Psychological functioning 1 year after a brief intervention using micronutrients to treat stress and anxiety related to the 2011 Christchurch earthquakes : a naturalistic follow-up . OBJECTIVE We investigated whether micronutrients given acutely following the Christchurch earthquakes continued to confer benefit 1 year following the treatment . METHODS Sixty-four adults from the original 91 participants experiencing heightened anxiety or stress 2-3 months following the 22nd February 2011 earthquake and who had been randomized to receive three different doses of micronutrients completed on-line questionnaires assessing mood , anxiety , stress , and symptoms associated with post-traumatic stress disorder 1 year after completing the initial study . Twenty-one out of 29 nonrandomized controls who did not receive the treatment also completed the questionnaires . RESULTS Both the treated and control groups experienced significant improvement in psychological functioning compared with end-of-trial . However , treated participants had better long-term outcomes on most measures compared with controls ( ES=0.69-1.31 ) . Those who stayed on micronutrients through to follow-up or stopped all treatment reported better psychological functioning than those who switched to other treatments including medications . About 10 % of the sample continued to have post-traumatic stress disorder symptoms . CONCLUSIONS Disaster survivors improve psychologically over time regardless of receiving intervention ; however , those taking micronutrients during the acute phase following a disaster show better outcomes , identifying micronutrients as a viable treatment for acute stress following a natural disaster with maintenance of benefits 1 year later . ACTRN 12611000460909

micronutrients

micronutrients

three different doses of micronutrients

micronutrients

micronutrients

stress

anxiety

mood

anxiety

stress

, and

psychological functioning

long-term outcomes

psychological functioning

post-traumatic stress disorder symptoms

outcomes

acute stress

stress and anxiety

adults

Twenty-one out

Disaster survivors


Evaluation of the efficacy and safety of the ophthalmic insert Mydriasert in patients undergoing retinal angiography . PURPOSE To verify the efficacy to obtain mydriasis and cardiovascular safety of Mydriasert ( ophthalmic insert containing tropicamide and phenylephrine ) in diabetic and nondiabetic patients undergoing retinal angiography by comparing it with usually administered eyedrops ( tropicamide 1 % and phenylephrine 10 % ) . METHODS This was a prospective randomized study . A total of 154 eyes of 77 patients were randomly divided into 2 groups : group 1 consisted of 78 eyes , group 2 consisted of 76 eyes , and the patients were monitored for pupillary dilation , blood pressure , heart rate , and possible adverse effects at 0 , 20 , 40 , 60 , and 90 minutes . RESULTS No severe adverse effects were observed in either group . In the entire sample studied , the mean pupillary diameter was greater in the eyedrops group after 20 and 40 minutes , while mydriasis was similar in the 2 groups after 60 minutes . The diabetic patients treated with Mydriasert had less mydriasis than those treated with eyedrops after 20 and 40 minutes , and diabetic patients showed less mydriasis than the nondiabetic patients after 60 and 90 minutes . There was no significant between-group difference in mean heart rate or systolic and diastolic blood pressure at any of the time points . CONCLUSIONS Mydriasert assures an adequate degree of mydriasis for retinal angiography in both diabetic and nondiabetic patients . There are no differences in efficacy or safety between the insert and the usually administered eyedrops , but the low total drug dose administered with the insert reduces the risk of cardiovascular side effects .

ophthalmic insert Mydriasert

Mydriasert

Mydriasert

severe adverse effects

mean pupillary diameter

mydriasis

mydriasis

mean heart rate

systolic

diastolic blood pressure

retinal angiography

diabetic and nondiabetic

diabetic patients

diabetic and nondiabetic


Decreased expression of Yes-associated protein is associated with outcome in the luminal A breast cancer subgroup and with an impaired tamoxifen response . BACKGROUND Yes-associated protein ( YAP1 ) is frequently reported to function as an oncogene in many types of cancer , but in breast cancer results remain controversial . We set out to clarify the role of YAP1 in breast cancer by examining gene and protein expression in subgroups of patient material and by downregulating YAP1 in vitro and studying its role in response to the widely used anti-estrogen tamoxifen . METHODS YAP1 protein intensity was scored as absent , weak , intermediate or strong in two primary breast cancer cohorts ( n = 144 and n = 564 ) and mRNA expression of YAP1 was evaluated in a gene expression dataset ( n = 1107 ) . Recurrence-free survival was analysed using the log-rank test and Cox multivariate analysis was used to test for independence . WST-1 assay was employed to measure cell viability and a luciferase ERE ( estrogen responsive element ) construct was used to study the effect of tamoxifen , following downregulation of YAP1 using siRNAs . RESULTS In the ER+ ( Estrogen Receptor α positive ) subgroup of the randomised cohort , YAP1 expression was inversely correlated to histological grade and proliferation ( p = 0.001 and p = 0.016 , respectively ) whereas in the ER- ( Estrogen Receptor α negative ) subgroup YAP1 expression correlated positively to proliferation ( p = 0.005 ) . Notably , low YAP1 mRNA was independently associated with decreased recurrence-free survival in the gene expression dataset , specifically for the luminal A subgroup ( p < 0.001 ) which includes low proliferating tumours of lower grade , usually associated with a good prognosis . This subgroup specificity led us to hypothesize that YAP1 may be important for response to endocrine therapies , such as tamoxifen , extensively used for luminal A breast cancers . In a tamoxifen randomised patient material , absent YAP1 protein expression was associated with impaired tamoxifen response which was significant upon interaction analysis ( p = 0.042 ) . YAP1 downregulation resulted in increased progesterone receptor ( PgR ) expression and a delayed and weaker tamoxifen in support of the clinical data . CONCLUSIONS Decreased YAP1 expression is an independent prognostic factor for recurrence in the less aggressive luminal A breast cancer subgroup , likely due to the decreased tamoxifen sensitivity conferred by YAP1 downregulation .

tamoxifen

tamoxifen

WST-1 assay

tamoxifen

expression of Yes-associated protein

Yes-associated protein ( YAP1 )

YAP1 protein intensity

mRNA expression of YAP1

Recurrence-free survival

cell viability

luciferase ERE

luminal A breast cancer subgroup

n = 144 and n = 564

n = 1107


Dentists United to Extinguish Tobacco ( DUET ) : a study protocol for a cluster randomized , controlled trial for enhancing implementation of clinical practice guidelines for treating tobacco dependence in dental care settings . BACKGROUND Although dental care settings provide an exceptional opportunity to reach smokers and provide brief cessation advice and treatment to reduce oral and other tobacco-related health conditions , dental care providers demonstrate limited adherence to evidence-based guidelines for treatment of tobacco use and dependence . METHODS/DESIGN Guided by a multi-level , conceptual framework that emphasizes changes in provider beliefs and organizational characteristics as drivers of improvement in tobacco treatment delivery , the current protocol will use a cluster , randomized design and multiple data sources ( patient exit interviews , provider surveys , site observations , chart audits , and semi-structured provider interviews ) to study the process of implementing clinical practice guidelines for treating tobacco dependence in 18 public dental care clinics in New York City . The specific aims of this comparative-effectiveness research trial are to : compare the effectiveness of three promising strategies for implementation of tobacco use treatment guidelines-staff training and current best practices ( CBP ) , CBP + provider performance feedback ( PF ) , and CBP + PF + provider reimbursement for delivery of tobacco cessation treatment ( pay-for-performance , or P4P ) ; examine potential theory-driven mechanisms hypothesized to explain the comparative effectiveness of three strategies for implementation ; and identify baseline organizational factors that influence the implementation of evidence-based tobacco use treatment practices in dental clinics . The primary outcome is change in providers ' tobacco treatment practices and the secondary outcomes are cost per quit , use of tobacco cessation treatments , quit attempts , and smoking abstinence . DISCUSSION We hypothesize that the value of these promising implementation strategies is additive and that incorporating all three strategies ( CBP , PF , and P4P ) will be superior to CBP alone and CBP + PF in improving delivery of cessation assistance to smokers . The findings will improve knowledge pertinent to the implementation , dissemination , and sustained utilization of evidence-based tobacco use treatment in dental practices . TRIAL REGISTRATION NCT01615237 .

clinical practice guidelines

comparative-effectiveness

tobacco dependence

smokers

tobacco use and dependence


Comparison of the cardiorespiratory effects of a combination of ketamine and propofol , propofol alone , or a combination of ketamine and diazepam before and after induction of anesthesia in dogs sedated with acepromazine and oxymorphone . OBJECTIVE To evaluate the cardiorespiratory effects of IV administration of propofol ( 4 mg/kg ) , ketamine hydrochloride and propofol ( 2 mg/kg each ; K-P ) , or ketamine hydrochloride ( 5 mg/kg ) and diazepam ( 0.2 mg/kg ; K-D ) before and after induction of anesthesia ( IoA ) in dogs sedated with acepromazine maleate and oxymorphone hydrochloride . ANIMALS 10 healthy adult Beagles . PROCEDURES Each dog was randomly allocated to receive 2 of 3 treatments ( 1-week interval ) . For instrumentation prior to each treatment , each dog was anesthetized with isoflurane . After full recovery , acepromazine ( 0.02 mg/kg ) and oxymorphone ( 0.05 mg/kg ) were administered IV . Fifteen minutes later ( before IoA ) , each dog received treatment IV with propofol , K-P , or K-D. Cardiorespiratory and arterial blood gas variables were assessed before , immediately after , and 5 minutes after IoA . RESULTS Compared with findings before IoA , dogs receiving the K-P or K-D treatment had increased cardiac output , oxygen delivery , and heart rate 5 minutes after IoA ; K-P administration did not change mean arterial blood pressure or stroke volume and decreased systemic vascular resistance . Propofol decreased mean arterial blood pressure and systemic vascular resistance immediately after IoA but did not change heart rate , cardiac output , or oxygen delivery . All treatments caused some degree of apnea , hypoventilation , and hypoxemia ( Pao2 < 80 mm Hg ) . CONCLUSIONS AND CLINICAL RELEVANCE In dogs , K-P treatment maintained mean arterial blood pressure better than propofol alone and increased heart rate , cardiac output , or oxygen delivery , as did the K-D treatment . Supplemental 100 % oxygen should be provided during IoA with all 3 treatments .

ketamine

propofol

propofol

ketamine

diazepam

propofol

ketamine hydrochloride and propofol

ketamine hydrochloride

diazepam

anesthesia

acepromazine maleate

oxymorphone hydrochloride

anesthetized with isoflurane

acepromazine

oxymorphone

propofol , K-P , or K-D.

K-P

K-D

K-P

K-P

K-D

cardiorespiratory effects

mean arterial blood pressure

systemic vascular resistance

heart rate

cardiac output

oxygen delivery

mean arterial blood pressure

heart rate

cardiac output

oxygen delivery


Are 'leaky gut ' and behavior associated with gluten and dairy containing diet in children with autism spectrum disorders ? OBJECTIVES Studies have suggested a link between diet and behavior in children with autism spectrum disorders ( ASDs ) . Parental reports of behavioral changes upon exposure to gluten and/or casein are common in clinical practice . An association between diet type , intestinal permeability ( IP ) ( 'leaky gut ' ) , and behavior has been long proposed but not substantiated . We explored this possible association in this trial . METHODS This randomized double-blind , placebo-controlled study explored the effects of gluten and milk on IP and behavior in children with ASDs over a period of 4 weeks . IP assessed by lactulose : mannitol ( L/M ) sugar permeability test and behavior assessed by the Aberrant Behavior Checklist and Conners Parent Rating were measured . Gastrointestinal symptoms in both groups were also monitored . RESULTS Neither the L/M ratio nor behavioral scores were different between groups exposed to gluten/dairy or placebo . The changes observed were noted to be small and not clinically significant . DISCUSSION Our study although underpowered to show small differences does not support an association between dietary gluten/milk , IP , and behavioral changes in subjects with ASD .

gluten

dairy

gluten and milk

'leaky gut '

behavior

behavior

behavior

Gastrointestinal symptoms

L/M ratio nor behavioral scores

behavioral changes

children

autism spectrum disorders

children

autism spectrum disorders ( ASDs )

children

ASDs

ASD


Activation of the carotid chemoreflex secondary to muscle metaboreflex stimulation in men . Recent work has shown that the carotid chemoreceptor ( CC ) contributes to sympathetic control of cardiovascular function during exercise , despite no evidence of increased circulating CC stimuli , suggesting enhanced CC activity/sensitivity . As interactions between metaboreceptors and chemoreceptors have been previously observed , the purpose of this study was to isolate the metaboreflex while acutely stimulating or inhibiting the CC to determine whether the metaboreflex increased CC activity/sensitivity . Fourteen young healthy men ( height : 177.0 ± 2.1 cm , weight : 85.8 ± 5.5 kg , age : 24.6 ± 1.1 yr ) performed three trials of 40 % maximal voluntary contraction handgrip for 2 min , followed by 3 min of postexercise circulatory occlusion ( PECO ) to stimulate the metaboreflex . In random order , subjects either breathed room air , hypoxia ( target SPo2 = 85 % ) , or hyperoxia ( FiO2 = 1.0 ) during the PECO to modulate the chemoreflex . After these trials , a resting hypoxia trial was conducted without handgrip or PECO . Ventilation ( Ve ) , heart rate ( HR ) , blood pressure , and muscle sympathetic nervous activity ( MSNA ) data were continuously obtained . Relative to normoxic PECO , inhibition of the CC during hyperoxic PECO resulted in lower MSNA ( P = 0.038 ) and HR ( P = 0.021 ) . Relative to normoxic PECO , stimulation of the CC during hypoxic PECO resulted in higher HR ( P < 0.001 ) and Ve ( P < 0.001 ) . The ventilatory and MSNA responses to hypoxic PECO were not greater than the sum of the responses to hypoxia and PECO individually , indicating that the CC are not sensitized during metaboreflex activation . These results demonstrate that stimulation of the metaboreflex activates , but does not sensitize the CC , and help explain the enhanced CC activity with exercise .

muscle metaboreflex stimulation

men


Collagen cross-linking with photoactivated riboflavin ( PACK-CXL ) for the treatment of advanced infectious keratitis with corneal melting . PURPOSE To investigate the efficacy and safety of corneal collagen cross-linking ( CXL ) with photoactivated riboflavin ( photoactivated chromophore for infectious keratitis [ PACK ] -CXL ) in the management of infectious keratitis with corneal melting . DESIGN Prospective clinical trial . PARTICIPANTS Forty eyes from 40 patients with advanced infectious keratitis and coexisting corneal melting . METHODS Twenty-one patients ( 21 eyes ) underwent PACK-CXL treatment in addition to antimicrobial therapy . The control group consisted of 19 patients ( 19 eyes ) who received only antimicrobial therapy . MAIN OUTCOME MEASURES The slit-lamp characteristics of the corneal ulceration , corrected distance visual acuity , duration until healing , and complications were documented in each group . The Mann-Whitney U test was used for statistical analysis . P values less than 0.05 were considered statistically significant . RESULTS The average time until healing was 39.76 ± 18.22 days in the PACK-CXL group and 46.05 ± 27.44 days in the control group ( P = 0.68 ) . After treatment and healing , corrected distance visual acuity was 1.64 ± 0.62 in the PACK-CXL group and 1.67 ± 0.48 in the control group ( P = 0.68 ) . The corneal ulceration 's width and length was significantly bigger in the PACK-CXL group ( P = 0.004 and P = 0.007 ) . Three patients in the control group demonstrated corneal perforation ; infection recurred in 1 of them . No serious complications occurred in the PACK-CXL group . CONCLUSIONS Corneal CXL with photoactivated riboflavin did not shorten the time to corneal healing ; however , the complication rate was 21 % in the control group , whereas there was no incidence of corneal perforation or recurrence of the infection in the PACK-CXL group . These results indicate that PACK-CXL may be an effective adjuvant therapy in the management of severe infectious keratitis associated with corneal melting .

corneal collagen cross-linking ( CXL )

only antimicrobial therapy

efficacy and safety

corrected distance visual acuity

duration until healing

complications

time until healing

Twenty-one patients


Effects of phosphorus-restricted diet and phosphate-binding therapy on outcomes in patients with chronic kidney disease . BACKGROUND Phosphorus is associated with mortality in patients with chronic kidney disease ( CKD ) not on dialysis , possibly through phosphorus-dependent vascular calcification . Although a phosphorus-restricted diet reduces serum phosphorus , it is unlikely that it reduces vascular calcification progression in CKD . This study evaluated whether a combined strategy of phosphorus-restricted diet and phosphate-binding therapy can reduce the risk of all-cause mortality and/or dialysis initiation by attenuating coronary artery calcification ( CAC ) progression in non-dialysis CKD patients . METHODS This was a post hoc analysis of a subgroup of patients from a study that evaluated the impact of two phosphorus binder regimens on hard outcomes in CKD . Patients ( n = 113 ) with stage 3-4 CKD and evidence of CAC on a phosphorus-restricted diet were randomized to receive either calcium carbonate or sevelamer added to their phosphorus-restricted diet . End-points were death for any cause and initiation of dialysis . Patients were monitored to the first event or to conclusion of the 36-month follow-up . RESULTS Overall , treatment with calcium carbonate was associated with increased CAC progression and occurrence of all-cause mortality , dialysis initiation , and the composite end-point . After adjustment for confounders , sevelamer use was the only independent predictive factor of reduced risk of each endpoint but only if CAC progression was either absent or moderate . Accelerated progression ( annual CAC increase > 75th percentile of the study cohort ) increased the risk of all-cause mortality and composite end-point ( p = 0.01 ) independently of the use of sevelamer . CONCLUSIONS A significant reduction in all-cause mortality , dialysis initiation , and composite end-point risk was achieved by combining phosphorus-restricted diet and sevelamer in non-dialysis CKD patients with absent or moderate but not accelerated CAC progression . Future studies should investigate the role of serum phosphorus , the usefulness of a phosphorus-restricted diet , and the appropriateness of current normal ranges of serum phosphorus concentration in relation to events in non-dialyzed CKD patients .

phosphorus-restricted diet

phosphate-binding therapy

phosphorus-restricted diet

phosphate-binding therapy

risk of all-cause mortality

dialysis initiation

patients with chronic kidney disease

patients with chronic kidney disease

CKD

non-dialysis CKD patients

CAC

CKD


Prospective randomized trial of bispectral index monitoring of sedation depth during flexible bronchoscopy . BACKGROUND The clinical benefits associated with the use of the bispectral index ( BIS ) to monitor the depth of sedation during flexible fiberoptic bronchoscopy ( FFB ) are questionable . OBJECTIVES To evaluate the added value in terms of procedural safety and patients ' awareness of monitoring sedation depth using the BIS compared to conventional clinical judgment alone in patients undergoing FFB under propofol sedation . METHODS The cohort included 81 patients undergoing diagnostic or therapeutic bronchoscopy under propofol sedation that were prospectively randomized to guide the depth of sedation by BIS monitoring ( BIS group ; n = 40 ) or conventional monitoring ( control group ; n = 41 ) . RESULTS The mean durations of the procedure were 18 and 19 min in the BIS and control groups , respectively . No significant difference was noted in the dosage of propofol used between the BIS and control groups ( 168.7 vs. 167.3 mg , respectively ) . Average sedation-related oxygen saturation drop and transcutaneous CO2 rise were not significantly different between groups . There was also no significant difference in the percentage of patients that required either hemodynamic support ( 5 vs. 7.5 % , respectively ) , oxygen supplementation by 100 % O2 mask ( 67.5 vs. 82.5 % , respectively ) or Ambu face mask manual ventilation ( 2.5 vs. 5 % , respectively ) between the groups . No significant difference was noted in terms of patients ' awareness during the procedure , which was assessed following recovery by a structured Brice interview . CONCLUSION Using BIS to guide the depth of sedation during propofol sedation in patients undergoing FFB of relatively short duration offers no clinically significant advantages over conventional monitoring .

monitoring

bispectral index ( BIS

propofol sedation

BIS monitoring

conventional monitoring

depth of sedation

depth of sedation

dosage of propofol

transcutaneous CO2

patients ' awareness


Safety and efficacy of a low molecular weight heparin ( Logiparin ) versus dextran as prophylaxis against thrombosis after total hip replacement . In order to study the plasma levels of factor XaI and IIaI activity an enzymatically depolymerized low molecular weight heparin ( LMW-heparin ; Logiparin ) was given s.c. in a dose of 35 XaI mu/kg b.w . once daily for 7 days to 10 patients undergoing total hip replacement ( THR ) in a pilot study . The XaI activity was less than or equal to 0.24 XaI units/ml and the IIaI activity less than or equal to 0.043 IIaI mu/ml . No accumulation of the activities were seen . No phlebographically verified thrombi or any bleeding complications were registered . From this study it was concluded that the given dose of Logiparin was safe with regard to bleeding complications . Based on these data , an open , randomized controlled trial was started . In this main study the thromboprophylactic effect of the LMW-heparin ( Logiparin ) in a dose of 35 XaI mu/kg b.w . once daily was compared with that of dextran 70 in patients undergoing THR . 100 patients were randomized . The over-all thrombosis rate was 28 % in patients treated with LMW-heparin and 39 % in those given dextran , a non-significant difference . No bleeding complications , deaths or pulmonary embolism were recorded in either group . Peroperative blood loss and transfusion requirements were similar in the two groups . In conclusion , the investigated LMW-heparin ( Logiparin ) is safe and effective in preventing postoperative thromboembolism in patients undergoing total hip replacement , but the dosage can probably be optimized .

Safety

efficacy

phlebographically verified thrombi

bleeding complications

thromboprophylactic effect

over-all thrombosis rate

bleeding complications

deaths

pulmonary embolism

total hip replacement

THR

undergoing THR


Do physicians ' implicit views of African Americans affect clinical decision making ? BACKGROUND Total knee replacement ( TKR ) is a cost-effective treatment option for severe osteoarthritis ( OA ) . While prevalence of OA is higher among blacks than whites , TKR rates are lower among blacks . Physicians ' implicit preferences might explain racial differences in TKR recommendation . The objective of this study was to evaluate whether the magnitude of implicit racial bias predicts physician recommendation of TKR for black and white patients with OA and to assess the effectiveness of a web-based instrument as an intervention to decrease the effect of implicit racial bias on physician recommendation of TKR . METHODS In this web-based study , 543 family and internal medicine physicians were given a scenario describing either a black or white patient with severe OA refractory to medical treatment . Questionnaires evaluating the likelihood of recommending TKR , perceived medical cooperativeness , and measures of implicit racial bias were administered . The main outcome measures included TKR recommendation , implicit racial preference , and medical cooperativeness stereotypes measured with implicit association tests . RESULTS Subjects displayed a strong implicit preference for whites over blacks ( P < .0001 ) and associated " medically cooperative " with whites over blacks ( P < .0001 ) . Physicians reported significantly greater liking for whites over blacks ( P < .0001 ) and reported believing whites were more medically cooperative than blacks ( P < .0001 ) . Participants reported providing similar care for white and black patients ( P = .10 ) but agreed that subconscious biases could influence their treatment decisions ( P < .0001 ) . There was no significant difference in the rate of recommendation for TKR when the patient was black ( 47 % ) versus white ( 38 % ) ( P = .439 ) , and neither implicit nor explicit racial biases predicted differential treatment recommendations by race ( all P > .06 ) . Although participants were more likely to recommend TKR when completing the implicit association test before the decision , patient race was not significant in the association ( P = .960 ) . CONCLUSIONS Physicians possessed explicit and implicit racial biases , but those biases did not predict treatment recommendations . Clinicians ' biases about the medical cooperativeness of blacks versus whites , however , may have influenced treatment decisions .

Total knee replacement ( TKR )

TKR

TKR

TKR .

TKR

TKR

TKR

" medically cooperative "

liking

medically cooperative

care

rate of recommendation for TKR

recommend TKR

OA


Intravenous lipid emulsion improves recovery time and quality from isoflurane anaesthesia : a double-blind clinical trial . Recovery time and quality after general anaesthesia is important for patient safety . This study aimed to determine whether intravenous lipid emulsion could improve recovery profiles from isoflurane anaesthesia in adult patients undergoing laparoscopic cholecystectomy . Sixty-six patients were enrolled . After anaesthesia induction , inspired isoflurane concentration was adjusted to maintain stable vital signs and the suitable conditions for operation . At the end of the operation , the isoflurane was discontinued , and either 2 ml/kg 30 % lipid emulsions or 0.9 % saline solution was administered intravenously . The time to eye opening , extubation and exit from the operation room was recorded , and the quality of recovery from anaesthesia was assessed . Sixty patients completed the study . The median time to eye opening and exit from the operation room was significantly shorter in the lipid emulsion group than in the saline group [ 15.5 ( interquartile range 9.0 ) versus 20.0 ( 10.0 ) min. , p = 0.01 ; 19.5 ( 8.3 ) versus 23.6 ( 6.3 ) min. , p = 0.04 , respectively ] , whereas the median time to extubation did not show any noticeable difference . The quality of recovery was better in the lipid emulsion group than that of the saline solution group with respect to drowsiness visual analogue scale score ( p < 0.01 ) , Observer 's Assessment of Alertness/Sedation score ( p < 0.01 ) , Mini-Mental State Examination score ( p = 0.04 ) and Modified Aldrete Post Anaesthesia Recovery score ( p = 0.03 ) . No serious adverse events were observed during the study period . In conclusion , intravenous lipid emulsion may effectively improve the recovery time and quality from isoflurane anaesthesia for laparoscopic cholecystectomy .

Intravenous lipid emulsion

isoflurane anaesthesia :

intravenous lipid emulsion

isoflurane anaesthesia

isoflurane

lipid emulsions

saline solution

lipid emulsion

isoflurane anaesthesia

adult

laparoscopic cholecystectomy

Sixty-six

Sixty patients


The effect of lowering LDL cholesterol on vascular access patency : post hoc analysis of the Study of Heart and Renal Protection . BACKGROUND AND OBJECTIVES Reducing LDL cholesterol ( LDL-C ) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD , including dialysis patients , but the effect of lowering LDL-C on vascular access patency is unclear . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS The Study of Heart and Renal Protection ( SHARP ) randomized patients with CKD to 20 mg simvastatin plus 10 mg ezetimibe daily versus matching placebo . This study aimed to explore the effects of treatment on vascular access occlusive events , defined as any access revision procedure , access thrombosis , removal of an old dialysis access , or formation of new permanent dialysis access . RESULTS Among 2353 SHARP participants who had functioning vascular access at randomization , allocation to simvastatin plus ezetimibe resulted in a 13 % proportional reduction in vascular access occlusive events ( 355 [ 29.7 % ] for simvastatin/ezetimibe versus 388 [ 33.5 % ] for placebo ; risk ratio [ RR ] , 0.87 ; 95 % confidence interval [ 95 % CI ] , 0.75 to 1.00 ; P=0.05 ) . There was no evidence that the effects of treatment differed for any of the separate components of this outcome . To test the hypothesis raised by SHARP , comparable analyses were performed using the AURORA ( A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis : An Assessment of Survival and Cardiovascular Events ) trial cohort . AURORA did not provide independent confirmation ( vascular access occlusive events : 352 [ 28.9 % ] for rosuvastatin versus 337 [ 27.6 % ] for placebo ; RR , 1.06 , 95 % CI , 0.91 to 1.23 ; P=0.44 ) . After combining the two trials , the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant ( 707 [ 29.3 % ] with any LDL-C-lowering therapy versus 725 [ 30.5 % ] with placebo ; RR , 0.95 , 95 % CI , 0.85 to 1.05 ; P=0.29 ) . CONCLUSIONS Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency , but there was no evidence of benefit in AURORA . Taken together , the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest .

statin-based therapy

placebo

simvastatin/ezetimibe

placebo

statin-based therapy

any access revision procedure

access thrombosis

removal of an old dialysis access

LDL-C

CKD

who had functioning vascular access


Short-term speech-language intervention for children with disorders of the autism spectrum . PURPOSE To assess any changes in the Functional Communicative Profile ( FCP ) and in the Social Cognitive Performance ( SCP ) of children with Autism Spectrum Disorders , based on two short periods of intervention . METHODS The study was conducted with 21 children with Autism Spectrum Disorder diagnoses , randomly allocated into two groups , who received the same short-term intervention types ( 6 weeks with the mother and 6 weeks with the support of an educational software program ) . The intervention process was conducted by speech-language pathologists who were part of a graduate program in this area . RESULTS Samples of 15-minute interaction sessions between the child and speech-language pathologist were used to assess the changes in the FCP and the SCP . The statistic analysis pointed out differences only in Group 1 for the variables " percentage of communicative space used " and " use of the mediating object " . CONCLUSION With the intervention sessions structured over 12 weeks , it was possible to observe a few changes in the children 's FCP and in the SCP . Therefore , we point out the need for new research studies of longer duration .

percentage of communicative space used

" and "

use of the mediating object

children

disorders of the autism spectrum

Spectrum


Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge . OBJECTIVES The objective was to test the hypothesis that hydrocodone/acetaminophen ( Vicodin [ 5/500 ] ) provides more efficacious analgesia than codeine/acetaminophen ( Tylenol # 3 [ 30/300 ] ) in patients discharged from the emergency department ( ED ) . Both are currently Drug Enforcement Administration ( DEA ) Schedule III narcotics . METHODS This was a prospective , randomized , double-blind , clinical trial of patients with acute extremity pain who were discharged home from the ED , comparing a 3-day supply of oral hydrocodone/acetaminophen ( 5 mg/500 mg ) to oral codeine/acetaminophen ( 30 mg/300 mg ) . Pain was measured on a valid and reproducible verbal numeric rating scale ( NRS ) ranging from 0 to 10 , and patients were contacted by telephone approximately 24 hours after being discharged . The primary outcome was the between-group difference in improvement in pain at 2 hours following the most recent ingestion of the study drug , relative to the time of phone contact after ED discharge . Secondary outcomes compared side-effect profiles and patient satisfaction . RESULTS The median time from ED discharge to follow-up was 26 hours ( interquartile range [ IQR ] = 24 to 39 hours ) . The mean NRS pain score before the most recent dose of pain medication after ED discharge was 7.6 NRS units for both groups . The mean decrease in pain scores 2 hours after pain medications were taken were 3.9 NRS units in the hydrocodone/acetaminophen group versus 3.5 NRS units in the codeine/acetaminophen group , for a difference of 0.4 NRS units ( 95 % confidence interval [ CI ] = -0.3 to 1.2 NRS units ) . No differences were found in side effects or patient satisfaction . CONCLUSIONS Both medications decreased NRS pain scores by approximately 50 % . However , the oral hydrocodone/acetaminophen failed to provide clinically or statistically superior pain relief compared to oral codeine/acetaminophen when prescribed to patients discharged from the ED with acute extremity pain . Similarly , there were no clinically or statistically important differences in side-effect profiles or patient satisfaction . If the DEA reclassifies hydrocodone as a Schedule II narcotic , as recently recommended by its advisory board , our data suggest that the codeine/acetaminophen may be a clinically reasonable Schedule III substitute for hydrocodone/acetaminophen at ED discharge . These findings should be regarded as tentative and require independent validation in similar and other acute pain models .

hydrocodone/acetaminophen

codeine/acetaminophen

hydrocodone/acetaminophen

codeine/acetaminophen

codeine/acetaminophen

codeine/acetaminophen

Pain

pain

side-effect profiles

patient satisfaction

median time from ED

mean NRS pain score

mean decrease in pain scores

pain

side effects

patient satisfaction

NRS pain scores

superior

pain relief

acute extremity pain

acute extremity pain


A blinded , randomized , controlled trial assessing conservative management strategies for frozen shoulder . BACKGROUND There is little evidence for the optimal form of nonoperative treatment in the management of frozen shoulder . This study assesses the efficacy of current physiotherapy strategies . METHODS All primary care referrals of frozen shoulder to our physiotherapy department were included during a 12-month period . Of these referrals , 17 % met the inclusion criteria for primary idiopathic frozen shoulder . The 75 patients were randomly assigned to 1 of 3 groups : group exercise class , individual physiotherapy , and home exercises alone . A single independent physiotherapist , who was blinded to the treatment groups , made all assessments . Range of motion , Constant score , Oxford Shoulder Score , Short Form 36 , and Hospital Anxiety and Disability Scale ( HADS ) outcome measures were performed at baseline , 6 weeks , 6 months , and 1 year . RESULTS The exercise class group improved from a mean Constant score of 39.8 at baseline to 71.4 at 6 weeks and 88.1 at 1 year . There was a significant improvement in shoulder symptoms on Oxford and Constant scores ( P < .001 ) . This improvement was greater than with individual physiotherapy or home exercises alone ( P < .001 ) . The improvement in range of motion was significantly greater in both physiotherapy groups over home exercises ( P < .001 ) . HADS scores significantly improved during the course of treatment ( P < .001 ) . The improvement in HADS anxiety score was significantly greater in both physiotherapy intervention groups than in home exercises alone . CONCLUSIONS A hospital-based exercise class can produce a rapid recovery from a frozen shoulder with a minimum number of visits to the hospital and is more effective than individual physiotherapy or a home exercise program .

group exercise class

individual physiotherapy

home exercises alone

hospital-based exercise class

Range of motion

Constant score

Oxford Shoulder Score

Short Form 36

Hospital Anxiety

and Disability Scale ( HADS )

mean Constant score

HADS scores

HADS anxiety score

frozen shoulder

frozen shoulder

frozen shoulder

primary idiopathic frozen shoulder

frozen shoulder


Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement . STUDY OBJECTIVES Previous studies have demonstrated pronounced reduction of REM sleep on the first nights following major surgery which may influence pain , analgesic use , and recovery . This placebo-controlled , randomized , double-blind study set out to evaluate the effect of zolpidem on sleep architecture in an elderly population undergoing fast-track total hip and knee arthroplasty ( THA/TKA ) with length of stay < 3 days . METHODS Twenty patients ( ≥ 60 years ) undergoing THA or TKA in a standardized setup with spinal anesthesia and multimodal opioid-sparing postoperative analgesia were included . Polysomnography measures were performed for 2 nights , 1 night at home prior to surgery and on the first night after surgery , when the patient received placebo or zolpidem 10 mg. Analgesic use , pain levels , and subjective measures of fatigue and sleep quality were recorded . Analysis of sleep data was performed according to the American Academy of Sleep Medicine manual . RESULTS Objective sleep data did not show a significant difference between groups in any of the sleep stages . However , subjective data on sleep quality and fatigue showed significantly less fatigue and better sleep quality in the zolpidem group ( p < 0.05 ) , and reduced objectively recorded number of arousals ( p = 0.004 ) . Levels of pain and opioid use were similar in the 2 groups . CONCLUSIONS Our objective data did not support the primary hypothesis that one night 's treatment with zolpidem would significantly improve sleep architecture following major surgery , although there was improved feeling of sleep quality and fatigue associated with fewer postoperative arousals . CITATION Krenk L ; Jennum P ; Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement .

zolpidem

zolpidem

zolpidem

reduction of REM sleep

pain , analgesic use

recovery .

sleep disturbances

elderly

knee arthroplasty

Twenty

≥ 60 years


Brief acceptance-based intervention for increasing intake attendance at a community mental health center . Intake no-show rates for psychotherapy vary from 20 % to 57 % ( Swenson & Pekarik , 1988 ) , and experiential avoidance may be related to failure to attend intake sessions . This pilot study attempted to increase intake attendance at a community mental health center by employing a brief experiential acceptance-based intervention . Those who scheduled intakes were randomly assigned to 1 of 2 groups : orientation letter or acceptance-enhanced orientation letter ; rates from these conditions were compared with a retrospective comparison control group . Participants were randomized by way of an online random number generator . Persons assigned to the orientation group did not have a higher show rate than persons within the control group ( ∼48 % compared with ∼52 % ) . Persons assigned to the acceptance group did have higher show rates than persons in the other two groups ( ∼67 % compared with ∼48 % and ∼52 % , respectively ) , however this difference was nonsignificant . Results suggest that brief acceptance-based interventions should be further studied for their potential value in maximizing client attendance .

acceptance-based intervention

control

intake attendance

show rate

higher show rates


Prophylactic training for the prevention of radiotherapy-induced trismus - a randomised study . BACKGROUND Radiotherapy-induced trismus ( RTIT ) is a debilitating condition without any proven effective treatment . This study investigates the effectiveness of prophylactic training to prevent RTIT during and up to 12 months after completed RT in patients with head and neck cancer ( HNC ) , also investigating the incidence of RTIT . METHODS Sixty-six consecutive patients from two RT clinics in Sweden were randomised into one of two groups : training with TheraBite ( ® ) Jaw Motion Rehabilitation System ( ™ ) or a control group . Maximum interincisal openings ( MIO ) were recorded at baseline and once a week during treatment , three , six and 12 months after completed RT . Training frequency was recorded by patients in a log book . RESULTS There were no significant differences in MIO between the intervention and control groups at any of the measurement points . Patients in both groups maintained their normal variation in MIO at 12 months after completed RT . A small group of patients in the control group had a 17 % mean decrease in MIO by week 6 compared to baseline and improved their MIO by using the training programme . There was a significant mean difference in MIO from baseline to week 6 ( 3 mm , p = 0.018 ) , and month 6 ( 2.7 mm , p = 0.040 ) , for patients receiving 3D conformal radiotherapy . There was a significant difference in MIO between patients treated with RT and concurrent chemotherapy compared to patients with RT only at 12 months ( p = 0.033 ) . CONCLUSIONS Patients with HNC undergoing high dose RT do not need to be burdened with an intense prophylactic training programme during RT and up to 12 months after completed RT . MIO measurements during RT and up to 12 months after completed RT are recommended to identify a small risk group who are an exception and may need a training programme .

Prophylactic training

prophylactic training

control

Sixty-six

Patients with HNC undergoing high dose


Sorafenib dose escalation is not uniformly associated with blood pressure elevations in normotensive patients with advanced malignancies . Hypertension after treatment with vascular endothelial growth factor ( VEGF ) receptor inhibitors is associated with superior treatment outcomes for advanced cancer patients . To determine whether increased sorafenib doses cause incremental increases in blood pressure ( BP ) , we measured 12-h ambulatory BP in 41 normotensive advanced solid tumor patients in a randomized dose-escalation study . After 7 days ' treatment ( 400 mg b.i.d . ) , mean diastolic BP ( DBP ) increased in both study groups . After dose escalation , group A ( 400 mg t.i.d . ) had marginally significant further increase in 12-h mean DBP ( P = 0.053 ) , but group B ( 600 mg b.i.d . ) did not achieve statistically significant increases ( P = 0.25 ) . Within groups , individuals varied in BP response to sorafenib dose escalation , but these differences did not correlate with changes in steady-state plasma sorafenib concentrations . These findings in normotensive patients suggest BP is a complex pharmacodynamic biomarker of VEGF inhibition . Patients have intrinsic differences in sensitivity to sorafenib 's BP-elevating effects .

Sorafenib

sorafenib

blood pressure ( BP )

normotensive

advanced malignancies

advanced cancer patients


Omitting radiotherapy in early positron emission tomography-negative stage I/II Hodgkin lymphoma is associated with an increased risk of early relapse : Clinical results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 trial . PURPOSE Combined-modality treatment is standard treatment for patients with clinical stage I/II Hodgkin lymphoma ( HL ) . We hypothesized that an early positron emission tomography ( PET ) scan could be used to adapt treatment . Therefore , we started the randomized EORTC/LYSA/FIL Intergroup H10 trial evaluating whether involved-node radiotherapy ( IN-RT ) could be omitted without compromising progression-free survival in patients attaining a negative early PET scan after two cycles of ABVD ( doxorubicin , bleomycin , vinblastine , and dacarbazine ) as compared with standard combined-modality treatment . PATIENTS AND METHODS Patients age 15 to 70 years with untreated clinical stage I/II HL were eligible . Here we report the clinical outcome of the preplanned interim futility analysis scheduled to occur after documentation of 34 events in the early PET-negative group . Because testing for futility in this noninferiority trial corresponds to testing the hypothesis of no difference , a one-sided superiority test was conducted . RESULTS The analysis included 1,137 patients . In the favorable subgroup , 85.8 % had a negative early PET scan ( standard arm , one event v experimental arm , nine events ) . In the unfavorable subgroup , 74.8 % had a negative early PET scan ( standard arm , seven events v experimental arm , 16 events ) . The independent data monitoring committee concluded it was unlikely that we would show noninferiority in the final results for the experimental arm and advised stopping random assignment for early PET-negative patients . CONCLUSION On the basis of this analysis , combined-modality treatment resulted in fewer early progressions in clinical stage I/II HL , although early outcome was excellent in both arms . The final analysis will reveal whether this finding is maintained over time .

Combined-modality treatment

positron emission tomography ( PET )

involved-node radiotherapy ( IN-RT )

doxorubicin

bleomycin

vinblastine

dacarbazine

combined-modality treatment

PET scan

PET scan

PET-negative

clinical stage I/II HL

age 15 to 70 years

favorable subgroup

unfavorable subgroup


Prophylactic vs therapeutic blood patch for obstetric patients with accidental dural puncture -- a randomised controlled trial . Epidural blood patch is a standard treatment for obstetric patients experiencing a severe post-dural puncture headache . Patients who sustained an accidental dural puncture during establishment of epidural analgesia during labour or at caesarean delivery were randomly assigned to receive a prophylactic epidural blood patch or conservative treatment with a therapeutic epidural blood patch if required . Eleven of 60 ( 18.3 % ) patients in the prophylactic epidural blood patch group developed a post-dural puncture headache compared with 39 of 49 ( 79.6 % ) in the therapeutic epidural blood patch group ( p < 0.0001 ) . A blood patch was performed in 36 ( 73.4 % ) of patients in the therapeutic group . The number of patients who needed a second blood patch did not differ significantly between the two groups : 6 ( 10.0 % ) for prophylactic epidural blood patch and 4 ( 11.1 % ) for therapeutic epidural blood patch . We conclude that prophylactic epidural blood patch is an effective method to reduce the development of post-dural puncture headache in obstetric patients .

Epidural blood patch

prophylactic epidural blood patch

prophylactic epidural blood

post-dural puncture headache

effective

Eleven

obstetric patients


Aerobic versus resistance training effects on health-related quality of life , body composition , and function of older adults . This study aimed to investigate the effects of training on health-related quality of life ( HRQoL ) , body composition , and function in older adults . Fifty participants were randomized into aerobic training ( AT -- 70 % -80 % HR reserve ) , resistance training ( RT -- 80 % 1RM ) , or controls . They had HRQoL , body composition , and function assessed before and after 8 months . Training groups reduced body fat , increased performance in the stair ascent , 8-ft up-and-go and sit-to-stand five-times tests , and improved their physical component score ( PCS ; p ≤ .03 ) . AT increased performance in the 6MWT test , and improved general and mental health ( MH ) domains when compared to controls ( p < .01 ) . Finally , changes in stair ascent were associated with changes in bodily pain , MH , and mental component score ( p ≤ .04 ) , while changes in handgrip strength were associated with changes in physical role and MH ( p = .03 ) . AT and RT were effective interventions for decreasing body fat and improving functionality and the PCS in older adults .

Aerobic versus resistance training

aerobic training

resistance training

controls .

health-related quality of life

body composition

function of older adults

body composition

function

HRQoL

body composition

function

reduced body fat

improved their physical component score

AT increased performance

with changes in bodily pain

MH , and mental component score

changes in handgrip strength

with changes in physical role and

decreasing body

improving functionality

the PCS in older adults

older adults

Fifty participants

the PCS


Factors associated with low consumption of fruits and vegetables by preschoolers of low socio-economic level . OBJECTIVE To evaluate factors associated with low consumption of fruits and vegetables among preschoolers from families treated at basic health centers in Porto Alegre , RS , Brazil . METHODS This was a cohort study nested in a randomized field trial . Data collection was performed through structured questionnaires to obtain demographic and dietary data , combined with two 24-hour recalls in the age groups 12-16 months and again at 2-3 years of age . Data on the consumption of one daily serving of fruits ( 80 g ) and vegetables ( 60 g ) were evaluated , as well as consumption of non-recommended foods such as candy , chocolate , and soft drinks . Statistical analyses were performed using Poisson regression with robust estimation . RESULTS A total of 388 children aged 2-3 years were evaluated ; of these , 58 % and 87.4 % did not consume one daily serving of fruits and vegetables , respectively . The following factors were negatively associated with fruit consumption : family income higher than four minimum wages , ( p=0.024 ) , lower paternal educational level ( p=0.03 ) , and lower fruit consumption at 12-16 months ( p=0.002 ) . Factors negatively associated with the consumption of vegetables were low paternal educational level ( p=0.033 ) and consumption of high-sugar content beverages at 12-16 months ( p=0.014 ) . CONCLUSION This study demonstrated a high prevalence of children who consumed less than one daily serving of fruit and vegetables ; early feeding practices , parental education , and family income were associated with this process .

fruits and vegetables

structured questionnaires

fruits ( 80 g ) and vegetables

non-recommended foods

candy , chocolate , and soft drinks .

fruits and vegetables

consumption of vegetables

family income

in the age groups 12-16 months

at 2-3 years of age .

388 children

2-3 years


Custom tray application of peroxide gel as an adjunct to scaling and root planing in the treatment of periodontitis : results of a randomized controlled trial after six months . OBJECTIVE Scaling and root planing ( SRP ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited . Consequently , various adjunctive therapies have been investigated to improve clinical outcome . This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months . METHODS An examiner-blind clinical trial was conducted among 30 subjects with moderate to advanced periodontitis who were randomized to SRP alone or SRP combined with prescription custom-tray application ( Perio Tray ) of 1.7 % hydrogen peroxide gel ( Perio Gel ) for a period of three months , then extended to six months . Following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase . SRP was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( PPD ) and bleeding index ( BI ) , were conducted at baseline and after two , five , 13 , and 26 weeks of peroxide gel applications . Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval . RESULTS A total of 13 test and 15 control subjects completed the original three-month trial , of whom 10 test and 13 control subjects finished the three-month extension . After two weeks of peroxide gel use prior to SRP , mean PPD for the test group significantly decreased from baseline by 0.21 mm and mean BI significantly dropped by 0.14 ; clinical parameters for the control group were unchanged . Two weeks following SRP , mean PPD significantly decreased from baseline by 0.65 mm for the test group and 0.17 mm for the control ; mean BI significantly dropped by 0.17 for the test group and 0.05 for the control . Ten weeks following SRP , mean PPD decreases were 0.77 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.14 for the test group and 0.00 for the control . For subjects who completed the three-month extension ( i.e. , 23 weeks post-SRP ) , mean PPD decreases were 0.72 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.05 for the test group and 0.01 for the control . Analysis of deeper pockets ( i.e. , > 5 mm at baseline ) showed the same relationship for PPD , but with larger differences between groups . For example , after two weeks of peroxide gel use prior to SRP , mean PPD decreased by 0.48 mm for the test group compared to 0.04 mm for the control . Two weeks after SRP , mean PPD decreased from baseline by 1.40 mm for the test group and 0.60 mm for the control , and 10 weeks after SRP by 1.57 mm for the test group and 0.58 mm for the control . After the extension ( i.e. , 23 weeks post-SRP ) , mean PPD changed from baseline by 1.50 mm for the test group and 0.55 mm for the control . With the exception of BI at 23 weeks post-SRP , all reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI for all comparisons . CONCLUSION When compared with SRP alone , clinical improvements in PPD ( e.g. , -1.0 mm for pockets > 5 mm at baseline ) were maintained for up to six months after SRP with adjunctive use of 1.7 % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis .

peroxide gel

scaling

and

root planing

Scaling and root planing ( SRP )

SRP

hydrogen peroxide gel

SRP

SRP

combined

SRP

peroxide gel

peroxide gel

SRP

SRP

SRP

peroxide gel

SRP

SRP

SRP

SRP

hydrogen peroxide gel

mean PPD

mean BI

mean PPD

mean PPD

mean BI

mean PPD

mean BI

mean PPD

mean PPD

mean PPD

periodontitis

chronic periodontitis

periodontitis

13 test

15 control

periodontitis


Left ventricular vortices as observed by vector flow mapping : main determinants and their relation to left ventricular filling . BACKGROUND Swirling flow , organized in vortices , contributes to adequate left ventricular function . In this study , we apply a novel echocardiographic flow-mapping technique , vector flow mapping ( VFM ) , to evaluate the main characteristics of left ventricular vortices and its relation to filling parameters . METHODS Forty-eight subjects underwent conventional transthoracic echocardiographic examination with additional intracardiac flow assessment with VFM using a Aloka Alpha-10 system and experimental VFM analysis software . To analyze vortex behavior , its rotation direction , duration , location inside the left ventricle , size , and intensity were assessed in apical long-axis view . Its relation to conventional left ventricular filling parameters was then analyzed . RESULTS Two vortex components were consistently identified following each transmitral filling wave . The anterior component of these visualized vortices was analyzed , due to its higher significance in the cardiac cycle , following early filling ( V1 ) and atrial contraction ( V2 ) . Differences were observed in several aspects of vortex behavior between V1 and V2 , particularly in patients with normal left ventricular filling parameters . These differences may be related to varying roles of vortices in different periods of the cardiac cycle . CONCLUSIONS Vector flow mapping allowed visualization and measurement of several parameters defining vortex behavior inside the cardiac cycle . The differences observed in these parameters between vortices in different phases of the cardiac cycle may be related to their role in optimizing cardiac function .

vector flow mapping

Vector flow mapping

Forty-eight subjects


Pegylated feline granulocyte colony-stimulating factor increases neutrophil levels in cats . Neutropenia can often be corrected by treatment with granulocyte-colony stimulating factor ( G-CSF ) and off-label use of commercial human G-CSF ( HuG-CSF ) is a commonly used treatment for neutropenic animals . However , long-term HuG-CSF treatment can be associated with adverse effects , including neutropenia . Here , feline ( Fe ) G-CSF was produced in Pichia pastoris , pegylated ( Peg ) FeG-CSF and tested in cats . A randomized controlled clinical trial was conducted to evaluate the efficacy of PegFeG-CSF compared to FeG-CSF or HuG-CSF in FIV-infected ( n=14 ) , FIV-uninfected healthy cats ( n=19 ) , and in HuG-CSF-induced neutropenic cats ( n=4 ) . Daily FeG-CSF doses induced higher neutrophil production than HuG-CSF after the second week of treatment ( P ⩽ 0.002 ) . Weekly doses of PegFeG-CSF induced higher neutrophil counts and showed greater sustained activity than weekly doses of FeG-CSF . PegFeG-CSF provided the most therapeutic and sustainable neutrophil production ( P < 0.001 ) in both FIV-uninfected and FIV-infected cats , without the development of neutralizing antibodies . Conversely , all HuG-CSF-treated cats developed neutralizing antibodies , suggesting cross-reactive antibodies to endogenous G-CSF in a majority of the cases with severe neutropenia . Strikingly , when PegFeG-CSF was used to rescue cats with HuG-CSF-induced neutropenia , clinically normal neutrophil numbers returned . Thus , PegFeG-CSF appears to be a superior treatment for neutropenia in feline patients .

HuG-CSF treatment

PegFeG-CSF

FeG-CSF

HuG-CSF

FeG-CSF

HuG-CSF

PegFeG-CSF

FeG-CSF

PegFeG-CSF

HuG-CSF-treated

PegFeG-CSF

HuG-CSF-induced

PegFeG-CSF

adverse effects

neutropenia .

efficacy

higher neutrophil production

showed greater sustained activity

sustainable neutrophil production

of neutralizing antibodies

developed neutralizing antibodies

HuG-CSF-induced neutropenia

normal neutrophil numbers

neutropenic animals

FIV-infected

FIV-uninfected healthy cats

FIV-uninfected

FIV-infected cats

HuG-CSF-treated cats

in feline patients


Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma . A randomized , open-label , phase 2 , multicenter clinical trial was conducted to evaluate the efficacy and safety of the addition of a recombinant human endostatin adenovirus ( E10A ) to cisplatin and paclitaxel in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma . Patients with locally advanced or metastatic head and neck squamous cell carcinoma or nasopharyngeal carcinoma not suitable for operation or radiotherapy were randomly assigned to receive E10A plus chemotherapy every 3 weeks for a maximum of six cycles or to receive chemotherapy only . One hundred and thirty-six eligible patients were randomly assigned . The addition of E10A did not significantly improve the objective response rate ( 29.9 versus 39.7 % , P = 0.154 ) . However , patients who received endostatin had longer progression-free survival ( 7.03 versus 3.60 months , P = 0.006 ; hazard ratio : 0.55 ) . The combination of E10A with chemotherapy benefited prior chemotherapy-treated patients and those who received three to four treatment cycles ( 6.50 versus 3.43 months , P = 0.003 ; 8.27 versus 4.27 months , P = 0.018 ; respectively ) . The overall disease control rate significantly increased from 80.6 % in the control group to 92.6 % in the test group ( P = 0.034 ) . Except for fever , no adverse events were associated with the E10A treatment . In summary , E10A plus chemotherapy is a safe and effective therapeutic approach in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma .

recombinant human endostatin adenovirus

E10A plus chemotherapy

chemotherapy only

efficacy and safety

objective response rate

progression-free survival

overall disease control rate

fever

adverse events

safe and effective therapeutic approach

One hundred and thirty-six


Predictors of local adverse effects caused by topical tretinoin cream 0·1 % in the Veterans Affairs Topical Tretinoin Chemoprevention trial . BACKGROUND Topical tretinoin is commonly prescribed , but its frequent adverse effects are barriers to use . Predictors of resistance or susceptibility to retinoid irritation are not known . OBJECTIVE To identify baseline patient characteristics associated with adverse effects of topical tretinoin . METHODS This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears . Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects . RESULTS One hundred and ninety-seven patients ( 61 % of those randomized to tretinoin ) reported local adverse effects within 6 months . Clinical signs of severe photodamage at baseline [ odds ratio ( OR ) 0·15 , 95 % confidence interval ( CI ) 0·04-0·54 ] and history of acne ( OR 0·46 , 95 % CI 0·27-0·77 ) were associated with a decreased risk of adverse effects to tretinoin . The use of other topical medications at enrolment ( OR 1·88 , 95 % CI 1·15-3·08 ) predicted an increase in adverse effects . CONCLUSIONS In this study population , the common indications of topical tretinoin treatment were associated with lower risks of adverse effects . The concurrent use of other topical medications may worsen irritation caused by tretinoin .

tretinoin

reported local adverse effects

of

severe photodamage

and history of acne

risk of adverse effects

increase in adverse

lower risks of adverse


[ Encephalopathy therapeutic tongue acupoint apparatus ( ETTAA ) for 42 cases of autism ] . OBJECTIVE To observe the efficacy of encephalopathy therapeutic tongue acupoint apparatus ( ETTAA ) in the treatment of autism . METHODS Eighty-four children of autism were randomly divided into a tongue acupuncture group ( group A ) and a conventional training group ( group B ) , 42 cases in each group . The behavior training and sensory integration training were carried out in group B and the ETTAA was added in group A . The apparatus was switched on for 20 min every time and 3 times a day . Treatment of two months were carried out in both groups . The score of childhood autism rating scale ( CARS ) and clinical efficacy in both groups were observed before and after treatment . RESULTS After treatment , the CARS in both groups were significantly reduced ( 42.39 +/- 6.86 vs 32.15 +/- 5.12 , P < 0.001 ; 44.58 +/- 6.76 vs 39.72 +/- 7.11 , P < 0.05 ) , which was more significant in group A ( P < 0.01 ) . The totally effective rate in group A [ 90.5 % ( 38/42 ) ] was superior to that in group B [ 66.7 % ( 28/42 ) , P < 0.01 ] . CONCLUSION The clinical efficacy in tongue acupuncture group is apparently superior to that in conventional training group , ETTAA combined with conventional training have a better curative effect in the treatment of autism .

tongue acupuncture

conventional training

tongue acupuncture

conventional training

efficacy

clinical efficacy

CARS

totally effective rate

clinical efficacy

curative effect

autism ]

autism

Eighty-four

children

autism

autism


Weight loss maintenance in overweight subjects on ad libitum diets with high or low protein content and glycemic index : the DIOGENES trial 12-month results . BACKGROUND A high dietary protein ( P ) content and low glycemic index ( LGI ) have been suggested to be beneficial for weight management , but long-term studies are scarce . OBJECTIVE The DIOGENES randomized clinical trial investigated the effect of P and GI on weight loss maintenance in overweight or obese adults in eight centers across Europe . This study reports the 1-year results in two of the centers that extended the intervention to 1 year . METHOD After an 8-week low-calorie diet ( LCD ) , 256 adults ( body mass index > 27 kg m ( - ) ( 2 ) ) were randomized to five ad libitum diets for 12 months : high P/LGI ( HP/LGI ) , HP/high GI ( HP/HGI ) , low P/LGI ( LP/LGI ) , LP/HGI and a control diet . During the first 6 months , foods were provided for free through a shop system and during the whole 12-month period , subjects received guidance by a dietician . Primary outcome variable was the change in body weight over the 12-month intervention period . RESULTS During the LCD period , subjects lost 11.2 ( 10.8 , 12.0 ) kg ( mean ( 95 % confidence interval ( CI ) ) ) . Average weight regain over the 12-month intervention period was 3.9 ( 95 % CI 3.0-4.8 ) kg . Subjects on the HP diets regained less weight than subjects on the LP diets . The difference in weight regain after 1 year was 2.0 ( 0.4 , 3.6 ) kg ( P=0.017 ) ( completers analysis , N=139 ) or 2.8 ( 1.4 , 4.1 ) kg ( P < 0.001 ) ( intention-to-treat analysis , N=256 ) . No consistent effect of GI on weight regain was found . There were no clinically relevant differences in changes in cardiometabolic risk factors among diet groups . CONCLUSION A higher protein content of an ad libitum diet improves weight loss maintenance in overweight and obese adults over 12 months .

ad libitum diets

high dietary protein ( P ) content

low glycemic index

control

Weight loss maintenance

effect

weight loss maintenance

change in body weight

Average weight regain

regained less weight

difference in weight regain

GI on weight regain

improves weight loss

overweight

overweight or obese

adults

256 adults

overweight and obese


The effect of modified eggs and an egg-yolk based beverage on serum lutein and zeaxanthin concentrations and macular pigment optical density : results from a randomized trial . UNLABELLED Increasing evidence suggests a beneficial effect of lutein and zeaxanthin on the progression of age-related macular degeneration . The aim of this study was to investigate the effect of lutein or zeaxanthin enriched eggs or a lutein enriched egg-yolk based buttermilk beverage on serum lutein and zeaxanthin concentrations and macular pigment levels . Naturally enriched eggs were made by increasing the levels of the xanthophylls lutein and zeaxanthin in the feed given to laying hens . One hundred healthy volunteers were recruited and randomized into 5 groups for 90 days . Group one added one normal egg to their daily diet and group two received a lutein enriched egg-yolk based beverage . Group three added one lutein enriched egg and group four one zeaxanthin enriched egg to their diet . Group five was the control group and individuals in this group did not modify their daily diet . Serum lutein and zeaxanthin concentrations and macular pigment densities were obtained at baseline , day 45 and day 90 . Macular pigment density was measured by heterochromatic flicker photometry . Serum lutein concentration in the lutein enriched egg and egg yolk-based beverage groups increased significantly ( p < 0.001 , 76 % and 77 % ) . A strong increase in the serum zeaxanthin concentration was observed in individuals receiving zeaxanthin enriched eggs ( P < 0.001 , 430 % ) . No changes were observed in macular pigment density in the various groups tested . The results indicate that daily consumption of lutein or zeaxanthin enriched egg yolks as well as an egg yolk-based beverage show increases in serum lutein and zeaxanthin levels that are comparable with a daily use of 5 mg supplements . TRIAL REGISTRATION ClinicalTrials.gov NCT00527553 .

lutein

Naturally enriched eggs

zeaxanthin

one normal egg to their daily diet

lutein enriched egg-yolk based beverage

one lutein enriched egg

control group

zeaxanthin enriched eggs

lutein or zeaxanthin enriched egg yolks

macular pigment densities

Macular pigment density

Serum lutein concentration

serum zeaxanthin concentration

macular pigment density

serum lutein and zeaxanthin levels

One hundred

healthy


Decreased glutathione and elevated hair mercury levels are associated with nutritional deficiency-based autism in Oman . Genetic , nutrition , and environmental factors have each been implicated as sources of risk for autism . Oxidative stress , including low plasma levels of the antioxidant glutathione , has been reported by numerous autism studies , which can disrupt methylation-dependent epigenetic regulation of gene expression with neurodevelopmental consequences . We investigated the status of redox and methylation metabolites , as well as the level of protein homocysteinylation and hair mercury levels , in autistic and neurotypical control Omani children , who were previously shown to exhibit significant nutritional deficiencies in serum folate and vitamin B₁₂ . The serum level of glutathione in autistic subjects was significantly below control levels , while levels of homocysteine and S-adenosylhomocysteine were elevated , indicative of oxidative stress and decreased methionine synthase activity . Autistic males had lower glutathione and higher homocysteine levels than females , while homocysteinylation of serum proteins was increased in autistic males but not females . Mercury levels were markedly elevated in the hair of autistic subjects vs. control subjects , consistent with the importance of glutathione for its elimination . Thus , autism in Oman is associated with decreased antioxidant resources and decreased methylation capacity , in conjunction with elevated hair levels of mercury .

antioxidant glutathione

redox

methylation metabolites

folate

status

indicative of oxidative stress

decreased methionine synthase activity

lower glutathione

higher homocysteine levels

females . Mercury levels

autism

redox and methylation metabolites

autistic and neurotypical control

autistic

males

females

autistic

autism


Clonidine in patients undergoing noncardiac surgery . BACKGROUND Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery . Low-dose clonidine , which blunts central sympathetic outflow , may prevent perioperative myocardial infarction and death without inducing hemodynamic instability . METHODS We performed a blinded , randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with , or at risk for , atherosclerotic disease who were undergoing noncardiac surgery . A total of 10,010 patients at 135 centers in 23 countries were enrolled . For the comparison of clonidine with placebo , patients were randomly assigned to receive clonidine ( 0.2 mg per day ) or placebo just before surgery , with the study drug continued until 72 hours after surgery . The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days . RESULTS Clonidine , as compared with placebo , did not reduce the number of primary-outcome events ( 367 and 339 , respectively ; hazard ratio with clonidine , 1.08 ; 95 % confidence interval [ CI ] , 0.93 to 1.26 ; P=0.29 ) . Myocardial infarction occurred in 329 patients ( 6.6 % ) assigned to clonidine and in 295 patients ( 5.9 % ) assigned to placebo ( hazard ratio , 1.11 ; 95 % CI , 0.95 to 1.30 ; P=0.18 ) . Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension ( 2385 patients [ 47.6 % ] vs. 1854 patients [ 37.1 % ] ; hazard ratio 1.32 ; 95 % CI , 1.24 to 1.40 ; P < 0.001 ) . Clonidine , as compared with placebo , was associated with an increased rate of nonfatal cardiac arrest ( 0.3 % [ 16 patients ] vs. 0.1 % [ 5 patients ] ; hazard ratio , 3.20 ; 95 % CI , 1.17 to 8.73 ; P=0.02 ) . CONCLUSIONS Administration of low-dose clonidine in patients undergoing noncardiac surgery did not reduce the rate of the composite outcome of death or nonfatal myocardial infarction ; it did , however , increase the risk of clinically important hypotension and nonfatal cardiac arrest . ( Funded by the Canadian Institutes of Health Research and others ; POISE-2 ClinicalTrials.gov number , NCT01082874 . ) .

Clonidine

low-dose clonidine versus

placebo

and low-dose aspirin versus placebo

clonidine with placebo

perioperative myocardial infarction

death

death

nonfatal myocardial infarction

primary-outcome events

Myocardial infarction

hypotension

nonfatal cardiac arrest

death

nonfatal myocardial infarction

clinically important hypotension

nonfatal cardiac arrest

patients undergoing noncardiac surgery


Aspirin in patients undergoing noncardiac surgery . BACKGROUND There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery , both among patients who are already on an aspirin regimen and among those who are not . METHODS Using a 2-by-2 factorial trial design , we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo . The results of the aspirin trial are reported here . The patients were stratified according to whether they had not been taking aspirin before the study ( initiation stratum , with 5628 patients ) or they were already on an aspirin regimen ( continuation stratum , with 4382 patients ) . Patients started taking aspirin ( at a dose of 200 mg ) or placebo just before surgery and continued it daily ( at a dose of 100 mg ) for 30 days in the initiation stratum and for 7 days in the continuation stratum , after which patients resumed their regular aspirin regimen . The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days . RESULTS The primary outcome occurred in 351 of 4998 patients ( 7.0 % ) in the aspirin group and in 355 of 5012 patients ( 7.1 % ) in the placebo group ( hazard ratio in the aspirin group , 0.99 ; 95 % confidence interval [ CI ] , 0.86 to 1.15 ; P=0.92 ) . Major bleeding was more common in the aspirin group than in the placebo group ( 230 patients [ 4.6 % ] vs. 188 patients [ 3.8 % ] ; hazard ratio , 1.23 ; 95 % CI , 1.01 , to 1.49 ; P=0.04 ) . The primary and secondary outcome results were similar in the two aspirin strata . CONCLUSIONS Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding . ( Funded by the Canadian Institutes of Health Research and others ; POISE-2 ClinicalTrials.gov number , NCT01082874 . ) .

Aspirin

aspirin

aspirin

aspirin

placebo

aspirin

aspirin

aspirin

aspirin

placebo

aspirin

aspirin

placebo

placebo

aspirin

aspirin

composite of death

nonfatal myocardial infarction

Major bleeding

rate of a composite of death

nonfatal myocardial infarction

major bleeding

patients undergoing noncardiac surgery


Interview skills for adults with autism spectrum disorder : a pilot randomized controlled trial . The purpose of this pilot study was to evaluate the efficacy of the interview skills curriculum ( ISC ) , a manualized 12-week group-delivered intervention for young adults with autism spectrum disorder ( ASD ) . This intervention aims to increase social-pragmatic skills essential to a successful job interview . Twenty-eight adults ( 18-36 years ) were randomly assigned to one of two groups : ISC or waitlist control . Results revealed that the experimental group showed larger gains in social-pragmatic skills observed during a mock job interview than the control group . Treatment effects on distal outcomes , including social adaptive behaviors and depressive symptoms were not significant , although the respective effect sizes were medium/large . Results indicate that a brief , low-intensity treatment can improve the job-interview performance of young adults with ASD .

interview skills curriculum ( ISC )

ISC

waitlist control

social-pragmatic skills

job-interview performance

adults

autism spectrum disorder

young adults

autism spectrum disorder ( ASD )

Twenty-eight

adults ( 18-36 years )

young adults

ASD


Triple combination as adjuvant to cryotherapy in the treatment of solar lentigines : investigator-blinded , randomized clinical trial . BACKGROUND Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines . OBJECTIVES To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01 % , hydroquinone 4 % and tretinoin 0.05 % as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum , and in the prevention of post-inflammatory hyperpigmentation after cryotherapy . METHODS This prospective , randomized , controlled , investigator-blinded , single-centre study enrolled 50 patients . Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone . After that , cryotherapy was performed in all patients followed by a 3-week recovery period . After this period , patients received the same initial treatment and were followed up for 8 weeks . Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer . Lentigines count , colour homogeneity and global improvement were also assessed . RESULTS The number of solar lentigines reduced in the first 2 weeks only in patients who used the triple combination 25 ± 7 vs. 22 ± 8 ( P < 0.0001 ) , and reduced at the end of the study for both groups ( P < 0.0001 ) . The melanin levels also reduced in the first 2 weeks only in patients who used the triple combination 297 ± 69 vs. 273 ± 66 ( P < 0.0001 ) and reduced at the end of the study for both groups ( P < 0.0001 ) . Erythema and residual blisters from cryotherapy were the reported adverse reactions . CONCLUSION Triple combination cream can be used to enhance the resolution of solar lentigines , and to significantly reduce melanin levels and lentigines count , improving treatment results . It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy .

hydroquinone

tretinoin

sunscreen alone

cryotherapy

treatment of solar lentigines :

hyperpigmentation

solar lentigines .

safety

efficacy

treatment of solar lentigines

solar lentigines

Twenty-five patients


A prospective , randomized controlled trial of single-incision laparoscopic vs conventional 3-port laparoscopic appendectomy for treatment of acute appendicitis . BACKGROUND Proponents of single-incision laparoscopic surgery ( SILS ) claim patients have less pain , faster recovery , and better long-term cosmetic results than patients who undergo multiport laparoscopy . However , randomized comparisons are lacking . This study presents the results of a prospective randomized trial of SILS or 3-port laparoscopic appendectomy . STUDY DESIGN Adults with uncomplicated acute appendicitis were randomized 1:1 to either SILS or 3-port laparoscopic appendectomy . The primary end point was early postoperative pain ( measured by opiate usage and pain score in the first 12 hours ) . Secondary end points were operative time , complication rate ( including conversions ) , and recovery time ( days of oral opiate usage and return to work ) . After 6 months , body image and cosmetic appearance were assessed using a validated survey . RESULTS The trial was planned for 150 patients , but was halted after 75 patients when planned interim analysis showed that SILS patients had more postoperative pain ( pain score : 4.4 ± 1.6 vs 3.5 ± 1.5 ; p = 0.01 ) and higher inpatient opiate usage ( hydromorphone use : 3.9 ± 1.9 mg vs 2.8 ± 1.7 mg ; p = 0.01 ) than 3-port laparoscopy . Operative time for SILS averaged 40 % longer ( 54 ± 17 minutes vs 38 ± 11 minutes ; p < 0.01 ) . Only 1 SILS case was converted to 3-port . There were no significant differences in length of stay , complications , oral pain medication usage after discharge , or return to work . After 6 months , body image and cosmetic appearance were excellent for both groups and indistinguishable by most measures . However , 3-port patients reported better physical attractiveness ( 4.0 ± 0.4 vs 3.8 ± 0.4 ; p = 0.04 ) and SILS patients reported better scars ( score 18.4 ± 2.7 vs 16.4 ± 3.0 ; p < 0.01 ) . Results are reported as mean ± SD . CONCLUSIONS Single-incision laparoscopic surgery appendectomy resulted in more pain and longer operative times without improving short-term recovery or complications . Long-term body image and cosmetic appearance were excellent in both groups .

single-incision laparoscopic

multiport laparoscopy

SILS

3-port laparoscopic appendectomy

SILS

3-port laparoscopic appendectomy

SILS

early postoperative pain

operative time ,

body image

cosmetic appearance

postoperative pain

Adults

acute appendicitis

postoperative pain


[ Prophylactic use of low molecular weight heparin in combination with graduated compression stockings in post-operative patients with gynecologic cancer ] . OBJECTIVE The aim of this study was to compare the efficacy of low molecular weight heparin ( LMWH ) combined with graduated compression stockings ( GCS ) with GCS alone as prophylactic measures for venous thromboembolism ( VTE ) in post-operative patients with gynecologic cancer . METHODS Patients diagnosed with gynecologic cancer undergoing primary major surgery between 2010 and 2011 in our institute were randomized to receive LMWH+GCS or GCS as VTE prophylaxis post-operatively . RESULTS Altogether 247 patients were enrolled . The incidence of VTE in patients treated with LMWH + GCS was significantly lower than that in patients using GCS alone ( 0.8 % Vs. 8.1 % , P = 0.01 ) . There were no severe bleeding complications in the patients with prophylactic use of LMWH and the occurrence rate of wound dehiscence was comparable between the two groups ( P > 0.05 ) . Multivariable logistic regression analysis revealed that age over 60 years ( P = 0.015 ) , duration of operation over 3 hours ( P = 0.04 ) and without prophylactic use of LMWH ( P = 0.02 ) were independent risk factors for VTE . CONCLUSIONS Dual prophylaxis with LMWH and GCS should be recommended for gynecologic cancer patients undergoing major surgery for its better efficacy than GCS . Prophylactic use of LMWH is safe and convenient . Patients with older age and prolonged operation time are at highest risk of developing VTE post-operatively .

low molecular weight heparin

graduated compression stockings

low molecular weight heparin ( LMWH )

graduated compression stockings ( GCS )

GCS alone

LMWH+GCS

GCS

LMWH

GCS

GCS

LMWH

LMWH

LMWH

GCS

GCS .

LMWH

incidence of VTE

severe bleeding complications

occurrence rate of wound dehiscence

efficacy

VTE post-operatively .

gynecologic cancer


A randomized controlled trial of an inference generation strategy intervention for adults with high-functioning autism spectrum disorder . PURPOSE The present intervention study investigated the efficacy of the ACT & Check Strategy intervention to improve inference generation when reading , metacognitive ability , general reading comprehension , and social inference ability in adults with high-functioning autism spectrum disorder ( HF-ASD ) . METHOD Twenty-five adults with HF-ASD were randomly assigned to either a treatment or a control group . Treatment sessions were conducted in 1-hr sessions , twice a week , for a total of 6 weeks . Treatment focused on explicit instruction of components of inference generation , categories of inferences , and increasingly independent strategy use . RESULTS The treatment group demonstrated significantly superior performance on 1 of 2 measures of inference generation in reading and 1 measure of metacognitive ability compared with the control group . Significant differences between groups were not found on measures of reading comprehension or social inference ability . CONCLUSION These findings suggest that the ACT & Check Strategy was effective in improving participants ' ability to generate inferences in reading and certain metacognitive abilities , but the skills do not appear to generalize to other social communication contexts , such as social inference generation . This research provides a measure of support for explicitly teaching inference generation to address a reading inference deficit in adults with HF-ASD .

ACT & Check Strategy intervention

control group .

ACT & Check Strategy

inference generation when reading

metacognitive ability

general reading comprehension

social inference ability

1 measure of metacognitive ability

measures of reading comprehension

social inference ability

certain metacognitive abilities

social inference generation

reading inference deficit

adults

autism spectrum disorder

autism spectrum disorder

Twenty-five

adults

HF-ASD

adults

HF-ASD


Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer . Three hundred twenty-five women with metastatic adenocarcinoma of the breast who had failed one prior chemotherapeutic regimen for advanced disease were randomized to receive 14 mg/m2 of mitoxantrone or 75 mg/m2 of doxorubicin intravenously ( IV ) every 3 weeks . Enrollment was closed on October 31 , 1984 , after 165 patients were randomized to mitoxantrone and 160 patients to doxorubicin . Patients randomized to the two treatment groups were compared for response rate , duration of response , time to progression or death , time to treatment failure ( TTF ) , and survival . The response rate to mitoxantrone was 20.6 % , to doxorubicin 29.3 % ( P = .07 ) . The median response duration was 151 days for the mitoxantrone group and 126 days for the doxorubicin group ( P = .16 ) . The median TTF was 70 days in the mitoxantrone group and 104 days in the doxorubicin group ( P = .36 ) . The median survival of patients initially randomized to receive mitoxantrone was 273 days ; for doxorubicin 268 days ( P = .40 ) . There were three responses among 77 patients crossed over to mitoxantrone after initial treatment with doxorubicin . The major dose-limiting toxicity for both drugs was leukopenia . There was significantly less severe and less frequent toxicity with mitoxantrone administration . Severe nausea and vomiting occurred in 9.5 % of mitoxantrone patients and 25.3 % of doxorubicin patients ( P less than .001 ) . The incidence of severe stomatitis and mucositis was 0.6 % in the mitoxantrone group and 8.4 % in the doxorubicin group ( P = .001 ) . Severe alopecia occurred in 5.1 % of mitoxantrone patients and 61.0 % of doxorubicin patients ( P less than .001 ) . A life-table comparison of the cumulative dose to the development of a cardiac event showed that mitoxantrone had significantly less cardiotoxicity than doxorubicin ( P = .0005 ) . This study demonstrates that mitoxantrone is active as a single agent in the treatment of metastatic breast cancer . Compared with doxorubicin it appears to be marginally less active and significantly less toxic . We conclude that mitoxantrone can be used alone or with other standard drugs to palliate the symptoms of metastatic breast cancer , especially in settings where drug toxicity is an important consideration .

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

doxorubicin

mitoxantrone

or

death

time to treatment failure ( TTF )

, and

survival

response rate

median response duration

median TTF

median survival

The major dose-limiting toxicity

leukopenia .

less severe and less frequent toxicity

Severe nausea and vomiting

severe stomatitis and mucositis

alopecia

cardiotoxicity

metastatic breast cancer .

drug toxicity


Safety evaluation of lasalocid use in Chinese ring-necked pheasants ( Phasianus colchicus ) . Coccidiosis remains a significant threat to the welfare of game farm-reared pheasants in the United States . Although lasalocid has been demonstrated to be effective against pheasant specific coccidia , information regarding its safety in this species is lacking . The purpose of this study was to gather data on the safety of lasalocid when fed to Chinese ring-necked pheasants at one , two , and three times the recommended high dose of lasalocid used for prevention of coccidiosis in other poultry at three times the normal treatment period . Pheasant chicks ( approximately 1 day-old ; n = 160 ) were randomly blocked by sex into four treatment groups and given their respective diets continuously for 6 wk . No significant differences were observed in overall feed consumption , weight gain , feed conversion rates , clinical pathology measurements , or tissue gross and histopathologic evaluations between controls and treatment groups associated with lasalocid administration . Based on the results of this study it appears that lasalocid fed at the recommended rate of 125 ppm is safe in Chinese ring-necked pheasants .

lasalocid

lasalocid

lasalocid

lasalocid

lasalocid

lasalocid

Safety

overall feed consumption

weight gain

feed conversion rates

clinical pathology measurements

safe

n = 160


A study of noninvasive positive-pressure mechanical ventilation in the treatment of acute lung injury with a complex critical care ventilator . OBJECTIVE To test the hypothesis that there would be better clinical outcomes following the treatment of patients with acute lung injury ( ALI ) using noninvasive positive-pressure mechanical ventilation ( NIPPV ) delivered via a complex critical care ventilator compared with a conventional mini-ventilator . METHODS Patients with ALI who required NIPPV were prospectively enrolled and randomly divided between three intervention groups : group A was ventilated using a mini-ventilator ; groups B and C were ventilated using a complex critical care ventilator using different settings . Clinical parameters were recorded before and after 8 h of mechanical ventilation . RESULTS A total of 51 patients with ALI were enrolled in the study . Clinical parameters in groups B and C underwent greater improvements than those in group A . Group C demonstrated the lowest treatment failure rate ( 23.5 % ) . Failure rates were highest in group A ( 58.8 % ) . CONCLUSION The findings of this present study suggest that there were more satisfactory clinical outcomes following the treatment of patients with ALI when NIPPV was delivered using a complex critical care ventilator compared with a conventional mini-ventilator .

conventional mini-ventilator

mini-ventilator

Clinical parameters

treatment failure rate

Failure rates

clinical outcomes


Cobedding of twin premature infants : calming effects on pain responses . BACKGROUND The purpose of this trial was to determine whether cobedding of preterm twins has analgesic effects during heel lancing or not . METHODS One hundred premature twins ( 50 sets ) born between 26 weeks ' and 34 weeks ' gestation undergoing heel blood sampling were randomly assigned into two groups : the cobedding group ( receiving care in the same incubator ) and the standard care group ( receiving care in separate incubators ) . Pain was assessed using the premature infant pain profile score . Duration of crying was measured after heel blood sampling , and salivary cortisol was measured prior to and after heel blood sampling . RESULTS Infants in the standard care group cried for a longer time during heel lancing than those in the cobedding group ( 42.6 ± 19.8 seconds vs. 36.4 ± 21.7 seconds , p = 0.03 ) . The mean premature infant pain profile score after heel lancing was significantly higher in the standard care group ( 9.8 ± 2.6 vs. 8.06 ± 2.8 , p = 0.002 ) . The mean salivary cortisol after heel lancing was also significantly higher in the standard care group ( 24.3 ± 7.4 nmol/L vs. 20.8 ± 7.4 nmol/L , p = 0.02 ) . No significant adverse effects were seen with cobedding . CONCLUSION Cobedding is a comforting measure for twin premature infants during heel lancing , which can be performed without any significant adverse effects .

Cobedding of twin premature infants :

cobedding of preterm twins

standard care

cobedding

effects

pain responses .

analgesic effects

Pain was assessed

the premature infant pain profile score

Duration of crying

salivary cortisol

cried for a longer time

was significantly higher

The mean salivary cortisol

significantly higher

No significant adverse effects

significant adverse effects

twin

premature infants

One hundred premature twins

twin

premature infants


An RCT comparing patient-centred outcome variables of guided surgery ( bone or mucosa supported ) with conventional implant placement . AIM To assess in a randomized study the patient-centred outcome of two guided surgery systems ( mucosa or bone supported ) compared to conventional implant placement , in fully edentulous patients . MATERIAL AND METHODS Fifty-nine patients ( 72 jaws ) with edentulous maxillas and/ or mandibles , were consecutively recruited and randomly assigned to one of the treatment groups . Outcome measures were the Dutch version of the McGill Pain Questionnaire ( MPQ-DLV ) , the Health-related quality of life instrument ( HRQOL ) , visual analogue scales ( VAS ) , the duration of the procedure , and the analgesic doses taken each day . RESULTS Three hundred and fourteen implants were placed successfully . No statistical differences could be shown between treatment groups on pain response ( MPQ-DLV ) , treatment perception ( VAS ) or number or kind of pain killers . For the HRQOLI-instrument , a significant difference was found between the Materialise Mucosa and Materialise Bone group at day 1 ( p = 0.02 ) and day 2 ( p = 0.01 ) . For the duration of the surgery , a statistical difference ( p = 0.005 ) was found between the Materialise mucosa and the Mental group , in favour of the first . CONCLUSION In this study little difference could be found in the patient outcome variables of the different treatment groups . However there was a tendency for patients treated with conventional flapped implant placement to experience the pain for a longer period of time .

bone

or

mucosa supported

surgery

mucosa

or

bone supported

conventional implant placement

Materialise Mucosa

Materialise Bone

Materialise mucosa

patient-centred outcome

visual analogue scales ( VAS )

duration of the procedure

analgesic doses taken each day

pain response ( MPQ-DLV )

treatment perception ( VAS )

number or kind of pain killers .

HRQOLI-instrument

duration of the surgery

fully edentulous patients

Fifty-nine patients

edentulous maxillas and/ or mandibles ,