there are no randomised controlled trials ( RCTs ) to support their routine use .


Overall , @,@ patients will be recruited from @ regional neurosurgical units in the UK and Ireland .


Patients of any age undergoing insertion of their first VPS are eligible .


Patients with previous indwelling VPS , active and on-going cerebrospinal fluid ( CSF ) or peritoneal infection , multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy , and ventriculoatrial or ventriculopleural shunt planned will be excluded .


Patients will be randomised @:@:@ to either standard silicone ( comparator ) , antibiotic-impregnated , or silver-impregnated VPS .


The primary outcome measure is time to VPS infection .


Secondary outcome measures include time to VPS failure of any cause , reason for VPS failure ( infection , mechanical failure , or patient failure ) , types of bacterial VPS infection ( organism type and antibiotic resistance ) , and incremental cost per VPS failure averted .


The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial ( the BASICS trial ) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS .


The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future .


To study the effect of inspiration on airway dimensions measured in voluntary inspiration breath-hold examinations .


@ subjects with normal spirometry were selected from the Danish Lung Cancer Screening Trial .


Subjects were examined annually for five years with low-dose CT. .


Automated software was utilized to segment lungs and airways , identify segmental bronchi , and match airway branches in all images of the same subject .


Inspiration level was defined as segmented total lung volume ( TLV ) divided by predicted total lung capacity ( pTLC ) .


Mixed-effects models were used to predict relative change in lumen diameter ( ALD ) and wall thickness ( AWT ) in airways of generation @ ( trachea ) to @ and segmental bronchi ( R@-R@ and L@-L@ ) from relative changes in inspiration level .


Relative changes in ALD were related to relative changes in TLV/pTLC , and this distensibility increased with generation ( p < @ ) .


Relative changes in AWT were inversely related to relative changes in TLV/pTLC in generation @ -- @ ( p < @ ) .


Segmental bronchi were widely dispersed in terms of ALD ( @ mm ) , AWT ( @ mm ) , and distensibility ( @ % ) .


Subjects who inspire more deeply prior to imaging have larger ALD and smaller AWT .


This effect is more pronounced in higher-generation airways .


Therefore , adjustment of inspiration level is necessary to accurately assess airway dimensions .


Airway lumen diameter increases and wall thickness decreases with inspiration .


The effect of inspiration is greater in higher-generation ( more peripheral ) airways .


Airways of generation @ and beyond are as distensible as lung parenchyma .


Airway dimensions measured from CT should be adjusted for inspiration level .


Clopidogrel is indicated for the treatment and prevention of peripheral vascular , cerebrovascular , and coronary artery diseases .


This clinical trial was designed to demonstrate that clopidogrel napadisilate ( CN ) is not inferior to clopidogrel bisulfate ( CB ) with respect to its effectiveness in inhibiting platelet aggregation .


This @ week multi-center , prospective , open-label , randomized trial was conducted at five clinical centers in South Korea .


Patients were randomized into the @ mg CN group or the @mg CB group .


Platelet aggregation was assessed by the VerifyNow assay .


The primary outcome was the difference of the percentage P@Y@ inhibition and the secondary outcome was the baseline and change in P@Y@ reaction units ( PRU ) .


There was no significant difference in the percentage P@Y@ inhibition ( CN vs. CB , @ @ % vs. @ @ % , p = @ ) .


The mean difference of the percentage P@Y@ inhibition between groups was @ % , their two-sided @ % confidence interval was -@ % to @ % , and the lower bound ( -@ % ) was greater than the acceptable non-inferiority margin of -@ % .


The baseline PRU was @ @ in the CN group and @ @ in the CB group ( p = @ ) , and the change in the PRU was -@ @ in the CN group and @ @ in the CB group ( p = @ ) .


Four subjects experienced AEs ( @ % , @ events ) in the CN group and @ subjects ( @ % , @ events ) in the CB group without statistical significance ( p = @ ) .


With respect to serious adverse events , @ events were reported in @ subjects , @ in each group .


Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability , and there were no clinically significant adverse events .


Pharmacists may improve medication-related outcomes during transitions of care .


The aim of the Iowa Continuity of Care Study was to determine if a pharmacist case manager ( PCM ) providing a faxed discharge medication care plan from a tertiary care institution to primary care could improve medication appropriateness and reduce adverse events , rehospitalization and emergency department visits .


Design .


Randomized , controlled trial of @ participants assigned to enhanced , minimal and usual care groups conducted @ to @ .


Subjects .


Participants with cardiovascular-related conditions and/or asthma or chronic obstructive pulmonary disease were recruited from the University of Iowa Hospital and Clinics following admission to general medicine , family medicine , cardiology or orthopedics .


Intervention .


The minimal group received admission history , medication reconciliation , patient education , discharge medication list and medication recommendations to inpatient team .


The enhanced group also received a faxed medication care plan to their community physician and pharmacy and telephone call @-@ days post-discharge .


Participants were followed for @ days post-discharge .


Main Outcomes and Measures .


Medication appropriateness index ( MAI ) , adverse events , adverse drug events and post-discharge healthcare utilization were compared by study group using linear and logistic regression , as models accommodating random effects due to pharmacists indicated little clustering .


Study groups were similar at baseline and the intervention fidelity was high .


There were no statistically significant differences by study group in medication appropriateness , adverse events or adverse drug events at discharge , @-day and @-day post-discharge .


The average MAI per medication as @ at discharge and increased to @ at @ days , and this was true across all study groups .


Post-discharge , about @ % of all participants experienced an adverse event , and this did not differ by study group ( p > @ ) .


Almost one-third of all participants had any type of healthcare utilization within @ days post-discharge , where @ % of all participants had a @-day readmission .


Healthcare utilization post-discharge was not statistically significant different at @ or @ days by study group .


The pharmacist case manager did not affect medication use outcomes post-discharge perhaps because quality of care measures were high in all study groups .


Pegloticase is approved in the US for treatment of refractory chronic gout .


Since chronic kidney disease ( CKD ) is common in these patients , we conducted a post-hoc analysis of @ replicate phase @ trials and the subsequent open-label extension study to determine the effects of pegloticase on renal function in patients with CKD stages @ and @ , as well as the effects of renal dysfunction on pegloticase efficacy and safety .


Patients with renal insufficiency were randomized to pegloticase @mg every @ weeks ( n = @ ) , pegloticase @mg every @ weeks ( n = @ ) , or placebo ( n = @ ) for @ months as defined by the study protocols .


Renal function was assessed by estimated glomerular filtration rate ( eGFR ) .


All patients completing the randomized trials could participate in an open-label extension study for a further @ years .


Uric acid response , the primary end point in the trials , was plasma uric acid < @ mg/dl for @ % of months @ and @ .


Mean eGFR in both pegloticase dosing cohorts remained constant over the randomized treatment phase and long-term open-label extension study .


The number of patients achieving uric acid response was similar across CKD stages ( @ % stage @ , @ % stage @ , @ % stage @ , and @ % stage @ , respectively , P = @ ) .


There was no difference in the pegloticase safety profile based on CKD stage .


Pegloticase treatment does not impact eGFR in CKD patients and response to pegloticase is independent of CKD stage .


The effect of positive vs. negative comments ( praise vs. criticism ) on trainees ' subsequent cognitive and technical performance is unknown , but of potential importance .


We performed a randomized trial of giving either praise or criticism during simulated normal vaginal deliveries ( using a high-fidelity birthing simulator ) to assess the differential effect of these types of comments on students ' cognitive and technical performance , and perceived confidence after their learning experience .


Medical and nursing students underwent stratified randomization to praise or criticism .


Students ( n = @ ) initially participated in a teaching demonstration and practiced normal spontaneous vaginal delivery using a birthing simulator .


A baseline assessment of cognitive and technical skills , and of self-confidence , was followed by a second simulation during which positive or negative comments were given using standardized scripts .


Cognitive performance , technical performance and confidence measures were then scored again .


Cognitive and technical performance scores in the `` praise '' group improved significantly by @ ( P = @ ) and @ ( P = @ ) , respectively , while those in the `` criticism '' group remained unchanged .


The self-reported confidence scores did not show any significant change from baseline in either group .


Praise strengthens students ' cognitive and technical performances , while criticism does not .


Intradermal MVA@A , a candidate vaccine against tuberculosis , induces high amounts of Ag@A-specific CD@ T cells in adults who have already received the BCG vaccine , but aerosol delivery of this vaccine might offer immunological and logistical advantages .


We did a phase @ double-blind trial to compare the safety and immunogenicity of aerosol-administered and intradermally administered MVA@A METHODS : In this phase @ , double-blind , proof-of-concept trial , @ eligible BCG-vaccinated healthy UK adults were randomly allocated ( @:@ ) by sequentially numbered , sealed , opaque envelopes into two groups : aerosol MVA@A and intradermal saline placebo or intradermal MVA@A and aerosol saline placebo .


Participants , the bronchoscopist , and immunologists were masked to treatment assignment .


The primary outcome was safety , assessed by the frequency and severity of vaccine-related local and systemic adverse events .


The secondary outcome was immunogenicity assessed with laboratory markers of cell-mediated immunity in blood and bronchoalveolar lavage samples .


Safety and immunogenicity were assessed for @ weeks after vaccination .


Immunogenicity to both insert Ag@A and vector modified vaccinia virus Ankara ( MVA ) was assessed by ex-vivo interferon - ELISpot and serum ELISAs .


Since all participants were randomised and vaccinated according to protocol , our analyses were per protocol .


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


Both administration routes were well tolerated and immunogenic .


Respiratory adverse events were rare and mild .


Intradermal MVA@A was associated with expected mild local injection-site reactions .


Systemic adverse events did not differ significantly between the two groups .


Three participants in each group had no vaccine-related systemic adverse events ; fatigue ( @/@ -LSB- @ % -RSB- ) and headache ( @/@ -LSB- @ % -RSB- ) were the most frequently reported symptoms .


Ag@A-specific systemic responses were similar across groups .


Ag@A-specific CD@ T cells were detected in bronchoalveolar lavage cells from both groups and responses were higher in the aerosol group than in the intradermal group .


MVA-specific cellular responses were detected in both groups , whereas serum antibodies to MVA were only detectable after intradermal administration of the vaccine .


Further clinical trials assessing the aerosol route of vaccine delivery are merited for tuberculosis and other respiratory pathogens .


We recently demonstrated a beneficial effect of metformin compared with glipizide in type @ diabetic patients regarding cardiovascular outcomes for @-year treatment in the SPREAD-DIMCAD study .


However , the potential mechanism for the clinical effects remains unclear .


Here , we performed a comprehensive lipidomics study to evaluate the different lipid metabolites in serum samples obtained from participants in this study .


Liquid chromatography-quadrupole time of flight-mass spectrometry was used to evaluate the different lipid metabolites in serum samples obtained from the participants ( @ patients in glipizide group and @ patients in metformin group ) before and after each year of treatment ( at @ -LSB- baseline -RSB- , @ , @ , and @ years of study drug administration ) .


A total of @ serum lipid molecular species was identified and quantified .


During treatment , metformin induced a substantially greater change in serum lipid species compared with glipizide , especially at the @ - and @-year time points ( with @ , @ , and @ lipid species being significantly different between the groups after each year of treatment -LSB- @ , @ , or @ years -RSB- , P < @ ) .


Among the significantly changed lipid species , three lipid metabolites were linked to long-term composite cardiovascular events ( adjusted P < @ ) .


After treatment , triacylglycerols ( TAGs ) of a relatively higher carbon number showed a clearly increased trend in metformin group compared with the glipizide group , whereas the changes in TAGs with different double bonds were minimal .


Our findings revealed the differential therapeutic effects of metformin and glipizide on comprehensive lipidomics , which were comparable with their different long-term effects on cardiovascular outcomes .


Proprioception is essential to motor control and joint stability during daily and sport activities .


Recent studies demonstrated that athletes have better joint position sense ( JPS ) when compared with controls matched for age , suggesting that physical training could have an effect on proprioception .


To evaluate the result of an @-week strength-training program on shoulder JPS and to verify whether using training intensities that are the same or divergent for the shoulder 's dynamic-stabilizer muscles promote different effects on JPS .


Randomized controlled clinical trial .


We evaluated JPS in a research laboratory and conducted training in a gymnasium .


A total of @ men , right handed and asymptomatic , with no history of any type of injury or shoulder instability .


For @ weeks , the participants performed the strength-training program @ sessions per week .


We used @ exercises ( bench press , lat pull down , shoulder press , and seated row ) , with @ sets each .


We measured shoulder JPS acuity by calculating the absolute error .


We found an interaction between group and time .


To examine the interaction , we conducted two @-way analyses of variance comparing groups at each time .


The groups did not differ at pretraining ; however , a difference among groups was noted posttraining .


Strength training using exercises at the same intensity produced an improvement in JPS compared with exercises of varying intensity , suggesting that the former resulted in improvements in the sensitivity of muscle spindles and , hence , better neuromuscular control in the shoulder .


Covered nitinol alloy self-expandable metal stents ( SEMSs ) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction .


In a randomized , multicenter trial , we compared stent patency , patient survival , and adverse events in patients with partly covered stents made from steel or nitinol .


A total of @ patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography ( ERCP ) to insertion of a steel or nitinol partially covered SEMS , with @ patients in each group.The primary outcome was confirmed stent failure during @ days of follow-up .


At @ days , the proportion of patients with patent stents was @ % in the steel group , compared with @ % in the nitinol group ( P = @ ) .


Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group , in @ versus @ patients ( P = @ ) .


Stent migration occurred in @ patients in the steel group and in @ patients in the nitinol group ( P = @ ) .


Median patient survival ( secondary outcome ) was @ days and @ days in the steel SEMS and nitinol SEMS groups , respectively ( P = @ ) .


The nitinol SEMS showed longer patency time , and the nitinol group had fewer patients with stent failure , compared with the steel SEMS group .


We could not detect any differences between the two groups regarding survival time , and regarding adverse event rate.Clinical trial registration : NCT @ .


To evaluate the combined effect of premedication of parecoxib sodium and local infiltration of ropivocaine on postoperative shoulder pain and incisional pain in patients undergoing diagnostic hysteroscopy and laparoscopy .


In the study , @ patients undergoing elective diagnostic hysteroscopy and laparoscopy were randomly allocated to two groups ( each with @ patients ) .


The patients in group @ were premedicated with @ mg parecoxib sodium ( diluted with @ mL normal saline ) , and @ % ropivacaine ( @ mL ) were infiltrated around the incision site before establishment of CO@ pneumoperitoneum .


The patients in group @ received @ mL normal saline intraveniously before anesthesia induction , and infiltration of @ % ropivacaine @ mL were also applied as group @ .


After anesthetic withdrawal , the patients ' postoperative anesthesia recovery time and the time point of opening eyes on verbal command were noted .


The intensities of postoperative shoulder pain and incisional pain were evaluated at @ , @ , @ , @ , @ , @ , and @ h after surgery .


The postoperative analgesic requirement was met by administration of tramadol .


Compared with group @ , the incidence of postoperative shoulder pain was less in group @ ( @ % vs. @ % , P = @ ) , and the occurence of severe pain was lower ( @ vs. @ , P = @ ) .


The numerical rating scales ( NRS ) of right shoulder pain of group @ were significantly reduced than those of group @ at @ h postoperatively -LSB- @ ( @ , @ ) vs. @ ( @ , @ ) , P = @ -RSB- .


Left shoulder pain did not appear at @ h and @ h in both groups , while at @ h and @ h postoperatively , the NRS scores of group @ were lower than those of group @ -LSB- @ ( @ , @ ) vs. @ ( @ , @ ) , P = @ ; @ ( @ , @ ) vs. @ ( @ , @ ) , P = @ -RSB- .


The dynamic and static abdominal pain scores of group @ were significantly decreased than those of group @ in post-anesthesia care unit ( PACU ) after surgery ( P = @ , P = @ ) .


The NRS scores of static abdominal pain of group @ were significantly reduced than those of group @ at @ h and @ h postoperatively ( P = @ , P = @ ) .


More patients in group @ needed tramadol within @ h postoperatively ( @ vs. @ , P = @ ) .


Premedication of parecoxib sodium combined with local infiltration of ropinvocaine before incision could significantly reduce the postoperative shoulder pain and incisional pain as well as reduce opioid consumption in patients undergoing diagnostic hysteroscopy and laparoscopy .


The use of live attenuated varicella vaccine ( Varilrix ( ) ) as an adjuvant treatment in severe cases of psoriasis has recently been postulated .


Its efficacy raised questions regarding its possible mechanisms of action .


To compare the efficacy and safety of combining Varilrix ( ) and cyclosporine to cyclosporine alone in the treatment of severe psoriasis .


Furthermore , to study the expression of T helper ( Th ) @ and T regulatory ( Tregs ) cells before and after therapy .


This randomized controlled trial included @ psoriatic patients , randomly divided into @ groups ( A and B ) .


All patients received cyclosporine at a daily dose of @ mg/kg/day .


In addition , group A received @ doses of Varilrix ( ) once/@ weeks , and group B received @ doses of subcutaneous saline .


Skin biopsies were obtained from all patients before and after therapy and from all controls for estimation of interleukin ( IL ) -@ , IL-@ and Forkhead boxP@ ( FoxP@ ) using RT-PCR .


Group A patients showed a significantly higher % of clinical improvement ( P = @ ) , which occurred earlier than group B.


At baseline , levels of IL-@ and IL-@ were significantly higher while the level of FoxP@ was significantly lower in patients ( P < @ ) compared to controls .


After therapy , both groups showed significant reductions in both IL-@ and IL-@ levels , and significant elevation in FoxP@ ( P < @ ) .


This change was significantly more evident in group A patients .


Live attenuated varicella vaccine could play a role in the treatment of psoriasis when combined with low dose cyclosporine through accentuating the influence on the Th@/Treg balance .


Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge .


The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial .


Breast cancer patients in Edmonton , Vancouver , and Ottawa , Canada receiving chemotherapy ( N = @ ) were randomized to a standard dose of @-@ minutes of aerobic exercise ( STAN ) , a higher dose of @-@ minutes of aerobic exercise ( HIGH ) , or a higher dose of @-@ minutes of combined aerobic and resistance exercise ( COMB ) .


Predictors included demographic , medical , fitness , and quality of life variables .


Exercise adherence was measured as the percentage of supervised exercise sessions completed .


Overall adherence to the supervised exercise sessions was @ % ( SD = @ % ) .


In a multivariate regression model , six independent predictors explained @ % ( p < @ ) of the variance in exercise adherence .


Higher exercise adherence was achieved by breast cancer patients in Vancouver ( p < @ ) , with fewer endocrine symptoms ( p = @ ) , randomized to STAN ( p = @ ) , with fewer exercise limitations ( p = @ ) , receiving shorter chemotherapy protocols ( p = @ ) , and with higher VO@peak ( p = @ ) .


Disease stage ( p for interaction = @ ) and body mass index ( p for interaction = @ ) interacted with group assignment to predict adherence .


For disease stage , patients with stage I/IIa disease adhered equally well to all three exercise interventions whereas patients with stage IIb/III disease adhered better to the STAN intervention than the two higher dose exercise interventions .


For body mass index , healthy weight patients adhered equally well to all three exercise interventions whereas overweight patients adhered best to STAN and worst to COMB ; and obese patients adhered best to STAN and worst to HIGH .


Determinants of exercise adherence in breast cancer patients receiving chemotherapy are multidisciplinary and may vary by the exercise prescription .


A live oral cholera vaccine VA @ developed from a non-toxigenic Vibrio cholerae O@ El Tor strain using ctxB gene insertion was further developed into a clinical product following cGMP and was evaluated in a double-blind randomized placebo controlled parallel group two arm trial with allocation ratio of @ for safety and immunogenicity in men and women aged @-@ years from Kolkata , India .


A lyophilized dose of @ CFU ( n = @ ) or a placebo ( n = @ ) reconstituted with a diluent was administered within @ minutes of drinking @ ml of a buffer solution made of sodium bicarbonate and ascorbic acid and a second dose on day @ .


The vaccine did not elicit any diarrhea related adverse events .


Other adverse events were rare , mild and similar in two groups .


One subject in the vaccine group excreted the vaccine strain on the second day after first dose .


The proportion of participants who seroconverted ( i.e. had @-folds or higher rise in reciprocal titre ) in the vaccine group were @ % ( @ % CI : @ % -@ % ) at both @ days ( i.e. after @st dose ) and @ days ( i.e. after @nd dose ) .


None of the placebo recipients seroconverted .


Anti-cholera toxin antibody was detected in very few recipients of the vaccine .


This study demonstrates that VA @ at a single dose of @ is safe and immunogenic in adults from a cholera endemic region .


No additional benefit after two doses was seen .


The objective of this study was to evaluate the efficacy of belinostat , a histone deacetylase inhibitor , when added to paclitaxel/carboplatin in the empiric first-line treatment of patients with carcinoma of unknown primary site ( CUP ) .


In this randomized phase @ trial , previously untreated patients with CUP were randomized to receive belinostat plus paclitaxel/carboplatin ( group A ) or paclitaxel/carboplatin alone ( group B ) repeated every @ days .


Patients were re-evaluated every @ cycles , and those without disease progression continued treatment for @ cycles .


Patients in group A then continued receiving single-agent belinostat , whereas patients in group B stopped treatment .


The primary endpoint was progression-free survival ( PFS ) : The authors postulated that the addition of belinostat would improve PFS from @ months ( expected with paclitaxel/carboplatin ) to @ months .


In total , @ patients were randomized ( group A , n = @ ; group B , n = @ ) , and the demographics and disease characteristics were balanced between the @ groups .


The addition of belinostat to paclitaxel/carboplatin did not improve PFS ( group A , @ months -LSB- @ % confidence interval , @-@ @ months -RSB- ; group B , @ months -LSB- @ % confidence interval , @-@ @ months -RSB- ; P = @ ) .


Overall survival was @ months for group A versus @ months for group B ( P = @ ) .


The response rate favored the belinostat group ( @ % vs @ % ; P = @ ) .


Belinostat resulted in a modest increase in treatment toxicity .


The addition of belinostat to paclitaxel/carboplatin did not improve the PFS of patients with CUP who were receiving first-line therapy , although the patients who received belinostat had a higher investigator-assessed response rate .


Future trials in CUP should focus on specific subsets , defined either by the predicted tissue of origin or by the identification of targetable molecular abnormalities .


Epidemiological and toxicological evidence suggests lower risk of smokeless tobacco ( ST ) products compared to cigarettes .


Less is known , however , about consumer perceptions and use of novel forms of ST , including snus and dissolvable tobacco .


In this study , we conducted in-person experimental auctions in Buffalo , NY , Columbia , SC , and Selinsgrove , PA with @ smokers to test the impact of information and product trials on smokers ' preferences .


Auctions were conducted between November @-November @ .


We found no evidence of an impact of product trials on demand in our auctions .


Anti-ST information increased demand for cigarettes when presented alone , but when presented with pro-ST information it decreased demand for cigarettes .


It did not decrease demand for ST products .


Anti-smoking information increased demand for ST products , but did not affect cigarette demand .


These findings suggest that credible and effective communications about tobacco harm reduction should reinforce the negative effects of smoking .


To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH-LUTS ) with tadalafil using two definitions of response .


Post hoc integrated analysis of four placebo-controlled studies in men ( aged @ years ; International Prostate Symptom Score -LSB- IPSS -RSB- of @ ; maximum urinary flow rate -LSB- Q ( max ) -RSB- of @ to @ mL/s ) with BPH-LUTS randomised to tadalafil @ mg ( @ patients ) or placebo ( @ ) for @ weeks after a @-week placebo run-in .


Responders were defined as having a total IPSS improvement of @ points or @ % from randomisation to endpoint ( Week @ ) .


Response status was calculated per patient , and relative benefit and odds ratio ( OR ) with @ % confidence interval ( CI ) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures .


Tadalafil @ mg once daily resulted in a significantly greater proportion of patients achieving a @-point IPSS improvement ( @ % and @ % for tadalafil and placebo patients , respectively -LSB- OR @ , @ % CI @ , @ ; P < @ -RSB- ) and achieving a @ % improvement in total IPSS randomisation to endpoint ( @ % and @ % for tadalafil and placebo patients , respectively -LSB- OR @ , @ % CI @ , @ ; P < @ -RSB- ) .


About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms , based on two different definitions of responder status .


We investigated the longitudinal association of depression , with and without cognitive dysfunction , with hemoglobin A@c ( HbA@c ) , systolic blood pressure ( SBP ) , and low-density lipoprotein ( LDL ) in a predominantly minority cohort .


There were @ participants .


Presence of depression was defined by a score @ on the Short-CARE depression scale .


We tested participants for executive dysfunction using the Color Trails Test ( CTT ) , part @ , and for memory dysfunction using the total recall task of the Selective Reminding Test ( TR-SRT ) .


We classified performance in these tests as abnormal based on standardized score cutoffs ( < @th percentile and one standard deviation below the sample mean ) .


Random effects models were used to compare repeated measures of the diabetes control measures between those with depression versus those without depression and ever versus never cognitively impaired .


Baseline depression was present in @ % of participants .


Over a median follow-up of @ years , depression was not related to worse HbA@c , SBP , or LDL .


The presence of ( @ ) abnormal performance on a test of executive function and depression ( n = @ ) or ( @ ) abnormal performance on a test of verbal recall and depression ( n = @ ) was also not associated with clinically significant worse change in diabetes control .


Depression , with or without low performance in tests of executive function and memory , may not affect clinically significant measures of diabetes control in the elderly .


To investigate the long-term safety and maintenance of efficacy of monotherapy with once-daily zonisamide versus twice-daily controlled-release carbamazepine for partial seizures in adults with newly diagnosed epilepsy .


Long-term , double-blind , extension study , conducted in patients completing a phase III noninferiority trial comparing zonisamide and carbamazepine monotherapy .


Patients continued their randomized treatment , with dosing adjusted according to tolerability/response ( zonisamide @-@ mg/day ; carbamazepine @-@ ,@ mg/day ) .


Safety assessments included treatment-emergent adverse events ( TEAEs ) and clinical laboratory parameters .


Efficacy assessments included retention rate and the proportion of patients remaining seizure free for @ months .


Overall , @ ( @ % ) of @ patients randomized to zonisamide and @ ( @ % ) of @ patients randomized to carbamazepine completed the study .


More than three-fourths of patients were exposed to > @ months of treatment .


For zonisamide versus carbamazepine , incidences were similar for TEAEs ( @ % vs. @ % ) , serious treatment-related TEAEs ( @ % vs. @ % ) , and TEAEs leading to withdrawal ( @ % vs. @ % ) .


The incidence of treatment-related TEAEs was @ % for zonisamide compared with @ % for carbamazepine , and the most frequently reported treatment-related TEAEs were decreased weight ( @ % vs. @ % ) , decreased appetite ( @ % vs. @ % ) , memory impairment ( @ % vs. @ % ) , and decreased hemoglobin level ( @ % vs. @ % ) .


Most TEAEs were of mild or moderate intensity .


There were no reports of Stevens-Johnson syndrome or toxic epidermal necrolysis in either group .


Zonisamide was associated with small-to-moderate decreases in bicarbonate levels from baseline ( mean -@ mm ) .


There were no reports of metabolic acidosis .


Retention rates were generally similar between treatment groups at all time points throughout the extension study .


The proportion of patients remaining seizure free for @ months was also similar for zonisamide ( @ % ) and carbamazepine ( @ % ) .


Once-daily zonisamide monotherapy demonstrated favorable long-term safety and maintenance of efficacy in treating partial seizures in adults with newly diagnosed epilepsy .


No new or unexpected safety findings emerged .


Inflammatory response during sepsis is incompletely understood due to small sample sizes and variable timing of measurements following the onset of symptoms .


The vasopressin in septic shock trial ( VASST ) compared the addition of vasopressin to norepinephrine alone in patients with septic shock .


During this study plasma was collected and @ cytokines measured in a @ patients at both baseline ( before treatment ) and @ hours .


Clinical features relating to both underlying health and the acute organ dysfunction induced by the severe infection were collected during the first @ days of admission .


Cluster analysis of cytokines identifies subgroups of patients at differing risk of death and organ failure .


Circulating cytokines and other signaling molecules were measured using a Luminex multi-bead analyte detection system .


Hierarchical clustering was performed on plasma values to create patient subgroups .


Enrichment analysis identified clinical outcomes significantly different according to these chemically defined patient subgroups .


Logistic regression was performed to assess the importance of cytokines for predicting patient subgroups .


Plasma levels at baseline produced three subgroups of patients , while @ hour levels produced two subgroups .


Using baseline cytokine data , one subgroup of @ patients showed a high level of enrichment for severe septic shock , coagulopathy , renal failure , and risk of death .


Using data at @ hours , a larger subgroup of @ patients that largely encompassed the @ baseline subgroup patients had a similar enrichment profile .


Measurement of two cytokines , IL@ and CSF@ and their product were sufficient to classify patients into these subgroups that defined clinical risks .


A distinct pattern of cytokine levels measured early in the course of sepsis predicts disease outcome .


Subpopulations of patients have differing clinical outcomes that can be predicted accurately from small numbers of cytokines .


Design of clinical trials and interventions may benefit from consideration of cytokine levels .


Nasal packing is usually performed to control bleeding after endoscopic sinus surgery ( ESS ) .


Although new packing materials have been developed , they still cause pain .


This study was designed to evaluate the effect of lidocaine-soaked packs on pain after ESS .


A prospective , randomized , double-blind controlled trial was conducted in @ patients with CRS undergoing ESS .


At the conclusion of the operation , @ % lidocaine-soaked biodegradable synthetic polyurethane foam and saline-soaked polyurethane foam were inserted in both nasal cavities of @ patients and @ control patients , respectively .


The same lidocaine or saline was reapplied into the nasal packs at postoperative @ hours .


Pain was evaluated using a visual analog scale at postoperative @ , @ , @ , @ , @ , and @ hour ( s ) .


The number of gauze that cleaned the blood around the nose was counted .


Heart rate , rhythm , and blood pressures were checked preoperatively and postoperatively to evaluate the influence of lidocaine on vital signs .


Postoperative pain decreased in lidocaine group at all of the postoperative time periods ( p < @ ) .


Lidocaine reduced postoperative bleeding at postoperative @ and @ hours .


Changes of blood pressure from preoperative values in the lidocaine group were not different from those in the control group ( p > @ ) .


Heart rate in the lidocaine group was more stable than that in the control group ( p < @ ) .


Lidocaine-soaked packs significantly reduced postoperative pain without serious changes on vital sign .


These findings suggest that topical lidocaine application to nasal packs could be a useful method to reduce pain during the early postoperative period after ESS .


The anti-influenza virus activity of green tea catechins has been demonstrated in experimental studies , but clinical evidence has been inconclusive .


School-aged children play an important role in the infection and spread of influenza in the form of school-based outbreaks .


Preventing influenza infection among students is essential for reducing the frequency of epidemics and pandemics .


As a non-pharmaceutical intervention against infection , gargling is also commonly performed in Asian countries but has not yet been extensively studied .


A randomized , open label , @-group parallel study of @ high school students ( @ to @ years of age ) was conducted for @ days during the influenza epidemic season from December @st , @ to February @th , @ , in @ high schools in Shizuoka Prefecture , Japan .


The green tea gargling group gargled @ times a day with bottled green tea , and the water gargling group did the same with tap water .


The water group was restricted from gargling with green tea .


The primary outcome measure was the incidence of laboratory-confirmed influenza using immunochromatographic assay for antigen detection .


@ participants were enrolled and @ participants completed the study ( @ in the green tea group and @ in the water group ) .


Multivariate logistic regression indicated no significant difference in the incidence of laboratory-confirmed influenza between the green tea group ( @ participants ; @ % ) and the water group ( @ participants ; @ % ) ( adjusted OR , @ ; @ % CI , @ to @ ; P = @ ) .


The main limitation of the study is the adherence rate among high school students was lower than expected .


Among high school students , gargling with green tea three times a day was not significantly more efficacious than gargling with water for the prevention of influenza infection .


In order to adequately assess the effectiveness of such gargling , additional large-scale randomized studies are needed .


The purpose of this study is to investigate the effects of urocortin-@ as adjunct therapy in acute decompensated heart failure ( ADHF ) .


Urocortin-@ produced favorable integrated effects in experimental heart failure but there are no equivalent human data .


We describe the first therapeutic study of urocortin-@ infusion in ADHF .


Fifty-three patients with ADHF were randomly assigned to @ ng/kg/min of urocortin-@ or placebo infusion for @ h as an adjunct therapy .


Changes in vital signs , plasma neurohormonal and renal indices during treatment were compared using repeated-measures analysis of covariance .


Ten patients in each arm underwent more detailed invasive hemodynamic evaluation .


Urocortin-@ produced greater falls in systolic blood pressure compared to placebo ( @ @ mm Hg , p < @ ) with nonsignificant increases in heart rate ( @ @ beats/min , p = @ ) and increased cardiac output ( @ @ l/min vs. -@ @ l/min , p < @ ) associated with a @ % reduction in calculated total peripheral resistance ( p = @ ) .


Falls in pulmonary artery and pulmonary capillary wedge pressures did not differ significantly between groups .


Urocortin-@ reduced urine volume and creatinine clearance during infusion but these returned to above baseline level in the @ h after infusion .


Plasma renin activity rose briefly with urocortin-@ coinciding with reductions in blood pressure ( p < @ ) .


B-type natriuretic peptide levels fell significantly over @ h with urocortin-@ ( p < @ ) but not with placebo .


Urocortin-@ infusion in ADHF markedly augmented cardiac output without significant reflex tachycardia .


Renal indices fell transiently concurrent with urocortin-@-induced reductions in blood pressure .


Further investigations are required to uncover the full potential of urocortin-@ in treating ADHF .


Many HIV-infected pregnant women identified during antenatal care ( ANC ) do not enroll in long-term HIV care , resulting in deterioration of maternal health and continued risk of HIV transmission to infants .


We performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya .


Twelve facilities were randomized to provide either integrated services ( ANC , prevention of mother-to-child transmission , and HIV care delivered in the ANC clinic ; n = @ intervention facilities ) or standard ANC services ( including prevention of mother-to-child transmission and referral to a separate clinic for HIV care ; n = @ control facilities ) .


There were high patient attrition rates over the course of this study .


Among study participants who enrolled in HIV care , there was @-month follow-up data for @ of @ ( @ % ) women and postpartum data for only @ of @ ( @ % ) women .


By @ months of age , @ of @ ( @ % ) infants at intervention sites and @ of @ ( @ % ) at control sites had tested for HIV -LSB- odds ratio ( OR ) @ , @ % confidence interval ( CI ) : @ to @ -RSB- ; @ % of infants tested HIV positive at intervention sites compared with @ % of infants at control sites ( OR @ , @ % CI : @ to @ ) .


The composite clinical/immunologic progression into AIDS was similar in both arms ( @ % vs. @ % , OR @ , @ % CI : @ to @ ) .


Despite the provision of integrated services , patient attrition was substantial in both arms , suggesting barriers beyond lack of service integration .


Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes .


It is still unclear whether D@ lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively .


The aim of this multicentre randomized trial was to compare D@ and D@ lymphadenectomy in the treatment of gastric cancer .


Between June @ and December @ , patients with gastric adenocarcinoma were assigned randomly to either D@ or D@ gastrectomy .


Intraoperative randomization was implemented centrally by telephone .


Primary outcome was overall survival ; secondary endpoints were disease-specific survival , morbidity and postoperative mortality .


A total of @ eligible patients were allocated to either D@ ( @ patients ) or D@ ( @ ) resection .


Morbidity ( @ versus @ per cent respectively ; P = @ ) and operative mortality ( @ versus @ per cent ; P = @ ) rates did not differ significantly between the groups .


Median follow-up was @ ( range @-@ @ ) years for surviving patients and @ ( @-@ @ ) years for those who died , and was not different in the two treatment arms .


There was no difference in the overall @-year survival rate ( @ versus @ per cent for D@ and D@ lymphadenectomy respectively ; P = @ ) .


Subgroup analyses showed a @-year disease-specific survival benefit for patients with pathological tumour ( pT ) @ disease in the D@ group ( @ per cent versus @ per cent for the D@ group ; P = @ ) , and for patients with pT@-@ status and positive lymph nodes in the D@ group ( @ per cent versus @ per cent for the D@ group ; P = @ ) .


No difference was found in overall @-year survival between D@ and D@ resection .


Subgroup analyses suggest that D@ lymphadenectomy may be a better choice in patients with advanced disease and lymph node metastases .


Patients with lymphoma are at higher-risk of secondary malignancies mainly due to effects of cancer therapy as well as frequent radiological surveillance .


We thus aimed to investigate the objective and subjective image quality as well as radiation exposure and risk of full-dose standard ( FDS ) , full-dose iterative ( FDI ) , and half-dose iterative ( HDI ) image reconstruction in patients with lymphoma .


In @ lymphoma patients , contrast-enhanced whole-body staging was performed on a dual-source CT. .


To acquire full-dose and half-dose CT data simultaneously , the total current-time product was equally distributed on both tubes operating at @ kV .


HDI reconstructions were calculated by using only data from one tube .


Quantitative image quality was assessed by measuring image noise in different tissues of the neck , thorax , and abdomen .


Overall diagnostic image quality was assessed using a @-point Likert scale .


Radiation doses and risks were estimated for a male and female reference person .


For all anatomical regions apart from the lungs image noise was significantly lower and the overall subjective image quality significantly better when using FDI and HDI instead of FDS reconstruction ( p < @ ) .


For the half-dose protocol , the risk to develop a radiation-induced cancer was estimated to be less than @ / @ % for an adult male/female .


Image quality of FDI and more importantly of HDI is superior to FDS reconstruction , thus enabling to halve radiation dose and risk to lymphoma patients .


The aim of this study was to investigate the potential benefits of an extract obtained from seeds/fruits of an Oleaceae ( Fraxinus excelsior L. ) on glucose homeostasis and associated metabolic markers in non-diabetic overweight/obese subjects .


This study was performed in @ participants ( @-@ years-old ; BMI @ kg/m ( @ ) ) .


The design was a longitudinal , randomized , crossover , double-blind , placebo-controlled @-week nutritional intervention .


The participants received daily @ capsules each containing either @ mg of an extract from Fraxinus excelsior L. seeds ( Glucevia ( ) ) or placebo capsules ( control ) in a random order for @ weeks with @ week of washout between treatments .


Moreover , they followed a balanced covert energy-restricted diet ( -@ % energy ) .


All variables were measured at the beginning and at the end of each period .


Compared to baseline , the administration of @ g of Glucevia ( ) for @ weeks resulted in significantly lower incremental glucose area under the curve ( -@ % ; p < @ ) , and significantly lower @ h blood glucose values ( -@ % ; p < @ ) following an oral glucose tolerance test .


No significant changes were found in the control group ( -@ % AUC , -@ % @h blood glucose ) .


Furthermore , significant differences were found between responses in the control and Glucevia ( ) groups with respect to serum fructosamine and plasma glucagon levels ( p < @ and p < @ , respectively ) .


Interestingly , administration of Glucevia ( ) significantly increased the adiponectin : leptin ratio ( p < @ ) and decreased fat mass ( p < @ ) compared to control ( p < @ ) .


The administration of an extract from Fraxinus excelsior L. seeds/fruits in combination with a moderate hypocaloric diet may be beneficial in metabolic disturbances linked to impaired glucose tolerance , obesity , insulin resistance and inflammatory status , specifically in older adults .


With modern initial aggressive combination treatments with synthetic disease-modifying antirheumatic drugs ( sDMARD ) , most patients with rheumatoid arthritis ( RA ) achieve remission , have marginal radiographic progression , and sustain normal function .


Here we aim to identify the patients failing these targets even after aggressive treatment .


Ninety-nine patients with early , active RA were treated with a combination of @ sDMARD and prednisolone ( PRD ) , and either infliximab or placebo infusions during the first @ months , aiming at strict remission .


After @ months , the treatments became unrestricted .


At @ months , @ evident clinical features of treatment failure were defined : area under curve ( AUC ) between @-@ months for disease activity score assessing @ joints > @ ; AUC @-@ for health assessment questionnaire > @ ; progression in total Sharp/van der Heijde score @-@ months > @ units ; and need of PRD or biologic DMARD treatment at @ months .


A total of @ patients were followed up for @ months .


Of them , @ had no features of treatment failure , @ had @ , @ had @ , @ had @ , and @ patient had all @ features .


Having @-@ features of treatment failure at @ years was predicted by the health assessment score at baseline , and by even low residual disease activity at @ and @ months .


Only @ % of the patients with RA treated early with combination sDMARD and PRD have more than @ clinical feature of treatment failure at @ months .


Residual clinical disease activity at @-@ months was the most important predictor for identifying these patients .


The study was registered at www.clintrials.gov ( NCT@ ) .


Anxiety , depressive and substance use disorders account for three quarters of the disability attributed to mental disorders and frequently co-occur .


While programs for the prevention and reduction of symptoms associated with ( i ) substance use and ( ii ) mental health disorders exist , research is yet to determine if a combined approach is more effective .


This paper describes the study protocol of a cluster randomised controlled trial to evaluate the effectiveness of the CLIMATE Schools Combined intervention , a universal approach to preventing substance use and mental health problems among adolescents .


Participants will consist of approximately @ students aged @ to @-years-old from @ secondary schools in New South Wales , Western Australia and Queensland , Australia .


The schools will be cluster randomised to one of four groups ; ( i ) CLIMATE Schools Combined intervention ; ( ii ) CLIMATE Schools - Substance Use ; ( iii ) CLIMATE Schools - Mental Health , or ( iv ) Control ( Health and Physical Education as usual ) .


The primary outcomes of the trial will be the uptake and harmful use of alcohol and other drugs , mental health symptomatology and anxiety , depression and substance use knowledge .


Secondary outcomes include substance use related harms , self-efficacy to resist peer pressure , general disability , and truancy .


The link between personality and substance use will also be examined .


Compared to students who receive the universal CLIMATE Schools - Substance Use , or CLIMATE Schools - Mental Health or the Control condition ( who received usual Health and Physical Education ) , we expect students who receive the CLIMATE Schools Combined intervention to show greater delays to the initiation of substance use , reductions in substance use and mental health symptoms , and increased substance use and mental health knowledge .


Hyperkalemia increases the risk of death and limits the use of inhibitors of the renin-angiotensin-aldosterone system ( RAAS ) in high-risk patients .


We assessed the safety and efficacy of patiromer , a nonabsorbed potassium binder , in a multicenter , prospective trial .


Patients with chronic kidney disease who were receiving RAAS inhibitors and who had serum potassium levels of @ to less than @ mmol per liter received patiromer ( at an initial dose of @ g or @ g twice a day ) for @ weeks ( initial treatment phase ) ; the primary efficacy end point was the mean change in the serum potassium level from baseline to week @ .


Eligible patients at the end of week @ ( those with a baseline potassium level of @ to < @ mmol per liter in whom the level decreased to @ to < @ mmol per liter ) entered an @-week randomized withdrawal phase in which they were randomly assigned to continue patiromer or switch to placebo ; the primary efficacy end point was the between-group difference in the median change in the serum potassium level over the first @ weeks of that phase .


In the initial treatment phase , among @ patients receiving patiromer who had at least one potassium measurement at a scheduled visit after day @ , the mean ( SE ) change in the serum potassium level was -@ mmol per liter ( P < @ ) .


At week @ , @ % ( @ % confidence interval , @ to @ ) of the patients had reached the target potassium level ( @ to < @ mmol per liter ) .


Subsequently , @ patients were randomly assigned to patiromer ( @ patients ) or placebo ( @ patients ) for the randomized withdrawal phase .


The median increase in the potassium level from baseline of that phase was greater with placebo than with patiromer ( P < @ ) ; a recurrence of hyperkalemia ( potassium level , @ mmol per liter ) occurred in @ % of the patients in the placebo group as compared with @ % in the patiromer group through week @ ( P < @ ) .


Mild-to-moderate constipation was the most common adverse event ( in @ % of the patients ) ; hypokalemia occurred in @ % .


In patients with chronic kidney disease who were receiving RAAS inhibitors and who had hyperkalemia , patiromer treatment was associated with a decrease in serum potassium levels and , as compared with placebo , a reduction in the recurrence of hyperkalemia .


( Funded by Relypsa ; OPAL-HK ClinicalTrials.gov number , NCT@ . )


The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain .


Internationally , research suggests that schools often fail to implement practices consistent with healthy school canteen policies .


Without a population wide implementation , the potential benefits of these policies will not be realised .


The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales ( NSW ) , Australia , government known as the ` Fresh Tastes @ School NSW Healthy School Canteen Strategy ' .


The parallel randomised trial will be conducted in @ primary schools located in the Hunter region of New South Wales , Australia .


Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy .


Schools will be randomly allocated after baseline data collection in a @:@ ratio to either an intervention or control group using a computerised random number function in Microsoft Excel .


Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff , staff training , resources , recognition and incentives , consensus and leadership strategies , follow-up support and implementation feedback .


The @ schools allocated to the control group will not receive any intervention support as part of the research trial .


The primary outcome measures will be i ) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ( ` red ' and ` banned ' items ) and ii ) the proportion of schools where healthy canteen items ( ` green ' items ) represent the majority ( > @ % ) of products listed on the menu .


Outcome data will be collected via a comprehensive menu audit , conducted by dietitians blind to group allocation .


Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values .


The proposed trial will represent a novel contribution to the literature , being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy .


Adherence to the Mediterranean diet ( MD ) is associated with reduced morbidity and mortality due to cardiovascular disease .


However , how the MD exerts its effects is not fully known .


To assess the @-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED ( Prevencin con Dieta Mediterrnea ) study .


A total of @ participants at high risk for cardiovascular disease were randomized into three diet groups : MD supplemented with @mL/d of extra virgin olive oil ( MD+EVOO ) or @ g/d of nuts ( MD+N uts ) and a low-fat diet .


Changes in classical cardiovascular risk factors , inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after @ months of intervention .


Compared to participants in the low-fat diet group , those receiving MD+EVOO and MD+N uts showed a higher decrease in systolic ( @mmHg ) and diastolic ( @mmHg ) blood pressure ( P = @ ; both ) , as well as a reduction of @ % and @ % in LDL-cholesterol ( P = @ ) , respectively .


Patients in the MD+N uts group showed a significant reduction of @ % in CD@ expression on monocyte surface compared to low-fat diet patients ( P = @ ) .


In addition , inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-@ were reduced by @ % and @ % and @ % and @ % in the MD+EVOO and MD+N uts groups , respectively ( P < @ ; all ) compared to the low-fat diet group .


Likewise , sICAM and P-selectin were also reduced by @ % and @ % , respectively in the MD+EVOO group ( P = @ ) and P-selectin by @ % in MD+N uts group ( P = @ ) compared to the low-fat diet group .


Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain , at least in part , the protective role of MD against ischemic heart disease .


External cephalic version ( ECV ) is offered to reduce the number of Caesarean delivery indicated by breech presentation which occurs in @-@ % of term pregnancies .


ECV is commonly performed aided by the application of aqueous gel or talcum powder to the maternal abdomen .


We sought to compare gel with powder during ECV on achieving successful version and increasing tolerability .


We enrolled @ women ( @ weeks gestation ) on their attendance for planned ECV .


All participants received terbutaline tocolysis .


Regional anaesthesia was not used .


ECV was performed in the standard fashion after the application of the allocated aid .


If the first round ( maximum of @ attempts ) of ECV failed , crossover to the opposing aid was permitted .


@ women were randomised to powder and @ to gel .


Self-reported procedure related median -LSB- interquartile range -RSB- pain scores ( using a @-point visual numerical rating scale VNRS ; low score more pain ) were @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- P = @ in favor of gel .


ECV was successful in @/@ ( @ % ) vs. @/@ ( @ % ) RR @ @ % CI @-@ @ P = @ for powder and gel arms respectively .


Crossover to the opposing aid and a second round of ECV was performed in @/@ ( @ % ) following initial failure with powder and @/@ ( @ % ) after failure with gel ( RR @ @ % CI @-@ P = @ ) .


ECV success rate was @/@ ( @ % ) vs. @/@ ( @ % ) P = @ after crossover use of gel or powder respectively .


Operators reported higher satisfaction score with the use of gel ( high score , greater satisfaction ) VNRS scores @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- P = @ .


Women find gel use to be associated with less pain .


The ECV success rate is not significantly different .


Effective patient/provider communication is important to ensure patient understanding , safety , and satisfaction .


Our hypothesis was that interactive patient/provider counseling using a web-based tool ( iPad application ) would have a greater impact on patient satisfaction with understanding prolapse symptoms compared with standard counseling ( SC ) .


Women with complaints of seeing/sensing a vaginal bulge were enrolled in this randomized controlled trial .


Participants completed pre - and postvisit Likert scale questionnaires on satisfaction with prolapse knowledge and related anxiety .


After new patient histories and physical examinations , study participants were randomized to SC or SC with iPad .


Ninety participants were required to detect a @ % difference in satisfaction with prolapse knowledge between the two groups .


Ninety women were randomized to SC ( n = @ ) or SC with iPad ( n = @ ) .


At baseline , @ % of women were satisfied with their understanding of bulge symptoms ( @ % SC vs. @ % SC with iPad , p = @ ) .


After counseling , @ % of women reported increased satisfaction with understanding of bulge symptoms ( p < @ ) , with no difference between groups -LSB- @/@ ( @ % ) SC vs. @/@ ( @ % ) SC with iPad , p = @ -RSB- .


Baseline anxiety was high : @ % ( @ % SC vs. @ % SC with iPad , p = @ ) .


After counseling , anxiety decreased to @ % ( p < @ ) , with improvement in both groups ( @ % SC vs. @ % SC with iPad , p = @ ) .


Counseling times were similar between groups ( @ min. , SC vs. @ min. , SC with iPad , p = @ ) .


Interactive counseling was associated with increased patient satisfaction with understanding bulge symptoms and decreased anxiety whether a web-based tool was used or not .


Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk ( CVAR ) to manage patients .


This randomized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk , including prescription of antihypertensive and lipid-lowering medication .


A cluster randomized controlled trial was conducted from @ to @ in Sydney , Australia .


Family practices were randomized , and patients aged @ to @ years were invited to participate .


Intervention family physicians ( FP ) were trained in use of CVAR , provided with an electronic CVAR calculator , and assessed their patients ' absolute risk in a dedicated consultation .


Control practice patients received a general health check .


Primary outcome analyzed was the proportion of patients in each group on antihypertensive and/or lipid-lowering medication at @ months .


Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy .


The study recruited @ FPs from @ practices and @,@ patients , of which @ ( @ % ) completed @-month follow-up .


At @ months , there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives ( @ % vs @ % , P = @ ) , but control group patients were more likely to be on lipid-lowering medications ( @ % vs @ % , P = @ ) .


After multilevel analysis , this difference was not present .


Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group .


Single-risk factor management remains a strong influence on FP prescribing practices .


Shifting to an approach based on CVAR will require more intensive intervention .


Chronic obstructive pulmonary disease ( COPD ) is characterized by irreversible airflow limitation and is associated with weight loss and decreased muscle strength and exercise capacity .


A double-blinded randomized controlled trial of @ male COPD patients ( age , @ @ years ) was carried out to assess effects of anabolic steroid in terms of a daily high-protein , high-calorie diet alone or one combined with anabolic steroids on body composition , lung function , and health-related quality of life ( HRQL ) .


Outcomes were assessed by anthropometric and spirometric measurements , peak expiratory flow rate , partial pressure of oxygen in arterial blood , @-minute walk test ( @MWT ) , hand grip test , and HRQL index scores .


Measurements were made at baseline and end of treatment ( @ weeks ) .


All patients showed significant difference ( P < @ ) in pulmonary function parameters and anthropometric measurements after @ weeks of intervention ( within-group changes ) ; however , no significant improvement occurred in the pulmonary function parameters between the groups .


The difference in exercise capacity ( @MWT ) and HRQL scores in the treatment group were statistically significant ( P < @ ) compared with control group after @ weeks of intervention .


In the treatment group , the average @MWT distance increased from @ m to @ m at @-week follow-up , and HRQL scores increased from @ to @ .


Also , HRQL and @MWT parameters were positively correlated in response to steroid supplementation at the end of the study .


Weekly administration of anabolic steroids during @ weeks increased exercise capacity and quality of life in patients with COPD .


Implantable cardioverter defibrillator ( ICD ) remote follow-up and ICD remote monitoring ( RM ) are established means of ICD follow-up .


The reduction of the number of in-office visits and the time to decision is proven , but the true clinical benefit is still unknown .


Cost and cost-effectiveness of RM remain leading issues for its dissemination .


The MONITOR-ICD study has been designed to assess costs , cost-effectiveness , and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial .


Patients indicated for single - or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD ( Lumax VR-T or Lumax DR-T ; Biotronik SE & Co KG , Berlin , Germany ) .


Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol .


As of December @ , recruitment has been completed , and @ patients have been enrolled .


Subjects are followed-up for a minimum of @months and a maximum of @months , ending in January @ .


Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups .


Secondary end points include ICD shocks ( including appropriate and inappropriate shocks ) , cardiovascular hospitalizations and cardiovascular mortality , and additional health economic end points .


The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in @ .


Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM .


This study aims to assess the effects of proanthocyanidin-a class of polyphenol antioxidants extracted from grape seeds-on menopausal symptoms , body composition , and cardiovascular parameters in middle-aged women .


We conducted a randomized , double-blind , placebo-controlled study in @ women aged @ to @ years who had at least one menopausal symptom .


The study participants were randomized to receive grape seed extract tablets containing either low-dose ( @ mg/d ) or high-dose ( @ mg/d ) proanthocyanidin , or placebo , for @ weeks .


Their menopausal symptoms were evaluated using the Menopausal Health-Related Quality of Life Questionnaire , Hospital Anxiety and Depression Scale , and Athens Insomnia Scale before and after @ and @ weeks of treatment .


Body composition and cardiovascular parameters were also measured .


A total of @ women ( @ % ) completed the study .


Background characteristics , including age , menopause status , subjective symptom scores , body composition , and cardiovascular parameters , were similar among the groups .


The following significant changes were observed during the course of the study : ( @ ) physical symptom score , hot flash score , and ( @ ) Athens Insomnia Scale score decreased in the high-dose group after @ weeks of treatment ; ( @ ) Hospital Anxiety and Depression Scale Anxiety score and ( @ ) systolic and diastolic blood pressure decreased in the low-dose and high-dose groups after @ weeks ; and , ( @ ) lastly , muscle mass increased in the low-dose and high-dose groups after @ weeks of treatment .


Grape seed proanthocyanidin extract is effective in improving the physical and psychological symptoms of menopause while increasing muscle mass and reducing blood pressure in middle-aged women .


Medications for the treatment of substance use disorders ( SUDs ) are not widely available in publicly funded SUD treatment programs .


Few studies have drawn on longitudinal data to examine the organizational characteristics associated with programs transitioning from not delivering any pharmacotherapy to adopting at least one SUD medication .


Using two waves of panel longitudinal data collected over a @-year period , we measured the transition to medication adoption in a cohort of @ publicly funded treatment organizations that offered no SUD medications at baseline .


Independent variables included organizational characteristics , medical resources , funding , treatment culture , and detailing activities by pharmaceutical companies .


Of @ programs not offering SUD pharmacotherapy at baseline , @ % transitioned to offering at least one SUD medication at follow-up approximately @ years later .


Multivariate logistic regression results indicated that the employment of at least one physician at baseline , having a greater proportion of Medicaid clients , and pharmaceutical detailing were positively associated with medication adoption .


Adoption of pharmacotherapy was more likely in programs that had greater medical resources , Medicaid funding , and contact with pharmaceutical companies .


Given the potential expansion of Medicaid under the Affordable Care Act , patients served by publicly funded programs may gain greater access to such treatments , but research is needed to document health reform 's impact on this sector of the treatment system .


The relationship between alcohol use and risky sexual behavior is complex and depends on psychological and environmental factors .


The alcohol myopia model predicts that , due to alcohol 's impact on attention , the behavior of intoxicated individuals will become increasingly directed by salient cues .


Autonomic arousal ( AA ) may have a similar effect on attention .


Experiential delay discounting ( DD ) may be increased by both alcohol consumption and AA due to their common effects and may mediate the relationship between these conditions and risky sex .


This study employed a @ ( alcohol , placebo , control ) @ ( high , low arousal ) experimental design to examine the effects of acute alcohol intoxication and AA on experiential delay discounting , subjective sexual arousal , and risky sex .


Path models revealed complex results that only partially supported study hypotheses .


Ratings of subjective sexual arousal did not differ across either beverage or arousal conditions .


DD was also unrelated to any study variable .


However , subjective sexual arousal was positively related to risky sexual intentions .


Alcohol intoxication was also positively associated with increased unprotected sex intentions , consistent with past studies .


These results affirm the role of subjective sexual arousal and alcohol intoxication in risky sexual decision-making , yielding effect sizes similar to comparable past studies .


The lack of differences across autonomic arousal groups also suggests that effects of attentional myopia may be behavior-specific .


Failure to replicate effects of alcohol intoxication on DD also suggests reservation regarding its involvement in alcohol-involved risky sex .


This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive , recurrent ovarian cancer , fallopian tube cancer , or primary peritoneal cancer ( EOC ) .


Patients with recurrent platinum-sensitive EOC with no more than @ prior courses of chemotherapy were randomized to single-agent sorafenib @ mg twice daily or combination sorafenib @ mg bid ( days @-@ ) with IV carboplatin ( AUC @ ) and IV paclitaxel @ mg/m ( @ ) ( S+C / T ) every @ weeks .


Single agent sorafenib could cross over to combination upon progression .


Patients were initially randomized to either arm , however , due to poor accrual , sorafenib arm was prematurely closed .


A total of @ patients were evaluable for response to sorafenib and @ patients were evaluable for response to S+C / T. Objective response rate ( RR ) was @ % for patients on sorafenib vs. @ % for patients on S+C / T ( p = @ ) ; stable disease was seen in @ % and @ % , respectively .


Clinical benefit rate ( CBR ) at @ months ( mos . )


was @ % for S and @ % for S+C / T.


The median progression free survival was @ months on sorafenib vs. @ months on S+C / T ( p = @ ) and there was no significant difference of overall survival between two arms ( p = @ ) with median overall survival @ months under sorafenib vs. @ months on S+C / T. Patients remained on trial for a median of @ cycles on sorafenib and @ cycles on S+C / T.


Sorafenib , alone or in combination with carboplatin and paclitaxel , has activity in patients with platinum-sensitive EOC .


Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS ; however , there were increased grade and frequencies of toxicities .


The aim of this study was to evaluate the safety , pharmacokinetics , and clinical response of brodalumab ( AMG @ ) , a human , anti-IL-@ receptor A ( IL-@RA ) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis ( RA ) .


This phase Ib , randomized , placebo-controlled , double-blind multiple ascending dose study enrolled subjects with moderate to severe RA ( @/@ swollen and @/@ tender joints ) .


Subjects were randomized @:@ to receive brodalumab ( @ mg , @ mg , or @ mg subcutaneously every two weeks for @ doses per group ; or @ mg or @ mg intravenously every @ weeks for two doses per group ) or placebo .


Endpoints included incidence of adverse events ( AEs ) and pharmacokinetics .


Exploratory endpoints included pharmacodynamics , and improvements in RA clinical metrics .


Forty subjects were randomized to investigational product ; one subject discontinued due to worsening of RA ( placebo ) .


The study was not designed to assess efficacy .


AEs were reported by @ % ( @/@ ) of placebo subjects and @ % ( @/@ ) of brodalumab subjects .


Three serious AEs were reported in two subjects ; there were no opportunistic infections .


Brodalumab treatment resulted in inhibition of IL-@ receptor signaling and receptor occupancy on circulating leukocytes .


No treatment effects were observed with individual measures of RA disease activity .


On day @ ( week @ ) @ % ( @/@ ) of brodalumab subjects and @ % ( @/@ ) of placebo subjects achieved ACR@ ; @ % ( @/@ ) brodalumab subjects and @ % ( @/@ ) of placebo subjects achieved ACR@ ; and @ % ( @/@ ) brodalumab subjects and @ % ( @/@ ) of placebo subjects achieved ACR@ .


Multiple dose administration of brodalumab was tolerated in subjects with active RA .


There was no evidence of a clinical response to brodalumab in subjects with RA .


To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer .


Twenty patients who underwent @-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri @ ( @ ) colony-forming units and @ g of soluble fiber ( Nestl ) or placebo .


The questionnaire EORTC QLQ-PRT@ was applied before the beginning of radiation therapy and in every week for the first @ weeks of treatment .


The sum of both the complete ( proctitis symptoms plus quality of life ) and partial ( proctitis symptoms ) scores of the EORTC QLQ-PRT@ ( European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-@ items ) questionnaire were the main endpoints .


This pilot study showed that the complete questionnaire score ( median -LSB- range -RSB- ) was higher in the second ( @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- , P < @ ) and third ( @ -LSB- @-@ -RSB- vs @ -LSB- @-@ -RSB- , P < @ ) weeks in the placebo group .