Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction : the MYSTAR prospective , randomized study . BACKGROUND Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction ( AMI ) . We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches . METHODS Patients with left ventricular ejection fraction less than 45 % after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI . Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy . RESULTS A total of 60 patients were treated . The mean changes in infarct size at 3 months were -3.5 +/- 5.1 % ( 95 % CI -5.5 % to -1.5 % , P = 0.001 ) in the early group and -3.9 +/- 5.6 % ( 95 % CI -6.1 % to -1.6 % , P = 0.002 ) in the late group , and changes in ejection fraction were 3.5 +/- 5.6 % ( 95 % CI 1.3-5.6 % , P = 0.003 ) and 3.4 +/- 7.0 % ( 95 % CI 0.7-6.1 % , P = 0.017 ) , respectively . At 9-12 months after AMI , ejection fraction remained significantly higher than at baseline in both groups . In the early and late groups , a mean of 200.3 +/- 68.7 x 10 ( 6 ) and 194.8 +/- 60.4 x 10 ( 6 ) stem cells , respectively , were delivered to the myocardium , and 1.30 +/- 0.68 x 10 ( 9 ) and 1.29 +/- 0.41 x 10 ( 9 ) cells , respectively , were delivered into the artery . A high number of cells was required for significant improvements in the primary end points . CONCLUSIONS Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function .

Combined delivery approach

bone-marrow-derived stem cell therapy

stem cells

stem cell delivery

intramyocardial injection

cardiac stem cell delivery

safety and feasibility

changes in infarct size

and

changes in ejection fraction

ejection fraction

stem cells

number of cells

myocardial infarct size

and

left ventricular function

myocardial infarction


Comparison between lithium and valproate in the treatment of acute mania .

lithium and valproate

acute mania


Comparing two web-based smoking cessation programs : randomized controlled trial . BACKGROUND Smoking cessation remains a significant public health problem . Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change . To date , the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals . OBJECTIVE We describe the 6-month follow-up results of a randomized controlled trial in which participants recruited online were randomly assigned to either a Web-based smoking cessation program ( Quit Smoking Network ; QSN ) or a Web-based exercise enhancement program ( Active Lives ) adapted somewhat to encourage smoking cessation . METHODS The study was a two-arm randomized controlled trial that compared two Web-based smoking cessation programs : ( 1 ) the QSN intervention condition presented cognitive-behavioral strategies , and ( 2 ) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting . The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting . The QSN condition was designed to be more engaging ( eg , it included multimedia components ) and to present much greater content than is typically found in smoking cessation programs . RESULTS Contrary to our hypotheses , no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessments . While participants in the QSN intervention condition spent more time than controls visiting the online program , the median number of 1.0 visit in each condition and the substantial attrition ( 60.8 % at the 6-month follow-up ) indicate that participants were not as engaged as we had expected . CONCLUSIONS Contrary to our hypothesis , our test of two Web-based smoking cessation conditions , an intervention and an attention placebo control , failed to show differences at 3- and 6-month assessments . We explored possible reasons for this finding , including limited engagement of participants and simplifying program content and architecture . Future research needs to address methods to improve participant engagement in online smoking cessation programs . Possible approaches in this regard can include new informed consent procedures that better explain the roles and responsibilities of being a research participant , new program designs that add more vitality ( changing content from visit to visit ) , and new types of reminders pushed out to participants to encourage return visits . Simplifying program content through a combination of enhanced tailoring and information architecture also merits further research attention .

QSN condition

Active Lives condition

smoking cessation

Smoking cessation

smoking cessation

smoking cessation

smoking cessation

smoking abstinence

smoking cessation

web-based smoking cessation programs :

participants recruited online


Visual field progression in the Collaborative Initial Glaucoma Treatment Study the impact of treatment and other baseline factors . PURPOSE To evaluate factors associated with visual field ( VF ) progression , using all available follow-up through 9 years after treatment initiation , in the Collaborative Initial Glaucoma Treatment Study ( CIGTS ) . DESIGN Longitudinal follow-up of participants enrolled in a randomized clinical trial . PARTICIPANTS Six hundred seven newly diagnosed glaucoma patients . METHODS In a randomized clinical trial , 607 subjects with newly diagnosed open-angle glaucoma initially were treated with either medication or trabeculectomy . After treatment initiation and early follow-up , subjects were evaluated clinically at 6-month intervals . Study participants in both arms of the CIGTS were treated aggressively in an effort to reduce intraocular pressure ( IOP ) to a level at or below a predetermined , eye-specific target pressure . Visual field progression was analyzed using repeated measures models . MAIN OUTCOME MEASURES Visual field progression , measured by Humphrey 24-2 full-threshold testing and assessed by the change in the mean deviation ( MD ) , and an indicator of substantial worsening of the VF ( MD decrease of > or =3 dB from baseline ) , assessed at each follow-up visit . RESULTS Follow-up indicated minimal change from baseline in each initial treatment group 's average MD . However , at the 8-year follow-up examination , substantial worsening ( > or =3 dB ) of MD from baseline was found in 21.3 % and 25.5 % of the initial surgery and initial medicine groups , respectively . The effect of initial treatment on subsequent VF loss was modified by time ( P < 0.0001 ) , baseline MD ( P = 0.03 ) , and diabetes ( P = 0.01 ) . Initial surgery led to less VF progression than initial medicine in subjects with advanced VF loss at baseline , whereas subjects with diabetes had more VF loss over time if treated initially with surgery . CONCLUSIONS The CIGTS intervention protocol led to a lowering of IOP that persisted over time in both treatment groups . Progression in VF loss was seen in a subset , increasing to more than 20 % of the subjects . The findings regarding initial surgery being beneficial for subjects with more advanced VF loss at presentation , but detrimental for patients with diabetes , are noteworthy and warrant independent confirmation . FINANCIAL DISCLOSURE ( S ) The author ( s ) have no proprietary or commercial interest in any materials discussed in this article .

Initial surgery

initial medicine

visual field ( VF ) progression

reduce intraocular pressure ( IOP )

MD

worsening ( > or =3 dB ) of MD

VF loss

VF progression

VF loss

lowering of IOP

VF loss

patients with diabetes


Parecoxib for analgesia after craniotomy . BACKGROUND Pain after craniotomy is often under-treated . Opiates carry distinct disadvantages . Non-steroidal anti-inflammatory drugs have an anti-platelet action and carry a bleeding risk . Cyclo-oxygenase 2 inhibitors such as parecoxib are not associated with a bleeding risk and would be welcome analgesics if shown to be effective . METHODS In a prospective double-blind , randomized , placebo-controlled study , we investigated the analgesic effect of a single dose of parecoxib 40 mg given at dural closure in 82 patients undergoing elective craniotomies . Remifentanil was used intraoperatively , and i.v . morphine was titrated to the requirement in the post-anaesthetic unit . On the ward , i.m . morphine 5 mg as required and regular acetaminophen was prescribed . Morphine use and visual analogue pain scores were recorded at 1 , 6 , 12 , and 24 h after surgery . RESULTS Parecoxib reduced pain scores at 6 h and morphine use at 6 and 12 h after operation . However , overall , it had only minimal impact on postoperative analgesia . We found a wide variability in analgesic requirements where 11 % of patients required no opioids and 16 % required more than 15 mg i.v . morphine 1 h after the surgery . CONCLUSIONS We found only limited evidence to support parecoxib as an analgesic after craniotomy .

Parecoxib

placebo-controlled

parecoxib 40 mg

Remifentanil

morphine

morphine 5 mg

acetaminophen

Morphine

reduced pain scores

postoperative analgesia .

analgesia after craniotomy .


Stepping Stones Triple P : an RCT of a parenting program with parents of a child diagnosed with an autism spectrum disorder . Whilst the Triple P Positive Parenting Program has a large evidence base ( Sanders , Clinical Child and Family Psychology Review 2:71-90 , 1999 ; Sanders , Journal of Consulting and Clinical Psychology 68:624-640 , 2000 ) and preliminary evidence indicates that Stepping Stones Triple P is also efficacious ( Roberts , Journal of Clinical Child and Adolescent Psychology , 35 ( 2 ) :180-193 , 2006 ) , to date Stepping Stones has not been evaluated with the ASD population . Fifty-nine families with a child with ASD aged between 2 and 9 participated in this randomized controlled trial . The results demonstrate significant improvements in parental reports of child behaviour and parenting styles with the treatment effects for child behaviour , parental over reactivity and parental verbosity being maintained at follow-up 6 months later . Further , the results suggest significant improvements in parental satisfaction and conflict about parenting as well as a sleeper effect for parental efficacy . The results indicate that Stepping Stones Triple P is a promising intervention for parents of children with ASD . Limitations and future research are also addressed .

Stepping Stones Triple P :

parenting program

Triple P Positive Parenting Program

Stepping Stones Triple P

Stepping Stones

Stepping Stones Triple P

parental reports of child behaviour

parenting styles

child behaviour

parental over reactivity

parental verbosity

parental satisfaction

conflict about parenting

parental efficacy


Impacts of a disease management program for dually eligible beneficiaries . The LifeMasters Supported SelfCare demonstration program provides disease management ( DM ) services to Florida Medicare beneficiaries who are also enrolled in Medicaid and have congestive heart failure ( CHF ) , diabetes , or coronary artery disease ( CAD ) . The population-based program provides primarily telephonic patient education and monitoring services . Findings from the randomized , intent-to-treat design over the first 18 months of operations show virtually no overall impacts on hospital or emergency room ( ER ) use , Medicare expenditures , quality of care , or prescription drug use for the 33,000 enrollees . However , for beneficiaries with CHF who resided in high-cost South Florida counties , the program reduced Medicare expenditures by 9.6 percent .

disease management program

disease management ( DM ) services

Medicare expenditures

quality of care

prescription drug use

Medicare expenditures


Acceptability of an Electronic Self-Report Assessment Program for patients with cancer . Eliciting symptom and quality of life information from patients is an important component of medical and nursing care processes . Traditionally , this information has been collected with paper and pencil . However , this approach presents several barriers , including delays in receiving information , difficulty in integrating responses with electronic records , and the time required to manually score questionnaires for measurement purposes . One solution that addresses many of these barriers is the adoption of computerized screening for symptom and quality-of-life information . This research explored the acceptability of asking symptom and quality-of-life questions using the Electronic Self Report Assessment-Cancer program on wireless laptops equipped with touch-screen format . Acceptability data were explored with respect to whether any differences may be attributed to demographics and symptom and quality-of-life levels , such as depression and cognitive and emotional functioning . This evaluation used descriptive and univariate statistics to examine data from 342 participants from the ongoing ESRA-C randomized clinical trial . Research participants for the ESRA-C study were recruited from the Seattle Cancer Care Alliance , a consortium among the University of Washington Medical Center , Fred Hutchinson Cancer Research Center , and Children 's Hospital and Regional Medical Center in Seattle , WA . The sample consisted of 342 adult participants who completed both baseline and follow-up survey sessions . Medical oncology represented the largest recruitment group ( 45.3 % ) , followed by stem cell transplant ( 34.5 % ) and radiation oncology ( 20.2 % ) . The primary finding was that patients were generally able to use ESRA-C quickly and without difficulty in a real-world clinical setting and that they were overall quite satisfied with the ESRA-C program . Significant differences were found in several acceptability areas with respect to demographics and quality of life measures such as age , sex , and severe distress . This analysis confirms that the ESRA-C application for collecting symptom and quality of life information is easy for patients to use and acceptable across a range of user characteristics . We intend to build on our work by using the survey platform in other modalities while ensuring that the patient 's preferences are considered at all times .

ESRA-C

ESRA-C

ESRA-C

ESRA-C program

acceptability

Acceptability data

quality-of-life levels

able to use ESRA-C quickly

satisfied with the ESRA-C program

acceptability

recruitment group


Treatment of bulimia nervosa with lithium carbonate . A controlled study . Ninety-one female bulimic outpatients received lithium carbonate or placebo on a random basis , after being separated into depressed and nondepressed subgroups , in an 8-week double-blind trial . Sixty-eight patients who completed the study experienced a significant decrease in bulimic episodes after the 8 weeks . Lithium , in a dosage yielding relatively low plasma levels , was not more effective than placebo . However , depression and other psychopathologies decreased with improvement in bulimic behavior .

lithium carbonate .

lithium carbonate

placebo

Lithium

placebo .

bulimia nervosa

bulimic episodes

relatively low plasma levels

depression and other psychopathologies

bulimic behavior

bulimia nervosa

bulimic

depressed and nondepressed

Sixty-eight


Pre-operative radiochemotherapy for rectal cancer . A prospective randomized trial comparing pre-operative vs. postoperative radiochemotherapy in rectal cancer patients . PURPOSE The aim of the study was to find out whether pre-operative radiochemotherapy had any survival advantage over postoperative radiochemotherapy for rectal carcinoma patients without distant metastasis or peritoneal carcinomatosis . MATERIAL AND METHODS Between January 1998 and December 2003 , 51 rectal carcinoma patients without distant metastasis or peritoneal carcinomatosis were randomly divided into pre-operative ( PRE ) and postoperative ( POST ) radiochemotherapy groups . Twenty-six were assigned to the PRE group and were operated on 5 to 8 weeks after the completion of radiotherapy . The other 25 patients were operated on immediately and received radiotherapy postoperatively 2 to 4 weeks after surgery . The patients were followed up for between 4 to 51 months . RESULTS In the PRE group the rates of disease-free survival were 92 % , 70 % , 56 % and 56 % at the end of the 1st , 2nd , 3rd and 4th years , respectively . In the POST group those percentages were 83 % , 68 % , 51 % and 51 % at the 1st , 2nd , 3rd and 4th years , respectively ( p = 0.707 ) . One-year and 4-year overall survival rates in the PRE group were 100 % and 86 % respectively and 100 % and 60 % in the POST group ( p = 0.520 ) . CONCLUSION No statistical difference was found between the survival rates of the rectal carcinoma patients receiving radiotherapy either pre-operatively or postoperatively . However , the disease-free survival rates of the PRE group were higher than the POST group 's during each year and overall survival rates were higher after the third and fourth years . We conclude that pre-operative radiotherapy is at least as effective as postoperative radiotherapy .

Pre-operative radiochemotherapy

pre-operative

postoperative radiochemotherapy

pre-operative radiochemotherapy

postoperative radiochemotherapy

pre-operative ( PRE )

radiotherapy

PRE

POST

pre-operative radiotherapy

postoperative radiotherapy

survival advantage

rates of disease-free survival

survival rates

disease-free survival rates

overall survival rates

at least as effective as


Maintenance of response following stabilization of mixed index episodes with olanzapine monotherapy in a randomized , double-blind , placebo-controlled study of bipolar 1 disorder . BACKGROUND In a population of patients with manic and mixed mood episodes , olanzapine has proven effective in maintaining response , as compared to placebo . Whether this is true for the subpopulation of patients with a mixed index episode is not known . METHODS Post-hoc analyses were conducted on data from patients presenting with a mixed index episode who were enrolled in a larger double-blind , placebo-controlled trial . Patients who met remission criteria at 2 consecutive weekly visits during 6 to 12 weeks of open-label olanzapine treatment were randomly assigned to olanzapine or placebo treatment for 48 weeks . The incidence of and time to symptomatic relapse were calculated for any mood episode , and for depressive , manic , hypo-manic , and mixed mood episodes . RESULTS A total of 121 of 304 patients ( 39.8 % ) met criteria for symptomatic remission in the open-label treatment phase and were randomly assigned to olanzapine ( n=76 ) or placebo ( n=45 ) . Compared to the placebo group , the olanzapine group had a lower incidence of ( 59.2 % versus 91.1 % , p < 0.001 ) and a longer time to ( 46 versus 15 days , p < 0.001 ) symptomatic relapse of any kind . Olanzapine-treated patients also experienced longer time to depressive symptomatic relapse ( 85 versus 22 days , p=0.001 ) and manic symptomatic relapse ( too few relapses to calculate versus 42 days , p < 0.001 ) than did placebo-treated patients . CONCLUSIONS Compared with placebo , olanzapine treatment was associated with longer maintenance of response in patients presenting with a mixed index episode of bipolar I disorder .

olanzapine

placebo-controlled

olanzapine

placebo-controlled

olanzapine

olanzapine

placebo

olanzapine

placebo

olanzapine

Olanzapine-treated

placebo

olanzapine

symptomatic relapse

symptomatic remission

symptomatic relapse

time to depressive symptomatic relapse

manic symptomatic relapse

maintenance of response

bipolar 1 disorder

mood episodes

mixed index episode

bipolar I disorder


Timing for delivering individualized patient education intervention to Coronary Artery Bypass Graft patients : An RCT . BACKGROUND The primary focus of this study is on the timing of the delivery of education to patients who had CABG surgery . AIM To determine the efficacy of an individualized telephone patient education intervention , delivered at two different points in time ( 1-2 days pre-discharge versus 1-2 days post-discharge ) in enhancing the CABG patient 's knowledge of self-care behaviours , performance of self-care behaviours , and symptom frequency . METHOD A randomized clinical trial that included a convenience sample of first time CABG patients . Individuals who received education pre-discharge were compared to individuals who received education post-discharge on the outcomes . RESULTS Results indicated no statistically significant difference in outcomes between the two time points . As well , anxiety levels were found to be significantly higher in the pre-discharge group than the post-discharge group . CONCLUSIONS The individualized nature of the educational intervention may have accounted for non-significant findings reported in outcomes between the two time points . PRACTICE IMPLICATIONS Nurses may consider assessing anxiety levels prior to delivery of educational interventions , implement interventions aimed at reducing anxiety levels , and provide individualized teaching .

CABG surgery .

education pre-discharge

educational intervention

outcomes between the two time points .

anxiety levels

anxiety levels

Coronary Artery Bypass Graft

had CABG surgery

CABG patient

first time CABG patients


Effect of diltiazem on symptomatic and asymptomatic episodes of ST segment depression occurring during daily life and during exercise . BACKGROUND Silent myocardial ischemia is an adverse prognostic marker in patients with coronary disease ; however , controlled data on the effect of treatment are sparse and contradictory , and the relations among the occurrence of ST segment depression , drug efficacy , and heart rate are unclear . METHODS AND RESULTS Sixty patients with stable coronary artery disease , a positive treadmill exercise test and asymptomatic ST segment depression on ambulatory electrocardiographic recording were assessed in a multicenter , double-blind , placebo-controlled , cross-over trial . Treadmill exercise tests and 72-hour electrocardiographic recordings were obtained at the end of two 2-week treatment periods with sustained-release diltiazem 180 mg b.i.d . or equivalent placebo . Episodes of asymptomatic ST depression decreased by 50 % or more in 70 % of the patients from a median number of 4.5 ( range , 0-19 ) to 1.5 ( range , 0-13 ) ( p = 0.0001 ) ; their cumulative duration also decreased from 78.5 ( range , 0-60 ) to 24.5 ( range , 0-411 ) minutes ( p = 0.001 ) . No circadian variation was found in the efficacy of diltiazem . The occurrence of ischemic type ST segment depression was modulated by changes in heart rate rather than by absolute heart rate . Diltiazem also improved exercise test end points but to a lesser extent . Time to ST segment depression increased to 341 +/- 148 from 296 +/- 154 seconds ( p = 0.005 ) . Although less frequent with diltiazem administration ( 45 versus 54 patients , p less than 0.03 ) , exercise-induced ST depression was more often asymptomatic ( 98 % versus 72 % of patients , p less than 0.0001 ) . CONCLUSIONS Diltiazem reduces the frequency and severity of ischemic type ST depression in patients with stable coronary artery disease .

diltiazem

placebo-controlled

Treadmill exercise

sustained-release diltiazem

placebo .

diltiazem .

Diltiazem

diltiazem

Diltiazem

ST segment depression

ST segment depression

Treadmill exercise tests

72-hour electrocardiographic recordings

Episodes of asymptomatic ST depression

cumulative duration

circadian variation

ischemic type ST segment depression

changes in heart rate

exercise test end points

Time to ST segment depression

exercise-induced ST depression

ischemic type ST depression

ST segment depression

coronary disease

Sixty

stable coronary artery disease

positive treadmill exercise test

asymptomatic ST segment depression


[ Safety of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer ] . OBJECTIVE To investigate the safety and tolerance of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer . METHODS From January 2004 to December 2006 , 101 patients with high-risk breast cancer after surgical resection were enrolled into this study . The patients were divided into two groups : dose-dense and regular groups . Each patient received 6 cycles of chemotherapy with intravenous administration of paclitaxel ( 175 mg/m2 , on D3 ) and epirubicin ( 60 mg/m2 , on Dl and D2 ) . The dose-dense group had repeated treatment every two weeks , while the regular group repeated it every three weeks . G-CSF was used in a dose of 3 microg/kg on D5-D9 during each cycle in the dose-dense group . While in the regular group , it was used only under the condition that grade II neutropenia occurred . RESULTS The toxicity could be evaluated in 101 patients . Major grade II-IV toxicities included : neutropenia , nausea , vomiting and alopecia . The incidence of grade III-IV neutropenia was 16.0 % in the dose-dense group versus 54.9 % in the regular group ( P = 0.000 ) ; postponing of chemotherapy was 2.4 % versus 6.0 % ( P = 0.027 ) . Ninety-eight patients completed the chemotherapy as planed . After a median follow-up of 24 months , the median DFS and OS were not reached . The relapse-free rate and survival rate were 89.8 % and 100 % in the dose-dense group , which were 87.8 % and 93.9 % in the regular group . The relapse-free rate of the high-risk patients in the dose-dense group was 86.8 % versus 81.3 % in the regular group , and the corresponding survival rate was 100 % versus 90.6 % . CONCLUSION Adjuvant dose-dense chemotherapy with paclitaxel and epirubicin is safe , tolerable and promising for high-risk breast cancer .

safety and tolerance

toxicity

nausea

vomiting and alopecia

grade III-IV neutropenia

median DFS and OS

relapse-free rate and survival rate

high-risk breast cancer

high-risk breast cancer

101 patients

101 patients

Ninety-eight patients completed the

high-risk breast cancer


Preliminary findings of the minimally-invasive surgery plus rtPA for intracerebral hemorrhage evacuation ( MISTIE ) clinical trial . INTRODUCTION Compared to ischemic stroke , intracerebral hemorrhage ( ICH ) is easily and rapidly identified , occurs in younger patients , and produces relatively small initial injury to cerebral tissues -- all factors suggesting that interventional amelioration is possible . Investigations from the last decade established that extent of ICH-mediated brain injury relates directly to blood clot volume and duration of blood exposure to brain tissue . Using minimally-invasive surgery plus recombinant tissue plasminogen activator ( rtPA ) , MISTIE investigators explored aggressive avenues to treat ICH . METHODS We investigated the difference between surgical intervention plus rtPA and standard medical management for ICH . Subjects in both groups were medically managed according to standard ICU protocols . Subjects randomized to surgery underwent stereotactic catheter placement and clot aspiration . Injections of rtPA were then given through hematoma catheter every 8 h , up to 9 doses , or until a clot-reduction endpoint . After each injection the system was flushed with sterile saline and closed for 60 min before opening to spontaneous drainage . RESULTS Average aspiration of clots for all patients randomized to surgery plus rtPA was 20 % of mean initial clot size . After acute treatment phase ( aspiration plus rtPA ) , clot was reduced an average of 46 % . Recorded adverse events were within safety limits , including 30-day mortality , 8 % ; symptomatic re-bleeding , 8 % ; and bacterial ventriculitis , 0 % . Patients randomized to medical management showed 4 % clot resolution in a similar time window . Preliminary analysis indicates that clot resolution rates are greatly dependent on catheter placement . Location of ICH also affects efficacy of aggressive treatment of ICH . CONCLUSION There is tentative indication that minimally-invasive surgery plus rtPA shows greater clot resolution than traditional medical management .

minimally-invasive surgery plus rtPA

surgical intervention plus rtPA

standard medical management for

Injections of rtPA

sterile saline

intracerebral hemorrhage evacuation

Average aspiration of clots

clot

30-day mortality

symptomatic re-bleeding

bacterial ventriculitis

clot resolution

clot resolution rates

greater clot resolution

intracerebral hemorrhage

younger

groups


Moist Exposed Burn Ointment ( MEBO ) in partial thickness burns - a randomized , comparative open mono-center study on the efficacy of dermaheal ( MEBO ) ointment on thermal 2nd degree burns compared to conventional therapy . OBJECTIVE Wound healing in burn wounds presents a challenge in healthcare , and there is still a lack of alternatives in topical burn wound treatments . - The purpose of this study was to evaluate the efficacy of a new therapeutic ointment ( MEBO ) in the treatment of partial thickness burns . METHODS 40 patients received either topical treatment with Moist Exposed Burn Ointment ( MEBO ) or standard Flammazine treatment . All patients suffered from partial-thickness burn injuries ( < 20 % TBSA ) . Wounds were evaluated for 60 up to days regarding wound healing , water loss , inflammation , and pain alleviation . RESULTS For transepidermal water loss , there was a difference of 2.3 gr/m2/h between MEBO , and Flammazine , favoring MEBO . However , this difference was not statistically significant ( p=0.78 ) . For all secondary efficacy parameter results were similar . - CONCLUSIONS This study showed that MEBO ointment for topical treatment of burn injuries presents an attractive alternative for the topical treatment of limited partial thickness thermal burns .

Moist Exposed Burn Ointment ( MEBO )

dermaheal ( MEBO )

MEBO

Moist Exposed Burn Ointment ( MEBO )

Flammazine treatment

MEBO

Flammazine

MEBO

MEBO ointment

wound healing

water loss

inflammation

pain alleviation

transepidermal water loss

secondary efficacy

partial thickness burns

thermal 2nd degree burns

partial-thickness burn injuries

limited partial thickness thermal burns


Changes of activated circulating endothelial cells and survivin in patients with non-small cell lung cancer after antiangiogenesis therapy . BACKGROUND Although antiangiogenesis therapy plays an important role in anti-neoplastic treatment with its recognized efficacy and slight adverse effect , there is no prospective clinical trial to define ideal markers for predicting efficacy of antiangiogenic therapy . This study was undertaken to investigate the changes of activated circulating endothelial cells ( aCECs ) and survivin after anti-angiogenesis therapy and their significance in predicting the efficacy of the therapy . METHODS Patients of non-small cell lung cancer ( NSCLC ) treated with chemotherapy with or without Endostar were observed . The amount of activated CECs was detected by flow cytometry , and the expression of survivin mRNA was determined by real-time polymerase chain reaction ( PCR ) . RESULTS After treatment , the amount of activated CECs decreased significantly in clinical benefit cases ( P = 0.021 in chemotherapy alone , P = 0.001 in chemotherapy plus Endostar ) , increased in disease progressive cases ( P = 0.015 in chemotherapy alone , but P = 0.293 in chemotherapy with Endotatar ) . After therapy , the expression of survivin mRNA decreased in clinical benefit cases ( P = 0.001 ) and increased in disease progressive cases ( P = 0.018 ) . A positive correlation was found between activated CECs and survivin in the chemotherapy group pre- and post-therapy ( P = 0.001 and 0.021 , respectively ) , but only in the chemotherapy with Endostar group pre-therapy ( P = 0.030 ) rather than post-therapy . A positive correlation was found between the decreased activated CECs after therapy and time to progression ( TTP ) ( r = 0.322 , P = 0.012 ) ; a negative correlation was found between the amount of survivin mRNA in serum post-therapy and TTP ( r = -0.291 , P = 0.048 ) . CONCLUSIONS Activated CECs and survivin may be ideal markers forecasting efficacy and prognosis of NSCLC . The former can reflect more sensitively antiangiogenic efficacy and the latter is more sensitive to shrinkage or swelling of tumors . Their combination can evaluate more accurately the efficacy of antiangiogenic therapy of NSCLC .

antiangiogenesis therapy

antiangiogenesis therapy

anti-neoplastic treatment

antiangiogenic therapy

chemotherapy with or without Endostar

chemotherapy

chemotherapy plus Endostar

chemotherapy

chemotherapy with Endotatar

chemotherapy

chemotherapy with Endostar

antiangiogenic therapy

activated CECs

disease progressive cases

expression of survivin mRNA

disease progressive cases

activated CECs

activated CECs

time to progression ( TTP )


Three-year clinical outcome after primary stenting of totally occluded native coronary arteries : a randomized comparison of bare-metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions ( Primary Stenting of Totally Occluded Native Coronary Arteries [ PRISON ] II study ) . BACKGROUND The purpose of this study was to examine the 3-year clinical outcome in patients enrolled in the Primary Stenting of Totally Occluded Native Coronary Arteries II study . METHODS Patients with totally occluded coronary arteries randomized to either sirolimus-eluting Cypher stents ( SESs ) ( Cordis , a Johnson & Joshson Company , Miami Lakes , FL ) ( 100 patients ) or bare-metal BxVelocity stents ( BMSs ) ( Cordis ) ( 100 patients ) were followed clinically for 3 years . RESULTS Between 1 and 3 years , there were infrequent additional clinical events that were equally distributed between the SES and the BMS group . After 3 years , target lesion revascularization was 7 % in the SES group versus 27 % in the BMS group ( P < .001 ) ; and target vessel revascularization was seen in 11 % in the SES group versus 30 % in the BMS group ( P = .002 ) . Major adverse cardiac events were noted in 10 % of the SES group versus 34 % in the BMS group ( P < .001 ) . There were no statistically significant differences in death , myocardial infarction , and stent thrombosis according to the Academic Research Consortium criteria between the 2 groups . CONCLUSIONS Clinical outcome up to 3 years after implantation of SESs for total coronary occlusions continues to demonstrate a significant reduction in adverse clinical events compared with BMSs without the evidence for either disproportionate late restenosis or late stent thrombosis .

bare-metal BxVelocity stents ( BMSs )

target lesion revascularization

vessel revascularization

Major adverse cardiac events

death

myocardial infarction

stent thrombosis

occluded native coronary arteries

total coronary occlusions

totally occluded coronary arteries


Altered growth hormone response after growth hormone releasing hormone administration in chronic renal failure . Eleven chronic renal failure patients and 11 matched controls , received growth hormone GHRH ( 1 microgram/kg iv ) or TRH ( 400 microgram iv ) on separate occasions , immediately before undergoing hemodialysis . GHRH-induced GH peak in uremics ( 22.7 +/- 5.2 micrograms/l ) was not different from that obtained in control subjects ( 16.0 +/- 4.3 micrograms/l ) . However , the uremic patients did not show the habitual post-peak fall , remaining GH levels over 10 micrograms/l till the end of the test . Differences between the two groups were significant ( p less than 0.05 ) . Uremic patients showed PRL values higher than in controls , however their TRH-induced PRL peak ( 20.6 +/- 6.6 micrograms/l ) was not different from that of controls ( 26.5 +/- 3.0 micrograms/l ) . Again chronic renal failure patients showed PRL plasma values abnormally elevated till the end of the test . Differences between the two groups were significant ( p less than 0.05 ) . Administration of placebo to a different group of seven uremic patients did not alter GH and PRL plasma levels . This sustained secretion of both GH and PRL in uremia could be attributed to reduced kidney clearance . However , when subjects were examined individually both the GHRH- and the TRH-induced hormonal peaks and the subsequent fall were not different in both groups . Unlike with controls , in uremic patients GHRH-stimulated GH and TRH-stimulated PRL/GH peaks were dispersed throughout the 120 min period . In controls GH and PRL peaks clustered around 15-30 min . The peak dispersion created a false impression of flattened curves or sustained hypersecretion in uremia . ( ABSTRACT TRUNCATED AT 250 WORDS )

growth hormone releasing hormone

growth hormone GHRH

TRH

GHRH-induced

TRH-induced

placebo

GHRH-

TRH-induced

GHRH-stimulated

TRH-stimulated

growth hormone response

GH levels

PRL values

TRH-induced PRL peak

PRL plasma values

GH and PRL plasma levels

GH and PRL

PRL/GH peaks

GH and PRL

Eleven chronic renal failure

uremic


Recombinant human granulocyte-macrophage colony stimulating factor ( rhGM-CSF ) reduces infection-related mortality after allogeneic T-cell depleted BMT .

infection-related mortality

after allogeneic T-cell depleted BMT .


A randomized comparison of parecoxib/valdecoxib and placebo for the prevention of cystoid macular edema after scleral buckling surgery . AIMS To assess the impact of valdecoxib on the incidence of macular edema , after scleral buckling surgery . METHODS Prospective randomized double masked placebo controlled study . Patients undergoing scleral buckle surgery over 18 months were recruited and randomized to receive either oral valdecoxib or placebo . Patients also received two doses of either parecoxib ( pro-drug of valdecoxib ) intravenously 40 mg 6 hourly day one postoperative or identical placebo injection Patients underwent retinal examination , optical coherence tomography and retinal thickness analyzer scan of the macula preoperatively , and at 2 and 6 weeks postoperatively . Outcome measures were the incidence of macular edema , retinal thickness , visual acuity , contrast sensitivity and presence of persistent subretinal fluid . RESULTS Interim analysis was performed with 116 patients were recruited , 58 to each treatment arm . The incidence of macular edema in all patients was 5 % at visit 1 and 2.2 % at visit 2 postoperatively . This incidence was much lower than the expected incidence used in the power calculation to determine study size . It was therefore apparent that a much larger study population would be required to test for an effect and that this was not achievable within the study time period . The study was therefore terminated early . There was no evidence of a difference between COX 2 inhibitor and placebo groups in the incidence of edema , retinal thickness or visual outcome . The presence of residual subretinal fluid at the macula was significantly reduced by COX 2 inhibitor treatment . CONCLUSIONS The rate of cystoid macular edema after scleral buckling surgery is low and is not influenced by prophylactic use of valdecoxib . The rate of residual subretinal fluid was reduced by COX 2 inhibitor treatment . Enhanced antiinflammatory therapy has the potential to improve outcomes in scleral buckling surgery .

parecoxib/valdecoxib

placebo

valdecoxib

placebo

oral valdecoxib

placebo

identical placebo injection

valdecoxib

incidence of macular edema

much lower

scleral buckling surgery .

scleral buckle surgery

116 patients


Validation of an FFQ for evaluation of EPA and DHA intake . OBJECTIVE To validate an FFQ for the assessment of dietary EPA and DHA against their relative concentrations in red blood cells ( RBC ) . DESIGN Cross-sectional analysis of baseline data . Intakes of marine food products and EPA and DHA were estimated by FFQ on the basis of consumption of marine food products in the last month . Fatty acid composition of RBC membranes was quantified by GC . SETTING Saint-François d'Assise Hospital , Québec , Canada . SUBJECTS A total of sixty-five middle-aged women who participated in a randomized clinical trial . RESULTS Spearman 's correlation coefficient between intake of EPA , DHA and EPA + DHA and their corresponding concentration in RBC was 0.46 , 0.40 and 0.42 , respectively ( all P < 0.05 ) . Multiple regression analysis of EPA+DHA intake and RBC EPA + DHA concentration indicated positive and significant correlations for oily fish ( beta = 0.44 , 95 % CI 0.16 , 0.72 , P = 0.0027 ) , total fish ( beta = 0.42 , 95 % CI 0.19 , 0.64 , P = 0.0005 ) and marine food products ( beta = 0.42 , 95 % CI 0.20 , 0.64 , P = 0.0003 ) . No other marine food products significantly predicted RBC EPA + DHA concentration . CONCLUSIONS Although the present validation study was undertaken among middle-aged women with low consumption of marine food products ( < 3 servings/week ) , our FFQ provided estimates of EPA and DHA intakes that correlated fairly well with their RBC concentrations . However , the absence of correlations between EPA + DHA intakes from different marine species suggests that a minimum EPA + DHA intake is necessary to observe a relationship with RBC EPA + DHA concentrations .

EPA

DHA

marine food products

EPA

DHA

marine food products

EPA and DHA intake

EPA and DHA


Effect of recombinant adenovirus-p53 combined with radiotherapy on long-term prognosis of advanced nasopharyngeal carcinoma . PURPOSE To centrally assess the safety , efficacy , and 6-year follow-up of recombinant adenovirus-p53 ( rAd-p53 ) combined with radiotherapy ( RT ) for patients with nasopharyngeal carcinoma ( NPC ) . PATIENTS AND METHODS A randomized controlled clinical study on rAd-p53 combined with RT in 42 patients with NPC was compared with a control group of 40 patients with NPC treated with RT alone . In the group receiving rAd-p53 combined with RT , rAd-p53 was intratumorally injected once a week for 8 weeks . Concurrent RT ( 70 Gy in 35 fractions ) was given to the nasopharyngeal tumor and neck lymph node . Patients and tumors were monitored for adverse events and responses . RESULTS rAd-p53-specific p53 mRNA was detected in postinjection of rAd-p53 biopsies from 16 ( 94.1 % ) of 17 patients . Upregulation of p21/WAF1 and Bax and downregulation of vascular endothelial growth factor were observed in postinjection tumor biopsy . Complete response rate in the group receiving rAd-p53 combined with RT was observed at 2.73 times that of the group receiving RT alone ( 66.7 % v 24.4 % ) . Six-year follow-up data showed that rAd-p53 significantly increased the 5-year locoregional tumor control rate by 25.3 % for patients with NPC treated with irradiation ( P = .002 ) . The 5-year overall survival rate and 5-year disease-free survival rate of the group receiving rAd-p53 combined with RT were 7.5 % ( P = .34 ) and 11.7 % ( P = .21 ) higher than those of the group receiving RT alone . No dose-limiting toxicity or adverse events appeared , except for transient fever after rAd-p53 administration . CONCLUSION In patients with NPC , rAd-p53 was safe and biologically active . Our results indicated that rAd-p53 improves radiotherapeutic tumor control and survival rate in patients with NPC .

rAd-p53 combined with RT

RT alone .

rAd-p53 combined with RT , rAd-p53

rAd-p53 combined with RT

RT alone

rAd-p53 combined with RT

RT alone

long-term prognosis

adverse events and responses .

rAd-p53-specific p53 mRNA

p21/WAF1 and Bax

vascular endothelial growth factor

Complete response rate

5-year locoregional tumor control rate

dose-limiting toxicity

transient fever

advanced nasopharyngeal carcinoma

nasopharyngeal carcinoma ( NPC ) .

42 patients

NPC

40 patients

NPC .


A randomized breast-feeding promotion intervention did not reduce child obesity in Belarus . The evidence that breast-feeding protects against obesity is based on observational studies , with potential for confounding and selection bias . This article summarizes a previously published study in which we assessed whether an intervention designed to promote exclusive and prolonged breast-feeding affects children 's height , weight , adiposity , and blood pressure ( BP ) at age 6.5 y . The Promotion of Breastfeeding Intervention Trial ( PROBIT ) is a cluster-randomized trial of a breast-feeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative . A total of 17,046 healthy breast-fed infants were enrolled from 31 Belarussian maternity hospitals and affiliated clinics , of whom 13,889 ( 81.5 % ) were followed up at 6.5 y with duplicate measurements of height , weight , waist circumference , triceps and subscapular skinfold thicknesses , systolic and diastolic BP . Analysis was based on intention to treat , with statistical adjustment for clustering within hospitals/clinics to permit inferences at the individual level . The experimental intervention led to a large increase in exclusive breast-feeding at 3 mo ( 43.3 % vs. 6.4 % , P < 0.001 ) and a significantly higher prevalence of any breast-feeding throughout infancy . No significant intervention effects were observed on height , BMI , adiposity measures , or BP . The breast-feeding promotion intervention resulted in substantial increases in the duration and exclusivity of breast-feeding yet did not reduce measures of adiposity at age 6.5 y . Previous reports of protective effects against obesity may reflect uncontrolled bias caused by confounding and selection .

breast-feeding promotion

Promotion of Breastfeeding

breast-feeding promotion

exclusive breast-feeding at 3 mo


Modified constraint-induced therapy combined with mental practice : thinking through better motor outcomes . BACKGROUND AND PURPOSE Modified constraint-induced therapy ( mCIT ) is an outpatient therapy encouraging repetitive , task-specific practice with the affected arm . mCIT has shown efficacy in all stages poststroke . Given its efficacy when combined with other therapy regimens , the current study examined the efficacy of mental practice when combined with mCIT versus mCIT only using randomized , controlled methods . METHOD Ten patients with chronic stroke ( 7 males ; mean age , 61.4+/-3.02 years ; age range , 48 to 79 years ; mean time since stroke , 28.5 months ; range , 13 to 42 months ) exhibiting stable , affected arm motor deficits were administered mCIT , consisting of : ( 1 ) structured therapy emphasizing affected arm use in functional activities 3 days/week for 10 weeks ; and ( 2 ) less affected arm restraint 5 days/week for 5 hours . Both of these components were administered during a 10-week period . Subjects randomly assigned to the mCIT+mental practice experimental condition also received 30-minute mental practice sessions provided directly after therapy sessions . These mental practice sessions required daily cognitive rehearsal of the activities of daily living practiced during mCIT clinical sessions . RESULTS No pre-existing differences were found between groups on any demographic variable or movement scale . All subjects exhibited marked reductions in affected arm impairment and functional limitation . However , subjects in the mCIT+mental practice group exhibited significantly larger changes on both movement measures after intervention : Action Research Arm Test , +15.4-point change versus +8.4-point change for mCIT only subjects ( P < 0.001 ) ; Fugl-Meyer , +7.8-point change versus +4.1-point change for the mCIT only subjects ( P=0.01 ) . These changes were sustained 3 months after intervention . CONCLUSIONS mCIT remains a promising motor intervention . However , its efficacy appears to be enhanced by use of mental practice provided directly after mCIT clinical sessions .

Modified constraint-induced therapy

mental practice :

mCIT

mental practice

mCIT

mCIT only

mCIT

mCIT+mental practice

mental practice

mCIT

mCIT+mental practice

mCIT only

mCIT only

mCIT

mental practice

mCIT

movement measures


Two different methods for donor hepatic transection : cavitron ultrasonic surgical aspirator with bipolar cautery versus cavitron ultrasonic surgical aspirator with radiofrequency coagulator-A randomized controlled trial . The aim of this study was to compare the Cavitron ultrasonic surgical aspirator ( CUSA ) with bipolar cautery ( BP ) to CUSA with a radiofrequency coagulator [ TissueLink ( TL ) ] in terms of efficacy and safety for hepatic transection in living donor liver transplantation . Twenty-four living liver donors ( n = 12 for each group ) were randomized to undergo hepatic transection using CUSA with BP or CUSA with TL . Blood loss during parenchymal transection and speed of transection were the primary endpoints , whereas the degree of postoperative liver injury and morbidity were secondary endpoints . Median blood loss during liver transection was significantly lower in the TL group than in the BP group ( 195.2 +/- 84.5 versus 343.3 +/- 198.4 mL ; P = 0.023 ) , and liver transection was significantly faster in the TL group than in the BP group ( 0.7 +/- 0.2 versus 0.5 +/- 0.2 cm ( 2 ) /minute ; P = 0.048 ) . Significantly fewer ties were required during liver transection in the TL group than in the BP group ( 15.8 +/- 4.8 versus 22.8 +/- 7.9 ties ; P = 0.023 ) . The morbidity rates were similar for the 2 groups . In conclusion , CUSA with TL is superior to CUSA with BP for donor hepatectomy in terms of blood loss and speed of transection with no increase in morbidity .

CUSA with BP

CUSA with TL

speed of transection

liver transection

fewer ties

morbidity rates

blood loss

speed of transection

morbidity


Effects of flumazenil on cerebral blood flow and oxygen consumption after midazolam anaesthesia for craniotomy . Cerebral blood flow ( CBF ) and cerebral metabolic rate for oxygen ( CMRO2 ) were measured by a modification of the Kety-Schmidt technique using i.v . xenon-133 in 20 patients undergoing craniotomy for supratentorial cerebral tumours . Anaesthesia was induced and maintained with midazolam , fentanyl and nitrous oxide . Pancuronium was given for neuromuscular block . The lungs were ventilated to normocapnia . The first flow measurements were performed approximately 1 h after induction of anaesthesia . At the end of operation the patients were allocated to two groups . Ten patients were given flumazenil 0.01 mg kg-1 and 5 min later the second flow measurement was performed . In the other 10 patients the second flow measurement was performed before the administration of flumazenil . Plasma concentrations of midazolam were measured at the time of each measurement of CBF . There was no difference between the groups in plasma concentration of midazolam , CBF or CMRO2 . Flumazenil had no effect on CBF and CMRO2 .

flumazenil

midazolam

craniotomy

midazolam

fentanyl

nitrous oxide

Pancuronium

flumazenil

flumazenil

midazolam

midazolam

Flumazenil

cerebral blood flow

oxygen consumption

Cerebral blood flow ( CBF )

Plasma concentrations of midazolam

plasma concentration of midazolam

CBF

no effect on CBF


Financial and quality-of-life burden of dysfunctional uterine bleeding among women agreeing to obtain surgical treatment . PURPOSE In this study , we sought to 1 ) describe elements of the financial and quality-of-life burden of dysfunctional uterine bleeding ( DUB ) from the perspective of women who agreed to obtain surgical treatment ; 2 ) explore associations between DUB symptom characteristics and the financial and quality-of-life burden ; 3 ) estimate the annual dollar value of the financial burden ; and 4 ) estimate the most that could be spent on surgery to eliminate DUB symptoms for which medical treatment has been unsuccessful that would result in a $ 50,000/quality-adjusted life-year incremental cost-effectiveness ratio . METHODS We collected baseline data on DUB symptoms and aspects of the financial and quality-of-life burden for 237 women agreeing to surgery for DUB in a randomized trial comparing hysterectomy with endometrial ablation . Measures included out-of-pocket pharmaceutical expenditures , excess expenditures on pads or tampons , the value of time missed from paid work and home management activities , and health utility . We used chi2 and t tests to assess the statistical significance of associations between DUB characteristics and the financial and quality-of-life burden . The annual financial burden was estimated . RESULTS Pelvic pain and cramps were associated with activity limitations and tiredness was associated with a lower health utility . Excess pharmaceutical and pad and tampon costs were $ 333 per patient per year ( 95 % confidence interval [ CI ] , $ 263- $ 403 ) . Excess paid work and home management loss costs were $ 2,291 per patient per year ( 95 % CI , $ 1847- $ 2752 ) . Effective surgical treatment costing $ 40,000 would be cost-effective compared with unsuccessful medical treatment . CONCLUSION The financial and quality-of-life effects of DUB represent a substantial burden .

Financial and quality-of-life burden

financial and quality-of-life burden

financial and quality-of-life burden

financial and quality-of-life burden

financial and quality-of-life effects

excess expenditures on pads or tampons

health utility

Pelvic pain and cramps

activity limitations

tiredness

lower health utility

Effective surgical treatment

cost-effective


Intravenous lidocaine does not cause shivering-like tremor or alter thermoregulation . We tested the hypotheses that systemic absorption of epidural lidocaine : ( 1 ) contributes to the shivering-like tremor seen during epidural anesthesia by causing central nervous system disinhibition of spinal reflexes , or ( 2 ) activates or alters thermoregulatory mechanisms . In a double-blind , placebo , cross-over study , nine healthy volunteers were given intravenous lidocaine ( or saline ) to approximate the plasma levels of lidocaine achieved during epidural anesthesia for major abdominal surgery . Five volunteers were studied in a warm room ( to test for nonthermoregulatory tremor ) , and four volunteers were studied in a cold room ( to test the effects of lidocaine on normal thermoregulation ) . Central temperatures , peripheral vasoconstriction , tremor and clonus were unaffected by intravenous lidocaine . We conclude that the systemic absorption of epidural lidocaine does not contribute to tremor or shivering by these mechanisms .

lidocaine

lidocaine :

placebo

intravenous lidocaine

saline

lidocaine

lidocaine

lidocaine

shivering-like tremor

alter thermoregulation

nonthermoregulatory tremor

normal thermoregulation

tremor or shivering

major abdominal surgery .


Prevention of postoperative hypocalcemia with routine oral calcium and vitamin D supplements in patients with differentiated papillary thyroid carcinoma undergoing total thyroidectomy plus central neck dissection . BACKGROUND Routine oral calcium and vitamin D supplementation may prevent hypocalcemic crisis , but its efficacy has not been studied in patients undergoing thyroidectomy plus central neck dissection ( CND ) . The authors therefore prospectively evaluated the clinical usefulness of routine oral calcium and vitamin D supplementation for prevention of hypocalcemia after total thyroidectomy and CND . METHODS Of 197 patients with differentiated papillary thyroid carcinoma , 49 underwent total thyroidectomy alone , and 148 underwent total thyroidectomy plus CND . The latter were randomized to oral calcium ( 3 g/day ) plus vitamin D ( 1 mg/day ) ( Group A , n=49 ) , calcium alone ( Group B , n=49 ) , or no supplements ( Group C , n=50 ) . Hypocalcemic symptoms , serum calcium , and parathyroid hormone ( PTH ) levels were compared among the groups . RESULTS Group C had significantly higher incidences of symptomatic ( 26.0 % vs 6.1 % ; P < .015 ) and laboratory ( 44.0 % vs 14.3 % ; P < .015 ) hypocalcemia than the group without CND . The incidences of symptomatic and laboratory hypocalcemia were significantly decreased in Groups A ( 2.0 % and 8.2 % , respectively ) and B ( 12.2 % and 24.5 % , respectively ) ( P < .05 ) . Serum calcium levels decreased in most patients after surgery , but recovered earliest in Group A. Hypercalcemia and PTH inhibition did not occur in gs A and B . CONCLUSIONS Compared with total thyroidectomy alone , CND significantly increases the rate of postoperative hypocalcemia , which can be prevented by routine postoperative supplementation with oral calcium and vitamin D .

calcium

vitamin D supplements

oral calcium

vitamin D supplementation

total thyroidectomy plus CND

oral calcium

vitamin D

calcium alone

hypocalcemia

symptomatic and laboratory hypocalcemia

Serum calcium levels

postoperative hypocalcemia


Detection of traumatic arthrotomy of the knee using the saline solution load test . BACKGROUND The saline solution load test helps to determine if a wound extends into the knee joint . Little is known about the volume of injected intra-articular saline solution that is needed to effectively rule in or rule out a traumatic arthrotomy of the knee . The purpose of the present study was to determine the appropriate volume and needle location for the diagnosis of a traumatic knee arthrotomy and to assess the effect of associated variables , including knee circumference , body mass index , and sex . METHODS Fifty-six consecutive patients scheduled for knee arthroscopy were enrolled . A standard inferolateral arthroscopic portal was made with a single stab incision with use of a number-11 blade . Injection sites were randomized to either a superomedial or inferomedial location . The injection of normal saline solution at a rate of 5 mL/sec through an 18-gauge needle was continued while the knee was moved through a range of motion until fluid extravasated from the iatrogenic laceration . The volume of injected fluid was recorded . RESULTS The study group included thirty-one female patients and twenty-five male patients with a combined average age of fifty years and an average body mass index of 30.9 . In order to effectively diagnose 50 % of the arthrotomies , 75 mL of injected fluid was needed ; the volumes that were needed in order to effectively diagnose 75 % , 90 % , 95 % , and 99 % of the arthrotomies were 110 , 145 , 155 , and 175 mL , respectively . The mean volumes of injected fluid needed for a positive result at the inferomedial and superomedial needle locations were 64.0 and 95.2 mL , respectively ; this difference was significant ( p = 0.01 ) . There was no correlation between necessary injection volume and sex , body mass index , or knee circumference . CONCLUSIONS In order to detect 95 % of 1-cm inferolateral arthrotomies of the knee with use of the saline solution load test , 155 mL must be injected . An inferomedial injection location requires significantly less fluid than a superomedial injection location does for the diagnosis of inferolateral arthrotomies of the knee .

saline solution load test

saline solution load test

saline solution

appropriate volume

needle location

average body mass index

diagnose 50 % of the arthrotomies

significantly less fluid

Fifty-six

scheduled for knee arthroscopy

thirty-one

female

patients and twenty-five

male

patients

average age of fifty years


Measuring social cognition in adolescents : implications for students with TBI returning to school . In everyday adolescent communication , the ability to empathise with the mental state of others , recognise or infer intentions , or make judgements about emotional state , is a non-conscious but vital prerequisite of relating . Execution of these skills in social interactions supports both the exchange of social knowledge and also the development and maintenance of personal relationships . Thus , adolescents with impairments in these skills are at risk for a variety of negative outcomes . In this paper , we present data to illustrate that adolescents with traumatic brain injury ( TBI ) are likely to have impairments in processes such as emotion recognition and mental state attribution , and that these might not be identified on standardised tests . This is considered from the perspective of clinical assessment and intervention in school contexts .

adolescent communication

infer intentions

social cognition

adolescents :

students

TBI

adolescents

adolescents

traumatic brain injury

TBI


Effects of static stretching on repeated sprint and change of direction performance . PURPOSE To examine the effects of static stretching during the recovery periods of field-based team sports on subsequent repeated sprint ability ( RSA ) and change of direction speed ( CODS ) performance . METHODS On four separate occasions , 12 male team-sport players performed a standardized warm-up , followed by a test of either RSA or CODS ( on two occasions each ) in a counterbalanced design . Both tests involved three sets of six maximal sprint repetitions , with a 4-min recovery between sets . During the break between sets , the participants either rested ( control [ CON ] ) or completed a static stretching protocol ( static stretch [ SS ] ) . The RSA test involved straight-line sprints , whereas the CODS test required a change of direction ( 100 degrees ) every 4 m ( total of four ) . Mean , total ( sum of six sprints ) , first , and best sprint times ( MST , TST , FST , and BST , respectively ) were recorded for each set . RESULTS There was a consistent tendency for RSA times to be slower after the static stretching intervention , which was supported by statistical significance for three performance variables ( MST 0-5 m set 2 , MST 0-20 m set 2 , and TST set 2 ; P < 0.05 ) . This tendency was also supported by moderate effect sizes and qualitative indications of " likely " harmful or detrimental effects associated with RSA-SS . Further , sprint times again tended to be slower in the CODS-SS trial compared with the CODS-CON across all sprint variables , with a significantly slower ( P < 0.05 ) BST recorded for set 3 after static stretching . CONCLUSION These results suggest that an acute bout ( 4 min ) of static stretching of the lower limbs during recovery periods between efforts may compromise RSA performance but has less effect on CODS performance .

static stretching

static stretching

repeated sprint ability ( RSA )

change of direction speed ( CODS )

RSA

CODS

rested ( control [ CON ] )

RSA

straight-line sprints

CODS

static stretching intervention

RSA-SS

CODS-SS

CODS-CON

static stretching

repeated sprint

and change of direction performance

repeated sprint ability ( RSA )

RSA

best sprint times

RSA times

sprint times

RSA performance

CODS performance

male


Face composite effects reveal abnormal face processing in Autism spectrum disorders . Although it has been suggested that individuals with an Autism spectrum disorder ( ASD ) process faces less holistically than typically developing controls , there are few direct investigations of this hypothesis . This question was addressed before using the composite paradigm ( Teunisse , J. P. , & de Gelder , B . ( 2003 ) . Face processing in adolescents with autistic disorder : The inversion and composite effects . Brain Cognition , 52 ( 3 ) , 285-294. ) . The results had revealed that adolescents with ASDs were less sensitive than controls to the misalignment of face parts and it was concluded their face processing was less holistic . However , because of shortcomings of the design , it was not possible to distinguish whether individuals with Autism processed both aligned and misaligned composites in a part-based fashion , or both in a holistic fashion . We compared adolescents with ASDs to controls matched on sex , age and IQ on a more complete version of the composite paradigm . The results indicate that individuals with ASDs , like controls , experience interference from facial features that they are told to ignore . However , while such interference is released for controls if parts of face composites are misaligned , individuals with ASDs show comparable interference from irrelevant parts regardless of alignment . Two different interpretations are discussed , both compatible with the idea that perceptual and or attentional abnormalities in ASDs result in a diminished level of expertise for faces .

Face composite

adolescents with ASDs

controls

composite paradigm

experience interference

comparable interference


Probiotics prevent IgE-associated allergy until age 5 years in cesarean-delivered children but not in the total cohort . BACKGROUND Less microbial exposure in early childhood is associated with more allergic disease later . Allergic children have a different fecal microflora , with less lactobacilli and bifidobacteria . Beneficial effects regarding the development of allergy have been suggested to come through probiotic supplementation . OBJECTIVE We sought to study the effect of probiotic and prebiotic supplementation in preventing allergies . METHODS In a double-blinded , placebo-controlled study we randomized 1223 mothers with infants at high risk for allergy to receive a probiotic mixture ( 2 lactobacilli , bifidobacteria , and propionibacteria ) or placebo during the last month of pregnancy and their infants to receive it from birth until age 6 months . Infants also received a prebiotic galacto-oligosaccharide or placebo . At 5 years , we evaluated the cumulative incidence of allergic diseases ( eczema , food allergy , allergic rhinitis , and asthma ) and IgE sensitization . RESULTS Of the 1018 intent-to-treat infants , 891 ( 88 % ) attended the 5-year visit . Frequencies of allergic and IgE-associated allergic disease and sensitization in the probiotic and placebo groups were similar : 52.6 % versus 54.9 % and 29.5 % versus 26.6 % , respectively , and 41.3 % in both . No significant difference appeared in frequencies of eczema ( 39.3 % vs 43.3 % ) , atopic eczema ( 24.0 % vs 25.1 % ) , allergic rhinitis ( 20.7 % vs 19.1 % ) , or asthma ( 13.0 % vs 14.1 % ) between groups . However , less IgE-associated allergic disease occurred in cesarean-delivered children receiving probiotics ( 24.3 % vs 40.5 % ; odds ratio , 0.47 ; 95 % CI , 0.23 % to 0.96 % ; P = .035 ) . CONCLUSIONS No allergy-preventive effect that extended to age 5 years was achieved with perinatal supplementation of probiotic bacteria to high-risk mothers and children . It conferred protection only to cesarean-delivered children .

Probiotics

probiotic and prebiotic supplementation

placebo-controlled

placebo

prebiotic galacto-oligosaccharide

placebo

probiotic

placebo

probiotics

probiotic bacteria

IgE sensitization

sensitization

frequencies of eczema

atopic eczema

allergic rhinitis

asthma

IgE-associated allergic disease

in cesarean-delivered

children

Allergic

1223 mothers

infants

high risk for allergy

infants

age 6 months

1018 intent-to-treat

891 ( 88 % ) attended

high-risk


Recommendations for implementing stereotactic radiotherapy in peripheral stage IA non-small cell lung cancer : report from the Quality Assurance Working Party of the randomised phase III ROSEL study . BACKGROUND A phase III multi-centre randomised trial ( ROSEL ) has been initiated to establish the role of stereotactic radiotherapy in patients with operable stage IA lung cancer . Due to rapid changes in radiotherapy technology and evolving techniques for image-guided delivery , guidelines had to be developed in order to ensure uniformity in implementation of stereotactic radiotherapy in this multi-centre study . METHODS/DESIGN A Quality Assurance Working Party was formed by radiation oncologists and clinical physicists from both academic as well as non-academic hospitals that had already implemented stereotactic radiotherapy for lung cancer . A literature survey was conducted and consensus meetings were held in which both the knowledge from the literature and clinical experience were pooled . In addition , a planning study was performed in 26 stage I patients , of which 22 were stage 1A , in order to develop and evaluate the planning guidelines . Plans were optimised according to parameters adopted from RTOG trials using both an algorithm with a simple homogeneity correction ( Type A ) and a more advanced algorithm ( Type B ) . Dose conformity requirements were then formulated based on these results . CONCLUSION Based on current literature and expert experience , guidelines were formulated for this phase III study of stereotactic radiotherapy versus surgery . These guidelines can serve to facilitate the design of future multi-centre clinical trials of stereotactic radiotherapy in other patient groups and aid a more uniform implementation of this technique outside clinical trials .

stereotactic radiotherapy

stereotactic radiotherapy

stereotactic radiotherapy

stereotactic radiotherapy

stereotactic radiotherapy


Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients ( JATOS ) . The benefits of lowering a systolic blood pressure below 140 mmHg in elderly hypertension remain controversial . This study is a prospective , randomized , open-label study with blinded assessment of endpoints to compare the 2-year effect of strict treatment to maintain systolic blood pressure below 140 mmHg with that of mild treatment to maintain systolic blood pressure below 160 but at or above 140 mmHg in elderly hypertensive patients . Patients with essential hypertension ( 65-85 years old , with a pretreatment systolic blood pressure of above 160 mmHg ) were randomly assigned to receive strict treatment ( n=2,212 ) or mild treatment ( n=2,206 ) . The baseline drug was efonidipine hydrochloride , a long-acting calcium antagonist . The primary endpoint was the combined incidence of cardiovascular disease and renal failure , and the secondary endpoints were total deaths and any safety problems . Although final blood pressures ( systolic/diastolic ) were significantly lower in the strict-treatment group compared with the mild-treatment group ( 135.9/74.8 vs. 145.6/78.1 mmHg ; p < 0.001 ) , the incidence of the primary endpoint was similar in the two groups ( 86 patients in each group ; p=0.99 ) . Total deaths were 54 in the strict-treatment group vs. 42 in the mild-treatment group ( p=0.22 ) , and treatment was withdrawn because of adverse events in 36 patients in each group ( p=0.99 ) . An interaction between age and treatment for the primary endpoints ( p=0.03 ) was seen . Complex clinical features associated with aging seem to have obscured the difference in effect between the two treatments . Further studies are needed to assess the optimal treatment strategy for hypertension in the elderly .

strict treatment

mild treatment

efonidipine hydrochloride

renal failure

total deaths

safety problems

blood pressures ( systolic/diastolic )

deaths


Ondansetron has similar clinical efficacy against both nausea and vomiting . Ondansetron is widely believed to prevent postoperative vomiting more effectively than nausea . We analysed data from 5161 patients undergoing general anaesthesia who were randomly stratified to receive a combination of six interventions , one of which was 4 mg ondansetron vs placebo . For the purpose of this study a 20 % difference in the relative risks for the two outcomes was considered clinically relevant . Nausea was reduced from 38 % ( 969/2585 ) in the control to 28 % ( 715/2576 ) in the ondansetron group , corresponding to a relative risk of 0.74 , or a relative risk reduction of 26 % . Vomiting was reduced from 17 % ( 441/2585 ) to 11 % ( 293/2576 ) , corresponding to a relative risk of 0.67 , or a relative risk reduction of 33 % . The relative risks of 0.67 and 0.74 were clinically similar and the difference between them did not reach statistical significance . We thus conclude that ondansetron prevents postoperative nausea and postoperative vomiting equally well .

Ondansetron

Ondansetron

anaesthesia

ondansetron

placebo

ondansetron

ondansetron

clinical efficacy

nausea

vomiting

vomiting

nausea

Nausea

Vomiting

postoperative nausea

postoperative vomiting


Effect of testosterone and a nutritional supplement , alone and in combination , on hospital admissions in undernourished older men and women . BACKGROUND In older people , undernutrition is associated with increased hospitalization rates and mortality . Because weight loss in older people often reflects a disproportionate reduction of skeletal muscle , anabolic treatments may be beneficial . OBJECTIVE Our aim was to evaluate the hypothesis that testosterone treatment and a nutritional supplement have additive benefits . DESIGN Oral testosterone undecanoate ( 40 mg daily for women , 80 mg twice daily for men ) and an oral nutritional supplement ( 475 kcal/d ) were administered , alone or combined , for 1 y to 49 community-dwelling , undernourished people [ Mini Nutritional Assessment score < 24 and low body weight ( body mass index , in kg/m ( 2 ) : < 22 ) or recent weight loss ( > 7.5 % over 3 mo ) ] aged > 65 y ( mean age : 77 y ; 26 women and 23 men ) . Hospital admissions and other variables were assessed . RESULTS In subjects receiving combined testosterone and nutritional supplements ( n = 11 ) , there were no hospital admissions , whereas there were 9 admissions ( 2 elective ) in 13 subjects in the no-treatment group , 4 in the testosterone-treated group ( n = 12 ) , and 5 in the supplement-treated group ( n = 13 ) ; P = 0.06 with no-treatment compared with combined treatment . When compared with the no-treatment group , the combined-treatment group had significantly fewer subjects admitted to hospital ( 0 compared with 5 , P = 0.03 ) , fewer days in hospital ( 0 compared with 74 , P = 0.041 ) , and a longer time to hospital admission ( P = 0.017 ) . CONCLUSIONS In undernourished older people , combined treatment with testosterone and nutritional supplementation reduced the number of people hospitalized and the duration of hospital admissions , which are important endpoints in this group . Larger , confirmatory studies are now needed . This trial was registered before commencement at clinical trials.gov as NCT00117000 .

testosterone

nutritional supplement

in combination

testosterone treatment

nutritional supplement

Oral testosterone undecanoate

oral nutritional supplement

alone

combined

combined testosterone

nutritional supplements

no-treatment

testosterone-treated

supplement-treated

no-treatment

combined-treatment

testosterone

nutritional supplementation

hospital admissions

hospitalization rates

mortality

Hospital admissions

other variables

hospital admissions

subjects admitted to hospital

days in hospital

undernourished

older

men and women

community-dwelling

undernourished people

aged > 65 y ( mean age : 77 y ;

26 women and 23 men

older


A double-blind , placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder . Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism . A randomized , double-blind , placebo-controlled , parallel groups , dose-ranging study of oral , human immunoglobulin ( IGOH 140 , 420 , or 840 mg/day ) was utilized with 125 children ( ages 2-17 years ) with autism and persistent GI symptoms . Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale ( validated in irritable bowel syndrome studies ) , number of daily bowel movements , days of constipation , or severity of problem behaviors . IGOH was well-tolerated ; there were no serious adverse events . This study demonstrates the importance of conducting rigorous trials in children with autism and casts doubt on one GI mechanism presumed to exert etiological and/or symptomatic effects in this population .

placebo-controlled

oral human immunoglobulin

placebo-controlled

oral , human immunoglobulin

IGOH

global improvement scale

well-tolerated ;

serious adverse events .

gastrointestinal dysfunction

children

autistic disorder

ages 2-17 years

autism and persistent GI symptoms

children

autism


Adjuvant goserelin and ovarian preservation in chemotherapy treated patients with early breast cancer : results from a randomized trial . The purpose of this randomized study was to examine if goserelin concomitant to CMF-chemotherapy as adjuvant treatment for premenopausal breast cancer , protects the ovaries from premature failure . A total of 285 premenopausal breast cancer patients , in a randomized adjuvant trial ( Zoladex in premenopausal patients ( ZIPP ) ) , were assigned to a study on ovarian function . Node positive patients were assigned to CMF- ( cyclophosphamide , methotrexate and 5-fluorouracil ) chemotherapy in addition to endocrine therapy . All patients were randomly assigned to receive 2 years of goserelin , goserelin plus tamoxifen , tamoxifen alone or no endocrine treatment . We studied , if menses were affected in the treatment groups , up to 36 months after randomization . One year after completed CMF- and endocrine therapy , 36 % of the women in the goserelin group reported menses , compared to 7 % in the goserelin plus tamoxifen group , 13 % in the tamoxifen group and 10 % of the controls . Among women treated with goserelin , there was a statistically significant increase in the proportion of menstruating women , 1 year after completed treatment compared to at 24 months of treatment ( P = 0.006 ) , in contrast to all other treatment groups , who were unchanged or more often amenorrheic . In our study , there is some evidence of protective effect of goserelin on ovarian function in CMF treated women . This effect was not observed in the combined tamoxifen and goserelin treatment .

Zoladex

endocrine therapy

goserelin

goserelin plus tamoxifen

tamoxifen alone

no endocrine treatment

protects the ovaries

menses

menses

increase

proportion of menstruating women

amenorrheic .

breast cancer

premenopausal breast cancer


Randomized prospective study to evaluate child abuse documentation in the emergency department . OBJECTIVES The objective was to determine whether an educational intervention for health care providers would result in improved documentation of cases of possible physical child abuse in children < 36 months old treated in the emergency department ( ED ) setting . METHODS This study had a statewide group-randomized prospective trial design . Participating EDs were randomized to one of three intervention groups : no intervention , partial intervention , or full intervention . Medical records for children < 36 months of age were abstracted before , during , and after the intervention periods for specific documentation elements . The main outcome measure was the change in documentation from baseline . Generalized estimating equations ( GEEs ) were used to test for intervention effect . RESULTS A total of 1,575 charts from 14 hospitals EDs were abstracted . Hospital and demographic characteristics were similar across intervention groups . There were 922 ( 59 % ) injury visits and 653 ( 41 % ) noninjury visits . For each specific documentation element , a GEE model gave p-values of > 0.2 in independent tests , indicating no evidence of significant change in documentation after the intervention . Even among the 26 charts in which the possibility of physical abuse was noted , documentation remained variable . CONCLUSIONS The educational interventions studied did not improve ED documentation of cases of possible physical child abuse . The need for improved health care provider education in child abuse identification and documentation remains . Future innovative educational studies to improve recognition of abuse are warranted .

no intervention

partial intervention

full intervention

educational interventions

abuse

documentation

ED documentation

recognition of abuse


Effectiveness of education for gastric cancer patients : a controlled prospective trial comparing interactive vs. lecture-based programs . OBJECTIVE Although patient education may enhance knowledge , coping with illness , and quality of life among cancer patients , it is uncertain which didactic method is most effective . We compared the impact of an interactive , patient-oriented group program to a lecture-based , information-only program in gastric cancer patients . METHODS In this prospective , controlled trial , 121 gastric cancer patients attending inpatient rehabilitation after surgical treatment received either the interactive intervention or lectures providing information . The outcomes were patients ' disease-related knowledge , active coping with illness , and quality of life ( QoL ) at the end of their stay and 6 and 12 months thereafter . RESULTS Both groups improved their knowledge and QoL during rehabilitation ; however , knowledge was significantly higher in the interactive group compared to the lecture group . This difference was maintained at the 6- and 12-months follow-ups . In addition , the interactive group proved superior to the lecture group regarding active coping with illness and QoL at the end of rehabilitation , but not during follow-up . CONCLUSIONS A structured , interactive patient education program proved superior to lecture-based provision of information in regards to short-term and long-term knowledge as well as short-term coping and QoL . PRACTICE IMPLICATIONS In gastric cancer patients , interactive patient education seems preferable over lectures .

interactive vs. lecture-based programs

patient education

interactive patient education

patients ' disease-related knowledge

active coping with illness

, and

quality of life ( QoL )

improved their knowledge

and QoL during rehabilitation

knowledge

active coping with illness

QoL

gastric cancer

cancer

gastric cancer


Do catheter washouts extend patency time in long-term indwelling urethral catheters ? A randomized controlled trial of acidic washout solution , normal saline washout , or standard care . PURPOSE Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue , but evidence on optimal management is lacking . Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage . DESIGN A multisite randomized controlled trial . SUBJECTS AND SETTING Adults with long-term indwelling catheters that required changing every 3 weeks or less , living in the community , and requiring supportive or continuing care were recruited . Participants were randomly assigned to 1 of 3 groups : control ( usual care , no washout ) , saline washout , or commercially available acidic washout solution ( Contisol Maelor Pharmaceuticals Ltd , Wrexham , UK ) . METHODS At baseline visit , the catheter was changed and participants were followed weekly for 8 weeks , with checks for catheter patency and urine pH . Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution . Endpoints were 8 weeks ( completion data ) , 3 or more catheter changes in the 8-week period , or symptomatic urinary tract infection ( UTI ) requiring antibiotics . The study hypothesis was that catheter life would be extended by 25 % in the commercial solution group . It was not possible to blind participants or research nurses to washout versus no intervention , but participants in the saline and washout solution groups were blinded to solution type . RESULTS One hundred twelve potential participants were screened ; 73 were enrolled , randomized , and included in the final analysis . Of these , 53 completed the full 8 weeks of data collection ; 16 terminated early because of 3 catheter changes or self-reported 'UTI ' . Other reasons for termination were hematuria , latex sensitivity , deceased/severe illness , or personal choice . Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study . Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change . CONCLUSION At this time , the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking . No increased risk of UTI was associated with washout regimes .

catheter washouts

standard care .

catheter washouts

control ( usual care , no washout

saline washout

, or

saline or commercial solution

washout

commercial solution

washout versus

no intervention

saline and washout solution

saline

Contisol

usual care with no washout

washout regimes .

patency time

long-term indwelling

catheter blockage

checks for catheter patency

urine pH

termination

hematuria

personal choice

time to first catheter change

risk of UTI


An emergency clinical pathway for stroke patients -- results of a cluster randomised trial ( isrctn41456865 ) . BACKGROUND Emergency Clinical Pathways ( ECP ) for stroke have never been tested in randomized controlled trials ( RCTs ) . OBJECTIVE To evaluate the effectiveness of an ECP for stroke patients in Latium ( Italy ) emergency system . METHODS cluster-RCT designed to compare stroke patient referrals by Emergency Medical Service ( EMS ) and Emergency Room ( ER ) health professionals trained in the ECP , with those of non-trained EMS and ER controls . Primary outcome measure was the proportion of eligible ( aged < /= 80 and symptom onset < /= 6 hours ) stroke patients referred to a stroke unit ( SU ) . Intention to treat ( ITT ) and per-protocol ( PP ) analyses were performed , and risk ratios ( RR ) adjusted by age , gender and area , were calculated . RESULTS 2656 patients in the intervention arm and 2239 in the control arm required assistance ; 78.3 % of the former and 80.6 % of the latter were admitted to hospitals , and respectively 74.8 % and 78.3 % were confirmed strokes . Of the eligible confirmed strokes , 106/434 ( 24.4 % ) in the intervention arm and 43/328 ( 13.1 % ) in the control arm were referred to the SU in the ITT analysis ( RR = 2.01 ; 95 % CI : 0.79-4.00 ) , and respectively 105/243 ( 43.2 % ) and 43/311 ( 13.8 % ) in the PP analysis ( RR = 3.21 ; 95 % CI : 1.62-4.98 ) . Of patients suitable for i.v . thrombolysis , 15/175 ( 8.6 % ) in the intervention arm and 2/115 ( 1.7 % ) in the control arm received thrombolysis ( p = 0.02 ) in the ITT analysis , and respectively 15/99 ( 15.1 % ) and 2/107 ( 1.9 % ) ( p = 0.001 ) in the PP analysis . CONCLUSION Our data suggest potenti efficiency and feasibility of an ECP . The integration of EMS and ERs with SU networks for organised acute stroke care is feasible and may ameliorate the quality of care for stroke patients . TRIAL REGISTRATION Current Controlled Trials ( ISRCTN41456865 ) .

Emergency Clinical Pathways ( ECP )

ECP

ECP

effectiveness

Intention to treat ( ITT )

per-protocol ( PP ) analyses

assistance

admitted to hospitals

confirmed strokes

confirmed strokes

SU

efficiency and feasibility

quality of care


Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures-a randomized , controlled , clinical trial . OBJECTIVE To compare elastic stable intramedullary nailing ( ESIN ) with nonoperative treatment of fully displaced midshaft clavicular fractures in adults . DESIGN The study was a randomized , controlled , clinical trial . SETTING Level 1 trauma center . PATIENTS AND METHODS Sixty patients between 18 and 65 years of age participated and completed the study . They were randomized to either operative or nonoperative treatment with a 2-year follow-up . INTERVENTION Thirty patients were treated with a simple shoulder sling and 30 patients with ESIN within 3 days after trauma . MAIN OUTCOME MEASUREMENT Complications after operative and nonoperative treatments , Disabilities of the Arm , Shoulder and Hand ( DASH ) score and Constant Shoulder Score for outcome measurement , and clavicular shortening . RESULTS Fracture union was achieved in all patients in the operative group , whereas nonunion was observed in 3 of 30 patients of the nonoperative group . Two symptomatic malunions required corrective osteotomy in the nonoperative group . Medial nail protrusion occurred in 7 cases in the operative group . Implant failure with revision surgery was necessary in 2 patients after an additional adequate trauma . DASH scores were lower in the operative group throughout the first 6 months and 2 years after trauma , with a significant difference during the first 18 weeks . Constant scores were significantly higher after 6 months and 2 years after intramedullary stabilization . Patients in the operative group showed a significant improvement of posttraumatic clavicular shortening ; they were also more satisfied with cosmetic appearance and overall outcome . CONCLUSIONS ESIN of displaced midshaft clavicular fractures resulted in a lower rate of nonunion and delayed union , a faster return to daily activities , and a better functional outcome . Clavicular shortening was significantly lower , and overall satisfaction was higher in the operative group .

Elastic stable intramedullary nailing

nonoperative treatment

nonoperative treatment

simple shoulder sling

ESIN

Complications

Disabilities of the Arm

Shoulder and Hand ( DASH ) score

Constant Shoulder Score

clavicular shortening

Fracture union

nonunion

symptomatic malunions

Medial nail protrusion

Implant failure with revision surgery

DASH scores

Constant scores

posttraumatic clavicular shortening

satisfied

overall outcome

nonunion

delayed union

return to daily activities

functional outcome

Clavicular shortening

overall satisfaction

Level 1 trauma

Sixty

18 and 65 years


Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours . The efficacy of pegfilgrastim+/-chemotherapy for mobilizing stem cells in patients with solid tumours was assessed . In cycle 0 , a 14-day prechemotherapy cycle , patients ( N=61 ) were randomized open-label to single doses of pegfilgrastim ( 6 , 12 or 18 mg ) on day 1 , or daily filgrastim ( 10 microg/kg ) for < or =7 days . Mean peak peripheral CD34+ cell counts increased with pegfilgrastim dose , but were significantly higher than filgrastim only at the 18 mg dose ( 10.17 vs 4.96 x 10 ( 4 ) /ml ; P=0.014 ) . In the clinically relevant period of days 3-7 , both 12 and 18 mg pegfilgrastim doses produced significantly higher peak CD34+ counts ( 8.18 and 9.96 vs 4.51 x 10 ( 4 ) /ml for filgrastim ; P=0.034 and 0.006 ) . In cycle 1 , patients received carboplatin/paclitaxel on day 1 , followed from day 2 by pegfilgrastim 6-18 mg or daily filgrastim ( 5 microg/kg/day for < or =14 days ) as per randomization in cycle 0 . There were no significant differences in mean peak CD34+ count between pegfilgrastim and filgrastim , but there was an advantage for pegfilgrastim 18 mg in the relevant period of days 7-12 ( 3.14 vs 1.19 x 10 ( 4 ) /ml ; P=0.043 ) . A single pegfilgrastim dose ( > or =6 mg ) could be substituted for daily filgrastim in cytokine-only peripheral CD34+ cell mobilization .

Pegfilgrastim

pegfilgrastim+/-chemotherapy

pegfilgrastim

filgrastim

pegfilgrastim

filgrastim

pegfilgrastim

filgrastim

carboplatin/paclitaxel

pegfilgrastim

filgrastim

pegfilgrastim

filgrastim

pegfilgrastim

pegfilgrastim

filgrastim

efficacy

Mean peak peripheral CD34+ cell counts

significantly higher

significantly higher peak CD34+ counts

no significant differences

mean peak CD34+ count

patients with solid tumours

solid tumours

patients ( N=61 )


Netilmicin in the neonate : pharmacokinetic analysis and influence of parenteral nutrition . OBJECTIVE The aim of this study was to investigate the impact of parenteral nutrition on netilmicin pharmacokinetics in critically ill neonates during the first week of life . METHOD A total of 200 neonates ( gestational ages 26.4-41 weeks ) treated with netilmicin ( 4-5 mg/kg in extended dosing intervals ) for postnatal sepsis in the first week of life received either fluid therapy or parenteral nutrition . Netilmicin peak and trough serum concentrations were monitored and netilmicin pharmacokinetic parameters were compared with and without parenteral nutrition . RESULTS There were no statistically significant differences between the pharmacokinetic parameters of netilmicin ( volume of distribution , elimination half-life , clearance ) in critically ill neonates > 32 weeks during the first week of life that received either fluid therapy or parenteral nutrition . For neonates < 32 weeks this comparison was not feasible as the majority were parenterally fed . CONCLUSION Provision of parenteral nutrition ( versus fluid therapy ) in critically ill neonates > 32 weeks did not significantly affect netilmicin pharmacokinetics and therefore does not require modification of recommended netilmicin dosage regimens .

Netilmicin

parenteral nutrition

netilmicin

netilmicin

parenteral nutrition

parenteral nutrition

parenteral nutrition

pharmacokinetics

volume of distribution

elimination half-life

clearance

netilmicin pharmacokinetics

netilmicin


A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome : polysomnographic evaluation of periodic leg movements and sleep disturbance . OBJECTIVE To evaluate , both polysomnographically and by subjective scales , the efficacy and safety profile of pramipexole for restless legs syndrome ( RLS ) via a 3-week , double-blind , placebo-controlled , parallel-group , dose-ranging study . METHODS At baseline and after 3 weeks , periodic limb movements ( PLM ) and sleep parameters were assessed by polysomnography , and patients self-assessed their sleep disturbance and overall RLS severity using the international RLS study group rating scale ( IRLS ) . Four pramipexole doses were evaluated : 0.125 , 0.25 , 0.50 , and 0.75mg/d . Data from 107 patients were included in the intent-to-treat ( ITT ) analysis . RESULTS For pramipexole recipients , the primary outcome measure , PLM per hour in bed asleep or awake ( the PLM index , or PLMI ) , decreased by a median of -26.55 to -52.70 depending on dosage group , vs. -3.00 for placebo ( p < 0.01 or 0.001 for each group vs. placebo ; Wilcoxon-Mann-Whitney test ) . Improvements in the secondary endpoints of PLM while asleep and while awake were also significantly superior for pramipexole . At 3 weeks , all pramipexole doses reduced the median for PLM while asleep to levels considered normal ( < 5PLM/h ) . Except for delta-sleep time and awakenings/arousals , sleep parameters remained unchanged or favored pramipexole . Median sleep latency was reduced by -5.00 to -11.75min in the pramipexole groups , vs. -2.00 for placebo ( p < 0.05 for all groups except 0.25mg/d ) . Median total sleep time increased by 25.75-66.75min , vs. 25.50 ( p < 0.05 for 0.50mg/d ) , and median time in stages 2-4/rapid eye movement ( REM ) sleep increased by 37.00-68.00min , vs. 26.75 ( p < 0.05 for 0.50mg/d ) . By subjective IRLS ratings , all pramipexole doses were significantly superior to placebo . Safety analysis demonstrated no dose-dependent increase in adverse events , and no drug-related increase in daytime somnolence was observed . CONCLUSIONS Pramipexole is effective and well tolerated in RLS , most notably among objective measures , for reducing PLM and decreasing sleep latency . Although other sleep parameters showed lesser , usually insignificant change , patients ' subjective ratings of RLS severity and sleep disturbance were significantly improved ( p0.0023 ) .

pramipexole

pramipexole

pramipexole

pramipexole

placebo

pramipexole

pramipexole .

placebo

pramipexole

placebo .

Pramipexole

periodic leg movements

efficacy

safety

periodic limb movements ( PLM )

sleep parameters

sleep disturbance

RLS severity

PLM per hour in bed asleep or awake

median for PLM while asleep

Median sleep latency

Median total sleep time

2-4/rapid eye movement ( REM ) sleep

adverse events

daytime somnolence

effective

well tolerated

reducing PLM

decreasing sleep latency

RLS severity

sleep disturbance

restless legs syndrome :

restless legs syndrome ( RLS )

107 patients


Bevacizumab compared with macular laser grid photocoagulation for cystoid macular edema in branch retinal vein occlusion . INTRODUCTION To evaluate the outcome of cystoid macular edema treated with intravitreal injections of bevacizumab and macular grid laser photocoagulation ( GLP ) , in patients with perfused branch retinal vein occlusion . METHODS Thirty eyes of 30 consecutive patients with cystoid macular edema secondary to nonischemic branch retinal vein occlusion were assigned to either GLP group or to intravitreal bevacizumab ( IB ) group . Complete ophthalmologic examinations were performed just before GLP and IB injection at 1 , 3 , 6 , and 12 months after treatment . Changes in logarithm of minimum angle of resolution ( logMAR ) best-corrected visual acuity ( BCVA ) , central macular thickness ( CMT ) shown by optical coherence tomography-3 were evaluated . RESULTS Baseline BCVA ( logMAR ) and CMT were , respectively , 0.89 +/- 0.13 and 650 +/- 140 microm for the GLP group , 0.87 +/- 0.16 and 690 +/- 120 microm for the IB group . After the treatment , at 1 , 3 , 6 , and 12 months in the GLP group , BCVA had improved by 0.19 , 0.22 , 0.21 , and 0.20 logMAR , CMT had decreased by 40 % , 41.3 % , 40.5 % , and 42 % . In the IB group , BCVA had improved by 0.31 , 0.32 , 0.30 , and 0.31 logMAR and CMT had decreased by 59.5 % , 59 % , 60 % , and 60.3 % . The group receiving bevacizumab had better BCVA and lower CMT values at all time points ( P < 0.05 ) . CONCLUSION Intravitreal bevacizumab injection improves BCVA and reduces CMT more than GLP . Intravitreal bevacizumab injection was well tolerated and could be used as primary treatment in patients with cystoid macular edema secondary to perfused branch retinal vein occlusion .

Bevacizumab

macular laser grid photocoagulation

intravitreal injections of bevacizumab

GLP

intravitreal bevacizumab ( IB )

GLP

IB

GLP

IB

GLP

IB

bevacizumab

bevacizumab

bevacizumab

Complete ophthalmologic examinations

Baseline BCVA ( logMAR ) and CMT

BCVA

CMT

BCVA

logMAR

CMT

BCVA

CMT

BCVA

CMT