Although potentially effective for these purposes , chronic lithium use in regard to safety in the elderly needs to be better explored .


To evaluate the effect of long-term lithium treatment at subtherapeutic doses on renal function in older adults .


Secondary aims were to evaluate the clinical safety and tolerability of this treatment and its effects on thyroid , immune , and glycemic functions .


Between February @ and October @ , a @-year randomized , double-blind , placebo-controlled trial followed by a single-blinded phase for an additional @ years .


Sixty-one patients with mild cognitive impairment ( Mayo Clinic criteria ) were randomized to receive lithium or placebo .


Renal function was estimated by the abbreviated Modification of Diet in Renal Disease ( aMDRD ) and the Chronic Kidney Disease-Epidemiology study ( CKD-EPI ) equations .


Leukocytes , serum thyroid-stimulating hormone ( TSH ) and free thyroxine ( T ) , and serum glucose and insulin were determined .


Tolerability was evaluated at @-month intervals through systematic clinical examinations and by the UKU Side Effect Rating Scale .


Analysis of longitudinal regression indicated that no significant changes in renal function were detected by the aMDRD ( P = @ ) and CKD-EPI ( P = @ ) equations after @ years of lithium treatment .


Significant increases in the number of neutrophils ( P = @ ) , serum TSH ( P = @ ) , and body weight ( P = @ ) were observed in the lithium group .


The lithium group presented more overall adverse events ( P = @ ) , particularly interfering in daily activities ( P < @ ) .


In addition , those patients had a higher incidence of diabetes mellitus ( P = @ ) and arrhythmia ( P = @ ) .


Chronic use of lithium at low doses did not affect renal function and was clinically safe .


However , some other potentially relevant adverse events were observed and others could not be ruled out due to limitations of the study design .


Age-related cognitive decline ( ARCD ) is of major societal concern in an ageing population , with the development of dietary supplements providing a promising avenue for amelioration of associated deficits .


Despite initial interest in the use of phospholipids ( PLs ) for ARCD , in recent years there has been a hiatus in such research .


Because of safety concerns regarding PLs derived from bovine cortex , and the equivocal efficacy of soybean-derived PLs , there is an important need for the development of new PL alternatives .


Phospholipids derived from milk proteins represent one potential candidate treatment .


In order to reduce the effects of age-associated memory impairment ( AAMI ) the Phospholipid Intervention for Cognitive Ageing Reversal ( PLICAR ) was developed to test the efficacy of a milk protein concentrate rich in natural , non-synthetic milk phospholipids ( Lacprodan PL-@ ) .


PLICAR is a randomized , double-blind , placebo-controlled parallel-groups study where @ ( N = @/group ) AAMI participants aged > @ years will be randomized to receive a daily supplement of Lacprodan PL-@ or one of two placebos ( phospholipid-free milk protein concentrate or inert rice starch ) over a @-month ( @-day ) period .


Participants will undergo testing at baseline , @ days and @ days .


The primary outcome is a composite memory score from the Rey Auditory Verbal Learning Test .


Secondary outcomes include cognitive ( verbal learning , working memory , prospective and retrospective memory , processing speed and attention ) , mood ( depression , anxiety , stress and visual analogue scales ) , cardiovascular ( blood pressure , blood velocity and pulse wave pressure ) , gastrointestinal microbiota and biochemical measures ( oxidative stress , inflammation , B vitamins and Homocysteine , glucoregulation and serum choline ) .


Allelic differences in the Apolipoprotein E and ( APOE ) and Methylenetetrahydrofolate reductase ( MTHFR ) gene will be included for subgroup analysis .


A subset ( N = @ ; @/group ) ) will undergo neuroimaging using functional magnetic resonance imaging ( fMRI ) and magnetoencephalography ( MEG ) in order to further explore in vivo central mechanisms of action of Lacprodan PL-@ .


This study will enable evaluation of the efficacy of milk-derived phospholipids for AAMI , and their mechanisms of action .


The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention ( PCI ) has been debated .


Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin ( now called sirolimus ) or its analogues ( everolimus or zotarolimus ) have produced contradictory results , ranging from equivalence between stent types to superiority of everolimus-eluting stents .


We randomly assigned @ patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent .


We used a noninferiority trial design with a noninferiority margin of @ percentage points for the upper boundary of the @ % confidence interval of the risk difference .


The primary end point was target-vessel failure , which was defined as a composite of cardiac death , target-vessel myocardial infarction , or ischemia-driven target-vessel revascularization at the @-year follow-up .


At @ year , paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point ( rate of target-vessel failure , @ % vs. @ % ; risk difference , @ percentage points -LSB- @ % confidence interval , @ to @ -RSB- ; relative risk , @ -LSB- @ % confidence interval , @ to @ -RSB- ; P = @ for noninferiority ) .


There was a significantly higher @-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure ( P = @ ) , spontaneous myocardial infarction ( @ % vs. @ % , P = @ ) , stent thrombosis ( @ % vs. @ % , P = @ ) , target-vessel revascularization ( @ % vs. @ % , P = @ ) , and target-lesion revascularization ( @ % vs. @ % , P = @ ) .


In patients with diabetes mellitus and coronary artery disease undergoing PCI , paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents , and they resulted in higher rates of target-vessel failure , myocardial infarction , stent thrombosis , and target-vessel revascularization at @ year .


( Funded by Boston Scientific ; TUXEDO-India Clinical Trials Registry-India number , CTRI/@/@ / @ ) .


The purpose of this study was to determine whether sleep changes are a consequence of nicotine presence or withdrawal during the night , we examined @ healthy non-smokers ( @ males , @ females , age : @-@ years ) after an adaptation night in a sleep laboratory setting .


Subjects were randomized to receive placebo or either @ or @ mg nicotine patches during the day or during the night in a double blind , parallel group design .


The @ mg nicotine patch applied during the night caused a reduced sleep period time and sleep efficiency as well as an increased wake time .


A reduced REM-sleep latency and subjective sleep quality rating were found in subjects receiving nicotine during the night .


Arousals , apneas and periodic leg movements were not affected by nicotine .


This study documents insomnia-like sleep changes in healthy non-smokers caused by nicotine in a dose-dependent manner .


There was no evidence for sleep-related withdrawal symptoms after @ h of nicotine application .


Dysmenorrhea , the occurrence of painful menstrual cramping of the uterus , is a major cause of activity restriction and absences from school and work among young women .


Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use .


Studies elsewhere have shown beneficial effects for use of vitamin K@ as an acupoint treatment , but the acceptability of this treatment to women in the United States has been unknown .


The study intended to examine the feasibility , acceptability , and preliminary effects of acupuncture point injection of vitamin K@ as an alternative treatment for primary dysmenorrhea among US women .


The research team conducted a pilot study using a blinded , randomized , crossover trial design .


The study took place at the University of California , San Francisco ( UCSF ) .


The study was conducted in the San Francisco Bay Area among women @ to @ y of age who had been diagnosed with primary dysmenorrhea .


Fourteen women completed all of the study 's visits .


Women with primary dysmenorrhea were randomized into @ groups to receive bilateral injections of vitamin K@ in the Spleen-@ ( SP-@ ) acupuncture point at the start of menstruation and then , following a @-mo washout period , saline in a nonacupuncture point at the start of menstruation .


One group received the vitamin K@ injection first , while the other group received the saline injection first .


Dysmenorrhea pain intensity was measured using a @-@ numeric rating scale ( NRS ) , before and after injections .


Women had an average @-point decrease in pain after a vitamin K@ injection in the SP-@ acupoint ( P < @ ) , as compared with a @-point decrease after a saline injection ( P < @ ) .


Change scores for vitamin K@ , as compared with a saline injection , approached statistical significance ( P < @ ) .


Intensity and duration of menstrual symptoms , as measured by the Cox retrospective symptom scale , also decreased following injections .


After participating , @ % of the women remained agreeable to receiving the injection therapy , and @ % reported they would come every month were the treatment available .


Findings suggested high acceptability for an acupuncture point injection of vitamin K@ as treatment for primary dysmenorrhea among young women in San Francisco .


Pain decreased with both treatments , with a trend toward greater pain reduction for the vitamin K@/SP -@ injection .


This finding is consistent with outcomes from the Obstetrics and Gynecology Hospital in Shanghai , China , where the protocol was developed .


Current guidelines recommend unfractionated heparin ( UFH ) or low-molecular-weight heparin plus an oral anticoagulant for the prevention of thromboembolism in patients undergoing electric cardioversion of atrial fibrillation ( AF ) .


Selective factor Xa inhibitors , such as fondaparinux , which has a favourable benefit-risk profile in the prevention and treatment of venous thromboembolism and the management of acute coronary syndromes , have not been systematically evaluated in this setting .


To evaluate the efficacy and safety of fondaparinux versus standard treatment in patients undergoing echocardiographically-guided cardioversion of AF .


In this multicentre , randomized , open-label , controlled , two-parallel-group , phase II pilot study , patients with AF undergoing electric cardioversion following transoesophageal echocardiography ( TEE ) were randomized to fondaparinux or standard therapy ( UFH plus vitamin K antagonist -LSB- VKA -RSB- ) .


Patients showing an atrial thrombus in the first TEE ( clot-positive ) were randomized to treatment with fondaparinux or standard care for @ weeks before cardioversion .


The primary endpoint ( combined rate of cerebral neurological events , systemic thromboembolism , all-cause death and major bleeding events ) occurred in @ of @ ( @ % ) patients on fondaparinux and @ of @ ( @ % ) patients on UFH+VKA .


The rate of thrombus disappearance among clot-positive patients was higher in the fondaparinux arm ( @ of @ ; @ % ) than in the UFH+VKA arm ( @ of @ ; @ % ) .


Incidences of adverse events were similar ( @ % with fondaparinux and @ % with UFH+VKA ) .


In this pilot study in patients with TEE-guided cardioversion , the use of fondaparinux appeared to be well tolerated , with similar efficacy to UFH+VKA .


Furthermore , a trend to greater thrombus resolution was observed .


It remains unclear whether concomitant radiofrequency ablation procedure in valvular surgery could offer additional benefits to patients with rheumatic valvular disease .


We designed a prospective and randomized control study to evaluate the efficacy of surgical radiofrequency ablation in patients with rheumatic heart disease .


From June @ to July @ , @ patients with chronic atrial fibrillation and rheumatic heart disease were randomized : ( @ ) control group , patients underwent only valve replacement followed by amiodarone for rhythm control , ( @ ) left atrial group ( LA group ) , patients underwent valve replacement and left atrial mono-polar radiofrequency ablation , ( @ ) bi-atrial group ( BA group ) , patients underwent valve replacement and bi-atrial mono-polar radiofrequency ablation .


The primary endpoints included : cardiac death , stroke , and recurrent AF after discharge .


There was no perioperative death .


One patient died @ months after MVR in BA group .


In univariate Cox analysis , the two ablation groups were associated with less AF ( BA group vs control group : P < @ ; LA group vs control group : P < @ ) as well as atrial tachycardia arrhythmia ( AF/AT/AFL ) recurrent ( BA group vs control group : P < @ ; LA group vs control group : P = @ ) .


The comparison between BA and LA groups revealed no differences in terms of AF ( P = @ ) or AF/AT/AFL ( P = @ ) .


Atrial transport function restoration rate @ months after operation was @ % in LA group , @ % in BA group , and @ % in control group respectively ( P < @ ) .


Radiofrequency ablation concurring with valvular surgery can bring a higher sinus rhythm restoration rate when compared with medical anti-arrhythmic drug therapy in low-medium risk rheumatic heart disease .


The trial was registered on Clinicaltrials.gov ( registry number NCT@ ) .


This study examined the role of independence centrality ( the personal importance of being functionally independent ) in adapting to functional disability in persons with spinal cord injury ( SCI ) .


We assessed how changes in disability related to changes in depressive symptoms , the association between independence centrality and depressive symptoms , and the role of independence centrality in moderating the association between changes in disability and changes in depressive symptoms .


Using data from a randomized controlled trial , we focused on @ survivors of SCI who completed baseline and @-month follow-up measures of independence centrality , disability ( activities of daily living and instrumental activities of daily living needs ) , and depressive symptoms .


Consistent with our predictions , increased disability was related to increased depressive symptoms , and higher independence centrality was associated with more depressive symptoms at baseline .


Consistent with the life span theory of control , SCI survivors with high independence centrality experienced more depressive symptoms when disability increased , but less depressive symptoms when disability decreased .


Survivors of SCI with low independence centrality were less affected by changing levels of disability .


Persons with SCI with high independence centrality have higher levels of depressive symptoms and are more responsive to changes in functional status .


Given the functional status trajectories of survivors of SCI , having low independence centrality may be adaptive because it facilitates disengagement from unattainable goals .


Creatinine ( Cr ) has been implicated as an independent predictor of hypertension and exercise has been reported as adjunct therapy for hypertension .


The purpose of the present study was to investigate the effect of continuous training programme on blood pressure and serum creatinine concentration in black African subjects with hypertension .


Three hundred and fifty seven male patients with mild to moderate ( systolic blood pressure -LSB- SBP -RSB- between @-@ & diastolic blood pressure -LSB- DBP -RSB- between @-@ mmHg ) essential hypertension were age matched and randomly grouped into continuous & control groups .


The continuous group involved in an @ weeks continuous training ( @-@ % HR reserve ) of between @ minutes to @ minutes , @ times per week , while the control group remain sedentary .


SBP , DBP , VO@max , serum Cr , body mass index ( BMI ) , waist hip ratio ( WHR ) and percent ( % ) body fat .


Analysis of covariance ( ANCOVA ) and Pearson correlation tests were used in data analysis .


Findings of the study revealed significant decreased effects of continuous training programme on SBP , DBP , Cr , BMI , WHR , % body fat and significant increase in VO@max at p < @ .


Serum Cr is significantly and negatively correlated with SBP ( -@ ) , DBP ( @ ) , BMI ( @ ) , WHR ( -@ ) and % body fat ( -@ ) at p < @ .


The present study demonstrated a rationale bases for the adjunct therapeutic role of moderate intensity continuous exercise training as a multi-therapy in the down regulation of blood pressure , serum Cr , body size and body fat in hypertension .


Exercise is consistently recommended for older adults with knee pain related to osteoarthritis .


However , the effects from exercise are typically small and short-term , likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time .


The BEEP randomised trial aims to improve patients ' short and long-term outcomes from exercise .


It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions ( Individually Tailored Exercise and Targeted Exercise Adherence ) to improve the individual tailoring of , and adherence to exercise , compared with usual physiotherapy care .


Based on the learning from a pilot study ( ISRCTN @ ) , the BEEP trial is a multi-centre , pragmatic , parallel group , individually randomised controlled trial , with embedded longitudinal qualitative interviews .


@ adults in primary care , aged @ years and over with knee pain will be randomised to @ of @ treatment groups delivered by fully trained physiotherapists in up to @ NHS services .


These are : Usual Physiotherapy Care ( control group consisting of up to @ treatment sessions of advice and exercise ) , Individually Tailored Exercise ( an individualised , supervised and progressed lower-limb exercise programme ) or Targeted Exercise Adherence ( supporting patients to adhere to exercise and to engage in general physical activity over the longer-term ) .


The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index .


A comprehensive range of secondary outcomes are also included .


Outcomes are measured at @ , @ ( primary outcome time-point ) , @ , @ and @ months .


Data on adverse events will also be collected .


Semi-structured , qualitative interviews with a subsample of @ participants ( @ from each treatment group ) will be undertaken at two time-points ( end of treatment and @ to @ months later ) and analysed thematically .


This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care .


The findings will have important implications for healthcare commissioners , general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners .


It may also serve to delay or prevent some individuals from becoming surgical candidates .


To investigate whether Myofascial release ( MFR ) when used as an adjunct to specific back exercises ( SBE ) reduces pain and disability in chronic low back pain ( CLBP ) in comparison with a control group receiving a sham Myofascial release ( SMFR ) and specific back exercises ( SBE ) among nursing professionals .


Randomized , controlled , single blinded trial .


Nonprofit research foundation clinic in Kerala , India .


Nursing professionals ( N = @ ) with chronic low back pain ( CLBP ) .


MFR group or control group .


The techniques were administered by physiotherapists certified in MFR and consisted of @ sessions per client over @ weeks .


The McGill Pain Questionnaire ( MPQ ) was used to assess subjective pain experience and Quebec Back Pain Disability Scale ( QBPDS ) was used to assess the disability associated with CLBP .


The primary outcome measure was the difference in MPQ and QBPDS scores between week @ ( pretest score ) , week @ ( posttest score ) , and follow-up at week @ after randomization .


The simple main effects analysis showed that the MFR group performed better than the control group in weeks @ and @ ( P < @ ) .


The patients in the MFR group reported a @ % reduction in their pain and @ % reduction in functional disability as shown in the MPQ and QBPDS scores in week @ , whereas patients in the control group reported a @ % and @ % reduction in their MPQ and QBPDS scores in week @ , which persisted as a @ % reduction of pain and @ % reduction of functional disability in the follow-up at week @ in the MFR group compared to the baseline .


The proportion of responders , defined as participants who had at least a @ % reduction in pain between weeks @ and @ , was @ % in the MFR group and @ % in the control group , which was @ % for functional disability in the MFR and control group .


This study provides evidence that MFR when used as an adjunct to SBE is more effective than a control intervention for CLBP in nursing professionals .


Persons with a mental disorder smoke at higher rates and suffer disproportionate tobacco-related burden compared with the general population .


The aim of this study was to determine if a smoking cessation intervention initiated during a psychiatric hospitalization and continued postdischarge was effective in reducing smoking behaviors among persons with a mental disorder .


A randomized controlled trial was conducted at an Australian inpatient psychiatric facility .


Participants were @ patient smokers allocated to a treatment as usual control ( n = @ ) or a smoking cessation intervention ( n = @ ) incorporating psychosocial and pharmacological support for @ months postdischarge .


Follow-up assessments were conducted at @ week , @ , @ , and @ months postdischarge and included abstinence from cigarettes , quit attempts , daily cigarette consumption , and nicotine dependence .


Rates of continuous and @-day point prevalence abstinence did not differ between treatment conditions at the @-month follow-up ; however , point prevalence abstinence was significantly higher for intervention ( @ % ) compared with control ( @ % ) participants at @ months ( OR = @ , p = @ ) .


Participants in the intervention condition reported significantly more quit attempts ( F -LSB- @ , @ -RSB- = @ , p = @ ) , lower daily cigarette consumption ( F -LSB- @ , @ -RSB- = @ , p < @ ) , and lower levels of nicotine dependence ( F -LSB- @ , @ -RSB- = @ , p < @ ) compared with controls at all follow-up assessments .


Postdischarge cessation support was effective in encouraging quit attempts and reducing cigarette consumption up to @ months postdischarge .


Additional support strategies are required to facilitate longer-term cessation benefits for smokers with a mental disorder .


The aim of this study was test the hypothesis that homeopathy ( H ) enhances the effects of scaling and root planing ( SRP ) in patients with chronic periodontitis ( CP ) .


@ patients with CP were randomly allocated to one of two treatment groups : SRP ( C-G ) or SRP + H ( H-G ) .


Assessments were made at baseline and after @ and @ months of treatments .


The local and systemic responses to the treatments were evaluated by clinical and serologic parameters , respectively .


Both groups displayed significant improvements , however , using clinical attachment gain and reductions in HDL , LDL and Total Cholesterol , Triglycerides , Glucose and Uric acid , from baseline to @ year , as criteria for treatment success , H-G performed significantly better than C-G .


The findings of this @-year follow-up randomized clinical trial suggest that homeopathic medicines , as an adjunctive to SRP , can provide significant local and systemic improvements for CP patients .


Sublingual misoprostol , used for labor induction , produces earlier and higher peak plasma concentrations of misoprostol than vaginal or rectal misoprostol .


The sublingual route could be expected to be more effective and safer than the vaginal route and by avoiding a direct effect on the cervix , it might reduce the risk of uterine hyperstimulation and be safer .


This study aimed to compare the efficacy of @-g sublingual misoprostol with @-g intravaginal misoprostol for cervical ripening prior to labor induction in primiparous women .


In a double-blind , parallel randomized controlled equivalence trial , we recruited @ primiparous women at @-@ weeks of gestation requiring labor induction who referred to Alzahara hospital in Rasht , Iran .


The women were randomly assigned to receive @-g sublingual misoprostol with vaginal placebo ( n = @ ) or @-g intravaginal misoprostol with sublingual placebo ( n = @ ) .


The dose was repeated every @ h ( maximum @ doses ) .


The primary outcome was the interval from the start of induction to vaginal delivery .


There were no significant differences between the two groups with regard to the interval from the start of induction to vaginal delivery ( @ @ h in the vaginal group vs. @ @ h in the sublingual group ) , duration of active phase , Bishop Scores after @h , and rate of the vaginal delivery under @ h. Also , the rate of hyperstimulation , tachysystole , type of delivery , cause of cesarean section , Apgar scores less than @ and admission to the NICU were similar in these two groups .


The mean dose of misoprostol applied was significantly lower in the sublingual group ( P = @ ) .


Sublingual administration of @-g of misoprostol appears to be as effective as @ g intravaginal misoprostol for cervical ripening and labor induction .


Optimal ventilator management for patients with acute respiratory distress syndrome ( ARDS ) remains uncertain .


Lower tidal volume ventilation appears to be beneficial , but optimal management of positive end-expiratory pressure ( PEEP ) remains unclear .


The Esophageal Pressure-Guided Ventilation @ Trial ( EPVent@ ) aims to examine the impact of mechanical ventilation directed at maintaining a positive transpulmonary pressure ( PTP ) in patients with moderate-to-severe ARDS .


EPVent@ is a multicentre , prospective , randomised , phase II clinical trial testing the hypothesis that the use of a PTP-guided ventilation strategy will lead to improvement in composite outcomes of mortality and time off the ventilator at @days as compared with a high-PEEP control .


This study will enrol @ study participants from @ hospitals across North America .


The trial will utilise a primary composite end point that incorporates death and days off the ventilator at @days to test the primary hypothesis that adjusting ventilator pressure to achieve positive PTP values will result in improved mortality and ventilator-free days .


This study examines the impact of major depressive disorder ( MDD ) and its treatment on quality of life ( QOL ) .


From the Sequenced Treatment Alternatives to Relieve Depression ( STAR * D ) trial , we analyzed complete data of @ adult MDD out-patients at entry/exit of each level of antidepressant treatments and after @ months of entry to follow-up .


QOL was measured using the QOL Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) .


The proportions of patients scoring ` within-normal ' QOL ( within @ % of Q-LES-Q community norms ) and those with ` severely impaired ' QOL ( > @SD below Q-LES-Q community norms ) were analyzed .


Before treatment , no more than @ % of MDD patients experienced ` within-normal ' QOL .


Following treatment , statistically significant improvements were detected ; however , the proportion of patients achieving ` within-normal ' QOL did not exceed @ % , with > @ % of patients experiencing ` severely impaired ' QOL .


Although remitted patients had greater improvements compared with non-remitters , @-@ % continued to experience reduced QOL .


@-month follow-up data revealed that the proportion of patients experiencing ` within-normal ' QOL show a statistically significant decrease in non-remitters .


Symptom-focused treatments of MDD may leave a misleading impression that patients have recovered when , in fact , they may be experiencing ongoing QOL deficits .


These findings point to the need for investigating specific interventions to ameliorate QOL in MDD .


This intervention sought to promote healthy eating with the ultimate goal of reducing childhood obesity risk .


Three hundred and sixty-one Latino families living on the US-Mexico border with at least one child between @-@ years of age were eligible to participate .


Families randomly assigned to the four-month intervention received @ contacts with a promotora ( community health worker ) , consisting of @ home visits and three telephone calls ; the control condition was a delayed treatment intervention .


Children reported on their dietary intake at baseline , immediately post-intervention and at the six month follow-up visit .


The intervention reduced weekly consumption of fast food ( p < @ ) .


A dose-response relationship was observed such that for every seven hours of promotora contact , monthly variety of fruits ( p < @ ) and vegetables ( p < @ ) increased by one .


No other intervention effects were observed .


Family-based interventions can improve children 's eating habits , with the amount of contact with the promotora being key to success .


Spastic pes equinovarus is a frequent pathological posture of the lower extremity .


Botulinum toxin ( BoNT/A ) has been successfully applied to treat lower limb spasticity .


However , the best time to initiate treatment remains unclear .


A beneficial effect of an early treatment has been suggested in previous studies .


A single-centre double-blind randomized placebo-controlled trial was performed to investigate the efficacy of BoNT/A to reduce muscle hypertonicity at the ankle .


Fifty-two patients with unilateral or bilateral spastic pes equinovarus with a modified Ashworth score ( mAS ) of at least @ + after stroke , traumatic brain injury or hypoxic encephalopathy were allocated to receive either BoNT/A or placebo treatment .


A second , open injection was optional at week @ .


Patients received unilateral or bilateral injections with @ or @U onabotulinumtoxinA , respectively .


The course of the mAS was explored during the open study phase .


Patients who had received BoNT/A treatment had lower mAS compared with placebo at week @ ( P < @ ) .


During the open label phase , patients from the placebo group showed further deterioration of muscle tone despite starting from a similar baseline and receiving BoNT treatment .


Spastic feet that had received BoNT/A in the first cycle had comparatively lower mAS scores over all follow-up data and at week @ ( P < @ ) .


The study demonstrates a reduction of muscular hypertonicity in spastic pes equines with BoNT/A treatment given during the first @months after the lesion .


Exploratory analyses of the course of muscular hypertonicity during the open phase favour earlier to later treatment .


Chronic obstructive pulmonary disease ( COPD ) is recognized as a systemic illness with significant extra-pulmonary features , such as exercise intolerance and muscle weakness .


Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD .


However , limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care .


Furthermore , it is unknown if improved exercise capacity translates into enhanced daily physical activities .


The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD .


In this randomized controlled trial situated in the primary care setting , @ patients with mild to moderate airflow obstruction ( FEV@ @ % of predicted ) , dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group .


The intervention group receives a @-month physical exercise training programme at a local physiotherapy practice , which includes exercise training , resistance training , breathing exercises and advises on how to increase the level of physical activity .


The control group receives usual care , i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected .


Primary outcome is functional exercise capacity at @-months measured on the six-minute walk distance .


Secondary outcomes include peripheral muscle strength , physical activity in daily life , health related quality of life , Medical Research Council ( MRC ) dyspnoea score and patients ' perceived effectiveness .


Follow-up measurement will take place at @ months after baseline .


This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care .


The results of this trial may give a unique insight into the potential of the implementation of an easy , close-to-home rehabilitation programme .


Single-site laparoscopic surgery ( SSLS ) is still only used in limited situations to treat children with appendicitis .


Using conventional laparoscopic ( CL ) equipment to perform SSLS appendectomy is considered a valuable application in China .


This prospective randomized trial aims to evaluate the surgical outcome of SSLS and CL appendectomy using CL equipment .


Sixty patients were recruited and randomly assigned to receive SSLS or @-port CL appendectomy between February @ and June @ .


Each case of SSLS appendectomy was performed using CL instruments .


Surgery outcomes , including operative time , conversion rates , postoperative complications , hospital stays , and hospital costs were evaluated .


Patient characteristics were similar between groups .


The SSLS using CL instruments was successful in all the @ patients and no conversions occurred .


Mean operative time was longer in the SSLS group than the CL group ( @ vs @ min , respectively ; p = @ ) .


Complication rates , lengths of hospital stay , and hospital costs were similar between the two groups .


The findings of this study demonstrate that using conventional instruments to perform SSLS is technically feasible and safe in children .


Although SSLS appendectomy does increase the operative time , it does not increase the complication rate and hospital cost .


Research has shown that participation in Alcoholics Anonymous ( AA ) confers significant recovery benefit to adults suffering from alcohol use disorder ( AUD ) .


Concerns persist , however , that AA may not work as well for younger adults , who tend to have shorter addiction histories , different social circumstances , and less spiritual/religious interest than adults .


Secondary data analysis of Project MATCH , using a prospective , moderated multiple mediation analysis to test and compare six previously identified mechanisms of change in younger adults ( n = @ ) vs. adults aged @ + ( n = @ ) .


Nine clinical sites within the United States .


Treatment-seeking adults ( n = @ ) suffering from AUD who participated in @ weeks of outpatient treatment and completed follow-ups at @ - , @ - and @-months .


AA attendance during treatment ; mediators at @ months ; and outcomes -LSB- percentage of days abstinent ( PDA ) and drinks per drinking day ( DDD ) -RSB- at @ months .


AA attendance was associated with improved drinking outcomes in both younger adults ( PDA : F ( @ , @ ) = @ , p < @ ; DDD : F ( @ , @ ) = @ , p < @ ) and adults aged @ + ( PDA : F ( @ , @ ) = @ , p < @ ; DDD : F ( @ , @ ) = @ , p < @ ) .


Only two of the six hypothesized pathways ( i.e. , decreases in pro-drinking social networks , self-efficacy in social situations ) appeared to work in younger adults .


Unidentified mechanisms of behavior change that are mobilized by AA participation appear to be at work in young people .


Once identified , these mechanisms may shed new light on how exactly AA confers similar benefits for young people and , more broadly , may enhance our understanding of recovery-related change for young adults that could yield novel intervention targets .


The current study was a randomized controlled trial investigating the effect of an innovative , short-term lifestyle intervention on weight gain in female freshman college students .


Ninety-five freshmen were recruited from a large public university in the United States .


Participants completed baseline assessments and were randomized to a @-session , @-week intervention or wait-list control , with assessments at posttest and @-month follow-up .


The hypothesized time by group interaction was not significant , p = @ ; however , trends suggested that control participants maintained baseline weight , whereas intervention participants lost -@ kg by posttest but regained @ kg at follow-up .


Significantly more intervention participants ( @ % ) decreased their daily caloric intake by @ kcal compared with control ( @ % ) , p = @ .


Brief intervention to prevent weight gain was not effective in this sample .


Future studies should investigate lengthening the intervention to enhance effectiveness and increasing recruitment to improve statistical power .


Seroma formation remains a significant problem in abdominoplasty procedures -- the cause of which remains to be elucidated .


It has been suggested that one of the causative factors for seroma formation is the use of handheld electrocautery as opposed to scalpel for abdominal flap dissection .


Prospective trial in @ consecutive abdominoplasty patients randomised to have abdominal flap dissection with either handheld electrocautery device on ` coagulation setting ' or sharp dissection with scalpel and monopolar electrocautery forceps for haemostasis .


In all other aspects the surgical technique was identical between the two groups .


All drains were removed at @ h , irrespective of drain volume .


Primary outcome measure is postoperative seroma formation on clinical examination , secondary outcome measures are drain volume , weight of tissue removed , effect of liposuction and patient BMI .


Both study groups were similar in demographics with no significant difference in weight of tissue excised , BMI , drain output or post operative complictions .


There was no significant difference in seroma formation rates between the handheld electrocautery group ( @ % ) and the sharp dissection group ( @ % ) .


Overall , the seroma rate was @ % .


Liposuction to the flanks at the time of abdominoplasty was found to significantly increase the incidence of seroma , compared to patients having abdominoplasty alone .


Use of handheld electrocautery rather than scalpel for tissue dissection does not lead to increased seroma formation in abdominoplasty patients .


Concomitant liposuction at the time of abdominoplasty increases the risk of seroma formation compared to patients having abdominoplasty alone .


Preclinical evidence demonstrates that inorganic nitrite , after its in situ conversion to nitric oxide , attenuates consequent myocardial reperfusion injury .


We investigated whether intracoronary injection of nitrite during primary percutaneous coronary intervention might improve infarct size in ST-elevated myocardial infarction .


Patients undergoing primary percutaneous coronary intervention ( n = @ ) were randomized to receive intracoronary ( @ mL ) sodium nitrite ( @ mol ) or NaCl ( placebo ) before balloon inflation .


The primary end point was infarct size assessed by measuring creatine kinase release .


Secondary outcomes included infarct size assessed by troponin T release and by cardiac MRI on day @ .


Baseline characteristics were similar between the groups .


No evidence of differences in creatine kinase release ( P = @ ) , troponin T ( P = @ ) , or cardiac MRI-assessed infarct size ( P = @ ) were evident .


In contrast , there was an improvement -LSB- corrected -RSB- in myocardial salvage index ( P = @ ) and reduction in -LSB- corrected -RSB- major adverse cardiac event at @ year ( @ % versus @ % ; P = @ ) in the nitrite group .


In a @-patient subgroup with thrombolysis in myocardial infarction @ flow , there was reduced serum creatine kinase ( P = @ ) and a @ % reduction in cardiac MRI-determined infarct size ( P = @ ) with nitrite .


No adverse effects of nitrite were detected .


In this phase II study , intracoronary nitrite infusion did not alter infarct size , although a trend to improved myocardial salvage index and a significant reduction in major adverse cardiac event was evident .


In a subgroup of patients with thrombolysis in myocardial infarction flow @ , nitrite reduced infarct size and major adverse cardiac event and improved myocardial salvage index , indicating that a phase III clinical trial assessing intracoronary nitrite administration as an adjunct to percutaneous coronary intervention in ST-elevated myocardial infarction patients is warranted .


The mechanism of action of vagus nerve stimulation ( VNS ) in intractable epilepsy is not entirely clarified .


It is believed that VNS causes alterations in cytokines , which can lead to rebalancing the release of neurotoxic and neuroprotective tryptophan metabolites .


We aimed to evaluate VNS effects on tryptophan metabolites and on epileptic seizures and investigated whether the antiepileptic effectiveness correlated with changes in tryptophan metabolism .


Forty-one children with intractable epilepsy were included in a randomized , active-controlled , double-blind study .


After a baseline period of @ weeks , all children underwent implantation of a vagus nerve stimulator and entered a blinded active-controlled phase of @ weeks .


Half of the children received high-output ( therapeutic ) stimulation ( n = @ ) , while the other half received low-output ( active control ) stimulation ( n = @ ) .


Subsequently , all children received high-output stimulation for another @ weeks ( add-on phase ) .


Tryptophan metabolites were assessed in plasma and cerebrospinal fluid ( CSF ) by use of liquid chromatography-tandem mass spectrometry ( LC-MS/MS ) and compared between high - and low-output groups and between the end of both study phases and baseline .


Seizure frequency was recorded using seizure diaries .


Mood was assessed using Profile of Mood States ( POMS ) questionnaires .


Regarding tryptophan metabolites , anthranilic acid ( AA ) levels were significantly higher at the end of the add-on phase compared with baseline ( p = @ ) and correlated significantly with improvement of mood ( = -@ , p = @ ) and seizure frequency reduction ( = -@ , p < @ ) .


No significant changes were found between high - and low-output groups regarding seizure frequency .


Vagus nerve stimulation induces a consistent increase in AA , a neuroprotective and anticonvulsant tryptophan metabolite .


Moreover , increased AA levels are associated with improvement in mood and reduction of seizure frequency .


This study was conducted to compare the oral bioavailability of an itopride extended-release ( ER ) formulation with that of the reference immediate-release ( IR ) formulation in the fasting state .


The effect of food on the bioavailability of itopride ER was also assessed .


A single-center , open-label , randomized , multiple-dose , three-treatment , three-sequence , crossover study was performed in @ healthy male subjects , aged @-@ years , who randomly received one of the following treatments for @ days in each period : itopride @ mg ER once daily under fasting or fed conditions , or itopride @ mg IR three times daily in the fasting state .


Steady-state pharmacokinetic parameters of itopride , including peak plasma concentration ( Cmax ) and area under the plasma concentration versus time curve over @ hours after dosing ( AUC ( @-@h ) ) , were determined by noncompartmental analysis .


The geometric mean ratio of the pharmacokinetic parameters was derived using an analysis of variance model .


A total of @ healthy Korean subjects participated , @ of whom completed the study .


The geometric mean ratio and its @ % confidence interval of once-daily ER itopride versus IR itopride three times a day for AUC ( @-@h ) were contained within the conventional bioequivalence range of @-@ @ ( @ -LSB- @-@ @ -RSB- ) , although Cmax was reached more slowly and was lower for itopride ER than for the IR formulation .


Food delayed the time taken to reach Cmax for itopride ER , but AUC ( @-@h ) was not affected .


There were no serious adverse events and both formulations were generally well tolerated .


At steady state , once-daily itopride ER at @ mg has a bioavailability comparable with that of itopride IR at @ mg given three times a day under fasting conditions .


Food delayed the absorption of itopride ER , with no marked change in its oral bioavailability .


Mechanical pleurodesis is widely used to treat primary spontaneous pneumothorax to decrease postoperative recurrence after thoracoscopic bullectomy , but it is unclear whether it actually reduces primary spontaneous pneumothorax recurrence .


We aimed to investigate the effectiveness of mechanical pleurodesis after thoracoscopic treatment of primary spontaneous pneumothorax .


In our parallel-group , prospective , randomized , controlled trail at @ hospitals in China , @ patients were enrolled from January @ to January @ .


Patients were randomly assigned ( @:@ ) to receive thoracoscopic wedge resection only ( WR group ) or thoracoscopic wedge resection and mechanical pleurodesis ( WR+MP group ) .


This trial is registered with ClinicalTrial.gov ( NCT@ ) .


Intraoperative bleeding and postoperative pleural drainage were significantly lower in the thoracoscopic WR only group .


Postoperative recurrence rate did not significantly differ between groups ( log-rank test p = @ ; Breslow test p = @ ) .


In the thoracoscopic WR only group , no recurrences were found when bullae were isolated or limited ; recurrence was @ % with the presence of multiple bullae .


Younger patients had an increased risk of recurrence ( relative risk @ ; @ % confidence interval @ to @ ) .


Thoracoscopic mechanical pleurodesis did not significantly decrease primary spontaneous pneumothorax recurrence compared with simple wedge resection , but intraoperative bleeding and postoperative pleural drainage rates were higher .


Younger age increases the risk of recurrence .


Due to time constraints that limit physician 's ability to deliver detailed contraception counseling , patients increasingly require supplemental education opportunities .


Applications for smartphones and tablets are being designed to educate patients about contraceptive methods and simplify communication between patient and provider .


We designed a mobile application entitled Plan A Birth Control to provide targeted information about the @ most common , nonpermanent contraceptive methods with emphasis on long-acting reversible methods .


We developed a mobile application designed to provide tailored information about the @ most common nonpermanent contraceptive methods .


After pilot testing with @ volunteers from the clinic , @ participants were recruited for a randomized controlled trial .


( ClinicalTrials.gov identifier : NCT@ ) Participants were assigned by simple randomization to contraception counseling via tablet or health educator .


We compared participants ' contraceptive choice between the @ groups .


Secondary outcomes included knowledge of the method of choice and satisfaction with counseling .


Of the @ participants in the primary study , @ chose long-acting reversible methods .


The uptake of long-acting reversible contraceptives was similar between the groups ( @ received health educator counseling and @ received mobile application counseling ) .


Both groups were demographically similar in age and educational status .


Knowledge of long-acting methods did not differ significantly between the groups ( P = @ ) .


Results from our study suggest that Plan A Birth Control did not adversely affect highly effective birth control uptake in our study population .


This can save time for physicians and health educators if used as an adjunct to contraception counseling in waiting room settings .


Clinical guidelines recommend point-of-care glucose testing and the use of supplemental doses of rapid-acting insulin before meals and at bedtime for correction of hyperglycemia .


The efficacy and safety of this recommendation , however , have not been tested in the hospital setting .


In this open-label , randomized controlled trial , @ general medicine and surgery patients with type @ diabetes treated with a basal-bolus regimen were randomized to receive either supplemental insulin ( n = @ ) at bedtime for blood glucose ( BG ) > @ mmol/L or no supplemental insulin ( n = @ ) except for BG > @ mmol/L .


Point-of-care testing was performed before meals , at bedtime , and at @:@ a.m.


The primary outcome was the difference in fasting BG .


In addition to the intention-to-treat analysis , an as-treated analysis was performed where the primary outcome was analyzed for only the bedtime BG levels between @ and @ mmol/L .


There were no differences in mean fasting BG for the intention-to-treat ( @ @ vs. @ @ mmol/L , P = @ ) and as-treated ( @ @ vs. @ @ mmol/L , P = @ ) analyses .


Only @ % of patients in the supplement and @ % in the no supplement groups received bedtime supplemental insulin .


Hypoglycemia ( BG < @ mmol/L ) did not differ between groups for either the intention-to-treat ( @ % vs. @ % , P = @ ) or the as-treated ( @ % vs. @ % , P = @ ) analysis .


The use of insulin supplements for correction of bedtime hyperglycemia was not associated with an improvement in glycemic control .


We conclude that routine use of bedtime insulin supplementation is not indicated for management of inpatients with type @ diabetes .


The method of administration of oral phosphodiesterase-@ inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration .


The aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction ( ED ) for intermediate-term period .


This multicenter , randomized , double-blind clinical trial included @ ED patients ( placebo , udenafil @mg , udenafil @mg ) .


Subjects were treated with each medication once daily for @ weeks .


Subjects were asked to complete the International Index of Erectile Function ( IIEF ) - erectile function ( EF ) domain at baseline , @ weeks , and @ weeks and the development of adverse drug reactions ( ADRs ) was inspected .


Both dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both @ and @ weeks .


When patients were divided according to the severity of baseline EF score , significant improvement was observed only with udenafil @mg regardless of the degree of ED .


At @ weeks , the proportions of patients who reported a return to normal EF ( IIEF-EF over @ ) were @ % for udenafil @mg and @ % for udenafil @mg .


In terms of safety , ADRs were observed in @ % , @ % , and @ % for placebo , udenafil @mg , and @mg , respectively .


Although a statistically higher rate of ADRs was observed in the udenafil @mg group ( P = @ ) , the majority were mild and recovered without treatment .


Once-daily administration of udenafil @mg and @mg for @ weeks resulted in improvement of EF .


In particular , udenafil @mg improves EF regardless of the baseline degree of ED .


Immunization of healthy volunteers by bites from Plasmodium falciparum-infected mosquitoes during chloroquine chemoprophylaxis ( hereafter , chemoprophylaxis and sporozoites -LSB- CPS -RSB- immunization ) induces sterile protection against malaria .


CPS-induced protection is mediated by immunity against pre-erythrocytic stages , presumably at least partially by cytotoxic cellular responses .


We therefore aimed to investigate the association of CPS-induced cytotoxic T-cell markers with protection .


In a double-blind randomized controlled trial , we performed dose titration of CPS immunization followed by homologous challenge infection in @ subjects .


Immune responses were assessed by in vitro restimulation of peripheral blood mononuclear cells and flow cytometry .


Dose-dependent complete protection was obtained in @ of @ volunteers after immunization with bites from @ P. falciparum-infected mosquitoes , in @ of @ volunteers with bites from @ , and in @ of @ volunteers with bites from @ ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ ) .


Completely protected subjects had significantly higher proportions of CD@ T cells expressing the degranulation marker CD@a ( OR , @ ; @ % CI , @-@ ; P = @ ) and CD@ cells producing granzyme B ( OR , @ ; @ % CI , @-@ ; P = @ ) after P. falciparum restimulation .


These data underline the efficiency of CPS immunization to induce sterile protection and support a possible role for cytotoxic CD@ and CD@ T-cell responses in pre-erythrocytic immunity .


We compare the safety and efficacy of ecallantide with placebo in subjects undergoing assessment for acute angiotensin-converting enzyme inhibitor-induced angioedema ( ACEIA ) in an emergency department ( ED ) .


This was a multicenter , phase @ , double-blind study with subjects randomized to receive a single subcutaneous dose of ecallantide ( @ , @ , or @ mg ) or placebo plus physician-directed conventional therapy .


The primary endpoint was defined as meeting predetermined discharge eligibility criteria within @ hours of study drug administration .


Discharge criteria included improvement of edema , stable vital signs , absence of stridor , absence of dyspnea or use of accessory muscles during respiration , absence of drooling , and ability to drink without difficulty .


An interim analysis showed that a high percentage of subjects met the primary endpoint , and the study was halted .


Overall , @ subjects were randomized and @ had data for analysis .


Most had mild ( @ % ) or moderate ( @ % ) ACEIA .


The discharge eligibility endpoint was met by @ % of the placebo group and @ % , @ % , and @ % of the ecallantide @ - , @ - , and @-mg groups , respectively .


This difference in meeting discharge eligibility endpoint criteria between treatment groups was not statistically significant .


The incidence of treatment-emergent adverse events was similar between placebo and active-treatment groups .


The addition of ecallantide to standard therapy does not appear to improve angioedema compared with placebo in ED patients with ACEIA .


Our data suggest that most ED patients presenting with mild to moderate ACEIA are likely to meet our discharge eligibility criteria within @ hours of treatment , regardless of intervention .


Further studies to assess the utility of ecallantide in patients with more severe angioedema may be useful .


No new safety signals related to ecallantide administration were identified .


To determine the effects of dietary-induced weight loss ( D ) and weight loss plus exercise ( D + E ) compared to exercise alone ( E ) on bone mineral density ( BMD ) in older adults with knee osteoarthritis ( OA ) .


Data come from @ older ( @ @ years ) , overweight/obese ( body mass index ( BMI ) @ @ kg/m@ ) , adults with knee OA enrolled in the Intensive Diet and Exercise for Arthritis ( IDEA ) study .


Participants were randomized to @ months of walking and strength training ( E ; n = @ ) , dietary-induced weight loss targeting @ % of baseline weight ( D ; n = @ ) or a combination of the two ( D + E ; n = @ ) .


Body weight and composition ( DXA ) , regional BMD , were obtained at baseline and @ months .


E , D , and D + E groups lost @ @ kg , @ @ kg and @ @ kg , respectively ( P < @ ) .


Significant treatment effects were observed for BMD in both hip and femoral neck regions , with the D and D + E groups showing similar relative losses compared to E ( both P < @ ) .


Despite reduced BMD , fewer overall participants had T-scores indicative of osteoporosis after intervention ( @ at @ months vs @ at baseline ) .


Within the D and D + E groups , changes in hip and femoral neck , but not spine , BMD correlated positively with changes in body weight ( r = @ and @ respectively , both P @ ) .


Weight loss via an intensive dietary intervention , with or without exercise , results in bone loss at the hip and femoral neck in overweight and obese , older adults with OA .


Although the exercise intervention did not attenuate weight loss-associated reductions in BMD , classification of osteoporosis and osteopenia remained unchanged .


To evaluate the feasibility of a low-dose contrast medium protocol for @-detector row computed tomography angiography ( CTA ) of the neck using a low-tube-voltage/high-tube-current setting .


A phantom study was performed using @-detector row spiral CT at multiple tube voltage and current settings .


Iodine contrast medium attenuation curves were acquired by processing and used to select the best contrast medium-to-noise ratio ( CNR ) .


A prospective clinical study was then performed on @ patients requiring neck CTA .


Patients were randomly divided into two groups of @ .


Group A was examined using the conventional imaging protocol ( @ kV , @ mAs ) and group B was examined at @ kV and @ mAs along with a @ % reduction in contrast medium dose .


The CT dose index-volume ( CTDI ( vol ) ) , background noise ( BN ) , and CNR were measured and statistically analysed .


Various image quality criteria were evaluated by two senior radiologists using a qualitative five-point scale .


Comparing group B with A , CTDIvol decreased by @ % ( B : @ mGy , A : @ mGy ) , however , the CNR increased by @ % .


The mean attenuation , which was caused by venous streak artefacts , was significantly lower in group B than A. Qualitative image analysis found that all criteria were significantly better for group B than A.


At @-detector row spiral CT , the low-tube-voltage/high-tube-current with low-dose contrast medium protocol was superior to the conventional protocol regarding radiation dose , venous streak artefacts , and image quality , and is feasible for CTA of the neck .


Dyslipidemia is highly prevalent among patients with HIV infection and contributes to an increased risk of cardiovascular disease .


We investigated the influence of a frequently used statin , atorvastatin , on the pharmacokinetics of the HIV-integrase inhibitor raltegravir and vice versa .


Open-label , crossover @-period phase I trial in @ healthy volunteers .


Subjects took raltegravir @ mg two times a day for @ days , atorvastatin @ mg once a day for @ days , and the combination of atorvastatin @ mg once a day + raltegravir @ mg two times a day for @ days with @-week washout periods in between .


Intensive steady-state @ - and @-hour pharmacokinetic blood sampling was performed .


Geometric mean ratios of the test treatment ( combination raltegravir + atorvastatin ) versus the reference treatment ( raltegravir or atorvastatin alone ) and @ % confidence intervals were calculated for the area under the plasma concentration-time curve ( AUC ) .


Fasting lipid profiles were obtained to assess short-term lipid-lowering effect of atorvastatin with or without concomitant raltegravir use .


Twenty-four healthy volunteers ( @ males ) were enrolled .


All but @ subject completed the trial , and no serious adverse events were reported .


Geometric mean ratios ( @ % confidence interval ) were @ ( @-@ @ ) for raltegravir AUC ( @-@h ) and @ ( @-@ @ ) for atorvastatin AUC ( @-@h ) .


The AUC ( @-@h ) metabolite-to-parent ratio for atorvastatin lactone , ortho-hydroxy , and para-hydroxy atorvastatin did not change during concomitant raltegravir use .


The effect of atorvastatin on low-density lipoprotein cholesterol was not significantly different when combined with raltegravir versus atorvastatin alone ( P = @ ) .


Atorvastatin @ mg has no clinically relevant effect on the pharmacokinetics of raltegravir and vice versa .


The combination was well tolerated and can be administered without dose adjustments .


To compare the role of topically applied serum therapy with preservative-free artificial tear ( AT ) drops in patients with moderate to severe dry eye in Hansen 's disease along with change in tear protein profile .


@ consecutive patients were randomly divided into three groups .


After a baseline examination of clinical parameters , each of the patients received designated modality of topical therapy six times a day for @weeks .


Post-treatment documentation of clinical parameters was done at @weeks , and then at @weeks after discontinuation of topical therapy .


Analysis of three tear proteins using gel electrophoresis ( sodium dodecyl sulfate polyacrylamide gel electrophoresis ) was done at baseline , at the first and second post-treatment visits .


In the cord blood serum ( CBS ) group , except for McMonnies score and staining score , all other clinical parameters showed continued improvement in the first and second post-treatment analyses .


In the autologous serum ( ALS ) group , all the clinical parameters except Schirmer 's I showed significant improvement in the first post-treatment analysis .


This was sustained at a significant level in the second analysis except for tear film break-up time ( TBUT ) and conjunctival impression cytology grading .


In the AT group , all the parameters improved at a non-significant level except for TBUT in the first analysis .


In the next analysis , apart from McMonnies score and TBUT , other clinical parameters did not improve .


In the ALS and CBS groups , tear lysozyme , lactoferrin levels improved in both post-treatment measurements ( statistically insignificant ) .


Total tear protein continued to increase at statistically significant levels in the first and second post-treatment analyses in the CBS group and at a statistically insignificant level in the ALS group .


In the AT group , the three tear proteins continued to decrease in both the analyses .


In moderate to severe dry eye in Hansen 's disease , serum therapy in comparison with AT drops , improves clinical parameters and causes betterment in tear protein profile .


Heart failure ( HF ) has a major effect on patients ' health status , including their symptom burden , functional status , and health-related quality of life .


To determine the effectiveness of a collaborative care patient-centered disease management ( PCDM ) intervention to improve the health status of patients with HF .


The Patient-Centered Disease Management ( PCDM ) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF .


A population-based sample of @ patients with an HF diagnosis from @ Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire ( KCCQ ) overall summary score of less than @ ( heavy symptom burden and impaired functional status and quality of life ) were enrolled between May @ and June @ .


The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator , cardiologist , psychiatrist , and primary care physician ; home telemonitoring and patient self-management support ; and screening and treatment for comorbid depression .


The primary outcome was change in the KCCQ overall summary score at @ year ( a @-point change is clinically significant ) .


Mortality , hospitalization , and depressive symptoms ( Patient Health Questionnaire @ ) were secondary outcomes .


There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention ( n = @ ) vs usual care ( n = @ ) ; baseline mean KCCQ overall summary scores were @ vs @ ( P = @ ) .


There was significant improvement in the KCCQ overall summary scores in both groups after @ year ( mean change , @ points in each group ) , with no significant difference between groups ( P = @ ) .


The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using @-month , @-month , and @-month data ( P = @ ) .


Among secondary outcomes , there were significantly fewer deaths at @ year in the intervention arm ( @ of @ -LSB- @ % -RSB- ) than in the usual care arm ( @ of @ -LSB- @ % -RSB- ) ( P = @ ) .


Among those who screened positive for depression , there was a greater improvement in the Patient Health Questionnaire @ scores after @ year in the intervention arm than in the usual care arm ( @ points lower , P = @ ) .


There was no significant difference in @-year hospitalization rates between the intervention arm and the usual care arm ( @ % vs @ % , P = @ ) .


This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care .


Low back pain is highly prevalent in patients with HTLV-@ .


The effects of physical activity on this condition are not known , but postural misalignment and motor deficits are frequently present .


To assess the effect of Pilates exercises on chronic low back pain in these patients , and its impact on quality of life .


A randomized crossover clinical trial was conducted , involving @ patients from a reference center in Salvador , Bahia , Brazil .


The VAS was used to evaluate the effect of Pilates on pain intensity and the SF-@ to assess its impact on quality of life .


Our results provide evidence of positive effects on pain intensity and almost all domains of quality of life when patients followed the Pilates exercise program described .


The Pilates method may be a useful tool in alleviating the symptoms of low back pain , and had a significant impact on quality of life in this sample of patients .


Communication is essential for triage , but intervention trials to improve it are scarce .


Referral Writer ( RW ) , a referral letter software program , enables documentation of clinical data and extracts relevant patient details from clinical software .


To evaluate whether specialists are more confident about scheduling appointments when they receive more information in referral letters .


Single-blind , parallel-groups , controlled design with a @:@ randomisation .


Australian GPs watched video vignettes virtually .


GPs wrote referral letters after watching vignettes of patients with cancer symptoms .


Letter content was scored against a benchmark .


The proportions of referral letters triagable by a specialist with confidence , and in which the specialist was confident the patient had potentially life-limiting pathology were determined .


Categorical outcomes were tested with ( @ ) and continuous outcomes with t-tests .


A random-effects logistic model assessed the influence of group randomisation ( RW versus control ) , GP demographics , clinical specialty , and specialist referral assessor on specialist confidence in the information provided .


The intervention ( RW ) group referred more patients and scored significantly higher on information relayed ( mean difference @ -LSB- @ % confidence intervals -LCB- CI -RCB- = @ to @ -RSB- ) .


There was no difference in the proportion of letters for which specialists were confident they had sufficient information for appointment scheduling ( RW @ % versus control @ % , P = @ ) .


In the logistic model , limited agreement among specialists contributed substantially to the observed differences in appointment scheduling ( P = @ % -LSB- @ % CI @ % to @ % -RSB- ) .


In isolation , referral letter templates are unlikely to improve the scheduling of specialist appointments , even when more information is relayed .


The clinical results of restoring defective teeth with two types of glass fiber prothetic systems is investigated to acquire clinical experience for further application of glass fiber posts with independent intellectual property rights .


A total of @ out-patients with restored defective teeth were selected from the Department of Stomatology , Beijing Xuanwu Hospital of Traditional Chinese Medicine and Peking University School and Hospital of Stomatology and randomly divided into two groups .


OUYA FIBER posts and Tenax Fiber White posts were used to restore defective teeth in the experimental group and the control group , respectively .


Clinical evaluation was conducted one week and three months post-restoration .


Both clinical satisfactory rates of OUYA FIBER posts and Tenax Fiber White posts were higher than @ % one week post-restoration and higher than @ % three months post-restoration .


No significant differences were observed between the clinical results of restoring defective teeth with the two types of fiber posts .


Throughout the healing process , no root canal fracture or marginal staining were observed .


OUYA FIBER post and Tenax Fiber White post showed similar clinical outcomes during the period of observation in this study .


However , the long-term effects should be observed in future studies .


Delayed gastric emptying ( DGE ) is a major problem after pancreatoduodenectomy ( PD ) .


A recent multicentre randomized trial reported no difference in gastric emptying rates between retrocolic and antecolic reconstruction routes .


The present study looked at quality of life with these two approaches and the correlation with gastric emptying .


This was a substudy of patients completing a panel of quality-of-life questionnaires within a randomized trial comparing retrocolic and antecolic gastroenteric reconstruction after PD .


Gastric emptying was assessed by scintigraphy @week after surgery .


Quality of life was measured with the EuroQoL - @D questionnaire ( EQ-@D ) , the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ( QLQ-C@ ) with its pancreatic cancer module ( PAN@ ) , and the Gastrointestinal Quality of Life Index ( GIQLI ) .


There were @ patients in the retrocolic and @ in the antecolic group .


Baseline characteristics and clinical outcomes were similar in the two groups .


Median time to half-emptying of stomach content after surgery was @ and @min in the retrocolic and antecolic group respectively ( P = @ ) .


Median percentages of residual activity after @h were @ and @ per cent respectively ( P = @ ) .


Quality of life did not differ at any time point between the groups .


At @weeks after surgery , patients with DGE had significantly worse outcomes on two EQ-@D domains , ten QLQ-C@ / PAN@ subscales , and two GIQLI subscales and total score .


Effect sizes were moderate to large .


The route of gastroenteric reconstruction after PD does not influence either gastric emptying at scintigraphy or quality of life .


The impact of DGE on quality of life is clinically significant .


Registration number NTR@ ( www.trialregister.nl ) .


Switches between anti-tumor necrosis factor agents in the treatment of Crohn 's disease ( CD ) occur in case of treatment failure , intolerance , or patient preference .


No data are currently available on the usefulness of a second infliximab treatment after earlier discontinuation and previous switch to an alternative anti-tumor necrosis factor agent .


In this study , we evaluated the clinical benefit of infliximab retreatment in patients with CD after sequential use of both infliximab and adalimumab .


Twenty-nine patients with CD who had received earlier treatments with sequential infliximab and adalimumab and were then restarted on infliximab were retrieved from a multicenter registry designed for the follow-up of adalimumab treatment for CD .


Short-term and sustained effects of infliximab retreatment were evaluated retrospectively by reviewing clinical records .


Follow-up was @ months for all patients .


In @/@ ( @ % ) patients , infliximab was reintroduced at intensified dosing schedule ( > @ mg/kg or < @ wk ) for @/@ ( @ % ) of patients similar to the schedule who were on at time of previous discontinuation .


During the second infliximab treatment course , dosing was further intensified in @ out of @ ( @ % ) patients .


After @ months @/@ ( @ % ) , patients were still on continued therapy of their second infliximab treatment .


Infliximab was discontinued ( after a median of @ mo ) in @ out of @ patients for loss of response ( n = @ -LSB- @ % -RSB- ) , intolerance ( n = @ -LSB- @ % -RSB- ) , or non-compliance ( n = @ -LSB- @ % -RSB- ) .


Use of induction schedule or concomitant immunomodulators were not significantly associated with treatment benefit .


The majority of patients with CD benefit from a second treatment with infliximab after previous treatment with infliximab and adalimumab , which offer a meaningful therapeutic option in often highly refractory patients .


To evaluate the efficacy and safety of Yindan Xinnaotong Soft Capsule ( YXSC ) on cerebral infarction ( CI ) reconvalescents of static blood blocking collaterals syndrome ( SBBCS ) .


Totally @ CI reconvalescents of SBBCS were randomly assigned to the test group ( treated by YXSC ) and the control group -LSB- treated by Naoxintong Capsule ( NC ) -RSB- , @ in each group .


The therapeutic course for all was @ weeks .


Changes of National Institute of Health Stroke Scale ( NIHSS ) , Barthel Index ( BI ) , modified Rankin Scale ( mRS ) , Chinese medical syndrome scores , and serum lipid indices were observed in the two groups .


Compared with the control group , the patient proportion of improving activities of daily life by more than or equal to @ score was elevated ( @ % vs @ % ; P < @ ) .


Compared with before treatment in the same group , the NIHSS score decreased at post-treatment @ , @ , and @ weeks in the two groups ( P < @ ) .


The patient proportion of dropped NIHSS score by more than or equal to @ score was lowered ( @ % vs @ % ) , and the total effective rate of improving Chinese medical syndromes was superior in the test group after @-week treatment ( @ % vs @ % , all P < @ ) .


After @-week treatment there was no statistical difference in the patient proportion of lowering mRS lower than or equal to @ or blood lipids between the two groups ( P > @ ) .


YXSC showed certain effect in improving activities of daily life , attenuating the neurological impairment , and elevating the total effective rate of improving Chinese medical syndromes in CI patients in the recovery stage .


Compare relapse clinical severity , post-relapse residual disability , and the probability of confirmed complete recovery from relapse between patients who relapsed during natalizumab ( n = @/@ -LSB- @ % -RSB- ) and placebo ( n = @/@ -LSB- @ % -RSB- ) treatments in the AFFIRM trial .


In this post-hoc analysis , relapse clinical severity and residual disability were defined by change in Expanded Disability Status Scale ( EDSS ) score occurring between pre-relapse and at-relapse assessment and between pre-relapse and post-relapse assessment , respectively .


Patients were considered completely recovered from relapse when their post-relapse EDSS score was less than or equal to their pre-relapse EDSS score , and this was maintained for @ or @ weeks .


At relapse , an increase in EDSS score of @ points occurred in @ % of natalizumab and @ % of placebo patients ( P = @ ) ; an increase of @ point occurred in @ % of natalizumab and @ % of placebo patients ( P = @ ) ( mean increase in EDSS at relapse : natalizumab = @ ; placebo = @ ; P = @ ) .


After relapse , residual disability of @ EDSS points remained in @ % of natalizumab and @ % of placebo patients ( P = @ ) ( mean post-relapse residual EDSS increase : natalizumab = @ ; placebo = @ ; P = @ ) .


In patients with an increase in EDSS of @ or @ during relapse , natalizumab increased the probability of @-week confirmed complete recovery from relapse by @ % ( hazard ratio -LSB- HR -RSB- = @ ; P = @ ) and @ % ( HR = @ ; P = @ ) compared to placebo , respectively .


In AFFIRM , natalizumab treatment decreased the clinical severity of relapses and improved recovery from disability induced by relapses .


These beneficial effects would limit the step-wise accumulation of disability .


Reduction of infarct size by ischemic postconditioning ( IPost ) has been reported in smaller proof-of-concept clinical studies , but has not been confirmed in other smaller studies .


The principle needs to be evaluated in larger groups of ST-elevation myocardial infarction ( STEMI ) patients before being implemented in clinical practice .


This study assessed the effect of ischemic postcoditioning ( IPost ) on infarct size in patients with STEMI treated by primary percutaneous coronary intervention ( PCI ) .


Patients with first-time STEMI , < @ hours from symptom onset , referred to primary PCI were randomized to IPost or control groups .


IPost was administered by @ cycles of @-minute reocclusion and @-minute reperfusion , starting @ minute after opening , followed by stenting .


In the control group , stenting was performed immediately after reperfusion .


The primary endpoint was infarct size measured by cardiac magnetic resonance after @ months .


A total of @ patients were randomized .


Infarct size ( percent of left ventricular mass ) after @ months ( median values and interquartile range ) was @ % ( @ , @ ) and @ % ( @ , @ ) in the control group and IPost group , respectively ( P = @ ) .


No significant impact of IPost was found when controlling for baseline risk factors of infarct size in a multivariate linear regression model ( P = @ ) .


The effects of IPost on secondary endpoints , including markers of necrosis , myocardial salvage , and ejection fraction , as well as adverse cardiac events during follow-up , were consistently neutral .


In contrast to several smaller trials reported previously , we found no significant effects of IPost on infarct size or secondary study outcomes .


The present study aimed at investigating the effects of Lactobacillus casei @ supplementation on symptoms and inflammatory biomarkers of rheumatoid arthritis ( RA ) in women .


In this randomized double-blind clinical trial , female patients with established RA for more than @ year , @-@ years of age and body mass index ( BMI ) lower than @ , who followed stable medication for @ months prior to the supplementation , were randomly allocated to receive either one capsule containing @ ( @ ) colony forming units ( CFU ) of L. casei @ , or a placebo for @ weeks ; allocation was stratified by BMI and menopausal status .


Disease activity score-@ ( DAS@ ) was calculated , European League Against Rheumatism ( EULAR ) response was evaluated and the cytokines , interleukin ( IL ) -@ , IL-@ , IL-@ , IL-@ and tumor necrosis factor ( TNF ) - were measured .


Thirty patients were recruited in each group ; @ and @ patients were analyzed in the probiotic and placebo groups , respectively .


L. casei @ supplementation decreased serum high-sensitivity C-reactive protein ( hs-CRP ) levels , tender and swollen joint counts , global health ( GH ) score and DAS@ ( P < @ ) .


More patients in the L. casei @ group had moderate response to the treatment , based on the EULAR criteria , at the end of the study ( P < @ ) .


At the end of the study , a significant difference was observed between the two groups for IL-@ , IL-@ and TNF - changes through the study course ( P < @ ) , in favor of the probiotic group .


No adverse effects were reported for the intervention .


Probiotic supplementation may be an appropriate adjunct therapy for RA patients and help alleviate symptoms and improve inflammatory cytokines .


In-home iron fortification for infants in developing countries is recommended for control of anaemia , but low absorption typically results in > @ % of the iron passing into the colon .


Iron is essential for growth and virulence of many pathogenic enterobacteria .


We determined the effect of high and low dose in-home iron fortification on the infant gut microbiome and intestinal inflammation .


We performed two double-blind randomised controlled trials in @-month-old Kenyan infants ( n = @ ) consuming home-fortified maize porridge daily for @ months .


In the first , infants received a micronutrient powder ( MNP ) containing @ mg iron as NaFeEDTA or the MNP without iron .


In the second , they received a different MNP containing @ mg iron as ferrous fumarate or the MNP without the iron .


The primary outcome was gut microbiome composition analysed by @S pyrosequencing and targeted real-time PCR ( qPCR ) .


Secondary outcomes included faecal calprotectin ( marker of intestinal inflammation ) and incidence of diarrhoea .


We analysed the trials separately and combined .


At baseline , @ % of the total microbial @S rRNA could be assigned to Bifidobacteriaceae but there were high prevalences of pathogens , including Salmonella Clostridium difficile , Clostridium perfringens , and pathogenic Escherichia coli .


Using pyrosequencing , + FeMNPs increased enterobacteria , particularly Escherichia/Shigella ( p = @ ) , the enterobacteria/bifidobacteria ratio ( p = @ ) , and Clostridium ( p = @ ) .


Most of these effects were confirmed using qPCR ; for example , + FeMNPs increased pathogenic E. coli strains ( p = @ ) .


+ FeMNPs also increased faecal calprotectin ( p = @ ) .


During the trial , @ % of infants in +@ mgFeMNP required treatment for diarrhoea versus @ % in -@ mgFeMNP ( p = @ ) .


There were no study-related serious adverse events in either group .


In this setting , provision of iron-containing MNPs to weaning infants adversely affects the gut microbiome , increasing pathogen abundance and causing intestinal inflammation .


The control of labor pain and the prevention of suffering are major concerns of clinicians and their patients .


The aim of this study was to evaluate the effect of music on labor pain and anxiety , maternal hemodynamics , fetal-neonatal parameters and postpartum analgesic requirement in primiparous women .


Overall , @ primiparous women who expected vaginal delivery were recruited and randomly assigned to a music group ( n = @ ) or a control group ( n = @ ) .


Women in the music group listened to music during labor .


Pain intensity and anxiety level were measured using a visual analogue scale ( @-@ cm ) .


The two groups were compared in terms of pain severity , anxiety level , maternal hemodynamics , fetal-neonatal parameters and postpartum analgesic requirement .


Mothers in the music therapy group had a lower level of pain and anxiety compared with those in the control group at all stages of labor ( p < @ ) .


A signicant difference was observed between the two groups in terms of maternal hemodynamics and fetal heart rate after intervention ( p < @ ) .


Postpartum analgesic requirement significantly decreased in the music therapy group ( p < @ ) .


Listening to music during labor has a positive impact on labor pain and anxiety , maternal-fetal parameters and analgesic requirement .


The aim of the study was to determine native coronary artery patency @ year after coronary artery bypass grafting and to identify clinical and angiographic predictors for the development of a chronic total occlusion ( CTO ) .


In contrast to the large body of information regarding graft patency , data regarding atherosclerosis progression and vessel patency in surgically bypassed native coronary arteries arelessclear .


Of the @ patients who underwent @-year follow-up angiography as part of the multicenter RAPS ( Radial Artery Patency Study ) , included in our study were @ patients ( @ % ) for whom angiograms were available for review .


Angiograms were reviewed for native coronary artery patency in an independent blinded manner .


On the pre-operative angiogram , CTO of at least @ native coronary vessel was demonstrated in@ patients ( @ % ) having @ occluded vessels .


At @ year after coronary artery bypass grafting , atleast @ new native coronary artery CTO occurred in @ patients ( @ % ) .


In @ % of patients , the native artery and the graft supplying that territory were both occluded .


A new CTO was almost @ times more likely to occur in coronary vessels with a pre-operative proximal stenosis > @ % compared with vessels with proximal stenosis < @ % ( @ % vs. @ % , respectively , p < @ ) .


Patients with a new CTO had significantly more baseline Canadian Cardiovascular Society class @ angina compared with patients without a new CTO .


A new CTO was less likely to occur in the left anterior descending artery ( @ % ) , supplied by the left internal thoracic artery .


When comparing radial artery and saphenous veingrafts , neither the type of graft nor graft patency had any association with native coronary artery occlusion .


CTO of surgically bypassed coronary arteries @ year after coronary artery bypass grafting is extremely common .


It is unclear whether using fetal electrocardiographic ( ECG ) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes .


We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than @ weeks of gestation and who had cervical dilation of @ to @ cm were randomly assigned to `` open '' or `` masked '' monitoring with fetal ST-segment analysis .


The masked system functioned as a normal fetal heart-rate monitor .


The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected .


The primary outcome was a composite of intrapartum fetal death , neonatal death , an Apgar score of @ or less at @ minutes , neonatal seizure , an umbilical-artery blood pH of @ or less with a base deficit of @ mmol per liter or more , intubation for ventilation at delivery , or neonatal encephalopathy .


A total of @,@ patients underwent randomization ; @ were assigned to the open group , and @ to the masked group .


The primary outcome occurred in @ fetuses or neonates of women in the open group ( @ % ) and @ fetuses or neonates of women in the masked group ( @ % ) ( relative risk , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Among the individual components of the primary outcome , only the frequency of a @-minute Apgar score of @ or less differed significantly between neonates of women in the open group and those in the masked group ( @ % vs. @ % , P = @ ) .


There were no significant between-group differences in the rate of cesarean delivery ( @ % and @ % , respectively ; P = @ ) or any operative delivery ( @ % and @ % , respectively ; P = @ ) .


Adverse events were rare and occurred with similar frequency in the two groups .


Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates .


( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical ; ClinicalTrials.gov number , NCT@ . )


To compare the therapeutic effects of arthroscopy and manipulation of Traditional Chinese medicine ( TCM ) in the treatment of patellofemoral joint disease .


The patients met with the criteria of patellofemoral joint disease were divided into manipulation of TCM group and arthroscopy group randomly , @ patients in each group .


There were @ patients in manipulation of TCM group , including @ males and @ females , with an average age of ( @ + / - @ ) years old ; and the patients were treated with manipulation .


There were @ patients in arthroscopy group , including @ males and @ females , with an average age of ( @ + / - @ ) years old ; the patients were treated with arthroscopy .


The HSS knee joint score , fitness angle of patellofemoral joint and lateral angle of patellofemoral joint in X-ray were compared in each group and between the two groups before and after treatment respectively .


The two therapeutics had equally efficacious in which improved HSS score significantly .


After treatment , the HSS scores in manipulation of TCM group and arthroscopy group were @ + / - @ and @ + / - @ separately , the score in manipulation of TCM group was higher than that of arthroscopy group .


Comparing with the arthroscopy group , lateral angle of patellofemoral joint with weight-hearing position were improved significantly in manipulation of TCM group .


Arthroscopy and manipulation of TCM have equally efficacious in the treatment of patellofemoral joint disease , but manipulation has advantage of minimal trauma , and is better to treat patella extraversion .


Noninvasive blood pressure ( NIBP ) monitoring methods are widely used in critically ill patients despite poor evidence of their accuracy .


The erroneous interpretations of blood pressure ( BP ) may lead to clinical errors .


To test the accuracy and reliability of aneroid ( ABP ) and oscillometric ( OBP ) devices compared to the invasive BP ( IBP ) monitoring in an ICU population .


Fifty adult patients ( @ comparisons ) were included in a randomized crossover trial .


BP was recorded simultaneously by IBP and either by ABP or by OBP , taking IBP as gold standard .


Compared with ABP , IBP systolic values were significantly higher ( mean difference standard deviation @ @ ; P < @ ) .


Both diastolic ( -@ @ ; P < @ ) and mean ( -@ @ ; P = @ ) IBP were instead lower .


Compared with OBP , systolic ( @ @ ; P < @ ) and mean ( @ @ ; P < @ ) IBP were higher , while diastolic IBP ( -@ @ ; P < @ ) was lower .


Bland-Altman plots showed wide limits of agreement in both NIBP-IBP comparisons .


BP measurements with different devices produced significantly different results .


Since in critically ill patients the importance of BP readings is often crucial , noninvasive techniques can not be regarded as reliable alternatives to direct measurements .


Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications .


Reports of serious adverse events followed , leading to its abandonment .


This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy ( ETAC ) compared with open inferior capsular shift ( ICS ) and reviews the role of randomized trials in adopting new technology .


Patients ( > @years ) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled .


Patients with bone lesions or labral , biceps anchor , or full-thickness rotator cuff tears were excluded intraoperatively .


Outcomes included Western Ontario Shoulder Instability Index , function and recurrent instability at @ years postoperatively , and surgical times .


Fifty-four subjects ( mean age , @years ; @ women ) were randomized to ETAC ( n = @ ) or open ICS ( n = @ ) .


The groups were comparable at baseline , except for external rotation at the side .


At @ years postoperatively , there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index ( P = @ ) , American Shoulder and Elbow Surgeons score ( P = @ ) , Constant score ( P = @ ) , and active range of motion .


Recurrent instability was not statistically different ( ETAC ,@ ; open ,@ ; P = @ ) .


ETAC ( @minutes ) was significantly shorter than open ICS ( @minutes ) ( P < @ ) surgery .


Three subjects ( @ ETAC , @ open ) had stiff shoulders .


At @ years postoperatively , quality of life and functional outcomes between groups were not clinically different .


ETAC had fewer complications and episodes of recurrence compared with open surgery .


This evidence reinforces the need to critically evaluate new technology before widespread clinical use .


We compared the safety and efficacy of bipolar transurethral resection and monopolar resection for bladder tumors .


A single center , parallel arm , randomized , controlled trial was performed from May @ to August @ .


All patients with suspected bladder tumors were eligible for study inclusion .


Those who refused consent and those undergoing routine restaging transurethral resection of bladder tumor were excluded from analysis .


The primary end point was the incidence of obturator jerk .


Secondary study outcomes included the decrease in hematocrit , rates of recoagulation and transfusion , bladder perforation , decrease in sodium , resection syndrome and resection time .


Pathological quality was assessed by comparing deep muscle and the degree of severe cautery artifact in the @ arms .


A total of @ transurethral resections were performed during the study period .


After exclusion @ patients were randomized , including @ in the monopolar arm and @ in the bipolar arm .


There were @ and @ protocol violations in the monopolar and bipolar arms , respectively .


Intent to treat and per protocol analyses were performed .


The incidence of obturator jerk was greater in the bipolar arm ( @ % vs @ % , p = @ ) .


There was no significant difference between secondary outcomes .


The only significant difference was a significantly lower incidence of severe cautery artifact in the bipolar arm ( @ % vs @ % , p = @ ) .


Bipolar transurethral resection of bladder tumor was not superior to monopolar resection with respect to obturator jerk , bladder perforation and hemostasis .


There was a significantly lower incidence of severe cautery artifact after bipolar resection .


Safety and tolerability of peginterferon-based hepatitis C virus ( HCV ) infection therapy remains suboptimal , even when direct-acting antiviral agents are added .


This study assessed the efficacy , safety and tolerability of mericitabine combined with ritonavir-boosted danoprevir ( danoprevir/r ) ribavirin for up to @ weeks in treatment-nave HCV genotype ( G ) @ infected patients .


Patients received twice daily mericitabine ( @ mg ) and danoprevir/r ( @ mg/@ mg ) plus either ribavirin ( @/@ mg/day ; Arm A ) or placebo ( Arm B ) for @ or @ weeks .


Patients with HCV RNA < @ IU/ml between Weeks @ and @ and HCV RNA < @ IU/ml at Week @ were rerandomized ( @:@ ) at Week @ to discontinue/continue assigned regimens until Week @ .


Because of unacceptable relapse rates in both @-week arms and in ribavirin-free Arm B , treatment was extended to @ weeks and patients in Arm B received peginterferon alfa-@a / ribavirin .


The primary outcome was sustained virological response @ weeks after end of treatment ( SVR@ ) .


In Arm A , the SVR@ rate in patients receiving @ weeks of therapy was @ % ( @/@ ) ; @ % ( @/@ ) in G@b and @ % ( @/@ ) in G@a patients .


Virologic breakthrough and relapse were associated with danoprevir-resistant virus in most cases .


The mericitabine-resistance mutation ( NS@BS@T ) was detected in two patients bearing dual resistant virus NS@ R@K/NS@B S@T and dual resistance mutation L@F/L@F in one patient .


Treatment was safe and well tolerated .


Mericitabine , danoprevir/r plus ribavirin for @ weeks were safe and well tolerated .


However , SVR rates were poor , achieving rates of only @ % in G@a and @ % in G@b patients .


To evaluate and compare @-month effects of @weeks of an integrative treatment ( IT ) , therapeutic acupuncture ( TA ) , and conventional treatment ( CT ) in reducing symptoms of anxiety , depression and in improving health-related quality of life ( HRQL ) and sense of coherence ( SOC ) in psychologically distressed primary care patients .


Patients who had participated in an open , pragmatic randomized controlled trial were followed up six months after treatment .


The study sample consisted of @ adults ( @ per treatment arm ) aged @ to @years referred from four different primary health care centres in western Sweden for psychological distress .


Assessments were made at baseline after eight weeks and after @weeks .


Anxiety and depression were evaluated with the Hospital Anxiety and Depression scale ( HADS ) , HRQL with the SF-@ Mental Component Summary scores ( MCS ) and SOC with the Sense of Coherence-@ questionnaire .


No baseline differences were found between groups on any outcome variable .


At @weeks , IT and TA had significantly better values than CT on all variables .


All three groups showed significant improvements from baseline on all variables , except HAD depression in CT ; however , improvements were significantly greater in IT and TA than in CT. .


IT and TA did not differ on any outcome variable .


Effect sizes were large in IT and TA for all variables and small or moderate in CT. .


Improvements on all variables seen after @-weeks of IT and TA remained stable at @weeks and the CT group improved on HAD anxiety .


IT and TA seem to be more beneficial than CT in reducing anxiety , depression , and in improving quality of life and sense of coherence after @weeks of follow up in patients with psychological distress .


More research is needed to confirm these results .


The objective of the study is to determine the efficacy of oral granisetron ( a long-acting @-HT@ receptor antagonist ) in stopping vomiting subsequent to discharge from emergency department ( ED ) , in @-month-old to @-year-old patients with gastroenteritis-related vomiting and dehydration , who had failed an initial trial of oral rehydration ( ORT ) .


Eligible patients were offered ORT on a slowly advancing schedule .


Patients who tolerated the initial ORT were discharged home .


Patients who vomited were randomized to receive either @ g/kg of granisetron or placebo , and ORT was resumed .


Patients who tolerated the postrandomization ORT were discharged home with another dose of the study drug .


Parents were contacted by telephone every @ hours until complete resolution of symptoms .


The primary outcome was the proportion of patients with vomiting at @ hours .


Of the @ eligible patients , @ ( @ % ) tolerated the initial ORT and were discharged home .


Of the patients who vomited during the initial ORT , @ were included in the final study sample ( placebo , n = @ ; granisetron , n = @ ) .


There was no statistically significant difference in the proportion of patients with vomiting at @ hours ( granisetron , n = @ ; placebo , n = @ ; odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


A similar trend in the proportion of patients with vomiting was noted for the entire follow-up period ( granisetron , n = @ ; placebo , n = @ ; odds ratio , @ ; P = @ ; @ % confidence interval , @-@ @ ) .