Male sex and SLCO@B@ c. @CA polymorphism together influenced rifampin AUC@-@hour ( R ( @ ) = @ ) and weight-normalized clearance ( R ( @ ) = @ ) .


All four volunteers with rifampin Cmax less than@g/ml ( lower end of the normal range ) had c. @CA genotype .


Rifampin Cmax and AUC@-@hour had no significant relationship with the efavirenz AUC@-@hour ratio or weight-normalized clearance ratio in the presence versus absence of rifampin ( p > @ ) .


Men with the SLCO@B@c @ CA genotype are at increased risk of lower rifampin plasma exposure .


However , plasma rifampin concentrations did not correlate with the extent of induction of efavirenz clearance by rifampin during coadministration .


The aim of this study is to assess the prevalence of non-opioid drug use among opioid-addicted , buprenorphine injecting individuals in Georgia , during and after a @-week course of buprenorphine-naloxone ( Suboxone ) or methadone .


Randomized controlled trial with daily observed Suboxone or methadone and weekly counseling , urine tests and timeline followback ( TLFB ) in weeks @-@ and @ , and the Addiction Severity Index ( ASI ) at weeks @ , @ , @ , @ , @ .


Of the @ patients ( @/group , @ women ) , @ ( @ % ) completed the @-weeks of study treatment and @ ( @ % ) completed the @-week follow-up .


At baseline , injecting more than one drug in the last @ days was reported by @ % of patients in the methadone and @ % in the Suboxone groups .


Drug use was markedly reduced in both treatment conditions but there were significant differences in the prevalence of specific drugs with more opioid ( @ vs. @ % ; p = @ ) , less amphetamine ( @ vs. @ % ; p < @ ) and less marijuana ( @ vs. @ % ; p < @ ) positive urine tests in the methadone vs. Suboxone groups .


At the @-week follow-up , TLFB results on the @ that continued methadone or the @ on Suboxone showed less opioid ( @ vs. @ % ; p < @ ) , illicit buprenorphine ( @ vs. @ % ; p = @ ) , benzodiazepine ( @ vs. @ % ; p < @ ) , and marijuana ( @ vs. @ % ; p < @ ) use than the @ who did not continue opioid substitution therapy .


Despite small but significant differences in opioid and other drug use , both treatments were highly effective in reducing opioid and non-opioid drug use .


To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis .


Physiotherapists were randomly allocated to a @-h interactive educational course with the collaboration of three patient partners or no intervention .


Assessments comprised questionnaires on adherence ( score range @-@ ) , knowledge ( score range @-@ ) , and barriers to use the guideline ( score range @-@ ) .


Assessments were conducted @ week before the interactive course ( T@ ) immediately after ( T@ ) , and @ months thereafter ( T@ ) .


Change scores were compared between the groups by means of Mann-Whitney U tests and linear mixed models .


@ of @ eligible PTs ( @ % ) were included .


The intervention ( n = @ ) was significantly more effective than no intervention ( n = @ ) concerning self-reported adherence and knowledge with mean differences in change scores ( @ % CI ) at T@ and T@ being @ ( @-@ @ ) and @ ( @-@ @ ) for adherence and @ ( @-@ @ ) and @ ( @-@ @ ) for knowledge , ( all p values < @ ) .


In both groups the barrier score increased at T@ and decreased at T@ , with a significantly larger increase at T@ and decrease at T@ in the intervention group ( mean differences @ ( @-@ @ ) and @ ( @-@ @ ) , respectively .


A short interactive educational course with patient participation on a PT guideline on hip and knee osteoarthritis showed a small to moderate positive effect on self-reported guideline adherence and knowledge , whereas for perceived barriers an advantage was only seen on the longer term .


Moderate , regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce .


We evaluated the relations between wine consumption , health status , circulating biomarkers , and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial .


A brief questionnaire on dietary habits was administered at baseline to @ patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell ` Insufficienza Cardiaca-Heart Failure ( GISSI-HF ) trial .


The relations between wine consumption , fatal and nonfatal clinical end points , quality of life , symptoms of depression , and circulating biomarkers of cardiac function and inflammation ( in subsets of patients ) were evaluated with simple and multivariable-adjusted statistical models .


Almost @ % of the patients reported drinking at least @ glass of wine per day .


After adjustment , clinical outcomes were not significantly different in the predefined @ groups of wine consumption .


However , patients with more frequent wine consumption had a significantly better perception of health status ( Kansas City Cardiomyopathy Questionnaire score , adjusted P < @ ) , less frequent symptoms of depression ( Geriatric Depression Scale , adjusted P = @ ) , and lower plasma levels of biomarkers of vascular inflammation ( osteoprotegerin and C-terminal proendothelin-@ , adjusted P < @ , and pentraxin-@ , P = @ ) after adjusting for possible confounders .


We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status , lower prevalence of depression , and less vascular inflammation , but does not translate into more favorable clinical @-year outcomes .


Recent randomised controlled trials have compared the effects of albumin and hydroxyethyl starch ( HES ) v crystalloids on patient-centred outcomes in critically ill patients .


The Saline v Albumin Fluid Evaluation ( SAFE ) trial reported patient-centred outcomes at @ days in @ patients assigned to fluid resuscitation with either @ % albumin or @ % saline ; the Crystalloid v Hydroxyethyl Starch Trial ( CHEST ) reported patient-centred outcomes at @ days in @ patients assigned to fluid resuscitation with either @ % HES ( @/@ @ ) or @ % saline .


As the two trials used a common reference fluid ( @ % saline ) and had most trial methods and data collection points harmonised , a comparison of @ % albumin and @ % HES ( @/@ @ ) on patient-centred outcomes at @ days in critically ill patients using the individual patient data from the two trials is feasible .


To prepublish the statistical analysis plan ( SAP ) of an individual patient data comparative analysis of the SAFE and CHEST studies .


The statistical analyses are described in detail with the appropriate statistical analysis specified .


The planned statistical analyses are described in detail for the SAFE and CHEST individual patient data comparative analysis .


We outline the proposed statistical analysis for the baseline characteristics , processes of care and the outcomes .


Subgroups are defined with statistical comparisons between the fluid groups and in each subgroup explained .


We have developed a SAP for the SAFE / CHEST individual patient data comparative analysis to increase the internal validity of the study and minimise bias .


Studies have shown that tiotropium once daily reduces lung hyperinflation and dyspnea during exercise and improves exercise tolerance in patients with COPD .


Mechanisms underlying the effects of the muscarinic receptor antagonist tiotropium on COPD have not been fully understood .


In this study , we investigated whether improvement in neural respiratory drive is responsible for reducing dyspnea during exercise and improving exercise tolerance in COPD .


Twenty subjects with severe COPD were randomized into two groups : no treatment ( Control , n = @ , @ years , FEV@ @ % pred ) or inhaled tiotropium @g once daily for @ month ( n = @ , @ years , FEV@ @ % pred ) .


All subjects were allowed to continue their daily medications other than anti-cholinergics during the study .


Constant cycle exercise with @ % of maximal workload and spirometry were performed before and @ month after treatment .


Diaphragmatic EMG ( EMGdi ) and respiratory pressures were recorded with multifunctional esophageal catheter .


Efficiency of neural respiratory drive , defined as the ratio of minute ventilation ( VE ) and diaphragmatic EMG ( VE/EMGdi % max ) , was calculated .


Modified British Medical Research Council Dyspnea Scale ( mMRC ) was used for the evaluation of dyspnea before and after treatment .


There was no significant difference in spirometry before and after treatment in both groups .


Diaphragmatic EMG decreased significantly at rest ( @ % vs. @ % , P < @ ) and mean efficiency of neural respiratory drive at the later stage of exercise increased ( @ vs. @ , P < @ ) after @-month treatment with tiotropium .


There were no remarkable changes in resting EMGdi and mean efficiency of neural respiratory drive post-treatment in control group .


The score of mMRC decreased significantly ( @ vs. @ , P < @ ) after @-month treatment with tiotropium , but without significantly difference in control group .


Tiotropium significantly reduces neural respiratory drive at rest and improves the efficiency of neural respiratory drive during exercise , which might account for the improvement in exercise tolerance in COPD .


Combined treatment with a bisphosphonate and vitamin D has been proposed for postmenopausal osteoporosis .


A new , fixed-dose combination tablet of ibandronate plus vitamin D@ has been developed for monthly administration to treat postmenopausal osteoporosis .


The main objective of the present study was to compare the pharmacokinetics of vitamin D@ administered in @ forms : a newly developed ibandronate @-mg/vitamin D@ @,@-IU tablet ( DP-R@ , test drug ) and a stand-alone vitamin D@ @,@-IU tablet ( reference drug ) .


A secondary objective was to evaluate the safety and tolerability of DP-R@ in healthy adult male Korean volunteers .


This study was a single-dose , open-label , randomized-sequence , @-treatment , @-way crossover trial .


Blood samples were collected from @ hours ' predose to @ hours ' postdose .


The plasma concentrations of vitamin D@ were analyzed by using a validated HPLC-MS/MS method .


Pharmacokinetic parameters were calculated , and the @ % CIs of the ratios of the geometric means of the parameters were determined from the logarithmically transformed data by using ANOVA .


Thirty-sex healthy adult male Korean volunteers with a mean ( SD ) age of @ ( @ ) years , a mean height of @ ( @ ) cm , and a mean weight of @ ( @ ) kg were enrolled ; @ participants completed the study .


The @ % CIs of the ratios of the geometric means ( test drug/reference drug ) of the baseline-corrected Cmax , AUC@-last , and AUC@ - values were @ to @ , @ to @ , and @ to @ , respectively .


The @ % CIs of the ratios of the geometric means ( test drug/reference drug ) of the baseline-uncorrected Cmax , AUC@-last , and AUC@ - values were @ to @ , @ to @ , and @ to @ , respectively .


Eighty-four adverse events ( AEs ) were reported in @ of @ subjects receiving DP-R@ , and @ AEs were reported in @ of @ subjects receiving the vitamin D@ @,@-IU tablet .


All of the subjects who experienced AEs recovered without sequelae , and no serious AEs were observed .


The vitamin D@ pharmacokinetics were similar for DP-R@ and the @,@-IU vitamin D@ tablet .


DP-R@ was well tolerated .


Care management interventions in the German health-care system have been evaluated with promising results , but further research is necessary to explore their full potential in the context of multi-morbidity .


Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type @ diabetes mellitus and multiple co-occurring chronic conditions .


The study is designed as a prospective , @-month , multicentre , investigator-blinded , two-arm , open-label , individual-level , randomized parallel-group superiority trial .


We will enrol @ patients with type @ diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient .


Data will be collected at baseline ( T@ ) , at the primary endpoint after @months ( T@ ) and at follow-up after @months ( T@ ) .


The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T@ using a German version of the revised Summary of Diabetes Self-Care Activities ( SDSCA-G ) .


The secondary outcomes will be the differences between the intervention and control groups in : changes in scores on the SDSCA-G subscales , glycosylated haemoglobin A level , health-related quality of life , self-efficacy , differences in ( severe ) symptomatic hypoglycaemia , cost-effectiveness and financial family burden .


The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements : ( @ ) three home visits , including structured assessment of medical and social needs ; ( @ ) @ structured telephone monitoring contacts ; and ( @ ) self-monitoring of blood glucose levels after T@ in @-month intervals .


The control group will receive usual care .


The confirmatory primary analysis will be performed following the intention-to-treat ( ITT ) principle .


The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G .


Secondary analyses will be performed according to the ITT principle .


In health economic evaluations , we will estimate the incremental cost-effectiveness ratios .


We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs .


To determine if cats anaesthetised with alfaxalone have different recoveries to cats anaesthetised with a combination of ketamine and diazepam .


Anaesthesia for ovariohysterectomy was induced in cats with either alfaxalone ( n = @ ) or a combination of ketamine and diazepam ( n = @ ) .


All cats were premedicated with combinations of acepromazine and morphine .


Recoveries were scored using a categorical grading scheme applied to @ parameters over @ minutes following extubation .


The parameters scored covered movement , sensitivity to touch , sound and light , body position , sneezing and vocalisation .


One person scored all recoveries and they were blinded to the induction drug used .


Scores were compared between drugs at different times using the Kruskal-Wallis rank sum test .


Recovery scores were not normally distributed .


Analysis of the data using the Kruskal-Wallis rank sum test revealed that cats induced with alfaxalone showed an increase in recovery scores at @ minutes for pawing at the head ( p = @ ) .


No parameters differed significantly at @ and @ minutes .


For cats anaesthetised with ketamine and diazepam there was an increase at @ minutes in pacing , jerky sudden movements , unsettledness and increased sensitivity to touch at the surgical site and on the head ( p@ @ ) .


At @ minutes cats anaesthetised with ketamine and diazepam still showed an increase in unsettledness compared to those cats anaesthetised with alfaxalone ( p = @ ) .


The results suggest that recoveries of cats following alfaxalone induction are significantly different to recoveries after induction with ketamine and diazepam .


Overall , cats induced with ketamine and diazepam had more active and unsettled recoveries than alfaxalone over the @-minute period observed .


Cats recovering from alfaxalone anaesthesia have more settled recoveries than cats recovering from ketamine and diazepam anaesthesia .


If a quiet settled recovery is desired following a surgical procedure , alfaxalone is likely to be a better choice than ketamine and diazepam .


Psychosocial stress is accompanied by an increase in the activity of the hypothalamic-pituitary-adrenocortical ( HPA ) - axis and by an increase in food intake .


At present , no studies have been conducted to examine the impact of a potent laboratory stress test on the chewing frequency .


Thirty-one healthy participants ( @ females , mean age @ ) were compared after they had fulfilled the protocol of a standardized psychosocial stress test , the Trier Social Stress Test ( TSST ) , and after a resting condition of silent reading in reference to their chewing frequency , chewing efficacy , food intake , and eating preferences .


As part of the design free salivary cortisol levels and heart rate variability were measured repeatedly before and after the TSST and the resting condition .


After the TSST , the participants exhibited a significantly higher mean chewing frequency than after the resting condition ( F ( @,@ ) = @ , p = @ , ( @ ) = @ ) .


The testing condition had no influence on the amount of food intake .


Following the psychosocial stress , however , the participants reported a significantly less general appetite ( Z = -@ , p < @ ) and less of an appetite for eggs ( Z = -@ , p = @ ) than after their resting condition .


No correlation was found between the salivary cortisol response and the chewing frequency .


The results indicated that psychosocial stress is associated with an increase in chewing frequency , as measured with a sound-based apparatus , and with a decrease in appetite .


Health knowledge and literacy are among the main determinants of health .


Assessment of these issues via Web-based surveys is growing continuously .


Research has suggested that approximately one-fifth of respondents submit cribbed answers , or cheat , on factual knowledge items , which may lead to measurement error .


However , little is known about methods of discouraging cheating in Web-based surveys on health knowledge .


This study aimed at exploring the usefulness of imposing a survey time limit to prevent help-seeking and cheating .


On the basis of sample size estimation , @ undergraduate students were randomly assigned in a @:@ ratio to complete a Web-based survey on nutrition knowledge , with or without a time limit of @ minutes ( @ seconds per item ) ; the topic of nutrition was chosen because of its particular relevance to public health .


The questionnaire consisted of two parts .


The first was the validated consumer-oriented nutrition knowledge scale ( CoNKS ) consisting of @ true/false items ; the second was an ad hoc questionnaire ( AHQ ) containing @ questions that would be very difficult for people without health care qualifications to answer correctly .


It therefore aimed at measuring cribbing and not nutrition knowledge .


AHQ items were somewhat encyclopedic and amenable to Web searching , while CoNKS items had more complex wording , so that simple copying/pasting of a question in a search string would not produce an immediate correct answer .


A total of @ of the @ subjects started the survey .


Dropout rates were similar in both groups ( @ % , @/@ and @ % , @/@ in the untimed and timed groups , respectively ) .


Most participants completed the survey from portable devices , such as mobile phones and tablets .


To complete the survey , participants in the untimed group took a median @ minutes longer than those in the timed group ; the effect size was small ( Cohen 's r = @ ) .


Subjects in the untimed group scored significantly higher on CoNKS ( mean difference of @ points , P = @ ) and the effect size was medium ( Cohen 's d = @ ) .


By contrast , no significant between-group difference in AHQ scores was documented .


Unexpectedly high AHQ scores were recorded in @ % ( @/@ ) and @ % ( @/@ ) untimed and timed respondents , respectively , very probably owing to `` e-cheating '' .


Cribbing answers to health knowledge items in researcher-uncontrolled conditions is likely to lead to overestimation of people 's knowledge ; this should be considered during the design and implementation of Web-based surveys .


Setting a time limit alone may not completely prevent cheating , as some cheats may be very fast in Web searching .


More complex and contextualized wording of items and checking for the `` findability '' properties of items before implementing a Web-based health knowledge survey may discourage help-seeking , thus reducing measurement error .


Studies with larger sample sizes and diverse populations are needed to confirm our results .


Trametinib , an oral mitogen/extracellular signal-related kinase ( MEK ) @/@ inhibitor , holds promise for malignancies with rat sarcoma ( RAS ) mutations , like pancreas cancer .


This phase II study was designed to determine overall survival ( OS ) in patients with pancreas cancer treated with trametinib and gemcitabine .


Secondary end-points included progression-free survival ( PFS ) , overall response rate ( ORR ) and duration of response ( DOR ) ; safety end-points were also assessed .


Adults with untreated metastatic adenocarcinoma of the pancreas were randomised ( @:@ ) to receive intravenous gemcitabine @ mg/m ( @ ) ( weekly @ for @ weeks , then days @ , @ and @ of @-day cycles ) plus trametinib or placebo @mg daily .


RAS mutations were determined in circulating free DNA ( cfDNA ) and archival tumour tissue .


OS was evaluated in kirsten rat sarcoma viral oncogene homolog ( KRAS ) mutant and wild-type subgroups .


Baseline characteristics for @ patients were similar in both treatment arms .


There was no significant difference in OS ( hazard ratio ( HR ) @ ; @ % confidence interval ( CI ) , @-@ @ ; P = @ ) ; median OS was @ months with gemcitabine plus trametinib and @ months with gemcitabine plus placebo .


Median PFS ( @ versus @ weeks ) , ORR ( @ % versus @ % ) and median DOR ( @ versus @ weeks ) were also similar for trametinib and placebo arms , respectively .


KRAS mutation-positive patients ( n = @ ) showed no difference in OS between arms .


Thrombocytopenia , diarrhoea , rash and stomatitis were more frequent with trametinib , as was grade @ anaemia .


The addition of trametinib to gemcitabine did not improve OS , PFS , ORR or DOR in patients with previously untreated metastatic pancreas cancer .


Outcomes were independent of KRAS mutations determined by cfDNA .


Transurethral resection of prostate ( TURP ) is considered the gold standard for the surgical treatment of BPH .


Irrigant fluid absorption by the patient is a potentially serious complication of TURP and can lead to dilutional hyponatremia and TURP syndrome .


Other common complications of TURP include urinary tract infection and secondary haemorrhage .


The objective of this study was to compare the frequency of postoperative complications ( Urinary Tract infection and dilutional hyponatremia ) between @ % glycine and sterile distilled water used as irrigant in BPH patients after TURP .


This randomized controlled trial was conducted in department of Urology , PIMS Islamabad , from August @ to February @ .


A total of @ adult male patients between @-@ years of age undergoing TURP with prostate volume more than @cc on ultrasound .


@ patients each were randomly allocated to two groups .


In group-A , glycine was used as irrigan , t solution during TURP while in group-B distilled water was used .


Serum sodium levels were measured at @th postoperative hour to look for dilutional hyponatremia .


On the @th postoperative day they were inquired about any clinical features of urinary tract infection .


Also urine routine examination was performed to look for the presence of WBCs in the urine .


Post-operative dilutional hyponatremia was observed in @ ( @ % ) patients in Group A and in @ ( @ % ) patients in group-B .


The difference between both the groups being nonsignificant ( p-value = @ ) .


Frequency of postoperative urinary tract infection on @th postoperative day in group-A was @ ( @ % ) while in group-B it was @ ( @ % ) , the difference among both the groups being insignificant ( p-value = @ ) .


Although the frequency of postoperative complications like UTI and dilutional hyponatremia was less with sterile distilled water , yet , the difference was statistically not significant .


To compare efficacy and safety of two , once-daily basal insulin formulations -LSB- insulin lispro protamine suspension ( ILPS ) vs. insulin glargine ( glargine ) -RSB- added to oral antihyperglycaemic medications ( OAMs ) and exenatide BID in suboptimally controlled type @ diabetes ( T@D ) patients .


This @-week , open-label , multicentre trial randomized patients to bedtime ILPS ( n = @ ) or glargine ( n = @ ) .


Non-inferiority of ILPS versus glargine was assessed by comparing the upper limit of @ % confidence intervals ( CIs ) for change in haemoglobin A@c ( HbA@c ) from baseline to week @ ( adjusted for baseline HbA@c ) with non-inferiority margin @ % .


Non-inferiority of ILPS versus glargine was demonstrated : least-squares mean between-treatment difference ( ILPS minus glargine ) ( @ % CI ) was @ % ( @ , @ ) .


Mean HbA@c reduction was less for ILPS - versus glargine-treated patients ( -@ vs. -@ % , p = @ ) .


Endpoint HbA@c < @ % was achieved by @ % ( ILPS ) and @ % ( glargine ) ( p = NS ) .


Overall hypoglycaemia rates ( p = NS ) and severe hypoglycaemia incidence ( p = NS ) were similar .


Nocturnal hypoglycaemia rate was higher in patients treated with ILPS versus glargine ( p = @ ) .


Weight gain was similar between groups ( ILPS : @ kg ; glargine : @ kg , p = NS ) .


Endpoint total insulin doses were lower in patients treated with ILPS versus glargine ( @ vs. @ IU/kg/day , p < @ ) .


ILPS was non-inferior to glargine for HbA@c change over @weeks , but was associated with less HbA@c reduction and more nocturnal hypoglycaemia .


Treat-to-target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to OAMs and exenatide BID for suboptimally controlled T@D .


Cerebral blood flow velocity ( CBFV ) measured by transcranial Doppler sonography has provided information on cerebral perfusion in patients undergoing infant heart surgery , but no studies have reported a relationship to early postoperative and long-term neurodevelopmental outcomes .


CBFV was measured in infants undergoing biventricular repair without aortic arch reconstruction as part of a trial of hemodilution during cardiopulmonary bypass ( CPB ) ; CBFV ( Vm , mean ; Vs , systolic ; Vd , end-diastolic ) in the middle cerebral artery and change in Vm ( rVm ) were measured intraoperatively and up to @ hours post-CPB .


Neurodevelopmental outcomes , measured at @ year of age , included the psychomotor development index ( PDI ) and mental development index ( MDI ) of the Bayley Scales of Infant Development-II .


CBFV was measured in @ infants ; @ with D-transposition of the great arteries , @ with tetralogy of Fallot , and @ with ventricular septal defects .


Lower Vm , Vs , Vd , and rVm at @ hours post-CPB were independently related to longer intensive care unit duration of stay ( p < @ ) .


In the @ patients who returned for neurodevelopmental testing , lower Vm , Vs , Vd , and rVm at @ hours post-CPB were independently associated with lower PDI ( p < @ ) and MDI ( p < @ , except Vs : p = @ ) scores .


Higher Vs and rVm at @ hours post-CPB were independently associated with increased incidence of brain injury on magnetic resonance imaging in @ patients .


Postoperative CBFV after biventricular repair is related to early postoperative and neurodevelopmental outcomes at @ year of age , possibly indicating that low CBFV is a marker of suboptimal postoperative hemodynamics and cerebral perfusion .


Patients with acute coronary syndromes ( ACS ) display diffuse coronary atheroma instability and heightened risk of early and late recurrent coronary events .


We compared the long-term antiatherosclerotic efficacy of high-intensity statins in patients with ACS when compared with stable disease .


Study of Coronary Atheroma by Intravascular Ultrasound : Effect of Rosuvastatin Versus Atorvastatin ( SATURN ) used serial intravascular ultrasound measures of coronary atheroma volume in patients treated with rosuvastatin @ mg or atorvastatin @ mg for @ months .


The overall effect of high-intensity statins on the change in coronary percent atheroma volume and major adverse cardiovascular events ( death/nonfatal myocardial infarction/coronary revascularization ) were evaluated in this post hoc analysis .


When compared with non-ACS patients ( n = @ ) , patients with ACS ( n = @ ) were younger , actively smoking , and have had a previous myocardial infarction ( all P < @ ) .


At baseline , patients with ACS exhibited lower high-density lipoprotein cholesterol ( @ versus @ mg/dL ; P = @ ) , a higher apolipoprotein B : apolipoprotein A-@ ratio ( @ versus @ ; P < @ ) and greater percent atheroma volume ( @ % versus @ % ; P = @ ) when compared with non-ACS patients .


Despite similar achieved levels of lipid and inflammatory markers after high-intensity statin therapy , patients with ACS demonstrated greater percent atheroma volume regression than non-ACS patients ( -@ versus -@ ; P = @ ) .


After propensity-weighted multivariable adjustment , baseline percent atheroma volume ( P < @ ) and an ACS clinical presentation ( P = @ ) independently associated with plaque regression .


The @-month major adverse cardiovascular events-free survival was similar between patients with ACS and non-ACS ( @ versus @ % ; P = @ ) .


Long-term high-intensity statin therapy caused greater plaque regression and comparable major adverse cardiovascular events rates in ACS when compared with non-ACS patients .


Despite a higher clinical risk profile , patients with ACS harbor a more modifiable disease substrate and seem to benefit the most from potent statin therapy .


Beside traditional dysphagia therapy , neuromuscular electrical stimulation ( NMES ) has been proposed to treat patients with dysphagia .


Considering the complexity of the nerve-muscle interaction during swallowing , the underlying physiology of NMES remains unclear .


Here , we addressed the question of whether NMES can modify upper esophageal sphincter ( UES ) dynamics .


In a prospective study , @ healthy volunteers performed water swallows with and without NMES .


The stimulus was applied in a participant - and operator-initiated stimulation above , near , and below the motor threshold .


Swallowing parameters were measured using high-resolution manometry .


The UES relaxation time was found to be extended by @ % , indicating a modification in UES dynamics .


The chosen NMES paradigm influenced the involuntary swallowing phase by extending relaxation time , providing more time for bolus passage into the esophagus .


Future studies will have to evaluate if this effect can be found in patients with dysphagia and whether it is beneficial for treatment .


Aim of this prospective study was to investigate the effectiveness of eutectic mixture of local anaesthetic ( EMLA ) patches on every abdominal incision for pain relief after gynaecologic laparoscopic surgery .


A total of @ women were prospectively randomised to receive either placebo ( control group ) or EMLA ( study group ) patches on all abdominal incisions .


Postoperative pain was assessed @ and @ h after surgery using the short form of the McGill Pain Questionnaire ( SF-MPQ ) .


The amount of analgesic pain medication on demand was assessed in both groups .


Sixty women were allocated to the study group and @ patients to the control group before laparoscopic surgery .


There were no statistically significant differences regarding age , body mass index ( BMI ) , duration of surgery and blood loss comparing both groups .


There were no statistically significant differences between both groups with regard to postoperative total pain scores @ h ( McGill total score : @ @ vs. @ @ , p = @ ) and @ h ( McGill total score : @ @ vs. @ @ , p = @ ) after surgery .


Time to mobilisation after surgery ( hours ) was significantly shorter in the study group ( @ @ vs. @ @ , p = @ ) .


Despite of a significant reduction of time for mobilisation transdermal anaesthetic patches after gynaecologic laparoscopic surgery did not lead to decreased postoperative pain scores .


Haiti has experienced rapid urbanization that has exacerbated poverty and undernutrition in large slum areas .


Stunting affects @ in @ young children .


We aimed to test the efficacy of a daily lipid-based nutrient supplement ( LNS ) for increased linear growth in young children .


Healthy , singleton infants aged @-@ mo ( n = @ ) were recruited from an urban slum of Cap Haitien and randomly assigned to receive : @ ) a control ; @ ) a @-mo LNS ; or @ ) a @-mo LNS .


The LNS provided @ kcal and other nutrients including vitamin A , vitamin B-@ , iron , and zinc at @ % of the recommended amounts .


Infants were followed monthly on growth , morbidity , and developmental outcomes over a @-mo intervention period and at one additional time point @ mo postintervention to assess sustained effects .


The Bonferroni multiple comparisons test was applied , and generalized least-squares ( GLS ) regressions with mixed effects was used to examine impacts longitudinally .


Baseline characteristics did not differ by trial arm except for a higher mean age in the @-mo LNS group .


GLS modeling showed LNS supplementation for @ mo significantly increased the length-for-age z score ( SE ) by @ @ and the weight-for-age z score by @ @ compared with in the control group after adjustment for child age ( P < @ ) .


The effects were sustained @ mo postintervention .


Morbidity and developmental outcomes did not differ by trial arm .


A low-energy , fortified product improved the linear growth of young children in this urban setting .


The trial was registered at clinicaltrials.gov as NCT@ .


Blood pressure ( BP ) control for renal protection is essential for patients with type @ diabetes .


Our objective in this analysis of Veterans Affairs Diabetes Trial ( VADT ) data was to learn whether on-study systolic BP ( SBP ) , diastolic BP ( DBP ) , and pulse pressure ( PP ) affected renal outcomes measured as albumin-to-creatinine ratio ( ACR ) and estimated glomerular filtration rate ( eGFR ) .


The VADT was a prospective , randomized study of @,@ veterans with type @ diabetes to determine whether intensive glucose control prevented major cardiovascular events .


In this post hoc study , time-varying covariate survival analyses and hazard ratios ( HR ) were used to determine worsening of renal outcomes .


Compared with SBP @-@ mmHg , the risk of ACR worsening increased significantly for SBP @-@ mmHg ( HR @ -LSB- @ % CI @-@ @ -RSB- ; P = @ ) and for SBP @ mmHg ( @ -LSB- @-@ @ -RSB- ; P < @ ) .


Compared with a PP range of @-@ mmHg , PP < @ was associated with significantly lowered risk of worsening ACR ( @ -LSB- @-@ @ -RSB- ; P = @ ) and PP @ with significantly increased risk ( @ -LSB- @-@ @ -RSB- ; P < @ ) .


Analyses of BP ranges associated with eGFR worsening showed significantly increased risk with rising baseline SBP and an interaction effect between SBP @ mmHg and on-study A@C .


These patients were @ % more likely than those with SBP < @ mmHg to experience eGFR worsening ( @ -LSB- @-@ @ -RSB- ; P = @ ) for each @ % ( @ mmol/mol ) A@C increase .


SBP @ mmHg and PP > @ mmHg were associated with worsening ACR .


The results suggest that treatment of SBP to < @ mmHg may lessen ACR worsening .


The interaction between SBP @ mmHg and A@C suggests that the effect of glycemic control on reducing progression of renal disease may be greater in hypertensive patients .


Protease inhibitor-based antiretroviral therapy ( ART ) has been associated with preterm birth in some studies .


We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir ( LPV/r ) - or efavirenz ( EFV ) - based ART .


This was a planned secondary analysis of the PROMOTE-Pregnant Women and Infants Study , an open-label , randomized controlled trial comparing the risk of placental malaria among HIV-infected , ART-naive pregnant Ugandan women assigned to initiate LPV/r - or EFV-based ART at @-@ weeks gestation .


Gestational age was determined based on last menstrual period and ultrasound biometry .


All women received bednets and trimethoprim-sulfamethoxazole .


Stillbirths , spontaneous abortions , and multiple gestations were excluded from the primary analysis .


Potential risk factors for preterm birth ( < @ weeks gestation ) were evaluated by univariate and multivariate logistic regression .


Three hundred fifty-six women were included in this analysis .


At enrollment , median gestational age was @ weeks and median CD@ cell count was @ cells per cubic millimeter .


@ % of deliveries in the EFV arm and @ % in the LPV/r arm were preterm .


Preterm birth was associated with gestational weight gain below @ kg/week versus @ kg/week or more -LSB- odds ratio ( OR ) = @ ; @ % confidence interval ( CI ) : @ to @ ; P = @ -RSB- .


Neither ART regimen of LPV/r versus EFV ( OR = @ ; @ % CI : @ to @ ; P = @ ) nor placental malaria ( OR = @ ; @ % CI : @ to @ ; P = @ ) was associated with preterm birth .


LPV/r was not associated with an increased risk of preterm birth compared with EFV .


However , interventions are needed to address modifiable risk factors for preterm birth , such as nutritional status ( ClinicalTrials.gov , NCT@ ) .


The optimal substrate ablation approach in patients with persistent atrial fibrillation ( Per AF ) remains unclear .


This was a prospective randomized study comparing the efficacy of limited ( continuous complex fractionated atrial electrogram , CFAE : < @ milliseconds ) versus extensive ( continuous CFAE plus variable CFAE : < @ milliseconds ) atrial substrate modification in Per AF patients .


We enrolled @ Per AF patients in the study , and @ patients with AF termination after pulmonary vein isolation ( PVI ) were excluded .


In the remaining @ patients , @ were treated with limited approach ( Group @ ) and @ with an extensive approach ( Group @ ) .


The end point of the study was the incidence of an atrial arrhythmia recurrence postblanking period .


The patients were followed up for @ months with @-month clinical reviews , electrograms ( ECGs ) , Holter recordings , and echocardiographic monitoring .


Procedural AF termination and the single procedural efficacy were statistically comparable between the @ groups ( @ % vs. @ % in Groups @ and @ , respectively , P = @ ) .


During the follow-up , patients who received limited ablation had a lower incidence of recurrent AFL ( P = @ ) , and better reverse remodeling of the left atrium ( LA , P = @ ) .


After @ procedures , the freedom from any atrial arrhythmia was better in Group @ ( @ % vs. @ % , P = @ ) .


Those with longstanding AF and a larger baseline LA size responded better to the extensive ablation .


In the Per AF patients who failed to achieve AF termination after PVI alone , a specific atrial substrate modification approach targeting only continuous CFAEs could be considered as an initial ablation strategy .


Alcohol misuse among military service members from the recent conflicts in Iraq and Afghanistan is over two times higher compared to misuse in the civilian population .


Unfortunately , in addition to experiencing personal consequences from alcohol misuse , partners and family members of alcohol-misusing service members also suffer in negative ways from their loved one 's drinking .


These family members represent important catalysts for helping their loved ones identify problem drinking and overcoming the barriers to seeking care .


This paper describes the protocol to a pilot study evaluating a @-session , web-based intervention ( WBI ) for concerned partners ( CPs ) of service members with alcohol misuse .


The WBI will be adapted from the Community Reinforcement and Family Training ( CRAFT ) intervention .


In the first phase , we will develop and beta-test the WBI with @-@ CPs .


In the second phase , we will randomize CPs to WBI ( n = @ ) or to delayed-WBI ( n = @ ) and evaluate the impact of the WBI on CPs ' perceptions of service member help-seeking and drinking , as well as the CP 's well-being and relationship satisfaction @months after the intervention .


In the third phase , we will recruit @-@ service members whose partners have completed the study .


We will interview the service members to learn how the CP-focused WBI affected them and to assess whether they would be receptive to a follow-on WBI module to help them .


This project has the potential to benefit a large population of military service members who may be disproportionately affected by recent conflicts and whose drinking misuse would otherwise go undetected and untreated .


It also develops a new prevention model that does not rely on service members or partners attending a hospital or clinical facility to access care .


To identify predictive factors associated with the development of pressure ulcers in patients at risk who receive standardized preventive care .


Numerous studies have examined factors that predict risk for pressure ulcer development .


Only a few studies identified risk factors associated with pressure ulcer development in hospitalized patients receiving standardized preventive care .


Secondary analyses of data collected in a multicentre randomized controlled trial .


The sample consisted of @ consecutive patients at risk for pressure ulcer development ( Braden Score < @ ) receiving standardized preventive care measures .


Patient demographic information , data on skin and risk assessment , medical history and diagnosis were collected during @months ( December @-January @ ) .


Predictive factors were identified using multivariate statistics .


Pressure ulcers in category II-IV were significantly associated with non-blanchable erythema , urogenital disorders and higher body temperature .


Predictive factors significantly associated with superficial pressure ulcers were admission to an internal medicine ward , incontinence-associated dermatitis , non-blanchable erythema and a lower Braden score .


Superficial sacral pressure ulcers were significantly associated with incontinence-associated dermatitis .


Despite the standardized preventive measures they received , hospitalized patients with non-blanchable erythema , urogenital disorders and a higher body temperature were at increased risk for developing pressure ulcers .


Improved identification of at-risk patients can be achieved by taking into account specific predictive factors .


Even if preventive measures are in place , continuous assessment and tailoring of interventions is necessary in all patients at risk .


Daily skin observation can be used to continuously monitor the effectiveness of the intervention .


The use of liver as a reference tissue for semi-quantification of tumour FDG uptake may not be valid in hepatic steatosis ( HS ) .


Previous studies on the relation between liver FDG uptake and HS have been contradictory probably because they ignored blood glucose ( BG ) .


Because hepatocyte and blood FDG concentrations equalize , liver FDG uptake parallels BG , which must therefore be considered when studying hepatic FDG uptake .


We therefore re-examined the relation between HS and liver uptake taking BG into account .


This was a retrospective study of @ patients undergoing routine PET/CT with imaging @min post-FDG .


Average standard uptake value ( SUVave ) , maximum SUV ( SUVmax ) and CT density ( index of HS ) were measured in a liver ROI .


Blood pool SUV was based on the left ventricular cavity ( SUVLV ) .


Correlations were assessed using least squares fitting of continuous data .


Patients were also divided into BG subgroups ( < @ , @-@ , @-@ , @-@ , @-@ and @ + mmol/l ) .


SUVave , SUVmax and SUVLV displayed similar relations with BG .


SUVmax/SUVLV , but not SUVave/SUVLV , correlated significantly with BG .


SUVmax , but not SUVave , correlated inversely with CT density before and after adjusting for BG .


SUVmax/SUVave correlated more strongly with CT density than SUVmax .


CT density correlated inversely with SUVmax/SUVLV but positively with SUVave/SUVLV .


Hepatic SUV is more influenced by BG than by HS .


Its relation with BG renders it unsuitable as a reference tissue .


Nevertheless , hepatic fat does correlate positively with liver SUV , although this is seen only with SUVmax because SUVave is ` diluted ' by hepatic fat .


To test whether a breakfast including eggs ( EB ) containing high-quality protein decreases subsequent food intake and increases satiety-related hormones in overweight or obese adults more than a breakfast including cereal ( CB ) of lower protein quality , but matched for energy density and macronutrient composition .


Twenty healthy overweight or obese subjects were randomized to eat an EB or a CB daily under supervision for one week , followed by a crossover to the opposite breakfast week after a two-week washout period .


On days @ and @ of each test week , a structured lunch was provided ad libitum .


Food intake , hunger and satiety scores , and blood parameters were measured before and after breakfast .


Outcomes were analyzed using mixed effects statistical models for repeated measures analysis of variance .


Compared to the CB week , during the EB week , a ) feeling of fullness was greater ( P < @ ) on day @ but not on day @ ; b ) energy intake was not significantly lower on either day ; c ) right before lunch , acylated ghrelin was lower and PYY@-@ was higher on day @ ( P < @ and < @ , respectively ) but not on day @ ; d ) PYY@-@ , but not ghrelin , showed greater rise between breakfast and lunch on days @ ( P < @ ) and @ ( P < @ ) .


Despite a highly similar energy density and macronutrient composition , the higher protein quality breakfast significantly influenced fullness , ghrelin and PYY@-@ .


Only the effect on PYY@-@ lasted throughout the week .


A next step would be to test if the benefits are pronounced and lasting , if protein quality of all meals is increased .


Neoadjuvant chemotherapy with trastuzumab for patients with HER@-positive breast cancer can produce a pathological complete response in the breast in @-@ % of patients .


We investigated the effect of the timing of trastuzumab administration with anthracycline and taxane neoadjuvant chemotherapy .


This randomised trial was done at @ centres in the USA and Puerto Rico .


Women with operable HER@-positive invasive breast cancer were randomly assigned ( @:@ ) with a biased coin minimisation algorithm , stratified for age , tumour size , and hormone receptor status .


Neither patients nor investigators ( except for a cardiac safety review panel ) were masked to treatment assignment .


Patients randomly assigned to sequential treatment received fluorouracil @ mg/m ( @ ) , epirubicin @ mg/m ( @ ) , and cyclophosphamide @ mg/m ( @ ) ( FEC-@ ) on day @ of a @-day cycle for four cycles followed by paclitaxel @ mg/m ( @ ) and trastuzumab @ mg/kg ( after a @ mg/kg loading dose ) once per week for @ weeks , while those randomly assigned to the concurrent treatment group received paclitaxel and trastuzumab once per week for @ weeks followed by four cycles of FEC-@ ( on day @ of each @-day cycle ) and once-weekly trastuzumab , in the same doses as the sequential group .


Surgery , including evaluation of the axilla , was done within @ weeks of completion of neoadjuvant treatment .


The primary outcome was the percentage of patients who had a pathological complete response in the intention-to-treat population .


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


From Sept @ , @ , to Dec @ , @ , @ women were enrolled ( @ in the sequential group , @ in the concurrent group ) .


Two patients in the sequential group withdrew consent before starting treatment .


@ of @ ( @ % , @ % CI @-@ ) patients who received sequential treatment had a pathological complete response in the breast versus @ of @ ( @ % , @ % CI @-@ ) who received concurrent treatment ( difference @ % , @ % CI -@ to @ ) .


No treatment-related deaths occurred .


The most common severe toxic effects were neutropenia ( @ -LSB- @ % -RSB- of @ patients in the sequential group vs @ -LSB- @ % -RSB- of @ patients in the concurrent group ) and fatigue ( six -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Left ventricular ejection fraction dropped below the institutional lower limit of normal at week @ in one ( @ % ) of @ patients who received sequential treatment and four ( @ % ) of @ patients who received concurrent treatment ; by week @ , it had dropped below this limit in nine ( @ % ) of @ patients and in six ( @ % ) of @ patients , respectively .


Concurrent administration of trastuzumab with anthracyclines offers no additional benefit and is not warranted .


To compare the difference of the efficacy on knee osteoarthritis ( KOA ) between the combined therapy of acupuncture and moxibustion and western medication , and explore the better therapeutic method for KOA .


One hundred and sixty patients were divided into a combined therapy group and a western medication group , @ cases in each one according to the visit sequence , with the random number table adopted .


In the combined therapy group , the main points were selected from the local painful sites , combined with the acupoints based on the syndrome differentiation and distal acupoints on the affected meridians .


The lifting , thrusting or rotating technique was used and the reinforcing or reducing manipulation was applied according to the syndrome differentiation .


`` Duanci '' or `` Shuci '' needling technique was used specially at the extra points and Ashi points .


The needling sensation relied on the patients ' tolerance .


After acupuncture , the heat-sensitive moxibustion with pure moxa stick was applied over the local painful sites around knee joint and Shenshu ( BL @ ) to detect the heat-sensitized points .


Acupuncture and moxibustion were given once every day .


The treatment of @ days made @ session .


There were @ days at the interval between two sessions .


In the western medication group , glucosamine sulfate capsules were prescribed for oral administration , @ capsules each time , three times a day .


Additionally , the joint cavity injection was combined .


On the first day , sodium hyaluronate @ mg and triamcinolone acetonide acetate @ mg were injected .


Afterwards , on the @th , @th , @nd and @th days , sodium hyaluronate injection @ mg was used only .


The treatment was for @ weeks totally in the two groups .


The efficacy was analyzed statistically in @ weeks .


The follow-up visit was conducted in @ months and @ months after @ weeks treatment , respectively .


The Western Ontario and Mcmaster Universities Osteoarthritis Index ( WOMAC ) and visual analogue scale ( VAS ) were adopted to assess the recovery of joint function .


The efficacy in @ weeks of treatment was different significantly between the two groups ( P < @ ) .


The efficacy in the western medication group was better than that in the combined therapy group .


The difference in the safety assessment was remarkable ( P < @ ) .


The result in the combined therapy group was superior remarkably to the western medication group .


In @-month follow-up visit after treatment , the knee joint function was not different obviously between the two groups ( P > @ ) .


In @-month followup visit after treatment , the knee joint function was different obviously between the two groups ( P < @ ) .


The result in the combined therapy group was better remarkably than that in the western medication group .


The combined therapy of acupuncture and moxibustion achieves the safe and effective therapeutic effect with less adverse reactions in the treatment of KOA .


The immediate effect in the combined therapy group is not so obvious as compared with the western medication , but the long-term efficacy is remarkably superior to western medication .


The prognostic value of time from symptom onset to reperfusion may be enhanced by the identification of Q waves on the presenting electrocardiogram ( ECG ) in patients with ST-segment elevation myocardial infarction ( STEMI ) .


We evaluated whether the relative prognostic utility of these @ metrics was altered by sex .


Q waves in the distribution of the ST-segment elevation on the baseline ECG were evaluated by a blinded core laboratory in @ STEMI patients ( @ men and @ women ) from the PLATelet inhibition and patient Outcomes ( PLATO ) trial who underwent percutaneous coronary intervention ( PCI ) within @ hours of symptom onset .


Women were older ( median @ vs @ years ) , more likely to be diabetic ( @ % vs @ % ) , hypertensive ( @ % vs @ % ) , and a higher Killip class > I ( @ % vs @ % ) , as compared with men .


Whereas the Q waves frequency rose progressively over time to ECG in men , this relationship was attenuated in women ( P = @ ) .


Q waves on the baseline ECG were associated with a higher excess hazard of @-year vascular death in men ( hazard ratio -LSB- HR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , and a similar trend existed in women ( HR @ ; @ % CI , @-@ @ ) .


Women with baseline Q waves tended to have higher risk of @-year vascular death than men as continuous time from symptom onset to PCI increased ( P -LSB- interaction -RSB- = @ ) .


These differences in the evolution of baseline Q waves and relationship between time from symptom onset and vascular death in women and men deserve recognition in future studies of STEMI .


In many countries a high proportion of births begin as induced labours .


Induction can be lengthy if cervical priming is required prior to induction .


This usually occurs as an inpatient , however , an alternative is to allow women to go home after satisfactory fetal monitoring .


The aim of this study was to assess the preferences of women for cervical priming for induction of labour in an outpatient or inpatient setting .


A discrete choice experiment ( DCE ) was conducted alongside a randomised trial of inpatient and outpatient cervical priming ( the OPRA trial ) in two maternity hospitals in South Australia .


@ participants were included , and women 's preferences for cervical priming for induction of labour were assessed .


Women were willing to accept an extra @ trips to hospital ( @ trips total ) and a total travel time of @ minutes to be able to return to their own home while waiting for the priming to work .


For enhanced inpatient services , women were willing to accept a total travel time of @ minutes to have a private room with private bathroom while waiting for the priming to work .


The overall benefit score for outpatient priming was @ , @ for enhanced inpatient care and @ for basic inpatient care , suggesting slightly greater preferences for outpatient priming .


Preferences for outpatient priming increased when women could return to their own home ( compared to other offsite accommodation ) , and decreased with more trips to hospital and longer travel time .


Our results suggest that outpatient priming was slightly more preferred than either enhanced inpatient priming or basic care ; these results should be confirmed in different clinical settings .


There may be merit in providing women information about both options in the future , as preferences varied according to the characteristics of the services on offer and the sociodemographic background of the woman .


Tesamorelin is a synthetic analogue of growth hormone-releasing factor ( GRF ) , which increases basal and pulsatile growth hormone ( GH ) secretion and subsequently increases insulin-like growth factor ( IGF ) -@ .


Limited information is available about the pharmacokinetics of this compound .


Consequently , the aim of this study was to characterize the population pharmacokinetics of tesamorelin in HIV-infected patients and healthy subjects .


A total of @ HIV-infected patients and healthy subjects receiving subcutaneous tesamorelin doses of @ or @mg administered daily during @ consecutive days were included in the analysis .


An open one-compartment model with first - and zero-order absorption and first-order elimination was developed to best describe the data using NONMEM ( ) VII .


The effect of different covariates on tesamorelin pharmacokinetics was investigated .


Model evaluation was performed using predictive checks and non-parametric bootstrap .


Plasma clearance and its interindividual variability -LSB- % coefficient of variation ( CV ) -RSB- was estimated to be @,@ L/h ( @ % ) .


Volume of distribution was calculated to be @L ( @ % ) .


Age , body size measures , race and health status were not related to tesamorelin pharmacokinetic parameters within the range of covariates studied .


The fraction of tesamorelin absorbed by a first-order process is @ % higher on day @ compared with day @ .


Predictive checks and non-parametric bootstrap demonstrated that the model is appropriate in describing the time course of tesamorelin plasma concentrations in both HIV-infected patients and healthy subjects .


An open one-compartment model with first and zero order absorption processes and linear elimination is suitable to characterize the pharmacokinetics of tesamorelin .


The fraction of tesamorelin absorbed by a first-order process evolves with time .


No clinically relevant covariates were identified as predictors of tesamorelin pharmacokinetics .


Neuron-specific enolase ( NSE ) is a widely-used biomarker for prognostication of neurological outcome after cardiac arrest , but the relevance of recommended cutoff values has been questioned due to the lack of a standardized methodology and uncertainties over the influence of temperature management .


This study investigated the role of NSE as a prognostic marker of outcome after out-of-hospital cardiac arrest ( OHCA ) in a contemporary setting .


A total of @ patients hospitalized after OHCA were randomized to targeted temperature management at either @C or @C .


NSE levels were assessed in blood samples obtained @ , @ , and @ h after return of spontaneous circulation .


The primary outcome was neurological outcome at @ months using the cerebral performance category score .


NSE was a robust predictor of neurological outcome in a baseline variable-adjusted model , and target temperature did not significantly affect NSE values .


Median NSE values were @ ng/ml versus @ ng/ml , @ ng/ml versus @ ng/ml , and @ ng/ml versus @ ng/ml for good versus poor outcome at @ , @ , and @ h , respectively ( p < @ ) .


At @ and @ h , NSE predicted neurological outcome with areas under the receiver-operating curve of @ and @ , respectively .


High NSE cutoff values with false positive rates @ % and tight @ % confidence intervals were able to reliably predict outcome .


High , serial NSE values are strong predictors of poor outcome after OHCA .


Targeted temperature management at @C or @C does not significantly affect NSE levels .


( Target Temperature Management After Cardiac Arrest -LSB- TTM -RSB- ; NCT@ ) .


Physical activity ( PA ) has documented health benefits , but older Latinos are less likely to engage in leisure time PA than older non-Latino whites .


Dance holds a promise as a culturally appropriate form of PA that challenges individuals physically and cognitively .


This paper describes a randomized controlled trial that will test the efficacy of BAILAMOS , a @-month Latin dance program followed by a @-month maintenance program , for improving lifestyle PA and health outcomes .


Older adults ( n = @ ) , aged @ + , Latino/Hispanic , Spanish speaking , with low PA levels , and at risk for disability will be randomized to one of two programs , a dance program or health education control group .


BAILAMOS is a @-month program that meets two times per week for one @h per session .


Dance sessions focus on instruction , including four styles of dance , and couples dancing .


Bi-monthly Fiestas de Baile ( dance parties ) are also included , in which participants dance and practice what they have learned .


Monthly @-hour discussion sessions utilize a Social Cognitive framework and focus on knowledge , social support , and self-efficacy to increase lifestyle PA. .


The health education control group will meet one time per week for two @h per session .


Primary outcomes including PA changes and secondary outcomes including self-efficacy , physical function , cognitive function , and disability will be assessed at baseline , @ , and @ months .


It is hypothesized that PA , self-efficacy , physical function , cognitive function , and functional limitations and disability scores will be significantly better in the BAILAMOS group at @ and @ months compared to the control group .


The purpose of this study was to evaluate the influence of an early cardiac rehabilitation ( CR ) program on health-related quality of life ( HRQL ) and functional capacity in patients who recently experienced an acute myocardial infarction ( AMI ) .


This program was initiated in the inpatient setting and was followed by an unsupervised outpatient intervention .


After the same inpatient care plan , low-risk patients who experienced an AMI were randomized into @ groups : ( @ ) a control group ( CG ) ( n = @ ) entailing usual care and ( @ ) an intervention group ( IG ) ( n = @ ) entailing outpatient ( unsupervised ) CR primarily centered on a progressive walking program .


Initially , all patients underwent a supervised exercise program with early mobilization beginning @hours after an AMI .


On hospital discharge , all patients were classified according to cardiovascular risk .


Quality of life was evaluated by the MacNew Heart Disease HRQL questionnaire @ days after discharge .


Functional capacity was determined by a @-minute walk test ( @MWT ) distance on the day of inpatient discharge as well as @ days afterward .


The HRQL global score was higher in the IG compared with the CG @ days after discharge ( P < @ ) ; physical and emotional domain scores were both significantly higher in the IG ( P < @ ) .


Furthermore , the IG showed a greater @MWT distance compared with the CG ( P < @ ) .


A CR program based on early progressive exercises , initiated by supervised inpatient training and followed by an unsupervised outpatient program , improved HRQL and functional capacity in patients at low cardiovascular risk who recently experienced an AMI .


To determine the dose-related effects of a novel probiotic combination , I. @ , on irritable bowel syndrome ( IBS ) - related quality of life ( IBS-QoL ) .


A multicenter , randomized , double-blind , placebo-controlled intervention clinical trial with three parallel arms was designed .


A total of @ patients ( @ female , @ male ; age range @-@ years ) with IBS and diarrhea according to Rome-III criteria were randomly allocated to receive one capsule a day for @ wk containing : ( @ ) I. @ high dose ( n = @ ) ; ( @ ) I. @ low dose ( n = @ ) ; and ( @ ) placebo ( n = @ ) .


At baseline , and @ and @ wk of treatment , patients filled the IBSQoL , Visceral Sensitivity Index ( VSI ) , and global symptom relief questionnaires .


During treatment , IBS-QoL increased in all groups , but this increment was significantly larger in patients treated with I. @ than in those receiving placebo ( P = @ ) .


After @ wk of treatment , IBS-QoL increased by @ @ and @ @ points in the high and the low dose groups , respectively ( P = @ and P = @ vs placebo ) , but only @ @ in the placebo group .


Gut-specific anxiety , as measured with VSI , also showed a significantly greater improvement after @ wk of treatment in patients treated with probiotics ( by @ @ and @ @ points , high and low dose respectively , P < @ for both vs @ @ score increment in placebo ) .


Symptom relief showed no significant changes between groups .


No adverse drug reactions were reported following the consumption of probiotic or placebo capsules .


A new combination of three different probiotic bacteria was superior to placebo in improving IBS-related quality of life in patients with IBS and diarrhea .


Pantoprazole magnesium ( pantoprazole-Mg ) may display extended inhibition of the proton pump with the potential for improved clinical efficacy in gastro-oesophageal reflux disease ( GERD ) .


To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD .


Gastro-oesophageal reflux disease ( Los Angeles grades A-D ) patients were randomised to @weeks of treatment with pantoprazole-Mg ( n = @ ) or esomeprazole ( n = @ ) , both @mg once daily , in this multicentre ( @ Brazilian sites in @ cities ) , double-blind study , with an additional @weeks ' treatment in nonresponding patients .


Severity of oesophagitis ( at endoscopy ) and GERD-related symptoms ( ReQuest-GI ) were assessed .


The primary end point was the proportion of patients in complete remission ( ReQuest-GI score < @ plus endoscopic healing ) at week @ .


Complete remission occurred in @ % of patients in each treatment group at @weeks ( primary endpoint ) and in @ % and @ % of patients in the pantoprazole-Mg and esomeprazole groups at @weeks , with no significant differences .


Mucosal healing rates were high and not significantly different .


At @weeks , symptom relief with pantoprazole-Mg was significantly greater than that with esomeprazole ( @ % vs. @ % , P = @ ) because of continued improvement in symptoms with pantoprazole-Mg from week @ to week @ ( P = @ ) .


Pantoprazole-Mg @mg was at least as effective as esomeprazole @mg for complete remission and the mucosal healing rate was high .


Symptom relief with pantoprazole-Mg continued to improve from @ to @weeks and was greater than that with esomeprazole at week @ , suggesting an extended period of treatment effect ( ClinicalTrials.gov identifier : NCT@ ) .


Retaining HIV patients in medical care promotes access to antiretroviral therapy , viral load suppression , and reduced HIV transmission to partners .


We estimate the programmatic costs of a US multisite randomized controlled trial of an intervention to retain HIV patients in care .


Six academically affiliated HIV clinics randomized patients to intervention ( enhanced personal contact with patients across time coupled with basic HIV education ) and control -LSB- standard of care ( SOC ) -RSB- arms .


Retention in care was defined as @-month visit constancy , that is , at least @ primary care visit in each @-month interval over a @-month period .


We used microcosting methods to collect unit costs and measure the quantity of resources used to implement the intervention in each clinic .


All fixed and variable labor and nonlabor costs of the intervention were included .


Visit constancy was achieved by @ % ( @/@ ) of patients in the SOC arm and by @ % ( @/@ ) of patients in the intervention arm , representing an increase of @ patients ( relative improvement @ % ; @ % confidence interval : @ % to @ % ; P < @ ) .


The total annual cost of the intervention at the @ clinics was $ @,@ , the average cost per patient was $ @ , and the estimated cost per additional patient retained in care beyond SOC was $ @ .


Our analyses showed that a retention in care intervention consisting of enhanced personal contact coupled with basic HIV education may be delivered at fairly low cost .


These results provide useful information for guiding decisions about planning or scaling-up retention in care interventions for HIV-infected patients .


Although previous studies have demonstrated that a variety of local anesthetics are effective to decrease pain associated with tenaculum placement , no studies directly compare an injection with a topical anesthetic .


The objective of this study was therefore to compare mean pain scores with tenaculum placement after an intracervical lidocaine injection or topical lidocaine gel .


A randomized , single-blinded trial of women presenting for office gynecologic procedures that required a tenaculum .


Women aged @ years or older were randomized to receive either a @ % lidocaine intracervical injection or topical application of @ % lidocaine gel to the cervix immediately prior to tenaculum placement .


The primary outcome was pain at the time of tenaculum placement , measured on a @ mm Visual Analog Scale .


Secondary outcomes included pain with the intervention and satisfaction with tenaculum placement .


Seventy-four women were enrolled and randomized ; @ subjects in each group met criteria for analysis .


The two groups had similar socio-demographic characteristics .


Women who received the injection had lower mean pain levels at tenaculum placement -LSB- @ mm ( S.D. @ mm ) versus @ mm ( S.D. @ mm ) , p < @ -RSB- but higher mean pain levels with study drug application -LSB- @ mm ( S.D. @ mm ) versus @ mm ( S.D. @ mm ) , p < @ -RSB- .


Satisfaction with tenaculum placement was similar for the two groups .


Mean pain with tenaculum placement is lower after receiving a lidocaine injection than after receiving a topical lidocaine gel .


Satisfaction with tenaculum placement is similar with both interventions .


Over @ mastectomies are performed in England and Wales annually .


Acute postoperative pain and nausea are common .


The most frequently occurring long-term complications are chronic pain ( up to @ % ) and reduced shoulder function ( reported at @ % ) .


Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications .


This study assesses the effectiveness of a @-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy .


This is a randomised , double blind , placebo-controlled , two-centre , parallel group trial in women undergoing mastectomy with or without axillary involvement .


One hundred and sixty participants will be randomised in a @:@ ratio to receive either @ % levobupivacaine or @ % saline by subpectoral infusion postoperatively for @h .


All participants will be provided with an intravenous morphine patient-controlled analgesia ( PCA ) system .


Participants will be followed-up for @h in hospital and at approximately @days and @months postoperatively .


Joint primary outcome measures are total morphine consumption and total pain score ( captured via patient-recorded visual analogue scale ( VAS ) @ hourly ) during the first @h postoperatively .


Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph .


Secondary outcomes include PCA attempts in first @h ; VAS pain scores and shoulder function by goniometry at @h , @days ( approximately ) and @months ; Verbal Rating Scale pain scores in first @h ; Brief Pain Inventory and Oxford Shoulder Score at @months ; duration of hospital stay ; incidence of postoperative nausea and vomiting ; cost-effectiveness .


The study is approved by the South West England Research Ethics Committee ( @/SW/@ ) .


will be published in a peer-reviewed journal and presented at local , national and international scientific meetings .


Case conferences for people with dementia and challenging behaviors ( e.g. , apathy ) are recommended as useful tools that enable staff in nursing homes to understand the behavior of people with this type of disease .


Understanding peoples ' behaviors is the basis for the initiation of targeted interventions to improve the quality of care for people with dementia .


Furthermore , case conferences demonstrate positive effects on burnout , dementia-specific burden , and vocational action competence of the staff .


The two likely approaches for conducting case conferences include the following : A ) using a structured assessment instrument , which guides the staff in understanding the residents ' behaviors and B ) using a narrative approach in which the staff must identify the reasons for the residents ' behaviors in an unstructured manner .


Case conferences are a complex intervention , and evaluating their multiple effects is challenging .


The aim of this study protocol was to describe a likely solution for evaluating this type of complex intervention using a special cluster randomized trial .


In this stepped-wedged cluster randomized trial , the two interventions will be sequentially implemented every three months in a group of @ nursing homes ( clusters ) with a minimum of @ residents over @months ( @months of intervention for each cluster and follow-up ) .


The primary outcome is the reduction of challenging behavior ( measured with the neuropsychiatric inventory-nursing home version -LSB- NPI-NH -RSB- ) .


Secondary outcomes are residents ' quality of life , prescription of psychotropic medications , staff burnout , dementia-related stress , and vocational action competence .


The effectiveness of the study will be accompanied by a process evaluation .


The primary data will be analyzed using a Bayesian mixed effect model ; the secondary data will be analyzed using descriptive statistics and mixed effects models .


The implementation and effect measurement of complex interventions such as case conferences within a cluster randomized trial are challenging ( e.g. , complex and intensive training , delayed treatment effect ) .


In this study protocol , the methodological advantages and disadvantages of using the stepped wedge design to answer the research questions are discussed .


Owing to their potential to act as estrogen receptor modulators and interfere with aromatase enzyme in animal studies , phytoestrogens ( PE ) may be useful as part of ovulation induction for polycystic ovary syndrome ( PCOS ) .


Patients < @ years , presenting with infertility and PCOS , were included and randomly allocated to either group I ( clomiphene citrate ; CC ) or group II ( CC plus Cimicifugae racemosae ; CR ) .


Primary outcome was pregnancy rate .


Secondary outcomes included ovulation , midcycle serum estradiol and luteinizing hormone ( LH ) as well as mid-luteal serum progesterone .


Analysis included @ patients in group I versus @ patients in group II .


Both groups were matched regarding demographics and basic data .


Significant differences were elicited when comparing days until HCG injection ( @ @ versus @ @ , p = @ ) , endometrial thickness ( mm ) ( @ @ versus @ @ , p < @ ) , serum levels of mid-luteal and midcycle estradiol ( p < @ ; Figure @ ) , LH ( IU/ml ) ( p < @ ) as well as mid-luteal progesterone ( p < @ ) .


PE plus CC group had significantly higher clinical pregnancies per cycle ( @/@ ( @ % ) versus @/@ ( @ % ) , p < @ ) , compared to the CC only group .


Adding CR to clomiphene-induction cycles with timed intercourse in polycystic ovarian syndrome improves cycle outcomes and pregnancy rates .


To compare response to upper-limb treatment using robotics plus motor learning ( ML ) versus functional electrical stimulation ( FES ) plus ML versus ML alone , according to a measure of complex functional everyday tasks for chronic , severely impaired stroke survivors .


Single-blind , randomized trial .


Medical center .


Enrolled subjects ( N = @ ) were > @ year postsingle stroke ( attrition rate = @ % ; @ completed the study ) .


All groups received treatment @d/wk for @h/d ( @ sessions ) , with unique treatment as follows : ML alone ( n = @ ) ( @h/d partial - and whole-task practice of complex functional tasks ) , robotics plus ML ( n = @ ) ( @ h/d of ML and @ h/d of shoulder/elbow robotics ) , and FES plus ML ( n = @ ) ( @ h/d of ML and @ h/d of FES wrist/hand coordination training ) .


Primary measure : Arm Motor Ability Test ( AMAT ) , with @ complex functional tasks ; secondary measure : upper-limb Fugl-Meyer coordination scale ( FM ) .


There was no significant difference found in treatment response across groups ( AMAT : P. @ ; FM coordination : P. @ ) .


All @ treatment groups demonstrated clinically and statistically significant improvement in response to treatment ( AMAT and FM coordination : P. @ ) .


A group treatment paradigm of @:@ ( therapist/patient ) ratio proved feasible for provision of the intensive treatment .


No adverse effects .


Severely impaired stroke survivors with persistent ( > @y ) upper-extremity dysfunction can make clinically and statistically significant gains in coordination and functional task performance in response to robotics plus ML , FES plus ML , and ML alone in an intensive and long-duration intervention ; no group differences were found .


Additional studies are warranted to determine the effectiveness of these methods in the clinical setting .


The IMMEDIATE ( Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care ) Trial , a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium ( GIK ) administered in ambulances in the out-of-hospital setting , used the Exception from Informed Consent Requirements ( EFIC ) for Emergency Research under Title @ of the Code of Federal Regulations .


EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback .


Although not the primary purpose of the community consultation process , a common concern to research sponsors , staff , and institutional review boards ( IRBs ) is whether there will be a sufficient number of participants to justify mounting a study in their community .


Information from community consultation regarding the community acceptance might inform this question .


We evaluated the utility of telephone survey data done as part of the EFIC process as a way to project the ultimate rate of trial participant enrollment .


A telephone survey community consultation process was undertaken in nine communities planning to be IMMEDIATE Trial sites using a representative sampling of the target population in the areas covered by participating emergency medical service ( EMS ) agencies .


Survey respondents were read a description of the planned study and its informed consent approach that included the option for patients to decline participation in the trial while being transported for acute care in an ambulance .


Survey respondents were then asked whether they would object to participating in the study .


At the conclusion of actual trial enrollment , the Coordinating Center compared the survey results with the actual rates of enrollment at each site .


Approximately @ ( range = @-@ ) respondents completed the survey in each of the study communities .


Of @ survey respondents , @ % ( range = @ % -@ % ) said that they would not object to participating in the trial if experiencing a heart attack , and @ % ( range = @ % -@ % ) said that they would allow the study to be done in their community .


During actual trial enrollment in the communities , @ % ( range = @ % -@ % ) of the @ potential participants agreed in the ambulance to have the study drug started and provided informed consent at the hospital , an average of @ percentage-points higher than projected by the survey ( @ % confidence interval ( CI ) : @ % -@ % ) , @ % higher on a relative scale ( CI : @ % -@ % ) .


The survey-based approach to community consultation proved to be an efficient way to obtain representative input from potential clinical trial participants .


The survey data generated a relatively good and conservative estimate of the ultimate rate of trial enrollment .


This information could be useful to investigators and IRBs in projecting enrollment for clinical trials using EFIC .


To verify the clinical efficacy of acupuncture on motor dysfunction in ischemic stroke of subacute stage .


The multi-central randomized controlled trial was adopted .


One hundred and twenty-six cases of ischemic stroke of subacute stage were randomized into an acupuncture group ( @ cases ) and a conventional treatment group ( @ cases ) .


The basic treatment of western internal medicine and rehabilitation training were applied to the patients of the two groups .


In the acupuncture group , acupuncture was supplemented at the body points located on the extensor of the upper limbs and the flexor of the lower limbs .


In combination , scalp acupuncture was applied to NS@ , MS@ and MS@ on the affected side .


The treatment was given @ times a week and totally @ weeks were required .


The follow-up observation lasted for @ months .


The scores in Fugl-Meyer scale and NIHSS scale and Barthel index were compared between the two groups before treatment , in @ and @ weeks of treatment and the @-month follow-up observation after treatment separately .


In @ and @ weeks of treatment and the follow-up observation , Fugl-Meyer scale score was improved obviously in the patients of the two groups ( all P < @ ) .


In @ weeks of treatment and the follow-up observation , Fugl-Meyer scale score in the acupuncture groupwas im proved much apparently as compared with that in the conventional treatment group -LSB- @ ( @,@ ) vs @ ( @ , @ ) , @ ( @ , @ ) vs @ ( @ , @ ) , both P < @ -RSB- .


Except that NIHSS scale score was not reduced apparently in @ weeks of treatment in the conventional treatment group ( P > @ ) , the results of NIHSS scale at the other time points were all decreased obviously as compared with those before treatment in the patients of the two groups ( all P < @ ) .


In @ weeks of treatment and the follow-up observation , the results in the acupuncture group were reduced much apparently as compared with those in the conventional treatment group -LSB- @ ( @,@ ) vs @ ( @,@ ) , @ ( @,@ ) vs @ ( @,@ ) , both P < @ -RSB- .


In @ weeks of treatment and the follow-up observation , Barthel index was improved obviously as compared with that before treatment in the patients of the two groups ( all P < @ ) .


The improvement in the acupuncture group was much more significant as compared with the conventional treatment group -LSB- @ ( @,@ ) vs @ .


O ( @ , @ ) , P < @ .


Based on the conventional treatment , Acupuncture achieves the satisfactory clinical efficacy on motor dysfunction in ischemic stroke of subacute stage .


Fluorouracil and irinotecan-based , and gemcitabine-based regimens , are the standard of care in the first-line treatment of patients with metastatic pancreatic cancer .


New approaches are needed to improve survival and quality of life .


Whether a sequential approach alternating irinotecan , fluorouracil and gemcitabine may be effective and tolerable in patients with metastatic pancreatic cancer is unknown .


In this randomised , multicentre , open-label , phase @ trial , patients with metastatic pancreatic adenocarcinoma , World Health Organisation ( WHO ) performance status @-@ , and bilirubin levels < @ upper limit of normal values ( ULN ) were randomised @:@ to receive as first-line treatment either FOLFIRI @ ( irinotecan , leucovorin and fluorouracil ) alternating with fixed-dose rate gemcitabine as @-month periods ( FIRGEM , arm A ) , or fixed-dose rate gemcitabine alone ( arm B ) .


Treatment was continued until disease progression or limiting toxicity .


The primary end-point was the crude progression-free survival ( PFS ) rate at @ months .


The study is registered with EudraCT ( N @-@-@ ) .


Between October @ and March @ , @ patients were enroled .


The observed @-month PFS rate was @ % ( @ % confidence interval ( CI ) , -LSB- @-@ @ % -RSB- ) in arm A reaching the Fleming decision rules criteria to reject H@ and @ % ( @ % CI -LSB- @-@ @ % -RSB- ) in arm B. Objective response rates were @ % ( @-@ % ) in arm A and @ % ( @-@ % ) in arm B. Median PFS ( @ versus @ months , hazard ratio ( HR ) = @ -LSB- @-@ @ -RSB- ) and overall survival ( @ versus @ months , HR = @ -LSB- @-@ @ -RSB- ) were higher in arm A compared to arm B.


The most frequent grade @-@ toxicities were neutropenia ( @ % / @ % ; febrile neutropenia , @ % / @ % in arms A/B ) , diarrhoea ( arm A , @ % and arm B , @ % ) , and nausea/vomiting ( @ % / @ % ) .


No toxic deaths occurred .


The FIRGEM strategy appears to be effective and feasible in patients with metastatic pancreatic cancer .


Antidepressant prescriptions have increased exponentially , burdening health care costs .


To evaluate the costs and effects of an antidepressant cessation advice in case of inappropriate long-term use in primary care , i.e. long-term usage without a ( current ) indication .


A economic evaluation during @-year follow-up was performed , from a societal perspective , as part of a cluster-randomised controlled clinical trial ( PANDA ) .


Costs were assessed using the Trimbos/iMTA questionnaire for costs associated with psychiatric illness .


Health-related quality of life was measured using the EuroQol @D .


Outcome was costs per quality adjusted life year ( QALY ) .


Missing values were estimated using multiple imputation , bootstrap simulations were performed to address the uncertainty surrounding the incremental cost-effectiveness ratios ( ICERs ) .


There was no difference in average QALYs between the intervention ( @ ) and control group ( @ ) -LSB- difference -@ ( @ % CI -@ to @ ) -RSB- .


The intervention group , however , was less expensive than the control group ( total costs @ versus @ , respectively ) .


Most cost-effectiveness pairs were located in the south-west quadrant of the cost-effectiveness plane , implying the intervention was less effective but also less costly .


The ICER of the pooled data was @,@ , meaning that for one QALY lost , @,@ is saved .


This study shows that an antidepressant cessation advice given to patients ( and their FPs ) with inappropriate long-term antidepressant usage , albeit not effective , does seem to result in a reduction of societal costs .


This reduction in costs is mostly due to reduction of productivity losses , possibly due to patient empowerment and loss of stigma .


Evidence is weak for the ability of long-term non-invasive positive pressure ventilation ( NPPV ) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease ( COPD ) .


Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings .


This study investigated the effect of long-term NPPV , targeted to markedly reduce hypercapnia , on survival in patients with advanced , stable hypercapnic COPD .


This investigator-initiated , prospective , multicentre , randomised , controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure ( PaCO@ ) of @ kPa ( @ mm Hg ) or higher and pH higher than @ .


NPPV was targeted to reduce baseline PaCO@ by at least @ % or to achieve PaCO@ values lower than @ kPa ( @ mm Hg ) .


Patients were randomly assigned ( in a @:@ ratio ) via a computer-generated randomisation sequence with a block size of four , to continue optimised standard treatment ( control group ) or to receive additional NPPV for at least @ months ( intervention group ) .


The primary outcome was @-year all-cause mortality .


Analysis was by intention to treat .


The intervention was unblinded , but outcome assessment was blinded to treatment assignment .


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


Patients were recruited from @ respiratory units in Germany and Austria , starting on Oct @ , @ , and terminated with a record of the vital status on July @ , @ patients were randomly assigned to the NPPV group ( n = @ ) or to the control group ( n = @ ) .


All patients from the control group and the NPPV group were included in the primary analysis .


@-year mortality was @ % ( @ of @ patients ) in the intervention group and @ % ( @ of @ patients ) in the control group ; hazard ratio @ ( @ % CI @-@ @ ; p = @ ) .


@ ( @ % ) patients reported facial skin rash , which could be managed by changing the type of the mask .


No other intervention-related adverse events were reported .


The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic , stable COPD when NPPV is targeted to greatly reduce hypercapnia .


Previous phase III studies in patients with advanced Parkinson 's disease ( PD ) not adequately controlled on levodopa demonstrated significant reduction of ` off ' time with rotigotine transdermal system up to @ mg/@ h. However , the minimal effective dose has not been established .


This international , randomized , double-blind , placebo-controlled study ( SP@ ; NCT@ ) investigated rotigotine dose response up to @ mg/@ h.


Patients with advanced idiopathic PD ( @ h of daily ` off ' time on stable doses of levodopa ) were randomized @:@:@:@:@ to receive rotigotine @ , @ , @ , or @ mg/@ h or placebo , titrated over @ weeks and maintained for @ weeks .


The primary efficacy variable was change from baseline to end of maintenance in absolute time spent ` off ' .


@/@ ( @ % ) randomized patients completed maintenance .


Mean ( SD ) baseline daily ` off ' times ( h/day ) were placebo : @ ( @ ) , rotigotine @-@ mg/@ h : @ ( @ ) .


Rotigotine @ mg/@ h was the minimal dose to significantly reduce ` off ' time versus placebo .


LS mean ( SE ) absolute change in daily ` off ' time ( h/day ) from baseline was -@ ( @ ) with rotigotine @ mg/@ h , and -@ ( @ ) with placebo ; absolute change in ` off ' time in the @ mg/@ h group compared with placebo was -@ h/day ( @ % CI -@ , -@ ; p = @ ) .


There was an apparent dose-dependent trend .


Adverse events ( AEs ) reported at a higher incidence in the rotigotine @ mg/@ h group versus placebo included application site reactions , nausea , dry mouth , and dyskinesia ; there was no worsening of insomnia , somnolence , orthostatic hypotension , confusional state or hallucinations , even in patients @ years of age .


The minimal statistically significant effective dose of rotigotine to reduce absolute ` off ' time was @ mg/@ h.


The AE profile was similar to previous studies .


Metformin reduces cardiovascular risk in patients with type @ diabetes seemingly independent of lowering blood glucose concentration .


We assessed the cardiovascular effects of metformin in individuals without type @ diabetes .


We did a single-centre , double-blind , placebo-controlled trial at the Glasgow Clinical Research Facility ( Glasgow , UK ) .


We enrolled patients taking statins who did not have type @ diabetes but who did have coronary heart disease and large waist circumferences .


Participants were randomly assigned ( @:@ ) by computer to either metformin ( @ mg twice daily ) or matching placebo in block sizes of four .


Patients , investigators , trial staff , and statisticians were masked to treatment allocation .


The primary endpoint was progression of mean distal carotid intima-media thickness ( cIMT ) over @ months in the modified intention-to-treat population .


Secondary endpoints were changes in carotid plaque score ( in six regions ) , measures of glycaemia ( HbA@c , fasting glucose , and insulin concentrations , and Homeostasis Model Assessment of Insulin Resistance -LSB- HOMA-IR -RSB- ) , and concentrations of lipids , high sensitivity C-reactive protein , and tissue plasminogen activator .


The trial was registered at ClinicalTrials.gov , number NCT@ .


We screened @ patients , of whom we enrolled @ ( @ in the metformin group , @ in the placebo group ) .


Average age was @ years .


At baseline , mean cIMT was @ mm ( SD @ ) and mean carotid plaque score was @ ( SD @ ) .


cIMT progression did not differ significantly between groups ( slope difference @ mm per year , @ % CI -@ to @ ; p = @ ) .


Change of carotid plaque score did not differ significantly between groups ( @ per year , @ % CI -@ to @ ; p = @ ) .


Patients taking metformin had lower HbA@c , insulin , HOMA-IR , and tissue plasminogen activator compared with those taking placebo , but there were no significant differences for total cholesterol , HDL-cholesterol , non-HDL-cholesterol , triglycerides , high sensitivity C-reactive protein , or fasting glucose .


@ adverse events occurred in @ patients in the metformin group versus @ in @ patients in the placebo group .


Diarrhoea and nausea or vomiting were more common in the metformin group than in the placebo group ( @ vs @ ) .


Metformin had no effect on cIMT and little or no effect on several surrogate markers of cardiovascular disease in non-diabetic patients with high cardiovascular risk , taking statins .


Further evidence is needed before metformin can be recommended for cardiovascular benefit in this population .


Most patients with hip fractures are characterised by older age ( > @ years ) , frailty , and functional deterioration , and their long-term outcomes are poor with increased costs .


We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care .


We did a prospective , single-centre , randomised , parallel-group , controlled trial .


Between April @ , @ , and Dec @ , @ , we randomly assigned home-dwelling patients with hip-fractures aged @ years or older who were able to walk @ m before their fracture , to either comprehensive geriatric care or orthopaedic care in the emergency department , to achieve the required sample of @ patients .


Randomisation was achieved via a web-based , computer-generated , block method with unknown block sizes .


The primary outcome , analysed by intention to treat , was mobility measured with the Short Physical Performance Battery ( SPPB ) @ months after surgery for the fracture .


The type of treatment was not concealed from the patients or staff delivering the care , and assessors were only partly masked to the treatment during follow-up .


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


We assessed @ patients for eligibility , and excluded @ , mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than @ years .


Of the remaining patients , we randomly assigned @ to comprehensive geriatric care and @ to orthopaedic care .


At @ months , @ patients remained in the comprehensive geriatric care group and @ in the orthopaedic care group ; the main reason for dropout was death .


Mean SPPB scores at @ months were @ ( SE @ ) for comprehensive geriatric care and @ ( SE @ ) for orthopaedic care ( between-group difference @ , @ % CI @-@ , p = @ ) .


Immediate admission of patients aged @ years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at @ months , compared with the usual orthopaedic care .


The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care .


Community level interventions to improve maternal and child health have been supported and well evaluated in resource poor settings , but less so in developed countries .


PRISM -- Program of Resources , Information and Support for Mothers -- was a primary care and community-based cluster-randomised trial in sixteen municipalities in Victoria , Australia , which aimed to reduce depression in mothers and improve their physical health .


The aim of this paper is to report the longer term outcomes of PRISM and to reflect on lessons learned from this universal community intervention to improve maternal health .


Maternal health outcome data in PRISM were collected by postal questionnaire at six months and two years .


At two years , the main outcome measures included the Edinburgh Postnatal Depression Scale ( EPDS ) and the SF-@ .


Secondary outcome measures included the Experience of Motherhood Scale ( EOM ) and the Parenting Stress Index ( PSI ) .


A primary intention to treat analysis was conducted , adjusting for the randomisation by cluster .


@,@ / @,@ ( @ % ) women responded to the postal questionnaire at two years -@,@ ( @ % ) in the intervention arm and @,@ ( @ % ) in the comparison arm .


Respondents were mostly representative on available population data comparisons .


There were no differences in depression prevalence ( EPDS@ ) between the intervention and comparison arms ( @ % vs @ % ; ORadj = @ , @ % CI @-@ @ ) .


Nor did women 's mental health ( MCS : @ vs @ ) or physical health scores ( PCS : @ vs @ ) on the SF-@ differ between the trial arms .


Improvement in maternal mental and physical health outcomes at the population level in the early years after childbirth remains a largely unmet challenge .


Despite the lack of effectiveness of PRISM intervention strategies , important lessons about systems change , sustained investment and contextual understanding of the workability of intervention strategies can be drawn from the experience of PRISM .


Trial Registration .


Controlled-Trials .


com ISRCTN@ .


To compare the safety and efficacy of a single subconjunctival injection of methylprednisolone and a standard postoperative steroid regimen in terms of intraocular inflammation and intraocular pressure ( IOP ) after uncomplicated phacoemulsification surgery .


Two groups of @ patients each were included in this prospective randomized controlled trial .


Patients in the injection group were given a subconjunctival injection of @ mg methylprednisolone and the topical group received the conventional postoperative care with steroid eye drops ( dexamethasone @ mg/ml ) .


The patients were examined @ week and @ month after surgery .


Slit-lamp evaluation of anterior chamber inflammation and IOP were performed .


Changes in IOP of @ mmHg were considered clinically relevant .


In the injection group , mean IOP decreased from @ @ mmHg ( baseline ) to @ @ mmHg at @ week ( p = @ ) .


The topical group had a stable IOP at @ week ( @ @ mmHg ) compared to baseline ( @ @ mmHg ; p = @ ) .


At @ month , mean IOP was @ @ mmHg ( p = @ ) in the injection group and @ @ mmHg ( p = @ ) in the topical group .


The intragroup changes were neither statistically significant nor clinically relevant at any postoperative visit .


Both groups had the highest values of intraocular inflammation at the @-week postoperative visit , followed by a decline to barely traceable levels at @ month .


The difference was not clinically relevant at any postoperative visit .


The subconjunctival injection of methylprednisolone appears to be as safe and effective as the conventional treatment , and it might therefore be considered for treatment of individuals with compliance issues .


To examine the feasibility , acceptability , and potential effectiveness of an online intervention targeting college smokers .


The incentives involved discounted or free goods and services from businesses proximal to each campus .


A randomized controlled trial was conducted with @ current smokers recruited from @ Southeastern US universities .