Compared with the high-dose PEG group , the low-dose PEG group had an increased need for therapy adjustment of borderline significance ( relative risk @ , @ % confidence interval @-@ @ ) , an increased risk of painful defecation , a lower number of stools per week , and lower parental satisfaction .


Adverse events were similar in both groups .


To achieve treatment success , both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation .


We sought to assess the prognostic role of collaterals in a large population of patients presenting with an acute coronary syndrome ( ACS ) .


The coronary collateral circulation was assessed by an independent angiographic core laboratory using the Rentrop Score in patients enrolled in the randomised Acute Catheterization and Urgent Intervention Triage Strategy trial .


The cohort comprised @ patients with moderate to high risk ACS .


A total of @ patients ( @ % ) had visible collaterals while @ patients ( @ % ) had no collaterals .


After multivariable adjustment , there were no differences in clinical outcomes at @ year between the groups , including major adverse cardiac events ( MACE ) ( HR @ ( @ % CI @ to @ ) , p = @ ) , mortality ( HR @ ( @ to @ ) , p = @ ) , myocardial infarction ( MI ) ( HR @ ( @ to @ ) , p = @ ) and unplanned target vessel revascularisation ( TVR ) ( HR @ ( @ to @ ) , p = @ ) .


Similarly , in the subgroup of patients undergoing percutaneous coronary intervention ( PCI ) , the adjusted HR for major adverse cardiac events was @ ( @ to @ ) , p = @ ; @ ( @ to @ ) , p = @ for mortality ; and @ ( @ to @ ) , p = @ for MI .


The risk of unplanned TVR was increased ( HR @ ( @ to @ ) , p = @ ) .


In contrast to other studies , this large core laboratory-based analysis does not confirm a beneficial role of visible coronary collateral vessels on clinical outcomes in patients with ACS ; the presence of collaterals was even associated with increased mortality in the unadjusted analysis .


Collaterals were associated with a higher risk of TVR in patients undergoing PCI , a finding that may not have been fully corrected given confounders and clinical differences between the groups .


The goal of this work was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of calcaneodynia .


Between February @ and February @ , @ evaluable patients were recruited for this prospective trial .


All patients received orthovoltage radiotherapy .


One course consisted of @ fractions/@ weeks .


In case of insufficient remission of pain after @ weeks a second series was performed .


Patients were randomly assigned to receive either single doses of @ or @ Gy .


Endpoint was pain reduction .


Pain was measured before , right after ( early response ) , @ weeks ( delayed response ) , and approximately @ years after radiotherapy ( long-term response ) with a questionnaire-based visual analogue scale ( VAS ) and a comprehensive pain score ( CPS ) .


The median follow-up was @ months ( range @-@ months ) .


The overall early , delayed , and long-term response rates for all patients were @ , @ , and @ % .


The mean VAS values before treatment , for early , delayed , and long-term response for the @ and @ Gy groups were @ and @ ( p = @ ) , @ and @ ( p = @ ) , @ and @ ( p = @ ) , and @ and @ ( p = @ ) .


The mean CPS values before treatment , for early , delayed , and log-term response were @ and @ ( p = @ ) , @ and @ ( p = @ ) , @ and @ ( p = @ ) , and @ and @ ( p = @ ) , respectively .


No significant differences in long-term response quality between the two arms were found ( p = @ ) .


Radiotherapy is a very effective treatment for the management of benign calcaneodynia .


For radiation protection reasons , the dose for a RT series should not exceed @ Gy .


In the present study , we applied two incisionless suture techniques for otoplasty : Haytoglu et al. 's modification of incisionless otoplasty technique and Fritsch 's incisionless otoplasty technique for correction of prominent ears .


In this prospective study , @ patients with prominent ears were included in the study .


In Group @ , @ ears of @ patients ( @ bilateral and @ unilateral ) were operated with Haytoglu et al. 's modification of incisionless otoplasty technique .


In Group @ , @ ears of @ patients ( @ bilateral and @ unilateral ) were operated with Fritsch 's incisionless otoplasty technique .


For comparison of two methods , auriculocephalic distances were measured at three levels which were level @ ( the most superior point of the auricle ) , level @ ( the midpoint of the auricle ) and level @ ( level of the lobule ) pre-operatively ( preop ) ; and measurements were repeated at the end of the surgery ( PO ( @-day ) ) , @st month ( PO ( @-Mo ) ) and @th month ( PO ( @-Mo ) ) after the surgery , in both groups .


Patient satisfaction was evaluated using a visual analog scale ( VAS ) .


Moreover , Global Aesthetic Improvement Scale ( GAIS ) was rated by an independent , non-participating plastic surgeon at @ months after the surgery .


Operation time was @ min in Group @ ( Haytoglu et al. 's ) and @ min in Group @ ( Fritsch ) .


Hematoma , infection , bleeding , keloid scar formation , sharp edges or irregularities of the cartilage were not observed in any group .


Suture extrusion was detected in @ % of Group @ and @ % of Group @ .


No statistically significant difference was observed between auriculocephalic distances at levels @-@ of groups at preop , PO ( @-day ) , PO ( @-Mo ) and PO ( @-Mo ) separately .


Similarly , difference in auriculocephalic distances ( preop values-PO ( @-Mo ) values ) was not detected as statistically significant in Groups @ and @ at three levels .


In both techniques , No statistically significant difference was observed in patient satisfaction at @th months after the operation which was measured using Visual Analogue Scale ( VAS ) on @ to @ scales .


According to GAIS , the patients were rated as @ % `` improved '' and @ % `` no change '' in Group @ ; as @ % `` improved '' and @ % `` no change '' in Group @ .


Due to the similar results , Haytoglu et al. 's and Fritsch 's incisionless otoplasty techniques are good options in the treatment of prominent ears , especially in pediatric patients with isolated inadequate development of antihelical ridge , and with soft auricular cartilage .


Determine if oral treatment with a vasoconstrictor decreases the blood to middle ear exchange rate of the perfusion-limited gas , nitrous oxide ( N@O ) .


Randomized , double-blind , crossover study .


Ten adult subjects with and @ without past middle ear disease completed paired experimental sessions , identical except for oral treatment with either pseudoephedrine hydrochloride or lactose placebo .


At each session , subjects were fitted with a nonrebreathing mask and breathed room air for @ minutes ( acclimation period ) , @ % N@O :@ % O@ for @ minutes ( experimental period ) , and @ % O@ for @ minutes ( recovery period ) .


Throughout , heart rate , blood pressure , and O@ saturation were monitored , and bilateral middle ear pressures were recorded by tympanometry every minute .


The primary outcome was the slope of the middle ear pressure-time function for the experimental period , which estimates the volume N@O exchange rate .


Using repeated measures analysis of variance , the effects of group ( disease history ) , treatment ( active vs. placebo ) , and period ( @ vs. @ ) on the recorded vital signs , and of group , treatment , and ear ( left/right ) on the middle ear pressure-time slope were evaluated for statistical significance .


Statistically significant effects of period on O@ saturation ( period @ > period @ ) and of treatment on heart rate ( active > placebo ) were documented .


Only treatment was statistically significant for the middle ear pressure-time slope , with a shallower slope characterizing the active treatment session .


The volume exchange rate across the middle ear mucosa of perfusion-limited gases can be modulated pharmacologically .


Theoretically , similar drugs can be used to reduce the requisite eustachian tube opening efficiency for adequate middle ear pressure regulation .


Pain attitudes and beliefs are hypothesized to influence pain and adjustment to pain .


Valid and reliable measures of these beliefs are necessary to test their hypothesized associations with outcomes .


The Pediatric version of the Survey of Pain Attitudes ( Peds-SOPA ) is a new measure with limited evidence regarding its psychometric properties .


This study sought to : @ ) evaluate the predictive validity , reliability , and factor structure of the Peds-SOPA ; and @ ) determine if there are sex - or age-related differences in children 's attitudes toward pain .


Longitudinal study .


Five hundred and sixty-one schoolchildren between @ and @ years old participated in this study .


Factor analyses supported the seven-factor structure described by the original authors .


The Peds-SOPA showed acceptable reliability with Cronbach alpha values ranging from @ to @ .


The Peds-SOPA scales also demonstrated prospective predictive validity via their associations with pain intensity , and pain status at @-year follow-up .


The findings also showed some few sex - and age-specific differences in the Peds-SOPA scores .


The current findings provide additional support for the reliability and validity of the Peds-SOPA , and suggest that children 's pain attitudes and beliefs might be important intervention targets in pain treatment .


This is the third study in a Phase @ program evaluating onabotulinumtoxinA treatment of crow 's feet lines ( CFL ) .


To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines ( GL ) in subjects with moderate-to-severe CFL and GL ( maximum smile ) .


This @-month extension of a @-month study randomized subjects who originally received onabotulinumtoxinA @ U ( CFL only ; n = @ ) or @ U ( @ U for CFL + @ U for GL ; n = @ ) to retreatment with the same dose .


Placebo-treated subjects were rerandomized to onabotulinumtoxinA @ U ( n = @ ) or placebo ( n = @ ) .


Primary efficacy end point ( Day @ ) was the proportion of subjects who achieved a CFL severity rating of none or mild ( maximum smile ) on the investigator-assessed Facial Wrinkle Scale ( FWS ) .


Additional efficacy end points and adverse events were evaluated .


Responder rates ( primary end point ) were significantly greater in onabotulinumtoxinA-treated groups ( @ U : @ % ; @ U : @ % ; placebo : @ % ; p < @ ) .


Improvements on most patient-reported outcomes ( PROs ) favored the @-U group over the @-U group .


Adverse events did not differ among groups ; most were mild or moderate .


Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs .


Adverse event profiles remain consistent with approved GL labeling .


Few randomized clinical trials have investigated antiretroviral regimens in very advanced HIV-@-infected patients .


The objective was to study the immune reconstitution in very immunosuppressed antiretroviral-naive , HIV-@-infected individuals by comparing an efavirenz-based regimen with @ ritonavir-boosted protease inhibitor regimens .


Randomized , controlled , open-label , multicenter clinical trial .


Eighty-nine HIV-@-infected antiretroviral-naive patients with < @ CD@ cells per cubic millimeter were randomly assigned in a @:@:@ ratio to efavirenz ( n = @ ) , atazanavir/ritonavir ( n = @ ) , or lopinavir/ritonavir ( n = @ ) combined with tenofovir plus emtricitabine .


The primary outcome was median increase in CD@ cell count at week @ .


Secondary end points were the proportion of patients with HIV-@ RNA < @ copies per milliliter , adverse events , disease progression , and death .


In the on-treatment analysis , the median ( interquartile range ) increase in the CD@ count after @ weeks was +@ ( @-@ ) cells per microliter in the efavirenz arm , +@ ( @-@ ) cells per microliter in the ritonavir-boosted atazanavir arm , and +@ ( @-@ ) cells per microliter in the ritonavir-boosted lopinavir arm ( P = @ ) .


The percentage of patients achieving viral suppression was similar in all @ treatment arms at @ weeks -LCB- efavirenz , @ % -LSB- @ % confidence interval ( CI ) : @ to @ -RSB- ; atazanavir , @ % -LSB- @ % CI : @ to @ -RSB- ; and lopinavir , @ % -LSB- @ % CI : @ to @ -RSB- ; P = @ -RCB- .


Bacterial translocation , inflammation , immune activation , and apoptotic markers , but not D-dimer , declined significantly and similarly in the @ treatment arms .


Adverse events had a similar incidence in all @ antiretroviral regimens .


No patients died .


The immune reconstitution induced by an efavirenz-based regimen in very advanced HIV-@-infected patients was similar to that induced by a ritonavir-boosted protease inhibitor-based regimen ( ClinicalTrials.gov registration number : NCT@ ) .


There is a major unmet need for effective treatments in patients with squamous cell carcinoma of the lung .


LUX-Lung @ compared afatinib ( an irreversible ErbB family blocker ) with erlotinib ( a reversible EGFR tyrosine kinase inhibitor ) , as second-line treatment for patients with advanced squamous cell carcinoma of the lung .


We did this open-label , phase @ randomised controlled trial at @ cancer centres in @ countries worldwide .


We enrolled adults with stage IIIB or IV squamous cell carcinoma of the lung who had progressed after at least four cycles of platinum-based-chemotherapy .


Participants were randomly assigned ( @:@ ) to receive afatinib ( @ mg per day ) or erlotinib ( @ mg per day ) until disease progression .


The randomisation was done centrally with an interactive voice or web-based response system and stratified by ethnic origin ( eastern Asian vs non-eastern Asian ) .


Clinicians and patients were not masked to treatment allocation .


The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) .


The key secondary endpoint was overall survival .


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


@ eligible patients were randomly assigned ( @ to afatinib , @ to erlotinib ) .


Median follow-up at the time of the primary analysis of progression-free survival was @ months ( IQR @-@ ) , at which point enrolment was not complete .


Progression free-survival at the primary analysis was significantly longer with afatinib than with erlotinib ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- , p = @ ) .


At the time of the primary analysis of overall survival ( median follow-up @ months -LSB- IQR @-@ -RSB- ) , overall survival was significantly greater in the afatinib group than in the erloinib group ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; HR @ -LSB- @ % CI @-@ -RSB- , p = @ ) , as were progression-free survival ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; HR @ -LSB- @ % CI @-@ -RSB- , p = @ ) and disease control ( @ -LSB- @ % -RSB- of @ patients vs @ -LSB- @ % -RSB- of @ ; p = @ ) .


The proportion of patients with an objective response did not differ significantly between groups ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; p = @ ) .


Tumour shrinkage occurred in @ ( @ % ) of @ patients versus @ ( @ % ) of @ patients .


Adverse event profiles were similar in each group : @ ( @ % ) of @ patients in the afatinib group versus @ ( @ % ) of @ in the erlotinib group had grade @ or higher adverse events .


We recorded higher incidences of treatment-related grade @ diarrhoea with afatinib ( @ -LSB- @ % -RSB- vs nine -LSB- @ % -RSB- ) , of grade @ stomatitis with afatinib ( @ -LSB- @ % -RSB- vs none ) , and of grade @ rash or acne with erlotinib ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


The significant improvements in progression-free survival and overall survival with afatinib compared with erlotinib , along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung .


Physicians adopt evidence-based guidelines with variable consistency .


Narratives , or stories , offer a novel dissemination strategy for clinical recommendations .


The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians ( ACEP ) .


This was a prospective , randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline .


The experiment was modeled after the free-recall test , an established technique in studies of memory .


At a regional conference , emergency physicians ( EPs ) were randomized to read either a summary of the guideline ( control ) or a narrative ( intervention ) .


The fictional narrative was constructed to match the summary in content and length .


One hour after reading the text , participants listed all content that they could recall .


Two reviewers independently scored the responses to assess recall of the six themes .


The primary outcome was the total number of themes recalled per participant .


Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information .


Ninety-five physicians were randomized .


Eighty-two physicians completed the experiment , for a response rate of @ % .


The mean of the total number of themes recalled per participant was @ in the narrative arm versus @ in the summary arm ( difference = @ , @ % confidence interval -LSB- CI -RSB- = @ to @ ) .


For three themes , the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm , with the differences ranging from @ % to @ % .


For one theme , recall was significantly greater in the summary arm .


For two themes , there was no statistically significant difference in recall between the arms .


In the summary arm , @ % of responses were found to contain falsely recalled or extraneous information versus @ % of responses in the narrative arm ( difference = @ % , @ % CI = @ % to @ % ) .


Physicians exposed to a narrative about opioid guidelines were more likely to recall guideline content at @ hour than those exposed to a summary of the guidelines .


Future studies should examine whether the incorporation of narratives in dissemination campaigns improves guideline adoption and changes clinical practice


Paullinia cupana ( guaran ) is an Amazonian plant that has been previously shown to be effective in treating chemotherapy-related fatigue ( CRF ) in patients with breast cancer .


We aimed to evaluate the efficacy of a purified dry extract of P. cupana ( PC-@ ) in patients with various solid tumors treated with chemotherapy .


We included @ patients with solid tumors who showed increases in their Brief Fatigue Inventory ( BFI ) questionnaire scores after @ week of systemic chemotherapy .


PC-@ was administered at @ mg by mouth two times per day ( PO bid ) , starting after @ week of chemotherapy , for @ weeks ( induction phase ) .


Patients who had an improvement in or stabilization of their BFI scores were randomized to receive either PC-@ at the same dose or placebo for the following @ weeks ( maintenance phase ) .


After PC-@ treatment , the BFI fatigue scores improved or stabilized in @ out of the @ patients ( mean BFI score difference = @ ; @ % confidence interval : @-@ @ , p = @ ) .


Three weeks after randomization ( @ patients on PC-@ and @ on placebo ) , we observed no significant differences in the BFI , Functional Assessment of Chronic Illness Therapy , Hospital Anxiety and Depression Scale , and Pittsburgh Sleep Quality Index scores between patients randomized to PC-@ versus placebo .


We conclude that the PC-@ extract may be effective for the treatment of CRF in patients with a variety of solid tumors .


A conditioning effect , which was observed in patients who had a beneficial effect of PC-@ on CRF , may explain the better than expected fatigue scores of the placebo-treated patients .


A single session of left prefrontal rTMS has been shown to have analgesic effects , and to reduce post-operative morphine use .


We sought to test these findings in a larger sample , and try and see if multiple sessions had additive analgesic benefit .


@ patients undergoing laparoscopic gastric bypass surgery received two sessions of @ Hz rTMS ( @ % of motor threshold ) over the left dorsolateral prefrontal cortex ( one immediately following surgery and one @ h later ) .


Participants were randomly assigned to receive @ sessions of real rTMS , @ sessions of sham , @ real then @ sham , or @ sham then @ real rTMS treatments .


Patients and study staff were blind to rTMS conditions .


Unlike previous rTMS trials for post-operative pain , no differences emerged between groups with respect to total patient-controlled analgesia usage ( IV hydromorphone ) .


However , despite no difference in IV analgesic usage , subjects that received @ real rTMS sessions rated both the affective and sensory dimensions of their pain significantly lower than those in the shamsham group at several time points during the post-surgical/post-rTMS period .


This study suggests that left prefrontal rTMS may produce significant analgesic effects in the perioperative setting .


However , further work is needed to understand this effect and attempt to make it clinically useful in light of the lack of effect on PCA hydromorphone use .


Increasing physical activity is an important public-health goal worldwide , but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases .


This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with @ men in Eastern Cape Province , South Africa .


Twenty-two matched-pairs of neighborhoods were randomly selected .


Within pairs , neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline , immediate-post , and @ - and @-month post-intervention assessments .


Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome , self-reported physical activity averaged over the @ - and @-month post-intervention assessments , using a product-of-coefficients approach in a generalized-estimating-equations framework .


Data were collected in @-@ .


Attitude , subjective norm , self-efficacy , and intention were significant mediators of intervention-induced increases in self-reported physical activity .


The descriptive norm , not affected by the intervention , was not a mediator , but predicted increased self-reported physical activity .


The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men .


To observe the intervention effect of nourishing Xin and Shen method ( NXSM ) on the cognitive function of mild cognitive impairment due to subcortical small vessel disease ( MCI-SSVD ) .


All @ MCI-SSVD patients came from Department of Traditional Chinese Medicine , Affiliated Union Hospital of Fujian Medical University from June @ to August @ .


They were randomly assigned to the treatment group ( @ cases ) and the control group ( @ cases ) .


Another @ volunteers were recruited as a healthy control group .


On the basis of targeting risk factors of blood vessels , MCI-SSVD patients were treated respectively with NXSM and donepezil hydrochloride , with the therapeutic course of @ weeks .


Neuropsychological scales -LSB- mini-mental state examination ( MMSE ) and Montreal cognitive assessment ( MoCA ) -RSB- , and Chinese medical dementia syndrome scales were performed in all subjects , and results were compared among groups or intra-group before and after treatment .


MMSE and MoCA scores of the two treatment groups decreased more , when compared with those of the healthy control group ( P < @ ) .


In particular , MoCA score was significantly decreased ( P < @ ) .


MMSE and MoCA scores of the two treatment groups increased more after treatment than before treatment ( P < @ ) .


But there was no statistical difference in MMSE or MOCA score after treatment between the two groups ( P > @ ) .


Chinese medical dementia syndrome scales decreased more significantly in the treatment group , when compared with before treatment ( P < @ ) .


But there was no statistical difference in Chinese medical dementia syndrome scales in the control group between before and after treatment ( P > @ ) .


Visual spatial and executive function scores or delayed recall scores of the two treatment groups increased more , when compared with the same group before treatment ( P < @ , P < @ ) .


NXSM could effectively improve cognitive functions of MCI-SSVD .


To optimize the therapeutic programs for periarthritis of shoulder treated with acupuncture , moxibustion and kinetohterapy with orthogonal design method adopted .


The orthogonal design table of L@ ( @ ( @ ) ) hierarchical principle was used to randomly divide @ patients of periarthritis of shoulder into @ groups , @ cases in each one .


Separately , @ factors and each different @ levels were adopted in treatment , named acupuncture timing ( factor A : A , acute stage , A@ adhesion stage ) , acupoint combination ( factor B : B , local acupoints , B@ local acupoints and distal acupoints along meridians ) , filiform needling and warm needling therapy ( factor C : C@ acupuncture with filiform needle , CZ acupuncture with filiform needle and warm needling therapy ) and positive functional exercise ( factor D : D@ without positive functional exercise , D@ with positive functional exercise ) .


The treatment was given once a day , @ treatments made one session and @ sessions were required totally .


The time points of observation were the point after @ session of treatment and after @ sessions of treatment .


The short-form McGill pain questionnaire ( MPQ ) and shoulder joint motor disturbance score were adopted for evaluation .


In the orthogonal design analysis , taking the hierarchical factors into consideration , the age was considered as the main factor in the evaluation of shoulder pain and shoulder motor disturbance ( P < @ ) , and the shoulder function grade apparently impacted pain evaluation and the efficacy on shoulder motor disturbance ( P < @ ) .


The best combination of @ factors and @ levels were A@B@CzD@ and A@ BC@D@ .


SAS statistical analysis showed that at acute stage and adhesion stage , CZ Dz , meaning acupuncture with fifiform needling and warm needling therapy combined with positive functional exercise , is the main factor of the improvements of shoulder motor function ( P < @ ) .


For periarthritis of shoulder at acute stage , the combined therapy of acupuncture at local acupoints , warm needling and positive functional exercise is adopted .


At chronic stage , the combined therapy of acupuncture at local acupoints and distal acupoints , acupuncture with filiform needle and warm needling and positive functional exercise is the best program .


Additionally , in clinical treatment , the patients ' age , sex , shoulder joint function and duration of treatment should be considered comprehensively for the impacts on the efficacy .


Inappropriate drug use has been identified as one of the most important problems affecting the quality of care in older people .


Inappropriate drug use may increase the risk of the occurrence of ` geriatric giants ' such as immobility , instability , incontinence and cognitive impairment .


There are indications that clinical medication reviews ( CMR ) can reduce inappropriate drug use .


However , CMRs have not yet been implemented at a large scale in primary care .


An innovative medication review program in primary care will be developed which tackles the most important obstacles for a large scale implementation of CMRs .


The aim of this study is to assess whether this CMR program is ( cost - ) effective compared with usual general practice care for older patients with geriatric symptoms with regard to quality of life and geriatric symptoms .


A cluster randomised controlled trial will be performed in @ Dutch general practices including @ patients .


Patients of @years and older are eligible if they newly present with pre-specified geriatric symptoms in general practice and chronic use of at least one prescribed drug .


GP practices will be stratified by practice size and randomly allocated to control ( n = @ ) or intervention group ( n = @ ) .


The intervention consists of CMRs which will be facilitated and prepared by an expert team consisting of a GP and a pharmacist .


Primary outcome measures are patient 's quality of life and the presence of self-reported geriatric symptoms during a follow-up period of @months .


Secondary outcomes are costs of healthcare utilisation , feasibility , number of drug related problems , medication adherence and satisfaction with medication .


This study is expected to add evidence on the ( cost - ) effectiveness of an optimally facilitated , prepared and structured CMR in comparison with usual care in older patients who present a geriatric symptom to their GP .


The strength of this study is that it will be conducted in daily clinical practice .


This improves the possibilities to implement the CMRs in the primary care setting on a large scale .


To evaluate the safety and efficacy of various initial strategies of loop diuretic administration in patients with acute decompensated heart failure ( ADHF ) on diuresis , renal function , electrolyte balance and clinical outcomes .


Consecutive patients admitted with ADHF were randomized into three groups - intravenous furosemide infusion + intravenous dopamine , intravenous furosemide bolus in two divided doses and intravenous furosemide continuous infusion alone .


At @h , the treating physician could adjust the diuretic strategy .


Primary endpoint was negative fluid balance at @h after admission .


Secondary end points were duration of hospital stay , negative fluid balance at @ , @ , @h , the trend of serum electrolytes , and renal function and @ day clinical outcome ( death and emergency department visits ) .


Overall ninety patients ( thirty in each group ) were included in the study .


There was a greater diuresis in first @h ( p = @ ) and a shorter hospital stay ( p = @ ) with the bolus group .


There was no significant difference in renal function and serum sodium and serum potassium levels .


There was no difference in the number of emergency department visits among the three groups .


All three modes of diuretic therapies can be practiced with no difference in worsening of renal function and electrolyte levels .


Bolus dose administration with itsrapid volume loss and shorter hospital stay might be a more effective diuretic strategy .


Missed scheduled HIV appointments lead to increased mortality , resistance to antiretroviral therapy , and suboptimum virological response .


We aimed to assess whether reminders sent to carers by text message , mobile phone call , or concomitant text message and mobile phone call increase attendance at medical appointments for HIV care in a population of children infected with or exposed to HIV in Cameroon .


We also aimed to ascertain the most cost-effective method of mobile-phone-based reminder .


MORE CARE was a multicentre , single-blind , factorial , randomised controlled trial in urban , semi-urban , and rural settings in Cameroon .


Carers of children who were infected with or had been exposed to HIV were randomly assigned electronically in blocks of four and allocated ( @:@:@:@ ) sequentially to receive a text message and a call , a text message only , a call only , or no reminder ( control ) .


Investigators were masked to group assignment .


Text messages were sent and calls made @ or @ days before a scheduled follow-up appointment .


The primary outcomes were efficacy ( the proportion of patients attending a previously scheduled appointment ) and efficiency ( attendance / -LSB- measures of staff working time cost of the reminders -RSB- ) , as a measure of cost-effectiveness .


The primary analysis was by intention to treat .


This study is registered with the Pan African Clinical Trials Register , number PACTR@ .


The study took place between Jan @ and May @ , @ .


We randomly assigned @ adult-child ( carer-patient ) pairs into four groups : text message plus call ( n = @ ) , call ( n = @ ) , text message ( n = @ ) , and control ( n = @ ) .


@ participants ( @ % ) in the text message plus call group , @ ( @ % ) in the call group , @ ( @ % ) in the text message group , and @ ( @ % ) in the control group attended their scheduled appointment .


Compared with control , the odds ratios for improvement in the primary efficacy outcome were @ ( @ % CI @-@ ; p < @ ) for text message plus call , @ ( @-@ ; p = @ ) for call , and @ ( @-@ ; p = @ ) for text message .


No significant differences were seen in comparisons of the three intervention groups with each other , and there was no synergism between text messages and calls .


For the primary efficiency outcome , the mean difference for text message versus text message plus call was @ ( @ % CI @ to @ ; p = @ ) , for call versus text message plus call was @ ( @ to @ ; p < @ ) , and for call versus text message was @ ( -@ to @ ; p = @ ) .


Mobile-phone-based reminders of scheduled HIV appointments for carers of paediatric patients in low-resource settings can increase attendance .


The most effective method of reminder was text message plus phone call , but text messaging alone was the most efficient ( ie , cost-effective ) method .


Safe and cost-effective programs for implementing early infant male circumcision ( EIMC ) in Africa need to be piloted .


We present results on a relative cost analysis within a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe .


Between January and June @ , male infants who met inclusion criteria were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor , using a @:@ allocation ratio .


We evaluated the overall unit cost plus the key cost drivers of EIMC using both AccuCirc and Mogen clamp .


Direct costs included consumable and nonconsumable supplies , device , personnel , associated staff training , and environmental costs .


Indirect costs comprised capital and support personnel costs .


In @-way sensitivity analyses , we assessed potential changes in unit costs due to variations in main parameters , one at a time , holding all other values constant .


The unit costs of EIMC using AccuCirc and Mogen clamp were $ @ and $ @ , respectively .


Key cost drivers were consumable supplies , capacity utilization , personnel costs , and device price .


Unit prices are likely to be lowest at full capacity utilization and increase as capacity utilization decreases .


Unit prices also fall with lower personnel salaries and increase with higher device prices .


EIMC has a lower unit cost when using AccuCirc compared with Mogen clamp .


To minimize unit costs , countries planning to scale-up EIMC using AccuCirc need to control costs of consumables and personnel .


There is also need to negotiate a reasonable device price and maximize capacity utilization .


A number of perioperative risk factors may suppress the immune system and contribute to the development of post-operative complications .


The association between surgical site infection ( SSI ) and other wound-related complications resulting from immunosuppression through either perioperative administration of dexamethasone , pre-operative smoking or alcohol abuse is , however , uncertain .


This study was a post hoc analysis of data from the PROXI randomized trial in @ patients who underwent emergency or elective laparotomy .


We assessed the associations of use of dexamethasone , smoking status and alcohol abuse with the primary outcome , being a composite of SSI , anastomotic leak , wound dehiscence , burst abdomen and @-day mortality .


The primary outcome occurred in @ % of patients receiving dexamethasone versus @ % of patients not receiving dexamethasone , and this was not statistically significant when adjusting for stratification variables originally used in the PROXI trial -LSB- OR @ , @ % CI ( @-@ @ ) -RSB- .


In smokers , the primary outcome occurred in @ % , compared with @ % of non-smokers ( P = @ ) .


Smokers also had a higher frequency of SSI ( @ % vs @ % , P < @ ) and burst abdomen ( @ % vs @ % , P = @ ) .


In alcohol abusers , the primary outcome occurred in @ % , compared with @ % in patients who did not abuse alcohol ( P = @ ) .


Burst abdomen occurred more commonly in alcohol abusers ( @ % vs @ % , P < @ ) .


Perioperative administration of dexamethasone was not significantly associated with SSI or other wound-related complications .


Conversely , smoking and alcohol abuse were both significant predictors of the primary outcome consisting of wound-related complications and mortality .


While research suggests primary prescription opioid ( PO ) abusers may exhibit less severe demographic and drug use characteristics than primary heroin abusers , less is known about whether a lifetime history of heroin use confers greater severity among PO abusers .


In this secondary analysis , we examined demographic and drug use characteristics as a function of lifetime heroin use among @ PO-dependent adults screened for a trial evaluating the relative efficacy of buprenorphine taper durations .


Exploratory analyses also examined contribution of lifetime heroin use to treatment response among a subset of participants who received a uniform set of study procedures .


Baseline characteristics were compared between participants reporting lifetime heroin use @ ( H ( + ) ; n = @ ) vs. < @ ( H ( - ) ; n = @ ) times .


Treatment response ( i.e. , illicit opioid abstinence and treatment retention at end of study ) was examined in the subset of H ( + ) and H ( - ) participants randomized to receive the @-week taper condition ( N = @ ) .


H ( + ) participants were significantly older and more likely to be male .


They reported longer durations of illicit opioid use , greater alcohol-related problems , more past-month cocaine use , greater lifetime IV drug use , and greater lifetime use of cigarettes , amphetamines and hallucinogens .


H ( + ) participants also had lower scores on the Positive Symptom Distress and Depression subscales of the Brief Symptom Inventory .


Finally , there was a trend toward poorer treatment outcomes among H ( + ) participants .


A lifetime history of heroin use may be associated with elevated drug severity and unique treatment needs among treatment-seeking PO abusers .


To evaluate the onset and duration of improvement in best-corrected visual acuity ( BCVA ) in eyes treated with dexamethasone intravitreal implant @ mg ( DEX implant ) for macular edema after branch or central retinal vein occlusion .


Post hoc analysis of data from @ previously reported multicenter , @-month , randomized sham-controlled clinical trials .


Patients received a single DEX implant ( n = @ ) or sham procedure ( n = @ ) in the study eye .


The primary endpoint was the percentage of eyes with @-letter improvement in BCVA from baseline at postimplant Day @ .


The baseline mean BCVA was @/@ .


At Day @ , @ % of DEX implant-treated eyes versus @ % of sham-treated eyes ( P < @ ) had @-letter improvement in the BCVA , and @ % of DEX implant-treated eyes versus @ % of sham-treated eyes had @-letter improvement ( P < @ ) .


The mean improvement at Day @ was @ letters ( branch retinal vein occlusion , @ ; and central retinal vein occlusion , @ ) with DEX implant and @ letters ( branch retinal vein occlusion , @ ; and central retinal vein occlusion , @ ) with sham ( P < @ ) .


The mean time from initial observation of @-letter BCVA gain to the last observation of @-letter BCVA gain was @ days .


Dexamethasone intravitreal implant treatment led to improvement in BCVA compared with sham procedure as early as postimplant Day @ .


The duration of @-line improvement was typically @ to @ months .


To investigate the effect of luteal phase support with vaginal progesterone on pregnancy rates of the gonadotropin-stimulated intrauterine insemination ( IUI ) cycles in patients with unexplained infertility with regard tofollicular growth .


A total of @ patients with unexplained infertility who underwent @ recombinant follicle stimulated hormone -- stimulated IUI cycles were prospectively randomized into @ groups for luteal phase support .


The study group ( n = @ ) received vaginal progesterone gel supplementation , and the control group ( n = @ ) received no drug for luteal support .


The clinical pregnancy rates and live birth rates per cycle and per patient were compared between the groups .


The differences between the groups with regard to clinical pregnancy rates and live birth rates per patient or per cycle were not different among all patients .


In cycles with > @ dominant follicle ( multifollicular response ) , the clinical pregnancy rate per patient was significantly higher in the supported cycles as compared with the unsupported cycles ( @ % vs. @ % , respectively , p = @ ) .


Reproductive outcomes in cycles with a single dominant follicle ( monofollicular response ) were not different between supported and unsupported cycles .


Luteal phase support with vaginal progesterone affects the success of gonadotropin-stimulated IUI cycles with multifollicular response but not with monofollicular response .


Linifanib , a potent , selective inhibitor of vascular endothelial growth factor ( VEGF ) and platelet-derived growth factor ( PDGF ) receptors , has single-agent activity in non-small-cell lung cancer ( NSCLC ) .


We evaluated linifanib with carboplatin and paclitaxel as first-line therapy of advanced nonsquamous NSCLC .


Patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned to @-week cycles of carboplatin ( area under the curve @ ) and paclitaxel ( @ mg/m ( @ ) ) with daily placebo ( arm A ) , linifanib @ mg ( arm B ) , or linifanib @ mg ( arm C ) .


The primary end point was progression-free survival ( PFS ) ; secondary efficacy end points included overall survival ( OS ) and objective response rate .


One hundred thirty-eight patients were randomly assigned ( median age , @ years ; @ % men ; @ % smokers ) .


Median PFS times were @ months ( @ % CI , @ to @ months ) in arm A ( n = @ ) , @ months ( @ % CI , @ to @ months ) in arm B ( n = @ ) , and @ months ( @ % CI , @ to @ months ) in arm C ( n = @ ) .


Hazard ratios ( HRs ) for PFS were @ for arm B versus A ( P = @ ) and @ for arm C versus A ( P = @ ) .


Median OS times were @ , @ , and @ months in arms A , B , and C , respectively .


HRs for OS were @ for arm B versus A ( P = @ ) and @ for arm C versus A ( P = @ ) .


Both linifanib doses were associated with increased toxicity , including a higher incidence of adverse events known to be associated with VEGF/PDGF inhibition .


Baseline plasma carcinoembryonic antigen/cytokeratin @ fragments biomarker signature was associated with PFS improvement and a trend toward OS improvement with linifanib @ mg .


Addition of linifanib to chemotherapy significantly improved PFS ( arm B ) , with a modest trend for survival benefit ( arm C ) and increased toxicity reflective of known VEGF/PDGF inhibitory effects .


To compare the effects of two of the most effective lipid-lowering therapies with similar LDL-cholesterol reduction capacity on the innate and adaptive immune responses through the evaluation of autoantibodies anti-oxidized LDL ( anti-oxLDL Abs ) and electronegative LDL -LSB- LDL ( - ) -RSB- levels .


We performed a prospective , randomized , open label study , with parallel arms and blinded endpoints .


One hundred and twelve subjects completed the study protocol and received rosuvastatin @ mg or ezetimibe/simvastatin @/@ mg for @ weeks .


Lipids , apolipoproteins , LDL ( - ) , and anti-oxLDL Abs ( IgG ) were assayed at baseline and end of study .


Main clinical and laboratory characteristics were comparable at baseline .


Lipid modifications were similar in both treatment arms , however , a significant raise in anti-oxLDL Abs levels was observed in subjects treated with rosuvastatin ( p = @ vs. baseline ) , but not in those receiving simvastatin/ezetimibe .


( p = @ vs. baseline ) , thus suggesting modulation of adaptive immunity by a potent statin .


Titers of LDL ( - ) were not modified by the treatments .


Considering atherosclerosis as an immune disease , this study adds new information , showing that under similar LDL-cholesterol reduction , the choice of lipid-lowering therapy can differently modulate adaptive immune responses .


The aim of the study was to compare two techniques of pyramidalis muscle dissection during cesarean section .


A total of @ patients undergoing a cesarean section were randomly allocated to group I ( N = @ ) , with the pyramidalis muscle left attached to the rectus muscles , and group II ( N = @ ) , with preservation of the connection between the pyramidalis muscle and the rectus sheath .


There were no statistically significant differences between the groups regarding surgery duration , blood loss and postoperative pain .


After three months , patients from group II more frequently reported paresthesia in the scar region ( @ vs. @ % ; p = @ ) , but their self-assessment of the abdominal appearance and presence of the bulging below the wound were comparable with group I.


None of the two techniques of pyramidalis muscle dissection appear to be superior to the other .


The technique leaving the pyramidalis muscle attached to the fascia gave more frequent paresthesia during a @-month follow-up .


The importance of functional properties of high-density lipoproteins ( HDL ) for atheroprotection is increasingly recognized .


We determined the impact of lipid-lowering therapy on @ key HDL functionalities in Type @ diabetes mellitus ( T@DM ) .


A placebo-controlled , randomized cross-over study ( three @-week treatment periods with simvastatin ( @ mg daily ) , bezafibrate ( @ mg daily ) , alone and in combination ) was carried out in @ men with T@DM .


Cholesterol efflux was determined using human THP-@ monocyte-derived macrophages , HDL antioxidative capacity was measured as inhibition of low-density lipoprotein oxidation in vitro , and HDL anti-inflammatory capacity was assessed as suppression of thrombin-induced monocyte chemotactic protein @ expression in human umbilical vein endothelial cells .


Pre -- HDL was assayed using crossed immunoelectrophoresis .


While cholesterol efflux increased in response to simvastatin , bezafibrate and combination treatment ( +@ to +@ % ; anova , P = @ ) , HDL antioxidative capacity ( P = @ ) and HDL anti-inflammatory capacity ( P = @ ) did not change significantly .


Averaged changes in cellular cholesterol efflux during active treatment were correlated positively with changes in HDL cholesterol , apoA-I and pre -- HDL ( P < @ to P < @ ) .


There were no inter-relationships between changes in the three HDL functionalities during treatment ( P > @ ) .


Changes in HDL antioxidative capacity and anti-inflammatory capacity were also unrelated to changes in HDL cholesterol and apoA-I , while changes in HDL antioxidative capacity were related inversely to pre -- HDL ( P < @ ) .


Simvastatin and bezafibrate increase cholesterol efflux , parallel to HDL cholesterol and apoA-I responses .


The antioxidative and anti-inflammatory properties of HDL are not to an important extent affected by these therapeutic interventions .


Regulatory Foxp@-expressing T cells ( Tregs ) , IL-@-producing B cells ( Bregs ) , and IDO-expressing dendritic cells ( DCregs ) downregulate inflammatory processes and induce peripheral tolerance , while Th@A and Th@ cell subpopulations are of proinflammatory nature .


The aims of the study were to characterize and to enumerate peripheral Tregs , Bregs , and DCregs and Th@A and Th@ cell subpopulations in kidney transplant recipients ( KTRs ) under belatacept or cyclosporine treatment .


Forty-one KRT patients ( @ under belatacept treatment and @ under cyclosporine treatment ) and @ healthy donors ( HDs ) were included in the study .


CD@ ( + ) - expressing peripheral B lymphocytes were purified by positive selection .


IL-@-producing B cells , CD@ ( + ) / CD@ ( high ) Foxp@ ( + ) , and CD@ ( + ) / CD@ ( - ) Foxp@ ( + ) Tregs , CCR@ ( + ) / CD@ ( + ) / IDO ( + ) DCs , as well as Th@A and Th@ cell subpopulations were quantitated by flow cytometry .


Of the IL-@-producing Bregs , CD@ ( + ) / CD@ ( high ) / CD@ ( high ) / CD@ ( + ) , CD@ ( + ) / CD@ ( high ) / CD@ ( high ) / CD@ ( + ) , CD@ ( + ) / CD@ ( high ) / CD@ ( high ) / CD@ ( + ) , and CD@ ( + ) / CD@ ( high ) / CD@ ( high ) / CD@ ( - ) had significant higher frequency in patients under belatacept treatment when compared with those under cyclosporine .


Only CD@ ( + ) / CD@ ( high ) / CD@ ( high ) / CD@ ( + ) and CD@ ( + ) / CD@ ( high ) / CD@ ( high ) / CXCR@ ( + ) cells had significant higher frequency in patients under cycloporine treatment when compared to those under belatacept .


The percentages of IDO-expressing pDC , CD@ ( + ) / CD@ ( high ) Foxp@ ( + ) , and CD@ ( + ) / CD@ ( - ) Foxp@ ( + ) were significantly higher in the belatacept group when compared the cyclosporine one , while Th@A and Th@ cells had significant higher frequency in the latter group .


Belatacept seems to maintain and enhance , at least systemically , a tolerant profile to renal allograft in transplant recipients by means of higher circulatory frequencies of regulatory B , T and pDC subpopulations .


In the United Kingdom , patients with locally advanced rectal cancer routinely receive neoadjuvant chemoradiotherapy .


However , the effects of this on physical fitness are unclear .


This pilot study is aimed to investigate the effect of neoadjuvant chemoradiotherapy on objectively measured in vivo muscle mitochondrial function and whole-body physical fitness .


We prospectively studied @ patients with rectal cancer who completed standardized neoadjuvant chemoradiotherapy , recruited from a large tertiary cancer centre , between October @ and July @ .


All patients underwent a cardiopulmonary exercise test and a phosphorus magnetic resonance spectroscopy quadriceps muscle exercise-recovery study before and after neoadjuvant chemoradiotherapy .


Data were analysed and reported blind to patient identity and clinical course .


Primary variables of interest were the two physical fitness measures ; oxygen uptake at estimated anaerobic threshold and oxygen uptake at Peak exercise ( ml.kg-@ .


min-@ ) , and the post-exercise phosphocreatine recovery rate constant ( min-@ ) , a measure of muscle mitochondrial capacity in vivo .


Median age was @ years ( IQR @-@ ) .


Differences ( @ % CI ) in all three primary variables were significantly negative post-NACRT : Oxygen uptake at estimated anaerobic threshold -@ ml.kg-@ .


min-@ ( -@ , -@ ) , p = @ ; Oxygen uptake at Peak -@ ml.kg-@ .


min-@ ( -@ , -@ ) , p = @ ; and post-exercise phosphocreatine recovery rate constant -@ min-@ ( -@ , -@ ) , p < @ .


The significant decrease in both whole-body physical fitness and in vivo muscle mitochondrial function raises the possibility that muscle mitochondrial mechanisms , no doubt multifactorial , may be important in deterioration of physical fitness following neoadjuvant chemoradiotherapy .


This may have implications for targeted interventions to improve physical fitness pre-surgery .


To evaluate the effect of periodontal treatment on gingival overgrowth in a group of renal transplant patients .


Twenty-five renal transplant recipients receiving immunosuppressive therapy with cyclosporine A ( CsA ) were randomly assigned to @ groups .


Group @ ( n = @ ) included patients who had been specifically referred to a dental clinic to prevent gingival overgrowth and were given full periodontal therapy .


Group @ ( n = @ ) was comprised of patients who did not receive any professional periodontal cleaning .


Patients from both groups were examined to determine their periodontal status before and after @ , @ and @ months in terms of their plaque index , gingival index and gingival overgrowth .


During the examination , their overall health was stable .


For group @ , the scores were @ ( baseline ) , @ ( @ months ) and @ ( @ months ) , and hence there were significant reductions ( p = @ ) .


The gingival indices were @ ( baseline ) , @ ( @ months ) and @ ( @ months ) , and the reductions were also significant ( p = @ ) .


A significant association was observed between poor oral hygiene and the degree of gingival overgrowth .


The @-year post-treatment follow-up showed that patients in group @ did not develop gingival overgrowth due to the use of CsA as group @ did without prior periodontal therapy .


Oral hygiene status was the most important variable related to the development and degree of gingival overgrowth due to the use of CsA .


The use of heat and moisture exchangers ( HME ) during noninvasive ventilation ( NIV ) can increase the work of breathing , decrease alveolar ventilation , and deliver less humidity in comparison with heated humidifiers ( HH ) .


We tested the hypothesis that the use of HH during NIV with ICU ventilators for patients with acute respiratory failure would decrease the rate of intubation ( primary endpoint ) as compared with HME .


We conducted a multicenter randomized controlled study in @ centers .


After stratification by center and type of respiratory failure ( hypoxemic or hypercapnic ) , eligible patients were randomized to receive NIV with HH or HME .


Of the @ patients included , @ patients were allocated to the HME group and @ to the HH group .


Patients were comparable at baseline .


The intubation rate was not significantly different : @ % in the HME group and @ % in the HH group ( p = @ ) .


PaCO@ did not significantly differ between the two arms , even in the subgroup of hypercapnic patients .


No significant difference was observed for NIV duration , ICU and hospital LOS , or ICU mortality ( HME @ vs. HH @ % , p = @ ) .


In this study , the short-term physiological benefits of HH in comparison with HME during NIV with ICU ventilators were not observed , and no difference in intubation rate was found .


The physiologic effects may have been obscured by leaks or other important factors in the clinical settings .


This study does not support the recent recommendation favoring the use of HH during NIV with ICU ventilators .


Chronic pain can disrupt the cortical representation of a painful body part .


This disruption may play a role in maintaining the individual 's pain .


Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions .


However , there is little evidence for the effectiveness of this intervention for chronic low back pain ( CLBP ) .


The primary aim of this study was to inform the development of a fully powered randomised controlled trial ( RCT ) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP .


The secondary aim was to obtain qualitative feedback about the intervention .


In this mixed-methods pilot RCT @ individuals were randomised to either an intervention ( tactile acuity training ) or a placebo group ( sham tactile acuity training ) .


All participants received @ sessions of acuity training ( intervention or sham ) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer ( friend/relative ) .


All participants also received usual care physiotherapy .


The primary outcome measures were pain ( @-@visual analogue scale ( VAS ) ) and function ( Roland Morris Disability Questionnaire ( RMDQ ) ) .


Participants and their informal carers were invited to a focus group to provide feedback on the intervention .


The placebo group improved by the greatest magnitude for both outcome measures , but there was no statistically significant difference ( Mean difference ( @ % CI ) , p-value ) between groups for change in pain ( @ ( -@ to @ ) , p = @ ) or function ( @ ( -@ to @ ) , p = @ ) .


Comparing the number of individuals achieving a minimally clinically significant improvement , the placebo group had better outcomes for pain with all participants achieving @ % improvement compared to only a third of the intervention group ( @/@ vs. @/@ , p = @ ) .


Qualitatively , participants reported that needing an informal carer was a considerable barrier to the home training component of the study .


This pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP .


That the intervention could not be self-applied was a considerable barrier to its use .


Chronic obstructive pulmonary disease ( COPD ) is a chronic , progressively debilitating condition that is prevalent in the US and worldwide .


Patients suffer from progressive dyspnea and exercise intolerance .


Physical exercise is beneficial , but conventional pulmonary rehabilitation programs are underutilized .


There remains a need for novel interventions that improve symptoms , quality-of-life , and functional capacity .


Tai chi is an increasingly popular mind-body exercise that includes physical exercise , breathing training , mindful awareness , and stress management -- components that are essential to the self-management of COPD .


There are , however , limited data on the effectiveness of tai chi as a therapeutic intervention in this population .


The Primary Aims are to evaluate the efficacy , safety , and feasibility of a @-week tai chi program for patients with COPD .


We utilize a randomized controlled trial design , with participants assigned in a @:@ ratio to either a group tai chi program ( N = @ ) or a time/attention-matched education control ( N = @ ) .


Our primary outcomes are COPD-specific quality-of-life and exercise capacity .


Secondary outcomes include dyspnea , mood , functional status , self-efficacy , and lung function .


Cardiopulmonary exercise testing is done in a subset of patients ( N = @ ) .


To explore optimal training duration , a subgroup of patients in tai chi are randomly assigned to complete an additional @ weeks training ( total @ weeks ) ( Exploratory Aim @ ) .


To explore the impact of a simplified seated intervention including only a subset of tai chi 's training components , a third randomly assigned group ( N = @ ) receives a @ - week mind-body breathing program ( N = @ ) ( Exploratory Aim @ ) .


Results of the BEAM study ( Breathing , Education , Awareness , Movement ) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD , including information regarding optimal duration .


They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention , and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi .


Should the results be positive , tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD .


To determine whether a pharmacist-led medications review in primary care reduces the number of drugs and the number of drug-related problems .


Prospective randomized controlled trial .


Liljeholmen Primary Care Centre , Stockholm , Sweden .


@ patients aged @ years with five or more different medications .


Intervention .


Patients answered a questionnaire regarding medications .


The pharmacist reviewed all medications ( prescription , non-prescription , and herbal ) regarding recommendations and renal impairment , giving advice to patients and GPs .


Each patient met the pharmacist before seeing their GP .


Control patients received their usual care .


Drug-related problems and number of drugs .


Secondary outcomes included health care utilization and self-rated health during @ months of follow-up .


No significant difference was seen when comparing change in drug-related problems between the groups .


However , a significant decrease in drug-related problems was observed in the intervention group ( from @ per patient at baseline to @ at follow-up , p < @ ) .


The change in number of drugs was more pronounced in the intervention group ( p < @ ) .


Intervention group patients were not admitted to hospital on fewer occasions or for fewer days , and there was no significant difference between the two groups regarding utilization of primary care during follow-up .


Self-rated health remained unchanged in the intervention group , whereas a drop ( p < @ ) was reported in the control group .


This resulted in a significant difference in change in self-rated health between the groups ( p < @ ) .


The addition of a skilled pharmacist to the primary care team may contribute to reductions in numbers of drugs and maintenance of self-rated health in elderly patients with polypharmacy .


Exercise evokes pulsatile GH release followed by autonegative feedback , whereas glucose suppresses GH release followed by rebound-like GH release ( feedforward escape ) .


Here we test the hypothesis that age , sex steroids , insulin , body composition and physical power jointly determine these dynamic GH responses .


This was a prospectively randomized glucose-blinded study conducted in the Mayo Center for Advancing Translational Sciences in healthy men ages @-@ years ( N = @ ) .


Three conditions , fasting/rest/saline , fasting/exercise/saline and fasting/rest/iv glucose infusions , were used to drive GH dynamics during @-min blood sampling for @h .


Linear correlation analysis was applied to relate peak/nadir GH dynamics to age , sex steroids , insulin , CT-estimated abdominal fat and physical power ( work per unit time ) .


Compared with the fasting/rest/saline ( control ) day , fasting/exercise/saline infusion evoked peak GH within @h , followed by negative feedback @-@h later .


The dynamic GH excursion was strongly ( R ( @ ) = @ ) influenced by ( i ) insulin negatively ( P = @ ) , ( ii ) power positively ( P = @ ) , and ( iii ) E@ positively ( P = @ ) .


Dynamic glucose-modulated GH release was determined by insulin negatively ( P = @ ) and power positively ( P = @ ) ( R ( @ ) = @ ) .


Under rest/saline , power ( P = @ ) and total abdominal fat ( P = @ ) ( R ( @ ) = @ ) were the dominant correlates of GH excursions .


In healthy men , dynamic GH perturbations induced by exercise and glucose are strongly related to physical power , insulin , estradiol , and body composition , thus suggesting a network of regulatory pathways .


Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of weighing oneself , or tracking weight , is associated with better weight outcomes .


Conversely , it has also been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss , but there are minimal experimental data that address this concern in the context of an active weight loss program .


To achieve the long-term goal of strengthening behavioral weight loss programs , the purpose of this randomized controlled trial ( the Tracking Study ) is to test variations on frequency of self-weighing during a behavioral weight loss program , and to examine psychosocial and mental health correlates of weight tracking and weight loss outcomes .


This paper describes the study design , intervention features , recruitment , and baseline characteristics of participants enrolled in the Tracking Study .


Three hundred thirty-nine overweight and obese adults were recruited and randomized to one of three variations on weight tracking frequency during a @-month weight loss program with a @-month follow-up : daily weight tracking , weekly weight tracking , or no weight tracking .


The primary outcome is weight in kilograms at @ months .


The weight loss program integrates each weight tracking instruction with standard behavioral weight loss techniques ( goal setting , self-monitoring , stimulus control , dietary and physical activity enhancements , lifestyle modifications ) ; participants in weight tracking conditions were provided with wireless Internet technology ( wi-fi-enabled digital scales and touchscreen personal devices ) to facilitate weight tracking during the study .


This study was successful in recruiting adult male and female participants and is positioned to enhance the standard of care with regard to weight tracking recommendations .


This Stage II trial builds on a Stage I trial comparing the single-gender Women 's Recovery Group ( WRG ) to mixed-gender Group Drug Counseling ( GDC ) that demonstrated preliminary support for the WRG in treating women with substance use disorders .


The Stage II trial aims were to ( @ ) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance of abuse and co-occurring psychiatric disorders , and ( @ ) demonstrate the feasibility of implementing WRG in an open-enrollment group format at two sites .


In this randomized clinical trial , participants were included if they were substance dependent and had used substances within the past @ days ( n = @ ) .


Women were randomized to WRG ( n = @ ) or GDC ( n = @ ) ; men were assigned to GDC ( n = @ ) .


Substance use outcomes were assessed at months @-@ and @ .


Women in both the WRG and GDC had reductions in mean number of substance use days during treatment ( @ vs @ day reductions for WRG and GDC , respectively ) and @ months post-treatment ( @ vs @ day reductions ) ; however , there were no significant differences between groups .


The WRG demonstrated comparable effectiveness to standard mixed-gender treatment ( i.e. , GDC ) and is feasibly delivered in an open-group format typical of community treatment .


It provides a manual-based group therapy with women-focused content that can be implemented in a variety of clinical settings for women who are heterogeneous with respect to their substance of abuse , other co-occurring psychiatric disorders , and life-stage .


Recently , attention has been paid to dexmedetomidine , a selective -@ adrenoceptor agonist , as a possible additive for local anesthesia .


However , the effect of locally injected dexmedetomidine on the anesthetic action in humans has not fully been clarified .


Thus , the purpose of the present study was to evaluate the effect of dexmedetomidine injected into the oral mucosa in combination with lidocaine on local anesthetic potency in humans .


Twenty healthy volunteers were included in the present crossover double-blinded study .


Lidocaine solution or lidocaine plus dexmedetomidine solution was submucosally injected into the alveolar mucosa in a crossover and double-blinded manner .


The local anesthetic effect of the solutions was evaluated by measuring the current perception threshold ( CPT ) in the oral mucosa for @ minutes after injection .


Furthermore , the sedation level , blood pressure , and heart rate of the volunteers were evaluated .


For statistical analysis , the Wilcoxon signed rank test and @-way repeated measures analysis of variation were used .


The CPT was increased with the @ solutions and peaked @ minutes after injection .


CPT values @ and @ minutes after injection of lidocaine plus dexmedetomidine solution were considerably higher than those with lidocaine solution .


The duration of an important increase in the CPT after injection with lidocaine plus dexmedetomidine solution was longer than that with lidocaine .


Furthermore , the area under the time curve of CPT was considerably higher with lidocaine plus dexmedetomidine solution than with lidocaine solution .


No volunteer showed a change in sedation level , blood pressure , or heart rate after injection with either test solution throughout the experiment .


The present study showed that a combination of dexmedetomidine plus lidocaine considerably enhances the local anesthetic potency of lidocaine without any major influences on the cardiovascular system when locally injected into the oral mucosa .


The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer .


This was a multicenter cluster randomized controlled trial in Melbourne , Australia comprising @ clinicians : @ clinicians were randomized to refer eligible participants ( n = @ ) to a @-week exercise program comprising @ supervised gym sessions and @ home-based session per week , and @ clinicians were randomized to follow usual care ( n = @ ) .


The primary outcome was self-reported physical activity ; the secondary outcomes were quality of life , anxiety , and symptoms of depression .


A significant intervention effect was observed for vigorous-intensity exercise ( effect size : Cohen 's d , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ ) but not for combined moderate and vigorous exercise levels ( effect size : d , @ ; @ % CI , -@ to @ ; P = @ ) .


Significant intervention effects were also observed for meeting exercise guidelines ( @ min/wk ; odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) ; positive intervention effects were observed in the intervention group for cognitive functioning ( effect size : d , @ ; @ % CI , -@ to @ ; P = @ ) and depression symptoms ( effect size : d , -@ ; @ % CI , -@ to @ ; P = @ ) .


Eighty percent of participants reported that the clinician 's referral influenced their decision to participate in the exercise program .


The clinician referral and @-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer .


Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations .


To compare the effectiveness and safety of the hemoglobin-based nitric oxide scavenger , pyridoxalated hemoglobin polyoxyethylene , against placebo in patients with vasopressor-dependent distributive shock .


Multicenter , randomized , placebo-controlled , open-label study .


Sixty-one participating ICUs in six European countries ( Austria , Belgium , Germany , the Netherlands , Spain , and United Kingdom ) .


All patients admitted with distributive shock , defined as the presence of at least two systemic inflammatory response syndrome criteria , persisting norepinephrine dependence and evidence of organ dysfunction/hypoperfusion despite adequate fluid resuscitation .


Patients were randomized to receive @ mL/kg/hr pyridoxalated hemoglobin polyoxyethylene ( @ mg Hb/kg/hr ) or an equal volume of placebo , infused for up to @ hours , in addition to conventional vasopressor therapy .


The study was stopped after interim analysis showed higher mortality in the pyridoxalated hemoglobin polyoxyethylene group and an increased prevalence of adverse events .


At this time , @ patients had been randomized to pyridoxalated hemoglobin polyoxyethylene ( n = @ ) or placebo ( n = @ ) .


Age , gender , type of patient ( medical/surgical ) , and Acute Physiology and Chronic Health Evaluation II scores were similar between groups .


Twenty-eight-day mortality rate was @ % in the pyridoxalated hemoglobin polyoxyethylene group versus @ % in the placebo group ( OR , @ ; @ % CI , @-@ @ ; p = @ ) .


In patients with higher organ dysfunction scores ( Sepsis-related Organ Failure Assessment > @ ) , mortality rates were significantly higher in the pyridoxalated hemoglobin polyoxyethylene group when compared with those in placebo-treated patients ( @ % vs @ % ; p = @ ) .


Survivors who received pyridoxalated hemoglobin polyoxyethylene had a longer vasopressor-free time ( @ vs @ d ; p = @ ) .


In this randomized , controlled phase III trial in patients with vasopressor-dependent distributive shock , administration of a pyridoxalated hemoglobin solution decreased the need for vasopressors but was associated with a trend to increased mortality .


Few Iranian women take the Papanicolaou test despite its important role in preventing cervical cancer .


This study aimed to determine the effectiveness of an educational intervention based on the protection motivation theory ( PMT ) variables and implementation intentions in the first and second Pap test practice among Iranian women .


In this quasi-randomized controlled trial , @ women who were referred to @ primary health care clinics in Tehran were randomly selected .


PMT variables and Pap test practice were measured at baseline and again after @ and @ months .


The @-week educational intervention program was conducted for the intervention group .


Following the intervention , the mean scores of self-efficacy , perceived vulnerability , and behavior intention variables were significantly higher in the intervention group when compared to the control group ( p < @ ) .


No significant differences were found in the perceived severity , response efficacy , response cost , and fear between the two groups following the intervention .


Higher percent of women in the intervention group had obtained first and second Pap test compared to the controls .


The PMT and implementation intentions provide a suitable theory-based framework for developing educational interventions regarding Pap test practice in Iran .


Pelvic floor muscle training ( PFMT ) has level @ evidence of reducing the size and symptoms associated with pelvic organ prolapse ( POP ) .


There is scant knowledge , however , regarding whether PFMT has an effect on sexual function .


The aim of the trial was to evaluate the effect of PFMT on sexual function in women with POP .


In this randomized controlled trial , @ women were randomized to an intervention group ( @ months of PFMT and lifestyle advice ) and @ women were randomized to a control group ( lifestyle advice only ) .


Participants completed a validated POP-specific questionnaire to describe frequency and bother of prolapse , bladder , bowel , and sexual symptoms and answered a semi-structured interview .


No significant change in number of women being sexually active was reported .


There were no significant differences between groups regarding change in satisfaction with frequency of intercourse .


Interview data revealed that @ ( @ % ) of women in the PFMT group experienced improved sexual function vs. two ( @ % ) in the control group ( P < @ ) .


Specific improvements reported by some of the women were increased control , strength and awareness of the pelvic floor , improved self-confidence , sensation of a `` tighter '' vagina , improved libido and orgasms , resolution of pain with intercourse , and heightened sexual gratification for partners .


Women who described improved sexual function demonstrated the greatest increases in pelvic floor muscle ( PFM ) strength ( mean @ @ cmH@ @ ) and endurance ( mean @ @ cmH@ @s ) ( P < @ ) .


PFMT can improve sexual function in some women .


Women reporting improvement in sexual function demonstrated the greatest increase in PFM strength and endurance .


Service user satisfaction with therapy is a key part of the therapeutic process .


The aim of this study was to investigate service user experiences of an @-week group positive psychology intervention for psychosis ( WELLFOCUS PPT ) in the context of a randomized controlled trial ( ISRCTN@ ) .


Participants were @ individuals ( @ % male ; mean age @ years ) receiving the intervention as part of the trial .


Semistructured interviews and focus groups were conducted to investigate participants ' views of WELLFOCUS PPT .


Transcripts were analyzed both deductively and inductively to identify common themes .


Feedback about the group experience was positive throughout .


Components found helpful included learning to savor experiences , identifying and developing strengths , forgiveness , gratitude , and therapist self-disclosure .


Findings emphasize the importance of considering service users ' perceptions of therapy and can be used to guide clinicians in deciding whether to include one or more of the components of WELLFOCUS PPT in therapy .


To determine the effectiveness of a single perioperative prophylactic @g dose of cephalexin in preventing surgical site infection ( SSI ) following excision of skin lesions from the lower limb .


Prospective double-blinded placebo-controlled trial testing for difference in infection rates .


Primary care in regional North Queensland , Australia .


@ patients undergoing lower limb skin lesion excision .


@g dose of cephalexin @-@min before excision .


Incidence of SSI .


Incidence of SSI was @ % ( @ % CI @ % to @ % ) in the cephalexin group compared with @ % ( @ % CI @ % to @ % ) in the placebo group ( p = @ ) .


This represented an absolute reduction of @ % ( @ % CI -@ % to @ % ) , relative reduction of @ % ( @ % CI -@ % to @ % ) and number-needed-to-treat of @ .


Administration of a single @g dose of cephalexin @-@min before skin lesion excision from the lower limb may produce a reduction in the incidence of infection ; however , this study was underpowered to statistically determine this .


Multicentric Castleman 's disease is a rare lymphoproliferative disorder driven by dysregulated production of interleukin @ .


No randomised trials have been done to establish the best treatment for the disease .


We assessed the safety and efficacy of siltuximab-a chimeric monoclonal antibody against interleukin @-in HIV-negative patients with multicentric Castleman 's disease .


We did this randomised , double-blind , placebo-controlled study at @ hospitals in @ countries worldwide .


We enrolled HIV-negative and human herpesvirus-@-seronegative patients with symptomatic multicentric Castleman 's disease .


Treatment allocation was randomised with a computer-generated list , with block size six , and stratification by baseline corticosteroid use .


Patients and investigators were masked to treatment allocation .


Patients were randomly assigned ( @:@ ) to siltuximab ( @ mg/kg intravenous infusion every @ weeks ) or placebo ; all patients also received best supportive care .


Patients continued treatment until treatment failure .


The primary endpoint was durable tumour and symptomatic response for at least @ weeks for the intention-to-treat population .


Enrolment has been completed .


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


We screened @ patients , @ of whom were randomly assigned to siltuximab ( n = @ ) or placebo ( n = @ ) .


Durable tumour and symptomatic responses occurred in @ ( @ % ) of @ patients in the siltuximab group and none of @ in the placebo group ( difference @ % , @ % CI @-@ , p = @ ) .


The incidence of grade @ or more adverse events ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) and serious adverse events ( @ -LSB- @ % -RSB- vs five -LSB- @ % -RSB- ) was similar in each group despite longer median treatment duration with siltuximab than with placebo ( @ days -LSB- range @-@ -RSB- vs @ days -LSB- @-@ -RSB- ) .


The most common grade @ or higher were fatigue ( five vs one ) , night sweats ( four vs one ) , and anaemia ( one vs three ) .


Three ( @ % ) of @ patients had serious adverse events judged reasonably related to siltuximab ( lower respiratory tract infection , anaphylactic reaction , sepsis ) .


Siltuximab plus best supportive care was superior to best supportive care alone for patients with symptomatic multicentric Castleman 's disease and well tolerated with prolonged exposure .


Siltuximab is an important new treatment option for this disease .


This article evaluates the effectiveness of two interventions : a self-leveling pallet carousel designed to position the loads vertically and horizontally at origin , and an adjustable cart designed to raise loads vertically at destination to reduce spine loads .


Low back disorders among workers in manual material handling industries are very prevalent and have been linked to manual palletizing operations .


Evidence into the effectiveness of ergonomic interventions is limited , with no research that investigates interventions with adjustable load location .


Thirteen males experienced in manual material handling participated in simulated order selecting tasks where spine loads were quantified for each intervention condition : carousel to traditional cart , pallet to traditional cart , pallet to adjustable cart , and carousel to adjustable cart .


The results showed that combining both devices results in reduction in spine compression ( @ % ) , anterior-posterior shear ( @ % ) , and lateral shear ( @ % ) compared to traditional palletizing conditions .


Individually , the carousel was responsible for the greatest reductions , but the lowest values were typically achieved by combining the adjustable cart and carousel .


The combination of the interventions ( self-leveling carousel and adjustable cart ) was most effective in reducing the spine loads when compared to the traditional pallet-cart condition .


The individual interventions also reduced the loads compared to the traditional condition .


With de-palletizing/palletizing tasks being a major source of low back injuries , the combination of self-leveling carousel and adjustable cart has been found to be effective in reducing the peak spine loading as compared to traditional pallet on floor and nonadjustable flat cart conditions .


To determine the influence of omega-@ supplementation on vitreous vascular endothelial growth factor A ( VEGF-A ) levels in patients with exudative age-related macular degeneration ( wet AMD ) receiving intravitreal anti-VEGF treatment .


Prospective , randomized , open-label , single-center , clinical trial , consecutive interventional case series .


The study included @ cohorts with wet AMD and a control group with epiretinal membrane or macular hole .


Twenty wet AMD patients being treated with anti-VEGF were randomized to daily supplementation of antioxidants , zinc , and carotenoids with omega-@ fatty acids ( docosahexaenoic acid and eicosapentaenoic acid ; group @ , n = @ ) or without omega-@ fatty acids ( group @ , n = @ ) .


They were compared with an anti-VEGF treatment-nave wet AMD group ( group @ , n = @ ) and an epiretinal membrane or macular hole group ( group @ , n = @ ) .


Primary outcome was vitreal VEGF-A levels ( at the time of anti-VEGF injection ) .


Secondary outcomes were plasma VEGF-A and central foveal thickness .


Patients with new submacular hemorrhage or any other treatment within @ months were excluded .


Final analyses included @ , @ , @ , and @ patients in groups @ through @ , respectively .


Patients receiving omega-@s ( group @ ) had significantly lower levels of vitreal VEGF-A ( @ @ pg/mL ) when compared with group @ ( @ @ pg/mL ; P = @ ) and group @ ( @ @ pg/mL ; P = @ ) , but similar levels to group @ ( @ @ pg/mL ; P = @ ) .


All groups showed similar values for plasma VEGF-A and central foveal thickness measurements .


This study demonstrated that omega-@ supplementation combined with anti-VEGF treatment is associated with decreased vitreal VEGF-A levels in wet AMD patients .


Exercise at @-@ % of peak oxygen consumption ( VO@ peak ) stimulates maximal fat oxidation rates .


Despite a lower estimated work performed ; high-intensity intermittent exercise ( HIIE ) training produces greater fat mass reductions when compared with workload-matched continuous ( CON ) steady state exercise .


No metabolic basis has been documented nor mechanisms offered to explain this anomaly .


This study investigated the physiological and metabolic responses of two different workload-matched exercise protocols .


On separate occasions and at least @week apart , eight apparently healthy males cycled for @min at either @ % VO@ peak ( CON ) or performed repeated @s bouts of supramaximal exercise at @ % VO@ peak separated by @s rest ( HIIE ) .


The average heart rate , oxygen consumption , plasma glycerol and free fatty acid concentrations were not different during exercise and recovery between the trials .


Plasma lactate and hypoxanthine ( Hx ) concentrations were elevated and urinary excretion rates of Hx and uric acid were greater following HIIE as compared to CON ( P < @ ) .


Exercise-induced plasma Hx accumulation and urinary purine excretion are greater following HIIE and indirectly represents a net loss of adenosine triphosphate ( ATP ) from the muscle .


The subsequent restorative processes required for intramuscular de novo replacement of ATP may contribute to a negative energy balance and in part , account for the potential accelerated fat loss observed with HIIE when compared with CON training programs .


Single blinded , randomized clinical trial for the evaluation of lumbosacral orthoses ( LSOs ) in the management of lower back pain ( LBP ) .


To evaluate the effects of two types of LSOs on self-rated disability in patients with LBP .


LSOs are commonly used for the management of LBP , but their effectiveness may vary because of design .


An inextensible LSO ( iLSO ) reduces trunk motion and increases trunk stiffness , whereas an extensible LSO ( eLSO ) does not .


A total of @ participants with LBP were randomized to @ groups : ( @ ) standard care ( SC ) group , which included medication and physical therapy ( n = @ ) , ( @ ) SC with eLSO ( eLSO group ) ( n = @ ) , and ( @ ) SC with iLSO ( iLSO group ) ( n = @ ) .


Outcome measures were evaluated before and after @ weeks of treatment : modified Oswestry Disability Index ( ODI ) , Patient Specific Activity Scale , pain ratings , and Fear Avoidance Beliefs Questionnaire .


There were no statistically significant differences between groups at baseline .


Compared with the SC alone , iLSO group showed greater improvement on the ODI scores ( P = @ ) but not the eLSO group .


The ODI scores improved by a mean of @ ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , @ ( @ % CI , @-@ @ ) , and @ ( @ % CI , @-@ @ ) points for SC , eLSO , and iLSO groups , respectively .


Individuals wearing the iLSO had @ times higher odds of achieving @ % or greater improvement in the ODI scores than those assigned to SC ( @ % CI , @-@ @ , P = @ ) .


Both the eLSO and iLSO groups had a greater improvement in the Patient Specific Activity Scale scores than the SC group ( P = @ and P = @ , respectively ) , but the change did not meet the minimal clinically important difference .


Pain ratings improved for all @ groups , with no statistical difference between them .


Finally , no significant differences across groups were found for the Fear Avoidance Beliefs Questionnaire .


An iLSO led to greater improvement in ODI scores than SC and an eLSO .


We surmise that the likely mechanism responsible for this difference in outcome was the added trunk stiffness and motion restriction by the iLSO .


Ixekizumab is a humanised monoclonal antibody against the proinflammatory cytokine interleukin @A .


We report two studies of ixekizumab compared with placebo or etanercept to assess the safety and efficacy of specifically targeting interleukin @A in patients with widespread moderate-to-severe psoriasis .


In two prospective , double-blind , multicentre , phase @ studies ( UNCOVER-@ and UNCOVER-@ ) , eligible patients were aged @ years or older , had a confirmed diagnosis of chronic plaque psoriasis at least @ months before baseline ( randomisation ) , @ % or greater body-surface area involvement at both screening and baseline visits , at least a moderate clinical severity as measured by a static physician global assessment ( sPGA ) score of @ or more , and a psoriasis area and severity index ( PASI ) score of @ .


Participants were randomly assigned ( @:@:@:@ ) by computer-generated random sequence with an interactive voice response system to receive subcutaneous placebo , etanercept ( @ mg twice weekly ) , or one injection of @ mg ixekizumab every @ weeks , or every @ weeks after a @ mg starting dose .


Blinding was maintained with a double-dummy design .


Coprimary efficacy endpoints were proportions of patients achieving sPGA score @ or @ and @ % or greater improvement in PASI at week @ .


Analysis was by intention to treat .


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


Between May @ , @ , and Dec @ , @ , @ patients in UNCOVER-@ were randomly assigned to receive subcutaneous placebo ( n = @ ) , etanercept ( n = @ ) , or ixekizumab every @ weeks ( n = @ ) or every @ weeks ( n = @ ) ; between Aug @ , @ , and Feb @ , @ , @ patients in UNCOVER-@ were randomly assigned to receive placebo ( n = @ ) , etanercept ( n = @ ) , ixekizumab every @ weeks ( n = @ ) , or ixekizumab every @ weeks ( n = @ ) .


At week @ , both primary endpoints were met in both studies .


For UNCOVER-@ and UNCOVER-@ respectively , in the ixekizumab every @ weeks group , PASI @ was achieved by @ ( response rate @ % ; -LSB- effect size @ % ( @ % CI @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) and @ ( @ % ; -LSB- @ % ( @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) patients ; in the ixekizumab every @ weeks group , by @ ( @ % ; -LSB- @ % ( @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) and @ ( @ % ; -LSB- @ % ( @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) patients ; in the placebo group , by four ( @ % ) and @ ( @ % ) patients ; and in the etanercept group by @ ( @ % ) and @ ( @ % ) patients ( all p < @ vs placebo or etanercept ) .


In the ixekizumab every @ weeks group , sPGA @/@ was achieved by @ ( response rate @ % ; -LSB- effect size @ % ( @ % CI @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) and @ ( @ % ; -LSB- @ % ( @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) patients ; in the ixekizumab every @ weeks group by @ ( @ % ; -LSB- @ % ( @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) and @ ( @ % ; -LSB- @ % ( @-@ ) vs placebo ; @ % ( @-@ ) vs etanercept -RSB- ) patients ; in the placebo group by four ( @ % ) and @ ( @ % ) patients ; and in the etanercept group by @ ( @ % ) and @ ( @ % ) patients ( all p < @ vs placebo or etanercept ) .


In combined studies , serious adverse events were reported in @ ( @ % ) of @ patients given ixekizumab every @ weeks , @ ( @ % ) of @ given ixekizumab every @ weeks , seven ( @ % ) of @ given placebo , and @ ( @ % ) of @ given etanercept ; no deaths were noted .


Both ixekizumab dose regimens had greater efficacy than placebo and etanercept over @ weeks in two independent studies .


These studies show that selectively neutralising interleukin @A with a high affinity antibody potentially gives patients with psoriasis a new and effective biological therapy option .


Provoked vestibulodynia ( PVD ) , a frequent form of chronic genital pain , is associated with decreased sexual function for afflicted women , as well as impoverished sexual satisfaction for women and their partners .


Pain and sexuality outcomes for couples with PVD are influenced by interpersonal factors , such as pain catastrophizing , partner responses to pain , ambivalence over emotional expression , attachment style and perceived relationship and sexual intimacy .


Despite recommendations in the literature to include the partner in cognitive-behavioral therapy targeted at improving pain and sexuality outcomes , no randomized clinical trial has tested the efficacy of this type of intervention and compared it to a first-line medical intervention .


This bi-center , randomized clinical trial is designed to examine the efficacy of cognitive-behavioral couple therapy compared to topical lidocaine .


It is conducted across two Canadian university-hospital centers .


Eligible women diagnosed with PVD and their partners are randomized to one of the two interventions .


Evaluations are conducted using structured interviews and validated self-report measures at three time points : Pre-treatment ( T@ : prior to randomization ) , post-treatment ( T@ ) , and @-month follow-up ( T@ ) .


The primary outcome is the change in reported pain during intercourse between T@ and T@ .


Secondary outcomes focus on whether there are significant differences between the two treatments at T@ and T@ on ( a ) the multidimensional aspects of women 's pain and ( b ) women and partners ' sexuality ( sexual function and satisfaction ) , psychological adjustment ( anxiety , depression , catastrophizing , self-efficacy , and quality of life ) , relationship factors ( partner responses and dyadic adjustment ) and self-reported improvement and treatment satisfaction .


In order to detect an effect size as small as @ for secondary outcomes , a sample of @ couples is being recruited ( @ % dropout expected ) .


A clinically significant decrease in pain is defined as a @ % reduction .


The randomized clinical trial design is the most appropriate to examine the efficacy of cognitive-behavioral couple therapy , a recently developed and pilot-tested psychosocial intervention for couples coping with PVD , in comparison to a frequent first-line treatment option , topical lidocaine .


Findings from this study will provide important information about empirically supported treatment options for PVD , and inform future treatment development and research for this patient population .


At @ months of median follow-up , PHARE failed to show that @ was non-inferior to @ months of adjuvant trastuzumab .


From the results of PHARE , questions remain regarding whether the magnitude of benefit derived from @ year is sufficient to justify its systematic use for different patient subgroups .


Treatment effects were evaluated according to various tumour characteristics , and the multivariate Cox proportional hazards regression models were carried out on metastases-free survival ( MFS ) in the @ months control arm .


A prognostic score was defined providing the identification of patient categories with similar risks .


The @-month arm was used as a validation set in order to test for heterogeneity .


This study is registered at clinicaltrials.gov , number NCT@ .


A total of @ metastatic events were observed and four prognostic groups were defined : very low , low , intermediate and high risk in the @-month arm .


The corresponding @-year MFS rates were @ % , @ % , @ % and @ % in the four prognostic groups , respectively .


In the @-month arm , the @-year MFS rates were @ % , @ % , @ % and @ % in the four prognostic groups , respectively .


In the very low-risk group , the potential absolute benefit of standard duration of trastuzumab was small enough to indicate that optimal standard treatment might be clinically questionable .


On the other hand , the @-year metastasis occurrence rates strongly support the need for a search of a more efficient treatment in the low - , intermediate - and high-risk groups .


To compare the outcomes of shock wave lithotripsy ( SWL ) combined with inclined position and SWL alone in patients with lower pole calyx stones .


Seven hundred forty patients who underwent SWL treatment for lower pole renal stones with a total diameter of @ cm or less were prospectively randomized into two groups .


They were comparable in terms of age , sex , and stone diameters .


Patients with lower calyceal stones ( @-@ mm ) were randomized to SWL ( @ patients ) or SWL with simultaneous inclination ( @ patients ) with @o head down Trendelenburg position ) .


Shock wave and session numbers were standardized according to stone size .


Additional standardized shock waves were given to patients with stone fragments determined by kidney urinary bladder film and ultrasound at weeks @ , @ , @ .


The overall stone free rate ( SFR ) was @ % ( @/@ ) in patients with SWL alone and @ % ( @/@ ) in SWL with inclination at the end of @th week ( p = @ ) .


No significant adverse events were noted in both treatment groups .


Simultaneous inclination of patients during SWL session increase SFR in lower caliceal stones significantly compared to SWL treatment alone .


To study the effects of zinc and steroid in the treatment of traumatic anosmia .


A prospective , randomized study .


Academic medical center .


Patients with a clear history of loss of smell after head injury and whose thresholds were -@ measured by the phenyl ethyl alcohol threshold test were included in this study from January @ to May @ .


They were randomly divided into @ groups .


Patients in group @ were treated with zinc gluconate for a month and high-dose prednisolone with tapering for @ weeks .


Those in group @ took only zinc gluconate , and those in group @ took only prednisolone .


Patients in group @ did not take any medicine .


All patients were followed up by phenyl ethyl alcohol threshold testing , and magnetic resonance imaging was performed to measure the volume of olfactory bulbs .


Thirty-nine patients in group @ , @ in group @ , @ in group @ , and @ in group @ completed the study .


The recovery of olfactory function was observed in @ patients ( @ % ) in group @ , in @ ( @ % ) in group @ , in @ ( @ % ) in group @ , and in @ ( @ % ) in group @ .


The recovery rates of olfactory function of groups @ and @ were significantly higher than the recovery rate of group @ .


The volume of olfactory bulbs was not significantly different between those with and without improved olfactory function .


Our results show that zinc gluconate has a promising effect in treating traumatic anosmia .


Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden .


Australia has an opportunity to improve ways of caring for the growing number of people with diabetes , but this may require changes to the way care is funded , organised and delivered .


To inform how best to care for people with diabetes , and to identify the extent of change that is required to achieve this , the Diabetes Care Project ( DCP ) will evaluate the impact of two different , evidence-based models of care ( compared to usual care ) on clinical quality , patient and provider experience , and cost .