This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation .


2550 pregnant women ( 1311 interventions and 1239 controls ) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery .


24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care .


The intervention consisted of a mobile phone text-message and voucher component .


Primary outcome measure was four or more antenatal care visits during pregnancy .


Secondary outcome measures were tetanus vaccination , preventive treatment for malaria , gestational age at last antenatal care visit , and antepartum referral .


The mobile phone intervention was associated with an increase in antenatal care attendance .


In the intervention group 44 % of the women received four or more antenatal care visits versus 31 % in the control group ( OR , 2.39 ; 95 % CI , 1.03-5 .55 ) .


There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant .


The wired mothers ' mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services , more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred .


Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in resource-limited settings .


To compare the differences in pain reaction , hemodynamics and clinical efficacy between extracorporeal shock wave lithotripsy ( ESWL ) after injection with flurphen mixture ( mixture of droperidol and fentanyl citrate ) at Shenshu ( BL 23 ) and simple ESWL in the patients .


Sixty-four cases of urinary calculi with ESWL were randomized into an observation group and a control group , 32 cases in each one .


In the observation group , 15 to 20 min before ESWL , flurphen mixture ( droperidol injection 1.25 mg and fentanyl citrate injection 0.05 mg were diluted to 6 mL with 0.9 % sodium chloride solution 4.5 mL ) was injected at bilateral Shenshu ( BL 23 ) .


In the control group , no any adjuvant therapy and medication were used before ESWL .


The changes in blood pressure and heart rate , visual analogue scale ( VAS ) score , lithotripsy frequency till calculi complete removal and the rate of calculi complete removal after the first lithotripsy were observed in the two groups .


In the control group , blood pressure and heart rate were higher during lithotripsy than those before lithotripsy ( both P < 0.05 ) .


In the observation group , the differences in blood pressure and heart rate were not significant statistically as compared with those before lithotripsy ( both P > 0.05 ) .


The blood pressure and heart rate during lithotripsy in the observation group were apparently lower than those in the control group ( both P < 0.05 ) .


VAS scores during lithotripsy in the observation group were lower apparently than those in the control group ( both P < 0.05 ) .


The lithotripsy frequency in the observation group was less than that in the control group .


The rate of calculi complete removal in 1 week after the first lithotripsy in the observation group was higher than that in the control group [ 75.0 % ( 24/32 ) vs 50.0 % ( 16/32 ) , P < 0.05 ] .


The flurphen mixture at Shenshu ( BL 23 ) significantly alleviates pain reaction in patients undergoing ESWL , avoids the fluctuation of hemodynamics and improves the clinical effect of lithotripsy .


Despite progress , models that incorporate antecedent and mediating factors associated with shared decision making ( SDM ) - related outcomes remain limited .


An experimental study tests patient decision aid ( DA ) effects on a network of antecedents and mediators associated with patient empowerment prior to a medical decision-making consultation regarding cancer treatment .


A pilot study initially evaluated measurement scales , model fit , and the overall effect of the DA experience .


The pilot compared matched treatment and control group samples of US adult online panel members exposed to a vignette about meeting their dermatologist to decide on skin cancer treatment .


The treatment group also experienced a skin cancer DA with treatment options and value clarification activity , while the control group did not .


The main study employed a randomized experimental design to formally test hypothesized path coefficients across the groups .


The pilot study suggested an overall enhanced DA effect on self-empowerment .


In the experimental study , the DA experience strengthened the direct path from desire for medical information to self-empowerment and the indirect path from comprehension/participation confidence to self-empowerment through cancer attitude .


The DA had no strengthening effect on the direct path from life satisfaction to self-empowerment , but in the DA condition , the factor appeared to play a role by contributing to the enhanced association between confidence and cancer attitude .


Evidence from this research indicates that experiencing a DA prior to treatment decision making affects patient empowerment through a network that includes desire for information , life satisfaction , and multiple mediators .


The studies also demonstrate the role that theory-based , multigroup structural equation modeling ( SEM ) can play in increasing understanding of DA effects .


Such understanding is critical to improving SDM between patients and their physicians .


Randomized controlled trial .


To determine the validity of a previously suggested clinical prediction rule ( CPR ) for identifying patients most likely to experience short-term success following lumbar stabilization exercise ( LSE ) .


Background Although LSE is commonly used by physical therapists in the management of low back pain , it does not seem to be more effective than other interventions .


A 4-item CPR for identifying patients most likely to benefit from LSE has been previously suggested but has yet to be validated .


One hundred five patients with low back pain underwent a baseline examination to determine their status on the CPR ( positive or negative ) .


Patients were stratified by CPR status and then randomized to receive an LSE program or an intervention consisting of manual therapy ( MT ) and range-of-motion/flexibility exercises .


Both interventions included 11 treatment sessions delivered over 8 weeks .


Low back pain-related disability was measured by the modified version of the Oswestry Disability Index at baseline and upon completion of treatment .


The statistical significance for the 2-way interaction between treatment group and CPR status for the level of disability at the end of the intervention was P = .17 .


However , among patients receiving LSE , those with a positive CPR status experienced less disability by the end of treatment compared with those with a negative CPR status ( P = .02 ) .


Also , among patients with a positive CPR status , those receiving LSE experienced less disability by the end of treatment compared with those receiving MT ( P = .03 ) .


In addition , there were main effects for treatment and CPR status .


Patients receiving LSE experienced less disability by the end of treatment compared to patients receiving MT ( P = .05 ) , and patients with a positive CPR status experienced less disability by the end of treatment compared to patients with a negative CPR status , regardless of the treatment received ( P = .04 ) .


When a modified version of the CPR ( mCPR ) containing only the presence of aberrant movement and a positive prone instability test was used , a significant interaction with treatment was found for final disability ( P = .02 ) .


Of the patients who received LSE , those with a positive mCPR status experienced less disability by the end of treatment compared to those with a negative mCPR status ( P = .02 ) , and among patients with a positive mCPR status , those who received LSE experienced less disability by the end of treatment compared to those who received MT ( P = .005 ) .


The previously suggested CPR for identifying patients likely to benefit from LSE could not be validated in this study .


However , due to its relatively low level of power , this study could not invalidate the CPR , either .


A modified version of the CPR that contains only 2 items may possess a better predictive validity to identify those most likely to succeed with an LSE program .


Because this modified version was established through post hoc testing , an additional study is recommended to prospectively test its predictive validity .


Prognosis , level 1b - .


To evaluate the safety , tolerability and bioactivity of ascending doses of MP0112 , a designed ankyrin repeat protein ( DARPin ) that binds with high affinity to vascular endothelial growth factor-A ( VEGF-A ) , in treatment-naive patients with exudative age-related macular degeneration ( AMD ) .


Phase I/II , open-label , multicenter , dose-escalation study .


Patients were to receive a single intravitreal injection of MP0112 at doses ranging from 0.04 to 3.6 mg and be monitored for 16 weeks for safety , efficacy , pharmacokinetics , and dose response .


Altogether , 32 patients received a single injection of MP0112 .


The maximum tolerated dose was 1.0 mg because of a case of endophthalmitis in the 2.0 mg cohort .


Drug-related adverse events were reported by 13 ( 41 % ) of 32 patients ; they included ocular inflammation in 11 patients ( 7 mild , 4 moderate in severity ) .


Visual acuity scores were stable or improved compared with baseline for 4 weeks following injection ; both retinal thickness and fluorescein angiography leakage decreased in a dose-dependent manner .


Rescue therapy was administered to 20 ( 91 % ) of 22 patients who received 0.04-0 .4 mg MP0112 compared with 4 of 10 ( 40 % ) patients who received 1.0 or 2.0 mg .


Of patients in the higher-dose cohorts who did not require rescue treatment , 83 % ( 5/6 ) maintained reductions in central retinal thickness through week 16 .


A single injection of 1.0 or 2.0 mg MP0112 resulted in mean decreases in retinal thickness and leakage area despite ocular inflammation .


Larger-scale studies are warranted to confirm these observations .


Major depressive disorder ( MDD ) imposes a considerable disease burden on individuals and societies .


Web-based interventions have shown to be effective in reducing depressive symptom severity .


However , it is not known whether web-based interventions may also be effective in preventing the onset of MDD .


The aim of this study is to evaluate the ( cost - ) effectiveness of an indicated web-based guided self-help intervention ( GET.ON Mood Enhancer Prevention ) on the onset of MDD .


A randomised controlled trial ( RCT ) will be conducted to compare the ( cost - ) effectiveness of the GET.ON Mood Enhancer Prevention training with a control condition exclusively receiving online-based psychoeducation on depression .


Adults with subthreshold depression ( N = 406 ) will be recruited from the general population and randomised to one of the two conditions .


The primary outcome is time to onset of MDD within a 12-months follow-up period .


MDD will be assessed according to DSM-IV criteria as assessed by the telephone-administered Structured Clinical Interview for DSM-IV ( SCID ) .


Time to onset of MDD will be assessed using life charts .


Secondary outcomes include changes on various indicators of depressive symptom severity , anxiety and quality of life from baseline to post-treatment , to a 6-month and a 12-month follow up .


Additionally , an economic evaluation using a societal perspective will be conducted to examine the intervention 's cost-effectiveness .


This is one of the first randomised controlled trials that examines the effect of an indicated guided self-help web-based intervention on the incidence of major depression .


If shown to be effective , the intervention will contribute to reducing the disease burden due to MDD in the general population .


German Clinical Trial Registration DRKS00004709 .


Due to improved treatments and ageing population , many countries now report increasing prevalence in rates of ischemic heart disease and heart failure .


Cardiac rehabilitation has potential to reduce morbidity and mortality , but not all patients complete .


In light of favourable effects of cardiac rehabilitation it is important to develop patient education methods which can enhance adherence to this effective program .


The LC-REHAB study aims to compare the effect of a new patient education strategy in cardiac rehabilitation called ` learning and coping ' to that of standard care .


Further , this paper aims to describe the theoretical basis and details of this intervention .


Open parallel randomised controlled trial conducted in three hospital units in Denmark among patients recently discharged with ischemic heart disease or heart failure .


Patients are allocated to either the intervention group with learning and coping strategies incorporated into standard care in cardiac rehabilitation or the control group who receive the usual cardiac rehabilitation program .


Learning and coping consists of two individual clarifying interviews , participation of experienced patients as educators together with health professionals and theory based , situated and inductive teaching .


Usual care in cardiac rehabilitation is characterised by a structured deductive teaching style with use of identical pre-written slides in all hospital units .


In both groups , cardiac rehabilitation consists of training three times a week and education once a week over eight weeks .


The primary outcomes are adherence to cardiac rehabilitation , morbidity and mortality , while secondary outcomes are quality of life ( SF-12 , Health education impact questionnaire and Major Depression Inventory ) and lifestyle and risk factors ( Body Mass Index , waist circumference , blood pressure , exercise work capacity , lipid profile and DXA-scan ) .


Data collection occurs four times ; at baseline , at immediate completion of cardiac rehabilitation , and at three months and three years after the finished program .


It is expected that learning and coping incorporated in cardiac rehabilitation will improve adherence in cardiac rehabilitation and may decrease morbidity and mortality .


By describing learning and coping strategies the study aims to provide knowledge that can contribute to an increased transparency in patient education in cardiac rehabilitation .


Identifier NCT01668394 .


Health Economists in Denmark have reported poor outcomes and low and delayed return to work for patients treated for Sub-Acromial Impingement syndrome ( SAIS ) by Arthroscopic Sub-Acromial Decompression ( ASAD ) .


In this setting it is important to evaluate outcomes following this commonly performed operation to justify undertaking it on our patients .


The purpose of the study was to evaluate the effectiveness of ASAD for patients with SAIS and correlate clinical outcome with rate of return to work .


Prospective cohort study and retrospective review of data from the Nottingham Shoulder database .


Inclusion criteria : Patients diagnosed clinically with SAIS by an experienced shoulder surgeon , who have failed conservative treatment ( physiotherapy and sub-acromial injection ) , undergoing ASAD .


Pre-operative and 6-month post-operative Oxford Shoulder Score ( OSS ) and Constant Score ( CS ) were compared .


The rates of return to pre-operative work and hobbies were also analysed .


Statistical analysis was carried out using the Wilcoxon signed rank test .


73 patients with OSS ( 51 also with CS documentation ) were included .


The improvement in median OSS between pre-operative ( 24 ) and 6-month follow-up ( 39 ) was +15 ( Z = -6.726 , p < 0.0001 , T = 6 , r = 0.55 ) .


The difference in median CS between pre-operative ( 39 ) and 6-month follow-up ( 67 ) was +28 ( Z = -5.435 , p < 0.0001 , T = 6 , r = 0.59 ) .


Improvement in median pain score was +5 ( 7,12 , p < 0.0001 ) median ADL was +5.5 ( 10.5,16 , p < 0.0001 ) median ROM was +13 ( 18,31 , p < 0.0001 ) and median strength was +4 ( 3,7 , p < 0.0001 ) .


76 % returned to their pre-operative level of work ( mean time = 11.5 weeks post surgery ) .


79 % returned to pre-operative hobbies at a mean of 11.8 weeks after surgery .


There is a significant improvement in both subjective and objective outcome 6 months after ASAD in patients with SAIS who have had previous failed conservative treatment .


The rate of return to work was good for these patients in contrast to that reported for Danish patients .


ASAD is a successful method of treatment for patients with SAIS who have had an initial trial of failed conservative treatment .


Up to 18.1 % of Dutch children aged 3-5 are overweight and up to 3.3 % are obese , with higher levels in girls .


This study assessed the effect of a multidisciplinary intervention programme on health-related quality of life ( HRQoL ) in this patient group .


We randomised 75 children to a multidisciplinary intervention , comprising dietary advice , exercise sessions and psychological counselling for parents or the standard care programme , providing healthy lifestyle advice .


The parents completed quality of life and child health questionnaires at baseline and after 16weeks and 12months .


At 16weeks , children in the intervention group experienced more bodily pain and less mental health than the standard care group , but at 12months , this difference disappeared and they showed a more positive change in HRQoL than the standard care group , especially for the physical domain .


When we combined both groups , a decreased BMIz-score over 12months was associated with increased global health and reduced visceral fat correlated with increased general health .


At 12months , a multidisciplinary intervention programme for overweight and obese children aged 3-5years had beneficial effects on HRQoL , especially for the physical domain .


Reduced obesity parameters correlated with several increased HRQoL parameters .


The study aimed to evaluate the effect of 0.25 % sodium hypochlorite twice-weekly oral rinse on plaque and gingivitis in patients with minimally treated periodontitis .


The study included 30 patients with periodontitis , it lasted 3mo , and it was performed as a randomized , controlled , single-blinded , clinical trial in parallel groups .


Fifteen patients rinsed for 30s with 15mL of a fresh solution of 0.25 % sodium hypochlorite ( test ) and 15 patients rinsed with 15mL of water ( control ) .


Clorox ( ) regular bleach was the source of the sodium hypochlorite .


At baseline and at 2wk , the study patients received professional subgingival irrigation for 5min with either 0.25 % sodium hypochlorite or water , but no subgingival or supragingival scaling .


The presence or absence of supragingival plaque on facial and lingual surfaces was determined by visual inspection ; each tooth was dried with air and mouth mirror rotation was used to provide light reflection to identify plaque on smooth surfaces and at the tooth line angles .


Gingival bleeding within 30s after probing to full pocket depth was assessed in six sites of each tooth .


Adverse events were evaluated by questionnaire and visual examination .


All 30 patients in the study completed the baseline and the 2wk parts of the study and a subset of 12 participants completed the 3mo part of the study .


The sodium hypochlorite rinse group and the water rinse group , respectively , showed increases from baseline to 3mo of 94 % and 29 % ( 3.2-fold difference ) in plaque-free facial surfaces , of 195 % and 30 % ( 6.5-fold difference ) in plaque-free lingual surfaces , and of 421 % and 29 % ( 14.5-fold difference ) in number of teeth with no bleeding on probing .


The differences in clinical improvement between the sodium hypochlorite rinse group and the water rinse group were statistically significant .


No adverse events were identified in any of the study patients , except for minor complaints about the taste of bleach .


A twice-weekly oral rinse with 0.25 % sodium hypochlorite produced marked decreases in dental plaque level and bleeding on probing and may constitute a promising new approach to the management of periodontal disease .


Long-term controlled studies on the effectiveness of sodium hypochlorite oral rinse are needed and encouraged .


There is no evidence regarding the several short-term prophylaxis protocols for contrast-induced nephropathy ( CIN ) that may be most feasibly convenient in emergency settings .


The purpose of this study was to compare the efficacies of short-term CIN prophylaxis protocols of normal saline , N-acetylcysteine ( NAC ) plus saline , and sodium bicarbonate plus saline in emergency department ( ED ) patients at moderate or high risk of CIN after receiving intravenous ( IV ) contrast agent .


This single-center , randomized , nonblinded clinical trial was conducted in the ED with adult patients requiring contrast-enhanced computed tomography ( CT ) .


Patients with moderate to high risk of CIN according to the Mehran risk score , who consented to participate , were eligible .


Patients with continuous renal replacement therapy or who reported contrast allergy were excluded .


Enrolled patients were randomly assigned to receive 150 mg/kg NAC in 1000 mL of 0.9 % sodium chloride ( NaCl ) , 150 mEq of sodium bicarbonate in 1000 mL of 0.9 % NaCl , or 1000 mL of IV saline infusion , all given at 350 mL/hr for 3 hours .


All of the patients were administered less than 100 mL of nonionic , low-osmolality contrast agent .


The primary outcome of CIN was defined as a 25 % increase or a greater than 0.5 mg/dL increase in the serum creatinine level 48 to 72 hours later compared with the baseline measurement .


A total of 107 patients were randomized to NAC ( n = 36 ) , sodium bicarbonate ( n = 36 ) , and saline prophylaxis ( n = 35 ) .


The mean age of the patients was 71 years ( 95 % confidence interval [ CI ] = 65 to 77 years ) , and 58 ( 54.2 % ) were male .


The groups were similar regarding baseline characteristics and nephropathy risks .


Of the 16 ( 14.9 % ) patients who eventually developed CIN , seven ( 19.4 % ) were in the NAC plus saline group , four ( 11.1 % ) were in the sodium bicarbonate plus saline group , and five ( 14.2 % ) were in the saline group .


There were no significant differences between the groups in terms of the prevention of CIN ( p = 0.60 ) .


None of the short-term protocols with normal saline , NAC , or sodium bicarbonate was superior in ED patients requiring contrast-enhanced CT who had a moderate or high risk of CIN .


To evaluate the erectile function of male patients treated by neoadjuvant radiochemotherapy and neoadjuvant chemotherapy alone for mid-low rectal cancer .


The clinical data of 66 patients with rectal cancer from March 2011 to March 2013 were prospectively analyzed .


Of all the patients , 56 cases were finally included in the study and were randomly allocated to two groups .


Thirty patients were treated by neoadjuvant radiochemotherapy followed by surgery ( RCS group ) , and 26 were treated by neoadjuvant chemotherapy followed by surgery ( NCS group ) .


The five-item version of the international index of erectile function ( IIEF-5 ) questionnaire were used to determine erectile function before therapy and at least 12 months after surgery .


The impacts of age , location , size of tumor , and body mass index on erectile function were analyzed .


Total score was decreased significantly at follow-up compared to initial assessment in both RCS and NCS groups ( 23.4 1.30 vs. 11.7 5.8 , t = 10.748 , P < 0.01 ; 23.1 1.3 vs. 15.2 6.7 , t = 5.910 , P < 0.01 , respectively ) .


Score difference was statistically higher in RCS group compared with NCS group ( 11.7 5.6 vs. 8.0 6.0 , t = 2.394 , P = 0.020 ) .


In terms of tumor location for RCS group , difference was statistically higher in the patients with low rectal cancer compared with those with middle rectal cancer ( 14.5 3.5 vs. 9.5 6.0 , t = 2.894 , P = 0.008 ) .


The erectile functions of patients treated by neoadjuvant radiochemotherapy followed by surgery are more affected than that of patients treated by neoadjuvant chemotherapy followed by surgery in mid-low rectal cancer .


Also low rectal cancer are significantly associated with erectile dysfunction in the patients treated by neoadjuvant radiochemotherapy followed by surgery .


We planned to compare the impact of two beta blockers , metoprolol and nebivolol , on arterial blood pressure during exercise in patients with mild hypertension .


A total of 60 patients ( 13 males , 47 females ; mean age : 54.3 10.7 years ) were enrolled in the present study .


The patients were randomly selected to receive either nebivolol 5mg/day ( n = 30 ) or metoprolol 50mg/day ( n = 30 ) for 8 weeks .


At the end of the 8th week , each of the patients received exercise stress test according to Bruce protocol and their blood pressures were remeasured after rest , exercise , and recovery .


Blood pressures were determined to be similar between metoprolol and nebivolol groups during rest , exercise , and recovery periods .


Metoprolol and nebivolol achieved similar reductions in blood pressures during rest and exercise .


However , five patients in nebivolol group and four patients in metoprolol group developed exaggerated BP response to exercise but the difference between metoprolol and nebivolol was not meaningful ( P = 0.37 ) .


The results of the present study showed that metoprolol and nebivolol established comparable effects on the control of blood pressures during exercise in the patients with mild hypertensions .


To compare the efficacy of Dexmedetomidine and Propofol for short-term controlled sedation and analgesia in the early postoperative period after cardiac surgery .


We performed open randomized prospective comparative study in 55 cardiovascular surgery patients .


In the early postoperative period 28 patients received infusion of Dexmedetomidine ( 0.2-0 .7 microg/kg per hour ) while 27 patients -- Propofol ( 0.3-2 ( system text of symbol ) ) .


Analgesia was carried out with Ketoprofen 100 mg/12h and additional 20 mg of Trimeperidine in case of pain intensity > or = 3 points ( 5-level verbal pain score ) .


Sedation and agitation level ( RASS scale ) , speed of awakening ( Aldrete score ) , duration of mechanical ventilation and stay in the ICU , need for additional opioid injections , type and frequency of side effects were evaluated .


We did n't find any significant differences in the duration of mechanical ventilation or rate of awakening after the end of infusion between the groups .


Dexmedetomidine in the majority of cases resulted in mild or moderate sedation , Propofol -- in deeper level of sedation .


Retrograde amnesia was reached significantly more often ( p < 0.05 ) in Dexmetomedine group .


The daily dose of Trimeperidine in Propofol group was significantly higher ( 8 mg and 18 mg on average , p = 0.02 ) .


Differences in side effects between the groups were noted -- bradycardia ( Dexmetomedine -- 10 ( 39 % ) , Propofol -- 3 ( 11 % ) , p = 0.004 ) arterial hypotension ( Dexmetomedine -- 9 ( 32 % ) , Propofol -- 15 ( 59 % ) , p = 0.002 ) and general malaise ( Dexmetomedine -- 2 ( 7 % ) , Propofol -- 6 ( 24 % ) , p = 0.001 ) .


The length of stay in the ICU in Dexmetomedine group was significantly lower ( 1,1 days vs 2,6 days respectively , p = 0.006 ) .


To compare with Propofol Dexmetomedine induces less sedation level and more often provides retrograde amnesia with the same duration of mechanical ventilation and awakening rate .


Dexmetomedine provides its own analgesic effect and shortens the length of patient 's stay in ICU .


Bradycardia was noted more frequently in Dexmedetomidine while arterial hypotension , general malaise and delirium -- in Propofol group .


To characterize genital mycotic infections with canagliflozin , a sodium glucose co-transporter 2 inhibitor , in patients with type 2 diabetes mellitus ( T2DM ) using pooled data from Phase 3 studies .


Genital mycotic infections with canagliflozin 100 and 300mg were evaluated in Population 1 ( N = 2313 ; mean exposure [ weeks ] : canagliflozin , 24.3 ; placebo , 23.8 ) , including patients from four placebo-controlled studies , and Population 2 ( N = 9439 ; mean exposure [ weeks ] : canagliflozin , 68.1 ; control , 64.4 ) , including patients from eight placebo/active-controlled studies ( including older patients and those with renal impairment or high cardiovascular disease risk ) .


ClinicalTrials.gov , NCT01081834 ; NCT01106625 ; NCT01106677 ; NCT01106690 ; NCT01032629 ; NCT01064414 ; NCT01106651 ; NCT00968812 .


Adverse events suggestive of genital mycotic infections were recorded , with additional information collected using supplemental electronic case report forms .


In Population 1 , genital mycotic infection incidence was higher with canagliflozin 100 and 300mg than placebo ( 95 % confidence intervals excluded zero ) in females ( 10.4 % , 11.4 % , 3.2 % ) and males ( 4.2 % , 3.7 % , 0.6 % ) .


These were generally mild to moderate in intensity , none were serious , and few led to discontinuation .


Most events with canagliflozin were treated with antifungal therapies , and median symptom duration following treatment initiation was similar across groups ; few patients had > 1 event ( females , 2.3 % ; males , 0.9 % ) .


Findings with canagliflozin 100 and 300mg versus control were similar in Population 2 ( females : 14.7 % , 13.9 % , 3.1 % ; males : 7.3 % , 9.3 % , 1.6 % ) ; a low proportion of males underwent circumcision across groups .


Most events with canagliflozin occurred within the first 4 months in females and first year in males ; no consistent evidence of dose dependence was observed .


Key limitations included lack of laboratory confirmation for most events and variable treatment methods .


Genital mycotic infection incidences were higher with canagliflozin than control in patients with T2DM ; events were generally mild to moderate in intensity and responded to standard treatments .


Psychiatric stigma is a major barrier to the recovery of persons with serious mental illnesses .


This study tested the efficacy of an innovative peer-run photography-based intervention , called antistigma photovoice , which targets self-stigma and promotes proactive coping with public stigma .


A total of 82 individuals with serious mental illnesses enrolled at a university-based recovery center were randomly assigned to the antistigma photovoice program or to a wait-list control group .


Mixed-effects regression models were used to examine the impact of photovoice on self-stigma , coping with stigma , empowerment , perceived recovery , self-efficacy , and depression .


Participation in the photovoice intervention was associated with significantly reduced self-stigma , greater use of proactive coping with societal stigma , greater increase in a sense of community activism , and perceived recovery and growth .


The photovoice intervention demonstrated promise for reducing self-stigma and enhancing proactive coping with prejudice and discrimination .


Accurate immunosuppression is of critical importance in preventing rejection , while avoiding toxicity following lung transplantation .


The mainstay immunosuppressants are calcineurin inhibitors , which require regular monitoring due to interactions with other medications and diet .


Adherence to immunosuppression and patient knowledge is vital and can be improved through patient education .


Education using tablet-computers was investigated .


To compare tablet-PC education and conventional education in improving immunosuppression trough levels in target range 6 months after a single education .


Secondary parameters were ratio of immunosuppression level measurements divided by per protocol recommended measurements , time and patient satisfaction regarding education .


Single-centre , open labelled randomised controlled trial .


Patients > 6 months after lung-transplantation with < 50 % of calcineurin inhibitor trough levels in target range .


Tablet-pc education versus personal , nurse-led education .


Calcineurin inhibitor levels in target range 6 months after education , level variability , interval adherence , knowledge and adherence was studied .


As outcome parameter , renal function was measured and adverse events registered .


Sixty-four patients were 1:1 randomised for either intervention .


Levels of immunosuppression 6 months after education were equal ( tablet-PC 58 % vs. conventional 48 % , p = 0.27 ) , both groups improved in achieving a CNI trough level within target range by either education method ( delta tablet-PC 29 % vs. conventional 20 % ) .


In all patients , level variability decreased ( -20.4 % ) , whereas interval adherence remained unchanged .


Knowledge about immunosuppression improved by 7 % and compliance tests demonstrated universal improvements with no significant difference between groups .


Education is a simple , effective tool in improving adherence to immunosuppression .


Tablet-PC education was non-inferior to conventional education .


ClinicalTrials.gov NCT01398488 http://clinicaltrials.gov/ct2/show/NCT01398488 ?


term = gottlieb + tablet + pc + education & rank = 1 .


Surgery for colorectal liver metastases results in an overall survival of about 40 % at 5 years .


Progression-free survival is increased with the addition of oxaliplatin and fluorouracil chemotherapy .


The addition of cetuximab to these chemotherapy regimens results in an overall survival advantage in patients with advanced disease who have the KRAS exon 2 wild-type tumour genotype .


We aimed to assess the benefit of addition of cetuximab to standard chemotherapy in patients with resectable colorectal liver metastasis .


Patients with KRAS exon 2 wild-type resectable or suboptimally resectable colorectal liver metastases were randomised in a 1:1 ratio to receive chemotherapy with or without cetuximab before and after liver resection .


Randomisation was done using minimisation with factors of surgical centre , poor prognostic tumour ( one or more of : 4 metastases , N2 disease , or poor differentiation of primary tumour ) , and previous adjuvant treatment with oxaliplatin .


Chemotherapy consisted of oxaliplatin 85 mg/m ( 2 ) intravenously over 2 h and fluorouracil bolus 400 mg/m ( 2 ) intravenously over 5 min , followed by a 46 h infusion of fluorouracil 2400 mg/m ( 2 ) repeated every 2 weeks ( regimen one ) or oxaliplatin 130 mg/m ( 2 ) intravenously over 2 h and oral capecitabine 1000 mg/m ( 2 ) twice daily on days 1-14 repeated every 3 weeks ( regimen two ) .


Patients who had received adjuvant oxaliplatin could receive irinotecan 180 mg/m ( 2 ) intravenously over 30 min with fluorouracil instead of oxaliplatin ( regimen three ) .


Cetuximab was given as an intravenous dose of 500 mg/m ( 2 ) every 2 weeks with regimen one and three or a loading dose of 400 mg/m ( 2 ) followed by a weekly infusion of 250 mg/m ( 2 ) with regimen two .


The primary endpoint was progression-free survival .


This is an interim analysis , up to Nov 1 , 2012 , when the trial was closed , having met protocol-defined futility criteria .


This trial is registered , ISRCTN22944367 .


128 KRAS exon 2 wild-type patients were randomised to chemotherapy alone and 129 to chemotherapy with cetuximab between Feb 26 , 2007 , and Nov 1 , 2012.117 patients in the chemotherapy alone group and 119 in the chemotherapy plus cetuximab group were included in the primary analysis .


The median follow-up was 21.1 months ( 95 % CI 12.6-33 .8 ) in the chemotherapy alone group and 19.8 months ( 12.2-28 .7 ) in the chemotherapy plus cetuximab group .


With an overall median follow-up of 20.7 months ( 95 % CI 17.9-25 .6 ) and 123 ( 58 % ) of 212 required events observed , progression-free survival was significantly shorter in the chemotherapy plus cetuximab group than in the chemotherapy alone group ( 14.1 months [ 95 % CI 11.8-15 .9 ] vs 20.5 months [ 95 % CI 16.8-26 .7 ] , hazard ratio 1.48 , 95 % CI 1.04-2 .12 , p = 0.030 ) .


The most common grade 3 or 4 adverse events were low neutrophil count ( 15 [ 11 % ] preoperatively in the chemotherapy alone group vs six [ 4 % ] in the chemotherapy plus cetuximab group ; four [ 4 % ] vs eight [ 8 % ] postoperatively ) , embolic events ( six [ 4 % ] vs eight [ 6 % ] preoperatively ; two [ 2 % ] vs three [ 3 % ] postoperatively ) , peripheral neuropathy ( six [ 4 % ] vs one [ 1 % ] preoperatively ; two [ 2 % ] vs four [ 4 % ] postoperatively ) , nausea or vomiting ( four [ 3 % ] vs six [ 4 % ] preoperatively ; four [ 4 % ] vs two [ 2 % ] postoperatively ) , and skin rash ( two [ 1 % ] vs 21 [ 15 % ] preoperatively ; 0 vs eight [ 8 % ] postoperatively ) .


There were three deaths in the chemotherapy plus cetuximab group ( one interstitial lung disease and pulmonary embolism , one bronchopneumonia , and one pulmonary embolism ) and one in the chemotherapy alone group ( heart failure ) that might have been treatment related .


Addition of cetuximab to chemotherapy and surgery for operable colorectal liver metastases in KRAS exon 2 wild-type patients results in shorter progression-free survival .


Translational investigations to explore the molecular basis for this unexpected interaction are needed but at present the use of cetuximab in this setting can not be recommended .


To determine whether mental practice of wrist movements during forearm immobilization maintains range of motion .


Randomized controlled trial .


Eighteen healthy young men aged between 20 and 30 years were assigned to either a control or a mental practice group .


Both groups were immobilized with a circular forearm cast for 3 weeks to simulate a distal radial fracture .


The mental practice group received 1 60-min , followed by 3 30-min , sessions of supervised mental practice .


Consecutively , they were asked to perform 15 min/day of self-guided imagery sessions , during which they mentally exercised motion sequences of the immobilized joint .


The training program followed the Mental Gait Training procedure .


The control group did no training .


Wrist movement was measured with a goniometer before and after immobilization .


Mental practice preserved dorsal extension and ulnar abduction .


The sedentary control group showed due to this variables a significant decrease after cast removal .


There was no significant change in palmar flexion and radial abduction in either group .


Despite the study limitations , these results suggest that mental practice may be useful in preventing loss of hand function associated with mid-term immobilization .


Because of the expected clinical benefits , the low cost and simple application of the intervention , the effects of mental practice in orthopedic rehabilitation of the upper extremity warrant further study .


To assess the effects of perioperative comprehensive supportive care interventions on outcome of Chinese esophageal cancer patients in a prospective study .


60 patients with primary esophageal carcinoma were randomized into an intervention group ( IG , n = 31 ) and a control group ( CG , n = 29 ) .


The Chinese version of symptom checklist-90 ( SCL-90 ) was adopted to assess their psychological status .


The interventions , including health education , psychological support , stress management , coping strategies and behavior training , were carried out in 3 phases ( preoperative , postoperative I and postoperative II ) , and psychological effects were thereafter evaluated accordingly before surgery , and 1 week , 4 weeks and 24 weeks post-surgery .


Medical costs were estimated at discharge .


Survival of patients was estimated each year post-surgery .


General health status and satisfaction-with-hospital were surveyed by a follow-up questionnaire 4 years post-surgery .


All the subjects demonstrated higher scores in the preoperative phase than the normal range of Chinese population concerning 7 psychological domains including somatization , obsessive-compulsive , depression , anxiety , hostility , phobic anxiety and paranoid ideation .


Although no significant difference was observed between the two groups at admission , the scores of IG , which tended to decrease at a faster rate , were generally lower than those of CG at weeks 1 , 4 and 24 post-surgery .


The length of hospital stay and medical costs of IG were significantly less than those of CG and satisfaction-with-hospital was better .


However , there was no significant difference in 4-year survival or health status between two groups .


Appropriate perioperative comprehensive supportive care interventions help to improve the psychological state of Chinese patients with esophageal carcinoma , to reduce health care costs and to promote satisfaction of patients and their families with hospital .


The assurance of high-quality spirometry testing remains a challenge .


Spirometry training consisted of standardized coaching followed by certification for 35 spirometry-nave and 9 spirometry-experienced research assistants .


Spirometry was performed before and after bronchodilator ( BD ) in random population samples of 5176 people aged 40 years and older from 9 sites in Canada .


using the hand-held EasyOne spirometer ( ndd Medical Technologies Inc. , Andover , MA , USA ) .


Pulmonary function quality assurance with over reading was conducted centrally in Vancouver : spirograms were reviewed and graded according to ATS/ERS standards with prompt feedback to the technician at each site .


Descriptive statistics were calculated for manoeuvre acceptability and repeatability variables .


A logistic regression model was constructed for the predictors of spirometry quality success .


95 % of test sessions achieved pre-determined quality standards for back extrapolated volume ( BEV ) , time to peak flow ( PEFT ) and end of test volume ( EOTV ) .


The mean forced expiratory time ( FET ) was 11.2 seconds .


Then , 90 % and 95 % of all manoeuvres had FEV1 and FVC that were repeatable within 150 ml and 200 ml respectively .


Test quality was slightly better for post-BD test sessions compared with pre-BD for both groups of research assistants .


Independent predictors of acceptable test quality included participant characteristics : female sex , younger age , greater BD responsiveness ; but not study site or prior experience in completing spirometry by the technologist .


Good quality spirometry tests are attainable in large multicenter epidemiological studies by trained research assistants , irrespective of their prior experience in spirometry .


RECOVER ( NCT00474058 ) , a double-blind , placebo-controlled trial in patients with Parkinson 's disease ( PD ) and unsatisfactory early-morning motor symptom control , demonstrated significant improvements with rotigotine in early-morning motor function ( Unified Parkinson 's Disease Rating Scale [ UPDRS ] III ) , and nocturnal sleep disturbances ( modified Parkinson 's Disease Sleep Scale [ PDSS-2 ] ) , and improvements in nonmotor symptoms ( NMS ; Non-Motor Symptom Scale [ NMSS ] ) .


Post hoc analyses investigated the correlation between motor symptom and NMS severity in PD by evaluating associations between UPDRS III and both NMSS and PDSS-2 scores .


Categories were defined for UPDRS III , NMSS , and PDSS-2 total scores ; analyses were conducted for the full analysis set ( n = 267 ) .


There was a trend toward increasing PDSS-2 and NMSS total and domain scores with increasing UPDRS III category at baseline and end of maintenance ( EoM ) .


Pearson correlation coefficients between UPDRS III and both NMSS and PDSS-2 total and domain scores were r = 0.12-0 .44 ( r ( 2 ) = 0.01-0 .19 ) at baseline , r = 0.05-0 .38 ( r ( 2 ) = 0.00-0 .14 ) at EoM , and r = -0.02 -0.36 ( r ( 2 ) = 0.00-0 .13 ) for change from baseline to EoM .


There was only a small correlation between severity of early-morning motor symptoms and overall burden of NMS and nocturnal sleep disturbances in RECOVER , suggesting that motor symptoms and NMS originate , at least partly , from distinct pathophysiological pathways .


To evaluate a multistrain , high-dose probiotic in the prevention of eczema .


A randomised , double-blind , placebo-controlled , parallel group trial .


Antenatal clinics , research clinic , children at home .


Pregnant women and their infants .


Women from 36weeks gestation and their infants to age 6months received daily either the probiotic ( Lactobacillus salivarius CUL61 , Lactobacillus paracasei CUL08 , Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20 ; total of 10 ( 10 ) organisms/day ) or matching placebo .


Diagnosed eczema at age 2years .


Infants were followed up by questionnaire .


Clinical examination and skin prick tests to common allergens were done at 6months and 2years .


The cumulative frequency of diagnosed eczema at 2years was similar in the probiotic ( 73/214 , 34.1 % ) and placebo arms ( 72/222 , 32.4 % ; OR 1.07 , 95 % CI 0.72 to 1.6 ) .


Among the secondary outcomes , the cumulative frequency of skin prick sensitivity at 2years was reduced in the probiotic ( 18/171 ; 10.5 % ) compared with the placebo arm ( 32/173 ; 18.5 % ; OR 0.52 , 95 % CI 0.28 to 0.98 ) .


The statistically significant differences between the arms were mainly in sensitisation to cow 's milk and hen 's egg proteins at 6months .


Atopic eczema occurred in 9/171 ( 5.3 % ) children in the probiotic arm and 21/173 ( 12.1 % ) in the placebo arm ( OR 0.40 , 95 % CI 0.18 to 0.91 ) .


The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity .


However , the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood .


ISRCTN26287422 .


To estimate the prevalence of primary dysmenorrhoea among school girls and to compare the impact of exercise and hot water bottle on the occurrence and severity of primary dysmenorrhoea among the study population .


A cross sectional study was done to estimate the prevalence of dysmenorrhoea in two schools of Chandigarh , India .


For the Randomised Controlled Trial , group randomisation of the two schools was done into 2 intervention groups ( exercise & hot water bottle groups ) .


53 girls in school 1 and 75 girls in school 2 participated in the intervention .


Comparison of baseline Menstrual Distress Questionnaire ( MDQ ) scores & Visual Analogue Scale for Pain ( VASP ) scores were done with 1st , 2nd & 3rd month post intervention scores using mean , standard deviation , t-test .


Prevalence of dysmenorrhoea was 60.7 % .


Median age of the school girls was 14 years .


The mean VASP score decreased from 5.75 to 2.96 ( P < 0.0001 ) and from 5.16 to 2.06 ( P < 0.0001 ) at 3 months , in the exercise and hot water bottle group respectively .


The mean MDQ score decreased from 14.53 to 7.85 ( P < 0.0001 ) and from 14.92 to 8.16 ( P < 0.0001 ) at 3 months , in the exercise and hot water bottle group respectively .


Both exercise & hot water bottle can be used in dysmenorrhoeic girls in home setting to provide relief from pain and menstrual distress .


The efficacy of lidocaine-prilocaine cream ( EMLA ( ) ) analgesia in the practice of hysterosalpingography is controversial .


This study provides new drill results and a new method of application in terms of mode , time and place .


The aim of the paper is to investigate the efficacy of 5 % lidocaine 25 mg-prilocaine 25 mg/g cream applied to the uterine cervix for reducing pain during hysterosalpingography .


A randomized , double blinded , controlled study set in the general gynaecology clinic of a university teaching hospital between September 2012 and June 2013 .


One hundred successive patients programmed to undergo hysterosalpingography were randomized to either 3 ml of EMLA ( 50 ) cream or 3 ml of placebo ( 50 ) , placed endocervically and exocervically , 10 min before hysterosalpingography .


Patients ' intensity of pain was assessed in four steps : at baseline ( speculum application ) , after application of Pozzi tenaculum and cannula on the uterine cervix , during cervical traction and after contrast medium injection , using a 10-cm Visual Analogue Scale ( VAS ) immediately after the procedure .


The most painful step was also identified .


VAS was administered again at one-month follow-up visit .


NCT01303614 .


The contrast medium injection was the most painful step of hysterosalpingography in both groups ( EMLA 3.96 , placebo 4.54 , 95 % CI : -0.481 to 1.641 ) .


No differences were found between the two groups ( P = 0.281 ) during this step .


When comparing the VAS scale after the application of Pozzi tenaculum and cannula ( EMLA 1.06 , placebo 3.34 , 95 % CI : 1.495-3 .065 ) and after cervical traction ( EMLA 2.54 , placebo 3.46 , 95 % CI : 0.034-1 .806 ) , significantly less pain was experienced by the EMLA group than the placebo group : P = 0.000 and P = 0.042 , respectively .


Endocervical and exocervical topical application of EMLA 10 min before performing hysterosalpingography significantly reduced pain during cervical manipulation with tenaculum and cannula and during cervical traction , but did not reduce pain during injection of contrast that was the most painful step .


Inflammation is considered a key mediator of complications after cardiac surgery .


Sevoflurane has been shown to quench inflammation and to provide cardioprotection in preclinical studies .


Clinical studies using sevoflurane confirm this effect on inflammation but do not consistently show clinical benefits .


This paradox may indicate that the contribution of inflammation to postoperative sequalae is less than commonly thought or that systemic doses are too low in their local concentration .


To test the latter , we evaluated the effects of intramyocardial sevoflurane delivery .


Selective myocardial sevoflurane delivery was performed during aortic cross-clamping in patients undergoing valve surgery ( n = 11 ) .


Results were compared with a control group not receiving sevoflurane ( n = 10 ) .


A reference group ( n = 5 ) was added to evaluate the effects of systemic sevoflurane delivery .


Paired arterial and myocardial venous blood samples were collected at various time points post-reperfusion .


Inflammatory mediators and myocardial cell damage were studied .


Intramyocardial delivery was superior to systemic delivery in attenuation of interleukin-6 and interleukin-8 ( -44 % and -25 % , respectively ; both P = 0.001 ) .


Myocardial and systemic sevoflurane delivery effectively suppressed surgery-related inflammatory responses including postoperative C-reactive protein levels when compared with controls [ 63 ( 47-99 ) ( P = 0.01 ) and 58 ( 56-81 ) ( P = 0.04 ) compared with 107 ( 79-144 ) mg litre ( -1 ) ] .


Sevoflurane treatment did not reduce postoperative troponin T , creatine kinase , and creatine kinase-MB values .


This proof-of-concept study suggests that intramyocardial delivery compared with the systemic delivery of sevoflurane more strongly attenuates the systemic inflammatory response after cardiopulmonary bypass without reducing postoperative markers of myocardial cell damage .


Nederlands Trial Register NTR2089 .


To assess the long-term safety and efficacy of pramipexole as a once-daily ( q.d. ) extended-release oral formulation in early or advanced Parkinson 's disease ( PD ) .


In two double-blind ( DB ) studies of early PD and one of advanced PD,active-treatment arms received pramipexole immediate release ( IR ) or extended release ( ER ) , with exposure lasting up to 33 weeks .


In open-label ( OL ) extensions that followed immediately , subjects took ER q.d. for up to 80 weeks , with dosage adjustment permitted ( range 0.375-4 .5 mg q.d. ) .


Of 590 subjects completing an early-PD DB study , 511 entered the early-PD OL extension ; 408 completed it .


Reported adverse events ( AEs ) with incidence 10.0 % were somnolence ( 15.1 % ) , peripheral edema ( 11.7 % ) and back pain ( 10.6 % ) .


Of 465 subjects completing the advanced-PD DB study , 391 entered the advanced-PD OL extension ; 329 completed it .


Reported AEs with incidence 10.0 % were dyskinesia ( 27.4 % ) and somnolence ( 13.6 % ) .


Impulse control disorders were identified by semi-structured interview in 13 subjects ( 1.4 % of 902 ) .


In exploratory analyses , adjusted mean Unified Parkinson 's Disease Rating Scale ( UPDRS ) PartsII + III scores ( excluding ex-placebo recipients ) remained substantially improved from DB baseline scores prior to pramipexole introduction , at -6.6 and -6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks of pramipexole ( 33 DB plus 80 OL ) in early PD , and -11.5 and -9.1 after up to 113 weeks ( up to 33 DB plus 80 OL ) in advanced PD .


These results support the long-term safety and efficacy of pramipexole ER in early and advanced PD .


AEs were typical for dopaminergic medications , and UPDRS scores suggested sustained symptomatic benefit .


To examine the impact of telephone reinforcement ( TR ) on predictors of physical activity ( PA ) maintenance in older adults with osteoarthritis .


Mixed effects modeling was conducted of data from a randomized PA trial that used negotiated maintenance contracts , supplemented by TR , to test impact of TR on barriers , decisional balance , and stage of change at multiple points in time .


Participants who were referred to a PA program and received TR improved the most in barriers and decisional balance .


Participants who negotiated a tailored maintenance contract but did not receive TR improved the most in stage .


TR appears to positively affect perceptions around engagement , whereas negotiation positively impacts PA behavior .


Further research should examine the effectiveness of specific PA maintenance strategies .


To explore the long-term outcomes of CONECSI ( COping with NEuropathiC Spinal cord Injury pain ) , a multidisciplinary cognitive behavioural treatment programme in persons with spinal cord injury .


Long-term follow-up pre-post-intervention design .


A total of 29 subjects with a spinal cord injury and chronic neuropathic pain from 4 Dutch rehabilitation centres .


Primary outcomes were pain intensity and pain-related disability ( Chronic Pain Grade questionnaire ) .


Secondary outcomes were mood ( Hospital Anxiety and Depression Scale ) , participation in activities ( Utrecht Activities List ) , and life satisfaction ( Life Satisfaction Questionnaire ) .


Random coefficient analysis was used for the analyses of measurements before ( t1 ) , immediate post-intervention ( t2 ) , and 6 ( t3 ) , 9 ( t4 ) , and 12 ( t5 ) months follow-up .


The analyses showed significant improvements on pain intensity ( t1-t2 and t1-t5 ) and pain-related disability ( t1-t2 , t1-t4 , and t1-t5 ) , anxiety and participation in activities ( t1-t2 , t1-t3 , and t1-t5 ) .


This exploratory study suggests that a multidisciplinary cognitive behavioural programme might have lasting improvements on pain intensity , pain-related disability , anxiety , and participation in activities in people with chronic neuropathic spinal cord injury pain and highlights the potential of such programmes .


Although Black heterosexual men ( BHM ) in the United States rank among those most affected by HIV , research about how safer sex messages shape their safer sex behaviors is rare , highlighting the need for innovative qualitative methodologies such as critical discursive psychology ( CDP ) .


This CDP study examined how : ( a ) BHM construct safer sex and masculinity ; ( b ) BHM positioned themselves in relation to conventional masculinity ; and ( c ) discursive context ( individual interview vs. focus group ) shaped talk about safer sex and masculinity .


Data included individual interviews ( n = 30 ) and 4 focus groups ( n = 26 ) conducted with 56 self-identified Black/African American heterosexual men , ages 18 to 44 .


Analyses highlighted 5 main constructions : ( a ) condoms as signifiers of `` safe '' women ; ( b ) blaming women for STI/responsibility for safer sex ; ( c ) relationship/trust/knowledge ; ( d ) condom mandates ; and ( e ) public health safer sex .


Discourses positioned BHM in terms of conventional masculinity when talk denied men 's agency for safer sex and/or contraception , or positioned women as deceitful , or apathetic about sexual risk and/or pregnancy .


Notably , discourses also spotlighted alternative masculinities relevant to taking responsibility for safer sex or sexual exclusivity .


Discursive context , namely the homosocial nature of focus group discussions , shaped how participants conversed about safer sex , and masculinity but not the content of that talk .


In denying BHM 's responsibility for safer sex , BHM 's discourses about safer sex and masculinity often mirror public health messages , underscoring a critical need to sync these discourses to reduce sexual risk , and develop gender-transformative safer sex interventions for BHM .


Exercise has been shown to attenuate cigarette cravings during temporary smoking abstinence ; however , the mechanisms of action are not clearly understood .


The objectives of the study were to compare the effects of three exercise intensities on desire to smoke and explore potential neurobiological mediators of desire to smoke .


Following overnight abstinence , 40 participants ( 25 males , 18-59 years ) completed three 15 min sessions of light - , moderate - , or vigorous-intensity exercise on a cycle ergometer in a randomized crossover design .


Ratings of desire to smoke were self-reported pre - and post-exercise and heart rate variability was measured throughout .


Saliva and blood were analyzed for cortisol and noradrenaline in a sub-sample .


Exercise influenced desire to smoke ( F [ 2 , 91 ] = 7.94 , p < 0.01 ) , with reductions greatest immediately after vigorous exercise .


There were also significant time x exercise intensity interaction effects for heart rate variability and plasma noradrenaline ( F [ 8 , 72 ] = 2.23 , p = 0.03 ) , with a bias in noradrenaline occurring between light and vigorous conditions ( adjusted mean difference [ SE ] = 2850 ng/ml [ 592 ] , p < 0.01 ) at 5 min post-exercise .


There was no interaction of time x exercise intensity for plasma and salivary cortisol levels .


These findings support the use of vigorous exercise to reduce cigarette cravings , showing potential alterations in a noradrenergic marker .


To investigate the pathogenesis of bloodstream infection by Staphylococcus epidermidis , using the molecular epidemiology , in high-risk neonates .


We conducted a prospective study of a cohort of neonates with bloodstream infection using central venous catheters for more than 24h .


`` National Healthcare Safety Network '' surveillance was conducted .


Genotyping was performed by DNA fingerprinting and mecA genes and icaAD were detected by multiplex-PCR .


From April 2006 to April 2008 , the incidence of bloodstream infection and central venous catheter-associated bloodstream infection was 15.1 and 13.0 / 1000 catheter days , respectively , with S. epidermidis accounting for 42.9 % of episodes .


Molecular analysis was used to document the similarity among six isolates of bloodstream infection by S. epidermidis from cases with positive blood and central venous catheter tip cultures .


Fifty percent of neonates had bloodstream infection not identified as definite or probable central venous catheter-related bloodstream infection .


Only one case was considered as definite central venous catheter-related bloodstream infection and was extraluminally acquired ; the remaining were considered probable central venous catheter-related bloodstream infections , with one probable extraluminally and another probable intraluminally acquired bloodstream infection .


Additionally , among mecA + and icaAD + samples , one clone ( A ) was predominant ( 80 % ) .


A polyclonal profile was found among sensitive samples that were not carriers of the icaAD gene .


The majority of infections caused by S. epidermidis in neonates had an unknown origin , although 33.3 % appeared to have been acquired intraluminally and extraluminally .


We observed a polyclonal profile between sensitive samples and a prevalent clone ( A ) between resistant samples .


We examined the effects of an intensive lifestyle intervention ( ILI ) , compared with a diabetes support and education ( DSE ) control intervention , on long-term changes in depression symptoms , antidepressant medication ( ADM ) use , and health-related quality of life ( HRQoL ) in overweight/obese individuals with type 2 diabetes .


Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI ( designed to produce weight loss ) or DSE and followed for a median of 9.6 years .


The Beck Depression Inventory ( BDI ) was administered at baseline , annually at years 1-4 , and again at year 8 .


Mean BDI scores and incidence of BDI scores 10 , indicative of likely mild or greater depression , were examined .


Annually through year 10 , participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 ( SF-36 ) questionnaire , which yields physical component summary ( PCS ) and mental component summary ( MCS ) scores .


ILI significantly reduced the incidence of mild or greater depression symptoms ( BDI scores 10 ) compared with DSE ( hazard ratio [ HR ] = 0.85 ; 95 % CI 0.75-0 .97 ; P = 0.0145 ) .


Although SF-36 PCS scores worsened over time in both groups , ILI participants reported better physical function than DSE throughout the first 8 years ( all P values < 0.01 ) .


There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores .


ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL .


These findings should be considered when evaluating the potential benefits of ILIs .


To evaluate whether manual or electric vacuum aspiration results in greater immediate confirmation of completed abortion at less than 6 weeks of gestation .


Five hundred pregnant women presenting for surgical abortion with mean gestational sac diameter of less than 12 mm or no visible sac on ultrasonography were randomized to manual or electric vacuum aspiration .


Tissue examination was performed by operating physicians , not blinded to group assignment , and by trained medical assistants , blinded to group assignment .


Patients with no products of conception on gross inspection underwent repeat aspiration as necessary and serial human chorionic gonadotropin monitoring .


All patients were scheduled for follow-up visits .


The primary outcome was detection of products of conception in patients with subsequently confirmed completed abortion .


From April 2010 to October 2011 , 252 patients were randomized to manual vacuum aspiration and 248 to electric vacuum aspiration .


One hundred eighty-two ( 82 % ) patients in the manual vacuum aspiration group had products of conception identified and subsequently confirmed completed abortion compared with 164 ( 76 % ) patients undergoing electric vacuum patients ( P = .13 , relative risk 0.83 , 95 % confidence interval [ CI ] 0.64-1 .07 ) .


In pregnancies of sac size 3 mm or less , including no visible sac , five of 29 ( 17 % ) patients undergoing manual vacuum aspiration had accurate identification of products of conception compared with four of 31 ( 13 % ) patients undergoing electric vacuum aspiration ( P = .64 , relative risk 0.85 , 95 % CI 0.44-1 .63 ) .


Tissue reports of physicians and medical assistants had 90 % concordance .


Seventy-nine ( 16 % ) patients required human chorionic gonadotropin monitoring to confirm completed abortion .


There were seven ( 1.4 % ) ongoing pregnancies , including four false-positive products of conception results and , among the latter , one presumed ectopic pregnancy .


Our study supports providing abortions to women who request them before 6 weeks of gestation using either manual or electric vacuum aspiration .


Early aspiration is highly effective , although human chorionic gonadotropin monitoring may be necessary to confirm complete abortion .


I.


Neck pain is a common musculoskeletal complaint responsive to manual therapies .


Doctors of chiropractic commonly use manual cervical distraction , a mobilization procedure , to treat neck pain patients .


However , it is unknown if clinicians can consistently apply standardized cervical traction forces , a critical step toward identifying an optimal therapeutic dose .


To assess clinicians ' proficiency in delivering manually applied traction forces within specified ranges to neck pain patients .


An observational study nested within a randomized clinical trial .


Two research clinicians provided study interventions to 48 participants with neck pain .


Clinician proficiency in delivering cervical traction forces within three specified ranges ( low force , less than 20 N ; medium force , 21-50 N ; and high force 51-100 N ) .


Participants were randomly allocated to three force-based treatment groups .


Participants received five manual cervical distraction treatments over 2 weeks while lying prone on a treatment table instrumented with force sensors .


Two clinicians delivered manual traction forces according to treatment groups .


Clinicians treated participants first without real-time visual feedback displaying traction force and then with visual feedback .


Peak traction force data were extracted and descriptively analyzed .


Clinicians delivered manual cervical distraction treatments within the prescribed traction force ranges 75 % of the time without visual feedback and 97 % of the time with visual feedback .


This study demonstrates that doctors of chiropractic can successfully deliver prescribed traction forces while treating neck pain patients , enabling the capability to conduct force-based dose response clinical studies .


To compare the perioperative outcomes of patients with primary hepatic carcinoma treated with laparoscopic hepatectomy ( LH ) with those treated with open hepatectomy ( OH ) .


From January 2010 to August 2014 , 100 patients with primary hepatic carcinoma were randomly divided into the LH group and OH group respectively , 50 patients in each group .


And the incision length , blood loss , operative time , postoperative liver function , anus exhaust time , complications , length of postoperative hospital stay , and cost measures were compared .


LH could achieve shorter incision length , less blood loss , more rapid recovery in liver function and gastrointestinal function , and shorter postoperative hospital stay length compared with OH for primary hepatic carcinoma patients ( all P < 0.05 ) .


However , LH could not significantly shorten operative time , and reduce postoperative complications and hospitalization cost ( all P > 0.05 ) .


Compared with OH , LH could improve perioperative outcomes of primary hepatic carcinoma patients .


To develop and validate a self-efficacy measure of diabetes self-management , the Lifestyle Self-Efficacy Scale for Latinos with Diabetes ( LSESLD ) , designed for low-income , Spanish-speaking Latinos with diabetes .


Quantitative and qualitative methods .


Community health centers in central and western Massachusetts .


Low-income Latinos ( N = 252 ) enrolled in a randomized diabetes self-management intervention trial .


Construct validity , internal consistency , sensitivity to change over time .


The LSESLD demonstrated good internal consistency ( Cronbach 's alpha = .85 ) , reasonable construct validity ( moderate , significant associations between the LSESLD and validated measures of diabetes knowledge , dietary intake , physical activity , blood glucose self-monitoring , and HbA1c values ) , and sensitivity to intervention-related changes over time .


The LSESLD is a reliable and valid research instrument assessing self-efficacy related to diabetes self-management among low-income , Spanish-speaking populations .


Febrile neutropenia ( FN ) is a frequent , serious complication of intensive pediatric chemotherapy regimens .


The aim of this trial was to compare quality of life ( QOL ) between inpatient and outpatient intravenous antibiotic management of children and adolescents with low risk febrile neutropenia ( LRFN ) .


In this randomised non-blinded trial , patients between 1 and 21 years old , receiving low/moderate intensity chemotherapy were pre-consented and , on presentation to emergency ( ED ) with FN satisfying low risk criteria , randomised to either outpatient or inpatient care with intravenous cefepime 50mg/kg ( 12 hourly ) .


All patients continued antibiotics for at least 48hours , until afebrile for 24hours and demonstrating a rising absolute neutrophil count 200/mm ( 3 ) .


Several domains of QOL were examined by daily questionnaire .


Eighty-one patients presented to ED with 159 episodes of fever .


Thirty-seven FN presentations involving 27 patients were randomised to inpatient ( 18 ) and outpatient ( 19 ) management .


Combined QOL mean scores for parents were higher for the outpatient group and scores for three specific parent variables ( keeping up with household tasks/time spent with partner/time spent with other children ) were higher among outpatients .


There was no difference in parent confidence/satisfaction in care between groups .


Patients scored better in the outpatient group overall and for sleep and appetite .


The mean length of fever was equivalent between groups and there were no serious adverse events attributable to cefepime or outpatient care .


Outpatient cefepime management of LRFN provided significant benefit to parents and patients across several QOL domains and appeared both feasible and safe .


To observe the effect of Liandouqingmai recipe ( Chinese herbal medicine compound preparation ) on the quality of life ( QOL ) and inflammatory reaction of patients with coronary heart disease ( CHD ) .


A total of 101 CHD patients were randomized into two groups : treatment group ( n = 45 ) receiving standard treatment for CHD plus Liandouqingmai recipe , and control group ( n = 56 ) receiving standard treatment only .


The control group contained 16 normal healthy subjects .


Changes in hs-C-reactive protein ( CRP ) , peripheral blood leucocytes ( PBL ) , and interleukin ( IL ) -6 and IL-10 levels were measured .


The Seattle Angina Questionnaire ( SAQ ) was used to determine patient QOL before and after treatment for 2 weeks .


Before treatment , SAQ scores [ physical limitation ( PL ) , angina stability ( AS ) , angina frequency ( AF ) , treatment satisfaction ( TS ) , and disease perception ( DP ) ] were not statistically different between groups .


After treatment , AS and DP levels of controls were significantly increased compared with the other groups , while PL , AS , AF , TS , and DP levels of the treatment group were significantly increased compared with controls .


Treatment group SAQ scores ( PL , AS , AF , TS , and DP ) were significantly higher than for controls .


CHD patient IL-6 and IL-10 levels were significantly higher than controls .


Before treatment , mean levels of IL-6 , hs-CRP and PBL of the two groups were not statistically different .


After treatment , mean levels of IL-6 , IL-10 , hs-CRP and PBL of the two groups were significantly decreased compared with their before treatment values , and levels of IL-6 , hs-CRP , and PBL of the treatment group were lower than controls .


Although mean IL-10 levels of both groups decreased , there was no significant difference in between-group and in-roup comparisons before and after treatment .


Mean levels of IL-6 and IL-10 in the normal group were lower than in CHD patients .


SAQ scores of QOL were negatively associated with the inflammatory index ( IL-6 / IL-10 ) , and there was a significant negative association of IL-10 with AS ( r = - 0.15 , P < 0.05 ) .


Inflammatory reactions in CHD patients are related to angina status .


Coadministration of CHD standard treatment and Liandouqingmai recipe increased patient SAQ scores by decreasing IL-6 , IL-10 , hs-CRP , and PBL levels in CHD patients , which might inhibit endothelial inflammation to improve patient QOL .


We investigated whether expression of epidermal growth factor receptor ( EGFR ) was associated with survival and disease control in this secondary analysis of a phase II trial of cetuximab + chemoradiation for stage III non-small cell lung cancer .


Patients received cetuximab weekly before and during radiation ( 63 Gy/35 fractions/7 weeks ) with weekly carboplatin + paclitaxel .


We analyzed EGFR expression by immunohistochemistry ( IHC ) and fluorescence in situ hybridization ( FISH ) in pretreatment biopsy specimens and compared findings with overall and progression-free survival ( OS , PFS ) and time to progression ( TTP ) .


Specimens for IHC and FISH were collected from 51 and 45 of 87 evaluable patients .


Pretreatment characteristics did not differ for patients with ( n = 51 ) or without ( n = 36 ) EGFR IHC data , or with ( n = 45 ) or without ( n = 42 ) FISH data .


However , patients without IHC data had worse OS ( HR = 1.63 , P = 0.05 ) , worse PFS ( HR = 1.88 , P = 0.008 ) , and worse TTP [ HR = 1.99 , P = 0.01 ] than those with IHC data .


EGFR protein expression was not related to pretreatment characteristics or OS ; FISH-positive disease was associated with better performance status but not with OS , PFS , or TTP .


Surprisingly , outcomes differed not by EGFR expression but by the availability of samples for analysis , underscoring the importance of obtaining biopsy samples in such trials .


To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes , peripheral neuropathy , and a history of similar prior ulceration .


Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape - and pressure-based orthoses ( experimental , n = 66 ) or standard-of-care A5513 orthoses ( control , n = 64 ) .


Patients were followed for 15 months , until a study end point ( forefoot plantar ulcer or nonulcerative plantar forefoot lesion ) or to study termination .


Proportional hazards regression was used for analysis .


There was a trend in the composite primary end point ( both ulcers and nonulcerative lesions ) across the full follow-up period ( P = 0.13 ) in favor of the experimental orthoses .


This trend was due to a marked difference in ulcer occurrence ( P = 0.007 ) but no difference in the rate of nonulcerative lesions ( P = 0.76 ) .


At 180 days , the ulcer prevention effect of the experimental orthoses was already significant ( P = 0.003 ) when compared with control , and the benefit of the experimental orthoses with respect to the composite end point was also significant ( P = 0.042 ) .


The hazard ratio was 3.4 ( 95 % CI 1.3-8 .7 ) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study .


We conclude that shape - and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses , but they did not significantly reduce nonulcerative lesions .


Inflammation and malnutrition are important features in patients with ESRD ; however , data on changes in these parameters over time are scarce .


This study aimed to gain insight into changes over time in serum albumin , body mass index , high-sensitivity C-reactive protein , and IL-6 in patients with ESRD and aimed to identify clinical risk factors for deterioration of these parameters .


Data were analyzed from the Convective Transport Study , a randomized controlled trial conducted from June 2004 to January 2011 , in which 714 patients with chronic ESRD were randomized to either online hemodiafiltration or low-flux hemodialysis .


Albumin and body mass index were measured up to 6 years and predialysis C-reactive protein and IL-6 were measured up to 3 years in a subset of 405 participants .


Rates of change in these parameters over time were estimated across strata of predefined risk factors with linear mixed-effects models .


Albumin and body mass index decreased and C-reactive protein and IL-6 increased over time .


For every incremental year of age at baseline , the yearly excess decline in albumin was 0.003 g/dl ( -0.004 to -0.002 ; P < 0.001 ) and the excess decline in body mass index was 0.02 kg/m ( 2 ) per year ( -0.02 to -0.01 ; P < 0.001 ) .


In patients with diabetes mellitus , there was a yearly excess decline of 0.05 g/dl in albumin ( -0.09 to -0.02 ; P = 0.002 ) .


Compared with women , men had an excess decline of 0.03 g/dl per year in albumin ( -0.06 to -0.001 ; P = 0.05 ) and an excess increase of 11.6 % per year in IL-6 ( 0.63 % -23.6 % ; P = 0.04 ) .


Despite guideline-based care , all inflammatory and nutritional parameters worsened over time .


The deterioration of some of these parameters was more pronounced in men , older patients , and patients with diabetes mellitus .


Special focus on the nutritional status of at-risk patients by individualizing medical care might improve their prognosis .


To investigate the efficacy and safety of domestic tiotropium inhalation capsule in patients with chronic obstructive pulmonary disease ( COPD ) with multi-center randomized clinical trial .


Patients with stable slight to moderate COPD were randomized into trial group ( n = 109 ) with tiotropium 18 pg Qd or control group ( n = 111 ) with ipratropium 40 g Qid for a treatment of four weeks .


The spirometry and scoring questionaire were recorded at different visits during the treatment .


Rescue medication consumption and adverse events were recorded .


Results Forced expiratory volume in 1 s ( FEV1 ) of both groups increased obviously 30 min and 3 h after first dosing .


After four weeks treatments , FEV , and forced vital capacity ( FVC ) in both groups were improved obviously , and the improvement in tiotropium group was significantly higher than that ipratropium group .


COPD symptom scores were significantly reduced in both groups , and the improvement in tiotropium group was significantly better than that in ipratropium group .


There was no significant difference in rescue medication consumption between the two groups .


The ratios of adverse events were 22.02 % and 15.32 % in tiotropium and ipratropium group , respectively ( P = 0.23 ) .


Domestic tiotropium inhalation capsule is efficient and safe in the treatment of COPD .


Telephone-delivered interventions to provide health counseling for complex chronic medical conditions are convenient , acceptable , and cost-effective .


However , little is known about which patients are reached , their characteristics , and who benefits most from telephone-delivered counseling .


This study examined whether baseline characteristics are predictive of being easily reached for a monthly , telephone-delivered behavioral intervention to improve treatment adherence in Veterans with uncontrolled hypertension .


Participants were to complete a telephone session once a month for 6 months .


Participants completed an average of 5.71 out of a possible 6 sessions .


Participants who were unmarried , African American , unemployed , or younger or did not complete high school required significantly more call attempts per completed session .


Overall , telephone-delivered counseling is a feasible approach to reaching hypertensive patients .


Patients who are married , Hispanic , retired , or older or graduated college may be easier to reach and engage in telephone-delivered counseling .


Reaching patients with other sociodemographic characteristics may require more resources or alternate methods .


Noninvasive mechanical ventilation during the postoperative period ( PO ) following lung resection can restore residual functional capacity , improve oxygenation and spare the inspiratory muscles .


The objective of this study was to assess the efficacy of continuous positive airway pressure ( CPAP ) associated with physiotherapy , compared with physiotherapy alone after lung resection .


Open randomized clinical trial conducted in the clinical hospital of Universidade Estadual de Campinas .


Sessions were held in the immediate postoperative period ( POi ) and on the first and second postoperative days ( PO1 and PO2 ) , and the patients were reassessed on the discharge day .


CPAP was applied for two hours and the pressure adjustment was set between 7 and 8.5 cmH2O .


The oxygenation index ( OI ) , Borg scale , pain scale and presence of thoracic drains and air losses were evaluated .


There was a significant increase in the OI in the CPAP group in the POi compared to the Chest Physiotherapy ( CP ) group , P = 0.024 .


In the CP group the OI was significantly lower on PO1 ( P = 0,042 ) , than CPAP group .


The air losses were significantly greater in the CPAP group in the POi and on PO1 ( P = 0.001 , P = 0.028 ) , but there was no significant difference between the groups on PO2 and PO3 .


There was a statistically significant difference between the groups regarding the Borg scale in the POi ( P < 0.001 ) , but there were no statistically significant differences between the groups regarding the pain score .


CPAP after lung resection is safe and improves oxygenation , without increasing the air losses through the drains .


NCT01285648 .


The aim of this study was to investigate the effect of acute L-carnitine supplementation at two different doses on nitric oxide ( NO ) production and oxidative stress after exhaustive exercise .


The subjects were 26 healthy males aged 17-19 years .


Subjects were randomly divided into two groups of 13 each and received 3 or 4 g L-carnitine via a glass of fruit juice .


After 1 h , the treadmill test was started at a speed of 8 km/h , afterwards increasing the speed 1 km/h every 3 min with a 1 min rest before every speed increase until exhaustion .


Venous blood samples were collected again within 5 min following the exercise test .


One week later , the test was repeated on the same athletes with placebo fluids .


All subjects received a placebo via a glass of fruit juice .


1 h after the same exercise protocol mentioned above was performed and blood samples were drawn immediately .


These plasma samples were used for measurement of nitrate-nitrite ( NOx ) , which are known to be the stable end products of NO , TBARs as a lipid peroxidation indicator and an antioxidant glutathione ( GSH ) levels .


The results of this study have shown that L-carnitine applied at a 3 g dose provides strong antioxidant action by increasing the GSH and NOx level and decreasing the TBARs level .


Treatment of patients with single-segment degenerative lumbar instability using unilateral pedicle screw fixation can achieve stability and fusion rates similar to those of bilateral pedicle screw fixation .


The aim of this study was to analyze the clinical outcome of using unilateral pedicle screw fixation through a tubular retractor via the Wiltse approach to treat single-segment degenerative lumbar instability .


Thirty-nine consecutive patients with single-segment , low-grade , degenerative lumbar instability were randomly assigned to treatment with either unilateral ( n = 20 ) or bilateral ( n = 19 ) pedicle screw fixation .


In the unilateral group , patients underwent unilateral posterior lumbar interbody fusion ( PLIF ) and ipsilateral pedicle screw fixation through a tubular retractor via the Wiltse approach .


In the bilateral group , patients underwent modified bilateral PLIF with bilateral pedicle screw fixation via the posterior midline approach .


During follow-up , patients were evaluated using a visual analog scale ( VAS ) , the Japanese Orthopaedic Association ( JOA ) score , and the Oswestry Disability Index .


The unilateral group had a shorter operative duration ( p < 0.05 ) and less blood loss ( p < 0.001 ) .


All patients completed more than 2 years of follow-up ( mean 36 months ) .


In general , the time trends in improvement on the VAS and JOA differed slightly between the groups through 2 years , but no significant difference in back pain VAS score or leg pain VAS score was found between these 2 groups at the 2-year follow-up .


Complete bone fusion was shown on CT in all patients at the 2-year follow-up .


Unilateral pedicle screw fixation through a tubular retractor via the Wiltse approach appears to be as safe and effective as bilateral pedicle screw fixation for the treatment of single-segment degenerative lumbar instability .


To study the effects of both balneotherapy and mud-bath therapy treatments in patients affected by primary fibromyalgia ( FM ) using rheumatological , psychiatric , biochemical and proteomic approaches .


Forty-one FM patients ( 39 females , 2 males ) , who fulfilled the American College of Rheumatology criteria received a 2-week thermal therapy programme consisting of therapy once daily for 6 days/week .


Twenty-one patients received mud-bath treatment , while the other twenty balneotherapy .


Pain , symptoms , and quality of life were assessed .


Oxytocin , brain-derived neurotrophic factor ( BDNF ) , ATP and serotonin transporter levels during therapy were assayed .


Comparative whole saliva ( WS ) proteomic analysis was performed using a combination of two-dimensional electrophoresis ( 2DE ) and mass spectrometry techniques .


We observed a reduction in pain , FIQ values and improvement of SF36 in both groups of patients treated with mud-bath or balneotherapy .


The improvement of the outcome measures occurred with different timing and duration in the two spa treatments .


A significant decrease in BDNF concentrations was observed either after balneotherapy or mud-bath therapy when assayed after twelve weeks , while no significant change in oxytocin levels , ATP levels and serotonin transporter were detected .


Significant differences were observed for phosphoglycerate mutase1 ( PGAM1 ) and zinc alpha-2-glycoprotein 1 ( AZGP1 ) protein expression .


Our results showed that the thermal treatment might have a beneficial effect on the specific symptoms of the disease .


In particular , while balneotherapy gives results that in most patients occur after the end of the treatment but which are no longer noticeable after 3 months , the mud-bath treatment gives longer lasting results .


Success rate of catheter applications is low in supraclavicular block .


Thus , bupivacaine and levobupivacaine become important with their long effect time in single injection practices .


In this study , we aimed to compare the effectiveness , side effects and complications of bupivacaine and levobupivacaine in supraclavicular block .


Sixty patients aged between 20 and 65 , with body weight between 50 and 100 kg , in the ASA I-II-III group who were scheduled for hand , forearm and arm surgery using supraclavicular block were randomized into two groups of 30 .


The patients received 30 ml 0.5 % bupivacaine ( Group B ) or 30 ml 0.5 % levobupivacaine ( Group L ) .


Motor and sensory blocks were evaluated .


Motor and sensory block onset times , total block durations , postoperative pain , amount of postoperative analgesic used and patient satisfaction were recorded .


Demographic data , distribution of surgical area and hemodynamic data were similar between the two groups .


Surgery , motor and sensory block durations of Group B and L patients did not vary statistically significantly .


However , motor and sensory block onset times in Group B were significantly shorter than Group L ( p < 0.05 ) .


The mean time for first postoperative analgesic demand were 16.6 8.0 h in Group B and 14.4 7.3 h in Group L ( p > 0.05 ) .


30 ml 0.5 % bupivacaine and levobupivacaine provide similar block characteristics for supraclavicular block .


Bupivacaine leads to faster motor and sensory block onset compared to levobupivacaine however similar duration of postoperative analgesia .


Patients with muscle-invasive urothelial carcinoma of the bladder have poor survival after cystectomy .


The EORTC 30994 trial aimed to compare immediate versus deferred cisplatin-based combination chemotherapy after radical cystectomy in patients with pT3-pT4 or N + M0 urothelial carcinoma of the bladder .


This intergroup , open-label , randomised , phase 3 trial recruited patients from hospitals across Europe and Canada .


Eligible patients had histologically proven urothelial carcinoma of the bladder , pT3-pT4 disease or node positive ( pN1-3 ) M0 disease after radical cystectomy and bilateral lymphadenectomy , with no evidence of any microscopic residual disease .


Within 90 days of cystectomy , patients were centrally randomly assigned ( 1:1 ) by minimisation to either immediate adjuvant chemotherapy ( four cycles of gemcitabine plus cisplatin , high-dose methotrexate , vinblastine , doxorubicin , and cisplatin [ high-dose MVAC ] , or MVAC ) or six cycles of deferred chemotherapy at relapse , with stratification for institution , pT category , and lymph node status according to the number of nodes dissected .


Neither patients nor investigators were masked .


Overall survival was the primary endpoint ; all analyses were by intention to treat .


The trial was closed after recruitment of 284 of the planned 660 patients .


This trial is registered with ClinicalTrials.gov , number NCT00028756 .


From April 29 , 2002 , to Aug 14 , 2008 , 284 patients were randomly assigned ( 141 to immediate treatment and 143 to deferred treatment ) , and followed up until the data cutoff of Aug 21 , 2013 .


After a median follow-up of 7.0 years ( IQR 5.2-8 .7 ) , 66 ( 47 % ) of 141 patients in the immediate treatment group had died compared with 82 ( 57 % ) of 143 in the deferred treatment group .


No significant improvement in overall survival was noted with immediate treatment when compared with deferred treatment ( adjusted HR 0.78 , 95 % CI 0.56-1 .08 ; p = 0.13 ) .


Immediate treatment significantly prolonged progression-free survival compared with deferred treatment ( HR 0.54 , 95 % CI 0.4-0 .73 , p < 0.0001 ) , with 5-year progression-free survival of 47.6 % ( 95 % CI 38.8-55 .9 ) in the immediate treatment group and 31.8 % ( 24.2-39 .6 ) in the deferred treatment group .


Grade 3-4 myelosuppression was reported in 33 ( 26 % ) of 128 patients who received treatment in the immediate chemotherapy group versus 24 ( 35 % ) of 68 patients who received treatment in the deferred chemotherapy group , neutropenia occurred in 49 ( 38 % ) versus 36 ( 53 % ) patients , respectively , and thrombocytopenia in 36 ( 28 % ) versus 26 ( 38 % ) .


Two patients died due to toxicity , one in each group .


Our data did not show a significant improvement in overall survival with immediate versus deferred chemotherapy after radical cystectomy and bilateral lymphadenectomy for patients with muscle-invasive urothelial carcinoma .


However , the trial is limited in power , and it is possible that some subgroups of patients might still benefit from immediate chemotherapy .


An updated individual patient data meta-analysis and biomarker research are needed to further elucidate the potential for survival benefit in subgroups of patients .


Lilly , Canadian Cancer Society Research .


Continuous-flow left ventricular assist device ( CF-LVAD ) implantation is associated with improved quality of life , but the effect on exercise capacity is less well documented .


It is uncertain whether a fixed CF-LVAD pump speed , which allows for sufficient circulatory support at rest , remains adequate during exercise .


The aim of this study was to evaluate the effects of fixed versus incremental pump speed on peak oxygen uptake ( peak VO2 ) during a maximal exercise test .


In CF-LVAD ( HeartMate II ) patients exercise testing measuring peak oxygen uptake ( VO2 ) was performed on an ergometer bike twice in one day : once with fixed pump speed ( testfix ) and once with incremental pump speed ( testinc ) .


The order of testfix and testinc in each patient was determined by randomization .


During testinc pump speed was increased from the baseline value by 400rpm/2min .


Fourteen patients ( aged 2369years ) were included with a mean support duration of 465483days .


Baseline CF-LVAD speed was 9357238rpm and during testinc speed was increased by a mean of 1486775rpm .


Mean peak VO2 was significantly higher in testinc compared with testfix ( 15.45.9 mL/kg/min vs. 14.16.3 mL/kg/min ; P = 0.012 ) , corresponding to a 9.2 % increase .


All exercise tests ( n = 28 ) were adequately performed with RER > 1 .


Increasing pump speed during exercise augments peak VO2 in patients supported with CF-LVADs .


An automatic speed-change function in future generations of CF-LVADs might improve functional capacity .


The results of previous studies suggest that early goal-directed fluid therapy ( EGDT ) reduces delayed cerebral ischemia ( DCI ) after aneurysmal subarachnoid hemorrhage , but the effects of EGDT on clinical outcomes are still unclear .


This study aimed to determine whether EGDT improves outcomes compared with standard less-invasive hemodynamic therapy .


This study included 160 patients treated within 24 hours after subarachnoid hemorrhage , randomized to receive either ( 1 ) EGDT guided by preload volume and cardiac output monitored by transpulmonary thermodilution ( treatment group ) or ( 2 ) standard therapy guided by fluid balance or central venous pressure , assisted by uncalibrated less-invasive cardiac output monitoring during hyperdynamic therapy in patients with clinical or radiological indications of DCI ( control group ) .


DCI determined by clinical or radiological findings and functional outcome determined by the modified Rankin Scale score at 3 months were compared between groups .


For all clinical grades combined , there were no significant differences in the rates of DCI ( 33 % versus 42 % ; P = 0.33 ) or modified Rankin Scale score of 0 to 3 at 3 months ( 67 % versus 57 % ; P = 0.22 ) between the 2 groups .


For patients with poor clinical grade , those who received EGDT had a significantly lower rate of DCI ( 5 % versus 14 % ; P = 0.036 ) , modified Rankin Scale score of 0 to 3 at 3 months ( 52 % versus 36 % ; P = 0.026 ) , and shorter length of intensive care unit stay ( 14 versus 17 days ; P = 0.043 ) than those who received standard therapy .


EGDT is beneficial for reducing DCI and improving postoperative functional outcome in patients with poor clinical grade .


http://www.clinicaltrials.gov .


Unique identifier : UMIN000007509 .


Higher low-density lipoprotein cholesterol is associated with more rapid chronic kidney disease progression ; reduction in cholesterol with statins , in conjunction with statins ' pleiotropic effects , such as decreasing inflammation , may be renoprotective .


The Stroke Prevention by Aggressive Reduction in Cholesterol Levels ( SPARCL ) trial assessed the effect of statin treatment on the risk of nonfatal and fatal stroke in subjects with a noncardioembolic stroke or transient ischemic attack , no known coronary heart disease , and low-density lipoprotein cholesterol between 2.6 and 4.9 mmol/L ( 100-190 mg/dL ) .


We explored the effect of randomization to atorvastatin 80 mg/d or placebo on the change in estimated glomerular filtration rate ( eGFR ; using the 4-component Modification of Diet in Renal Disease Study equation ) in SPARCL subjects ( n = 4731 ) with ( eGFR , < 60 mL/min per 1.73 m2 ; n = 3119 ) and without ( eGFR , 60 mL/min per 1.73 m2 ; n = 1600 ) chronic kidney disease overall and by glycemic status at baseline .


Mean baseline eGFR was similar between treatment groups ( 65.50.26 versus 65.60.26 mL/min per 1.73 m2 atorvastatin versus placebo ; 33 % versus 34 % had chronic kidney disease , respectively ; P = 0.55 ) .


After 60 months , eGFR increased 3.460.33 mL/min per 1.73 m2 in those randomized to atorvastatin versus 1.420.34 mL/min per 1.73 m2 in those randomized to placebo ( P < 0.001 ) independent of baseline renal function .


In the subgroup with diabetes mellitus at randomization , eGFR increased 1.120.92 mL/min per 1.73 m2 in the atorvastatin group and decreased 1.690.92 mL/min per 1.73 m2 in placebo group during a period of 60 months ( P = 0.016 ) .


This post hoc analysis suggests that atorvastatin treatment may improve renal function in patients with prior stroke or transient ischemic attack with and without chronic kidney disease , and that atorvastatin treatment may prevent eGFR decline in patients with stroke and diabetes mellitus .


Unique identifier : NCT00147602 .


Fluralaner , a novel isoxazoline , has both acaricidal and insecticidal activity through potent blockage of GABA - and L-glutamate-gated chloride channels .


This study investigated the in vitro and in vivo effects of fluralaner exposure on flea ( Ctenocephalides felis ) reproduction .


Blood spiked with sub-insecticidal fluralaner concentrations ( between 0.09 and 50.0 ng/mL ) was fed to fleas for 10 days using a membrane system .


Cessation of reproduction in exposed fleas was assessed using flea survival , egg hatchability , and control of oviposition , pupae , and flea emergence .


Fluralaner efficacy for in vivo Ctenocephalides ( C. ) felis control on dogs was assessed using a simulated flea-infested home environment .


During a pre-treatment period , dogs were infested twice on days -28 and -21 with 100 adult unfed fleas to establish a thriving population by day 0 of the study .


On day 0 , one group of dogs was treated with fluralaner ( Bravecto ; n = 10 ) , while another group served as negative control ( n = 10 ) .


Following treatment , dogs were infested three times with 50 fleas on days 22 , 50 and 78 to simulate new infestations .


Live flea counts were conducted weekly on all dogs for 12 weeks starting 1 day before treatment .


Fluralaner potently inhibited flea reproduction capacity in vitro .


Oviposition ceased completely at concentrations as low as 25.0 ng/mL .