In a multicenter randomized placebo-controlled trial of redback spider antivenom for latrodectism , 224 patients ( > 7 years ) with a redback spider bite and severe pain , with or without systemic effects , were randomized to receive normal saline solution ( placebo ) or antivenom after receiving standardized analgesia .


The primary outcome was a clinically significant reduction in pain 2 hours after trial medication compared with baseline .


A second primary outcome for the subgroup with systemic features of envenomation was resolution of systemic features at 2 hours .


Secondary outcomes were improved pain at 4 and 24 hours , resolution of systemic features at 4 hours , administration of opioid analgesics or unblinded antivenom after 2 hours , and adverse reactions .


Two hours after treatment , 26 of 112 patients ( 23 % ) from the placebo arm had a clinically significant improvement in pain versus 38 of 112 ( 34 % ) from the antivenom arm ( difference in favor of antivenom 10.7 % ; 95 % confidence interval -1.1 % to 22.6 % ; P = .10 ) .


Systemic effects resolved after 2 hours in 9 of 41 patients ( 22 % ) in the placebo arm and 9 of 35 ( 26 % ) in the antivenom arm ( difference 3.8 % ; 95 % confidence interval -15 % to 23 % ; P = .79 ) .


There was no significant difference in any secondary outcome between antivenom and placebo .


Acute systemic hypersensitivity reactions occurred in 4 of 112 patients ( 3.6 % ) receiving antivenom .


The addition of antivenom to standardized analgesia in patients with latrodectism did not significantly improve pain or systemic effects .


Although screening colonoscopy is effective in preventing distal colon cancers , effectiveness in preventing right-sided colon cancers is less clear .


Previous studies have reported that retroflexion in the right colon improves adenoma detection .


We aimed to determine whether a second withdrawal from the right colon in retroflexion vs. forward view alone leads to the detection of additional adenomas .


Patients undergoing screening or surveillance colonoscopy were invited to participate in a parallel , randomized , controlled trial at two centers .


After cecal intubation , the colonoscope was withdrawn to the hepatic flexure , all visualized polyps removed , and endoscopist confidence recorded on a 5-point Likert scale .


Patients were randomized to a second exam of the proximal colon in forward ( FV ) or retroflexion view ( RV ) , and adenoma detection rates ( ADRs ) compared .


Logistic regression analysis was used to evaluate predictors of identifying adenomas on the second withdrawal from the proximal colon .


A total of 850 patients ( mean age 59.18.3 years , 59 % female ) were randomly assigned to FV ( N = 400 ) or RV ( N = 450 ) .


Retroflexion was successful in 93.5 % .


The ADR ( 46 % FV and 47 % RV ) and numbers of adenomas per patient ( 0.91.4 FV and 1.12.1 RV ) were similar ( P = 0.75 for both ) .


At least one additional adenoma was detected on second withdrawal in similar proportions ( 10.5 % FV and 7.5 % RV , P = 0.13 ) .


Predictors of identifying adenomas on the second withdrawal included older age ( odds ratio ( OR ) = 1.04 , 95 % confidence interval ( CI ) = 1.01-1 .08 ) , adenomas seen on initial withdrawal ( OR = 2.8 , 95 % CI = 1.7-4 .7 ) , and low endoscopist confidence in quality of first examination of the right colon ( OR = 4.8 , 95 % CI = 1.9-12 .1 ) .


There were no adverse events .


Retroflexion in the right colon can be safely achieved in the majority of patients undergoing colonoscopy for colorectal cancer screening .


Reexamination of the right colon in either retroflexed or forward view yielded similar , incremental ADRs .


A second exam of the right colon should be strongly considered in patients who have adenomas discovered in the right colon , particularly when endoscopist confidence in the quality of initial examination is low .


Botulinum toxin type A ( BoNT-A ) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles on single or multiple facial areas .


To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A ( ABO ) .


A total of 90 participants were enrolled .


Subjects had at least two indications for BoNT-A treatments on each third of the face ( upper , middle and lower ) .


They were randomized into 3 groups , with pre-defined total dose range of ABO , varying from 120 to 250 U.


Most of the subjects were women ( 96.5 % ) .


The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines , and more than 16 weeks for forehead wrinkles and crow 's feet , all P < 0.001 , with no differences between groups .


The most frequent adverse event ( excessive perioral weakness ) was related to high dose in the perioral area .


This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously .


As long as the recommended doses are used , concomitant injections of ABO are safe and efficient , with no increase in adverse events .


Because of frequent exposure to tick habitats , outdoor workers are at high risk for tick-borne diseases .


Adherence to National Institute for Occupational Safety and Health-recommended tick bite prevention methods is poor .


A factory-based method for permethrin impregnation of clothing that provides long-lasting insecticidal and repellent activity is commercially available , and studies are needed to assess the long-term effectiveness of this clothing under field conditions .


To evaluate the protective effectiveness of long-lasting permethrin impregnated uniforms among a cohort of North Carolina outdoor workers .


A double-blind RCT was conducted between March 2011 and September 2012 .


Subjects included outdoor workers from North Carolina State Divisions of Forestry , Parks and Recreation , and Wildlife who worked in eastern or central North Carolina .


A total of 159 volunteer subjects were randomized , and 127 and 101 subjects completed the first and second years of follow-up , respectively .


Uniforms of participants in the treatment group were factory-impregnated with long-lasting permethrin whereas control group uniforms received a sham treatment .


Participants continued to engage in their usual tick bite prevention activities .


Incidence of work-related tick bites reported on weekly tick bite logs .


Study subjects reported 1,045 work-related tick bites over 5,251 person-weeks of follow-up .


The mean number of reported tick bites in the year prior to enrollment was similar for both the treatment and control groups , but markedly different during the study period .


In our analysis conducted in 2013 , the effectiveness of long-lasting permethrin impregnated uniforms for the prevention of work-related tick bites was 0.82 ( 95 % CI = 0.66 , 0.91 ) and 0.34 ( 95 % CI = -0.67 , 0.74 ) for the first and second years of follow-up .


These results indicate that long-lasting permethrin impregnated uniforms are highly effective for at least 1 year in deterring tick bites in the context of typical tick bite prevention measures employed by outdoor workers .


Natural orifice transluminal endoscopic surgery ( NOTES ) has the potential to reduce postoperative pain .


We compared postoperative pain in the hybrid NOTES procedure transvaginal video-assisted cholecystectomy ( TVC ) with standard conventional laparoscopic cholecystectomy ( CLC ) .


Single-center , double-blind , randomized controlled trial in a level II hospital between June 2008 and June 2012 .


Female patients , older than 18 years of age with symptomatic cholecystolithiasis were randomized to receive either TVC or CLC .


The follow-up period was 7 days and the primary outcome of the study was postoperative pain .


We hypothesized that there is no reduction of pain ( Visual Rating Scale 1 ) while resting or coughing over a 48-h period after the operation .


Secondary outcome included wound infections , complications , and patient reported outcomes .


Sealed envelopes with computer-generated randomization information were kept for allocation in theater .


All patients received opaque wound dressing , as in standard four-trocar cholecystectomy and a vaginal tamponade .


Theater protocol and surgical notes were kept separate after the procedure .


Overall , 97 of 426 patients assessed for participation were randomized for either TVC or CLC .


A total of 41 patients had a TVC and 51 had a CLC .


Five patients were excluded from the analysis .


There was no difference in age , body mass index , American Society of Anesthesiologists ( ASA ) grade , or hospital stay , but anesthetic and surgical times were significantly longer in TVC ( p < 0.001 ) .


There was no statistical difference in postoperative pain between the two groups while resting or coughing .


Complications included conversion to laparotomy , bleeding , wound infections , and re-admission .


No difference in the rate of complications between the two groups was seen .


Overall , 86 and 93 % of CLC and TVC patients , respectively , would recommend the procedure to other patients .


In this study , no significant difference in pain on days 1 and 2 postoperatively between the two methods was found .


The safety profile of TVC is comparable to CLC , and TVC patients would generally recommend this procedure to other patients .


To compare the change in iris-trabecular contact ( ITC ) area using swept-source optical coherence tomography ( SS-OCT ) in eyes with primary angle closure glaucoma ( PACG ) and cataract that underwent phacoemulsification ( PE ) with intraocular lens implantation alone compared with PE with goniosynechialysis ( GSL ) .


One eye of 22 patients with PACG with peripheral anterior synechiae ( PAS ) detected by indentation gonioscopy was randomised into two groups ( PE alone ( n = 11 ) and PE+GSL ( n = 11 ) ) .


The anterior chamber angles were evaluated by SS-OCT under dark conditions before and 12months after surgery using the three-dimensional angle analysis scan protocol that simultaneously obtains 128 cross-sectional radial scans across the anterior chamber at equal intervals ( every 1.4 ) .


The ITC area , defined as the area of extent of the circumferential contact of peripheral iris to the angle wall , was computed automatically by SS-OCT after an observer marked the scleral spurs of all 128 scans of each eye .


The majority of the 22 subjects were women ( 77.3 % ) and the meanSD age was 67.35.8 years .


The ITC area was significantly reduced in the PE+GSL group compared with the PE alone group ( 10.2 mm2 vs. 4.6 mm2 , = 0.54 , p = 0.03 ) after adjusting for age , gender , intraocular pressure , extent of PAS and pupil diameter before surgery .


Smaller iris volume at baseline was associated with greater ITC area reduction by PE+GSL ( = -0.728 , p = 0.03 ) .


Eyes that undergo PE+GSL surgery have a greater reduction in circumferential ITC area than eyes that undergo PE alone .


Prior research supports the hypothesis that cancer survivors who help others face treatment experience a range of psychosocial and health-related benefits as a result of peer helping .


This study investigates an expressive helping ( EH ) intervention designed to harness those benefits by targeting survivorship problems among cancer survivors treated with hematopoietic stem cell transplant .


EH includes two components : ( a ) emotionally expressive writing ( EW ; writing one 's deepest thoughts and feelings about the transplant experience in a series of brief , structured writing sessions ) followed by ( b ) peer helping ( PH ; helping other people prepare for transplant by sharing one 's own transplant experiences along with advice and encouragement through a written narrative ) .


EH was compared with neutral writing ( NW ) , EW ( without PH ) , and PH ( without EW ) in a 4-arm randomized controlled trial in which survivors completed baseline measures , 4 structured writing exercises ( with instructions depending on randomization ) , and postintervention measures including validated measures of general psychological distress , physical symptoms , and health-related quality of life ( HRQOL ) .


Among survivors with moderate-severe survivorship problems , EH reduced distress ( compared with NW and PH ; ps < .05 ) and improved physical symptoms ( compared with NW , PH , and EW ; ps < .002 ) and HRQOL ( compared with NW ; p = .02 ) .


Peer helping through writing benefits transplant survivors with moderate-severe survivorship problems , but only if they have first completed expressive writing .


The TAXUS Libert Post Approval Study ( TL-PAS ) contributed patients treated with TAXUS Libert paclitaxel-eluting stent and prasugrel to the Dual Antiplatelet Therapy Study ( DAPT ) that compared 12 and 30 months thienopyridine plus aspirin therapy after drug-eluting stents .


Outcomes for 2191 TL-PAS patients enrolled into DAPT were assessed .


The DAPT coprimary composite end point ( death , myocardial infarction [ MI ] , or stroke ) was lower with 30 compared with 12 months prasugrel treatment ( 3.7 % versus 8.8 % ; hazard ratio [ HR ] , 0.407 ; P < 0.001 ) .


Rates of death and stroke were similar between groups , but MI was significantly reduced with prolonged prasugrel treatment ( 1.9 % versus 7.1 % ; HR , 0.255 ; P < 0.001 ) .


The DAPT coprimary end point , stent thrombosis , was also lower with longer therapy ( 0.2 % versus 2.9 % ; HR , 0.063 ; P < 0.001 ) .


MI related to stent thrombosis ( 0 % versus 2.6 % ; P < 0.001 ) and occurring spontaneously ( 1.9 % versus 4.5 % ; HR , 0.407 ; P = 0.007 ) were both reduced with prolonged prasugrel .


MI rates increased within 90 days of prasugrel cessation after both 12 and 30 months treatment .


Composite Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ( GUSTO ) moderate or severe bleeds were modestly increased ( 2.4 % versus 1.7 % ; HR , 1.438 ; P = 0.234 ) but severe bleeds were not more frequent ( 0.3 % versus 0.5 % ; HR , 0.549 ; P = 0.471 ) in the prolonged treatment group .


Prasugrel and aspirin continued for 30 months reduced ischemic events for the TAXUS Libert paclitaxel-eluting stent patient subset from DAPT through reductions in MI and stent thrombosis .


Withdrawal of prasugrel was followed by an increase in MI after both 12 and 30 months therapy .


The optimal duration of dual antiplatelet therapy with prasugrel after TAXUS Libert paclitaxel-eluting stent remains unknown , but appears to be > 30 months .


http://www.clinicaltrials.gov .


Unique identifier : NCT00997503 .


In the cervical spine , the ligamentum flavum ( LF ) is often incompletely fused at the midline .


Therefore , accessing the epidural space ( ES ) using the loss of resistance ( LOR ) technique via the midline approach could be less reliable than the paramedian approach .


Since the tactile sensation of LOR is due to abrupt loss of pressure upon entering the ES , we have compared pressure changes between the 2 different cervical epidural techniques .


The aim of this study was to compare pressure changes during the pathway to the cervical ES between the 2 approaches .


A prospective , open-labeled , randomized , comparative study .


An interventional pain management practice in a hospital , Republic of Korea .


The 74 patients were randomly assigned to either a midline or paramedian group .


The pressure changes were monitored and classified into 4 grades according to the following criteria : Grade I.


The pressure waveform sequence consisted of 3 components in chronological order : 1 ) a high positive pressure just prior to entering the ES ; 2 ) an abrupt pressure decrease at the moment of entering the ES ; and 3 ) a negative peak pressure before cervical epidural pressure equilibration .


Grade II .


A high positive pressure followed by a precipitous pressure drop , without negative peak pressure upon entering the ES .


Grade III .


High positive pressure before entering the ES , followed by continuous pressure decrease without negative pressure .


Grade IV .


No pressure changes before or after entering the cervical ES .


An abrupt pressure decrease at the moment of exiting the LF or entering the ES was more frequently observed when using the paramedian approach ( P < 0.05 ) with the odds ratio of 4.96 ( 95 % CI , 1.63 - 15.12 ) as compared with the midline approach .


A correlation between the abrupt pressure decrease and LOR tactile sensation has been assumed .


Under the assumption that the LOR sensation is due to an abrupt decrease in pressure the moment the needle enters the ES or exits the LF , this study claims that the accuracy of accessing the cervical ES can be improved significantly using the paramedian approach .


NCT01009385 .


Institutional Review Board ( IRB ) : H-1208-107-422 .


To compare the difference in depression relief in the treatment of depressive disorder at the acute stage between the combined therapy of acupuncture and 5-HT ( 5-hydroxytryptamine ) selective serotonini reuptake inhibitors ( SSRIs ) and the single application of SSRIs and explore the impact on the imbalance of 5-HT and TH1/TH2 .


Ninety cases of depressive disorder at the acute stage were randomized into a combined therapy group and a medication group , 45 cases in each one .


In the medication group , SSRIs were prescribed forl oral administration , once or twice a day , continuously for 4 weeks .


In the combined therapy group , on the basis of treatment as the medication group , acupuncture was combined .


The main acupoints were Baihui ( GV 20 ) , Yintang ( GV 29 ) , Shenting ( GV 24 ) , Fengchi ( GB 20 ) , Dazhui ( GV 14 ) and Sishencong ( EX-HN 1 ) , once every two .


days , continuously for 4 weeks .


Before treatment , and after the 1st , 2nd and 4th weeks of treatment , the Hamilton depression scale ( HAMD ) was used to evaluate the depression severity .


Separately , before and after the 4 weeks of treatment , the levels of serum 5-HT , interleukin-1 beta ( IL-1 ) , interleukin-6 ( IL-6 ) , interleukin-4 ( IL-4 ) and interleukin-10 ( IL-10 ) were determined and compared with those in 45 cases of the healthy group .


HAMD score was reduced in the 1st , 2nd and 4th weeks of treatment as compared with that before treatment in the combined therapy group ( all P < 0 01 ) .


HAMD score was reduced in the 2nd and 4th weeks of treatment as compared with that before treatment in the medication group ( all P < 0.01 ) .


HAMD scores in the combined therapy group were lower than those in the medication group in the 1st , 2nd and 4th weeks of treatment ( all P < 0.01 ) .


Before treatment , in the combined therapy group and the medication group , the levels of serum 5-HT , IL-4 and IL-10 were all lower than those in the healthy group ( all P < 0.01 ) ; the levels of IL-1 and IL-6 were higher than those in the healthy group ( all P < 0.01 ) .


In the combined therapy group and the medication group , the levels of 5-HT , IL-4 and IL-10 in 4 weeks of treatment were all increased as compared with those before treatment ( all P < 0.01 ) , and the levels of IL-1 and IL-6 were lower than those before treatment ( all P < 0.01 ) .


In the combined therapy group , the levels of IL-1 and IL-6 in 4 weeks of treatment were lower than those in the medication group , and the levels of 5-HT , IL-4 and IL-10 were higher than those in the medication group ( P < 0.01 , P < 0.05 ) .


The combined therapy of acupuncture and SSRIs achieves much quicker and more effective re - ' sult for relieving depression in the patients of depressive disorder as compared with simple oral administration of ' SSRIs , and much more contributes to adjust the imbalance of serum 5-HT and TH1/TH2 .


To determine whether the use of 3-dimensional ( 3D ) imaging translates into a better surgical performance of nave urologic laparoscopic surgeons during pyeloplasty ( PY ) and partial nephrectomy ( PN ) procedures .


Eighteen surgeons without any previous laparoscopic experience were randomly assigned to perform PY and PN in a porcine model using initially 2-dimensional ( 2D ) and 3D laparoscopy .


A surgical performance score was rated by an `` expert '' tutor through a modified 5-item global rating scale contemplating operative field view , bimanual dexterity , efficiency , tissue handling , and autonomy .


Overall surgical time , complications , subjective perception of participating surgeons , and inconveniences related to the 3D vision were recorded .


No difference in terms if operative time was found between 2D or 3D laparoscopy for both the PY ( P = .51 ) and the PN ( P = .28 ) procedures .


A better rate in terms of surgical performance score was noted by the tutors when the study participants were using 3D vs 2D , for both PY ( 3.6 [ 0.8 ] vs 3.0 [ 0.4 ] ; P = .034 ) and PN ( 3.6 [ 0.51 ] vs 3.15 [ 0.63 ] ; P = .001 ) .


No complications occurred in any of the procedures .


Most ( 77.2 % ) of the participating nave laparoscopic surgeons had the perception that 3D laparoscopy was overall easier than 2D .


Headache ( 18.1 % ) , nausea ( 18.1 % ) , and visual disturbance ( 18.1 % ) were the most common issues reported by the surgeons during 3D procedures .


Despite the absence of translation in a shorter operative time , the use of 3D technology seems to facilitate the surgical performance of nave surgeons during laparoscopic kidney procedures on a porcine model .


To evaluate the long-term effects of radiofrequency ablation ( RFA ) of renal masses ( RM ) and compare them with surgery .


A total of 203 RM ( 193 malignant ; mean size 30 mm ) in 137 patients ( 95 male subjects ; average age 64 years ) underwent RFA .


Complications and technique effectiveness were evaluated .


Overall survival , cancer-specific survival , and disease-free survival were calculated ( mean follow-up time 39 months ) .


Predictors for complications , technique effectiveness , and survival were investigated .


Seventeen ( 8.4 % ) adverse events were recorded ( 2 % major complications ) .


Exophytic development and smaller size were protective against adverse events .


Complete ablation was obtained in 87 % RM ( 93 % 3 cm , 89 % 4 cm ) .


T1a threshold was a positive predictor for complete ablation and central location a negative one .


Three - and 5-year overall survival were 84 and 75 % ; cancer-specific survival 96 and 91 % ; and disease-free survival 80 and 75 % .


Considering only the 79 patients with newly diagnosed renal cell carcinoma , T1a disease stage resulted a positive predictor for both overall survival ( 87 and 83 % at 3 and 5 years ) and cancer-specific survival ( 100 % at 5 years ) .


RFA of noncentral small RM is safe and effective , and it provides favorable long-term oncological outcomes .


Selection criteria for RFA can also include T1a renal cell carcinoma in patients without surgical contraindications , even though randomized controlled trials are needed to establish the best treatment .


To compare the free-hand ( FH ) technique of placing interlocking screws to a commercially available electromagnetic ( EM ) targeting system in terms of operating time , radiation dose , and accuracy of screw placement .


Between September 2011 and July 2012 , we prospectively randomized 100 consecutive femur shaft fractures in 99 patients requiring intramedullary nails to either FH using fluoroscopy ( n = 43 ) or EM targeting ( n = 38 ; Sureshot ) .


Single Level 1 University Hospital Trauma Center .


The 2 groups were assessed for distal locking with respect to time , radiation , and accuracy .


Eight-one fractures had data accurately recorded ( 38 EM/43 FH ) .


The average total operative time was 50 minutes ( range , 25-88 minutes ; SD , 13.9 minutes ) for the FH group and 57 minutes ( range , 40-103 minutes ; SD , 16.12 minutes ) for the EM group .


The average time for distal locking was 10 minutes ( range , 4-16 minutes ; SD , 3.56 minutes ) with FH and 11 minutes ( range , 6-28 minutes ; SD , 10.24 minutes ) with EM .


Average radiation dose for distal locking was significantly less ( P < 0.0001 ) for EM at 230.54 Gy ( range , 51-660 Gy ; SD , 0.17 Gy ) compared with 690.27 Gy ( range , 200-2310 Gy ; SD , 0.52 Gy ) for FH .


There were 2 misplaced drill bits in FH and 3 in EM .


This was not statistically significant ( P = 0.888 ) .


The electromagnetic targeting device ( Sureshot ) significantly reduced radiation exposure during placement of distal interlocking screws , without sacrificing operative time , and was equivalent in accuracy when compared with the FH technique .


Therapeutic level II .


The resin-based pit and fissure sealant is considered a successful tool in caries prevention , however there is a growing evidence of its use in controlling already established caries in posterior teeth .


The aim of this clinical trial is to verify the efficacy of pit and fissure sealants in arresting dentinal caries lesions compared to partial excavation and restorative treatment in primary molar teeth .


Thirty six patients with occlusal cavitated primary molar reaching outer half of dentin were selected .


The patients were randomly allocated into two groups : sealant application ( experimental group - n = 17 ) and restoration with composite resin ( control group - n = 19 ) .


Clinical and radiograph evaluation were performed after 6 , 12 and 18 months .


The chi-square test was used to verify the distribution of characteristics variables of the sample among the groups .


The survival rate of treatments was evaluated using Kaplan-Meier survival and log-rank test .


Fisher 's Exact and logistic regression tests were calculated in each evaluation period ( = 5 % ) .


The control group showed significantly better clinical survival after 18 months ( p = 0.0025 ) .


In both groups , no caries progression was registered on the radiographic evaluations .


Sealing had similar efficacy in the arrestment of caries progression of cavitated occlusal lesions compared to partial excavation of the lesions , even though the frequency of re-treatments was significantly higher in sealed lesions .


Registro Brasileiro de Ensaios Clnicos ( ReBEC ) : RBR-9kkv53 .


A previous randomised controlled trial that investigated Assertive Community Treatment ( ACT ) in the UK ( the REACT Study ) found no clinical advantage over usual care delivered by Community Mental Health Teams ( CMHTs ) at 18 and 36 month follow-ups .


No studies have investigated long term clinical and social outcomes for patients receiving ACT .


We investigated inpatient service use , social outcomes , service contact and adverse events for the 251 REACT study participants 10 years after randomisation through case note review .


Data were analysed using regression models adjusted for original treatment group allocation and changes in treatment group .


We found no statistically significant differences in outcomes by original treatment group over the 10 years .


Those whose care remained with ACT , or transferred to ACT or forensic services , had more inpatient days over the 10 years ( coefficient 223 , 95 % CI 83 to 363 , p = 0.002 ) than those whose care remained with the CMHTs or were discharged to primary care .


Being subject to a Community Treatment Order was associated with a greater chance of being under ACT at 10 year follow-up ( OR 6.39 , 95 % CI 2.98 to 13.70 , p < 0.001 ) .


The ACT teams in this study showed no clinical advantage over usual care provided by CMHTs at 10 year follow-up .


We also found that the ACT teams accrued patients from the original study sample who had more complex needs than those who remained with or transferred to the CMHTs or primary care during this period .


Further well conducted trials are needed to identify the most cost-effective approaches to supporting successful community living and optimum long term outcomes for this group .


The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries , but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions .


While most workers are eligible for job accommodation and disability compensation benefits , other workplace strategies might improve individual-level coping and problem solving to prevent work disability .


In this study , we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders .


In a randomized controlled trial ( RCT ) , workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment ( wait list ) control condition .


Volunteer employees ( n = 300 ) will be recruited from five participating employers and randomly assigned to intervention or control .


Participants in the intervention arm will attend facilitated group workshop sessions at work ( 10 hours total ) to explore methods for improving comfort , adjusting work habits , communicating needs effectively , applying systematic problem solving , and dealing with negative thoughts and emotions about work .


Work engagement and work limitation are the principal outcomes .


Secondary outcomes include fatigue , job satisfaction , self-efficacy , turnover intention , sickness absence , and health care utilization .


Measurements will be taken at baseline , 6 - , and 12-month follow-up .


A process evaluation will be performed alongside the randomized trial .


This study will be most relevant for organizations and occupational settings where some degree of job flexibility , leeway , and decision-making autonomy can be afforded to affected workers .


The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness .


Clinicaltrials.gov : NCT01978392 ( Issued November 6 , 2013 ) .


Asthma exacerbations are commonly precipitated by viral upper respiratory infections ( URIs ) .


Vitamin D insufficiency associates with susceptibility to URI in patients with asthma .


Trials of vitamin D in adults with asthma with incidence of exacerbation and URI as primary outcome are lacking .


To conduct a randomised controlled trial of vitamin D3 supplementation for the prevention of asthma exacerbation and URI ( coprimary outcomes ) .


250 adults with asthma in London , UK were allocated to receive six 2-monthly oral doses of 3mg vitamin D3 ( n = 125 ) or placebo ( n = 125 ) over 1year .


Secondary outcomes included asthma control test and St George 's Respiratory Questionnaire scores , fractional exhaled nitric oxide and concentrations of inflammatory markers in induced sputum .


Subgroup analyses were performed to determine whether effects of supplementation were modified by baseline vitamin D status or genotype for 34 single nucleotide polymorphisms in 11 vitamin D pathway genes .


206/250 participants ( 82 % ) were vitamin D insufficient at baseline .


Vitamin D3 did not influence time to first severe exacerbation ( adjusted HR 1.02 , 95 % CI 0.69 to 1.53 , p = 0.91 ) or first URI ( adjusted HR 0.87 , 95 % CI 0.64 to 1.16 , p = 0.34 ) .


No clinically important effect of vitamin D3 was seen on any of the secondary outcomes listed above .


The influence of vitamin D3 on coprimary outcomes was not modified by baseline vitamin D status or genotype .


Bolus-dose vitamin D3 supplementation did not influence time to exacerbation or URI in a population of adults with asthma with a high prevalence of baseline vitamin D insufficiency .


NCT00978315 ( ClinicalTrials.gov ) .


Topiroxostat , a selective xanthine oxidase inhibitor , shows effective reduction in the serum urate level in hyperuricemic patients with or without gout .


The objective of this study was to evaluate the efficacy and safety of topiroxostat in hyperuricemic stage 3 chronic kidney disease patients with or without gout .


The study design was a 22-week , randomized , multicenter , double-blind study .


The enrolled patients were randomly assigned to treatment with topiroxostat 160 mg/day ( n = 62 ) or to the placebo ( n = 61 ) .


The endpoints were the percent change in the serum urate level , change in the estimated glomerular filtration rate , the urinary albumin-to-creatinine ratio , the proportion of patients with serum urate levels of 356.88 mol/L or less , blood pressure , and serum adiponectin .


After 22 weeks , although the changes in the estimated glomerular filtration rate and blood pressure were not significant , the percent change in the serum urate level ( -45.38 vs. -0.08 % , P < 0.0001 ) and the percent change in urinary albumin-to-creatinine ratio ( -33.0 vs. -6.0 % , P = 0.0092 ) were found to have decreased in the topiroxostat as compared with the placebo .


Although the incidence of ` alanine aminotransferase increased ' was higher in the topiroxostat , serious adverse event rates were similar in the two groups .


Topiroxostat 160 mg effectively reduced the serum urate level in the hyperuricemic stage 3 chronic kidney disease patients with or without gout .


The aim of this study was to compare the ligation of the intersphincteric fistula track with the mucosal advancement flap in the treatment of high transsphincteric anal fistulas .


This was a prospective randomized study performed at academic medical centers .


Patients with transsphincteric anal fistulas involving the upper part of anal sphincter were included .


Patients were randomly assigned to either ligation of intersphincteric fistula track or mucosal advancement flap .


The primary end points of the study were fistula closure , recurrence within 1 year , and continence by using the Wexner score .


Secondary end points were morbidity , postoperative pain with the use of the visual analog scale , and quality of life with the use of the Cleveland Global Quality of Life score .


There were 70 patients ( 35 in each group ) .


Mean age was 36.1 years in patients undergoing ligation of the intersphincteric fistula track vs 32.9 years in patients undergoing mucosal advancement flap ( p = 0.33 ) .


Mean visual analog scale after 1 week was significantly higher in the mucosal advancement flap group than in the ligation of intersphincteric fistula track group ( 3.1 vs 4.8 , p = 0.04 ) , but no significant difference was found after 4 weeks .


Primary healing was achieved in 33 patients undergoing ligation of the intersphincteric fistula track vs 32 patients undergoing mucosal advancement flap ( p = 0.99 ) .


Mean healing time was 22.6 days in the ligation of intersphincteric fistula track group vs 32.1 days in mucosal advancement flap group ( p = 0.01 ) .


After 1 year of follow-up , successful outcome was achieved in 26 patients ( 74.3 % ) undergoing ligation of intersphincteric fistula track and in 20 patients ( 65.7 % ) undergoing mucosal advancement flap ( p = 0.58 ) .


No significant change in Wexner score occurred 4 weeks postoperatively .


There was no significant difference between groups regarding Cleveland Global Quality of Life score ( p = 0.5 and 0.07 after 4 and 12 weeks ) .


The short-term follow-up is a probable limitation .


Although the sample size was calculated to detect difference with 80 % power at a significance level of 5 % , the negative result within this relatively small number of patients might have resulted from type II statistical error .


In patients with high transsphincteric anal fistulas , both ligation of intersphincteric fistula track procedure and mucosal advancement flap have a similar long-term healing rate , recurrences , continence , and quality of life .


However , ligation of the intersphincteric fistula track has the advantage of less postoperative pain .


Executive dysfunction and psychomotor slowing in depressed patients have been associated with poor antidepressant clinical response , but little is known about the value of neurocognitive tests for differential prediction of response .


This report presents new findings for 70 depressed patients tested on neurocogntive tests before receiving treatment with a SSRI ( escitalopram or citalopram ) , NDRI ( bupropion ) or dual mechanism therapy including a serotonergic agent , and for 57 healthy controls .


As predicted from previous research , patients who did not respond to a SSRI or dual therapy showed poorer word fluency than responders , whereas this was not seen for patients treated with bupropion alone .


Longer choice reaction time ( RT ) was also found in nonresponders to a SSRI or dual therapy , but the opposite trend was seen for bupropion .


Using a combined index of word fluency and RT ( with normative performance as a cutoff ) yielded differential predictions of response .


Equal to or above normal performance predicted good response to a SSRI or dual therapy , with high positive predictive value ( 90 % ) and specificity ( 78 % ) but lower sensitivity ( 53 % ) .


In contrast , less than normal performance predicted good response to bupropion alone ( positive predictive value = 82 % ; specificity = 67 % ; sensitivity = 90 % ) .


Relatively small sample size , no placebo control , and combining across SSRI alone and dual treatments .


Although findings are preliminary due to small sample size , brief tests of word fluency and psychomotor speed may help identify depressed patients who are unresponsive to a serotonergic agent , but who may respond to bupropion alone .


Electroencephalogram ( EEG ) based depth of anesthesia algorithms developed in the adult population have not demonstrated the same reliability when applied to infants .


This may be due to frequency changes occurring in the EEG during development .


Amplitude-integrated EEG ( aEEG ) is based primarily in the time domain and hence may have greater utility in infants .


To investigate the relationship between age adjusted Minimal Alveolar Concentration ( MAC ) multiples and aEEG in children under 2 years of age .


The aEEG , Spectral Edge Frequency 90 % ( SEF90 ) and Bispectral Index ( BIS ) were investigated in a prospective study of children < 2 years of age .


After anesthetic induction , and caudal block administration , EEG data were collected simultaneously with BrainZ BRM2 and BIS monitors .


Using a randomized crossover design , children received up to three age adjusted concentrations of sevoflurane : 0.75 , 1 and 1.25 MAC .


After 15 min of stable anesthetic delivery EEG readings were obtained .


Prediction Probability ( Pk ) and correlation coefficients were calculated for each EEG parameter .


From 51 children 102 stable anesthetics concentrations were obtained .


For all age groups Pk of aEEG to multiple of age adjusted MAC was < 0.72 indicating a poor predictive power for aEEG .


In contrast for the SEF90 and BIS there was evidence for better predictive properties in children aged between 6 months and 2 years , with a Pk > 0.81 .


The aEEG is unlikely to be a useful measure of anesthesia depth in young children .


To investigate the impact of early skin-to-skin contact ( SSC ) provided for first 24h on incidence of hypothermia in stable newborns weighing 1800g or more during first 48h of life .


Stable newborns ( term and late preterm : Mean gestational age 37.7 ( 1.35 ) weeks , range 34-40 weeks ) having birth weight 1800g or more ( Mean weight 2605.6 ( 419.8 ) grams ) were enrolled after approval from Institutional Human Research Ethics Committee ( CTRI/2013/06 / 003790 ) and randomized into early SSC ( intervention group ) and conventional care ( control group ) .


Initial care in the delivery room for few minutes immediately after birth in both the groups was given under radiant warmer .


In the intervention group , newborns were provided SSC by their mother started between 30min and 1h after birth for first 24h with minimal interruption and were provided conventional care other than SSC for next 24h of life .


In the control group , newborns were kept with their mother and received conventional care other than SSC for first 48h .


Temperature and heart rate of newborns were recorded at 30min , 1 , 2 , 3 , 4 , 5 , 6 , 12 , 24 and at 48h of life in both the groups .


Independent Samples t-Test and relative risk were used to analyze the data .


Both groups had 50 neonates each with similar baseline characteristics .


Heart rates were in normal range in both the groups .


The intervention group provided an average ( s.d. ) of 16.98 ( 0.28 ) h of SSC over the first 24h period .


The mean temperature was significantly high in the SSC group at all time intervals starting from 1 to 48h ( P < 0.05 for all ) .


In the SSC group only two newborns ( 4 % ) had mild hypothermia ( cold stress ) , and , of these two newborns , one had two episodes of hypothermia .


All these three episodes of hypothermia occurred within first 3h of life .


In the control group 16 newborns ( 32 % ) developed hypothermia ( temperature < 36.5 C ) during first 48h of life .


Of them , 11 newborns had single episode , 4 newborns had two episodes and one newborn had three episodes of hypothermia .


Of these 22 hypothermic episodes , 20 occurred in the first 6h of life and 2 episodes occurred at 48h of life .


Moderate hypothermia was seen in two newborns , whereas rest had mild hypothermia .


The relative risk of developing hypothermia in the control group as compared with the SSC group was 8.00 ( 95 % CI 1.94-32 .99 ) .


There was no seasonal variation in incidence of hypothermia in both the groups .


Newborns in the SSC group achieved rapid thermal control as compared with the control group .


Early SSC for 24h after birth decreases incidence of hypothermia for initial 48h of life .


Early SSC needs to be aggressively promoted in term and late-preterm newborns to reduce incidence of hypothermia .


Subacromial impingement is a common cause of shoulder complaints in general practice .


When the initial treatment with acetaminophen and low dose Non Steroidal Anti Inflammatory Drugs fails , triamcinolone acetonide injections are commonly used .


Triamcinolone acetonide injections are effective at four to six weeks .


Little is known about the pain relief effect of triamcinolone acetonide injections in the first days after injection and the effect of repeated injection .


In this study we investigate the effect of triamcinolone acetonide injections compared to hyaluronic acid and NaCl injections using a pain diary .


159 Patients recruited for an RCT comparing the effect of subacromial injections of triamcinolone acetonide , hyaluronic acid and sodium chloride ( NaCl ) were used in this study .


They were blinded for their treatment and could receive up to three injections .


Primary outcome consisted of the patient perceived pain on a VAS score recorded on a daily basis during 21 days following injection .


Secondary outcome consisted of the amount of taken escape medication following injection and adverse effects .


All patients received the first injection .


150 patients also received the second and third injections .


97 % Of the paper and pencil pain diaries were returned for data analysis.The triamcinolone acetonide group showed the largest decrease in pain on the VAS scores after injection compared to the hyaluronic acid and NaCl group in the first week after injection .


The reduction in pain was best achieved after the first injection , the second triamcinolone acetonide injection showed a further reduction in pain .


The third triamcinolone acetonide injection only showed a slight improvement in pain reduction .


In this study we could show a booster effect in pain reduction after repeated triamcinolone acetonide injection .


The triamcinolone acetonide group showed a faster reduction in pain after injection compared to the hyaluronic acid and NaCl group .


The effect was best seen after the first and second triamcinolone acetonide injection , it is therefore questionable whether it is necessary to repeat triamcinolone acetonide injections more than two times .


ISRCTN51511455 .


Registered 20 December 2005 .


Managing the oxygen saturation of preterm infants to a target range has been the standard of care for a decade .


Changes in target ranges have been shown to significantly impact mortality and morbidity .


Selecting and implementing the optimal target range are complicated not only by issues of training , but also the realities of staffing levels and demands .


The potential for automatic control is becoming a reality .


Results from the evaluation of different systems have been promising and our own experience encouraging .


This study was conducted in two tertiary level newborn nurseries , routinely using an automated FiO2-SpO2 control system ( Avea-CLiO2 , Yorba Linda CA , USA ) .


The aim of this study was to compare the performance of the system as used routinely ( set control range of 87-93 % SpO2 ) , to a narrower higher range ( 90-93 % ) .


We employed a 12-hour cross-over design with the order of control ranges randomly assigned for each of up to three days .


The primary prospectively identified end points were time in the 87-93 % SpO2 target range , time at SpO2 extremes and the distribution of the SpO2 exposure .


Twenty-one infants completed the study .


The infants were born with a median EGA of 27 weeks and studied at a median age of 17 days and weight of 1.08 kg .


Their median FiO2 was 0.32 ; 8 were intubated , and the rest noninvasively supported ( 7 positive pressure ventilation and 6 CPAP ) .


The control in both arms was excellent , and required less than 2 manual FiO2 adjustments per day .


There were no differences in the three primary endpoints .


The narrower/higher set control range resulted in tighter control ( IQR 3.0 vs. 4.3 p < 0.001 ) , and less time with the SpO2 between 80-86 ( 6.2 % vs. 8.4 % , p = 0.006 ) .


We found that a shift in the median of the set control range of an automated FiO2-SpO2 control system had a proportional effect on the median and distribution of SpO2 exposure .


We found that a dramatic narrowing of the set control range had a disproportionally smaller impact .


Our study points to the potential to optimize SpO2 targeting with an automated control system .


Phambili , the Merck ( MRK ) - Adenovirus Type 5 ( Ad5 ) HIV-1 gag/pol/nef subtype B vaccine study , conducted in South Africa , suspended enrollment and vaccination when companion study , Step , was found non-efficacious .


Although the vaccine did not prevent HIV-1 infection or lower viral-load setpoint , immune responses recognized clades B and C HIV-1 subtypes .


We investigated predictors of the vaccine-induced antigen-specific immune responses .


Vaccine-induced immunogenicity was ascertained by interferon - ELISpot assays on the first 186 enrolled participants receiving two vaccinations .


Analyses , stratified by study arm/sex , were performed on baseline demographics [ sex , age , Body Mass Index ( BMI ) , site , Adenovirus Type-5 ( Ad5 ) titer , Herpes Simplex Virus Type-2 ( HSV2 ) status , heavy drinking ] .


Multivariate logistic regression determined predictors .


Of the 186 participants , 53.7 % ( n = 100 ) were female , median BMI was 22.5 [ IQR : 20.4-27 .0 ] , 85.5 % ( n = 159 ) were Ad5 seropositive , and 18.8 % ( n = 35 ) drank heavily .


All vaccine recipients responded to both clade B ( n = 87 ; 47 % ) and/or C ( n = 74 ; 40 % ) , p = 0.17 .


In multivariate analysis , female sex [ Adjusted Odds Ratio ( AOR ) : 6.478 ; p = 0.0159 ] , overweight/obese BMI ( AOR : 0.186 ; p = 0.0452 ) , and heavy drinking ( AOR : 0.270 ; p = 0.048 ) significantly predicted immune response to clade C for any antigens .


A marginally significant predictor of clade C-pol antigen was female sex ( AOR : 3.182 ; p = 0.0500 ) .


Sex , BMI , and heavy drinking affected vaccine-induced HIV-1 specific immune responses to clade C antigens .


The role of female sex and overweight/obese BMI boosting and suppressing vaccine-induced HIV-1 specific immune responses , respectively , requires elucidation , including any effect on HIV vaccine efficacy , especially in the era of colliding epidemics ( HIV and obesity ) .


This study was designed to test the effects of different types of influence on the expression of stereotypes towards people who are obese .


It was hypothesized that public social pressure would more significantly impact the expression of stereotypes towards obese people than other types of influence .


One-hundred fifty-eight undergraduate students were randomly assigned to one of three conditions or a control condition .


Participants completed measures of stereotypes towards obese people prior to and after receiving manipulated feedback depicting purported stereotypes possessed by others ( anonymously or publically ) or scientific information about the base rates of these stereotypical traits in the obese population ( i.e. , trait prevalence ) .


Participants also completed a measure of weight bias unrelated to the manipulated feedback .


Explicit beliefs were influenced more when people perceived that others ' views were inconsistent with their own in a public setting than an anonymous setting or when they received trait prevalence feedback .


However , levels of weight bias on a separate measure were unchanged .


Strong , public manipulations of social feedback have great potential to impact , at least , the short-term expression of stereotypes towards obese people .


Ulcerative colitis ( UC ) is a chronic idiopathic inflammatory disease in which reducing pro-inflammatory and/or increasing anti-inflammatory molecules is the mainstay of treatment .


The aim of this study was to evaluate the effects of supplementation with resveratrol as an antiinflammatory and antioxidant agent on inflammation and quality of life in patients with active UC .


In this randomized , double-blind , placebo-controlled study , 50 eligible patients with active mild to moderate UC were supplemented with either a 500-mg resveratrol or placebo capsule for 6 weeks .


Serum inflammatory markers , activity of NF-B in peripheral blood mononuclear cells ( PBMC ) and quality of life were assessed at baseline and at the end of the study .


Resveratrol supplementation led to a significant reduction in plasma levels of TNF - ( 19.70 12.80 to 17.20 10.09 pg/mL ) and hs-CRP ( 4764.25 2260.48 to 2584.50 1792.80 ng/mL ) and activity of NF-B in PBMCs ( 0.19 0.05 to 0.10 0.04 OD ) ( p < 0.001 ) , whereas there were no significant changes of these factors in placebo group .


Also , the score of inflammatory bowel disease questionnaire -9 ( IBDQ-9 ) increased , whereas the clinical colitis activity index score decreased significantly in the resveratrol group ( 32.72 7.52 to 47.64 8.59 ) ( p < 0.001 ) and when compared with the placebo group ( 35.54 9.50 to 41.08 6.59 ) ( p < 0.001 ) .


Our results indicate that 6 weeks supplementation with 500 mg resveratrol can improve quality of life and disease clinical colitis activity at least partially through inflammation reduction in patients with UC .


Whether these effects will be continued in longer duration of treatment remains to be determined .


Gestational diabetes ( GDM ) confers a high risk of type 2 diabetes .


In the Diabetes Prevention Program ( DPP ) , intensive lifestyle ( ILS ) and metformin prevented or delayed diabetes in women with a history of GDM .


The objective of the study was to evaluate the impact of ILS and metformin intervention over 10 years in women with and without a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study .


This was a randomized controlled clinical trial with an observational follow-up .


The study was conducted at 27 clinical centers .


Three hundred fifty women with a history of GDM and 1416 women with previous live births but no history of GDM participated in the study .


The participants had an elevated body mass index and fasting glucose and impaired glucose tolerance at study entry .


Interventions included placebo , ILS , or metformin .


Outcomes measure was diabetes mellitus .


Over 10 years , women with a history of GDM assigned to placebo had a 48 % higher risk of developing diabetes compared with women without a history of GDM .


In women with a history of GDM , ILS and metformin reduced progression to diabetes compared with placebo by 35 % and 40 % , respectively .


Among women without a history of GDM , ILS reduced the progression to diabetes by 30 % , and metformin did not reduce the progression to diabetes .


Women with a history of GDM are at an increased risk of developing diabetes .


In women with a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study , both lifestyle and metformin were highly effective in reducing progression to diabetes during a 10-year follow-up period .


Among women without a history of GDM , lifestyle but not metformin reduced progression to diabetes .


Minority race and lower socioeconomic status are associated with poorer patient ratings of health care quality and provider communication .


To examine the association of race/ethnicity or socioeconomic status with patients ' and families ' ratings of end-of-life care and communication about end-of-life care provided by physicians-in-training .


As a component of a randomized trial evaluating a program designed to improve clinician communication about end-of-life care , patients and patients ' families completed preintervention survey data regarding care and communication provided by internal medicine residents and medical subspecialty fellows .


We examined associations between patient and family race or socioeconomic status and ratings they gave trainees on two questionnaires : the Quality of End-of-Life Care ( QEOLC ) and Quality of Communication ( QOC ) .


Patients from racial/ethnic minority groups , patients with lower income , and patients with lower educational attainment gave trainees higher ratings on the end-of-life care subscale of the QOC ( QOCeol ) .


In path models , patient educational attainment and income had a direct effect on outcomes , while race/ethnicity did not .


Lower family educational attainment was also associated with higher trainee ratings on the QOCeol , while family non-white race was associated with lower trainee ratings on the QEOLC and general subscale of the QOC .


Patient race is associated with perceptions of the quality of communication about end-of-life care provided by physicians-in-training , but the association was opposite to our hypothesis and appears to be mediated by socioeconomic status .


Family member predictors of these perceptions differ from those observed for patients .


Further investigation of these associations may guide interventions to improve care delivered to patients and families .


Roller massagers are used as a recovery and rehabilitative tool to initiate muscle relaxation and improve range of motion ( ROM ) and muscular performance .


However , research demonstrating such effects is lacking .


To determine the effects of applying a roller massager for 20 and 60 seconds on knee-joint ROM and dynamic muscular performance .


Randomized controlled clinical trial .


University laboratory .


Ten recreationally active men ( age = 26.6 5.2 years , height = 175.3 4.3 cm , mass = 84.4 8.8 kg ) .


Participants performed 3 randomized experimental conditions separated by 24 to 48 hours .


In condition 1 ( 5 repetitions of 20 seconds ) and condition 2 ( 5 repetitions of 60 seconds ) , they applied a roller massager to the quadriceps muscles .


Condition 3 served as a control condition in which participants sat quietly .


Visual analog pain scale , electromyography ( EMG ) of the vastus lateralis ( VL ) and biceps femoris during roller massage and lunge , and knee-joint ROM .


We found no differences in pain between the 20-second and 60-second roller-massager conditions .


During 60 seconds of roller massage , pain was 13.5 % ( 5.7 0.70 ) and 20.6 % ( 6.2 0.70 ) greater at 40 seconds and 60 seconds , respectively , than at 20 seconds ( P < .05 ) .


During roller massage , VL and biceps femoris root mean square ( RMS ) EMG was 8 % and 7 % , respectively , of RMS EMG recorded during maximal voluntary isometric contraction .


Knee-joint ROM was 10 % and 16 % greater in the 20-second and 60-second roller-massager conditions , respectively , than the control condition ( P < .05 ) .


Finally , average lunge VL RMS EMG decreased as roller-massage time increased ( P < .05 ) .


Roller massage was painful and induced muscle activity , but it increased knee-joint ROM and neuromuscular efficiency during a lunge .


Intensive care units ( ICU ) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria ( ARGNB ) because of high rates of antibiotic usage , rapid patient turnover , immunological susceptibility of acutely ill patients , and frequent contact between healthcare workers and patients , facilitating cross-transmission .


Antibiotic stewardship programs are considered important to reduce antibiotic resistance , but the effectiveness of strategies such as , for instance , antibiotic rotation , have not been determined rigorously .


Interpretation of available studies on antibiotic rotation is hampered by heterogeneity in implemented strategies and suboptimal study designs .


In this cluster-randomized , crossover trial the effects of two antibiotic rotation strategies , antibiotic mixing and cycling , on the prevalence of ARGNB in ICUs are determined .


Antibiotic mixing aims to create maximum antibiotic heterogeneity , and cycling aims to create maximum antibiotic homogeneity during consecutive periods .


This is an open cluster-randomized crossover study of mixing and cycling of antibiotics in eight ICUs in five European countries .


During cycling ( 9 months ) third - or fourth-generation cephalosporins , piperacillin-tazobactam and carbapenems will be rotated during consecutive 6-week periods as the primary empiric treatment in patients suspected of infection caused by Gram-negative bacteria .


During mixing ( 9 months ) , the same antibiotics will be rotated for each consecutive antibiotic course .


Both intervention periods will be preceded by a baseline period of 4 months .


ICUs will be randomized to consecutively implement either the mixing and then cycling strategy , or vice versa .


The primary outcome is the ICU prevalence of ARGNB , determined through monthly point-prevalence screening of oropharynx and perineum .


Secondary outcomes are rates of acquisition of ARGNB , bacteremia and appropriateness of therapy , length of stay in the ICU and ICU mortality .


Results will be adjusted for intracluster correlation , and patient - and ICU-level variables of case-mix and infection-prevention measures using advanced regression modeling .


This trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs .


ClinicalTrials.gov NCT01293071 December 2010 .


The current study was performed to evaluate whether baseline acute and chronic prostate inflammation among men with an initial negative biopsy for prostate cancer ( PCa ) increased the risk of subsequent PCa detection in a clinical trial with systematic biopsies .


A retrospective analysis was performed of 6238 men aged 50 years to 75 years with prostate-specific antigen levels between 2.5 ng/mL and 10 ng/mL and a prior negative biopsy in the REduction by DUtasteride of PCa Events study who completed a 2-year biopsy .


PCa , acute prostate inflammation , and chronic prostate inflammation were assessed by central review .


The association between inflammation in baseline prostate biopsies and positive 2-year and 4-year repeat biopsies was evaluated with the chi-square test and logistic regression analysis adjusting for baseline covariates .


Acute and chronic inflammation and both were detected in 46 baseline biopsies ( 1 % ) , 3931 baseline biopsies ( 63 % ) , and 892 baseline biopsies ( 14 % ) , respectively .


Acute and chronic inflammation were found to be significantly associated with each other ( P < .001 ) .


Acute inflammation at baseline biopsy was associated with younger age , lower prostate-specific antigen levels , and a smaller prostate ( all P < .01 ) , whereas chronic inflammation was associated with older age and larger prostate glands ( all P < 0.01 ) .


At the 2-year biopsy , the prevalence of PCa was 14 % ( N = 900 patients ) .


On univariable and multivariable analysis , both acute and chronic inflammation were found to be significantly associated with a lower PCa risk ( acute univariable : odds ratio [ OR ] , 0.65 [ P < .001 ] and multivariable : OR , 0.75 [ P = .012 ] and chronic univariable : OR , 0.61 [ P < .001 ] and multivariable : OR , 0.65 [ P < .001 ] ) .


At the time of 4-year biopsy , only acute inflammation was found to be associated with a lower PCa risk .


Baseline acute and chronic inflammation were both found to be independently associated with a lower PCa risk .


From a clinical standpoint , inflammation in negative biopsies for PCa may lower the risk of subsequent PCa detection .


The benefits of rehabilitation after immobilization for ankle fracture are unclear .


To determine the effectiveness of a supervised exercise program and advice ( rehabilitation ) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex .


The EXACT trial was a pragmatic , randomized clinical trial conducted from December 2010 to June 2014 .


Patients with isolated ankle fracture presenting to fracture clinics in 7 Australian hospitals were randomized on the day of removal of immobilization .


Of 571 eligible patients , 357 chose not to participate and 214 were allocated to rehabilitation ( n = 106 ) or advice alone ( n = 108 ) , with 194 ( 91 % ) followed up at 1 month , 173 ( 81 % ) at 3 months , and 170 ( 79 % ) at 6 months .


There were no withdrawals attributed to adverse effects .


Recruitment terminated early on December 31 , 2013 ( planned enrollment , 342 ; actual , 214 ) , because funding was exhausted .


Supervised exercise program and advice about self-management ( rehabilitation ) ( individually tailored , prescribed , monitored , and progressed ) or advice alone , both delivered by a physical therapist .


Primary outcomes were activity limitation assessed using the Lower Extremity Functional Scale ( score range , 0-80 ; higher scores indicate better activity ) , and quality of life assessed using the Assessment of Quality of Life ( score range , 0-1 ; higher scores indicate better quality of life ) , measured at baseline and at 1 , 3 ( primary time point ) , and 6 months .


Mean activity limitation and quality of life at baseline were 30.1 ( SD , 12.5 ) and 0.51 ( SD , 0.24 ) , respectively , for advice and 30.2 ( SD , 13.2 ) and 0.54 ( SD , 0.24 ) for rehabilitation , increasing to 64.3 ( SD , 13.5 ) and 0.85 ( SD , 0.17 ) for advice vs 64.3 ( SD , 15.1 ) and 0.85 ( SD , 0.20 ) for rehabilitation at 3 months .


Rehabilitation was not more effective than advice for activity limitation ( mean effect at 3 months , 0.4 [ 95 % CI , -3.3 to 4.1 ] ) or quality of life ( -0.01 [ 95 % CI , -0.06 to 0.04 ] ) .


Treatment effects were not moderated by fracture severity or age and sex .


A supervised exercise program and advice did not confer additional benefits in activity limitation or quality of life compared with advice alone for patients with isolated and uncomplicated ankle fracture .


These findings do not support the routine use of supervised exercise programs after removal of immobilization for patients with isolated and uncomplicated ankle fracture .


anzctr.org.au Identifier : ACTRN12610000979055 .


To investigate the efficacy and safety of Ji-Tai tablet and Ji-Tai tablet combined with buprenorphine in the treatment of patients with acute withdrawal syndrome of mild heroin dependence .


A total of 150 patients with mild heroin dependence were recruited , and were randomly assigned to a Ji-Tai tablet group ( n = 50 ) , a Ji-Tai tablet combined with buprenorphine group ( n = 50 ) and a control group ( n = 50 ) during a 10-day clinical trial .


Opiate withdrawal scale ( OWS ) was used to measure the severity of withdrawal symptoms .


Anxiety symptoms assessments were made at 0 day ( baseline ) , the day 5 ( middle ) , and the day 10 ( end ) by the Hamilton anxiety scale ( HAMA ) .


Symptoms were assessed before and 1 h or 2 h after medication each day .


The total withdrawal symptoms scores and the daily reduction rate were used to measure the effect of Ji-Tai tablet vs Ji - Tai tablet plus buprenorphine .


Safety evaluation was carried out by the following measures : baseline of treatment , drug side effects after the treatment , vital signs ( blood pressure , heart rate , and respiration rate ) , laboratory examination ( routine blood and urine tests and the liver and kidney function tests ) , and electrocardiograms .


A total of 142 mild heroin dependence patients performed the experiments ( including 48 in the Ji-Tai tablet group , 48 in the Ji-Tai tablet with buprenorphine group and 46 in the control group ) .


The scores of baseline withdrawal symptoms were 43.52019.786 , 42.64017.648 and 47.10024.450 , respectively , with no significant differences among the 3 groups ( all P > 0.05 ) .


During the 10-day treatment , the reduction rate of acute withdrawal symptoms scores increased daily , the acute withdrawal syndrome scores and the anxiety symptoms scores declined from day 0 to day 10 , there was also no significant difference among the 3 groups ( all P > 0.05 ) .


Ji-Tai tablet did not affect vital signs such as blood pressure , heart rate , and respiration rate .


Ji-Tai tablet or Ji-Tai tablet combined with buprenorphine had no effect on acute withdrawal symptoms of mild heroin dependence .


Human infection with the avian influenza A H5N1 virus results in disease with a high fatality rate , against which antiviral treatments have limited efficacy .


We aimed to investigate the safety , pharmacokinetics , and therapeutic potential of specific polyclonal immunoglobulin equine F ( ab ' ) fragments raised against influenza A/Vietnam/1194 / 2004 virus ( H5N1 subtype ) in healthy volunteers .


We did a randomised , double-blind , placebo-controlled , single-centre phase 1 study .


In stage 1 ( one infusion ) and stage 2 ( five infusions ) of the trial , we randomly assigned healthy male volunteers to receive once-daily intravenous infusions of 085 U/kg body weight of F ( ab ' ) or once-daily saline placebo .


Randomisation was done centrally , with one block of four patients and one block for substitutes ( three actives , one placebo ) in stage 1 , and two blocks of six patients ( five actives and one placebo ) and the same block for substitutes in stage 2 .


The primary objective was assessment of the clinical and laboratory safety of F ( ab ' ) , which was monitored for 22 days in the group that received one dose ( assessments on days 0-2 , 4 , 8 , 15 , and 22 ) and 33 days in the group that received five doses ( days 0-6 , 8 , 10 , 12 , 19 , 26 , and 33 ) .


A final post-study safety assessment was done at 120 days .


We also assessed pharmacokinetic outcomes , and assayed haemagglutination and seroneutralisation activity .


Analysis was done according to intention-to-treat .


This trial is registered with ClinicalTrials.gov , number NCT02295813 .


We enrolled 16 healthy Asian men between Sept 28 and Dec 28 , 2012 , and randomly assigned 13 to one or five doses of F ( ab ' ) and three to placebo .


F ( ab ' ) was well tolerated , and no deaths or serious adverse events occurred .


Three patients had mild adverse events ( one each of blepharospasm , sinusitis , and pyrexia ) .


The pyrexia ( 38C ) was regarded as probably related to the infusion , and resolved after 37 min .


Our laboratory assessments of blood and urine samples and physical examinations of heart rate , electrocardiogram readings , and weight showed no clinically significant safety issues .


Mean peak plasma concentrations were 193 g/mL ( SD 35 ) with the one dose schedule and 230 g/mL ( 45 ) with the five-dose schedule .


F ( ab ' ) were still detectable in plasma on average up to 5 days after five doses .


Haemagglutination inhibition was only increased after the third dose , but in-vitro seroneutralisation activity was transiently increased after each of the five doses to concentrations regarded as clinically beneficial in infected patients .


F ( ab ' ) showed good safety , tolerability , and therapeutic potential for managing of H5N1 exposed patients .


Fab ` entech .


Declining inspiratory muscle function and structure and systemic low-level inflammation and oxidative stress may contribute to morbidity and mortality during normal ageing .


Therefore , we examined the effects of inspiratory muscle training ( IMT ) in older adults on inspiratory muscle function and structure and systemic inflammation and oxidative stress , and reexamined the reported positive effects of IMT on respiratory muscle strength , inspiratory muscle endurance , spirometry , exercise performance , physical activity levels ( PAL ) , and quality of life ( QoL ) .


Thirty-four healthy older adults ( 68 3 yr ) with normal spirometry , respiratory muscle strength , and physical fitness were divided equally into a pressure-threshold IMT or sham-hypoxic placebo group .


Before and after an 8-wk intervention , measurements were taken for dynamic inspiratory muscle function and inspiratory muscle endurance using a weighted plunger pressure-threshold loading device ; diaphragm thickness by using B-mode ultrasonography ; plasma cytokine concentrations by using immunoassays ; DNA damage levels in peripheral blood mononuclear cells by using comet assays ; spirometry , maximal mouth pressures , and exercise performance by using a 6-min walk test ; PAL by using a questionnaire and accelerometry ; and QoL using a questionnaire .


Compared with placebo , IMT increased maximal inspiratory pressure ( +34 % 43 % , P = 0.008 ) , diaphragm thickness at residual volume ( +38 % 39 % , P = 0.03 ) , and peak inspiratory flow ( +35 % 42 % , P = 0.049 ) but did not change other spirometry measures , plasma cytokine concentrations , DNA damage levels in peripheral blood mononuclear cells , dynamic inspiratory muscle function , inspiratory muscle endurance , exercise performance , PAL , or QoL .


These novel data indicate that in healthy older adults , IMT elicits some positive changes in inspiratory muscle function and structure but neither attenuates systemic inflammation and oxidative stress nor improves exercise performance , PAL , or QoL .


To be an older woman , live alone , have chronic pain , and be dependent on support are all factors that may have an impact on daily life .


One way to promote ability in everyday activities in people with pain-related conditions is to use individualized , integrated behavioral medicine in physical therapy interventions .


How this kind of intervention works for older women living alone at home , with chronic pain , and dependent on formal care to manage their everyday lives has not been studied .


The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women .


The study was a 12-week randomized trial with two-group design .


Primary effect outcomes were pain-related disability and morale .


Secondary effect outcomes focused on pain-related beliefs , self-efficacy for exercise , concerns of falling , physical activity , and physical performance .


In total , 23 women agreed to participate in the study and 16 women completed the intervention .


The results showed that the behavioral medicine in physical therapy intervention was feasible .


No effects were seen on the primary effect outcomes .


The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise .


Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study .


Results from this study are encouraging , but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability , pain-related beliefs , self-efficacy in everyday activities , and morale in the target group .


Further research is also needed to refine and evaluate effects from individualized reminder routines , support to collect self-report data , safety procedures for balance training , and training of personnel to enhance self-efficacy .


Although cilnidipine and valsartan are widely coadministered to patients with hypertension , their drug-drug interaction potential has not been investigated .


This study compared the pharmacokinetic ( PK ) , pharmacodynamic ( PD ) , and tolerability profiles of cilnidipine and valsartan , both alone and in combination , in healthy male subjects .


Fifty-four subjects , enrolled into an open-label , single-dose , three-treatment , three-period crossover study , randomly received cilnidipine ( 10 mg ) , valsartan ( 160 mg ) , or both according to one of six sequences .


Blood samples were collected at baseline and up to 24 hours after drug administration in each period .


Plasma concentrations of cilnidipine and valsartan were determined by liquid chromatography with tandem mass spectrometry .


Maximum plasma concentration ( Cmax ) and area under the concentration-time curve from 0 to the last measurable time ( AUC ( last ) ) were estimated using a noncompartmental method .


Tolerability was evaluated by assessing adverse events ( AEs ) , vital signs , electrocardiograms , and clinical laboratory tests .


Blood pressure was also measured for PD assessment .


A total of 51 subjects completed the study .


The PK profile of cilnidipine was not significantly affected by coadministered valsartan ; the geometric mean ratio and 90 % confidence interval ( 90 % CI ) of AUC ( last ) for cilnidipine with and without valsartan was 1.04 ( 0.98-1 .10 ) .


Likewise , cilnidipine did not affect the PK of valsartan ; the geometric mean ratio ( 90 % CI ) of AUC ( last ) for valsartan with and without cilnidipine was 0.94 ( 0.83-1 .07 ) .


Coadministration of cilnidipine and valsartan reduced blood pressure in an additive way .


No serious AEs were reported , and both cilnidipine and valsartan were well tolerated .


Coadministered cilnidipine and valsartan do not cause a significant PK or PD interaction , and they are well tolerated .


Little is known about the necessity of multiple same-day intraocular pressure ( IOP ) measurements in describing the effect of IOP-lowering surgical procedures , and such evidence could affect surgical trial recruitment and retention of participants .


To determine whether a single IOP measurement might adequately approximate the mean of several measurements in glaucoma surgical trials .


A prospective , multicenter , interventional cohort from the prerandomization phase of a randomized clinical trial evaluating use of a supraciliary implant for treatment of IOP was conducted at multiple ophthalmology clinics .


A total of 609 patients ( 609 eyes ) with primary open-angle glaucoma and cataract were included .


One IOP measurement was made while patients were receiving their usual medications to lower IOP , and 3 IOP measurements were made at 8 am , 12 pm , and 4 pm after patients underwent washout of all IOP-lowering eyedrops .


The proportion of eyes in which the increase in IOP after washout , using the mean of the 3 measurements , differed by more than 0.5 , 1.0 , 1.5 , or 2.0 mm Hg from the increase in IOP after washout using only 1 of the postwashout measurements .


A proportion of 10 % or less at the 1.5-mm Hg cutoff was considered clinically acceptable .


The hypothesis was formulated after data collection but before the data were examined .


The mean ( SD ) IOP before washout was 18.5 ( 4.0 ) mm Hg .


The mean increase in IOP after washout , using the mean of the 3 measurements , was 5.3 ( 4.2 ) mm Hg .


The percentage of eyes in which the increase in IOP using a single postwashout IOP differed from the increase in IOP using the mean of 3 measurements by more than 1.5 mm Hg was 35.1 % , 25.6 % , 34.2 % , 30.0 % , and 31.4 % when the single measurement was made at 8 am , 12 pm , 4 pm , a randomly chosen single measure of those 3 times , and the time closest to that of the prewashout IOP , respectively .


By logistic regression , the 12 pm postwashout IOP had the lowest proportion of eyes differing from the mean ( P < .001 ) and thus most closely approximated the mean diurnal IOP .


Although eliminating multiple IOP measurements would simplify the conduct of surgical trials in glaucoma , our data show that using a single IOP measurement after washout does not adequately approximate the mean of multiple IOP measurements .


To evaluate the clinical and ultrasonographic changes in the morphology and vascularity of the common extensor tendon after injecting platelet-rich plasma ( PRP ) or corticosteroid ( CS ) for recalcitrant lateral epicondylitis ( LE ) .


30 patients aged 18 to 60 years with recalcitrant ( > 6 months ) LE not responsive to oral medication or non-invasive treatment were randomised to receive PRP ( n = 15 ) or CS ( n = 15 ) injection .


Patients were assessed using the visual analogue scale ( VAS ) for pain , Disabilities of the Arm , Shoulder and Hand Scale ( DASH ) score , Oxford Elbow Score , modified Mayo Clinic performance index for the elbow ( modified Mayo score ) , and hand grip strength .


Ultrasonography was performed by a musculoskeletal ultrasonologist to evaluate for tear at the common extensor origin , oedema at the common extensor origin , cortical erosion , probe-induced tenderness , and thickness of the tendon .


The VAS for pain , DASH score , Oxford Elbow Score , modified Mayo score , and hand grip strength all improved significantly from pre-injection to the 6-month follow-up in the PRP and CS groups .


However , in the CS group , the scores generally peaked at 3 months and then deteriorated slightly at 6 months indicating recurrence of symptoms , which involved 46.7 % of the CS patients .


At 6 months , the number of patients positive for various ulrasonographic findings generally decreased .


However , in the CS group , the number of patients with reduced thickness of the common extensor tendon increased from 2 to 12 , and the number of patients with cortical erosion at the lateral epicondyle increased from 9 to 11 .


PRP appeared to enable biological healing of the lesion , whereas CS appeared to provide short-term , symptomatic relief but resulted in tendon degeneration .


To assess vitamin D status of pediatric patients with Crohn 's disease ( CD ) and to compare their serum 25-hydroxyvitamin D ( s-25OHD ) with established cutoffs and assess whether 6 months of supplementation with 2000 IU/d , vs 400 IU/d , would reduce the group prevalence of vitamin D below these cutoffs .


Subjects 8-18 years ( n = 83 ) with quiescent CD were randomized to either 400 or 2000 IU vitamin D3/d for 6 months .


Baseline mean SD s-25OHD was 24 8 ng/mL ; 13 subjects ( 16 % ) had an s-25OHD < 16 ng/mL , 27 ( 33 % ) < 20 ng/mL , and 65 ( 79 % ) < 30 ng/mL .


There was no significant difference between groups in achieving the cutoffs of 16 ng/mL or 20 ng/mL at 6 months ; however , only 35 % of the 400 IU group achieved the greater cutoff of 30 ng/mL compared with 74 % in the 2000 IU group ( P < .001 ) .


Baseline adjusted mean s-25OHD concentrations at 6 months were 9.6 ng/mL ( 95 % CI 6.0-13 .2 , P < .001 ) greater in the 2000 IU than the 400 IU group .


Disease activity was not affected by supplement dose .


Few subjects exceeded safety marker cutoffs , and this did not differ by dose .


At baseline , a high proportion of patients had a mean s-25OHD > 20 ng/mL .


2000 IU vitamin D3/d is more effective in raising s-25OHD concentrations to > 30 ng/mL in children with CD than 400 IU/d , but both treatments were equally effective at achieving 16 or 20 ng/mL .


Cerebral injury caused by hypoperfusion during the perioperative period is one of the main causes of disability and death in patients after major surgery .


No effective protective or preventative strategies have been identified .


This study was designed to evaluate the effects of Ginkgo biloba extract on cerebral oxygen and glucose metabolism in elderly patients with known , pre-existing cerebral ischemia .


Sixty ASA ( American Society of Anesthesiologists ) II-III patients , diagnosed with vertebral artery ischemia by transcranial Doppler ultrasonography ( TCD ) , and scheduled for elective total hip replacement surgery , were enrolled in the study .


They were randomly allocated to receive either 1mg/kg Ginkgo biloba extract ( G group n = 30 ) or normal saline ( D group n = 30 ) after induction of anesthesia .


Blood samples were collected from radial artery and jugular venous bulb catheters for blood gas analysis and determination of glucose and lactate concentrations preoperatively , before surgical incision , at the end of surgery , and on post-op day 1 .


Arterial O2 content ( CaO2 ) , jugular venous O2 content ( CjvO2 ) , arteriovenous O2 content difference ( Da-jvO2 ) , cerebral oxygen extraction rate ( CEO2 ) , and arteriovenous glucose and lactate content differences ( Da-jvGlu and Da-jvLac ) were calculated .


There were no significant differences in CaO2 or Da-jvGlu during surgery between groups ( p > 0.05 ) .


However , the Ginkgo group had higher CjvO2 , internal jugular venous oxygen saturation ( SjvO2 ) and lower CEO2 , Da-jvO2 and Da-jvLac at the end of surgery ( T2 ) and on post-op day 1 ( T3 ) than those in the control group ( p < 0.05 ) .


Ginkgo biloba extract can improve cerebral oxygen supply , decrease cerebral oxygen extraction rate and consumption , and help maintain the balance between cerebral oxygen supply and consumption .


It has no effect , however , on cerebral glucose metabolism in elderly patients with known , pre-existing cerebral ischemia .


Myocardial deformation analysis by speckle-tracking echocardiography ( STE ) has been shown to accurately predict viability in patients with chronic ischemic left ventricular ( LV ) dysfunction .


The aim of this study was to evaluate two-dimensional STE for the prediction of global and segmental LV functional changes after acute myocardial infarction ( AMI ) in comparison with late gadolinium enhancement ( LGE ) cardiac magnetic resonance ( CMR ) .


In 93 patients ( mean age , 60 11 years ) with first AMIs ( 55 with ST-segment elevation myocardial infarctions and 38 with non-ST-segment elevation myocardial infarctions ) treated with acute percutaneous coronary intervention , global peak longitudinal strain was determined to describe global function by STE , and peak systolic circumferential and longitudinal strain was determined for segmental function analysis .


LGE CMR was performed to define the amounts of global and segmental myocardial scar .


STE and LGE CMR were performed within 48 hours of AMI .


At 6-month follow-up , transthoracic echocardiography was repeated to determine global und segmental LV recovery and adverse LV remodeling ( increase in end-systolic volume > 15 % ) .


Accuracy to predict global functional improvement as well as LV remodeling at 6-month follow-up after AMI was similar for STE and LGE CMR ( areas under the curve , 0.715 vs 0.729 [ P = .8830 ] and 0.806 vs 0.824 [ P = .7141 ] , respectively ) .


Peak systolic circumferential strain < -14.2 % had sensitivity of 71.6 % and specificity of 58.1 % to predict segmental functional improvement .


Compared with LGE CMR , the predictive accuracy of transmural STE for segmental functional improvement at 6-month follow-up was lower ( area under the curve , 0.788 vs 0.668 ; P = .0001 ) .


Predictive accuracy for segmental functional improvement could be improved by analysis of endocardial circumferential strain ( area under the curve , 0.700 vs 0.668 for transmural speckle-tracking echocardiographic analysis ; P = .0023 ) .


Two-dimensional STE allows the prediction of global functional recovery as well as LV remodeling after AMI with accuracy comparable with that of LGE CMR .


Accuracy to predict segmental functional recovery using transmural deformation analysis by two-dimensional STE is inferior compared with LGE CMR but can be improved by a layer-specific analysis of endocardial deformation .


Studies indicate an effect of dietary calcium on change in body weight ( BW ) and waist circumference ( WC ) , but the results are inconsistent .


Furthermore , a relation could depend on genetic predisposition to obesity .


The objective was to examine whether genetic predisposition to higher body mass index ( BMI ) , WC , or waist-hip ratio ( WHR ) interacts with dietary calcium in relation to subsequent annual change in BW ( BW ) and WC ( WC ) .


The study was based on 7569 individuals from the MONItoring trends and determinants of CArdiovascular disease Study , a sample from the Danish Diet , Cancer and Health Study and the INTER99 study , with information on diet ; 54 single-nucleotide polymorphisms ( SNPs ) associated with BMI , WC , or WHR adjusted for BMI ; and potential confounders .


The SNPs were combined in 4 scores as indicators of genetic predisposition ; all SNPs in a general score and a score for each of 3 phenotypes : BMI , WC , and WHR .


Linear regression was used to examine the association between calcium intake and BW or WC adjusted for concurrent BW .


SNP score calcium interactions were examined by adding product terms to the models .


We found a significant BW of -0.076 kg ( P = 0.021 ; 95 % CI : -0.140 , -0.012 ) per 1000 mg Ca .


No significant association was observed between dietary calcium and WC .


In the analyses with BW as outcome , we found no significant interactions between the developed predisposition scores and calcium .


However , we found a significant interaction between a score of 6 WC-associated SNPs and calcium in relation to WC .


Each risk allele was associated with a WC of -0.043 cm ( P = 0.038 ; 95 % CI : -0.083 , -0.002 ) per 1000 mg Ca .


Our study suggests that dietary calcium relates weakly to BW loss .


We found no evidence of a general association between calcium and WC , but calcium may reduce WC among people genetically predisposed to a high WC .


However , further replication of this finding is needed .


We aimed to investigate whether combination therapy using intracoronary ( IC ) abciximab and aspiration thrombectomy ( AT ) enhances myocardial perfusion compared to each treatment alone in patients with ST-elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) .


We enrolled 40 patients with STEMI , who presented within 6 h of symptom onset and had Thrombolysis in MI flow 0/1 or a large angiographic thrombus burden ( grade 3/4 ) .


Patients were randomly divided into 3 groups : 10 patients who received a bolus of IC abciximab ( 0.25 mg/kg ) ; 10 patients who received only AT ; and 20 patients who received both treatments .


The index of microcirculatory resistance ( IMR ) was measured with a pressure sensor/thermistor-tipped guidewire following successful PCI .


Microvascular obstruction ( MVO ) was assessed using cardiac magnetic resonance imaging on day 5 .


IMR was lower in the combination group than in the IC abciximab group ( 23.57.4 U vs. 66.948.7 U , p = 0.001 ) and tended to be lower than in the AT group , with barely missed significance ( 23.57.4 U vs. 37.226.1 U , p = 0.07 ) .


MVO was observed less frequently in the combination group than in the IC abciximab group ( 18.8 % vs. 88.9 % , p = 0.002 ) and tended to occur less frequently than in the AT group ( 18.8 % vs. 66.7 % , p = 0.054 ) .


No difference of IMR and MVO was found between the IC abciximab and the AT group ( 66.948.7 U vs. 37.226.1 U , p = 0.451 for IMR ; 88.9 % vs. 66.7 % , p = 0.525 for MVO , respectively ) .


Combination treatment using IC abciximab and AT may synergistically improve myocardial perfusion in patients with STEMI undergoing primary PCI ( Trial Registration : clinicaltrials .


gov Identifier : NCT01404507 ) .


Polyetheretherketone ( PEEK ) cages have been widely used in the treatment of lumbar degenerative disc disorders , and show good clinical results .


Still , complications such as subsidence and migration of the cage are frequently seen .


A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible .


Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities , and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages .


This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis .


100 patients ( 18-75 years ) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included .


Patients will be randomly assigned to a PEEK cage or a silicon nitride cage , and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation .


Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire .


Secondary outcome parameters are the VAS leg , VAS back , SF-36 , Likert scale , neurological outcome and radiographic assessment of fusion .


After 1 year the fusion rate will be measured by radiograms and CT. .


Follow-up will be continued for 2 years .


Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up .


Analyses of radiograms and CT will be performed independently by two experienced radiologists .


In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders .


To our knowledge , this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders .


NCT01557829 .


Yoga is a popular mind-body therapy that has demonstrated beneficial effects on psychological , behavioral , and functional outcomes .


However , few studies have investigated effects on inflammatory processes .


This study tested the hypothesis that an Iyengar yoga intervention specifically designed for fatigued breast cancer survivors would lead to decreases in inflammation-related gene expression and circulating markers of proinflammatory cytokine activity .


Breast cancer survivors with persistent cancer-related fatigue were randomized to a 12-week Iyengar yoga intervention ( n = 16 ) or a 12-week health education control condition ( n = 15 ) .


Blood samples were collected at baseline , post-intervention , and at a 3-month follow-up for genome-wide transcriptional profiling and bioinformatic analyses .


Plasma inflammatory markers and salivary cortisol were also assessed .


In promoter-based bioinformatics analyses , the yoga group showed reduced activity of the pro-inflammatory transcription factor nuclear factor kappa B ( NF-B ) , increased activity of the anti-inflammatory glucocorticoid receptor , and reduced activity of cAMP response element-binding protein ( CREB ) family transcription factors relative to controls ( all ps < .05 ) .


There was also a significant intervention effect on the soluble tumor necrosis factor receptor type II ( sTNF-RII ) , a marker of TNF activity ; plasma levels of sTNF-RII remained stable in the yoga group , whereas levels of this marker increased in the health education group ( p = .028 ) .


A similar , non-significant trend was observed for the interleukin 1 receptor antagonist ( p = .16 ) .


No significant changes in C reactive protein ( CRP ) , interleukin 6 ( IL-6 ) , or diurnal cortisol measures were observed .


A 12-week restorative Iyengar yoga intervention reduced inflammation-related gene expression in breast cancer survivors with persistent fatigue .


These findings suggest that a targeted yoga program may have beneficial effects on inflammatory activity in this patient population , with potential relevance for behavioral and physical health .


High left ventricular ( LV ) pacing threshold ( PT ) may in some cases indicate the presence of scarred myocardium , a predictor of poor outcome in cardiac resynchronization therapy ( CRT ) treated patients .


We hypothesized that intraoperative LVPT can be used to determine echocardiographic and clinical responses to CRT .


The study comprised 975 patients enrolled in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) .


Multivariate regression analysis was performed to evaluate the relationship between LVPT and percent reduction in LV end-systolic volume ( ESV ) and left atrial volume ( LAV ) 1 year after CRT .


Cox proportional hazards analysis was used to evaluate the relationship between LVPT and heart failure ( HF ) events or death ( primary endpoint ) and all-cause death ( secondary endpoint ) .


An increasing LVPT was inversely related to percent reduction in both LVESV ( P = 0.02 ) and LAV ( P < 0.01 ) .


Patients with LVPT in the highest quartile ( > 1.8 V ) were less likely to achieve reverse LV remodeling ( 15 % LVESV reduction from baseline ) than those with LVPT in the lower quartiles ( hazard ratios [ HR ] OR 0.56 , P = 0.02 ) .


Mean percent reduction in LAV and LVESV was also significantly greater among those with lowest quartile LVPT .


Multivariate analysis showed borderline significant 13 % ( P = 0.06 ) and significant 22 % ( P = 0.03 ) increase in the risk of HF/death and death alone , respectively , per 1 volt increase in LVPT .


High intraoperative LVPT is associated with significantly lower echocardiographic and clinical response to CRT-D .


Insulin resistance plays a central role in the pathophysiology of metabolic syndrome ( MS ) .


Its cardiac deleterious effects are characterized by an increase in fibrous tissue that increases myocardial stiffness and contributes to subclinical left ventricular diastolic dysfunction ( LVDD ) and heart failure with preserved ejection fraction in patients with MS. In addition to lifestyle counseling ( LC ) , metformin treatment may attenuate or even reverse diastolic dysfunction in these patients .


This trial aims to evaluate if treating non-diabetic patients with MS and LVDD with metformin in addition to LC improves diastolic function and assess its impact in functional capacity and health-related quality of life ( HRQoL ) .


MET-DIME is a phase II prospective , randomized , open-label , blinded-endpoint trial with a scheduled follow-up of 24months .


Fifty-four patients ( adults 40-65years old with AHA/NHLBI criteria of MS and rest LVDD ) will be randomized by minimization to LC only or LC plus metformin ( target dose of 1,000 mg twice daily ) .


The primary endpoint will be change in mean of early diastolic mitral annular velocity , an echocardiographic parameter highly correlated with myocardial fibrosis ( serial measurements will be performed at 6 , 12 and 24months ) .


The secondary endpoints will include change in diastolic parameters at rest ; metabolic , inflammatory and remodeling biomarkers ; functional capacity ; adipose tissue volumes and HRQoL .


MET-DIME is a pragmatic trial designed to evaluate if adding metformin to the standard treatment of patients with MS improves diastolic dysfunction , assessing its impact in metabolic homeostasis , proinflammatory state , functional capacity and HRQoL .


EndoTAG-1 , composed of paclitaxel embedded in liposomal membranes targeting tumor endothelial cells , was evaluated for safety and efficacy in advanced triple-negative breast cancer ( TNBC ) .


One hundred and forty patients were treated with weekly EndoTAG-1 ( 22 mg/m ( 2 ) ) plus paclitaxel ( 70 mg/m ( 2 ) ) , twice weekly EndoTAG-1 ( 2 44 mg/m ( 2 ) ) , or weekly paclitaxel ( 90 mg/m ( 2 ) ) for greater than or equal to four cycles ( 3-week treatment + 1-week rest ) or until progression/toxicity .


Primary end point was progression-free survival ( PFS ) rate evaluated centrally after four cycles of therapy ( week 16 ) .


The study was not powered for intergroup comparisons .


The PFS rate at week 16 was 59.1 % [ one-sided 95 % CI : 45.6 , ] on combination treatment , 34.2 % [ 21.6 , ] on EndoTAG-1 , and 48.0 % [ 30.5 , ] on paclitaxel .


Median PFS reached 4.2 , 3.4 , and 3.7 months , respectively .


After complete treatment ( week 41 analysis ) , median overall survival ( OS ) was 13.0 , 11.9 , and 13.1 months for the modified Intention-to-Treat ( ITT ) population and 15.1 , 12.5 , and 8.9 months for the per-protocol population , respectively .


The clinical benefit rate was 53 % , 31 % , and 36 % for the treatment groups .


Safety analysis revealed known toxicities of the drugs with slight increases of grade 3/4 neutropenia on combination therapy .


Treatment of advanced TNBC with a combination of EndoTAG-1 and standard paclitaxel [ Taxol ( Bristol-Myers Squibb GmbH ) , or equivalent generic formulation ] was well tolerated and showed antitumor efficacy .


The positive trend needs to be confirmed in a randomized phase III trial .


European Clinical Trials Database : EudraCT number 2006-002221-23 .


ClinicalTrials.gov identifier : NCT00448305 .


To compare the difference in the clinical efficacy on infantile Tourette syndrome between the integrated therapy of acupuncture and pingganjianpi decoction and haloperidol tablets .


Forty-seven children were randomized into an observation group ( 25 cases ) and a control group ( 22 cases ) .


In the observation group , acupuncture was applied to Taichong ( LR 3 ) , Baihui ( GV 20 ) , Zhongwan ( CV 12 ) , Zusanli ( ST 36 ) , etc. .


The needles were retained for 30 min .


Acupuncture was given once a day and there were 5 days at intervals after 10 times of acupuncture .


Additionally , pinggan jianpi decoction was prescribed .


In the control group , haloperidol tablets were prescribed , starting from the small dose , 0.05 mg/kg per day , twice a day .


The treatment of 30 days made one session and 3 sessions were required .


Yale global tic severity scale ( YGTSS ) was adopted to observe tic time , tic frequency and tic severity score before treatment and in 30 days , 60 days and 90 days after treatment in the two groups .