The value of hyperbaric oxygen therapy ( HBOT ) in the treatment of diabetic ulcers is still under debate .


Available evidence suggests that HBOT may improve the healing of diabetic ulcers , but it comes from small trials with heterogeneous populations and interventions .


The DAMOCLES-trial will assess the ( cost - ) effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care .


In a multicenter randomized clinical trial , including @ hospitals and all @ HBOT centers in the Netherlands , we plan to enroll @ patients with Types @ or @ diabetes , a Wagner @ , @ or @ ulcer of the leg present for at least @ weeks , and concomitant leg ischemia , defined as an ankle systolic blood pressure of < @mmHg , a toe systolic blood pressure of < @mmHg or a forefoot transcutaneous oxygen tension ( TcpO@ ) of < @mmHg .


Eligible patients may be candidates for revascularization .


Patients will be randomly assigned to standard care with or without @ HBOT-sessions .


Primary outcome measures are freedom from major amputation after @ months and achievement of , and time to , complete wound healing .


Secondary endpoints include freedom from minor amputations , ulcer recurrence , TcpO@ , quality of life , and safety .


In addition , we will assess the cost-effectiveness of HBOT for this indication .


The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers , and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions .


This matches the treatment dilemma in current clinical practice .


To evaluate whether @ @ mm dental implants with a novel nanostructured calciumincorporated titanium surface could be an alternative to implants at least @ mm long placed in bone augmented with bone substitutes in posterior atrophic jaws .


A total of @ patients with atrophic posterior ( premolar and molar areas ) mandibles having @ to @ mm of bone height above the mandibular canal and @ patients with atrophic maxillae having @ to @ mm below the maxillary sinus , were randomised according to a parallel group design to receive one to three @ mm implants or one to three at least @ mm-long implants in augmented bone at two centres .


All implants had a diameter of @ mm .


Mandibles were vertically augmented with interpositional bovine bone blocks and resorbable barriers .


Implants were placed after @ months .


Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers and implants were placed simultaneously .


All implants were submerged and loaded after @ months with provisional prostheses .


Four months later , definitive screw-retained or provisionally cemented metal-ceramic or zirconia prostheses were delivered .


Patients were followed up to @ year post-loading and the outcome measures were prosthesis and implant failures , any complications and peri-implant marginal bone level changes .


One maxillary grafted patient dropped out before the @-year evaluation .


In mandibles , @ grafted patient did not want to go ahead with the treatment because of multiple complications and graft failure , and another grafted patient did not receive his prostheses due the loss of @ implants .


In maxillae , one @ @ mm implant failed with its provisional crown @ months post-loading .


There were no statistically significant differences in prostheses and implant failures .


Significantly more complications occurred at both mandibular and maxillary grafted sites : @ augmented patients were affected by complications versus @ patients treated with short implants in the mandible ( P = @ ; difference in proportion = -@ ; @ % CI -@ to -@ ) , and @ sinus-lift patients versus none treated with maxillary short implants ( P = @ ; difference in proportion = -@ ; @ % CI -@ to -@ ) .


Patients with mandibular short implants lost on average @ mm of peri-implant bone at @ year and patients with @ mm or longer mandibular implants lost @ mm .


Patients with maxillary short implants lost on average @ mm of peri-implant bone at @ year and patients with @ mm or longer maxillary implants lost @ mm .


There were no statistically significant differences in bone level changes up to @ year between short and longer implants in maxillae ( mean difference -@ mm , @ % CI -@ to @ , P = @ ) and in mandibles ( mean difference -@ mm , @ % CI -@ to @ , P = @ ) .


One year after loading , @ @ mm implants achieved similar results compared to longer implants placed in augmented bone .


Short implants might be a preferable choice to bone augmentation especially in posterior mandibles since the treatment is faster , cheaper and associated with less morbidity , however @ to @ years of post-loading data are necessary before making reliable recommendations .


Long-duration beta-lactam antibiotics are used for empirical treatment in female dogs with uncomplicated bacterial cystitis .


However , women with bacterial cystitis are treated with short-duration potentiated sulfonamides because longer courses of beta-lactams result in lower cure and higher recurrence rates .


Short-duration potentiated sulfonamide treatment is more efficacious than long-duration beta-lactam treatment in achieving clinical and microbiological cures in female dogs with uncomplicated bacterial cystitis .


Thirty-eight client-owned female dogs .


Randomized , double-blinded , placebo-controlled clinical trial .


Dogs were treated with TMP-SMX ( @ mg/kg PO q@h for @ days followed by a placebo capsule PO q@h for @ days ; Group SDS ; n = @ ) or cephalexin ( @ mg/kg PO q@h for @ days ; Group LDBL ; n = @ ) .


Dogs were monitored for clinical and microbiological cure during treatment and at short - and long-term follow-up .


No statistically significant differences were found between treatment groups in clinical cure rates after @ days of treatment ( @ % SDS , @ % LDBL ; P = @ ) and @ days ( @ % SDS , @ % LDBL ; P = @ ) or > @ days ( @ % SDS , @ % LDBL ; P = @ ) after conclusion of treatment or in microbiological cure rates @ days ( @ % SDS , @ % LDBL ; P = @ ) or > @ days ( @ % SDS , @ % LDBL ; P = @ ) after conclusion of treatment .


We did not identify a difference in cure rates between short-duration sulfonamide and long-duration beta-lactam treatments in female dogs with uncomplicated cystitis .


Long-term cure rates in both treatment groups were low .


In some female dogs , `` uncomplicated '' bacterial cystitis may be more complicated than previously recognized .


We evaluated the COX-@ inhibitors , etoricoxib and celecoxib , in Korean patients with osteoarthritis ( OA ) .


This study included patients ( @ years of age ) with a clinical and radiographic diagnosis of knee OA .


Patients were randomized to etoricoxib @ mg ( qd ) or celecoxib @ mg ( qd ) in a @ week randomized , controlled , double-blind study .


Prior NSAID users were to demonstrate a worsening of symptoms upon withdrawal of medication .


Efficacy endpoints included the time-weighted average change from baseline in the WOMAC VA @ Pain Subscale ( @ mm Visual Analog Scale -LSB- VAS -RSB- ; primary endpoint ) , the WOMAC VA @ Physical Function Subscale ( @ mm VAS ) , and Patient Global Assessment of Disease Status ( PGAD ) ( @ mm VAS ) .


The primary hypothesis was that etoricoxib @ mg is non-inferior to celecoxib @ mg as assessed by the primary endpoint ( the non-inferiority margin was set at @ mm VAS ) .


Adverse events ( AEs ) , laboratory parameters , and vital signs were monitored .


There were @ patients ( @ % female ; mean age : @ years ) randomized to etoricoxib @ mg ( n = @ ) and celecoxib @ mg ( n = @ ) .


The differences ( etoricoxib vs celecoxib ) in least square ( LS ) mean change ( @ % CI ) for WOMAC Pain , WOMAC Physical Function , and PGAD were -@ mm ( -@ , @ ) , -@ mm ( -@ , @ ) , and -@ mm ( -@ , @ ) , respectively .


Drug-related clinical AEs occurred in @ % ( etoricoxib ) and @ % ( celecoxib ) of patients .


This study was limited because it was not designed or powered to adequately capture and evaluate rare AEs associated with NSAID treatment .


Etoricoxib @ mg administered once daily in Korean patients with knee OA demonstrated non-inferior clinical efficacy to celecoxib @ mg over @ weeks of treatment as assessed by all primary and secondary outcomes .


Etoricoxib @ mg qd and celecoxib @ mg qd were generally safe and well tolerated .


Although eye exercises appear to help heterophoria , convergence insufficiency , and intermittent strabismus , results can be confounded by placebo , practice , and encouragement effects .


This study assessed objective changes in vergence and accommodation responses in naive young adults after a @-week period of eye exercises under controlled conditions to determine the extent to which treatment effects occur over other factors .


Asymptomatic young adults were randomly assigned to one of two no-treatment ( control ) groups or to one of six eye exercise groups : accommodation , vergence , both , convergence in excess of accommodation , accommodation in excess of convergence , and placebo .


Subjects were tested and retested under identical conditions , except for the second control group , who were additionally encouraged .


Objective accommodation and vergence were assessed to a range of targets moving in depth containing combinations of blur , disparity , and proximity/looming cues .


A total of @ subjects were included .


Response gain improved more for less naturalistic targets where more improvement was possible .


Convergence exercises improved vergence for near across all targets ( P = @ ) .


Mean accommodation changed similarly but nonsignificantly .


No other treatment group differed significantly from the nonencouraged control group , whereas encouraging effort produced significantly increased vergence ( P = @ ) and accommodation ( P = @ ) gains in the second control group .


True treatment effects were small , significantly better only after vergence exercises to a nonaccommodative target , and rarely related to the response they were designed to improve .


Exercising accommodation without convergence made no difference to accommodation to cues containing detail .


Additional effort improved objective responses the most .


Both propofol infusions with oxygen delivered through nasal cannula and isoflurane/N@O ( nitrous oxide ) delivered via a laryngeal mask airway ( LMA ) are used to provide anesthesia for children undergoing magnetic resonance imaging scans .


We compared the incidence of adverse events and perioperative physiologic responses in children anesthetized with these @ regimens .


One hundred-fifty healthy children , ages @ to @ years , were randomized to receive either a propofol infusion ( starting at @ g kgmin ) with oxygen via nasal cannula ( n = @ ) or isoflurane with @ % N@O in oxygen delivered via an LMA ( n = @ ) , both after a sevoflurane/N@O/oxygen induction .


Adverse airway events , as well as hemodynamic , respiratory , and other physiologic responses were recorded during the magnetic resonance imaging scans and in the postanesthesia care unit by a single research nurse who was blind to the treatments .


All parents were contacted postoperatively to complete a postanesthetic follow-up .


All @ children completed their scans .


The frequency of all adverse airway events during emergence and recovery after propofol ( @ % ) was significantly less than that after isoflurane/N@O/LMA ( @ % ) ( @ % confidence interval for the risk difference was @ % -@ % ) ( P = @ ) .


Hemodynamic responses and recovery times for the @ treatments were similar .


Early recovery , defined as the time interval from admission to the postanesthesia care unit until eye opening and wakefulness ( modified Aldrete score > @ ) , after propofol was more rapid than that after isoflurane/N@O/LMA ( P = @ and P = @ , respectively ) .


No scans had to be repeated .


The frequency of adverse airway events during emergence and recovery after propofol infusion with oxygen by nasal cannula is less than with isoflurane/N@O/LMA in children .


The Indian plant root Salacia reticulata , which is rich in alpha-glucosidase inhibitors , is used for metabolic disorders in Ayurvedic medicine .


Vitamin D is also used in the treatment of some metabolic diseases .


Our goal was to determine its potential effect for humans with obesity .


In a randomized open-label study , we investigated @ healthy participants aged @ - @ years , physically active , with a body mass index ( BMI ) of @ - @ .


The participants were randomly allocated into two groups .


Body weight , BMI , and body composition were measured .


Both groups ( A and B ) received a guideline for lifestyle and fitness training for @ weeks .


Group B additionally took one capsule containing @ mg of Salacia reticulata and @ g ( i. e. @ IU ) Vitamin D ( SRD ) @ times/day with the meals .


Significant weight and body-fat reduction within @ weeks was observed .


Group A lost @ kg or @ % , group B lost @ kg or @ % ( p = @ ) , therefore BMI reduction was achieved .


While Group A lost @ % of body fat , group B reduced it by @ % ( p = @ ) .


These promising results suggest that the combination of Salacia reticulata and Vitamin D might be highly valuable and potent to treat overweight and obesity , especially in addition to a modifying lifestyle program .


Further research is needed in addition to this study to clarify pathways and effect mechanisms .


Prior claims analyses suggest that the use of intravenous inotropic therapy for patients hospitalized with heart failure varies substantially by hospital .


Whether differences in the clinical characteristics of the patients explain observed differences in the use of inotropic therapy is not known .


We sought to characterize institutional variation in inotrope use among patients hospitalized with heart failure before and after accounting for clinical factors of patients .


Hierarchical generalized linear regression models estimated risk-standardized hospital-level rates of inotrope use within @ hospitals participating in Get With The Guidelines-Heart Failure ( GWTG-HF ) registry between @ and @ .


The association between risk-standardized rates of inotrope use and clinical outcomes was determined .


Overall , an inotropic agent was administered in @ of @ @ ( @ % ) heart failure hospitalizations : dobutamine @ % , dopamine @ % , milrinone @ % , or a combination @ % .


Patterns of inotrope use were stable during the @-year study period .


Use of inotropes varied significantly between hospitals even after accounting for patient and hospital characteristics ( median risk-standardized hospital rate , @ % ; interquartile range , @ % -@ % ; range , @ % -@ % ) .


After adjusting for case-mix and hospital structural differences , model intraclass correlation indicated that @ % of the observed variation in inotrope use was potentially attributable to random hospital effects ( ie , institutional preferences ) .


Hospitals with higher risk-standardized inotrope use had modestly longer risk-standardized length of stay ( P = @ ) but had no difference in risk-standardized inpatient mortality ( P = @ ) .


Use of intravenous inotropic agents during hospitalization for heart failure varies significantly among US hospitals even after accounting for patient and hospital factors .


The addition of domiciliary non-invasive ventilation ( NIV ) to standard therapy in chronic obstructive pulmonary disease ( COPD ) patients with compensated ventilatory failure ( CVF ) is reported to have beneficial effects .


Compliance with NIV is an important factor .


Volume assured NIV ( va-NIV ) may improve compliance and ventilation during sleep by automatically titrating ventilatory pressures .


A prospective single centre , randomised , parallel group trial comparing va-NIV and pressure preset NIV ( pp-NIV ) in COPD patients with CVF nave to domiciliary NIV was performed ( ISCRTN@ ) .


The primary outcomes were arterial blood gases , mean overnight oximetry ( mSpO@ ) and compliance after three months .


Secondary outcomes included pulmonary function , exercise capacity and health-related quality of life assessment .


Forty patients were randomised in a @:@ ratio .


The va-NIV median target minute ventilation was @ L/min and pp-NIV median inspiratory pressure was @ cmH@O .


There were no significant differences between groups in primary or secondary outcomes after three months .


Mean ( SD ) PaO@ @ ( @ ) versus @ ( @ ) kPa ( p = @ ) , PaCO@ @ ( @ ) versus @ ( @ ) kPa ( p = @ ) , mSpO@ @ ( @ ) versus @ ( @ ) % ( p = @ ) , compliance @ ( @ ) versus @ ( @ ) hours ( p = @ ) in va-NIV versus pp-NIV respectively .


Patients allocated va-NIV spent fewer days in hospital initiating therapy @ ( @ ) versus @ ( @ ) ( p = @ ) .


Both groups showed significant improvements in PaCO@ and mSpO@ after three months treatment .


Domiciliary va-NIV and pp-NIV have similar effects on physiological outcomes in COPD patients with CVF and both are well tolerated .


The protective effect of ischemic preconditioning ( IP ) in liver transplantation ( LT ) has been studied with controversial results .


We undertook this study to investigate whether IP of cadaveric donor livers is protective to allografts .


IP ( LT + IP , n = @ ) was induced by @-min hilar clamping .


These were compared to cadaver donors with no IP ( LT , n = @ ) .


Clinical data and blood were obtained in donors and recipients for biochemical and inflammatory mediator ( IM ) measurements ( P-selectin , leukotriene B@ , myeloperoxidase , ICAM-@ , IL-@ , IL-@ , and TNF - ) .


Liver tissue samples were obtained from donors and recipients ( @ min after reperfusion ) .


No significant differences were found in demographic characteristics between donors and recipients .


When comparing both groups ( LT + IP vs. LT only ) , ICU stay was longer in LT + IP group .


For biochemical parameters , a significant difference was found only with a higher total bilirubin at postoperative day @ in LT + IP group .


There was no statistical difference in IM between LT and LT + IP groups at different stages of the study .


Histological analysis of donor grafts indicated the presence of steatosis ( @ % ) in one graft from the LT + IP group .


However , in post-reperfusion biopsies neither neutrophil infiltration nor grade of necrosis showed significant difference between groups .


No incidence of primary graft nonfunction ( PGNF ) was observed and graft and patient survival was similar in the two groups at @ months .


IP does not seem to protect against I/R injury in cadaveric LT , and no PGNF was seen .


In subjects without kidney disease , adiponectin appears to have anti-inflammatory , anti-diabetic , and anti-atherogenic effects .


n-@ polyunsaturated fatty acids ( PUFA ) from seafood have several beneficial effects in patients with endstage renal disease ( ESRD ) and the aim of the present study was to assess the effect of n-@ PUFA supplementation on plasma adiponectin levels in ESRD patients .


In a double blinded intervention trial , @ ESRD patients ( mean age @ years @ , @ women and @ men ) undergoing chronic hemodialysis were randomized to @ g n-@ PUFA daily or placebo for @ months .


Adiponectin , plasma lipids and lipoproteins were measured at baseline and after the intervention period .


At baseline , adiponectin was positively correlated to HDL-cholesterol ( r = @ , p < @ ) and inversely correlated to plasma triglycerides , body mass index ( BMI ) and high sensitive C-reactive protein ( Hs-CRP ) ( r = -@ , p < @ , r = -@ , p < @ , and r = -@ , p < @ , respectively ) .


Furthermore , adiponectin was inversely correlated to the plasma levels of the two major n-@ PUFA docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) ( r = -@ , p < @ , and r = -@ , p < @ , respectively ) .


Baseline plasma adiponectin levels were high in both groups but after @ months of supplementation no significant change was observed in the groups .


Thus , n-@ PUFA supplementation did not change adiponectin levels .


We found an elevated plasma adiponectin level , which was inversely associated with plasma levels of DHA and EPA at baseline .


Supplementation with n-@ PUFAs for @ months did not change adiponectin levels .


The negative result in this study may be related to a relatively low dose and future studies with higher dose and longer duration are needed to explore this mechanism .


Smokers trying to quit encounter many challenges including nicotine withdrawal symptoms , cigarette craving , increased stress and negative mood and concern regarding weight gain .


These phenomena make it difficult to successfully quit smoking .


Studies in non-smoking populations show that yoga reduces stress and negative mood and improves weight control .


By increasing mindfulness we anticipate that yoga may also improve smokers ' ability to cope with the negative symptoms associated with quitting .


Yoga may also improve cognitive deliberation which is needed to make effective choices and avoid smoking in tempting situations .


The BreathEasy study is a rigorous , randomized controlled clinical trial examining the efficacy of Iyengar yoga as a complementary therapy to cognitive-behavioral therapy for smoking cessation .


All participants are given an @-week program of smoking cessation classes , and are randomized to either twice weekly yoga ( Yoga ) or twice-weekly health and wellness classes which serve as a control for contact and participant burden ( CTL ) .


Assessments are conducted at baseline , @ weeks , @ , @ , and @ months of follow-up .


The primary outcome is prolonged abstinence using an intention-to-treat approach .


Multiple internal and external audits using blind data collection are employed to ensure treatment fidelity and reliability of study results .


To understand why yoga may be more effective than CTL , we will examine the mechanisms of action ( i.e. , mediators ) underlying intervention efficacy .


We will examine the maintenance of yoga practice and smoking status at each follow-up .


Focus groups and interviews will be used to enrich our understanding of the relationship of yoga practice and smoking abstinence .


This study will provide a stringent test of the relative efficacy of yoga compared to a condition that controls for contact time and attention .


The use of mixed methodology also provides the opportunity to validate existing knowledge about yoga and helps to explore new themes for future mindfulness and yoga research .


The Korean Radiation Oncology Group ( KROG ) @-@ study protocol allowed radiation therapy ( RT ) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node ( IMN ) .


The purpose of this study was to assess dosimetric differences between the @ groups and potential influence on clinical outcome by a dummy run procedure .


All participating institutions were asked to produce RT plans without irradiation ( Arm @ ) and with irradiation to the IMN ( Arm @ ) for @ breast-conservation treatment case ( breast-conserving surgery -LSB- BCS -RSB- ) and @ mastectomy case ( modified radical mastectomy -LSB- MRM -RSB- ) whose computed tomography images were provided .


We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs .


A reference IMN was delineated by an expert panel group based on the study guidelines .


Also , we analyzed the potential influence of actual dose variation observed in this study on patient survival .


Although physicians intended to exclude the IMN within the RT field , the data showed almost @ % of the prescribed dose was delivered to the IMN in Arm @ .


However , the mean doses covering the IMN in Arm @ and Arm @ were significantly different for both cases ( P < @ ) .


Due to the probability of overdose in Arm @ , the estimated gain in @-year disease-free survival rate would be reduced from @ % to @ % for BCS cases and @ % for MRM cases .


The radiation doses to the ipsilateral lung , heart , and coronary artery were lower in Arm @ than in Arm @ .


Although this dummy run study indicated that a substantial dose was delivered to the IMN , even in the nonirradiation group , the dose differences between the @ groups were statistically significant .


However , this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN irradiation .


To explore the clinical efficacy of acupoint catgut embedding therapy on chronic pelvic cavity pain syndrome differentiated as kidney deficiency and stagnation of damp heat , and explore the impacts on plasma P substance ( SP ) , plasma beta-endorphin ( - EP ) .


One hundred and eighty cases were randomly divided into a catgut embedding group ( @ cases ) and a western medication group ( @ cases ) .


In the western medication group , tamsulosin capsules @ mg were prescribed for oral administration , once a day ; indometacin sustained release tablets , @ mg , three times a day .


Totally , the oral administration for @ weeks was required .


In the catgut embedding group , the acupoint catgut embedding therapy was applied to Qugu ( CV @ ) , Shenshu ( BL @ ) , Zhibian ( BL @ ) , Huiyin ( CV @ ) and Sanyinjiao ( SP @ ) , once every two weeks ; the treatment of @ weeks made one session , and two sessions were required .


Before and after treatment , TCM symptom score , NIH-CPSI ( the National Institute of Health Chronic Prostatitis Symptom Index ) score , lecithin body numbers in prostatic fluid , score in SAS ( self-rating anxiety scale ) , score in SDS ( self-rating depression scale ) , the levels of SP and - EP , etc. were observed in the two groups , and the clinical efficacy was assessed in the two groups .


( @ ) Ten cases were dropped in either group .


The total effective rate was @ % ( @/@ ) in the catgut embedding group , higher than @ % ( @/@ ) in the western medication group ( P < @ ) .


( @ ) After treatment , TCM symptom score , total score in NIH-CPSI , pain score and the scores in SAS and SDS were all reduced as compared with those before treatment in the two groups ( all P < @ ) .


After treatment , TCM symptom score , total score and pain score in NIH-CPSI , and the scores in SAS and SDS in the catgut embedding group were both lower than those in the western medication group ( all P < @ ) .


( @ ) After treatment , the lecithin body numbers were both increased as compared with those before treatment in the two groups ( both P < @ ) , and the result in the catgut embedding group was higher than that in the western medication group ( P < @ ) .


( @ ) After treatment , the SP level was lower than that before treatment in the two groups ( both P < @ ) ; the level of p-EP was increased as compared with that before treatment ( both P < @ ) .


The SP level in the catgut embedding group was lower than that in the western medication group ( P < @ ) ; the level of - EP was higher than that in the western medication group ( P < @ ) .


The acupoint catgut embedding therapy apparently relieves the clinical symptoms of chronic pelvic cavity pain syndrome differentiated as kidney deficiency and stagnation of damp heat as well as the condition of anxiety and depression , increases lecithin body numbers in prostatic fluid and - EP level and reduces SP level .


To assess the effects of tofacitinib on T lymphocytes in RA patients with a special focus on efficacy and infectious adverse events ( iAEs ) .


Forty-four RA patients participated in @-month phase II/III randomized clinical trials and an open-label extension trial .


Peripheral lymphocyte subsets and in vitro CD@ ( + ) T lymphocyte proliferation were measured in @ patients of @ at baseline and at the end of the @-month trial .


Forty-four patients -LSB- @ females , age @ years , disease duration @ months , simplified disease activity index ( SDAI ) @ , CRP @ mg/l , ESR @ mm/h , MMP-@ @ pg/ml , RF @ IU/ml , neutrophil count @ per l , lymphocyte count @ per l -RSB- were treated with tofacitinib .


At the end of the study , the SDAI improved to @ , but the peripheral lymphocyte count and absolute numbers of CD@ ( + ) and CD@ ( + ) subpopulations did not change during this period .


However , CD@ ( + ) T lymphocyte proliferation was suppressed , which correlated with the improvement in SDAI , but not with iAEs ( n = @ ) during the @-month treatment .


Receiver operating characteristic analysis identified a CD@ ( + ) T lymphocyte count @ per l at baseline as a significant predictor of clinically significant iAEs .


The efficacy of tofacitinib is mediated through the suppression of CD@ ( + ) T lymphocyte proliferation without affecting the absolute number of these cells in the periphery .


A low CD@ ( + ) T cell count at baseline correlated with the development of iAEs during the treatment of RA patients .


To evaluate the efficacy and safety of zonisamid as add-on in treatment of partial epilepsy in children , aged @ years and older , who received @ or @ antiepileptic drugs and its effect on their growth and development .


Children were randomized to treatment with zonisamid ( n = @ ) or placebo ( n = @ ) .


Dose was titrated beginning with @mg/kg daily with a progressive increase to @mg/kg .


After the double-blind phase was completed , patients of the placebo group received zonisamid with the same titration rate and doses .


The duration of the open phase was @-@ weeks .


The efficacy was assessed by the percentage of responders ( reduction in the number of seizures by @ % ) and patients who had not anymore seizures .


The safety was evaluated by recording of side-effects , changes in laboratory parameters , neurological and somatic status and ECG .


In the open phase , side-effects were recorded using the Tanner scale , bone age , behavioral scales , school records , verbal associative test .


The percentage of responders was @ % in the zonisamid group and @ % in the placebo group , stopping of seizures was @ and @ % , respectively .


The efficacy of zonisamid remained over long time ( more than one year ) : responders - @,@ % , stopping of seizures - @ % of patients .


The total frequency of side-effects was similar in both groups ( @,@ and @ % ) .


The open phase did not reveal new adverse effects .


Puberty and bone age did not change during one year of treatment .


Zonisamid did not exert a negative effect on behavior and learning .


Most of the patients and their parents evaluated the changes in the condition of the child as marked improvement or very marked improvement .


Zonisamid is an effective and well-tolerated medication as add-on in treatment of partial epilepsy in children aged @ years and older .


Was to evaluate the effect of different regional anesthetics ( articaine with epinephrine versus prilocaine with felypressin ) on stress in the extraction of impacted lower third molars in healthy subjects .


-LSB- corrected -RSB- A prospective single-blind , split-mouth cross-over randomized study was designed , with a control group .


The experimental group consisted of @ otherwise healthy male volunteers , with two impacted lower third molars which were surgically extracted after inferior alveolar nerve block ( regional anesthesia ) , with a fortnight 's interval : the right using @ % articaine with @:@ epinephrine , and the left @ % prilocaine with @:@ felypressin .


Patients were randomized for the first surgical procedure .


To analyze the variation in four stress markers , homovanillic acid , @-methoxy-@-hydroxyphenylglycol , prolactin and cortisol , @-mL blood samples were obtained at t = @ , @ , @ , and @ minutes .


The control group consisted of @ healthy volunteers , who did not undergo either extractions or anesthetic procedures but from whom blood samples were collected and analyzed in the same way .


Plasma cortisol increased in the experimental group ( multiple range test , P < @ ) , the levels being significantly higher in the group receiving @ % prilocaine with @:@,@ felypressin ( signed rank test , p < @ ) .


There was a significant reduction in homovanillic acid over time in both groups ( multiple range test , P < @ ) .


No significant differences were observed in homovanillic acid , @-methoxy-@-hydroxyphenylglycol or prolactin concentrations between the experimental and control groups .


The effect of regional anesthesia on stress is lower when @ % articaine with @:@,@ epinephrine is used in this surgical procedure .


The aim of this study was to investigate the role of pravastatin , as an adjunctive therapy , on inflammatory markers , lipid and glucose metabolism , psychopathology , and cognition in subjects with schizophrenia and schizoaffective disorder .


Schizophrenia or schizoaffective subjects ( N = @ ) were randomized to receive either a @-week supply of pravastatin @ mg/day or placebo treatment .


Anthropometric measures , lipids and glucose metabolism , inflammatory markers , psychopathology and cognitive performance were assessed at baseline , @ weeks and @ weeks .


Pravastatin use was associated with a significant decrease in total cholesterol , low density lipoprotein ( LDL ) cholesterol and LDL particle number levels , but was not associated with any significant changes in cognition or psychopathology in the participants , except a significant decrease in the Positive and Negative Syndrome Scale ( PANSS ) positive symptom score from baseline to week @ .


However , this decrease failed to remain significant at @ weeks .


Interestingly , triglycerides , LDL-cholesterol , total cholesterol , LDL particle number , small LDL particle number , large very low density lipoprotein ( VLDL ) particle number and C-reactive protein ( CRP ) followed a similar pattern at @ and @ weeks as psychopathology .


These results suggest that a randomized trial with a larger sample size and a higher dosage of pravastatin would be helpful in further evaluating the anti-inflammatory properties of pravastatin , its association with improvements in cognitive symptoms , and its potential to reduce positive and negative symptoms associated with schizophrenia or schizoaffective disorders .


To assess the rate of pegaptanib-associated sustained intraocular pressure ( IOP ) elevation .


A posthoc analysis was conducted on all IOP measurements , except the immediate @-min postinjection , from all subjects randomised to pegaptanib @ mg or sham injections continuously in the first @years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation ( V.I.S.I.O.N. ) study .


Measurements were taken with Goldmann applanation tonometer or Tonopen , except at baseline and in cases of an IOP reading > @mmHg when a Goldmann applanation tonometer was mandatory .


Of @ subjects , IOP measurements @mmHg were seen in @/@ and @/@ subjects of the pegaptanib and sham subgroups , respectively ( p = @ ) and measurements @mmHg were observed in eight and eight subjects in the pegaptanib and sham groups , respectively .


More than two measurements @mmHg occurred in six and @ subjects ( p = @ ) , and more than two measurements @mmHg were observed in one and four subjects in the pegaptanib and sham groups , respectively .


One patient with sustained IOP elevation in the pegaptanib study group , and four in the sham group , had IOP lowering medication added during the course of the study .


No subject required glaucoma surgery .


In V.I.S.I.O.N. , after @years , there was no evidence of sustained IOP elevation associated with pegaptanib @ mg use .


Statins are effective cholesterol-lowering agents that reduce cardiovascular disease risk but also have pleiotropic effects that may extend to other lipid classes .


The purpose of this article was to investigate , in a post hoc analysis , the dose-dependent effects of rosuvastatin on plasma sphingolipids and phospholipids in men with the metabolic syndrome .


Subjects ( n = @ ) were studied in a randomized , double-blind , triple-crossover trial of a @-week treatment period with placebo or rosuvastatin ( @ or @ mg/day ) with @-week washouts between treatments .


Plasma sphingolipid profiling was determined by liquid chromatography electrospray ionization-tandem mass spectrometry .


Rosuvastatin at @ mg/d ( R@ ) and @ mg/d ( R@ ) significantly ( all P < @ unless stated otherwise ) lowered plasma cholesterol ( -@ % and -@ % -LSB- % change with R@ and with R@ , respectively -RSB- ) , low-density lipoprotein cholesterol ( -@ % and -@ % ) and triglyceride ( -@ % , P = @ and -@ % ) concentrations .


Compared with placebo , R@ and R@ significantly decreased the plasma levels of total sphingolipids including those of ceramide ( -@ % and -@ % ) , sphingomyelin ( -@ % and -@ % ) , monohexosylceramide ( -@ % and -@ % ) , dihexosylceramide ( -@ % and -@ % ) , and trihexosylceramide ( -@ % and -@ % ) , and GM@ gangliosides ( -@ % and -@ % ) , lysophosphatidylcholine ( -@ % and -@ % ) , alkylphosphatidylcholine ( -@ % and -@ % ) , phosphatidylcholine ( -@ % and -@ % ) , alkenylphosphatidylcholine ( plasmalogen ) ( -@ % and -@ % ) , alkylphosphatidylethanolamine ( -@ % , P = @ and -@ % , P = @ ) , alkenylphosphatidylethanolamine ( plasmalogen ) ( -@ % , P = @ and -@ % , P = @ ) , phosphatidylglycerol ( -@ % , P = @ , -@ % , P = @ ) , and phosphatidylinositol ( -@ % and -@ % ) .


No significant changes were found with phosphatidylethanolamine and phosphatidylserine .


Significant dose effects were found with the majority of the plasma sphingolipids , whereas only phosphatidylcholine , lysophosphatidylcholine , alkylphosphatidylcholine , alkenylphosphatidylcholine ( plasmalogen ) , and phosphatidylinositol had significant dose effects .


Similar changes were found with plasma sphingolipids when results were normalized to the total phosphatidylcholine concentration .


Rosuvastatin dose-dependently lowers plasma sphingolipids and phospholipids , independent of low-density lipoprotein lowering , in men with the metabolic syndrome .


Chronic obstructive pulmonary disease ( COPD ) is frequently misdiagnosed or undiagnosed , which can delay disease management interventions .


The Screening , Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care @ ( SEARCH@ ) study assessed whether screening using the COPD Population Screener ( COPD-PS ) questionnaire to detect COPD risk factors and symptoms , with or without a handheld spirometer ( copd-@ ) to detect airflow limitation , can increase yields of COPD diagnosis and respiratory-related clinician actions in primary care .


A prospective , multi-center , pragmatic , comparative-effectiveness , cluster-randomized study conducted from September @ to October @ ( data analyzed from December @ to January @ ) .


Men and women aged @ years visiting their participating primary care practice for any reason .


Practices were randomized to three study arms : COPD-PS + copd-@ , COPD-PS alone , and usual care ( no interventions ) .


No practices received any specific education about COPD or its diagnosis .


The primary endpoint was yield of new clinical COPD diagnosis ; the secondary endpoint was yield of respiratory-related clinician actions .


Of @,@ patients enrolled , @,@ had no prior COPD diagnosis and were included in endpoint analyses .


Both interventions significantly increased COPD diagnostic yield over @ weeks .


Compared with a mean yield of @ % ( @ % ) ( controls ) , yields were @ % ( @ % ) ( OR = @ , @ % CI = @ , @ , p = @ ) and @ % ( @ % ) ( OR = @ , @ % CI = @ , @ , p = @ ) for COPD-PS and COPD-PS + copd-@ study arms , respectively .


Respiratory-related clinician actions were not significantly different across study arms .


Office-based assessment can significantly increase COPD diagnosis by primary care physicians .


Future trials must evaluate whether screening can improve outcomes for patients with COPD .


To estimate minimally important differences ( MIDs ) for the Visual Activities Questionnaire ( VAQ ) and the National Eye Institute-Visual Function Questionnaire ( NEI-VFQ ) .


A total of @ subjects with newly-diagnosed open-angle glaucoma ( OAG ) was enrolled in the Collaborative Initial Glaucoma Treatment Study ( CIGTS ) and randomized to initial treatment with medications or surgery .


Subjects underwent an ophthalmic examination and telephone-administered quality of life ( QOL ) interview before randomization and every six months thereafter .


The VAQ and NEI-VFQ were used to assess participants ' perceptions of their visual function .


Clinical measures included the mean deviation ( MD ) from Humphrey @-@ full threshold visual field ( VF ) testing , and best-corrected visual acuity ( VA ) measured using the Early Treatment Diabetic Retinopathy Study ( ETDRS ) protocol .


Anchor-based ( using MD and VA ) and distribution-based methods were used to estimate MIDs .


Anchor-based cross-sectional analyses at @ months follow-up found a @-letter increment in better eye VA corresponded to MIDs of @ units for VAQ and @ units for NEI-VFQ total scores .


A @-dB increment in the better eye MD yielded MIDs of @ and @ units for the same two questionnaires .


In longitudinal analyses , MIDs for the VAQ were @ units for a @-letter change of VA and @ units for a @-dB change in the MD. .


Distribution-based MIDs were larger .


A range of MIDs for the VAQ ( @-@ @ units ) and NEI-VFQ ( @-@ @ units ) was found .


Although similar in magnitude , MIDs were sensitive to the MID estimation method , the anchor chosen , and differences between questionnaires .


( ClinicalTrials.gov number , NCT@ . )


Cardiac resynchronization therapy ( CRT ) with multipoint left ventricular ( LV ) pacing in a single coronary sinus branch improves acute LV function .


We hypothesized that multipoint pacing ( MPP ) can improve midterm echocardiographic and clinical response compared with conventional CRT .


Consecutive patients receiving a CRT implant ( Unify Quadra MP or Quadra Assura MP CRT-D and Quartet LV lead , St. Jude Medical , Sylmar , CA , USA ) were randomized to receive biventricular ( BiV ) pacing with either conventional LV pacing ( CONV group ) or MPP ( MPP group ) .


For each patient , an optimal pacing configuration for the assigned pacing mode was programmed based on intraoperative pressure-volume ( PV ) loop measurements .


A clinical evaluation and transthoracic echocardiogram were performed before implant ( BASELINE ) and at @ months postimplant and analyzed by a blinded observer .


A reduction in end-systolic volume ( ESV ) of @ % relative to BASELINE was prospectively defined as response to CRT .


Forty-four patients ( NYHA Class III , EF @ @ % , QRS duration @ @ milliseconds ) were enrolled and randomized .


One patient in the MPP group was lost to follow-up and excluded from further analysis .


After @ months , @ of @ ( @ % ) CONV patients and @ of @ ( @ % ) MPP patients were classified as responders .


ESV reduction , EF increase , and NYHA class reduction relative to BASELINE were significantly greater in the MPP group than in the CONV group ( ESV : -@ @ vs. -@ @ % , P = @ ; EF : +@ @ vs. +@ @ percentage points , P < @ ; NYHA : -@ @ vs. -@ @ functional classes , P = @ ) .


PV loop optimized BiV pacing with MPP resulted in an improved rate of response to CRT .


Diabetes is a risk factor for pancreatic cancer but its association with survival from pancreatic cancer is poorly understood .


Our objective was to investigate the association of diabetes with survival among pancreatic cancer patients in a prospective cohort-based study where diabetes history was ascertained before pancreatic cancer diagnosis .


We evaluated survival by baseline ( @-@ ) self-reported diabetes history ( n = @ ) among @ participants that developed exocrine pancreatic cancer within the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial .


Hazard ratios ( HRs ) and @ % confidence intervals ( CIs ) for mortality were estimated using Cox proportional hazards model , adjusted for age , sex , body mass index , race , smoking , and tumour stage ( local , locally advanced , and metastatic ) .


The multivariable-adjusted HR for mortality comparing participants with diabetes to those without was @ ( @ % CI = @-@ @ , P-value < @ ) .


After excluding those diagnosed with pancreatic cancer within @ years of study enrolment , HR for mortality among those with diabetes was @ ( @ % CI = @-@ @ , P-value = @ ) .


Using prospectively collected data , our findings indicate that diabetes is associated with worse survival among patients with pancreatic cancer .


Korean American ( KA ) parents need a culturally tailored parent training that helps them bridge the Korean and American cultures and divergent parenting practices .


The Korean Parent Training Program ( KPTP ) was pilot tested with @ KA mothers of children between @ and @ years old using a partial group-randomized controlled experimental study design .


Researchers gathered self-report survey and observation data .


Analyses , which used generalized estimating equations , indicated the intervention group mothers increased use of effective parenting practices and their children decreased behavioral problems and reported less acculturation conflict with their mothers .


The KPTP is a promising way to promote effective parenting and increase positive child mental health in KA families .


To assess body composition modifications in post-pubertal schoolchildren after practice of a physical activity program during one school year .


The sample consisted of @ students aged between @ and @ years and divided into two groups : the study group ( SG ) comprised @ students and the control group ( CG ) , @ .


The SG was submitted to a physical activity program and the CG attended conventional physical education classes .


Body composition was assessed using body mass index ( BMI ) , percentage of body fat ( % BF ) , fat mass ( FM ) , and lean mass ( LM ) .


A positive effect of the physical activity program on body composition in the SG ( p < @ ) was observed , as well as on the interaction time x group in all the variables analyzed in both genders .


A reduction in % BF ( mean of differences = -@ % ) and waist circumference ( -@ cm ) , as well as an increase in LM ( +@ kg ) were observed in the SG for both genders , whereas the opposite was observed in the CG .


The practice of programmed physical activity promotes significant reduction of body fat in post-pubertal schoolchildren .


To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants .


Forty mothers with exclusively breast-fed infants were randomized to receive oral cholecalciferol ( vitamin D@ ) @ IU/d for @ days or @,@ IU once .


Maternal serum , breast milk , and urine were collected on days @ , @ , @ , @ , @ , and @ ; infant serum was obtained on days @ and @ .


Enrollment occurred between January @ , @ , and July @ , @ .


In mothers given daily cholecalciferol , concentrations of serum and breast milk cholecalciferol attained steady levels of @ and @ ng/mL , respectively , from day @ through @ .


In mothers given the single dose , serum and breast milk cholecalciferol peaked at @ and @ ng/mL , respectively , at day @ before rapidly declining .


Maternal milk and serum cholecalciferol concentrations were related ( r = @ ) .


Infant mean serum @-hydroxyvitamin D concentration increased from @ to @ ng/mL in the single-dose group and from @ to @ ng/mL in the daily-dose group ( P = @ ) .


All infants achieved serum @-hydroxyvitamin D concentrations of more than @ ng/mL .


Either single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants .


Spontaneous intracerebral hemorrhage ( ICH ) can be devastating , particularly if hematoma expansion ( HE ) occurs .


Tranexamic acid ( TA ) , an antifibrinolytic drug , significantly reduced mortality in bleeding patients after trauma in the large CRASH-@ trial .


The CRASH-@ ICH substudy found that TA nonsignificantly reduced mortality and dependency in traumatic ICH .


The aim of this study was to assess the feasibility of performing a randomized controlled trial of tranexamic acid in spontaneous ICH , ahead of a definitive study .


We performed a single-center , prospective , randomized ( @:@ ) , double-blind , placebo-controlled blinded endpoint trial of TA ( intravenous @ g bolus , @ g infusion/@ h ) in acute ( < @ hours ) spontaneous ICH .


The primary objective was to test the feasibility of recruiting to the trial .


Other objectives included tolerability ( adverse events ) and the effect of TA on HE and death and dependency .


The trial was feasible , with @ patients enrolled ( TA , n = @ ; placebo , n = @ ) between March @ and March @ , and acceptable-only @ patients declined to participate .


All patients received the correct randomized treatment ; @ patient in the TA group did not complete the infusion because of neurologic deterioration .


There were no significant differences in secondary outcomes including adverse events , HE , death , and dependency .


One patient in the TA group had a deep vein thrombosis .


This , the first randomized controlled trial of TA in ICH , found that the protocol could be delivered on schedule ( @ patients/mo ) and was feasible .


Larger studies are needed to assess safety and efficacy of TA in ICH .


Pulmonary vein isolation ( PVI ) is an established method for treatment of drug refractory atrial fibrillation .


The aim of this study was to evaluate whether a more active regular supply of analgesic and sedative drugs reduces pain and discomfort .


We also wanted to evaluate gender differences in pain perception and to compare standard radiofrequency ( RF ) with cryo balloon ablation ( Cryo ) from this perspective .


A total of @ patients , @ men , median age @ ( range @-@ ) years , who underwent PVI under conscious sedation were studied .


They were randomized to either standard treatment with morphine and diazepam ( control group , C ) or to a more active analgesic strategy ( A ) with pre-medication with oral midazolam mixture and intravenous alfentanil and midazolam regularly administrated during the procedure .


Forty patients were treated with RF and @ with Cryo .


The majority of the patients experienced pain during the procedure .


The maximal pain assessed with numerical rating scale ( NRS ) , was lower in the active group compared with that in controls ( p = @ ) .


Women experienced more pain than men ( p = @ ) .


RF was more painful than Cryo ( p < @ ) .


An active regular supply of analgesic and sedative drugs reduce pain and discomfort during PVI .


Women experience more pain than men during this procedure and PVI performed with Cryo is less painful than with RF .


We investigated the role of metformin on glucose kinetics during moderate exercise .


Before , during , and after a @-min bout of exercise at @ % VO@max , glucose kinetics were determined by isotope tracer technique in patients with type @ diabetes mellitus with metformin treatment ( DM@ + Met ) or without metformin treatment ( DM@ ) and in healthy control subjects ( CON ) matched for BMI and age .


Glucoregulatory hormones and metabolites were measured throughout the study .


Plasma glucose concentration was unchanged during exercise in CON but decreased in DM@ .


No significant change was found in DM@ + Met .


Hormones and metabolites showed no differences among the groups except for elevated exercise-induced concentrations of lactate in DM@ ( area under the curve -LSB- AUC -RSB- @ @ % vs. CON ) and glucagon in DM@ ( AUC @ @ % vs. DM@ + Met ) .


Free fatty acid levels were lower in DM@ + Met than in DM@ ( AUC -@ @ % ) .


Absolute values of the baseline glucose rate of appearance ( Ra ) were elevated in DM@ and DM@ + Met , but the increase in glucose Ra relative to baseline was blunted in DM@ ( @ @ % ) and DM@ + Met ( @ @ % ) compared with CON ( @ @ % ) .


Glucose rate of disappearance relative to baseline increased more in CON ( @ @ % ) than in DM@ ( @ @ % ) and DM@ + Met ( @ @ % ) , showing a small increase caused by metformin .


Glucose metabolic clearance rate relative to baseline was similar during exercise in DM@ ( @ @ % ) and CON ( @ @ % ) but was improved in DM@ + Met ( @ @ % ) compared with DM@ .


Metformin has a positive effect on glucose homeostasis during exercise .


To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change ( TTM ) in diabetic smokers attending primary care .


A cluster randomized controlled clinical trial was designed in which the unit of randomization ( intervention vs. usual care ) was the primary care team .


An intensive , individualized intervention using motivational interview and therapies and medications adapted to the patient 's stage of change was delivered .


The duration of the study was @ year .


A total of @ people with diabetes who were smokers ( @ in the intervention group and @ in the control group ) completed the study .


After @ year , continued abstinence was recorded in @ ( @ % ) patients in the intervention group and in @ ( @ % ) controls ( p = @ ) .


In patients with smoking abstinence , there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls ( @ % vs. @ % , p = @ ) .


When the precontemplation stage was taken as reference ( OR = @ ) , preparation/action stage at baseline showed a protective effect , decreasing @ times odds of continuing smoking ( OR = @ @ % CI @-@ @ , p < @ ) .


Contemplation stage at baseline also showed a protective effect , decreasing the odds of continuing smoking ( OR = @ , @ % CI @-@ @ , p = @ ) .


An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective , with a smoking cessation rate of @ % after @ year .


To observe the clinical effect of Yangyin Yiqi Huoxue Recipe ( YYHR , the basic recipe of Yangyin Tongnao Granule ) in treatment of ischemic stroke patients of deficiency of qi and yin syndrome ( DQYS ) and static blood obstructing collaterals syndrome ( SBOCS ) .


Totally @ patients were assigned to the control group ( @ cases ) and the treatment group ( @ cases ) using strati - fied randomized allocation method .


Patients in the treatment group were treated with modified YYHR , while those in the control group took Xueshuan Xinmaining .


The treatment course was @ weeks for all .


Constituent ratios of the acute stage and the recovery stage of DQYS and SBOCS and their complicated syndromes were observed in the two groups .


Changes of the clinical curative effect , clinical symptoms integral , whole blood viscosity ratio , plasma viscosity ratio , hematocrit , erythrocyte sedimentation rate ( ESR ) , total cho - lesterol ( TC ) , triglyceride ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , and low density lipoprotein cholesterol ( LDL-C ) were detected in the two groups before and after treatment .


There was statistical difference in constituent ratios of the acute stage and the recovery stage of DQYS SBOCS and its complicated syndromes between the two groups ( P < @ ) .


DQYS and SBOCS was basic syndrome types of the two groups .


The cured and markedly effective rate was @ % ( @/@ ) in the treatment group and @ % ( @/@ ) in the control group .


The total effective rate was @ % ( @/@ ) in the treatment group , higher than that of the control group ( @ % , @/@ ) with statistical difference ( P < @ ) .


There was statistical difference in the clinical symptoms integral , whole blood viscosity ratio , plasma viscosity ratio , hematocrit , ESR , TC , TG,HDL-C , and LDL-C ( P < @ , P < @ ) .


Symptoms of ischemic stroke patients could be improved by modified YYHR .


Indices such as the whole blood viscosity , plasma viscosity ratio , hematocrit , ESR , abnormal metabolism of blood lipids were also significantly improved .


Pathological changes of blood stasis induced by qi-yin deficiency exist in ischemic stroke patients , and DQYS and SBOCS were basic syndrome types .


Motivational and cognitive deficits are core features of schizophrenia , both closely linked with functional outcomes .


Although poor effort and decreased motivation are known to affect performance on cognitive tests , the extent of this relationship is unclear in patients with schizophrenia .


To evaluate the association between intrinsic motivation and cognitive test performance in patients with schizophrenia .


Cross-sectional and @-month prospective follow-up study performed at @ sites in the United States , including academic and community medical treatment centers , participating in the Clinical Antipsychotic Trials of Intervention Effectiveness study .


The primary sample included @ stable patients with a DSM-IV diagnosis of schizophrenia currently receiving a stable medication regimen .


Cognitive performance and intrinsic motivation were evaluated using a comprehensive neuropsychological test battery and a derived measure from the Heinrichs-Carpenter Quality of Life Scale , respectively .


Symptom severity and functional status were also assessed .


The primary outcome variable was global neurocognition .


Individual domains of cognition were also evaluated for their association with motivation .


Level of intrinsic motivation was significantly and positively correlated with global cognitive test performance , a relationship that held for each domain of cognition evaluated ( correlation range , @-@ @ ; P < @ ) .


This association was found to be reliable after statistically accounting for positive , negative , depressive , and overall symptom severity ( P < @ ) and after accounting for community functioning ( P < @ ) .


The relationship between motivation and cognitive performance also remained significant after controlling for antipsychotic dose ( P < @ ) .


Prospective increase in motivation during the @-month follow-up was also found to be significantly related to improvement in global cognitive performance ( P < @ ) .


The present findings provide strong support for a robust and reliable relationship between motivation and cognitive performance and suggest that test performance is not purely a measure of ability .


Future studies assessing cognition in patients with schizophrenia should consider potential moderating variables such as effort and motivation .


Implications for the assessment and interpretation of cognitive impairment based on neuropsychological test measures in schizophrenia are discussed , especially in the case of clinical trials for cognition-enhancing treatments .


We explored the hypothesis that injured neurons release lipocalin-@ as a help me signal .


In vivo lipocalin-@ responses were assessed in rat focal cerebral ischemia and human stroke brain samples using a combination of ELISA and immunostaining .


In vitro , microglia and astrocytes were exposed to lipocalin-@ , and various markers and assays of glial activation were quantified .


Functional relevance of neuron-to-glia lipocalin-@ signaling was examined by transferring conditioned media from lipocalin-@-activated microglia and astrocytes onto neurons to see whether activated glia could protect neurons against oxygen-glucose deprivation and promote neuroplasticity .


In human stroke samples and rat cerebral ischemia , neuronal expression of lipocalin-@ was significantly increased .


In primary cell cultures , exposing microglia and astrocytes to lipocalin-@ resulted in glial activation .


In microglia , lipocalin-@ converted resting ramified shapes into a long-rod morphology with reduced branching , increased interleukin-@ release , and enhanced phagocytosis .


In astrocytes , lipocalin-@ upregulated glial fibrillary acid protein , brain-derived neurotropic factor , and thrombospondin-@ .


Conditioned media from lipocalin-@-treated astrocytes upregulated synaptotagmin , and conditioned media from lipocalin-@-treated microglia upregulated synaptophysin and post-synaptic density @ ( PSD@ ) and protected neurons against oxygen-glucose deprivation .


These findings provide proof of concept that lipocalin-@ is released by injured neurons as a help me distress signal that activates microglia and astrocytes into potentially prorecovery phenotypes .


We compared the antihypertensive effect of valsartan ( VAL ) and amlodipine ( AML ) treatments in elderly hypertensive patients by examining the long-term changes in cognitive function and auditory P@ event-related potentials .


We enrolled @ outpatients , including @ men and @ women in the age group of @ to @ years who had mild to moderate essential hypertension .


The subjects were randomly allocated to receive either @ mg VAL once a day ( @ patients ) or @ mg AML once a day ( @ patients ) .


Neuropsychological assessment and auditory P@ event-related potentials were obtained before initiation of VAL or AML treatment and after @ months of the treatment with VAL or AML .


Neuropsychological assessment was evaluated by conducting the Mini-Mental State Examination , the verbal fluency , word-list memory , word-list recall test , word-list recognition , and Trails B tests .


Both the groups showed significantly reduced-blood pressure after @ months of treatment , and the intergroup difference was not significant .


The mean baseline Mini-Mental State Examination scores of the VAL and AML groups were not significantly different .


Amlodipine treatment did not significantly affect any test score , but VAL treatment significantly increased the word-list memory and word-list recall test scores .


Valsartan , and not AML , significantly reduced the mean P@ latency after @ months .


These results suggest that VAL exerts a positive effect on cognitive functions , independent of its antihypertensive effect .


Spasmodic dysphonia ( SD ) can be difficult to diagnose , and patients often see multiple physicians for many years before diagnosis .


Improving the speed of diagnosis for individuals with SD may decrease the time to treatment and improve patient quality of life more quickly .


To assess whether the diagnosis of SD can be accurately predicted through auditory cues alone without the assistance of visual cues offered by laryngoscopic examination .


Single-masked , case-control study at a specialized referral center that included patients who underwent laryngoscopic examination as part of a multidisciplinary workup for dysphonia .


Twenty-two patients were selected in total : @ with SD , @ with vocal tremor , and @ controls without SD or vocal tremor .


The laryngoscopic examination was recorded , deidentified , and edited to make @ media clips for each patient : video alone , audio alone , and combined video and audio .


These clips were randomized and presented to @ fellowship-trained laryngologist raters ( A.D.R. , A.T.H. , and A.M.K. ) , who established the most probable diagnosis for each clip .


Intrarater and interrater reliability were evaluated using repeat clips incorporated in the presentations .


We measured diagnostic accuracy for video-only , audio-only , and combined multimedia clips .


These measures were established before data collection .


Data analysis was accomplished with analysis of variance and Tukey honestly significant differences .


Of patients with SD , diagnostic accuracy was @ % , @ % , and @ % for video-only , audio-only , and combined , respectively ( P < @ , df = @ ) .


Of patients with vocal tremor , diagnostic accuracy was @ % , @ % , and @ % for video-only , audio-only , and combined , respectively ( P = @ , df = @ ) .


Of the controls , diagnostic accuracy was @ % , @ % , and @ % for video-only , audio-only , and combined , respectively ( P < @ , df = @ ) .


The diagnosis of SD during examination is based primarily on auditory cues .


Viewing combined audio and video clips afforded no change in diagnostic accuracy compared with audio alone .


Laryngoscopy serves an important role in the diagnosis of SD by excluding other pathologic causes and identifying vocal tremor .


Overexpression of epidermal growth factor receptor ( EGFR ) in many cancers makes it an attractive therapeutic target .


This study evaluated the clinical utility of nimotuzumab , a monoclonal anti-EGFR antibody , used concurrently with radiotherapy ( RT ) and chemoradiotherapy ( CRT ) in squamous cell carcinoma of the head and neck ( SCCHN ) .


This open-label study randomized @ treatment-nave patients ( @:@ ) with advanced SCCHN into chemoradiation ( CRT nimotuzumab ) or radiation ( RT nimotuzumab ) group by investigator 's discretion ; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups , respectively .


Treatment included @ cycles each of cisplatin ( @ mg/week ) , nimotuzumab ( @ mg/week ) , and RT ( total dose , @-@ Gy ) .


Response ( tumor size reduction ) was assessed at Month @ post-treatment and survival , at Month @ .


Forty and @ patients in the chemoradiation and radiation groups , respectively ( intent-to-treat population ) were evaluated .


Overall response at Month @ post-treatment was @ % with CRT + nimotuzumab , @ % with CRT , @ % with RT + nimotuzumab , and @ % with RT. .


At Month @ , overall survival was @ % with CRT + nimotuzumab , @ % with CRT ( P = @ ) , @ % with RT + nimotuzumab , and @ % with RT ( P > @ ) .


Median overall survival was not reached for CRT + nimotuzumab ; it was @ months for CRT ( P = @ ) , @ months for RT + nimotuzumab , and @ months for RT ( P = @ ) .


Risk of death was @ % lower with CRT + nimotuzumab than with CRT ( @ % CI : @ , @ ) , and @ % lower with RT + nimotuzumab than with RT ( @ % CI : @ , @ ) .


Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events .


Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit .


Sequential therapy is a two-step therapy achieving a promising eradication rate for Helicobacter pylori infection .


The rationale of sequential method has been proposed that amoxicillin weakens bacterial cell walls in the initial phase of treatment , preventing the development of drug efflux channels for clarithromycin and metronidazole used in the second phase .


The aim of this prospective , randomized , controlled study was to investigate whether the efficacy of reverse sequential therapy was noninferior to sequential therapy in the treatment of H.pylori infection .


From January @ to December @ , consecutive H.pylori-infected patients were randomly assigned to receive either sequential therapy ( a @-day dual therapy with pantoprazole plus amoxicillin , followed by a @-day triple therapy with pantoprazole plus clarithromycin and metronidazole ) or reverse sequential therapy ( a @-day triple therapy with pantoprazole plus clarithromycin and metronidazole , followed by a @-day dual therapy with pantoprazole plus amoxicillin ) .


H.pylori status was examined @weeks after the end of treatment by rapid urease and histology or urea breath test .


One hundred and twenty-two H.pylori-infected participants were randomized to receive sequential ( n = @ ) or reverse sequential therapy ( n = @ ) .


The eradication rates , by intention-to-treat analysis , were similar : @ % ( @ % confidence interval ( CI ) : @-@ @ % ) for sequential therapy and @ % ( @ % CI : @-@ @ % ) for reverse sequential therapy ( p = @ ) .


Per-protocol analysis also showed similar results : @ % ( @ % CI : @-@ @ % ) for sequential group and @ % ( @ % CI : @-@ @ % ) for reverse sequential therapy ( p = @ ) .


The two treatments exhibited comparable frequencies of adverse events ( @ % vs @ % , respectively ) and drug compliance ( @ % vs @ % , respectively ) .


The overall resistance rates of antibiotics were clarithromycin @ % , amoxicillin @ % , and metronidazole @ % of patients , respectively .


The dual resistance rate of clarithromycin and metronidazole was @ % .


Both therapies achieved a high eradication rate for clarithromycin-resistant strains ( @ % vs @ % , respectively ) and metronidazole-resistant strains ( @ % vs @ % , respectively ) by intention-to-treat analysis .


Ten-day reverse sequential therapy and standard sequential therapy are equally effective for H.Pylori eradication .


The finding indicates that the sequence of antibiotics administered in sequential therapy does not influence the efficacy of the treatment .


The phase III North American Intergroup E@ Trial ( Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin 's Lymphoma ) compared doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) with mechlorethamine , doxorubicin , vincristine , bleomycin , vinblastine , etoposide , and prednisone ( Stanford V ) .


We report results of a planned subgroup analysis in patients with stage I or II bulky mediastinal Hodgkin lymphoma ( HL ) .


Patients were randomly assigned to six to eight cycles of ABVD every @ days or Stanford V once per week for @ weeks .


Two to @ weeks after completion of chemotherapy , all patients received @ Gy of modified involved field radiotherapy ( IFRT ) to the mediastinum , hila , and supraclavicular regions .


Patients on the Stanford V arm received IFRT to additional sites @ cm at diagnosis .


Primary end points were failure-free survival ( FFS ) and overall survival ( OS ) .


Of @ eligible patients , @ had stage I or II bulky disease , @ received ABVD , and @ received Stanford V. Patient characteristics were matched .


The overall response rate was @ % with ABVD and @ % with Stanford V.


At a median follow-up of @ years , the study excluded a difference of more than @ % in @-year FFS and more than @ % in @-year OS between ABVD and Stanford V ( @-year FFS : @ % v @ % ; HR , @ ; @ % CI , @ to @ ; P = @ ; @-year OS : @ % v @ % ; HR , @ ; @ % CI , @ to @ ; P = @ ) .


In-field relapses occurred in < @ % of the patients in each arm .


For patients with stage I or II bulky mediastinal HL , no substantial statistically significant differences were detected between the two regimens , although power was limited .


To the best of our knowledge , this is the first prospective trial reporting outcomes specific to this subgroup , and it sets a benchmark for comparison of ongoing and future studies .


Hepatic encephalopathy ( HE ) is a common cause of hospitalization in patients with cirrhosis .


Pharmacologic treatment for acute ( overt ) HE has remained the same for decades .


To compare polyethylene glycol @-electrolyte solution ( PEG ) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE .


We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose .


The HELP ( Hepatic Encephalopathy : Lactulose vs Polyethylene Glycol @-Electrolyte Solution ) study is a randomized clinical trial in an academic tertiary hospital of @ patients with cirrhosis ( of @ screened ) admitted for HE .


Participants were block randomized to receive treatment with PEG , @-L dose ( n = @ ) , or standard-of-care lactulose ( n = @ ) during hospitalization .


The primary end point was an improvement of @ or more in HE grade at @ hours , determined using the hepatic encephalopathy scoring algorithm ( HESA ) , ranging from @ ( normal clinical and neuropsychological assessments ) to @ ( coma ) .


Secondary outcomes included time to HE resolution and overall length of stay .


A total of @ patients were randomized to each treatment arm .


Baseline clinical features at admission were similar in the groups .


Thirteen of @ patients in the standard therapy arm ( @ % ) had an improvement of @ or more in HESA score , thus meeting the primary outcome measure , compared with @ of @ evaluated patients receiving PEG ( @ % ) ( P < @ ) ; @ patient was discharged before final analysis and @ refused participation .


The mean ( SD ) HESA score at @ hours for patients receiving standard therapy changed from @ ( @ ) to @ ( @ ) compared with a change from @ ( @ ) to @ ( @ ) for the PEG-treated groups ( P = @ ) .


The median time for HE resolution was @ days for standard therapy and @ day for PEG ( P = @ ) .


Adverse events were uncommon , and none was definitely study related .


PEG led to more rapid HE resolution than standard therapy , suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE .


Iosimenol @ injection is a new , dimeric , iso-osmolar , iodinated contrast medium for X-ray angiography .


To compare the safety and efficacy of iosimenol injection to iodixanol injection in two randomized , controlled phase @ trials .


One hundred and forty-four adult patients were enrolled in the two trials , one for evaluation during arteriography and the other for evaluation during computed tomography .


Safety was compared by assessing adverse events , vital signs , ECGs , and laboratory parameters .


Efficacy was assessed as X-ray attenuation in the computed tomography ( CT ) trial and as the quality of contrast enhancement in the arteriography trial .


There were no statistically significant differences in terms of safety or efficacy between the two contrast media .


Both were well tolerated upon intravenous as well as intra-arterial injection .


The most common adverse event was a feeling of warmth ( observed in @ % of the patients with Iosimenol injection and @ % with iodixanol injection ) .


Iosimenol upon intravenous as well as upon intra-arterial injection exhibits a safety profile and shows an efficacy similar to that of iodixanol .


The harmonic scalpel ( HS ) has been used successfully in several head and neck surgical procedures .


Some authors highlighted its advantages in reducing operative time , blood loss , and damages to surrounding tissue .


In our study , we compared the results obtained during parotidectomy using the HS with the traditional approach to determine the benefits of the HS .


@ patients with benign parotid tumors were enrolled and randomized into two groups for this prospective study .


@ patients underwent HS parotidectomy , and @ patients received a parotidectomy using cold instruments and bipolar electrocautery hemostatic control ( CI ) .


@ HS and @ CI patients did not meet the inclusion criteria requirements , and were excluded .


The admission time was significantly shorter in the HS group than the CI group ( @ @ days and @ @ days , respectively , p < @ ) .


In the early post-operative period , @ % of HS patients and @ % of CI cases showed no facial nerve impairment ( p = @ ) .


Significantly more CI patients than HS patients showed the onset of Frey 's syndrome ( @ % and @ % , respectively , p = @ ) .


Multivariate stepwise regression analysis confirmed the reduction in admission length ( Odds Ratio ( OR ) : @ ; p = @ ) and the lower risk of Frey 's syndrome ( OR : @ ; p = @ ) in HS compared to CI parotidectomies .


In parotid surgery , the HS is useful in preventing Frey 's syndrome and reducing early transitory facial nerve dysfunction and admission times , and results in decreased medical costs and increased quality of life .


To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release ( ER ; @-@ mg bid ) based on patient-specific factors , including baseline pain intensity , prior opioid experience , gender , and body mass index ( BMI ) .


Data were pooled from three randomized , double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe , chronic osteoarthritis knee pain ( NCT@ , NCT@ ) or low back pain ( NCT@ ) .


In the original trials , patients were recruited at primary , secondary , and tertiary care centers , institutional settings , and private practices in North America , Europe , Australia , and New Zealand .


Data were analyzed separately for groups of patients divided by baseline pain intensity , prior opioid experience , gender , and BMI .


Patients received twice-daily placebo , tapentadol ER ( @-@ mg ) , or oxycodone HCl controlled release ( CR ; @-@ mg ) for a @-week titration and @-week maintenance period .


Changes from baseline in average pain intensity ( @-point numerical rating scale ) at week @ of the maintenance period and for the overall maintenance period .


Efficacy and tolerability were evaluated in @,@ and @,@ patients , respectively .


The efficacy of tapentadol ER was shown in subpopulations divided by baseline pain intensity , prior opioid experience , gender , and BMI .


Tapentadol ER was also shown to be well tolerated and associated with better gastrointestinal tolerability than oxycodone CR in the evaluated subpopulations ( divided by prior opioid experience and gender ) .


Results suggest that tapentadol ER ( @-@ mg bid ) provides similar pain relief and tolerability , regardless of baseline pain intensity , prior opioid experience , gender , or BMI .


Primary results from the phase @ ALSYMPCA trial showed that radium-@ dichloride ( radium-@ ) , a targeted - emitter , improved overall survival compared with placebo and was well tolerated in patients with castration-resistant prostate cancer and symptomatic bone metastases .


We did a prespecified subgroup analysis from ALSYMPCA to assess the effect of previous docetaxel use on the efficacy and safety of radium-@ .


In the phase @ , randomised , double-blind ALSYMPCA trial , patients with symptomatic castration-resistant prostate cancer , at least two symptomatic bone metastases , no known visceral metastases , and who were receiving best standard of care were randomly assigned ( @:@ ) via an interactive voice response system to receive six injections of radium-@ ( @ kBq/kg intravenously ) or matching placebo , with one injection given every @ weeks .


Patients had either received previous docetaxel treatment or were unsuitable for or declined docetaxel ; previous docetaxel use ( yes or no ) was a trial stratification factor .


We investigated the effect of previous docetaxel use on radium-@ treatment for the primary endpoint of overall survival , the main secondary efficacy endpoints , and safety .


Efficacy analyses were done for the intention-to-treat population ; safety analyses were done for the safety population .


The trial has been completed and is registered with ClinicalTrials.gov , number NCT@ .


Randomisation took place between June @ , @ , and Feb @ , @ ( @ % ) of @ randomly assigned patients had received previous docetaxel treatment ( @ in the radium-@ group and @ in the placebo group ) and @ ( @ % ) had not ( @ in the radium-@ group and @ in the placebo group ) .


Radium-@ prolonged median overall survival compared with placebo , irrespective of previous docetaxel use ( previous docetaxel use , hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p = @ ; no previous docetaxel use , HR @ , @-@ ; p = @ ) .


The benefit of radium-@ compared with placebo was seen in both docetaxel subgroups for most main secondary efficacy endpoints ; risk for time to time to first symptomatic skeletal event was reduced with radium-@ versus placebo in patients with previous docetaxel use , but the difference was not significant in those with no previous docetaxel use .


@ ( @ % ) of @ patients previously treated with docetaxel had grade @-@ adverse events , compared with @ ( @ % ) of @ patients without docetaxel .


Patients who had previously been treated with docetaxel had a higher incidence of grade @-@ thrombocytopenia with radium-@ than with placebo ( @ -LSB- @ % -RSB- of @ patients vs five -LSB- @ % -RSB- of @ patients ) , whereas the incidence was similar between treatment groups among patients with no previous docetaxel use ( seven -LSB- @ % -RSB- of @ patients vs one -LSB- @ % -RSB- of @ patients ) .


The incidences of grade @-@ anaemia and neutropenia were similar between the radium-@ and placebo groups within both docetaxel subgroups .


Radium-@ is effective and well tolerated in patients with castration-resistant prostate cancer and symptomatic bone metastases , irrespective of previous docetaxel use .


The objectives of this study were as follows : ( @ ) to evaluate frontal sinus ostial patency following balloon dilation with the Ventera Sinus Dilation System , compared with frontal sinusotomy ( Draf @a ) ; and ( @ ) to compare mean blood loss and mean surgical time for frontal sinusotomy using balloon dilation compared with traditional surgical methods .


A single blinded , randomized , controlled , prospective study was performed at St. Paul 's Sinus Center , Vancouver , a tertiary referral rhinology center .


Thirty patients undergoing functional endoscopic sinus surgery ( FESS ) for chronic rhinosinusitis ( CRS ) were randomized to a hybrid approach with exposure of the frontal recess using standard instrumentation and then balloon dilation of @ frontal sinus drainage pathway and traditional frontal sinusotomy for the opposite side .


Blood loss and surgical time for opening the frontal sinus drainage pathway was recorded for each side .


Patients acted as their own controls .


Ostial patency and size were assessed @ weeks and @ months postoperatively using endoscopy .


Ostial patency was also recorded at @ year following surgery .


All frontal sinus ostia in both groups ( n = @ ) were successfully opened and were patent with both techniques @ months postoperatively .


All frontal sinus ostia assessed at @ year ( @ % ) remained patent and none required revision frontal surgery .


Balloon dilation showed a mean surgical time of @ seconds compared to @ seconds for traditional FESS ( p = @ ) .


Mean blood loss was less with balloon dilation ( @ mL vs @ mL ; p = @ ) .


A hybrid balloon technique successfully dilates the frontal sinus drainage pathway with reduced blood loss .


Also , short-term patency appears to be comparable to traditional frontal sinusotomy .


Hematopoietic cell transplantation ( HCT ) may be detrimental to bone health and vitamin D status in children .


We conducted a prospective , multicenter cohort study to identify changes in bone health markers during the first @ days after allogeneic HCT in @ children .


Bone mineral density ( BMD ) , bone mineral content ( BMC ) , and serum @-hydroxyvitamin D ( @OHD ) concentrations were measured at baseline , @ days , and @ days after HCT .


Mean ( SD ) BMD and BMC Z-scores ( -@ @ and -@ @ , respectively ) were normal at baseline .


Repeated-measures analysis revealed significant declines in BMD and BMC Z-scores over the @ day study period , when adjusted for age , sex , Tanner stage , lean mass , fat mass , resting energy expenditure , total energy intake , insulin sensitivity , serum phosphorus , and inpatient steroid intake .


Adjusted mean ( SE ) @OHD concentrations declined from @ ( @ ) ng/ml at baseline , to @ ( @ ) ng/ml at @ days after HCT .


Vitamin D deficiency ( @OHD < @ng/ml ) was present in @ % of patients @ days after HCT .


Significant bone loss and vitamin D deficiency occur in children in the first @ days following allogeneic HCT .


Strategies to diminish acute bone loss during HCT in children are needed .


We compared the efficacy and safety of anterior colporrhaphy with transvaginal polypropylene mesh insertion for anterior vaginal wall prolapse at medium term followup .


In this prospective , randomized , controlled trial @ women with stage II or greater anterior vaginal wall prolapse assessed by POP-Q were randomized to anterior colporrhaphy ( controls ) or mesh insertion .


Anatomical outcomes were assessed by POP-Q measurement and prolapse stage .


Subjective outcomes and quality of life impact were evaluated by ICIQ questionnaires .


We evaluated the procedure safety profile according to intraoperative complication rates throughout followup .


In the mesh and control groups @ and @ women completed the @-month followup .


Point Ba did not significantly differ between the groups at baseline but at @-month followup it had significantly improved in the mesh group compared to controls .


However , no difference was found between the groups when considering @ cure criteria on prolapse stage and subjective parameters .


Asymptomatic mesh exposure developed on the anterior vaginal wall prolapse in @ patients ( @ % ) in the mesh group .


Minor mesh related complications consisted of mesh exposure , prepubic ecchymosis and groin pain , of which most were treated conservatively .


Urinary retention was treated surgically .


Nazca TC and anterior colporrhaphy provided good overall anatomical outcomes during a minimum @-month followup .


Vaginal and urinary symptoms , and quality of life improved postoperatively in each group .


From the patient perspective Nazca TC did not show superior overall outcomes compared to anterior colporrhaphy performed with or without a retropubic sling .


Severe atopic dermatitis ( AD ) has a high unmet need for effective and safe therapeutics .


In early-phase trials , dupilumab , a fully human mAb targeting IL-@ receptor , markedly improved disease activity , but the effect of IL-@ / IL-@ blockade on AD at the molecular level has not been characterized .


We sought to evaluate dupilumab modulation of the AD molecular signature .


We performed transcriptomic analyses of pretreatment and posttreatment skin biopsy specimens from patients with moderate-to-severe AD treated weekly with @ or @ mg of dupilumab or placebo .


Exacerbation of the AD transcriptome was observed in placebo-treated patients .


Dupilumab improved the AD signature in a dose-dependent manner .


Expression of genes upregulated in AD lesions decreased in patients treated with dupilumab by @ % ( @ % CI , @ % to @ % ) and @ % ( @ % CI , @ % to @ % ) for treatment with @ and @ mg , respectively .


Genes downregulated in AD lesions increased by @ % ( @ % CI , @ % to @ % ) and @ % ( @ % CI , @ % to @ % ) with dupilumab ( @ and @ mg , respectively ) .


The molecular changes paralleled improvements in clinical scores .


Adupilumab treatment signature of @ probes ( > @-fold change , P < @ ) significantly modulated in the @-mg dupilumab group at week @ compared with baseline was identified in this sample set .


Significant ( P < @ ) decreases in mRNA expression of genes related to hyperplasia ( K@ and MKI@ ) , T cells , and dendritic cells ( CD@b and CD@c ) and potent inhibition of TH@-associated chemokines ( CCL@ , CCL@ , CCL@ , and CCL@ ) were noted without significant modulation of TH@-associated genes ( IFNG ) .


This is the first report showing rapid improvement of the AD molecular signature with targeted anti-IL-@ receptor therapy .


These data suggest that IL-@ and IL-@ drive a complex , TH@-centered inflammatory axis in patients with AD .


We assessed the effect of cholecalciferol and calcium supplementation on mRNA expression of cathelicidin ( LL-@ ) , Th@ and Th@ cytokines and their transcription factors in the peripheral blood mononuclear cells ( PBMCs ) in healthy females with vitamin D deficiency ( VDD ) .


Subjects included @ females with biochemical VDD randomized to receive ( a ) oral cholecalciferol ( @,@ IU/week for @ weeks followed by @,@ IU/fortnight ( b ) calcium ( elemental calcium @ mg twice/day ) ( c ) , dual supplementation and ( d ) placebo for @ months .


The mRNA expression of cathelicidin , Th@ ( IFN - ) and Th@ ( IL-@ and its antagonist-IL-@ ) cytokines and their transcription factors ( T-bet , STAT@ , GATA-@ , STAT@ ) were measured in the PBMC by real-time PCR before and after intervention .


Cholecalciferol-supplemented groups showed significant rise of mean serum @ ( OH ) D ( @ @ and @ @ ng/ml ) .


The expression of LL-@ , IFN - , IL-@ , IL-@ and transcription factors were comparable in the four groups at baseline .


Despite significant increase in mean serum @ ( OH ) D in the cholecalciferol-supplemented groups , their mean mRNA transcripts of LL-@ , IFN - , IL-@ , transcription factors and their IFN - / IL-@ and T-bet/GATA -@ ratios were similar to that of calcium and placebo groups .


Six months of cholecalciferol/calcium supplementation in young females with VDD do not lead to significant alteration in mRNA expression of LL-@ , Th@/Th@ cytokines and their transcription factors .


Evaluate ustekinumab , an anti-interleukin ( IL ) -@ and IL-@ antibody , effects on radiographic progression in psoriatic arthritis ( PsA ) .


We conducted preplanned integrated analyses of combined radiographic data from PSUMMIT-@ and PSUMMIT-@ phase @ , randomised , controlled trials .


Patients had active PsA despite prior conventional and/or biologic disease-modifying antirheumatic drugs ( @/@ swollen , @/@ tender joints , C-reactive protein @ mg/L , documented plaque psoriasis ) .


Patients ( PSUMMIT-@ , n = @ ; PSUMMIT-@ , n = @ ) were randomised to ustekinumab @ mg , @ mg , or placebo , at weeks ( wk ) @ , @ and every ( q ) @ wks .


At wk @ , patients with < @ % improvement in tender/swollen joint counts entered blinded early escape .


All other placebo patients received ustekinumab @ mg at wk @ and wk @ , then q @ wks .


Radiographs of hands/feet at wks @/@/@ were assessed using PsA-modified van der Heijde-Sharp ( vdH-S ) scores ; combined PSUMMIT-@ and PSUMMIT-@ changes in total vdH-S scores from wk @ to wk @ comprised the prespecified primary radiographic analysis .


Treatment effects were assessed using analysis of variance on van der Waerden normal scores ( factors = treatment , baseline methotrexate usage , and study ) .


Integrated data analysis results indicated that ustekinumab-treated patients ( regardless of dose ) demonstrated significantly less radiographic progression at wk @ than did placebo recipients ( wk @-@ total vdH-S score mean changes : @-combined / individual ustekinumab dose groups , @-placebo ; all p < @ ) .


From wk @ to wk @ , inhibition of radiographic progression was maintained for ustekinumab-treated patients , and progression was substantially reduced among initial placebo recipients who started ustekinumab at wk @ or wk @ ( wk @ - wk @ , total vdH-S score mean change : @ ) .


Ustekinumab @ and @ mg treatments significantly inhibited radiographic progression of joint damage in patients with active PsA .


Obesity is one of the greatest public health challenges world wide and its prevalence has increased during the past @-@ years .


Obesity is related to physical and mental health and increased mortality .


There are few evidence-based treatment options for the obese available in Iceland .


The purpose of this pilot study was to develop a @ week group program based on Cognitive Behavior Therapy and Appetite Awareness Training for young obese women .


The participants were randomly allocated to two groups , A and B , in a convenience sample of @ women , aged @-@ with a BMI @-@ @ kg/m .


Group A attended the program while group B served as a control in a crossover design where group B subsequently participated in the program .


The effectiveness of the program was evaluated before , during and at the end of the program and at six and twelve month follow-up .


Information was collected on body weight , BMI , body fat and body fat mass , blood pressure , cholesterol , triglyceride , high density lipoprotein and @ ( OH ) D , quality of life ( SF-@ and OP scale ) , symptoms of depression ( BDI-II ) and anxiety ( BAI ) .


Additionally participants completed a questionnaire on demographics and their view on participating in the program was assessed .


Participants reduced their weight ( P = @ ) , BMI ( P = @ ) , body fat ( P = @ ) , body fat mass ( P = @ ) , diastolic blood pressure ( P = @ ) and vitamin D status improved ( P = @ ) .


Symptoms of depression and anxiety decreased ( P < @ and P < @ ) .


Quality of life measured with OP scale improved ( P = @ ) and the mental component summary ( MCS ) ( P = @ ) of the SF-@ scale .


The mean weight loss was @ kg following intervention which was maintained at follow up .


`` The enjoy eating '' program is a promising health promotion approach in the health care sector for obese women to improve mental health , quality of life and loose weight .


More than @ million children globally do not attain their developmental potential .


We hypothesized that a parent training program could be integrated into primary health center visits and benefit child development .


We conducted a cluster randomized trial in the Caribbean ( Jamaica , Antigua , and St Lucia ) .


Fifteen centers were randomly assigned to the control ( n = @ mother-child pairs ) and @ to the intervention ( n = @ mother-child pairs ) groups .


Participants were recruited at the @ - to @-week child health visit .


The intervention used group delivery at @ routine visits from age @ to @ months and comprised short films of child development messages , which were shown in the waiting area ; discussion and demonstration led by community health workers ; and mothers ' practice of activities .


Nurses distributed message cards and a few play materials .


Primary outcomes were child cognition , language , and hand-eye coordination and secondary outcomes were caregiver knowledge , practices , maternal depression , and child growth , measured after the @-month visit .


Eight-five percent of enrolled children were tested ( control = @ , intervention = @ ) .


Loss did not differ by group .


Multilevel analyses showed significant benefits for cognitive development ( @ points ; @ % confidence interval : @ to @ points ; effect size : @ SDs ) .


There were no other child benefits .


There was a significant benefit to parenting knowledge ( treatment effect : @ ; @ % confidence interval : @ to @ ; effect size : @ ) .


An innovative parenting intervention , requiring no additional clinic staff or mothers ' time , was integrated into health services , with benefits to child cognitive development and parent knowledge .


This is a promising strategy that merits further evaluation at scale .


To explore the effect of ear acupressure in relieving perineal pain in women during the first @ hours after delivery .


Perineal pain is a common problem during postpartum , and different treatment modalities have been used for relief .


Ear acupressure has been reported to have possible benefit on relieving acute postpartum perineal pain .


This study was designed as a prospective , randomised controlled trial .


Chinese women with a singleton vertex foetus at the gestation of @ weeks or above were recruited .


One hundred and twenty six and @ women were randomised into the intervention and control groups , respectively .


Women in the intervention group received application of tapes and seeds on four designated acupressure points on both ears , while women in the control group received tapes on four irrelevant points .


Both groups were instructed to stimulate the points in a similar fashion .


Pain perception was assessed by the Verbal Descriptive Pain Scale and the Visual Analogue Scale , and the consumption of analgesics was also reviewed .


No significant difference in perineal pain perception between the groups was observed in Verbal Descriptive Pain Scale .


Although the mean Visual Analogue Scale and the accumulative mean consumption of paracetamol were generally lower in the intervention group , statistical significance was not reached .


There is no evidence so far to conclude that ear acupressure can effectively relieve perineal pain based on the statistical results .


Further research is suggested to explore whether the effectiveness of pain relief is affected by the frequency and duration of acupressure point stimulation .


Training of midwives to perform this intervention is easy to achieve , but further evidence is required to prove its effectiveness .


A wealth of evidence has indicated that labor epidural analgesia is associated with an increased risk of hyperthermia and overt clinical fever .


Recently , evidence is emerging that the epidural analgesia-induced fever is associated with the types of the epidural analgesia and the variations in the epidural analgesia will affect the incidence of fever .


The aim of the present study was to investigate the effects of epidural analgesia with @ % or @ % ropivacaine on the maternal temperature during labor .


Two hundred healthy term nulliparas were randomly assigned to receive epidural analgesia with either @ % ropivacaine or @ % ropivacaine .


Epidural analgesia was initiated with @ ml increment of the randomized solution and @ g/ml sufentanyl after a negative test dose of @ ml of @ % lidocaine , and maintained with @ ml bolus doses of the above mentioned mixed analgesics every @ minutes by the patient-controlled epidural analgesia .


The measurements included the maternal oral temperature , visual analog scale pain scores , labor events and neonatal outcomes .


Epidural analgesia with @ % ropivacaine could significantly lower the mean maternal temperature at @ hours after the initiation of analgesia and the oxytocin administration during labor compared with the one with @ % ropivacaine .


Moreover , @ % ropivacaine treatment could provide satisfactory pain relief during labor and had no significant adverse effects on the labor events and neonatal outcomes .


Epidural analgesia with @ % ropivacaine may be a good choice for the epidural analgesia during labor .


To evaluate the clinical and radiological response of primary molars to direct pulp capping with calcium sulfate hemihydrate .


Forty primary molar teeth in @ healthy children aged @-@ years were treated by direct pulp capping .


Teeth were randomly assigned to two groups ( n = @ ) according to material used for capping , as follows : Group @ : calcium hydroxide cement ( Dycal ) ; Group @ : calcium sulfate hemihydrate ( Dentogen ) .


All teeth were restored with a conventional glass ionomer base ( Fuji IX ) and amalgam .


After @ months , the overall success rate of direct pulp capping was approximately @ % ( @/@ teeth , excluding exfoliations ) .


The success rate did not differ significantly between calcium hydroxide and calcium sulfate hemihydrate treatment .


Calcium sulfate hemihydrate was found to be as successful as calcium hydroxide for direct pulp capping of primary molars with Class I cavities .


Further histological studies are needed to support these findings .


Blacks have a higher prevalence of risk factors for atrial fibrillation ( AF ) , such as hypertension , obesity , and heart failure , than nonblacks .


Although population-based studies have demonstrated a lower prevalence and incidence of AF in blacks , the relationship of incident AF to race among hypertensive patients undergoing blood pressure lowering has been less extensively examined .