All patients will enter an inflammatory arthritis registry for long-term follow-up .


CADERA is a multi-parametric study describing cardiovascular abnormalities in early , treatment-nave RA patients , with assessment of changes at one year between early biological therapy and conventional therapy .


This trial was registered with Current Controlled Trials ( registration number : ISRCTN50167738 ) on 8 November 2013 .


To evaluate the effectiveness of efforts to translate and disseminate evidence-based guidelines about atypical antipsychotic use to nursing homes ( NHs ) .


Three-arm , cluster randomized trial .


NHs .


NHs in the state of Connecticut .


Evidence-based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders , and 42 NHs were recruited and randomized to one of three toolkit dissemination strategies : mailed toolkit delivery ( minimal intensity ) ; mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing ( moderate intensity ) ; and in-person toolkit delivery with academic detailing , on-site behavioral management training , and quarterly audit and feedback reports ( high intensity ) .


Outcomes were evaluated using the Reach , Effectiveness , Adoption , Implementation , Maintenance ( RE-AIM ) framework .


Toolkit awareness of 30 % ( 7/23 ) of leadership of low-intensity NHs , 54 % ( 19/35 ) of moderate-intensity NHs , and 82 % ( 18/22 ) of high-intensity NHs reflected adoption and implementation of the intervention .


Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs .


Antipsychotic prescribing levels declined during the study period , but there were no statistically significant differences between study arms or from secular trends .


RE-AIM indicators suggest some success in disseminating the toolkit and differences in reach , adoption , and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends .


Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents .


An intervention trial of the ` SuperAmma ' village-level intervention to promote handwashing with soap ( HWWS ) in rural India demonstrated substantial increases in HWWS amongst the target population .


We carried out a process evaluation to assess the implementation of the intervention and the evidence that it had changed the perceived benefits and social norms associated with HWWS .


The evaluation also aimed to inform the design of a streamlined shorter intervention and estimate scale up costs .


Intervention implementation was observed in 7 villages .


Semi-structured interviews were conducted with the implementation team , village leaders and representatives of the target population .


A questionnaire survey was administered in 174 households in intervention villages and 171 households in control villages to assess exposure to intervention activities , recall of intervention components and evidence that the intervention had produced changes in perceptions that were consistent with the intervention core messages .


Costs were estimated for the intervention as delivered , as well as for a hypothetical scale-up to 1,000 villages .


We found that the intervention was largely acceptable to the target population , maintained high fidelity ( after some starting problems ) , and resulted in a high level of exposure to most components .


There was a high recall of most intervention activities .


Subjects in the intervention villages were more likely than those in control villages to cite reasons for HWWS that were in line with intervention messaging and to believe that HWWS was a social norm .


There were no major differences between socio-economic and caste groups in exposure to intervention activities .


Reducing the intervention from 4 to 2 contact days , in a scale up scenario , cut the estimated implementation cost from $ 2,293 to $ 1,097 per village .


The SuperAmma intervention is capable of achieving good reach across men and women of varied social and economic status , is affordable , and has the potential to be effective at scale , provided that sufficient attention is given to ensuring the quality of intervention delivery .


Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management .


Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money .


This multicentre , randomised controlled trial with a parallel design will recruit 1200 overweight adults ( BMI 28kg/m2 ) through their primary care provider .


They will be randomised in a 2:5:5 allocation to : Brief Intervention , Commercial Programme for 12weeks , or Commercial Programme for 52weeks .


Participants will be followed up for two years , with assessments at 0 , 3 , 12 and 24months .


The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12months than BI , and whether CP52 achieves significantly greater weight loss from baseline to 12months than CP12 .


The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12months .


Clinical effectiveness will be also be assessed by measures of weight , fat mass , and blood pressure at each time point and biochemical risk factors at 12months .


Self-report questionnaires will collect data on psychosocial factors associated with adherence , weight-loss and weight-loss maintenance .


A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective .


Qualitative methods will be used to examine the participant experience .


The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention .


This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity ( 12months commercial referral vs. 12weeks ) leads to greater weight loss at one year and is sustained at 2years .


It will also evaluate the relative cost-effectiveness of the three interventions .


This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision .


Current Controlled Trials ISRCTN82857232 .


Date registered : 15/10/2012 .


Recent studies suggest that self-explanation ( SE ) while diagnosing cases fosters the development of clinical reasoning in medical students ; however , the conditions that optimise the impact of SE remain unknown .


The example-based learning framework justifies an exploration of students ' use of their own SEs combined with the study of examples .


This study aimed to assess the impact on medical students ' diagnostic performance of : ( i ) combining students ' SEs with their listening to examples of residents ' SEs , and ( ii ) the addition of prompts ( specific questions ) while working with examples .


This study consisted of a training phase and an assessment phase conducted 1 week later .


In the training phase , 54 Year 3 medical students were randomly assigned to one of three groups .


In all groups , students first solved four clinical cases using SE .


Subsequently , Group 1 listened to examples of residents ' SEs with prompts ; Group 2 listened to examples of residents ' SEs without prompts , and the control group solved word puzzles .


Then , all students again solved the same four cases .


One week later , all students solved four similar and four different cases .


Students ' diagnostic performance and diagnostic accuracy scores were assessed for each case at each time-point .


Although all groups ' diagnostic accuracy scores on similar cases improved significantly between the training and the assessment phase , Group 1 showed a significantly higher diagnostic performance score after 1 week than the control group ( p = 0.037 ) .


On different cases , Group 1 obtained significantly higher diagnostic accuracy ( p = 0.011 ) and diagnostic performance ( p < 0.001 ) scores than the control group and a significantly higher diagnostic performance score than Group 2 ( p = 0.018 ) .


Self-explanation seems to be an effective technique to help medical students learn clinical reasoning .


Its impact is increased significantly by combining it with examples of residents ' SEs and prompts .


Although students ' exposure to examples of clinical reasoning is important , their ` active processing ' of these examples appears to be critical to their learning from them .


To evaluate the effect of modulating pouch emptying ( PE ) and SI transit of glucose after Roux-en-Y gastric bypass ( RYGB ) on blood glucose , incretin hormones , glucose absorption and gastrointestinal ( GI ) symptoms .


Ten RYGB patients were studied twice in random order , receiving either a 150 ml glucose drink ( 200 kcal ) or the same solution infused into the proximal Roux-limb at 4 kcal/min .


Data were compared with 10 healthy volunteers who received a 4 kcal/min duodenal infusion .


PE , cecal arrival time ( CAT ) , blood glucose , plasma 3-O-methylglucose ( 3-OMG ) , insulin , glucose-dependent insulinotropic polypeptide ( GIP ) , and glucagon-like peptide-1 ( GLP-1 ) , and GI symptoms were measured .


In RYGB subjects , the glucose drink emptied very rapidly ( PE t50 = 31 min ) and intestinal glucose infusion was associated with higher blood glucose and plasma 3-OMG , but lower plasma GLP-1 , GIP , insulin , and GI symptoms than oral glucose ( all P < 0.001 ) , and comparable to volunteers .


In RYGB subjects , CAT correlated inversely with peak GLP-1 ( r = -0.73 , P = 0.01 ) , and plasma 3-OMG correlated tightly blood glucose ( r = 0.94 , P < 0.0001 ) .


After RYGB , reducing intestinal glucose delivery to 4 kcal/min is associated with higher blood glucose , greater glucose absorption , lower incretin responses , and less GI symptoms , supporting rapid transit contribution to the exaggerated incretin responses and `` dumping symptoms '' .


Vitamin A supplementation in children aged 6 months to 5 years has been shown to reduce mortality .


The efficacy of neonatal supplementation with vitamin A to reduce mortality in the first 6 months of life is plausible but not established .


We aimed to assess the efficacy of neonatal oral supplementation with vitamin A to reduce mortality between supplementation and 6 months of age .


We undertook an individually randomised , double-blind , placebo-controlled trial in Haryana , India .


We identified pregnant women through a surveillance programme undertaken every 3 months of all female residents in two districts of Haryana , India , aged 15-49 years , and screened every identified livebirth .


Eligible participants were neonates whose parents consented to participate , were likely to stay in the study area until at least 6 months of age , and were able to feed orally at the time of enrolment .


Participants were randomly assigned to receive oral capsules containing vitamin A ( retinol palmitate 50,000 IU plus vitamin E 95-126 IU ) or placebo ( vitamin E 95-126 IU ) within 72 h of birth .


Randomisation was in blocks of 20 according to a randomisation list prepared by a statistician not otherwise involved with the trial .


Investigators , participants ' families , and the data analysis team were masked to treatment allocation .


The primary outcome was mortality between supplementation and 6 months of age .


Analysis included all participants assigned to study groups .


This trial is registered with ClinicalTrials.gov , number NCT01138449 , and the Indian Council of Medical Research Clinical Trial Registry , number CTRI/2010/091 / 000220 .


Between June 24 , 2010 , and July 1 , 2012 we screened 47,777 neonates and randomly assigned 44,984 to receive vitamin A ( 22,493 ) or placebo ( 22,491 ) .


Between supplementation and 6 months of age , 656 infants died in the vitamin A group compared with 726 in the placebo group ( 292 per 1000 vs 323 per 1000 ; difference -31 per 1000 , 95 % CI -63 to 01 ; risk ratio 090 , 95 % CI 081 to 100 ) .


We noted no significant interactions between the intervention effect and sex on mortality at 6 months ( p = 0409 ) .


Supplementation with 50,000 IU vitamin A within the first 72 h of life was generally safe and well tolerated , with the exception of a small excess risk of transient bulging fontanelle ( 205 cases in the vitamin A group confirmed by physician vs 80 cases in the placebo group , risk ratio 256 [ 95 % CI 198-332 ] ) .


The findings of this study , done in a population in which vitamin A deficiency is a moderate public health problem , are consistent with a modest reduction in mortality between supplementation and 6 months of age .


These findings must be viewed together with similar trials in other populations to enable determination of appropriate public health policy .


Bill & Melinda Gates Foundation to WHO .


To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures .


This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures .


Patients were randomised using a multicentre , blinded assessor design , comparing a biodegradable stent ( BS ) with endoscopic dilatation ( ED ) .


The primary endpoint was the average dysphagia score during the first 6 mo. .


Secondary endpoints included repeat endoscopic procedures , quality of life , and adverse events .


Secondary analysis included follow-up to 12 mo. .


Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values .


Nonparametric tests were used .


Although both groups improved , the average dysphagia scores for patients receiving stents were higher after 6 mo : BS-ED 1.17 ( 95 % CI : 0.63-1 .78 ) P = 0.029 .


The finding was robust under different estimation methods .


Use of additional endoscopic procedures and quality of life ( QALY ) estimates were similar for BS and ED patients at 6 and 12 mo. .


Concomitant use of gastrointestinal prescribed medication was greater in the stent group ( BS 5.1 , ED 2.0 prescriptions ; P < 0.001 ) , as were related adverse events ( BS 1.4 , ED 0.0 events ; P = 0.024 ) .


Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment .


The oesophageal tract has somatic sensitivity and the process of the stent dissolving , possibly unevenly , might promote discomfort or reflux .


Stenting was associated with greater dysphagia , co-medication and adverse events .


Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology .


Memantine hydrochloride ( Memary ) , launched in June 2011 in Japan , is used in patients with moderate to severe Alzheimer 's disease .


We performed an integrated analysis of data obtained from different clinical studies of memantine hydrochloride conducted between 2002 and 2011 in Japan in order to examine the long-term tolerability and efficacy of this drug at a dose of 20 mg/day .


Using clinical studies of memantine hydrochloride performed in Japan between 2002 and 2011 , the therapeutic safety and the time course of MMSE scores in 702 subjects who had received memantine hydrochloride were examined .


The mean duration of memantine treatment was 798.1 days , with the longest duration of 3,373 days ( approximately nine years and two months ) .


The incidence of adverse events every 52 weeks of treatment ranged from 71.0 % to 88.9 % , and the incidence of adverse drug reactions ranged from 5.6 % to 32.1 % , with no associations between the incidence of adverse events and the treatment duration .


There were no adverse drug reactions specific to the long-term administration of this drug .


The occurrence of `` adverse events '' was the primary reason for drug discontinuation .


During the long-term study observation period , there were many cases of adverse events and treatment discontinuation due to the background factors of the subjects , including adverse events associated with aging and progression of the underlying conditions .


In addition , treatment discontinuation was also associated with admission to a nursing home or facility due to changes in home nursing care .


The degree of MMSE score reduction over time was lower in the patients treated with memantine than the expected MMSE score reduction observed in the untreated patients .


Based on these findings , there are no issues regarding the tolerability of memantine hydrochloride administered at a dose of 20 mg/day over the long term .


Considering changes in the MMSE score , the results indicated that memantine hydrochloride may inhibit worsening of the cognitive function for long periods of time in patients with Alzheimer 's disease .


Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks .


This was a 24-week extension to a randomized , 24-week , open-label , phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin .


Subjects received ITCA 650 mg ( 20 , 40 , 60 or 80 g/day ) .


Mean changes for HbA1c , weight , and fasting plasma glucose ( FPG ) were evaluated .


Mean changes in HbA1c from baseline to week 48 ranged from -0.85 % to -1.51 % .


At week 48 , 64 % of subjects with an HbA1c 7 % at week 24 maintained an HbA1c 7 % .


The incidence of adverse events ( AEs ) was dose-related and ranged from 13.3 % with 20 g/day to 37.5 % with 80 g/day .


Most AEs were mild and transient ; the incidence of nausea declined from 12.9 % to 9.5 % over the 24-week extension .


One subject on ITCA 650 80 g/day experienced mild intermittent vomiting .


Three ( 3.5 % ) subjects experienced severe AEs , but none were considered related to study drug .


Significant changes in HbA1c , body weight , and FPG attained with ITCA 650 were maintained to 48 weeks .


The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase .


Although several randomized controlled trials failed to show a benefit of B vitamin therapy on composite outcomes of cardiovascular death , myocardial infarction , and stroke among individuals with elevated homocysteine , recent post hoc analyses have suggested that several factors may interact with the effects of vitamin treatment .


One post hoc analysis revealed an interaction between B vitamin therapy and antiplatelet use ; however , those results have not been replicated in other studies or populations .


We conducted a post hoc analysis of the Vitamin Intervention for Stroke Prevention ( VISP ) trial , a randomized controlled trial evaluating treatment with high - versus low-dose B vitamin therapy for secondary prevention of vascular events among stroke survivors with elevated homocysteine .


Cox regression models were used to assess primary ( recurrent stroke ) and secondary ( stroke , myocardial infarction , or vascular death ) outcomes among individuals on high - versus low-dose vitamin therapy , categorized by antiplatelet use , after adjusting for covariates .


Among 3680 participants , 52 % took antiplatelet medications .


When compared with low-dose therapy , high-dose vitamin therapy was associated with higher stroke risk among individuals on antiplatelets ( hazard ratio , 1.43 ; 95 % confidence interval , 1.02-2 .01 ) , but trended toward lower risk among those not on antiplatelets ( hazard ratio , 0.86 ; 95 % confidence interval , 0.62-1 .19 ) .


High-dose B vitamin therapy may be associated with a higher risk of recurrent stroke among stroke survivors taking antiplatelets , but does not have a significant effect on recurrent stroke risk in those who are not on antiplatelets .


Future randomized controlled trials may consider evaluating the effect of homocysteine lowering among stroke survivors with elevated homocysteine who are not on antiplatelet therapy .


To clarify the immunogenicity and safety of influenza vaccine in patients with end-stage kidney disease ( ESKD ) on dialysis or who have received a kidney transplant .


Sixty adolescents and young adults with ESKD ( 25 on hemodialysis and 35 kidney transplant recipients ) were randomized 1:1 to receive a traditional trivalent split virion vaccine ( TIIV ) or a virosome-adjuvanted trivalent inactivated influenza vaccine ( VATIIV ) .


The immunogenicity and safety of the two vaccines was evaluated and compared with the findings observed in 30 healthy subjects of similar age and gender distribution who received TIIV .


The results indicate that the immune response of the patients to TIIV and VATIIV were similar .


The administered vaccines were safe and well tolerated , and no advantage was found with the use of VATIIV .


Given the potential clinical relevance of influenza in patients with ESKD , these findings support the official recommendation that they should receive annual influenza vaccinations .


To investigate the efficacy and safety of gemcitabine and platinum salt , with or without trastuzumab , in patients with locally advanced or metastatic urothelial carcinoma overexpressing Her2 .


The main eligibility criterion was Her2 overexpression on immunohistochemistry ( IHC 2 + or 3 + ) of primary tumour tissue confirmed by fluorescence in situ hybridisation ( FISH ) .


Patients were randomised to Arm A : gemcitabine 1000mg/m ( 2 ) ( days 1 and 8 ) plus either cisplatin ( 70mg/m ( 2 ) ) or carboplatin ( AUC = 5 ) ( day 1 every 3 weeks ) or Arm B : added trastuzumab ( 8mg/kg loading dose , then 6 mg/kg every 21 days until progression ) .


The primary end-point was progression-free survival ( PFS ) .


Among 563 screened patients , 75 ( 13.3 % ) were Her2 positive ( IHC 2 + / 3 + and FISH + ) and 61 met all eligibility criteria ( median age , 64 years ; 54/61 males ; 50/61 baseline ECOG-PS 0-1 ; 11 locally advanced and 50 metastatic ) .


There was no significant difference between Arms A and B in median PFS ( 10.2 versus 8.2 months , respectively , p = 0.689 ) , objective response rate ( 65.5 % versus 53.2 % , p = 0.39 ) , and median overall survival ( 15.7 versus 14.1 months , respectively , p = 0.684 ) .


In an exploratory analysis , trastuzumab-treated patients receiving cisplatin rather than carboplatin-based chemotherapy fared better ( PFS : 10.6 versus 8.0 ; OS : 33.1 versus 9.5 months ) .


Myelosuppression was the main grade 3/4 toxicity .


A case of grade 3 cardiotoxicity and one death from febrile neutropenia occurred in arm B.


The unexpectedly low incidence of Her2 overexpression precluded the detection of a significant difference in efficacy on addition of trastuzumab to platinum-based chemotherapy with gemcitabine .


However , the satisfactory tolerance of the combination warrants further studies , especially of the cisplatin-based combination , in well-defined patient subsets .


To investigate the therapeutic effect and biological changes of hepatic arterial infusion of p53 gene by the percutaneous port catheter system on advanced hepatocellular carcinoma ( HCC ) through a prospective randomized trial .


A total of 48 patients with advanced HCC between May 2005 and January 2009 were divided into the treatment group ( 30 ) and the control group ( 18 ) .


The port catheter system was implanted through the right external iliac artery approach in all the cases ; the target artery was determined according to the manifestation of the angiograph .


The patients in the treatment group were given arterial infusion of p53 gene ( Gendicine , Shenzhen Sibiono GeneTech Co , Ltd ) with Gendicine ( 10vp ) combined with hydroxycamptothecin ( 20 mg ) , once a week , for a course continuously for 3 weeks .


The arterial infusion with hydroxycamptothecin ( 20 mg ) was given to the patients in the control group .


Pretreatment/posttreatment a fetus protein and Karnofsky Performance Status values , change of tumor according to Response Evaluation Criteria in Solid Tumors ( RECIST ) , and the survival time were analyzed .


Pretreatment/posttreatment expression of mutant p53 gene and spontaneous micronucleus formation in the peripheral blood were evaluated by flow cytometry and micronucleus test in vivo .


The patients in the treatment group received 1 to 8 courses of treatment , in which the differences between pretreatment/posttreatment AFP and KPS values were significant ( P < 0.05 ) , whereas there was no significant difference ( P > 0.05 ) between pretreatment/posttreatment AFP and KPS values within the control group .


After 1 month , the survival rates of the treatment and control groups ( 96.6 % and 94.4 % , respectively ) and changes in the tumor evaluated according to RECIST were significantly different ( P < 0.05 ) between the 2 groups .


After 3 months , the survival rates of the treatment and control groups ( 83.3 % and 55.6 % , respectively ) and changes in the tumor were also significantly different between the 2 groups ( P < 0.05 ) .


After 6 months , the survival rates ( 50 % and 11 % , respectively ) and changes in the tumor were significantly different between the 2 groups ( P < 0.05 ) .


After 9 months , the survival rates ( 23.3 % and 0 % , respectively ) and changes in the tumor were significantly different between the 2 groups ( P < 0.05 ) .


Finally , after 12 months , the survival rates ( 6.67 % and 0 % , respectively ) and changes in the tumor were significantly different between the 2 groups ( P < 0.05 ) .


The difference between the pretreatment and posttreatment mean rates of p53 expression in patients in the treatment group was very significant ( P < 0.01 ) .


The difference between the posttreatment mean rates of the treatment group and the control group was also significant .


Sequential therapy of p53 gene transcatheter arterial infusion was safe and could prolong the survival time of the patients .


The biological study will play a positive role in guiding and monitoring the aspects of dosage selection and judgment of therapeutic efficacy .


The surgical treatment of hallux valgus deformity is connected with significant postoperative pain .


Spinal and general anesthesia as well as peripheral blocks are successfully used in foot surgery .


The purpose of this study was to evaluate the influence of local anesthetic infiltration before hallux valgus one-day surgery on postoperative pain and the need for analgesics .


134 patients underwent chevron or miniinvasive Mitchell-Kramer osteotomy of the first distal metatarsal .


After general anesthesia each patient randomly received an infiltration of 7ml of local anesthetic ( 4 ml of 0.25 % bupivacaine and 3 ml of 2 % lidocaine ) or the same amount of normal saline 15 minutes before the skin incision .


Both the patient and the surgeon were blinded .


The patient was discharged after approximately 2 hours of observation .


2 , 4 , 8 , 12 , 16 , 24 and 72 hours after the release of the tourniquet the level of pain was assessed by the visual analogue scale ( VAS ) .


Rescue analgesia , side effects and the use of painkillers were noted .


Preemptive local anesthetic infiltration significantly decreased pain during the first 24 hours after the surgery .


None of the patients from the injected group and 38 from the placebo group received 100 mg of ketoprofen intravenously for rescue analgesia in the first 2 hours after the release of the tourniquet .


During the first 24 hours we noted significantly decreased use of 1000 mg of paracetamol and 100 mg mg of ketoprofen orally in the injected group .


No systemic adverse effects were noted .


One patient from placebo group had allergic rush after use of 100 mg ketoprofen .


Preemptive local anesthetic infiltration in one-day hallux valgus surgery significantly decreases postoperative pain .


It is safe , efficient and allows fast discharge .


Trauma induces a state of immunosuppression , which is responsible for the development of nosocomial infections .


Hydrocortisone reduces the rate of pneumonia in patients with trauma .


Because alterations of dendritic cells and natural killer cells play a central role in trauma-induced immunosuppression , we investigated whether hydrocortisone modulates the dendritic cell/natural killer cell cross talk in the context of posttraumatic pneumonia .


Experimental study .


Research laboratory from an university hospital .


Bagg Albino/cJ mice ( weight , 20-24 g ) .


First , in an a priori substudy of a multicenter , randomized , double-blind , placebo-controlled trial of hydrocortisone ( 200 mg/d for 7 d ) in patients with severe trauma , we have measured the blood levels of five cytokines ( tumor necrosis factor - , interleukin-6 , interleukin-10 , interleukin-12 , interleukin-17 ) at day 1 and day 8 .


In a second step , the effects of hydrocortisone on dendritic cell/natural killer cell cross talk were studied in a mouse model of posttraumatic pneumonia .


Hydrocortisone ( 0.6 mg/mice i.p. ) was administered immediately after hemorrhage .


Twenty-four hours later , the mice were challenged with Staphylococcus aureus ( 7 10 colony-forming units ) .


Using sera collected during a multicenter study in patients with trauma , we found that hydrocortisone decreased the blood level of interleukin-10 , a cytokine centrally involved in the regulation of dendritic cell/natural killer cell cluster .


In a mouse model of trauma-hemorrhage-induced immunosuppression , splenic natural killer cells induced an interleukin-10-dependent elimination of splenic dendritic cell .


Hydrocortisone treatment reduced this suppressive function of natural killer cells and increased survival of mice with posthemorrhage pneumonia .


The reduction of the interleukin-10 level in natural killer cells by hydrocortisone was partially dependent on the up-regulation of glucocorticoid-induced tumor necrosis factor receptor-ligand ( TNFsf18 ) on dendritic cell .


These data demonstrate that trauma-induced immunosuppression is characterized by an interleukin-10-dependent elimination of dendritic cell by natural killer cells and that hydrocortisone improves outcome by limiting this immunosuppressive feedback loop .


Oral amoxicillin ( 50 mg/kg/day ) thrice daily is the first-line therapy for non-severe childhood pneumonia .


Compliance could be enhanced if two daily doses are employed .


We assessed the equivalence of oral amoxicillin ( 50 mg/kg/day ) thrice or twice daily in those patients .


This randomized ( 1:1 ) , controlled , triple-blinded investigation conducted at one centre in Brazil included children aged 2-59 months with non-severe pneumonia diagnosed by trained paediatricians based on respiratory complaints and radiographic pulmonary infiltrate/consolidation .


Participants were randomly assigned to receive one bottle ( Amoxicillin 1 ) at 6 am , 2 pm and 10 pm and the other bottle ( Amoxicillin 2 ) at 8 am and 8 pm : one bottle contained amoxicillin and the other placebo and vice versa .


Only the pharmacist knew patients ' allocation .


Follow-up assessments were done at 2 , 5 and 14 days after enrolment .


Chest radiographs were read by three independent radiologists .


Primary outcome was treatment failure ( development of danger signs , persistence of fever , tachypnoea , development of serious adverse reactions , death and withdrawal from the trial ) at 48 h. ClinicalTrials.gov : identifier NCT01200706 .


Four hundred and twelve and 408 participants received amoxicillin thrice or twice daily , respectively .


Treatment failure was detected in 94 ( 22.8 % ) and 94 ( 23.0 % ) patients in intention-to-treat analysis ( risk difference 0.2 % ; 95 % CI : -5.5 % -6.0 % ) and in 80 ( 20.1 % ) and 85 ( 21.3 % ) patients in per-protocol analysis ( risk difference 1.2 % ; 95 % CI : -4.4 % -6.8 % ) .


Pneumonia was radiologically confirmed by concordant reading in 277 ( 33.8 % ) cases , among whom treatment failure was registered in 25/133 ( 18.8 % ) and 27/144 ( 18.8 % ) participants from the thrice and twice daily doses subgroups , respectively ( risk difference -0.05 % ; 95 % CI : -9.3 % -9.2 % ) .


Oral amoxicillin ( 50 mg/kg/day ) twice daily is as efficacious as thrice daily .


Transcatheter aortic valve implantation ( TAVI ) results in the dislodgement of debris with risk of cerebral lesions or stroke .


The EMBOL-X protection device ( Edwards Lifesciences , Irvine , CA ) is positioned within the ascending aorta to capture such debris .


Between July 2012 and April 2014 we randomly assigned 30 high-risk patientsto undergo transaortic TAVI with the SAPIEN XT prosthesis ( Edwards Lifesciences ) combined with either the EMBOL-X device ( group-1 , n = 14 ) or without ( group-2 , n = 16 ) .


Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging ( DW-MRI ) at baseline and within 7 days post-procedurally .


New foci of restricted diffusion on cerebral DW-MRI were found in 69 % in group-2 and 50 % in group-1 .


Lesion size was smaller in patients treated with the EMBOL-X device than in those without ( 88 60 vs 168 217 mm ( 3 ) , p = 0.27 , t = 1.2 , degrees of freedom = 10 ) .


Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery ( 33 29 vs 76 67 mm ( 3 ) , p = 0.04 ) .


There were no neurologic events after transaortic TAVI .


The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions ( ClinicalTrials.gov number , NCT01735513 ) .


A functional polymorphism ( 5-HTTLPR ) in the promoter region of the serotonin transporter gene has been widely studied as a risk factor and moderator of treatment for a variety of psychopathologic conditions .


To evaluate whether 5-HTTLPR moderates the effects of treatment to reduce heavy drinking , we studied 112 high-functioning European-American men who have sex with men ( MSM ) .


Subjects participated in a randomized clinical trial of naltrexone ( NTX ) and cognitive behavioral therapy ( CBT ) for problem drinking .


Subjects were treated for 12 weeks with 100 mg/d of oral NTX or placebo ( PBO ) .


All participants received medical management with adjusted brief behavioral compliance enhancement treatment ( BBCET ) alone or in combination with modified behavioral self-control therapy ( MBSCT ; an amalgam of motivational interviewing and CBT ) .


Participants were genotyped for the tri-allelic 5-HTTLPR polymorphism ( i.e. , low-activity S ' or high-activity L' alleles ) .


During treatment , the number of weekly heavy drinking days ( HDD ; defined as 5 or more standard drinks per day ) was significantly lower in subjects with the L' L' ( N = 26 , p = 0.015 ) or L 'S ' ( N = 52 , p = 0.016 ) genotype than those with the S 'S ' ( N = 34 ) genotype regardless of treatment type .


There was a significant interaction of genotype with treatment : For subjects with the S 'S ' genotype , the effects of MBSCT or NTX on HDD were significantly greater than the minimal intervention ( i.e. , BBCET or PBO , p = 0.007 and p = 0.049 , respectively ) .


In contrast , for subjects with 1 or 2 L' alleles , the effects of the more intensive psychosocial treatment ( MBSCT ) or NTX did not significantly differ from BBCET or PBO .


These preliminary findings support the utility of the 5-HTTLPR polymorphism for personalizing treatment selection in problem drinkers .


Collagens have long been used in pharmaceuticals and food supplements for the improvement of skin .


We evaluated the efficacy of high advanced-collagen tripeptide ( HACP ) on wound healing and skin recovery .


Using an in vitro model , we performed HaCaT cell migration assays and collagen gel contraction assays using HACP concentrations of 1 , 10 and 100g/mL .


In this pilot study , eight healthy volunteers were randomly divided into two groups .


Both the control and experimental groups received fractional photothermolysis treatment , but in the experimental group , four subjects received 3g/day of oral collagen peptide ( CP ) for 4weeks .


To assess transepidermal water loss in each patient before and after the treatment , we used a Corneometer and a Cutometer , and we also assessed the patient 's Erythema Index .


The cell migration assay showed that HACP enhanced wound closure , but not in a dose-dependent manner .


The collagen gel contraction assay showed increased contractility when patients were treated with 100g/mL HACP , but the results were not significantly different from those of controls .


We found that post-laser erythema resolved faster in the experimental group than in the control group ( P < 0.05 ) .


In addition , the recovery of skin hydration after fractional laser treatment was greater in the experimental group than in the control group by day 3 ( P < 0.05 ) , and the experimental group showed significantly improved post-treatment skin elasticity compared with the controls by day 14 ( P < 0.05 ) .


Collagen tripeptide treatment appears to be an effective and conservative therapy for cutaneous wound healing and skin recovery after fractional photothermolysis treatment .


The natural history and manifestation of HIV-related neurologic disease have been ameliorated by combination antiretroviral therapy ( ART ) .


We describe the characteristics of white matter signal abnormalities ( WMSA ) on magnetic resonance imaging in children with HIV-related neurologic disease .


We reviewed magnetic resonance imaging scans of children with suspected HIV-related neurologic disease despite early ART and correlated with clinical , neurodevelopmental data , virologic markers and time on ART .


These children were also on the Children with HIV Early Antiretroviral ( CHER ) trial .


Magnetic resonance imaging scans were performed at a mean age 31.9 months ( range 8-54 ) on 44 children : 10 on deferred and 34 on early treatment arms , commencing ART at mean age of 18.5 and 8 weeks , respectively .


Multiple high signal intensity lesions on T2/fluid attenuated inversion recovery were documented in 22 patients ( 50 % ) , predominantly in frontal ( 91 % ) and parietal ( 82 % ) white matter .


No differences in neurodevelopmental scores comparing children with and without WMSA were found .


Neither lesion load nor distribution showed significant correlation with neurodevelopmental scores or neurologic examination .


Normal head growth was more common in the WMSA group ( P = 0.01 ) .


There was a trend for association of WMSA and longer time on ART ( P = 0.13 ) and nadir CD4 % ( P = 0.08 ) .


Half of children referred with HIV-related brain disease had WMSA on T2/fluid attenuated inversion recovery .


Our findings of the association with normal head growth and duration of ART require further study .


We suspect that WMSA can occur early and that initiating ART by 8 weeks of life may be too late to prevent HIV from entering the central nervous system .


Primaquine is the only available drug that clears mature Plasmodium falciparum gametocytes in infected human hosts , thereby preventing transmission of malaria to mosquitoes .


However , concerns about dose-dependent haemolysis in people with glucose-6-phosphate dehydrogenase ( G6PD ) deficiencies have limited its use .


We assessed the dose-response association of single-dose primaquine for gametocyte clearance and for safety in P falciparum malaria .


We undertook this randomised , double-blind , placebo-controlled trial with four parallel groups in Jinja district , eastern Uganda .


We randomly allocated Ugandan children aged 1-10 years with uncomplicated falciparum malaria and normal G6PD enzyme function to receive artemether-lumefantrine , combined with either placebo or with 0.1 mg/kg , 0.4 mg/kg , or 0.75 mg/kg ( WHO reference dose ) primaquine base .


Randomisation was done with computer-generated four-digit treatment assignment codes allocated to random dose groups in block sizes of 16 .


Study staff who provided care or assessed outcomes and the participants remained masked to the intervention group after assignment .


The primary efficacy endpoint was the non-inferiority of the mean duration of gametocyte carriage in the test doses compared with the reference group of 0.75 mg primaquine per kg , with a non-inferiority margin of 2.5 days .


The primary safety endpoint was the superiority of the arithmetic mean maximum decrease in haemoglobin concentration from enrolment to day 28 of follow-up in the primaquine treatment groups compared with placebo , with use of significance testing of pairwise comparisons with a cutoff of p = 0.05 .


The trial is registered with ClinicalTrials.gov , number NCT01365598 .


We randomly allocated 468 participants to receive artemether-lumefantrine combined with placebo ( 119 children ) or with 0.1 mg/kg ( 116 ) , 0.4 mg/kg ( 116 ) , or 0.75 mg/kg ( 117 ) primaquine base .


The mean duration of gametocyte carriage was 6.6 days ( 95 % CI 5.3-7 .8 ) in the 0.75 mg/kg reference group , 6.3 days ( 5.1-7 .5 ) in the 0.4 mg/kg primaquine group ( p = 0.74 ) , 8.0 days ( 6.6-9 .4 ) in the 0.1 mg/kg primaquine group ( p = 0.14 ) , and 12.4 days ( 9.9-15 .0 ) in the placebo group ( p < 0.0001 ) .


No children showed evidence of treatment-related haemolysis , and the mean maximum decrease in haemoglobin concentration was not associated with the dose of primaquine received-it did not differ significantly compared with placebo ( 10.7 g/L , SD 11.1 ) in the 0.1 mg/kg ( 11.4 g/L , 9.4 ; p = 0.61 ) , 0.4 mg/kg ( 11.3 g/L , 10.0 ; p = 0.67 ) , or 0.75 mg/kg ( 12.7 g/L , 8.2 ; p = 0.11 ) primaquine groups .


We conclude that 0.4 mg/kg primaquine has similar gametocytocidal efficacy to the reference 0.75 mg/kg primaquine dose , but a dose of 0.1 mg/kg was inconclusive for non-inferiority .


Our findings call for the prioritisation of further trials into the efficacy and safety of doses of primaquine between 0.1 mg/kg and 0.4 mg/kg ( including the dose of 0.25 mg/kg recently recommended by WHO ) , in view of the potential for widespread use of the drug to block malaria transmission .


Wellcome Trust and the Bill & Melinda Gates Foundation .


U.S. poison centers decrease medical visits by providing telephone advice for home management of potential poisonings , but are underutilized by low-income African-American and Latino parents , and those with limited English proficiency , due to lack of knowledge and misconceptions about poison centers .


To assess the effectiveness of a poison prevention video module in improving knowledge , behavior , and behavioral intention concerning use of poison centers in a population of low-income , language-diverse adults attending parenting courses offered by a community organization .


A randomized , blinded , controlled trial was conducted at 16 parenting course sites of a community organization and included 297 participants .


The organization 's instructors presented the video module ( intervention ) or the usual class curriculum ( control ) .


Participants completed questionnaires at baseline and a telephone interview 2-4 weeks later .


Changes from baseline to follow-up were compared between the intervention and control groups using analysis of variance and Chi-square tests .


Intervention group participants were stratified by English proficiency and compared to assess baseline and follow-up responses by language .


After the intervention , participants in the intervention group had a significantly greater increase in knowledge about the poison center , were more likely to have the correct poison center phone number at home , and had greater behavioral intention to use the poison center compared to control group participants .


At baseline , Spanish-primary-language participants with limited English proficiency had less knowledge about the poison center , were less likely to have the poison center number at home , and had lower behavioral intention to use the poison center than English proficient participants , but significantly improved after the intervention .


This video module , when presented by a community organization 's instructors , was highly effective in improving knowledge , behavior , and behavioral intention concerning use of poison centers within a low-income , language-diverse population .


To evaluate the potential benefit of systematic preoperative coronary-artery angiography followed by selective coronary-artery revascularization on the incidence of myocardial infarction ( MI ) in patients undergoing carotid endarterectomy ( CEA ) without a previous history of coronary artery disease ( CAD ) .


We randomised 426 patients who were candidates for CEA , with no history of CAD , a normal electrocardiogram ( ECG ) , and a normal cardiac ultrasound .


In group A ( n = 216 ) all patients underwent coronary angiography before CEA .


In group B ( n = 210 ) CEA was performed without coronary angiography .


Patients were not blinded for relevant assessments during follow-up .


Primary end-point was the occurrence of MI at 3.5 years .


The secondary end-point was the overall survival rate .


Median length of follow-up was 6.2 years .


In group A , coronary angiography revealed significant coronary artery stenosis in 68 patients ( 31.5 % ) .


Among them , 66 underwent percutaneous Intervention ( PCI ) prior to CEA and 2 received combined CEA and coronary-artery bypass grafting ( CABG ) .


Postoperatively , no MI was observed in group A , whereas 6 MI occurred in group B , one of which was fatal ( p = .01 ) .


During the study period , 3 MI occurred in group A ( 1.4 % ) and 33 were observed in group B ( 15.7 % ) , 6 of which were fatal .


The Cox model demonstrated a reduced risk of MI for patients in group A receiving coronary angiography ( HR , .078 ; 95 % CI , 0.024-0 .256 ; p < .001 ) .


In addition , patients with diabetes and patients < 70 years presented with an increased risk of MI .


Survival analysis at 6 years by Kaplan-Meier estimates was 95.63.2 % in Group A and 89.73.7 % in group B ( Log Rank = 6.54 , p = .01 ) .


In asymptomatic coronary-artery patients , systematic coronary angiography prior to CEA followed by selective PCI or CABG significantly reduces the incidence of late MI and increases long-term survival .


( ClinicalTrials.gov number , NCT02260453 ) .


Animal and in vitro studies suggest that volatile anaesthetics affect left atrial ( LA ) performance .


We hypothesized that human LA pump function and dimensions are altered by volatile anaesthetics in vivo .


We performed transthoracic echocardiographic ( TTE ) measurements in 59 healthy subjects ( aged 18-48 yr ) undergoing minor surgery under general anaesthesia .


The unpremedicated patients were randomly assigned to anaesthesia with sevoflurane , desflurane , or isoflurane .


TTE examinations were performed at baseline and after induction of anaesthesia and upon placement of a laryngeal mask during spontaneous breathing .


After changing to intermittent positive pressure ventilation ( IPPV ) , an additional TTE was performed .


The study focused on the velocity-time integral of late peak transmitral inflow velocity ( AVTI ) and maximum LA volume .


We found no evidence for relevant differences in the effects of the three volatile anaesthetics .


AVTI decreased significantly from 4.1 ( 1.2 ) cm at baseline to 3.2 ( 1.1 ) cm during spontaneous breathing of 1 minimum alveolar concentration of volatile anaesthetics .


AVTI decreased further to 2.8 ( 1.0 ) cm after changing to IPPV .


The maximum LA volume was 45.4 ( 18.6 ) cm ( 3 ) at baseline and remained unchanged during spontaneous breathing but decreased to 34.5 ( 16.7 ) cm ( 3 ) during IPPV .


Other parameters of LA pump function and dimensions decreased similarly .


Volatile anaesthetics reduced active LA pump function in humans in vivo .


Addition of IPPV decreased LA dimensions and further reduced LA pump function .


Effects in vivo were less pronounced than previously found in in vitro and animal studies .


Further studies are warranted to evaluate the clinical implications of these findings .


NCT0024451 .


To investigate the clinical effect of nasal packing of pulmicort respules combined withnasopore after endoscopic sinus surgery .


A total of 30 CRSwNP and CRSsNP patients with bilateral functional endoscopic sinus surgery and finished following up visit were randomly choosed , conventionally select the left nasal cavity as the experimental group , the right nasal cavity as the control group .


Experimental group to pack the nasal cavity with pulmicort respules union nasopore after surgery and control group to pack the nasal cavity with only nasopore after surgery .


The differences were observed in patients with subjective symptoms and recovery of mucosa of operative cavity between the two groups after two weeks , one month and three months .


( 1 ) The postoperative VAS symptoms score about nasal obstruction , nasal secretion , headache , dizziness and distending pain after two weeks , one month and three months in the experiment group were significantly better than those in the control group ( P < 0.05 ) .


( 2 ) The postoperative Lund-Kennedy endoscopic mucosa morphology score after two weeks , one month and three months in the experiment group were significantly better than those in the control group ( P < 0.05 ) ; ( 3 ) After three months , the experiment group had 28 cases with clinic symptoms cured ( 93.3 % ) , Total effective rate was 96.6 % ; The control group had 22 cases with clinic symptoms cured ( 73.3 % ) , total effective rate was 93.3 % .


The cure rate of the experiment group was significantly higher than the control group ( P < 0.05 ) , but there was no statistic difference between the two groups in the total effective rate ( P > 0.05 ) .


The application of nasal packing of pulmicort respules combined with nasopore after functional endoscopic sinus surgery can effectively relieve postoperative uncomfortable symptoms , promote recovery of mucosa of perative cavity , which deserves clinical promotion .


Physician recommendation is a strong predictor of colorectal cancer ( CRC ) screening adherence , but there are no sufficient data specific to primary colonoscopy screening programs .


The primary objective was to compare the effect of primary care physician 's ( PCP ) counseling with information leaflet about CRC screening on participation rate in opportunistic primary colonoscopy screening program .


Secondary objective was to determine the impact of this counseling on a decision to choose unsedated colonoscopy .


Six hundred consecutive subjects 50-65 years of age visiting PCP group practice for routine medical consultation were randomly assigned in a 1:1 ratio either to discuss CRC screening with PCP or to receive an information leaflet on CRC screening only .


The outcome measures were the participation rate and the proportion of unsedated colonoscopies assessed on subjects ' self-reports collected six months after the intervention .


Multivariate logistic regression model with backward selection was used to investigate the association between independent covariates and binary endpoints .


Participation rate was 47.0 % ( 141 subjects ) in the counseling group and 13.7 % ( 41 patients ) in the information leaflet group .


The rates of unsedated colonoscopies were 77.0 % and 39.0 % , respectively .


In a multivariate analyses , PCP 's counseling was associated with higher participation in CRC screening ( adjusted odds ratio [ OR ] 5.33 , 95 % confidence intervals [ 95 % CI ] 3.55-8 .00 ) and higher rate of unsedated colonoscopies ( OR 7.75 , 95 % CI 2.94-20 .45 ) .


In opportunistic primary colonoscopy screening , PCP 's counseling significantly increases participation rate and decreases demand for sedation compared to recruitment with information materials only .


NCT01688817 .


To compare the impact of low-grade haemorrhage on neurocognitive function in 16-year-old adolescents born preterm , by grade of intraventricular haemorrhage , and term controls .


We evaluated 338 preterm adolescents ( birth weight 600-1250g ) for intelligence , executive function and memory tasks .


Eleven had grade 3-4 haemorrhage , 44 had grade 2 , 31 had grade 1 , and 251 had no haemorrhage .


Group comparisons were made with 102 term age-matched controls , and regression models used to identify the risk that low-grade haemorrhage posed for cognitive , executive function and memory deficits .


Preterm adolescents with grade 2 haemorrhage had higher deficit rates of verbal intelligence , receptive vocabulary , phonemic fluency , cognitive flexibility and phonological fluency than preterm adolescents with grade 1 or no haemorrhage , compared with term controls .


After excluding preterm adolescents with both grade 2 haemorrhage and cystic periventricular leukomalacia , those with isolated grade 2 haemorrhage remained at greater risk of cognitive and executive function deficits than term controls and of cognitive deficits than preterm adolescents with no haemorrhage .


Our findings suggest that preterm adolescents born in the early 1990s with isolated grade 2 haemorrhage are at increased risk of learning challenges , including cognitive and executive function deficits .


A Mediterranean diet , with and without small daily amounts of red wine , and physical activity reduce the risk of cerebrovascular disease and improve cognition .


An increase in cerebral blood flow may be the underlying mechanism .


Under normal conditions , cerebral blood flow velocity changes in the internal carotid arteries and in large basal cerebral arteries correlate closely with cerebral blood flow changes , as the diameter of these vessels hardly changes and only the smaller vessels downstream change their diameter .


A prospective randomized controlled trial was performed in 108 patients with carotid atherosclerosis ( mean age 64 years , 67 % men , 66 % on statin therapy ) .


Half of them were advised to follow a polyphenol-rich modified Mediterranean diet including 1-2 tomatoes , 3-5 walnuts and a bar of dark chocolate ( 25 g ) a day and to perform moderate physical exercise for 30 min/day ( lifestyle changes ) .


Within these two groups , half of the patients were randomized either to avoid any alcohol or to drink 100 ml of red wine ( women ) or 200 ml of red wine ( men ) daily .


Bilateral middle cerebral and internal carotid blood flow velocity ( peak systolic , peak end-diastolic and mean ) was measured at baseline and after 4 and 20 weeks using colour-coded duplex ultrasound .


Insonation depth and insonation angle were used to identically place the sample volume during follow-up investigations .


A general linear model with Tukey-Kramer adjustment for multiple comparisons was used to assess the primary end points .


For the analysis we used the mean values of the right and left artery .


Neither lifestyle changes nor red wine had an effect on peak systolic , peak end-diastolic or mean cerebral blood flow velocity .


Advice on lifestyle changes , including a modified polyphenol-rich Mediterranean diet , a glass of red wine daily and physical exercise , did not affect middle cerebral and internal carotid blood flow velocity in our patient group with carotid atherosclerosis .


An increase in cerebral blood flow is thus unlikely to be the cause of the reduced risk of cerebrovascular disease and improved cognitive functioning described in the literature .


One possible explanation for the fact that blood flow velocity was not affected by red wine , diet and physical activity advice is that two thirds of our patients were already on statin therapy .


Statins increase cerebral blood flow and vasomotor reactivity via nitric oxide .


To compare the ability to successfully intubate extremely preterm baboons using conventional direct laryngoscopy ( DL ) vs videolaryngoscopy .


A prospective randomized crossover study using experienced and inexperienced neonatal intubators .


All participants were shown an educational video on intubation with each device , followed by attempt of the procedure .


The time for successful intubation was the primary outcome .


Seven subjects comprised the experienced group , while 10 individuals were in the inexperienced group .


The overall intubation success rate was comparable between both devices ( 53 % vs 26 % , P = 0.09 ) ; however , mean time to intubate with the conventional laryngoscope was faster ( 25.5 vs 39.4 s , P = 0.02 ) .


Although both groups intubated faster with DL , it only reached statistical significance in the inexperienced group ( 27.0 vs 48.7 s , P < 0.05 ) .


Conventional DL and videolaryngoscopy are suitable modes for intubating extremely preterm baboons .


Although experienced intubators prefer DL , intubation success rate and time to intubate with both devices were comparable .


In inexperienced intubators , participants preferred and intubated faster with DL .


Transluminal renal sympathetic denervation ( RDN ) has been shown to reduce blood pressure ( BP ) in patients with treatment-resistant hypertension .


We assessed the effect of multi-electrode RDN on short-term BP variability indexes in resistant hypertensives .


Thirty-one patients with drug-resistant uncontrolled hypertension , participants in the EnligHTN I study , underwent ambulatory BP measurements at baseline and 6months after RDN using the EnligHTN ablation catheter ( St. Jude Medical ) .


Twelve resistant hypertensives matched for office BP served as control group .


At 6months post-RDN , office BP and 24-hour BP were reduced by 25.6 / 10.3 mmHg and by 10.2 / 6mmHg ( p < 0.001 for all cases ) , respectively .


No significant changes were observed 6months post-RDN in standard short-term BP variability indexes including 24-hour systolic and diastolic average real variability .


The rates of systolic and diastolic 24-hour BP variation were decreased 6months after RDN , ( from 0.40 / 0.30 to 0.34 / 0.24 , p = 0.030 / 0.006 , respectively ) , especially in the responders group ( n = 23 , 74.2 % ) .


No significant differences in BP and BP variability parameters in the control group were detected .


ROC analysis revealed an area under the curve for prediction of response to RDN by systolic time rate of 66.8 % ( 95 % CI : 46.7 % to 87 % ; p = 0.16 ) and by diastolic time rate of 76.1 % ( 95 % CI : 58.2 % to 93.9 % ; p = 0.030 ) .


Although standard BP variability indexes remained unchanged , the rate of systolic and diastolic BP variation was significantly decreased 6months after RDN in patients with drug-resistant hypertension .


These novel indexes might also be useful as predictors of response .


It is a general belief among hip surgeons that minimally invasive surgical ( MIS ) approach for implantation of a total hip arthroplasty ( THA ) allows an improved and faster postoperative rehabilitation because of reduced muscle and soft-tissue damage , less postoperative pain and blood loss , and shorter hospital stay compared with conventional approaches .


In the published relative literature though , there are controversial reports and debates on this matter .


To our knowledge , there is no study on the medium-term functional results comparing MIS and traditional approaches for total hip replacement .


The purpose of this prospective comparative controlled study was to compare MIS with conventional approach , on terms of pain , blood loss , and functional recovery over a follow-up period of 4 years .


In a total of 90 consecutive randomly selected adult patients , who suffered from unilateral primary hip osteoarthritis , a cementless Zweymller-Plus THA ( SL-Plus stem , Bicon screw socket ) was implanted by a single senior orthopedic hip surgeon in one institution in the same period .


Forty-five patients ( group A ) were operated using an MIS anterolateral , short incision , muscle-sparing approach and 45 ( group B ) with a conventional ( anterolateral modified Watson-Jones ) approach under partial detachment of gluteus medius and minimus .


Anthropometric data , blood loss , short-form 36 questionnaire , visual analog scale pain score , and walking endurance were included in the analysis .


Approach-related surgical complications ( trochanter major fracture , Bicon malposition ) were recorded .


Data were collected postoperatively and at 4-year follow-up .


Two patients of group A and eight patients of group B were excluded from the final analysis .


Thus , 80 patients were eligible for the final evaluation 4 years postoperatively .


Postoperative pain score was less in the MIS group .


However , no differences in perioperative blood loss , functional outcome , and walking endurance were shown between groups .


No difference in Bicon cup implantation angle was measured in postoperative roentgenograms between group A and B patients , no intraoperative trochanter fracture occurred in any patient of both groups .


The present prospective randomized study revealed no significant mid-term clinical and functional benefit for patients who underwent a THA through an MIS in comparison with those who were managed with a conventional open approach .


Paper questionnaires are a common means to collect self-reported information in population-based epidemiological studies .


Over the past decades , the response rates to epidemiological studies have been decreasing which can affect the selection process of eligible subjects and lead to non-response bias .


Hence , research into strategies to increase questionnaire response rates is crucial .


The aim of this study was therefore to explore the effectiveness of single-sided questionnaires and an internet option for response in increasing response rates to a population-based study .


A 2 2 factorial experiment was embedded within a large population-based study of pain and pain management .


Persons in the study sample were 4600 residents in Grampian ( north of Scotland ) aged 25 years and over who were randomly selected from health board records .


Sampled persons were randomly assigned to either receive a single-sided or double-sided questionnaire with or without an internet option to respond .


The study questionnaire was distributed via post .


The overall study response rate was 36.3 % .


When compared to the reference group that received no intervention ( response rate = 35.5 % ) , the response rate changed only marginally when single-sided questionnaires were distributed ( 35.8 % ) or when an option to reply via the internet was provided ( 34.3 % ) .


A somewhat higher increase in response rates was achieved when both strategies were employed ( 39.6 % ) .


Overall , no significant effect on response rate was determined for each strategy or their interaction .


Evidence from this study suggests that neither single-sided questionnaires nor the option to reply via the internet resulted in a significant increase in response rates to population-based studies .


In an attempt to shed light on management of chronic pain conditions , there has long been a desire to complement behavioral measures of pain perception with measures of underlying brain mechanisms .


Using functional magnetic resonance imaging ( fMRI ) , we undertook this study to investigate changes in brain activity following the administration of naproxen or placebo in patients with pain related to osteoarthritis ( OA ) of the carpometacarpal ( CMC ) joint .


A placebo-controlled , double-blind , 2-period crossover study was performed in 19 individuals with painful OA of the CMC joint of the right hand .


Following placebo or naproxen treatment periods , a functionally relevant task was performed , and behavioral measures of the pain experience were collected in identical fMRI examinations .


Voxelwise and a priori region of interest analyses were performed to detect between-period differences in brain activity .


Significant reductions in brain activity following treatment with naproxen , compared to placebo , were observed in brain regions commonly associated with pain perception , including the bilateral primary somatosensory cortex , thalamus , and amygdala .


Significant relationships between changes in perceived pain intensity and changes in brain activity were also observed in brain regions previously associated with pain intensity .


This study demonstrates the sensitivity of fMRI to detect the mechanisms underlying treatments of known efficacy .


The data illustrate the enticing potential of fMRI as an adjunct to self-report for detecting early signals of efficacy of novel therapies , both pharmacologic and nonpharmacologic , in small numbers of individuals with persistent pain .


Lercanidipine hydrochloride and felodipine sustained-release tablets comparison for the treatment of patients with mild-to-moderate primary hypertension .


The study was designed as a multicenter , randomized , open-label , parallel-group clinical trial .


A total of 281 adult patients ( 18-75 years ) with a mild-to-moderate primary hypertension diagnosis were randomly assigned , in a 1:1 ratio , to lercanidipine hydrochloride ( n = 139 ; 81 males ) or felodipine sustained-release tablets ( n = 142 ; 87 males ) .


Study duration was 8 weeks , including two run-in weeks and 6 weeks of treatment .


The mean seated diastolic blood pressure ( BP ) change from baseline to 6 weeks of treatment was the primary endpoint .


Main secondary efficacy parameters were : ( i ) mean seated systolic BP change from baseline to 6 weeks of treatment ; ( ii ) normalization BP rate .


The incidence of adverse events was also considered .


BP monitoring showed a significant decrease compared with baseline in diastolic BP ( lercanidipine : from 964 to 836mmHg , p < 0.0001 ; felodipine : from 964 to 825mmHg , p < 0.0001 ) .


The mean systolic BP decreased , when compared with baseline values , by 18mmHg and 19mmHg in the lercanidipine and felodipine arm , respectively ( p < 0.0001 versus baseline for both comparisons ) .


The normalization rates of BP were 79.5 % and 87.2 % , in the lercanidipine and felodipine groups , respectively ( in-office monitoring ; p = n.s. ) .


In total , 73 patients experienced 103 AEs : 26.6 % ( 37/139 ) in the lercanidipine group and 25.3 % ( 36/142 ) in the felodipine arm ( p = n.s. ) .


The analysis of safety showed no unexpected adverse events .


Although the overall short follow-up of the present study should be taken into account , lercanidipine is an effective and safe treatment option for BP control in adult patients with mild-to-moderate primary hypertension .


There is evidence of a possible relationship between Archaea and periodontal disease ; however , to date few studies have assessed the changes in prevalence of this domain after periodontal therapy .


The aim of this randomized double-blind and placebo-controlled study was to assess if periodontal treatment with or without systemic antibiotic would change the prevalence of Archaea after periodontal therapy .


Thirty subjects were randomly assigned to receive scaling and root planing ( SRP ) alone or combined with metronidazole ( MTZ ) + amoxicillin ( AMX ) for 14days .


Clinical and microbiological examinations were performed at baseline and at six months post-SRP .


Nine subgingival plaque samples per subject were analysed for the presence of Archaea .


SRP alone or combined with MTZ + AMX significantly reduced the prevalence of subjects colonized by Archaea at six months post-therapy .


However , no significant differences between treatment groups were observed ( p > 0.05 ) .


Both therapies led to a statistically significant decrease in the mean percentage of sites colonized by Archaea ( p < 0.05 ) .


A negative Spearman correlation was observed between the presence of Archaea and the mean clinical attachment gain at six months post-therapy ( r ( 2 ) = -0.61 ; 95 % CI -0.80 - -0.31 ; p = 0.003 ) .


SRP alone or combined with MTZ + AMX provides a similar reduction in the prevalence of Archaea in the subgingival biofilm of subjects with generalized aggressive periodontitis .


To evaluate Medical Reserve Corps volunteers and public health workers in conducting chronic care triage by use of a rubric prior to sheltering to connect survivors with services .


Participants were randomly assigned to 1 of 3 algorithms or a control group during a simulated disaster scenario and were asked to rate 20 survivors arriving at a chronic care triage station with situation-appropriate transport services .


Survivors were simulated on the basis of the expected disability distributions of mobility , sensory-visual , cognition , medical devices , capacity to perform activities of daily living ( ADLs ) , age ( 18 to 90 years ) , weight , and gender expected in the general population but expanded to 90 % of those presenting .


Mean percentage correct scores were assessed by using one-way analysis of variance .


Accounting for personal care assistance and service methodology during chronic care triage increased efficiency by up to 8 % in meeting chronic care health service needs during disaster community mass care management .


A chronic care triage process as part of community mass care management that considers the availability of personal care assistance and service methodology will enhance the allocation of functional needs support services and increase compliance with Americans with Disabilities Act requirements regarding not segregating persons because of disability .


( Disaster Med Public Health Preparedness .


2015 ; 9:265 -274 ) .


Testosterone use in older men is increasing , but its long-term effects on progression of atherosclerosis are unknown .


To determine the effect of testosterone administration on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels .


Testosterone 's Effects on Atherosclerosis Progression in Aging Men ( TEAAM ) was a placebo-controlled , double-blind , parallel-group randomized trial involving 308 men 60 years or older with low or low-normal testosterone levels ( 100-400 ng/dL ; free testosterone < 50 pg/mL ) , recruited at 3 US centers .


Recruitment took place between September 2004 and February 2009 ; the last participant completed the study in May 2012 .


One hundred fifty-six participants were randomized to receive 7.5 g of 1 % testosterone and 152 were randomized to receive placebo gel packets daily for 3 years .


The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL .


Coprimary outcomes included common carotid artery intima-media thickness and coronary artery calcium ; secondary outcomes included sexual function and health-related quality of life .


Baseline characteristics were similar between groups : patients were a mean age of 67.6 years ; 42 % had hypertension ; 15 % , diabetes ; 15 % , cardiovascular disease ; and 27 % , obesity .


The rate of change in intima-media thickness was 0.010 mm/year in the placebo group and 0.012 mm/year in the testosterone group ( mean difference adjusted for age and trial site , 0.0002 mm/year ; 95 % CI , -0.003 to 0.003 , P = .89 ) .


The rate of change in the coronary artery calcium score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group ( adjusted mean difference , -10.8 Agatston units/year ; 95 % CI , -45.7 to 24.2 ; P = .54 ) .


Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone .


Sexual desire , erectile function , overall sexual function scores , partner intimacy , and health-related quality of life did not differ significantly between groups .


Hematocrit and prostate-specific antigen levels increased more in testosterone group .


Among older men with low or low-normal testosterone levels , testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life .


Because this trial was only powered to evaluate atherosclerosis progression , these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men .


clinicaltrials.gov Identifier : NCT00287586 .


Ulinastatin , a serine protease inhibitor , inhibits several pro-inflammatory proteases and decreases inflammatory cytokine levels and mortality in experimental sepsis .


We studied the effect of ulinastatin on 28-day all-cause mortality in a double-blind trial in patients with severe sepsis in seven Indian hospitals .


Patients with sepsis were randomized within 48 h of onset of one or more organ failures to receive intravenous administration of ulinastatin ( 200,000 IU ) or placebo 12 hourly for 5 days .


Of 122 randomized subjects , 114 completed the study ( 55 receiving ulinastatin , 59 receiving placebo ) .


At baseline , the mean APACHE II score was 13.4 ( SD = 4.4 ) , 48 ( 42 % ) patients were receiving mechanical ventilation , 58 ( 51 % ) were on vasopressors , and 35 % had multiple organ failure .


In the modified intention-to-treat analysis ( patients receiving six or more doses of study drugs ) , 28-day all-cause mortality was 7.3 % with ulinastatin ( 4 deaths ) versus 20.3 % ( 12 deaths ) with placebo ( p = 0.045 ) .


On multivariate analysis too , treatment with ulinastatin ( odds ratio 0.26 , 95 % CI 0.07-0 .95 ; p = 0.042 ) independently decreased 28-day all-cause mortality .


However , the mortality difference did not reach statistical significance in the intention-to-treat analysis [ 10.2 % ( 6/59 deaths ) with ulinastatin versus 20.6 % ( 13/63 deaths ) in the placebo group ; p = 0.11 ] .


The ulinastatin group had lower incidence of new-onset organ failure ( 10 vs. 26 patients , p = 0.003 ) , more ventilator-free days ( mean SD 19.4 10.6 days vs. 10.2 12.5 days , p = 0.019 ) , and shorter hospital stay ( 11.8 7.1 days vs. 24.2 7.2 days , p < 0.001 ) .


In this pilot study , intravenous administration of ulinastatin reduced mortality in patients with severe sepsis in the modified intention-to-treat analysis , but not in the intention-to-treat analysis .


Although robotic surgery decreases pain compared to laparotomy , postoperative pain can be a concern near the site of a larger assistant trocar site .


The aim of this study was to determine the efficacy of transversus abdominis plane ( TAP ) block on 24-hour postoperative opiate use after robotic surgery for gynecologic cancer .


Sixty-four subjects with gynecologic malignancies who were scheduled to undergo robotic surgery were enrolled into the study .


They were randomized to receive a unilateral TAP block to the side of the assistant port via ultrasound guidance .


The block was comprised of 30 cc of 0.25 % bupivacaine with 3 mcg/mL epinephrine or saline .


Opiate use was measured and converted into IV morphine equivalents .


Patient-reported pain was measured using the Brief Pain Inventory ( BPI ) and Visual Analog Scale ( VAS ) .


The treatment group used a mean of 64.9 mg morphine in the first 24h compared to 69.3 mg for controls ( primary outcome , p = 0.52 ) .


After age-adjustment , the treatment group used a mean of 11.1 mg morphine less than controls ( p = 0.09 ) .


Postoperative pain scores assessed by the BPI ( 6.44 vs. 6.97 , p = 0.37 ) and the VAS ( 3.12 vs. 3.61 , p = 0.30 ) were equivalent .


Block placement was uncomplicated in 98.4 % of participants with mean BMI of 35.3 kg/m ( 2 ) .


Linear regression revealed an approximate 8.1 mg decrease in morphine equivalents used per additional decade of life ( p = 0.0008 ) .


There was a positive correlation between the amount of opiates and BMI with an additional 8.8 mg of morphine per 10 kg/m ( 2 ) increase in BMI ( p = 0.0012 ) .


TAP block is safe and feasible in this patient population with a large proportion of morbid obesity .


Preoperative TAP block does not significantly decrease opiate use .


However ; based on these data , a clinically useful nomogram has been created to aid clinicians in postoperative opiate-dosing for patients based on age and BMI .


Air ambulances provide patients with timely access to referral centers .


Nonemergent transfers are planned for efficient aircraft use .


This study compares a novel flight planning optimization application to traditional planning methods .


This prospective study compared real-world use of the application to traditional methods in a large air medical system .


Each day was randomized to application use or manual methods .


Descriptive statistics compared the resulting schedules through ratios of distance flown and cost to minimum distance required .


Manual methods were used on 33 days to plan 479 requests , yielding 181 flights , 856 flying hours , and 289,627 km flown .


Ratios of distance flown and cost were 1.47 km flown and $ 4.98 per km required .


The application was used on 25 days to plan 360 requests , yielding 146 flights , 639 flying hours , and 216,944 km flown .


The corresponding ratios were 1.4 km flown and $ 4.65 per km required .


The average distance flown per distance required decreased by 5 % ( P = .07 ) , and the average cost per average required distance decreased by 7 % ( P = .03 ) when using the application .


Prospective , real-world use of the application results in efficiencies when planning nonurgent patient transfers .


Additional savings may be possible through further application refinements .


The aim of this study was to assess the efficacy and safety of ivabradine ( Iva ) noninferiority to atenolol ( Aten ) in Chinese patients with chronic stable angina pectoris .


In this double-blind , double-dummy trial , patients with symptomatic angina pectoris and positive exercise tolerance test were randomized into the Iva [ 5 or 7.5 mg bis in die ( BID ) ] or Aten group ( 12.5 or 25mg BID ) according to computer-generated random numbers for 12weeks .


One hundred and sixty-eight patients were randomized to the Iva group and 166 to the Aten group .


In a full analysis set , increases in the total exercise duration ( TED ) were 54.3120.1 seconds with Iva 5mg and 58.8114.7 seconds with Aten 12.5 mg at the fourth week , and at the 12th week , TED improved by 84.1130.5 seconds with Iva and 77.8126.6 seconds with Aten ( 95 % CI : -21.4 -34.1 seconds , p = 0.0011 for noninferiority ) .


The analysis of per protocol set yielded similar results ( 95 % CI : -31.4 -33.0 seconds , p = 0.0131 for noninferiority ) .


Heart rate was reduced in both groups at rest and during peak exercise .


There were small , nonsignificant differences in the number of adverse events between the two groups ( 66 in Iva and 73 in Aten , p > 0.05 ) .


Nine patients ( 5.42 % ) were reported to develop phosphenes/luminous phenomena and blurred vision in the Iva group ( p = 0.0035 ) .


Iva is effective in reducing heart rates and improving exercise capacity and noninferior to Aten in Chinese patients with chronic stable angina pectoris .


Iva is well tolerated and safe .


To investigate the effect of topical glucose on visual parameters in individuals with primary open-angle glaucoma ( POAG ) .


Double-blind , randomized , crossover study .


Nondiabetic pseudophakic patients with definite POAG were recruited ; 29 eyes of 16 individuals participated in study 1 .


A follow-up study ( study 2 ) included 14 eyes of 7 individuals .


Eyes were randomly allocated to receive 50 % glucose or saline eye drops every 5 minutes for 60 minutes .


The contrast sensitivity and best-corrected logarithm of the minimum angle of resolution ( logMAR ) .


The 50 % glucose reached the vitreous in pseudophakic but not phakic individuals .


Glucose significantly improved the mean contrast sensitivity at 12 cycles/degree compared with 0.9 % saline by 0.26 log units ( 95 % confidence interval [ CI ] , 0.13-0 .38 ; P < 0.001 ) and 0.40 log units ( 95 % CI , 0.17-0 .60 ; P < 0.001 ) in the follow-up study .


The intraocular pressure , refraction , and central corneal thickness were not affected by glucose ; age was not a significant predictor of the response .


Topical glucose temporarily improves psychophysical visual parameters in some individuals with POAG , suggesting that neuronal energy substrate delivery to the vitreous reservoir may recover function of `` sick '' retinal neurons .


The CAPRISA 004 trial showed that coitally dosed tenofovir 1 % gel reduced HIV acquisition by 39 % overall and 54 % when used consistently .


The objective of this analysis was to ascertain its pharmacokinetic-pharmacodynamic relationship to protect against HIV acquisition .


Genital and systemic tenofovir concentrations in 34 women who acquired HIV ( cases ) were compared with 302 randomly selected women who remained HIV uninfected ( controls ) during the CAPRISA 004 trial .


In total , 336 cervicovaginal fluid ( CVF ) , 55 plasma , and 23 paired cervical and vaginal tissue samples were assayed by validated methods for tenofovir and tenofovir diphosphate ( tenofovir-DP ) detection .


Tenofovir was detected in the genital tract in 8 ( 23.5 % ) cases and 119 ( 39.4 % ) controls ( P = 0.076 ) .


Among those with detectable genital tract tenofovir , the median CVF concentrations were 97 % lower in cases compared with controls , 476 versus 13,821 ng/mL ( P = 0.107 ) .


A total of 14.7 % ( 5/34 ) of cases and 32.8 % ( 99/302 ) of controls were found to have tenofovir CVF concentrations above 100 ng/mL [ odds ratio ( OR ) : 0.35 , P = 0.037 ] .


At a higher threshold , 8.8 % ( 3/34 ) of cases and 26.2 % ( 79/302 ) of controls were found to have tenofovir CVF concentrations above 1000 ng/mL ( OR : 0.27 , P = 0.036 ) .


Plasma tenofovir concentrations were < 1 ng/mL in all women and were detected only in controls ( 16.7 % ) and not in cases ( 0 % ) , ( P = 0.031 ) .


Returned used tenofovir gel applicators and CVF concentrations were correlated ( Spearman r = 0.22 , P = 0.001 ) .


A tenofovir concentration of 100 ng/mL in CVF was associated with 65 % ( 95 % CI : 6 % to 87 % ) protection against HIV , whereas a 1000 ng/mL concentration correlated with 76 % ( 95 % CI : 8 % to 92 % ) protection against HIV infection .


To compare effects of 2 acetylcholinesterase inhibitors on recovery quality of horses anesthetized with isoflurane .


6 horses in phase 1 , 7 horses in phase 2A , and 14 horses in phase 2B .


The study comprised 3 phases ( 2 randomized , blinded crossover phases in horses undergoing orthopedic procedures and 1 prospective dose-determining phase ) .


In phase 1 , horses were anesthetized with isoflurane and received neostigmine or saline ( 0.9 % NaCl ) solution prior to anesthetic recovery .


Phase 2A was a physostigmine dose-determining phase .


In phase 2B , horses were anesthetized with isoflurane and received neostigmine or physostigmine prior to recovery .


Objective recovery events were recorded and subjective visual analogue scale scores of recovery quality were assigned from video recordings .


Recovery measures in phase 1 were not different between horses receiving neostigmine or saline solution .


In phase 2A , 0.04 mg of physostigmine/kg was the highest cumulative dose that did not cause clinically relevant adverse behavioral or gastrointestinal effects .


Horses receiving physostigmine had higher mean SD visual analogue scale recovery scores ( 70.8 13.3 mm ) than did horses receiving neostigmine ( 62.4 12.8 mm ) in phase 2B , with fewer attempts until sternal and standing recovery .


Incidence of colic behavior did not differ among groups .


Inhibition with physostigmine improved anesthetic recovery quality in horses anesthetized with isoflurane , compared with recovery quality for horses receiving neostigmine .


Inhibition of central muscarinic receptors by inhalation anesthetics may underlie emergence delirium in horses recovering from anesthesia .


The purpose of this study is to test the feasibility of conducting a community-based randomized controlled trial evaluating a culturally tailored community-based group diabetes self-management education ( DSME ) program among rural African Americans .


Thirty-two African American rural adults with type 2 diabetes were recruited and 25 adults were retained and participated in an interventional study designed to test the effectiveness of the `` Taking Care of Sugar '' DSME program for the 2-year follow-up .


Participants were selected from rural central Virginia .


Primary outcomes variables included average blood sugar levels , cardiovascular risk factors , and general physical and mental health .


These outcomes were assessed at baseline , 3 months , 6 months , and 12 months post baseline .


From baseline to 3-month follow-up assessment , participants exhibited significant improvement on several physiological and behavioral measures .


Given the small sample size , hypothesis testing was limited .


Results show change from baseline over time , illustrating that the primary outcome of A1C decreased , although not significant .


Additionally , participants reported more knowledge about diabetes self-management and personal care skills ( ie , exercise and foot care ) that persisted over time .


The feasibility of the culturally tailored DSME was established , and participation with the program was high .


A community-based group DSME program using storytelling is feasible .


This research will help to inform clinicians and health policymakers as to the types of interventions that are feasible in a larger rural population .


If such a program is carried out , we can improve knowledge , reduce complications , and improve quality of life among rural African Americans .


The aim of this study was to evaluate the treatment results of the application of nitric oxide ( NO ) in the form of topical glyceryl trinitrate ( GTN ) for the treatment of lateral epicondylitis ( LE ) .


The study included 40 patients with LE randomized into 2 equal groups .


Selection criteria included the presence of pain , tenderness , and positive pain stimulating maneuvers .


Glyceryl trinitrate patches were applied to the area of maximal tenderness once a day in the treatment group and placebo patches in the control group .


Outcomes in terms of pain relief was assessed using the visual analog scale ( VAS ) and were evaluated according to the criteria of Verhaar et al. .


Excellent or good results were considered successful .


Differences in VAS scores between the two groups were calculated using the Mann-Whitney U-test and the chi-square test was used to investigate distributions of categorical variables ( sex , affected side ) and good and excellent results among groups .


There were no significant differences in any of the baseline clinical parameters between groups .


At the 3rd week follow-up , there were statistically significant differences in the pain measured using VAS between groups ( mean VAS score of the control and treatment groups were 6.45 and 3.15 , respectively ) ( p = 0.001 ) .


Patients in the GTN group and control group had lower VAS pain scores and reduced elbow pain at 3 weeks ( 3.15 vs 8.05 in the GTN and 6.45 vs 8.80 in the control group ) .


In the control group , no patient had excellent or good results while 18 ( 90 % ) patients in treatment group reported successful treatment .


There was statistically significant difference in the VAS measured at 6 months between groups ( mean VAS score of the control and treatment groups were 4.85 and 0.70 , respectively ) ( p = 0.001 ) .


The administration of NO directly over an area of tendinopathy through a GTN patch reduces pain and other symptoms in chronic LE .


CD4 count is a proxy for the extent of immune deficiency and declines in CD4 count are a measure of disease progression .


Decline in CD4 count is an important component : for estimating benefits of ARV treatment ; for individual level counselling on the rapidity of untreated disease progression and prognosis ; and can be used in planning demand for health services .


Our objective is to report CD4 decline and changes in viral load ( VL ) in a group of HIV-infected adults enrolled in a randomized trial of preventive treatment for TB in South Africa where clade C infection predominates .


HIV-infected , tuberculin skin test positive adults who were not eligible for antiretroviral ( ARV ) treatment were randomized to a trial of preventive treatment from 2003-2005 .


VL and CD4 count were assessed at enrollment and CD4 counts repeated at least annually .


During follow-up , individuals whose CD4 counts decreased to < 200 cells/mm ( 3 ) were referred for antiretroviral therapy ( ART ) and were analytically censored .


1106 ARV nave adults were enrolled .


Their median age was 30 years and male to female ratio was 1:5 .


Median baseline CD4 count was 490 cells/mm ( 3 ) ( IQR 351-675 ) .


The overall mean decline in CD4 count was 3.2 cells/mm ( 3 ) per annum [ corrected ] .


Adjusting for age , gender , baseline hemoglobin , smoking and alcohol use had little impact on the estimate of CD4 decline .


However , VL at baseline had a major impact on CD4 decline .


The percent decline in CD4 count was 13.3 % ( 95 % CI 12.0 % , 14.7 % ) , 10.6 % ( 95 % CI 8.8 % , 12.4 % ) , and 13.8 % ( 95 % CI 12.1 % , 15.5 % ) per annum for baseline VLs of < 10,000 ( N = 314 ) , 10,001-100 ,000 ( N = 338 ) , > 100,000 ( N = 122 ) copies/ml .


Our data suggests that six and a half years will elapse for an individual 's CD4 count to decline from 750 to 350 cells/mm3 in the absence of ART .


HLA-haploidentical hematopoietic stem cell transplantation ( HSCT ) is suitable for patients lacking related or unrelated HLA-matched donors .


Herein , we investigated whether plerixafor ( MZ ) , as an adjunct to G-CSF , facilitated the collection of mega-doses of hematopoietic stem cells ( HSC ) for TCR - / CD19-depleted haploidentical HSCT , and how this agent affects the cellular graft composition .


Ninety healthy donors were evaluated .


Single-dose MZ was given to 30 ` poor mobilizers ' ( PM ) failing to attain 40 CD34 + HSCs/L after 4 daily G-CSF doses and/or with predicted apheresis yields 12.0 x106 CD34 + cells/kg recipient 's body weight .


MZ significantly increased CD34 + counts in PM .


Nave/memory T and B cells , as well as natural killer ( NK ) cells , myeloid/plasmacytoid dendritic cells ( DCs ) , were unchanged compared with baseline .


MZ did not further promote the G-CSF-induced mobilization of CD16 + monocytes and the down-regulation of IFN - production by T cells .


HSC grafts harvested after G-CSF + MZ were enriched in myeloid and plasmacytoid DCs , but contained low numbers of pro-inflammatory 6-sulfo-LacNAc + ( Slan ) - DCs .


Finally , children transplanted with G-CSF + MZ-mobilized grafts received greater numbers of monocytes , myeloid and plasmacytoid DCs , but lower numbers of NK cells , NK-like T cells and Slan-DCs .


MZ facilitates the collection of mega-doses of CD34 + HSCs for haploidentical HSCT , while affecting graft composition .


To examine the hypothesis that improving insulin sensitivity improves vascular function in rheumatoid arthritis ( RA ) .


We performed a 20-week , single center , randomized , double-blind , placebo-controlled crossover study .


Patients with RA ( n = 34 ) with moderate disease activity who were receiving stable disease-modifying antirheumatic drug therapy were randomized to drug sequence , receiving either pioglitazone 45 mg/day or matching placebo for 8 weeks , followed by a 4-week washout period and the alternative treatment for 8 weeks .


We measured changes in vascular stiffness ( augmentation index and aortic pulse wave velocity [ PWV ] ) , endothelial function ( reactive hyperemia index ) , and blood pressure .


High-sensitivity C-reactive protein levels and the homeostatic model assessment of insulin resistance were also measured .


The treatment effect of pioglitazone on outcomes was analyzed using linear mixed-effects models .


Pioglitazone treatment resulted in a change in augmentation index of -4.7 % units ( 95 % confidence interval [ 95 % CI ] -7.9 , -1.5 ) ( P = 0.004 ) and in diastolic blood pressure of -3.0 mm Hg ( 95 % CI -5.7 , -0.2 ) ( P = 0.03 ) , but did not significantly change aortic PWV ( P = 0.33 ) or reactive hyperemia index ( P = 0.46 ) .


The improvements in augmentation index and diastolic blood pressure were not mediated by the effect of pioglitazone on insulin resistance or inflammation .


Our findings indicate that pioglitazone improves some indices of vascular function , including augmentation index and diastolic blood pressure , in patients with RA .


This is not mediated by improved insulin sensitivity .


Multiple sclerosis ( MS ) is a chronic autoimmune disease that can deteriorate cognitive function in at least 50 % of patients even in the early stages .


We conducted a three-arm parallel study with balanced randomization to evaluate the effect of various disease-modifying therapies ( DMTs ) on cognitive function in MS.


Ninety newly diagnosed , definite MS subjects referred to Ghaem Medical Center , Mashhad , Iran , were enrolled into this study between 2006 and 2009 .


They were randomly categorized into three DMT groups ; Avonex , Rebif and Betaferon .


Cognition status was assessed in MS patients at baseline and 12 months after treatment with DMTs using the 5 tests of the Brief Repeatable Battery of Neuropsychological Tests ( BRB-N ) .


The Symbol Digit Modalities Test scores improved in all groups at 12 month vs. baseline ( Avonex : 34.50 vs. 38.95 , p = 0.011 ; Rebif : 35.30 vs. 40.13 , p = 0.001 ; Betaferon : 26.18 vs. 29.32 , p = 0.029 ) .


The Selective Reminding Test ( SRT ) - Total , the 10/36-Delay , and the Paced Auditory Serial Addition Test-Easy were improved in Avonex and Rebif but not in Betaferon group .


The SRT-Delay and Word List Generation were improved only in the Avonex group .


There was no significant difference in other components of the BRB-N among these three treatment groups .


Different types of DMTs may improve some aspects of cognitive function in patients with MS. Treatment with Avonex and Rebif ( Interferon beta-1a preparations ) were more helpful in resolving the cognitive impairments in MS patients compared to Betaferon ( Interferon beta-1b ) as investigated in this study .


To compare the efficacy differences of electroacupuncture ( EA ) with intermittent wave , disperse-dense wave and continuous wave combined with rehabilitation therapy for post-stroke shoulder subluxation in order to provide clinical evidence for selection of electroacupuncture wave .


Seventy-five cases of shoulder subluxation were randomly divided into an intermittent wave ( IW ) group , a disperse-dense wave ( DW ) group and a continuous wave ( CW ) group , 25 cases in each one .


Based on regular treatment including blood pressure and sugar control , EA and rehabilitation therapy were given in three groups .


With EA at Jianqian ( Extra ) , Taijian ( Extra ) , Binao ( LI 14 ) , Jianzhong ( Extra ) , Jianzhen ( SI 9 ) , Naoshu ( SI 10 ) , Jianwaishu ( SI 14 ) and Bingfeng ( SI 12 ) , IW group was treated with intermittent wave with a frequency of 15 Hz , DW group was treated with disperse-dense wave with a frequency of 2 Hz/15 Hz and CW group was treated with continuous wave with a frequency of 15 Hz .


The EA treatment was given for 20 min , once a day , six times a week and totally for 4 weeks .


The Fugl-Meyer score and Barthel index score were used for assessment of function recovery before and after treatment respectively , also the efficacy of three groups was compared .


The total effective rate was 96.0 % ( 24/25 ) in the IW group , which was superior to 68.0 % ( 17 / 25 ) in the DW group and 64.0 % ( 16/25 ) in the CW group ( both P < 0.05 ) .


After the treatment , Fugl-Meyer score and Barthel index score in the three groups were obviously improved ( all P < 0.05 ) , which was most significant in the IW group ( all P < 0.01 ) .


Electroacupuncture with intermittent wave combined with rehabilitation therapy has superior effect to disperse-dense wave and continuous wave on the treatment of post-stroke shoulder subluxation , which could effectively improve shoulder subluxation and promote shoulder function recovery .


This research evaluates the impact of the achievement of an intermediate target glycemic band on the severity of organ failure and mortality .


Daily Sequential Organ Failure Assessment ( SOFA ) score and the cumulative time in a 4.0 to 7.0 mmol/L band ( cTIB ) were evaluated daily up to 14 days in 704 participants of the multicentre Glucontrol trial ( 16 centers ) that randomized patients to intensive group A ( blood glucose [ BG ] target : 4.4-6 .1 mmol/L ) or conventional group B ( BG target : 7.8-10 .0 mmol/L ) .


Sequential Organ Failure Assessment evolution was measured by percentage of patients with SOFA less than or equal to 5 on each day , percentage of individual organ failures , and percentage of organ failure-free days .


Conditional and joint probability analysis of SOFA and cTIB 0.5 or more assessed the impact of achieving 4.0 to 7.0 mmol/L target glycemic range on organ failure .


Odds ratios ( OR ) compare the odds risk of death for cTIB 0.5 or more vs cTIB less than 0.5 , where a ratio greater than 1.0 indicates an improvement for achieving cTIB 0.5 or more independent of SOFA or glycemic target .


Groups A and B were matched for demographic and severity of illness data .


Blood glucose differed between groups A and B ( P < .05 ) , as expected .


There was no difference in the percentage of patients with SOFA less than or equal to 5 , individual organ failures , and organ failure-free days between groups A and B over days 1 to 14 .


However , 20 % to 30 % of group A patients failed to achieve cTIB 0.5 or more for all days , and significant crossover confounds interpretation .


Mortality OR was greater than 1.0 for patients with cTIB 0.5 or more in both groups but much higher for group A on all days .


There was no difference in organ failure in the Glucontrol study based on intention to treat to different glycemic targets .


Actual outcomes and significant crossover indicate that this result may not be due to the difference in target or treatment .


Odds ratios-associated achieving an intermediate 4.0 to 7.0 mmol/L range improved outcome .


National Comprehensive Cancer Network guidelines recommend patients with head and neck cancer ( HNC ) receive treatment at centers with expertise , but whether provider experience affects survival is unknown .