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 @ 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 @ and @ in Japan in order to examine the long-term tolerability and efficacy of this drug at a dose of @ mg/day .


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


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


The incidence of adverse events every @ weeks of treatment ranged from @ % to @ % , and the incidence of adverse drug reactions ranged from @ % to @ % , 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 @ 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 @ in subjects with type @ diabetes treated for up to @ weeks .


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


Subjects received ITCA @ mg ( @ , @ , @ or @ g/day ) .


Mean changes for HbA@c , weight , and fasting plasma glucose ( FPG ) were evaluated .


Mean changes in HbA@c from baseline to week @ ranged from -@ % to -@ % .


At week @ , @ % of subjects with an HbA@c @ % at week @ maintained an HbA@c @ % .


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


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


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


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


Significant changes in HbA@c , body weight , and FPG attained with ITCA @ were maintained to @ weeks .


The incidence of AEs was lower in the @-week extension than in the initial @-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 @ participants , @ % 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 , @ ; @ % confidence interval , @-@ @ ) , but trended toward lower risk among those not on antiplatelets ( hazard ratio , @ ; @ % confidence interval , @-@ @ ) .


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 ( @ on hemodialysis and @ kidney transplant recipients ) were randomized @:@ 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 @ 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 Her@ .


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


Patients were randomised to Arm A : gemcitabine @mg/m ( @ ) ( days @ and @ ) plus either cisplatin ( @mg/m ( @ ) ) or carboplatin ( AUC = @ ) ( day @ every @ weeks ) or Arm B : added trastuzumab ( @mg/kg loading dose , then @ mg/kg every @ days until progression ) .


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


Among @ screened patients , @ ( @ % ) were Her@ positive ( IHC @ + / @ + and FISH + ) and @ met all eligibility criteria ( median age , @ years ; @/@ males ; @/@ baseline ECOG-PS @-@ ; @ locally advanced and @ metastatic ) .


There was no significant difference between Arms A and B in median PFS ( @ versus @ months , respectively , p = @ ) , objective response rate ( @ % versus @ % , p = @ ) , and median overall survival ( @ versus @ months , respectively , p = @ ) .


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


Myelosuppression was the main grade @/@ toxicity .


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


The unexpectedly low incidence of Her@ 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 p@ gene by the percutaneous port catheter system on advanced hepatocellular carcinoma ( HCC ) through a prospective randomized trial .


A total of @ patients with advanced HCC between May @ and January @ were divided into the treatment group ( @ ) and the control group ( @ ) .


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 p@ gene ( Gendicine , Shenzhen Sibiono GeneTech Co , Ltd ) with Gendicine ( @vp ) combined with hydroxycamptothecin ( @ mg ) , once a week , for a course continuously for @ weeks .


The arterial infusion with hydroxycamptothecin ( @ 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 p@ 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 @ to @ courses of treatment , in which the differences between pretreatment/posttreatment AFP and KPS values were significant ( P < @ ) , whereas there was no significant difference ( P > @ ) between pretreatment/posttreatment AFP and KPS values within the control group .


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


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


After @ months , the survival rates ( @ % and @ % , respectively ) and changes in the tumor were significantly different between the @ groups ( P < @ ) .


Finally , after @ months , the survival rates ( @ % and @ % , respectively ) and changes in the tumor were significantly different between the @ groups ( P < @ ) .


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


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


Sequential therapy of p@ 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 .


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


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


Both the patient and the surgeon were blinded .


The patient was discharged after approximately @ hours of observation .


@ , @ , @ , @ , @ , @ and @ 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 @ hours after the surgery .


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


During the first @ hours we noted significantly decreased use of @ mg of paracetamol and @ 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 @ 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 , @-@ g ) .


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


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


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


Using sera collected during a multicenter study in patients with trauma , we found that hydrocortisone decreased the blood level of interleukin-@ , 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-@-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-@ level in natural killer cells by hydrocortisone was partially dependent on the up-regulation of glucocorticoid-induced tumor necrosis factor receptor-ligand ( TNFsf@ ) on dendritic cell .


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


Oral amoxicillin ( @ 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 ( @ mg/kg/day ) thrice or twice daily in those patients .


This randomized ( @:@ ) , controlled , triple-blinded investigation conducted at one centre in Brazil included children aged @-@ 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 @ ) at @ am , @ pm and @ pm and the other bottle ( Amoxicillin @ ) at @ am and @ pm : one bottle contained amoxicillin and the other placebo and vice versa .


Only the pharmacist knew patients ' allocation .


Follow-up assessments were done at @ , @ and @ 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 @ h. ClinicalTrials.gov : identifier NCT@ .


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


Treatment failure was detected in @ ( @ % ) and @ ( @ % ) patients in intention-to-treat analysis ( risk difference @ % ; @ % CI : -@ % -@ % ) and in @ ( @ % ) and @ ( @ % ) patients in per-protocol analysis ( risk difference @ % ; @ % CI : -@ % -@ % ) .


Pneumonia was radiologically confirmed by concordant reading in @ ( @ % ) cases , among whom treatment failure was registered in @/@ ( @ % ) and @/@ ( @ % ) participants from the thrice and twice daily doses subgroups , respectively ( risk difference -@ % ; @ % CI : -@ % -@ % ) .


Oral amoxicillin ( @ 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 @ and April @ we randomly assigned @ high-risk patientsto undergo transaortic TAVI with the SAPIEN XT prosthesis ( Edwards Lifesciences ) combined with either the EMBOL-X device ( group-@ , n = @ ) or without ( group-@ , n = @ ) .


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


New foci of restricted diffusion on cerebral DW-MRI were found in @ % in group-@ and @ % in group-@ .


Lesion size was smaller in patients treated with the EMBOL-X device than in those without ( @ @ vs @ @ mm ( @ ) , p = @ , t = @ , degrees of freedom = @ ) .


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


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 , NCT@ ) .


A functional polymorphism ( @-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 @-HTTLPR moderates the effects of treatment to reduce heavy drinking , we studied @ 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 @ weeks with @ 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 @-HTTLPR polymorphism ( i.e. , low-activity S ' or high-activity L' alleles ) .


During treatment , the number of weekly heavy drinking days ( HDD ; defined as @ or more standard drinks per day ) was significantly lower in subjects with the L' L' ( N = @ , p = @ ) or L 'S ' ( N = @ , p = @ ) genotype than those with the S 'S ' ( N = @ ) 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 = @ and p = @ , respectively ) .


In contrast , for subjects with @ or @ 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 @-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 @ , @ and @g/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 @g/day of oral collagen peptide ( CP ) for @weeks .


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 @g/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 < @ ) .


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


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 @ months ( range @-@ ) on @ children : @ on deferred and @ on early treatment arms , commencing ART at mean age of @ and @ weeks , respectively .


Multiple high signal intensity lesions on T@/fluid attenuated inversion recovery were documented in @ patients ( @ % ) , predominantly in frontal ( @ % ) and parietal ( @ % ) 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 = @ ) .


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


Half of children referred with HIV-related brain disease had WMSA on T@/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 @ 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-@-phosphate dehydrogenase ( G@PD ) 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 @-@ years with uncomplicated falciparum malaria and normal G@PD enzyme function to receive artemether-lumefantrine , combined with either placebo or with @ mg/kg , @ mg/kg , or @ 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 @ .


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 @ mg primaquine per kg , with a non-inferiority margin of @ days .


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


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


We randomly allocated @ participants to receive artemether-lumefantrine combined with placebo ( @ children ) or with @ mg/kg ( @ ) , @ mg/kg ( @ ) , or @ mg/kg ( @ ) primaquine base .


The mean duration of gametocyte carriage was @ days ( @ % CI @-@ @ ) in the @ mg/kg reference group , @ days ( @-@ @ ) in the @ mg/kg primaquine group ( p = @ ) , @ days ( @-@ @ ) in the @ mg/kg primaquine group ( p = @ ) , and @ days ( @-@ @ ) in the placebo group ( p < @ ) .


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 ( @ g/L , SD @ ) in the @ mg/kg ( @ g/L , @ ; p = @ ) , @ mg/kg ( @ g/L , @ ; p = @ ) , or @ mg/kg ( @ g/L , @ ; p = @ ) primaquine groups .


We conclude that @ mg/kg primaquine has similar gametocytocidal efficacy to the reference @ mg/kg primaquine dose , but a dose of @ 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 @ mg/kg and @ mg/kg ( including the dose of @ mg/kg recently recommended by WHO ) , in view of the potential for widespread use of the drug to block malaria transmission .


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 @ parenting course sites of a community organization and included @ 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 @-@ 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 @ patients who were candidates for CEA , with no history of CAD , a normal electrocardiogram ( ECG ) , and a normal cardiac ultrasound .


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


In group B ( n = @ ) 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 @ years .


The secondary end-point was the overall survival rate .


Median length of follow-up was @ years .


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


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


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


During the study period , @ MI occurred in group A ( @ % ) and @ were observed in group B ( @ % ) , @ of which were fatal .


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


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


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


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 , NCT@ ) .


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 @ healthy subjects ( aged @-@ 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 @ ( @ ) cm at baseline to @ ( @ ) cm during spontaneous breathing of @ minimum alveolar concentration of volatile anaesthetics .


AVTI decreased further to @ ( @ ) cm after changing to IPPV .


The maximum LA volume was @ ( @ ) cm ( @ ) at baseline and remained unchanged during spontaneous breathing but decreased to @ ( @ ) cm ( @ ) 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 .


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


A total of @ 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 .


( @ ) 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 < @ ) .


( @ ) 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 < @ ) ; ( @ ) After three months , the experiment group had @ cases with clinic symptoms cured ( @ % ) , Total effective rate was @ % ; The control group had @ cases with clinic symptoms cured ( @ % ) , total effective rate was @ % .


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


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 @-@ years of age visiting PCP group practice for routine medical consultation were randomly assigned in a @:@ 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 @ % ( @ subjects ) in the counseling group and @ % ( @ patients ) in the information leaflet group .


The rates of unsedated colonoscopies were @ % and @ % , respectively .


In a multivariate analyses , PCP 's counseling was associated with higher participation in CRC screening ( adjusted odds ratio -LSB- OR -RSB- @ , @ % confidence intervals -LSB- @ % CI -RSB- @-@ @ ) and higher rate of unsedated colonoscopies ( OR @ , @ % CI @-@ @ ) .


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


NCT@ .


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


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


Eleven had grade @-@ haemorrhage , @ had grade @ , @ had grade @ , and @ had no haemorrhage .


Group comparisons were made with @ 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 @ haemorrhage had higher deficit rates of verbal intelligence , receptive vocabulary , phonemic fluency , cognitive flexibility and phonological fluency than preterm adolescents with grade @ or no haemorrhage , compared with term controls .


After excluding preterm adolescents with both grade @ haemorrhage and cystic periventricular leukomalacia , those with isolated grade @ 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 @s with isolated grade @ 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 @ patients with carotid atherosclerosis ( mean age @ years , @ % men , @ % on statin therapy ) .


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


Within these two groups , half of the patients were randomized either to avoid any alcohol or to drink @ ml of red wine ( women ) or @ 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 @ and @ 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 @ individuals were in the inexperienced group .


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


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


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 @months after RDN using the EnligHTN ablation catheter ( St. Jude Medical ) .


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


At @months post-RDN , office BP and @-hour BP were reduced by @ / @ mmHg and by @ / @mmHg ( p < @ for all cases ) , respectively .


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


The rates of systolic and diastolic @-hour BP variation were decreased @months after RDN , ( from @ / @ to @ / @ , p = @ / @ , respectively ) , especially in the responders group ( n = @ , @ % ) .


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 @ % ( @ % CI : @ % to @ % ; p = @ ) and by diastolic time rate of @ % ( @ % CI : @ % to @ % ; p = @ ) .


Although standard BP variability indexes remained unchanged , the rate of systolic and diastolic BP variation was significantly decreased @months 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 @ years .


In a total of @ 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 @ ( group B ) with a conventional ( anterolateral modified Watson-Jones ) approach under partial detachment of gluteus medius and minimus .


Anthropometric data , blood loss , short-form @ 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 @-year follow-up .


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


Thus , @ patients were eligible for the final evaluation @ 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 @ @ factorial experiment was embedded within a large population-based study of pain and pain management .


Persons in the study sample were @ residents in Grampian ( north of Scotland ) aged @ 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 @ % .


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


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


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 , @-period crossover study was performed in @ 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 @ adult patients ( @-@ years ) with a mild-to-moderate primary hypertension diagnosis were randomly assigned , in a @:@ ratio , to lercanidipine hydrochloride ( n = @ ; @ males ) or felodipine sustained-release tablets ( n = @ ; @ males ) .


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


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


Main secondary efficacy parameters were : ( i ) mean seated systolic BP change from baseline to @ 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 @ to @mmHg , p < @ ; felodipine : from @ to @mmHg , p < @ ) .


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


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


In total , @ patients experienced @ AEs : @ % ( @/@ ) in the lercanidipine group and @ % ( @/@ ) 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 @days .


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 > @ ) .


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


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


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 @ of @ algorithms or a control group during a simulated disaster scenario and were asked to rate @ 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 ( @ to @ years ) , weight , and gender expected in the general population but expanded to @ % 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 @ % 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 .


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 @ men @ years or older with low or low-normal testosterone levels ( @-@ ng/dL ; free testosterone < @ pg/mL ) , recruited at @ US centers .


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


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


The dose was adjusted to achieve testosterone levels between @ and @ 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 @ years ; @ % had hypertension ; @ % , diabetes ; @ % , cardiovascular disease ; and @ % , obesity .


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


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


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 @ 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 .


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 @-day all-cause mortality in a double-blind trial in patients with severe sepsis in seven Indian hospitals .


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


Of @ randomized subjects , @ completed the study ( @ receiving ulinastatin , @ receiving placebo ) .


At baseline , the mean APACHE II score was @ ( SD = @ ) , @ ( @ % ) patients were receiving mechanical ventilation , @ ( @ % ) were on vasopressors , and @ % had multiple organ failure .


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


On multivariate analysis too , treatment with ulinastatin ( odds ratio @ , @ % CI @-@ @ ; p = @ ) independently decreased @-day all-cause mortality .


However , the mortality difference did not reach statistical significance in the intention-to-treat analysis -LSB- @ % ( @/@ deaths ) with ulinastatin versus @ % ( @/@ deaths ) in the placebo group ; p = @ -RSB- .


The ulinastatin group had lower incidence of new-onset organ failure ( @ vs. @ patients , p = @ ) , more ventilator-free days ( mean SD @ @ days vs. @ @ days , p = @ ) , and shorter hospital stay ( @ @ days vs. @ @ days , p < @ ) .


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 @-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 @ cc of @ % bupivacaine with @ 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 @ mg morphine in the first @h compared to @ mg for controls ( primary outcome , p = @ ) .


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


Postoperative pain scores assessed by the BPI ( @ vs. @ , p = @ ) and the VAS ( @ vs. @ , p = @ ) were equivalent .


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


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


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


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 @ days to plan @ requests , yielding @ flights , @ flying hours , and @,@ km flown .


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


The application was used on @ days to plan @ requests , yielding @ flights , @ flying hours , and @,@ km flown .


The corresponding ratios were @ km flown and $ @ per km required .


The average distance flown per distance required decreased by @ % ( P = @ ) , and the average cost per average required distance decreased by @ % ( P = @ ) 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 -LSB- @ or @ mg bis in die ( BID ) -RSB- or Aten group ( @ or @mg BID ) according to computer-generated random numbers for @weeks .


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


In a full analysis set , increases in the total exercise duration ( TED ) were @ seconds with Iva @mg and @ seconds with Aten @ mg at the fourth week , and at the @th week , TED improved by @ seconds with Iva and @ seconds with Aten ( @ % CI : -@ -@ seconds , p = @ for noninferiority ) .


The analysis of per protocol set yielded similar results ( @ % CI : -@ -@ seconds , p = @ 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 ( @ in Iva and @ in Aten , p > @ ) .


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


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 ; @ eyes of @ individuals participated in study @ .


A follow-up study ( study @ ) included @ eyes of @ individuals .


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


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


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


Glucose significantly improved the mean contrast sensitivity at @ cycles/degree compared with @ % saline by @ log units ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P < @ ) and @ log units ( @ % CI , @-@ @ ; P < @ ) 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 @ trial showed that coitally dosed tenofovir @ % gel reduced HIV acquisition by @ % overall and @ % 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 @ women who acquired HIV ( cases ) were compared with @ randomly selected women who remained HIV uninfected ( controls ) during the CAPRISA @ trial .


In total , @ cervicovaginal fluid ( CVF ) , @ plasma , and @ 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 @ ( @ % ) cases and @ ( @ % ) controls ( P = @ ) .


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


A total of @ % ( @/@ ) of cases and @ % ( @/@ ) of controls were found to have tenofovir CVF concentrations above @ ng/mL -LSB- odds ratio ( OR ) : @ , P = @ -RSB- .


At a higher threshold , @ % ( @/@ ) of cases and @ % ( @/@ ) of controls were found to have tenofovir CVF concentrations above @ ng/mL ( OR : @ , P = @ ) .


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


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


A tenofovir concentration of @ ng/mL in CVF was associated with @ % ( @ % CI : @ % to @ % ) protection against HIV , whereas a @ ng/mL concentration correlated with @ % ( @ % CI : @ % to @ % ) protection against HIV infection .


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


@ horses in phase @ , @ horses in phase @A , and @ horses in phase @B .


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


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


Phase @A was a physostigmine dose-determining phase .


In phase @B , 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 @ were not different between horses receiving neostigmine or saline solution .


In phase @A , @ 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 ( @ @ mm ) than did horses receiving neostigmine ( @ @ mm ) in phase @B , 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 @ diabetes were recruited and @ adults were retained and participated in an interventional study designed to test the effectiveness of the `` Taking Care of Sugar '' DSME program for the @-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 , @ months , @ months , and @ months post baseline .


From baseline to @-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 A@C 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 @ patients with LE randomized into @ 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 @rd 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 @ and @ , respectively ) ( p = @ ) .


Patients in the GTN group and control group had lower VAS pain scores and reduced elbow pain at @ weeks ( @ vs @ in the GTN and @ vs @ in the control group ) .


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


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


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


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


Decline in CD@ 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 CD@ 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 @-@ .


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


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


@ ARV nave adults were enrolled .


Their median age was @ years and male to female ratio was @:@ .


Median baseline CD@ count was @ cells/mm ( @ ) ( IQR @-@ ) .


The overall mean decline in CD@ count was @ cells/mm ( @ ) per annum -LSB- corrected -RSB- .


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


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


The percent decline in CD@ count was @ % ( @ % CI @ % , @ % ) , @ % ( @ % CI @ % , @ % ) , and @ % ( @ % CI @ % , @ % ) per annum for baseline VLs of < @,@ ( N = @ ) , @,@-@ ,@ ( N = @ ) , > @,@ ( N = @ ) copies/ml .


Our data suggests that six and a half years will elapse for an individual 's CD@ count to decline from @ to @ cells/mm@ 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 - / CD@-depleted haploidentical HSCT , and how this agent affects the cellular graft composition .


Ninety healthy donors were evaluated .


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


MZ significantly increased CD@ + 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 CD@ + 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 @-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 CD@ + 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 @-week , single center , randomized , double-blind , placebo-controlled crossover study .


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


We measured changes in vascular stiffness ( augmentation index and aortic pulse wave velocity -LSB- PWV -RSB- ) , 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 -@ % units ( @ % confidence interval -LSB- @ % CI -RSB- -@ , -@ ) ( P = @ ) and in diastolic blood pressure of -@ mm Hg ( @ % CI -@ , -@ ) ( P = @ ) , but did not significantly change aortic PWV ( P = @ ) or reactive hyperemia index ( P = @ ) .


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 @ % 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 @ and @ .


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


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


The Symbol Digit Modalities Test scores improved in all groups at @ month vs. baseline ( Avonex : @ vs. @ , p = @ ; Rebif : @ vs. @ , p = @ ; Betaferon : @ vs. @ , p = @ ) .


The Selective Reminding Test ( SRT ) - Total , the @/@-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-@a preparations ) were more helpful in resolving the cognitive impairments in MS patients compared to Betaferon ( Interferon beta-@b ) 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 , @ 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 @ ) , Jianzhong ( Extra ) , Jianzhen ( SI @ ) , Naoshu ( SI @ ) , Jianwaishu ( SI @ ) and Bingfeng ( SI @ ) , IW group was treated with intermittent wave with a frequency of @ Hz , DW group was treated with disperse-dense wave with a frequency of @ Hz/@ Hz and CW group was treated with continuous wave with a frequency of @ Hz .


The EA treatment was given for @ min , once a day , six times a week and totally for @ 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 @ % ( @/@ ) in the IW group , which was superior to @ % ( @ / @ ) in the DW group and @ % ( @/@ ) in the CW group ( both P < @ ) .


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


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 @ to @ mmol/L band ( cTIB ) were evaluated daily up to @ days in @ participants of the multicentre Glucontrol trial ( @ centers ) that randomized patients to intensive group A ( blood glucose -LSB- BG -RSB- target : @-@ @ mmol/L ) or conventional group B ( BG target : @-@ @ mmol/L ) .


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


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


Odds ratios ( OR ) compare the odds risk of death for cTIB @ or more vs cTIB less than @ , where a ratio greater than @ indicates an improvement for achieving cTIB @ 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 < @ ) , as expected .


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


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


Mortality OR was greater than @ for patients with cTIB @ 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 @ to @ 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 .


The effect of institutional experience on overall survival ( OS ) in patients with stage III or IV HNC was investigated within a randomized trial of the Radiation Therapy Oncology Group ( RTOG @ ) , which compared cisplatin concurrent with standard versus accelerated fractionation radiotherapy .


As a surrogate for experience , institutions were classified as historically low - ( HLACs ) or high-accruing centers ( HHACs ) based on accrual to @ RTOG HNC trials ( @ to @ ) .


The effect of accrual volume on OS was estimated by Cox proportional hazards models .


Median RTOG accrual ( @ to @ ) at HLACs was four versus @ patients at HHACs .


Analysis included @ patients in RTOG @ ( @ to @ ) with known human papillomavirus and smoking status .


Patients at HLACs versus HHACs had better performance status ( @ : @ % v @ % ; P = @ ) and lower T stage ( T@ : @ % v @ % ; P = @ ) but were otherwise similar .


Radiotherapy protocol deviations were higher at HLACs versus HHACs ( @ % v @ % ; P < @ ) .


When compared with HHACs , patients at HLACs had worse OS ( @ years : @ % v @ % ; P = @ ) .


Treatment at HLACs was associated with increased death risk of @ % ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ) after adjustment for prognostic factors and @ % ( HR , @ ; @ % CI , @ to @ ) after radiotherapy compliance adjustment .


OS is worse for patients with HNC treated at HLACs versus HHACs to cooperative group trials after accounting for radiotherapy protocol deviations .


Institutional experience substantially influences survival in locally advanced HNC .


Serial C-reactive protein ( CRP ) values may be useful for decision-making regarding duration of antibiotics in neonates .


However , established standard of practice for its use in preterm very low birth weight ( < @ g , VLBW ) infants are lacking .


Evaluate compliance with a CRP-guided computerized decision support ( CDS ) algorithm and compare characteristics and outcomes of compliant versus non-compliant cases .


Measure correlation between CRPs and white blood count ( WBC ) indices .


We examined @ populations : @ ) all preterm VLBW infants born at Vanderbilt @-@ - we assessed provider compliance with CDS algorithm and measured relevant outcomes ; @ ) all patients with positive blood culture results admitted to the Vanderbilt NICU @-@ - we tested the correlation between CRP and WBC results within @ days of blood culture phlebotomy ; @ ) @,@ randomly selected patients out of the @,@ patients admitted to the NICU @-@ - we correlated time-associated CRP values and absolute neutrophil counts .


Of @ VLBW infants in cohort @ ) , @ ( @ % ) received empiric antibiotics for suspected early-onset sepsis .


In @ infants ( @ % ) the CDS algorithm was followed ; antibiotics were discontinued @ hours in @ ( @ % ) with normal serial CRPs and continued in @ ( @ % ) with positive CRPs , resulting in significant reduction in antibiotic exposure ( p < @ ) without increase in complications or subsequent infections .


One hundred sixty ( @ % ) were considered non-compliant because antibiotics were continued beyond @ hours despite negative serial CRPs and blood cultures .


Serial CRPs remained negative in @ ( @ % ) of @ blood culture-positive infants from cohort @ , but only @ patients had clinically probable sepsis with single organisms and no immunodeficiency besides extreme prematurity .


Leukopenia of any cell type was not linked with CRPs in cohorts @ and @ .


CDS/CRP-guided antibiotic use is safe and effective in culture-negative VLBW infants .


CRP results are not affected by low WBC indices .


To assess the efficacy of neoadjuvant systemic therapy ( NST ) at increasing the rate of successful breast-conserving therapy ( BCT ) in triple negative breast cancer .


Inducing tumor regression to permit BCT is often cited to support administration of NST .


To quantify this benefit , we conducted a surgical companion study to CALGB@ , a randomized phase II , @ factorial trial of neoadjuvant paclitaxel carboplatin bevacizumab ( B ) followed by doxorubicin plus cyclophosphamide B in stage II-III triple negative breast cancer .


Before and after NST , treating surgeons evaluated BCT candidacy by clinico-radiographic criteria ; surgery performed was at surgeon and patient discretion .


We measured ( @ ) conversion rates from BCT-ineligible to BCT-eligible , ( @ ) surgical choices in BCT candidates , and ( @ ) rates of successful BCT with tumor-free margins .


Four hundred four patients were assessable for surgical outcomes .


Two hundred nineteen ( @ % ) were BCT candidates before NST .


One hundred ninety-seven ( @ % ) remained BCT candidates after NST , of whom @ ( @ % ) chose BCT , which was successful in @ ( @ % ) .


Of @ ( @ % ) who were not BCT candidates before NST , @ ( @ % ) converted to candidates with NST .


Of these , @ ( @ % ) chose BCT with a @ % ( @/@ ) success rate .


The overall BCT-eligibility rate rose from @ % to @ % ( @/@ ) with NST .


Addition of carboplatin , B , or both increased conversion rates .


This is the first study to document prospectively a @ % conversion rate from BCT-ineligible to BCT-eligible , resulting in a @ % absolute increase in BCT eligibility .


BCT was successful in @ % of patients who opted for it , but @ % of BCT-eligible patients still chose mastectomy .


To investigate the role of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction .


This was a double-blinded , single-center , prospective , randomized , placebo-controlled trial .


After a @-week phosphodiesterase type@ inhibitor washout period , patients were assessed with Sexual Health Inventory for Men , International Index of Erectile Function-ED domain scores and Erection Hardness Score .


Randomization into either the low-intensity extracorporeal shockwave therapy group or the sham group took place .


After the @-week treatment period , patients were followed up @ weeks later .


Follow-up assessment was in the form of International Index of Erectile Function-ED domain score and Erection Hardness Score .


A total of @ patients were recruited into the study , @ patients completed the study .


A total of @ patients were randomized into the sham therapy arm , and @ patients were randomized into the low-intensity extracorporeal shockwave therapy arm .


There was no significant difference between these two groups in baseline International Index of Erectile Function-ED domain score and Erection Hardness Score .


The mean International Index of Erectile Function-ED domain score of the low-intensity extracorporeal shockwave therapy arm and sham arm in week @ were @ and @ , respectively ( P = @ ) .


The mean Erection Hardness Scores in week@ were @ and @ , respectively ( P = @ ) .


When patients were stratified into different baseline Sexual Health Inventory for Men subgroups , the pre-intervention and post-intervention difference in low-intensity extracorporeal shockwave therapy was found to be significant in the subgroup with severe erectile dysfunction ( low-intensity extracorporeal shockwave therapy International Index of Erectile Function-ED domain improvement : @ vs sham therapy International Index of Erectile Function-ED domain improvement : @ ; P = @ ) .


The present trial shows the tolerability and clinical efficacy of low-intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction .


Cochlear implantation requires acclimatization to the electrical input .


Usually , cochlear implant ( CI ) listeners undergo an auditory rehabilitation program that includes auditory training sessions .


Recently , it was shown that a phoneme-based training may improve speech perception abilities even in experienced CI listeners .


The current study focuses on whether the effect of an auditory training program depends on the age of CI listeners .


Fifteen CI listeners took part in an auditory phoneme-based computer training program .


Before and after training , speech recognition tests in moderate and difficult noise ( +@ dB SNR and @ dB SNR , respectively ) were administered .


Additionally , speech recognition was tested @ months after the training ( follow-up ) .


A control group consisting of @ subjects underwent audiometric testing without any auditory training .


Speech perception in moderate noise improved significantly during the training as revealed by comparing pre - and posttraining scores evaluated in the moderate noise condition .


No significant change was observed for the difficult noise situation at @ dB SNR .


The speech perception measures of the control group remained unchanged .


No significant effect of age on the training effect was observed .


Speech recognition can be improved even in experienced CI listeners .


When motivated to participate , senior CI users with long-term CI experience may benefit in a similar way from an auditory , phoneme-based computer training program as younger CI users .


The aim of this study was to directly compare the effects of aerobic training ( AT ) with progressive resistance training ( RT ) after stroke to determine whether AT-induced fitness gains or RT-induced strength gains translate into improved ambulation across a @-wk intervention and whether gains are retained @ yr after cessation of formal training .


This study is a randomized controlled @-wk intervention trial with a @-yr follow-up .


Forty-three community-dwelling independent walkers with a chronic ischemic hemiparetic stroke were allocated to AT using a cycle ergometer ( n = @ ) , RT using training machines ( n = @ ) , or low-intensity sham training of the arms ( n = @ ) .


The main outcome measures were @-min walk distance and fast @-m walking speed .


Comparisons between AT , RT , and sham training revealed no clinically relevant effects on walking velocity or walking distance .


Muscle strength improved after RT ( P < @ ) and was preserved at @-yr follow-up ( P < @ ) .


Aerobic capacity increased after AT ( P < @ ) but was lost during the follow-up observation period .


Improvement of muscle strength or aerobic capacity using non-task-specific training methods does not result in improved ambulation in patients with chronic stroke .


Muscle strength gains were maintained at follow-up , whereas all improvements of aerobic capacity were lost , indicating a long-lasting effect of intensive RT even without maintenance training .


New designs of female condom have been developed to reduce costs and improve acceptability .


To secure regulatory approvals , clinical studies are needed to verify performance .


We aimed to assess the functional performance and safety of three new condom types-the Woman 's Condom , the VA worn-of-women ( wow ) Condom Feminine , and the Cupid female condom-against the existing second-generation female condom ( FC@ ) .


We did a randomised controlled , non-inferiority , four-period crossover trial at three sites in Shanghai , China , and one site in Durban , South Africa , between May @ , @ , and Jan @ , @ .


Participants aged @-@ years who were sexually active , monogamous , not pregnant , and not sex workers , were eligible for inclusion if they were literate , had no known allergies to the study products ; used a reliable , non-barrier method of contraception , and had no visible or reported sexually transmitted infections .


We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients ( @:@:@:@ ) to the FC@ control device , or the Woman 's , VA wow , or Cupid condoms , with @ potential allocations .


Randomisation was stratified by site .


Participants were not masked to condom type , but allocation was concealed from study investigators .


The primary non-inferiority endpoints were total clinical failure and total female condom failure , with a non-inferiority margin of @ % .


Women were asked to use five of each condom type and were interviewed after use of each type .


We also assessed safety data for each type .


We did both per-protocol and intention-to-treat analyses .


We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model .


This study is registered , number DOH-@-@-@ .


@ women were assessed for eligibility , of whom @ were randomly assigned to condom-type order ( @ , @ , and @ women in the three sites in China , and @ women in the site in South Africa ) .


@ women completed follow-up , with at least one condom of each type .


Total female condom failure was @ % for FC@ , @ % for the Woman 's Condom ( difference @ % , @ % CI -@ to @ ) , @ % for VA wow ( -@ % , -@ to @ ) , and @ % for Cupid ( @ % , -@ to @ ) ; total clinical failure was @ % , @ % ( @ % , -@ to @ ) , @ % ( -@ % , -@ to @ ) , and @ % ( @ % , -@ to @ ) , respectively .


Only two ( < @ % ) participants , in South Africa , reported serious adverse events , unrelated to use of the study products .


Non-inferiority was shown for all condom failure events for the three new devices versus the FC@ , within the predefined margin .


To investigate whether vaginal Group B Streptococcus ( GBS ) colonisation or other baseline characteristics of women with preterm premature rupture of membranes ( PPROM ) can help in identifying subgroups of women who would benefit from immediate delivery .


Secondary analysis of the PPROMEXIL trials .


Sixty hospitals in the Netherlands .


Women with PPROM between @ and @ weeks of gestation .


Random assignment of @ women to immediate delivery or expectant management .


Early onset neonatal sepsis .


Vaginal GBS colonisation status was the only marker which was significantly associated with the benefit of immediate delivery ( P for interaction : @ ) .


GBS colonisation was observed in @ % of women .


The risk of early onset neonatal sepsis in GBS-positive women was high ( @ % ) when they were managed expectantly but this risk was reduced to @ % with immediate delivery .


The early onset neonatal sepsis risk was much lower in neonates of GBS-negative women : @ % after expectant management and @ % with immediate delivery .


We estimated that by inducing labour only in GBS-positive women , there would be a @ % increase in term delivery rate , while keeping neonatal sepsis and caesarean delivery rates comparable to a strategy of labour induction for all .


Our post hoc findings suggest that women with PROM between @ and @ weeks might benefit from immediate delivery if they have GBS vaginal colonisation , while in GBS-negative women labour induction could be delayed until @ weeks .


Depletion of B lymphocytes is associated with suppression of inflammatory activity in multiple sclerosis .


We aimed to assess the safety and efficacy of atacicept , a recombinant fusion protein that suppresses B-cell function and antibody production .


In this placebo-controlled , double-blind , @-week , phase @ trial ( ATAMS ) in Australia , Canada , Europe , and the USA , patients aged @-@ years with relapsing multiple sclerosis were randomly assigned via an interactive voice response system in a @:@:@:@ ratio , stratified by geographical region , to receive weekly subcutaneous injections with atacicept ( @ , @ , or @ mg ) or placebo .


Both patients and study personnel were masked to treatment assignment .


The primary endpoint was the change in mean number of gadolinium-enhancing lesions on T@-weighted MRI per patient per scan between weeks @ and @ .


Efficacy endpoints were analysed in the intention-to-treat population .


Patients who completed week @ were eligible to participate in a long-term extension study ( ATAMS EXT ) , consisting of a double-blind phase followed by an open-label phase , for a total study time of up to @ years .


The study was terminated early after the independent data and safety monitoring board noted an increased annualised relapse rate with atacicept .


The protocol was subsequently amended to include a @-week safety follow-up , to allow treatment with approved multiple sclerosis drugs , and to change the primary endpoint to gadolinium-enhancing T@ lesions per scan during the entire double-blind period of ATAMS .


Both the trial and the extension are registered with ClinicalTrials.gov , numbers NCT@ ( ATAMS ) and NCT@ ( ATAMS EXT ) .


Between April @ , @ , and early study termination on Sept @ , @ , @ patients were randomly assigned : @ to placebo , @ to atacicept @ mg , @ to @ mg , and @ to @ mg .


@ ( @ % ) patients completed the week @ treatment visit , @ ( @ % ) discontinued before study termination ( including one who dropped out before receiving study treatment ) , and @ ( @ % ) discontinued because of study termination .