Additionally , stigma , disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care , suggesting that male involvement may be ` necessary , but not sufficient ' to reduce infant HIV incidence .


This study expands on a successful United States President 's Emergency Plan for AIDS Relief ( PEPFAR ) - supported PMTCT couples intervention pilot study conducted in the Mpumalanga province , targeting HIV-positive pregnant women and their partners , the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence .


The study follows a cluster randomized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from @ randomly assigned Community Health Centers ( CHC ) ( six experimental , six control ) .


The two cohorts will consist of women attending without their male partners ( n = @ ) and women attending with their male partners ( n = @ couples ) , in order to determine whether the influence of male participation itself , or combined with a behavioral PMTCT intervention , can significantly reduce infant HIV infection ante - , peri - and postnatally .


It is our intention to significantly increase PMTCT participation from current levels ( @ % ) in the Mpumalanga province to between @ and @ % through engaging women and couples in a controlled , six session ante - and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT ( such as stigma , disclosure , intimate partner violence , communication , infant feeding practices and safer conception ) that prevent women and men from utilizing treatment opportunities available to them and their infants .


Based upon the encouraging preliminary results from our pilot study , successful CHC adoption of the program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa : HIV-positive pregnant women and their infants .


The aim of this study was to evaluate the analgesic efficacy and safety of rectus sheath block combined with intraperitoneal instillation using two doses of ropivacaine in patients undergoing laparoscopic gynecological surgery .


Altogether @ consenting women were randomized to receive intraperitoneal infiltration with @ % ropivacaine or @ % ropivacaine followed by rectus sheath block with @ % ropivacaine .


The outcomes of clinical safety were measured using plasma concentration of local anesthetics and occurrence of toxic symptoms .


The analgesic efficacy was assessed using numerical rating scales for pain and morphine consumption up to @ hours after surgery .


Patients ' baseline characteristics , surgical factors , and analgesic outcomes were comparable between the two groups .


Although peak plasma concentration of ropivacaine was significantly higher in patients receiving @ % ropivacaine , none of analyzed concentrations was above the toxic ones .


Besides , no patients showed any symptoms of local anesthetic toxicity .


The present study showed that the combination of rectus sheath block with intraperitoneal instillation of ropivacaine was safe and potent enough to relieve pain after laparoscopic surgery .


Despite growing interest in the importance of , and challenges associated with the involvement of patient and population ( IPP ) in the process of developing and adapting clinical practice guidelines ( CPGs ) , there is a lack of knowledge about the best method to use .


This is especially problematic in the field of rehabilitation , where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process .


The goal of this pilot trial is to document the acceptability , feasibility and effectiveness of two methods of involving patients with a disability ( traumatic brain injury ) in CPG development .


A single-blind , randomized , crossover pragmatic trial will be performed with @ patients with traumatic brain injury ( TBI ) .


They will be randomized into two groups , and each will try two alternative methods of producing recommendations ; a discussion group ( control intervention ) and a Wiki , a webpage that can be modified by those who have access to it ( experimental intervention ) .


The participants will rate the acceptability of the two methods , and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods , and the number of support interventions required .


Twenty experts , blinded to the method of producing the recommendations , will independently rate the recommendations produced by the participants for clarity , accuracy , appropriateness and usefulness .


Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI .


Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings .


Evidence is often missing on social differentials in effects of nutrition interventions .


We evaluated the adherence to and effect of prenatal food and micronutrient supplementations on mortality before the age of five years in different social groups as defined by maternal schooling .


Data came from the MINIMat study ( Maternal and Infant Nutrition Interventions , Matlab ) , a randomized trial of prenatal food supplementation ( invitation early , about @ weeks -LSB- E -RSB- , or at usual time , about @ weeks -LSB- U -RSB- of pregnancy ) and @mg or @mg iron with @ gm folic acid , or multiple micronutrients ( Fe@F , Fe@F , MMS ) resulting in six randomization groups , EFe@F , UFe@F , EFe@F , UFe@F , EMMS , and UMMS ( n = @ ) .


Included in analysis after omissions ( fetal loss and out-migration ) were @ women and @ live births of which @ had information on maternal schooling .


The study site was rural Matlab , Bangladesh .


The main stratifying variable was maternal schooling dichotomized as < @years and @years .


We used Cox proportional hazard model for survival analyses .


Overall , women having < @ years of schooling adhered more to food ( @ vs. @ packets , P = @ ) but a little less to micronutrient ( @ vs. @ capsules , P = @ ) supplementation compared to women having more schooling , adjusted for maternal age ( years ) , parity and body mass index ( BMI , kg/m@ ) at week @ pregnancy .


Children of mothers with @years of schooling had lower under-five mortality , but the EMMS supplementation reduced the social difference in mortality risk ( using standard program and schooling < @years as reference ; standard program and schooling @years HR @ , @ % CI @-@ @ ; EMMS and schooling @years HR @ , @ % CI @-@ @ ; EMMS and schooling < @years HR @ , @ % CI @-@ @ ) , adjusted for maternal age ( years ) , parity and body mass index ( kg/m@ ) at week @ pregnancy .


The combination of an early invitation to prenatal food supplementation and multiple micronutrient supplementation lowered mortality in children before the age of five years and reduced the gap in child survival chances between social groups .


The pattern of adherence to the supplementations was complex ; women with less education adhered more to food supplementation while those with more education had higher adherence to micronutrients .


To create a risk model for neovascular age-related macular degeneration ( nAMD ) based on nongenetic factors .


In this case-control study , @ individuals were included , @ patients showed nAMD and @ were healthy controls .


Participants were randomly assigned into a training set ( containing two-thirds of individuals ) and a validation set .


Stepwise logistic regression analysis was performed for @ environmental risk factors in the training set .


The risk model with the remaining factors was then validated in the validation set using receiver operating characteristics ( ROC ) curve and Hosmer-Lemeshow-Test .


Additionally , a genetic risk model including variants in the complement factor H gene ( CFH , rs@ ) and the age-related maculopathy susceptibility @ gene ( ARMS@ , rs@ ) was generated .


The environmental risk model with the factors age , alcohol use , allergy , education , sunlight exposure , fish consumption , and physical exercise showed an AUC of @ ( @ % confidence interval -LSB- CI -RSB- @-@ @ ) in the training set .


Validation of the model showed adequate calibration ( Hosmer-Lemeshow P = @ ) .


The AUC for the genetic model was @ ( @ % CI @-@ @ ) , for the combined environmental and genetic model @ ( @ % CI @-@ @ ) .


Seven nongenetic factors are able to provide equivalent discrimination between nAMD patients and controls to genetic risk models .


Most of them are modifiable and give the opportunity for counseling patients .


The surgical wound of total knee arthroplasty ( TKA ) needs continuous flexion and extension movement .


Silicone gel treatment is widely used to treat hypertrophic scars and keloids since it is easily applied and prevents scar pain and itching .


The aim of this study was to evaluate the clinical efficacy and safety of silicone gel applied to surgical scars of TKA on postoperative scar pain and pruritus .


One hundred TKAs were randomized into a silicone gel group ( silicone gel was applied to the wound after stitch-out for @ month ) or a placebo group .


The postoperative scar pain and pruritus were evaluated with the use of a visual analog scale ( VAS ) at postoperative @ months , @ months and @ year .


Scar assessment was done using the Vancouver scar scale by evaluating scar pigmentation , vascularity , pliability , and height .


Although silicone gel group showed better pigmentation and height scales than placebo group ( P < @ ) , there were no significant differences in the postoperative scar pain and pruritus VAS scores between the groups ( P > @ ) .


Application of silicone gel had no beneficial effects on scar pain and itching relief during the early postoperative period of TKA .


I-Randomized Controlled Trial .


Two treatment strategies were compared in patients with type @ diabetes ( T@DM ) on basal insulin requiring intensification : addition of once-daily ( OD ) liraglutide ( Lira ) or OD insulin aspart ( IAsp ) with largest meal .


Subjects completing @weeks ( @-week main trial BEGIN ONCE-LONG + @-week extension ) on insulin degludec ( IDeg ) OD + metformin with HbA@c@ @ % ( @mmol/mol ) were randomized to IDeg + Lira -LSB- n = @ , mean HbA@c : @ % ( @mmol/mol ) -RSB- or IDeg + IAsp ( n = @ , mean HbA@c : @ % ) for @weeks , continuing metformin .


Subjects completing @weeks with HbA@c < @ % continued IDeg + metformin in a third , non-randomized arm ( n = @ ) .


IDeg + Lira reduced HbA@c ( -@ % - points ) significantly more than IDeg + IAsp ( -@ % - points ) ; estimated treatment difference ( ETD ) ( IDeg + Lira-IDeg + IAsp ) -@ % - points ( @ % CI -@ ; -@ ) ; p = @ .


More IDeg + Lira ( @ % ) than IDeg + IAsp ( @ % ) subjects achieved HbA@c < @ % without confirmed hypoglycaemia -LSB- plasma glucose < @ mmol/l ( < @mg/dl ) or severe hypoglycaemia ) and without weight gain ; estimated odds ratio ( IDeg + Lira/IDeg + IAsp ) @ ( @ % CI @ ; @ ) ; p < @ .


IDeg + Lira subjects had significantly less confirmed and nocturnal confirmed hypoglycaemia , and significantly greater weight loss ( -@ kg ) versus IDeg + IAsp ( +@ kg ) ; ETD ( IDeg + Lira-IDeg + IAsp ) -@ kg ( @ % CI -@ ; -@ ) ; p < @ .


Other than more gastrointestinal side effects with IDeg + Lira , no safety differences occurred .


Durability of IDeg was established in the non-randomized arm , as mean HbA@c remained < @ % -LSB- mean @ % ( @mmol/mol ) at end-of-trial -RSB- .


IDeg + Lira improved long-term glycaemic control , with weight loss and less hypoglycaemia versus adding a single daily dose of IAsp in patients with T@DM inadequately controlled with IDeg + metformin .


The effects of i.v. remifentanil in combination with an inhaled anesthetic to facilitate tracheal extubation of deeply anesthetized adults after otologic surgery are investigated .


Fifty patients undergoing middleear surgery were recruited for the study .


All patients were administered deep anesthesia ( i.v. fentanil , propofol , and mivacurium ) and intubated , with subsequent administration of inhaled sevoflurane for anesthesia maintenance .


Prior to endotracheal tube removal , the patients received i.v. dexamethasone , ondansetron hydrochloride , and parecoxib and were randomly allocated to two groups .


In group S ( n = @ ) , anesthesia was maintained with sevoflurane alone ( @ times the minimum effective alveolar concentration -LSB- MAC -RSB- ) , while patients in group SR ( n = @ ) received low-dose i.v. remifentanil and a reduced dose of sevoflurane ( @ MAC ) .


The mean remifentanil dosage was @ g/kg per minute .


Relative to patients in group S , patients in group SR had a significantly lower mean respiratory rate ( @ breaths per minute versus @ breaths per minute , p < @ ) and end-tidal carbon dioxide pressure ( @ mm Hg versus @ mm Hg , p < @ ) after extubation .


Postextubation airway obstructions requiring nasal airway placement were less frequent in group SR ( @ cases versus @ cases in group S , p < @ ) ; patients in group SR also had a shorter mean time to awakening ( @ minutes versus @ minutes , p < @ ) and a shorter mean time to orientation ( @ minutes versus @ minutes , p < @ ) .


Sevoflurane combined with remifentanil provided rapid recovery and appeared to be safe for deep-anesthesia tracheal extubation in adult patients after otologic surgery .


Evaluate the effect of high-oleic and conventional peanuts within a hypocaloric-diet on energy metabolism and body composition .


This @-week randomized clinical trial included males with BMI of @ kg m ( -@ ) and aged between @ and @ years .


Participants were assigned to the groups : control ( CT , n = @ ) that followed a hypocaloric-diet ; conventional peanuts ( CVP , n = @ ) or high-oleic peanuts ( HOP , n = @ ) that received the hypocaloric-diet including ( not adding ) @ g day ( -@ ) of peanuts .


Glucose , fat oxidation , and body fatness and lean mass were the main outcomes .


Body weight and composition did not differ between groups .


However , within group total body fat ( kg ) reduced with CVP and HOP , with a significant decrease in body fat percentage in HOP .


While total lean mass ( kg ) decreased in CT , total lean mass ( % ) increased in HOP .


Truncal lean mass decreased in the CT. .


At baseline , HOP had greater postprandial fat oxidation than the CVP .


After @-weeks , fasting fat oxidation increased in CVP and HOP .


Fat oxidation increased in CT and HOP during the @ min after meal intake compared to the fasting condition .


Regular peanut consumption , especially the high-oleic type , within a hypocaloric-diet increased fat oxidation and reduced body fatness in overweigh and obese men .


To determine the effects of the herbal fixed-dose combination PRO @/@ ( extracts from saw palmetto fruits and stinging nettle roots ) on nocturnal voiding frequency , as measured by question @ of the IPSS questionnaire , in patients with moderate-to-severe LUTS/BPH after @ weeks of treatment compared to placebo , to the - blocker tamsulosin , or to the @-reductase inhibitor finasteride .


The study is about post hoc evaluation of four published randomized , double-blind clinical trials on PRO @/@ , two compared with placebo , one with finasteride and one with tamsulosin .


In addition , a pooled data analysis of the two placebo-controlled trials was conducted .


We analyzed data from a total of @ patients with a mean age of @ years and a mean baseline nocturnal voiding frequency of @ .


In the pooled analysis of placebo-controlled trials , nocturnal voids improved by @ ( @ % ) with PRO @/@ compared to @ ( @ % ) with placebo ( p = @ , Wilcoxon test , one-tailed ) .


The @ % responder rate to PRO @/@ was significantly superior to the placebo response ( @ % ; p = @ , ( @ ) - test , two-tailed ) .


The majority of responders improved by @ void/night .


Absolute improvements and response rates were consistently higher with PRO @/@ than with placebo over a range of baseline nocturnal voiding frequencies .


There were no differences between PRO @/@ and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates .


PRO @/@ significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride .


That patients with acute radiculopathy caused by lumbar disc herniation ( LDH ) will benefit from spinal manipulation ( SM ) treatment has been taken for granted , despite no solid evidence to support that claim .


There is a demand for a win-win SM treatment that is both effective and less risky , and we attempt to use this trial to demonstrate such a treatment .


In this study , Feng 's Spinal Manipulative Therapy ( FSM ) is selected as the observational SM .


FSM can be performed with either manipulation or mobilization , and also can be easily mimicked as a sham SM .


Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups : sham SM , mobilization , or manipulation , according to a ratio of @:@:@ .


Participants in each group will receive specific FSM treatments four times , along with basic therapies over a course of @ weeks .


Two days after each SM appointment , risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions ( AUR ) .


The pain pressure threshold ( PPT ) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment .


Relative risk ( RR ) of AUR , number needed to harm ( NNH ) and the @ % confidence intervals of each group will be calculated and compared .


Benefit outcomes will be assessed by analyzing the following data recordings : the Numerical Rating Scale ( NRS ) , Oswestry Disability Index ( ODI ) , and Global Perceived Effect ( GPE ) before enrollment and at the @th , and @th day after the treatment .


Analyses will include comparisons of NRS , ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA , an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome ( MAO ) , and the determination of the minimal clinically important difference ( MCID ) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category ` improved ' on the GPE assessment .


To compare the differences in the efficacy on depression after breast cancer operation treated with auricular point sticking therapy , the combined program of auricular point sticking therapy and TCM psychotherapy and medication with deanxit .


Ninety patients were randomized into @ groups , @ cases in each one .


In the western medication group , the simple oral administration of deanxit was applied , one tablet a day .


In the auricular point group , Xin ( GO@ ) , Shen ( CO@ ) , Gan ( CO@ ) , Shenmen ( TF@ ) , Pizhixia ( AT ) , Neifenmi ( CO@ ) were selected and stimulated with auricular point sticking on either side in each treatment , once a week .


In the combined program group , on the basis of the treatment as the auricular point group , TCM psychotherapy was combined with .


The treatment of @ weeks made one session .


One session and @ weeks follow-up were required .


The self-rating depression scale ( SDS ) was used to compare the score before and after treatment in the patients of each group and the efficacy was assessed .


( @ ) Compared with those before treatment , in @ weeks of treatment and @ weeks of follow-up , SDS scores were all reduced apparently in the @ groups ( all P < @ ) .


After @ weeks of follow-up in the auricular point group , after @ and @ weeks of treatment and @ weeks of follow-up in the combined program group , SDS scores were all lower than those in the western medication group ( all P < @ ) .


( @ ) After @ weeks of treatment , the curative rate in the combined program group was higher than that in the auricular point group and the western medication group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , @ % ( @/@ ) , both P < @ ) -RSB- .


After @ weeks of follow-up , the curative rate in either the combined program group or the auricular point group was higher than that in the western medication group -LSB- @ % ( @/@ ) , @ % ( @/@ ) vs. @ % ( @/@ ) , both P < @ -RSB- .


The auricular point sticking therapy , the combined program of auricular point sticking therapy and TCM psychotherapy , and medication with deanxit all relieve depression after breast cancer operation .


The efficacy of the combined program with auricular point sticking therapy and TCM psychotherapy involved is the best , and the efficacy of the auricular point sticking therapy is better than the oral administration of deanxit .


Postoperative nausea and vomiting ( PONV ) are significant problems in laparoscopic surgery .


Compare the prophylactic use of metoclopramide and its combination with dexamethasone in the prevention of PONV in patients undergoing laparoscopic cholecystectomy ( LC ) .


One hundred patients aged @ to @ with American Society of Anesthesiologists ( ASA ) class @-@ who candidates for elective LC at Chiang Mai University Hospital , were included in this double-blind , randomized controlled trial ( parallel design ) .


Patients were randomly divided into two groups , by ` Block offour ` randomization .


Treatment group received @ mg dexamethasone and @ mg metoclopramide , and control group received @ mg metoclopramide and normal saline solution @ ml .


These medications were administered intravenously when the gallbladder was removedfrom gallbladder bed .


All of investigators , anesthetists , patients , care providers , and outcome assessor were blinded .


Patients were asked to assess their nausea and vomiting at @ , @ , @ , and @ hours postoperatively , and at discharge .


The overall score of PONV in each patient based on afour-point whole number of nausea and vomiting by verbal rating scale @-@ ( @ = no nausea and vomiting , @ = nausea , @ = nausea with vomiting , and @ = repeated vomiting > @ times ) .


Fifty eligible patients were randomized to each group , and all were analyzed .


There were no significant differences between baseline characteristics of patients in the two groups .


The combination of dexamethasone and metoclopramide indicated a greater antiemetic effect with significant statistical analysis , odds ratio = @ ( @ % confidence interval O. @-@ @ , p = @ ) .


Thepostoperative hospital stay in the combined group and metoclopramide group were , @ day = @ ( @ % ) and @ ( @ % ) , > @ day = @ ( @ % ) and @ ( @ % ) , respectively ( p = @ ) .


There were no postoperative complications occurred in both groups .


Intravenous administration of dexamethasone combined with metoclopramide had significant effects in prophylaxis of nausea and vomiting after LC and shorten the hospital stay .


Clinical trials registration number : TCTR@


The prevalence of type @ diabetes ( T@D ) in youth is increasing .


Treatment options beyond metformin and insulin are needed .


The safety , tolerability , pharmacokinetics , and pharmacodynamics of liraglutide once daily in youth ( @-@ years old ) with T@D were investigated in a randomized , double-blind , placebo-controlled trial .


Youth treated with diet/exercise alone or with metformin and having a hemoglobin A@c ( HbA@c ) level of @-@ % were randomized to liraglutide ( n = @ ) or placebo ( n = @ ) .


Starting at @ mg/day , doses were escalated weekly to @ , @ , @ , and @ mg/day ( or placebo equivalent ) for @ weeks .


Nineteen participants completed the trial .


Baseline characteristics were similar between groups , with mean ( SD ) values for age of @ ( @ ) years , weight of @ ( @ ) kg ( range , @-@ kg ) , diabetes duration of @ ( @ ) years , and HbA@c level of @ % ( @ % ) .


No serious adverse events ( AEs ) , including severe hypoglycemia , occurred .


Transient gastrointestinal AEs were most common at lower liraglutide doses during dose escalation .


No significant changes in safety and tolerability parameters occurred .


There was no evidence of pancreatitis or lipase elevations above three times the upper normal limit ; calcitonin levels remained within the normal range .


For liraglutide @ mg , mean half-life was @ h , and clearance was @ L/h .


After @ weeks , the decline in HbA@c level was greater with liraglutide versus placebo ( -@ vs. @ % , P = @ ) , whereas mean body weight remained stable ( -@ vs. -@ kg , P = @ ) .


Liraglutide was well tolerated in youth with T@D , with safety , tolerability , and pharmacokinetic profiles similar to profiles in adults .


We investigated single nucleotide polymorphisms ( SNPs ) of thrombospondin-@ ( TSP-@ ) on the risk of corneal allograft rejection .


The TSP-@ is known to be involved in the immune response of the anterior chamber of the eye , activating TGF-@ , promoting peripheral and systemic tolerance , and counteracting the proangiogenic activity of VEGF .


Three tagging SNPs spanning the TSP-@ region ( rs@ , A > G ; rs@ , C > T ; and rs@ , A > G ) were genotyped .


Association with risk of rejection was investigated in a group of @ corneal transplant recipients with risk factors for allograft rejection .


Transplant recipients had completed @-year follow-up .


The TSP-@ rs@ A SNP was associated significantly with an increased risk of corneal allograft rejection ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ ) and there was a trend toward the rs@ , rs@ , rs@ ACA haplotype increasing risk of rejection .


The results suggest that TSP-@ rs@ AA homozygotes may be at increased risk of corneal transplant rejection , especially if they carry the ACA haplotype .


Evolocumab ( AMG @ ) , a monoclonal antibody against proprotein convertase subtilisin/kexin type @ ( PCSK@ ) , significantly reduced low-density lipoprotein cholesterol ( LDL-C ) in phase @ studies of @ weeks ' duration .


The longer-term efficacy and safety of PCSK@ inhibition remain undefined .


Of @ randomized and dosed patients in the @ evolocumab phase @ parent studies , @ ( @ % ) elected to enroll into the Open-Label Study of Long-term Evaluation Against LDL-C ( OSLER ) study .


Regardless of their treatment assignment in the parent study , patients were randomized @:@ to receive either open-label subcutaneous evolocumab @ mg every @ weeks with standard of care ( SOC ) ( evolocumab + SOC , n = @ ) or SOC alone ( n = @ ) .


Ninety-two percent of patients in the evolocumab + SOC group and @ % of patients in the SOC group completed @ weeks of follow-up .


Patients who first received evolocumab in OSLER experienced a mean @ % -LSB- SE , @ % -RSB- reduction in LDL-C at week @ ( P < @ ) .


Patients who received @ of @ dosing regimens of evolocumab in the parent studies and received evolocumab + SOC in OSLER had persistent LDL-C reductions ( mean reduction , @ % -LSB- SE , @ % -RSB- at the end of the parent study versus @ % -LSB- SE , @ % -RSB- at @ weeks ; P = @ ) .


In patients who discontinued evolocumab on entry into OSLER , LDL-C levels returned to near baseline levels .


Adverse events and serious adverse events occurred in @ % and @ % of the evolocumab + SOC group patients and @ % and @ % of the SOC group patients , respectively .


Evolocumab dosed every @ weeks demonstrated continued efficacy and encouraging safety and tolerability over @ year of treatment in the largest and longest evaluation of a PCSK@ inhibitor in hypercholesterolemic patients to date .


There is a need to identify innovative , low-cost and broad-reaching strategies for promoting exercise and improving physical function in older adults with multiple sclerosis ( MS ) .


This randomised controlled pilot trial will test the efficacy of a @-month , DVD-delivered exercise intervention to improve functional performance and quality of life in older adults with MS. Participants will be randomised either into a DVD-delivered exercise condition or an attentional control condition .


This novel approach to programme delivery provides participants with detailed exercise instructions which are presented in a progressive manner and includes a variety of modifications to better meet varying levels of physical abilities .


The targeted exercises focus on three critical elements of functional fitness : flexibility , strength and balance .


It is hypothesised that participants who are randomised to the exercise DVD condition will demonstrate improvements in physical function compared with participants assigned to the attentional control condition .


Data analysis will include a @ ( condition ) @ ( time ) mixed factor analysis of variance ( ANOVA ) that follows intent-to-treat principles , as well as an examination of effect sizes .


Participants will take part in qualitative interviews about perspectives on physical activity and programme participation .


Poverty undermines the adherence of patients to tuberculosis treatment .


A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients ' adherence to treatment , and their treatment outcomes .


Although the trial showed a modest improvement in the treatment success rates of the intervention group , this was not statistically significant , due in part to the low fidelity to the trial intervention .


A qualitative process evaluation , conducted in the final few months of the trial , explained some of the factors that contributed to this low fidelity .


In-depth interviews were conducted with patients who received vouchers , nurses in intervention clinics , personnel in shops who administered the vouchers , and managers of the TB Control Programme .


These interviews were analyzed thematically .


The low fidelity to the trial intervention can be explained by two main factors .


The first was nurses ' tendency to ` ration ' the vouchers , only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable .


The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates , necessitating further visits to the clinics which they were not always able to make .


This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial .


It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ` street level bureaucrats ' who may profoundly affect the way an intervention is administered .


India has @ million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year .


There is an urgent need to develop and evaluate affordable , practicable and scalable interventions to promote cessation of tobacco use .


Because tobacco use is so harmful , an increase of as little as @ percentage point in long-term quit success rates can have an important public health impact .


This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India .


This is a pragmatic , two-arm , community-based cluster randomized controlled trial focused on tobacco users in low-income communities .


The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises ( BA-YBA ) and the control arm is very brief advice ( VBA ) .


Of a total of @ clusters , @ will be allocated to the intervention arm and @ to the control arm .


Each cluster will have @ participants , making a total of @ participants .


The primary outcome measure will follow the Russell Standard : self-report of sustained abstinence for at least @ months following the intervention confirmed at the final follow-up by salivary cotinine .


This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications .


Short children born small for gestational age ( SGA ) are treated with a GH dose based on body size , but treatment may lead to high levels of IGF@ .


The objective was to evaluate IGF@ titration of GH dose in contrast to current dosing strategies .


In the North European Small-for-Gestational-Age Study ( NESGAS ) , @ short pre-pubertal children born SGA were randomised after @ year of high-dose GH treatment ( @g/kg per day ) to three different regimens : high dose ( @g/kg per day ) , low dose ( @g/kg per day ) or IGF@ titration .


The average dose during the second year of the randomised trial did not differ between the IGF@ titration group ( @g/kg per day , s.d. @ ) and the low-dose group ( @g/kg per day , s.d. @ ; P = @ ) , but there was a wide variation in the IGF@ titration group ( range @-@g / kg per day ) .


The IGF@ titration group had significantly lower height gain ( @ SDS , s.d. @ ) during the second year of the randomised trial compared with the high-dose group ( @ SDS , s.d. @ ) , but not significantly lower than the low-dose group ( @ SDS , s.d. @ ; P = @ ) .


The IGF@ titration group had lower IGF@ levels after @ years of the trial ( mean @ , s.d. @ ) compared with both the low-dose ( mean @ , s.d. @ ) and the high-dose ( mean @ , s.d. @ ) groups .


IGF@ titration of GH dose in SGA children proved less effective than current dosing strategies .


IGF@ titration resulted in physiological IGF@ levels with a wide range of GH dose and a poorer growth response , which indicates the role of IGF@ resistance and highlights the heterogeneity of short SGA children .


To quantify the effect of food on the systemic exposure of lapatinib at steady state when administered @ h before and after meals , and to observe the safety and tolerability of lapatinib under these conditions in patients with advanced solid tumours .


This was a three-treatment , randomised , three-sequence cross-over study .


Lapatinib was administered @ h after a low - -LSB- B -RSB- or a high-fat -LSB- C -RSB- meal and systemic exposure was compared with that obtained following administration @ h before a low-fat meal -LSB- A -RSB- .


In total , @ patients were included , of whom @ were evaluable for the pharmacokinetic analysis .


Both low-fat and high-fat meals affected lapatinib exposure .


Lapatinib AUC@-@ increased following lapatinib administration @ h after a low-fat meal by @-fold ( @ % CI : @-@ @ ) and after a high-fat meal by @-fold ( @ % CI : @-@ @ ) .


Lapatinib Cmax increased following lapatinib administration @ h after a low-fat meal by @-fold ( @ % CI : @-@ @ ) and after a high-fat meal by @-fold ( @ % CI : @-@ @ ) .


The most commonly occurring treatment-related toxicity was diarrhoea ( @/@ , @ % CTCAE grade @ and @/@ , @ % grade @ ) and one treatment-related grade@ event occurred ( fatigue grade @ , @ % ) .


Both low-fat and high-fat food consumed @ h before lapatinib administration increased lapatinib systemic exposure compared with lapatinib administration @ h before a low-fat meal .


In order to administer lapatinib in a fasted state , it is advised to administer the drug @ h before a meal .


Inserting a nasogastric tube ( NGT ) in intubated patients may be difficult because they can not follow swallowing instructions , resulting in a high rate of first-attempt failure .


We introduce a simple technique for inserting an orogastric tube in an emergency department ( ED ) .


Fifty-six patients in the ED , who were intubated and required NGT insertion , were randomly allocated to @ groups .


We inserted the NGT using a conventional technique from the nostril ( control group ) and an endotracheal tube ( ET ) - assisted technique from the mouth ( ET group ) .


The procedures ' success rate , insertion duration , and complications were compared between the groups .


There was a significantly higher overall success rate in the ET group than the control group ( @ % vs @ % , P < @ ) .


Endotracheal tube group showed @ % first-attempt success rate , but @ % of the control group failed at first attempt .


Mean duration of the first trial was not significantly different between the ET and control groups ( @ vs @ seconds , P = @ ) , but total time for successful insertion was longer in the control group than the ET group ( @ vs @ seconds , P < @ ) .


There was less NGT kinking and more mucosal bleeding in the ET group than in the control group ( @ % vs @ % , P = @ ; @ % vs @ % , P = @ , respectively ) .


Endotracheal tube-assisted orogastric tube insertion technique showed a higher rate of successful insertion and shorter total duration .


With this result , ET-assisted orogastric tube insertion would be useful in ED .


Intramuscular botulinum toxin-A ( BoNT-A ) injections reduce spasticity by blocking neurotransmission at the motor endplate ( MEP ) .


The goal of this study was to assess the reduction in spasticity achieved by injecting BoNT-A at different sites of the gracilis muscle .


Thirty-four gracilis muscles , in @ children ( @ females and @ males , mean age of @ y -LSB- SD @ y -RSB- ) with spastic cerebral palsy ( unilateral and bilateral , Gross Motor Function Classification System -LSB- GMFCS -RSB- levels I-IV ) , were randomly assigned to one of two groups .


In one group BoNT-A was injected proximally ( at a site @ % of the distance from the pubic tubercle and the medial epicondyle ) and in the other it was injected at the MEP zones ( half of the dose was administered at @ % of this distance and half at @ % ) .


Spasticity was assessed before and after BoNT-A injection using simultaneous measurements of surface electromyography ( sEMG ) and angular velocity during passive muscle stretch applied at different velocities .


The primary outcome measure included the velocity-dependent change in average root mean square electromyography ( RMS-EMG ) .


Secondary outcome was assessed with the Modified Ashworth Scale ( MAS ) and Modified Tardieu Scale ( MTS ) .


Spasticity decreased more in MEP-targeted muscles than in proximally injected muscles , as demonstrated by a larger reduction in average RMS-EMG values ( p = @ ) , though this difference was not found with the MAS or MTS .


The results suggest that BoNT-A injection of the gracilis at sites with a high concentration of MEPs is effective at reducing spasticity .


These preliminary findings should be confirmed by larger studies .


In the case of long muscles , such as the gracilis , the injection site is important .


More than @ % of patients with advanced breast cancer develop bone metastases that may lead to multiple complications such as pathological fractures , bone pain or hypercalcaemia .


The standard treatment , besides endocrine , targeted-therapy or chemotherapy , is the use of bisphosphonates .


However , one of their main adverse side-effects is bisphosphonate-induced nephrotoxicity .


The mechanism by which the latter occurs is not well-understood , although emerging evidence suggests that the effect of bisphosphonates on the kidney may differ between agents .


The aim of this evaluation was to compare the renal toxicity of @ mg ibandronate i.v. versus @ mg zoledronic acid i.v. over a period of six months in women with breast cancer and bone metastases .


A prospective randomized trial was carried out to examine specific kidney and other parameters ( @ - and @-microglobulin , albumin , @-macroglobulin , IgG and C-reactive protein ( CRP ) generated from spontaneous urine samples from @ patients of each group .


We were unable to find any significant difference between the two treatment groups with regard to renal toxicity .


All patients , independently of the applied bisphosphonate , experienced only temporary renal dysfunction without any evidence of irreversible damage in terms of acute nephrotoxicity during the study period .


@-Microglobulin , a marker for proximal tubular damage , in particular , was not differently elevated in either group .


Both applied bisphosphonates were found to be well-tolerated and safe with regard to renal toxicity during a six-month treatment period in patients with otherwise healthy kidneys having advanced breast cancer and bone metastases .


In adults with Williams-Beuren syndrome ( WBS ) , a common endocrine abnormality is type @ diabetes mellitus ( T@DM ) or impaired glucose tolerance ( IGT ) .


However , few and sporadic data are available in children , adolescents , and young adults with WBS .


To evaluate the frequency of IGT and T@DM in a cohort of children and young patients with WBS .


We longitudinally evaluated @ patients ( @ males and @ females , median age at study onset @ years ) with WBS .


The median follow-up was @ years .


Variables of insulin resistance and - cell function were evaluated in all subjects using an oral glucose tolerance test .


The homeostasis model assessment ( HOMA ) of insulin resistance and the Matsuda index of insulin sensitivity were calculated .


The study of the GCK and HNF@ genes was performed in patients with glucose metabolism abnormalities .


@ age - and sex-matched healthy subjects and @ age - , sex - and BMI-matched subjects were recruited as two control groups .


Considering nutritional status , @ ( @ % ) patients were obese , @ ( @ % ) overweight , and @ ( @ % ) normal-weight .


One ( @ % ) patient had acanthosis nigricans .


IGT was diagnosed in @ ( @ % ) WBS patients and T@DM in @ ( @ % ) .


Considering all WBS patients , the median value of HOMA was @ ( range @-@ @ ; insulin @ @ U/ml ; glucose @ @ mg/dl ) .


Considering BMI values , HOMA was @ ( range @-@ @ ) , @ ( range @-@ @ ) , and @ ( range @-@ @ ) , and insulin was @ @ , @ @ , and @ @ U/ml in obese , overweight , and normal-weight WBS patients , respectively .


Comparing the results with the two control groups , WBS patients showed higher insulin values than healthy controls ( p < @ ) , but similar values as the BMI-matched control group ( p = n.s. ) .


However , WBS patients showed significantly higher values of glycemia ( healthy control group , p < @ ; BMI-matched control group , p < @ ) and HOMA ( healthy control group , p < @ ; BMI-matched control group , p < @ ) than the two control groups .


Finally , among WBS patients there was a higher number of subjects with IGT and T@DM than among healthy controls ( p < @ ) and the BMI-matched control group ( p = @ ) .


Our data strongly suggest that IGT and T@DM may be frequently discovered in children , adolescents , and young adults with WBS .


WBS should be included among the genetic syndromes associated with T@DM .


Further studies are necessary to evaluate the etiopathogenesis of this aspect .


With a prevalence of @ to @ % among women of reproductive age , severe premenstrual symptoms are very common .


Symptoms range from emotional and cognitive to physical changes .


Severe symptoms ( that is , premenstrual syndrome ) can have a strong impact on everyday functioning and quality of life .


Impairment can be as serious as that of dysthymic disorders .


Many affected women receive either no treatment at all or are unsatisfied with their treatment .


Although there is some evidence for the reduction of distress through cognitive behavioural therapy , there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach .


Thus , this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome .


The study is conducted as a randomised controlled trial .


The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview .


Eligible women are randomly assigned to either a treatment or a wait-list control group .


The intervention is based on cognitive behavioural therapy principles and is provided via the internet .


It consists of @ different modules on which participants work over @ consecutive weeks .


In addition to written information , participants receive email feedback from a clinical psychologist on a weekly basis .


Participants assigned to the wait-list receive the treatment after the end of the waiting period ( @ weeks ) .


The primary outcome measure is the Premenstrual Syndrome Impairment Measure .


Secondary outcomes include the Premenstrual Syndrome Coping Measure , the Short-Form Social Support Questionnaire , the Questionnaire for the Assessment of Relationship Quality , and the Perceived Stress Scale .


Data is collected during the premenstrual ( luteal ) phase at pre-treatment , post-treatment , and @-month follow-up .


So far , there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome .


The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options .


In North America , few studies have evaluated sublingual immunotherapy for allergic rhinitis with or without conjunctivitis ( AR/C ) ; pediatric data are sparse .


The authors report findings from the largest published immunotherapy trial yet conducted in adults and children .


To evaluate grass sublingual immunotherapy tablet ( MK-@ ) treatment in subjects with AR/C .


North American subjects ( @-@ years old ) with grass allergy were randomized @:@ to once-daily MK-@ ( @,@ BAU Phleum pratense ) or placebo .


The first dose was given at the investigator 's office ; subsequent doses were self-administered at home .


The primary end point was total combined score ( TCS ; rhinoconjunctivitis daily symptom score -LSB- DSS -RSB- plus daily medication score -LSB- DMS -RSB- ) over the entire grass pollen season ( GPS ) .


Key secondary end points included entire-season DSS , DMS , peak-season TCS , and rhinoconjunctivitis quality-of-life questionnaire scores .


Safety outcomes included adverse events ( AEs ) .


One thousand five hundred one subjects were randomized ( @ % polysensitized , @ % had asthma ) .


MK-@ yielded improvements vs placebo of @ % in entire-season TCS ( median difference-@ @ , P < @ ) , @ % in peak-season TCS ( median difference-@ @ , P < @ ) , @ % in entire-season DSS ( median difference-@ @ , P = @ ) , @ % in entire-season DMS ( mean difference-@ @ , P < @ ) , and @ % in peak-season rhinoconjunctivitis quality-of-life questionnaire ( median difference-@ @ , P = @ ) .


Efficacy between children and adults was similar .


Most AEs were transient local application-site reactions , with no serious treatment-related AEs or anaphylactic shock .


Three subjects ( @ placebo , @ MK-@ ) had moderate systemic allergic reactions .


MK-@ was effective in polysensitized grass-allergic North American children and adults with AR/C in this large trial , confirming previous research .


Pregnant women are the highest priority group for annual influenza vaccination .


Studies have shown unacceptably low uptake of both seasonal and pandemic A/H@N@ influenza vaccination among pregnant women .


This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong .


A randomised controlled trial will be conducted with pregnant women in at least the second trimester of pregnancy from four publicly funded hospital antenatal clinics in Hong Kong .


Participants will be randomly assigned to either one of the two treatment groups : standard care ( control ) or standard care plus brief education ( intervention ) .


Pregnant women in the standard care group will receive the usual antenatal care with an educational pamphlet developed by the Hong Kong Centre for Health Protection and those in the intervention group will be provided with usual care plus a brief ten-minute education intervention .


Content of the education session will cover four core components recommended in the research literature .


The primary study outcome will be the proportion of participants who have received influenza vaccine during their pregnancy .


A total of @ pregnant women ( @ per group ) will be required to give an @ % power to detect a treatment effect of @ % .


Most intervention studies aimed at improving influenza vaccination rates in pregnant women have targeted obstetric-care providers and the results of the two patient-oriented RCT interventions are conflicting .


The high priority for vaccination given to pregnant women and the low influenza vaccination rate among pregnant women worldwide strongly indicates a need for interventions to improve uptake .


Serious adverse events ( SAEs ) from heart failure ( HF ) therapy are frequent ; however , techniques to identify at-risk patients are inadequate .


Furthermore , the relationship between SAEs , quality of life ( QOL ) , and cardiac structure are unknown .


@ symptomatic patients with systolic HF were followed for a mean of @ months .


In this post hoc analysis , treatment-related SAEs included acute renal failure , dizziness , hypo/hyperkalemia , hypotension , and syncope .


At @ year , @ treatment-related SAEs occurred .


No difference in SAEs existed between the N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) - guided arm and the standard of care arm ( P = @ ) .


At baseline , patients who suffered SAEs were less likely to be receiving beta-blockers ( @ % vs @ % ; P = @ ) and had worse functional class and lower chloride levels .


Patients who experienced SAEs had less improvement in their Minnesota Living With Heart Failure Questionnaire scores and had a trend toward reduced echocardiographic reverse remodeling over the follow-up period .


Univariable and multivariable analyses were conducted to develop a risk score for SAE prediction ; patients in the highest risk quartile had the shortest time to first cardiovascular event ( P = @ ) .


NT-proBNP-guided HF care is safe .


Experiencing treatment-related SAEs is associated with worse QOL and potentially reduced reverse remodeling .


A risk score to prospectively predict SAEs in aggressive HF management was developed .


To investigate risk factors for disc hemorrhage detection in the Low-Pressure Glaucoma Treatment Study .


Cohort of a randomized , double-masked , multicenter clinical trial .


Low-Pressure Glaucoma Treatment Study patients with at least @months of follow-up were included .


Exclusion criteria included untreated intraocular pressure ( IOP ) of more than @mm Hg , visual field mean deviation worse than-@ dB , or contraindications to study medications .


Patients were randomized to topical treatment with timolol @ % or brimonidine @ % .


Stereophotographs were reviewed independently by @ masked graders searching for disc hemorrhages .


The main outcomes investigated were the detection of disc hemorrhage at any time during follow-up and their recurrence .


Ocular and systemic risk factors for disc hemorrhage detection were analyzed using the Cox proportional hazards model and were tested further for independence in a multivariate model .


Two hundred fifty-three eyes of @ subjects ( mean age , @ @ years ; women , @ % ; European ancestry , @ % ) followed up for an average standard deviation of @ @months were included .


In the multivariate analysis , history of migraine ( hazard ratio -LSB- HR -RSB- , @ ; P = @ ) , narrower neuroretinal rim width at baseline ( HR , @ ; P = @ ) , use of systemic - blockers ( HR , @ ; P = @ ) , low mean systolic blood pressure ( HR , @ ; P = @ ) , and low mean arterial ocular perfusion pressure during follow-up ( HR , @ ; P = @ ) were significant and independent risk factors for disc hemorrhage detection .


Treatment randomization was not associated with either the occurrence or recurrence of disc hemorrhages .


In this cohort of Low-Pressure Glaucoma Treatment Study patients , migraine , baseline narrower neuroretinal rim width , low systolic blood pressure and mean arterial ocular perfusion pressure , and use of systemic - blockers were risk factors for disc hemorrhage detection .


Randomization assignment did not influence the frequency of disc hemorrhage detection .


To investigate the effectiveness of repetitive facilitative exercise ( RFE ) under surface neuromuscular electrical stimulation ( NMES ) in patients with post-stroke hemiplegia .


This randomized , controlled , observer-blinded , pilot trial randomized @ adults with severe arm impairment -LSB- Fugl-Meyer Arm scale ( FMA ) @ -RSB- due to stroke of @-@ weeks duration into three groups and provided treatment on a @-week , @ minutes/day , @ days/week schedule .


The RFE-under-NMES group were given @-@ repetitions of standardized movements of shoulder , elbow and wrist joints of their affected arm with concurrent low-amplitude NMES for each corresponding musculature .


The RFE group was given the same exercise regimen but without NMES .


The control group was treated with a conventional arm rehabilitation programme without NMES .


FMA was assessed at baseline and @ weeks .


All @ participants ( nine in each group ) completed the trial .


At @ weeks , the RFE-under-NMES group evidenced significantly greater improvement compared with the control group on the FMA ( p = @ ) , but not with the RFE group ( p = @ ) .


The RFE group showed improvement compared with the control group , but it was not significant ( p = @ ) .


RFE under NMES is feasible in clinical settings and may be more effective than conventional rehabilitation in lessening arm impairment after sub-acute stroke .


In the critically ill undergoing urgent endotracheal intubation by direct laryngoscopy , multiple attempts are often required with a higher complication rate due to the urgency , uncontrolled setting , comorbidities , and variability in expertise of operators .


We hypothesized that Glidescope video laryngoscopy would be superior to direct laryngoscopy during urgent endotracheal intubation .


Single-center prospective randomized controlled trial .


Beth Israel Medical Center , an @-bed urban teaching hospital with a @-bed closed medical ICU .


Of @ consecutive patients undergoing urgent endotracheal intubation by pulmonary and critical care medicine fellows , @ met inclusion criteria .


Patients undergoing urgent endotracheal intubation were randomized to Glidescope video laryngoscopy or direct laryngoscopy as the primary intubation device .


The primary outcome measure was the rate of first-attempt success .


Acute Physiology and Chronic Health Evaluation II scores were similar between groups ( @ @ vs @ @ ) .


First-attempt success was achieved in @ % of the Glidescope video laryngoscopy group compared with @ % in the direct laryngoscopy group ( p < @ ) .


All unsuccessful direct laryngoscopy patients were successfully intubated with Glidescope video laryngoscopy , @ % on the first attempt .


There was no significant difference in rates of complications between direct laryngoscopy and Glidescope video laryngoscopy : esophageal intubations ( @ % vs @ % ; p = @ ) , aspiration events ( @ % vs @ % ; p = @ ) , desaturation ( @ % vs @ % ; p = @ ) , and hypotension ( @ % vs @ % ; p = @ ) .


Glidescope video laryngoscopy improves the first-attempt success rate during urgent endotracheal intubation performed by pulmonary and critical care medicine fellows when compared with direct laryngoscopy .


To observe the efficacy and safety of oral sanhuangwuji powder , anti-rheumatic drugs ( ARDs ) , and ginger-partitioned acupoint stimulation at zusanli ( ST @ ) on the treatment of rheumatoid arthritis ( RA ) complicated by peptic ulcer .


This prospective randomized controlled study included @ eligible inpatients and outpatients randomly assigned to an ARD treatment ( n. = @ ) , ginger-partitioned stimulation ( n = @ ) , or combination treatment ( n = @ ) .


Patients assigned to the ARD group were given oral celecoxib , methotrexate , and esomeprazole .


Patients assigned to the ginger-partitioned stimulation group were given ginger-partitioned acupoint stimulation at zusanli ( ST @ ) in addition to the ARDs .


Patients in the combination treatment group were given oral sanhuangwuji powder , ginger-partitioned acupoint stimulation at susanli ( ST @ ) , and ARDs .


All patients were followed up for @ months to evaluate clinical effects and safety .


The study was registered in the World Health Organization database at the General Hospital of Chengdu Military Area Command Chinese People 's Liberation Army ( ChiCTR-TCC@ ) .


The combination treatment group had significantly greater improvements in RA symptoms , laboratory outcomes , and gastrointestinal symptom scores , compared with the other groups ( P < @ ) .


The peptic ulcer healing rate in the combination treatment group was significantly greater than that in the ARD treatment group ( @ = @ , P < @ ) and the ginger-partitioned stimulation group ( @ = @ , P < @ ) .


Combination treatment with ginger-partitioned acupoint stimulation at zusanli ( ST @ ) , oral sanhuangwuji powder , and ARDs had a better clinical effect for RA with complicated peptic ulcer , compared with ARD treatmentalone or in combination with ginger-partitioned acupoint stimulation .


Survivors after cardiac arrest ( CA ) exhibits a systemic inflammatory response as part of post-cardiac arrest syndrome ( PCAS ) .


We investigated the association between systemic inflammation and severity of PCAS and whether level of targeted temperature management ( TTM ) modifies level of the inflammatory response .


We studied @ patients included at a single center in the TTM-trial , randomly assigned to TTM at @ C or @ C for @ h. Plasma samples were analyzed for inflammatory markers including interleukin ( IL ) IL-@ , IL-@ , IL-@ , IL-@ , tumor necrosis factor - ( TNF - ) , C-reactive protein ( CRP ) and procalcitonin ( PCT ) at randomization and @ , @ and @ h after CA .


Severity of PCAS was assessed by Sequential Organ Failure Assessment ( SOFA ) score .


Plasma levels of both IL-@ and IL-@ determined at randomization correlated with severity of PCAS at day @ ( r = @ and r = @ , p < @ ) and day @ ( r = @ and r = @ , p < @ ) .


IL-@ at randomization was an independent predictor of severity of PCAS at day @ ( p = @ ) and day @ ( p < @ ) and was a significantly stronger predictor of severity of PCAS at day @ compared to CRP ( p = @ ) and PCT ( p = @ ) .


Level of TTM did not modify level of the inflammatory markers IL-@ , IL-@ , TNF - , IL-@ , IL-@ , CRP and PCT , ( p = NS for each inflammatory marker ) .


Level of inflammatory response was associated with severity of PCAS with IL-@ being consistently and more strongly associated with severity of PCAS than the inflammatory markers CRP and PCT .


The systemic inflammatory response after CA was not modified by TTM at @ C or @ C.


Potassium-channels in the carotid body and the brainstem are important regulators of ventilation .


The BKCa-channel contains response elements for CO , O@ , and CO@ .


Its block increases carotid body signalling , phrenic nerve activity , and respiratory drive .


GAL-@ , a new BKCa-channel blocker , increases minute ventilation in rats and non-human primates .


This study assessed the single-dose safety , tolerability , pharmacokinetics ( PKs ) , and pharmacodynamics ( PDs ) of GAL-@ in healthy volunteers .


Thirty subjects participated in a nine-period , randomized , double-blinded , placebo-controlled , crossover , ascending dose , first-in-human study with i.v. infusions of @-@ @ mg kg ( -@ ) h ( -@ ) for @ h and intermediate doses up to @ h.


Adverse event rates were generally similar among dose levels and between placebo - and GAL-@-treated subjects .


At higher GAL-@ doses , a mild/moderate burning sensation at the infusion site occurred during the infusion .


No clinically significant changes in vital signs or clinical chemistries were noted .


Minute ventilation increased ( AUE@-@ h @ % , P < @ ) and end-tidal carbon dioxide ( -LSB- Formula : see text -RSB- ) decreased ( AUE@-@ h @ % , P < @ ) during the first hour at @ mg kg ( -@ ) h ( -@ ) with @/@-maximal -LSB- Formula : see text -RSB- and -LSB- Formula : see text -RSB- - change occurring by @ min .


Drug concentration rose rapidly during the infusion and decreased rapidly initially ( distribution t@/@ of @ min ) and then more slowly ( terminal t@/@ of @ h ) .


GAL-@ was safe and generally well tolerated with adverse events comparable with placebo except for an infusion site burning sensation .


GAL-@ stimulated ventilation at the highest doses suggesting that greater infusion rates may be required for maximum PD effects .


GAL-@ had PK characteristics consistent with an acute care medication .


This study evaluates the efficacy and safety of a sufentanil sublingual tablet system ( SSTS ) for the management of postoperative pain following open abdominal surgery .


At @ hospital sites in the United States , patients following surgery with pain intensity of greater than @ on an @-point numerical rating scale were randomized to receive SSTS dispensing a @-g sufentanil tablet sublingually with a @-minute lockout or an identical system dispensing a placebo tablet sublingually .


Pain intensity scores were recorded at baseline and for up to @ hours after starting study drug .


The primary end point was time-weighted summed pain intensity difference ( SPID ) over @ hours .


Secondary end points included SPID and total pain relief ( TOTPAR ) for up to @ hours and patient and health care provider global assessments of the method of pain control .


Summed pain intensity difference over @ hours was significantly higher in the SSTS group than in the placebo group ( least squares mean -LSB- SEM -RSB- , @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- ; P = @ ) .


Mean SPID and TOTPAR scores were significantly higher in the SSTS group at all time points from @ hour ( SPID ) or @ hours ( TOTPAR ) until @ hours ( P < @ ) .


In the SSTS group , patient global assessment and health care provider global assessment ratings of good or excellent were greater than placebo at all time points ( P < @ ) .


Safety parameters , including adverse events and vital signs , were similar for SSTS and placebo .


These results suggest that SSTS is effective and safe for the management of postoperative pain in patients following open abdominal surgery .


To investigate whether sacral nerve stimulation reduces irritable bowel syndrome ( IBS ) - specific symptoms by a randomized , controlled , crossover study .


IBS affects @ % to @ % of the population worldwide , but most patients continue to have symptoms despite treatment .


Patients included from our tertiary center had diarrhea-predominant or mixed IBS , with a minimum baseline IBS symptom score ( Gastrointestinal Syndrome Rating Scale-IBS questionnaire ) of @ points reduced by a minimum of @ % during the percutaneous nerve evaluation before permanent implantation .


Patients were randomized ( @:@ ) to have the stimulator ON or OFF for @ month and then the opposite for another month .


Investigators and patients were not informed of the setting .


IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires .


Primary endpoint was the IBS-specific symptom score .


Twenty-one patients were randomized .


Ten were eligible for analysis in each group .


IBS-specific symptom scores were significantly reduced during stimulation : the median difference in the ON-OFF group was @ ( range , -@ to @ ) and in the OFF-ON group -@ ( range , -@ to -@ ) ( P = @ ) .


IBS-specific quality-of-life scores improved significantly during stimulation : the median difference in the ON-OFF group was @ ( range , -@ to @ ) and in the OFF-ON group -@ ( range , -@ to @ ) ( P = @ ) .


At @-year follow-up , the median IBS-specific symptom score ( @ ; range , @-@ ) was significantly lower than that at baseline ( @ ; range , @-@ ) ( P = @ ) .


Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS .


Tenofovir ( TDF ) is associated with phosphaturia and elevated @,@ dihydroxy vitamin D ( @,@-OH ( @ ) D ) .


Fibroblast growth factor @ ( FGF@ ) causes phosphaturia and increases in response to elevated @,@-OH ( @ ) D. Vitamin D-binding protein ( VDBP ) binds to @,@-OH ( @ ) D , decreasing its biological activity , and is elevated in individuals with higher plasma tenofovir concentrations .


We compared FGF@ and VDBP before and after vitamin D@ ( VITD ) supplementation in youths treated with combination antiretroviral therapy ( cART ) containing or not containing TDF .


A randomized controlled trial in HIV-positive youths aged @-@ years enrolled participants based on cART treatment with TDF ( TDF ; n = @ ) or without TDF ( no-TDF ; n = @ ) , and randomized within those groups to VITD ( @,@ IU every @ weeks ) or placebo ( PL ) .


We measured FGF@ and VDBP and calculated free @,@-OH ( @ ) D at baseline and week @ , and compared changes by TDF treatment and VITD randomized group .


At baseline , serum FGF@ concentration showed a quadratic relationship with @,@-OH ( @ ) D most pronounced in the TDF group .


At week @ , total and free @,@-OH ( @ ) D increased in the VITD but not PL groups , independent of TDF use .


FGF@ increased in the TDF group receiving VITD , but there was no FGF@ change in the no-TDF group receiving VITD or the PL groups .


The adjusted mean change in FGF@ from baseline to week @ was @ pg/ml in the TDF/VITD group , compared with -@ ( no-TDF/VITD , P = @ ) , -@ ( TDF/PL , P = @ ) and @ ( no-TDF/PL , P = @ ) .


These results suggest that TDF-containing cART may alter the FGF@ response to vitamin D supplementation in HIV-infected youths .


Clinical trials number : NCT@ .


High level of serum cholesterol is considered to be a major risk factor for cardiovascular disease ( CVD ) .


A double-blinded , randomized , placebo-controlled trial was performed to test the hypothesis that a daily intake of Chlorella may improve serum lipid profile through enhancement of serum carotenoid concentration in mildly hypercholesterolemic subjects .


Eligible subjects ( n = @ ) were randomized to either Chlorella ( @g/day ) or placebo for a double-blinded trial with a @-week lead-in period and a @-week intervention period .


Serum triglycerides , total cholesterol , lipoproteins , apolipoproteins and carotenoids were assessed at the beginning and the end of the trial .


Compared with the control group , the Chlorella group exhibited remarkable changes in total cholesterol ( Chlorella -@ % ; placebo @ % ; P = @ ) , triglycerides ( Chlorella -@ % ; placebo @ % ; P = @ ) , lutein/zeaxanthin ( Chlorella @ % ; placebo -@ % ; P < @ ) , and - carotene ( Chlorella @ % ; placebo @ % ; P < @ ) .


Improvement of serum lipids was supported by significant reductions of very low-density lipoprotein cholesterol ( Chlorella -@ % ; placebo @ % ; P = @ ) , apolipoprotein B ( Chlorella -@ % ; placebo @ % ; P = @ ) , non high-density lipoprotein ( Chlorella -@ % ; placebo -@ % ; P = @ ) , and high-density lipoprotein/triglycerides ( Chlorella @ % ; placebo -@ % ; P = @ ) , suggesting an inhibitory effect of Chlorella on the intestinal absorption of dietary and endogenous lipids .


Further , the changes of serum lipids appeared to be associated with the changes of serum carotenoids .


Daily consumption of Chlorella supplements provided the potential of health benefits reducing serum lipid risk factors , mainly triglycerides and total cholesterol , in mildly hypercholesterolemic subjects .


The effect was related to carotenoid consumption .


Zinc sulfate is beneficial in the treatment of epithelial warts .


We conducted this study to compare the efficacy of combination therapy of oral zinc sulfate with conventional treatments in the treatment of vulvar warts .


This study was a randomized controlled trial .


The sample size was @ in each group .


Women aged @-@ years were placed by the block randomized method into six groups : the podophyllin - , imiquimod - and cryotherapy-treated groups , and another three groups receiving @-week combination therapy of @mg oral zinc sulfate with one of the above-mentioned treatments .


Data were analyzed using anova and Fischer 's exact test with spss@ .


A total of @ patients were recruited and completed the study in six treatment groups .


No significant difference was observed in the response to treatment among these groups .


Relapse after @ months was significantly higher in the podophyllin - , imiquimod - and cryotherapy-treated patients compared to patients receiving these treatments in combination with oral zinc sulfate ( P < @ ) .


Combined therapy of oral zinc sulfate with conventional treatments of vulvar warts appears to reduce the relapse rate .


Laryngoscopy and endotracheal intubation in the presence of cervical spine instability may put patients at risk of cervical cord injury .


Nevertheless , the biomechanics of intubation ( cervical spine motion as a function of applied force ) have not been characterized .


This study characterized and compared the relationship between laryngoscope force and cervical spine motion using two laryngoscopes hypothesized to differ in force .


Fourteen adults undergoing elective surgery were intubated twice ( Macintosh , Airtraq ) .


During each intubation , laryngoscope force , cervical spine motion , and glottic view were recorded .


Force and motion were referenced to a preintubation baseline ( stage @ ) and were characterized at three stages : stage @ ( laryngoscope introduction ) ; stage @ ( best glottic view ) ; and stage @ ( endotracheal tube in trachea ) .


Maximal force and motion occurred at stage @ and differed between the Macintosh and Airtraq : ( @ ) force : @ @ versus @ @ N , respectively , P = @ ; ( @ ) occiput-C@ extension : @ @ versus @ @ degrees , respectively , P = @ .


Between stages @ and @ , the motion/force ratio differed between Macintosh and Airtraq : @ @ versus @ @ degrees/N , respectively ; P = @ .


The relationship between laryngoscope force and cervical spine motion is : ( @ ) nonlinear and ( @ ) differs between laryngoscopes .


Differences between laryngoscopes in motion/force relationships are likely due to : ( @ ) laryngoscope-specific cervical extension needed for intubation , ( @ ) laryngoscope-specific airway displacement/deformation needed for intubation , and ( @ ) cervical spine and airway tissue viscoelastic properties .


Cervical spine motion during endotracheal intubation is not directly proportional to force .


Low-force laryngoscopes can not be assumed to result in proportionally low cervical spine motion .


Surgical resection enhances long-term survival after lung cancer , but survivors face functional deficits and report on poor quality of life long time after surgery .


This study evaluated short and long-term effects of supervised group exercise training on health-related quality of life and physical performance in patients , who were radically operated for lung cancer .


A randomized , assessor-blinded , controlled trial was performed on @ patients undergoing lung cancer surgery .


The intervention group ( IG , n = @ ) participated in supervised out-patient exercise training sessions , one hour once a week for ten weeks .


The sessions were based on aerobic exercises with target intensity of @-@ % of work capacity , resistance training and dyspnoea management .


The control group ( CG , n = @ ) received one individual instruction in exercise training .


Measurements consisted of : health-related quality of life ( SF@ ) , six minute walk test ( @MWT ) and lung function ( spirometry ) , assessed three weeks after surgery and after four and twelve months .


Both groups were comparable at baseline on demographic characteristic and outcome values .


We found a statistically significant effect after four months in the bodily pain domain of SF@ , with an estimated mean difference ( EMD ) of @ ( @ % CI :@ to @ , p = @ ) and a trend in favour of the intervention for role physical functioning ( EMD @ , @ % CI : -@ to @ , p = @ ) and physical component summary ( EMD @ , @ % CI : -@ to @ , p = @ ) .


At @ months , the tendency was reversed , with the CG presenting overall slightly better measures .


We found no effect of the intervention on @MWT or lung volumes at any time-point .


Supervised compared to unsupervised exercise training resulted in no improvement in health-related quality of life , except for the bodily pain domain , four months after lung cancer surgery .


No effects of the intervention were found for any outcome after one year .


This prospective randomized Phase II study was designed to evaluate the preventive effect of an oral nutrition supplement composed of beta-hydroxy-beta-methylbutyrate , arginine and glutamine ( beta-hydroxy-beta-methylbutyrate / arginine/glutamine ) on radiation dermatitis in head and neck cancer patients .


Forty patients with histologically proven head and neck cancer , treated with concurrent chemoradiotherapy involving cisplatin were recruited .


They were randomly assigned to the beta-hydroxy-beta-methylbutyrate / arginine/glutamine supplement treatment group ( Group A ) or the control group that received no supplement ( Group B ) .


The primary endpoint of this study was the percentage of patients developing Grade @ dermatitis .


The secondary endpoints were the percentage of patients developing Grade @ dermatitis , and the duration of each grade of dermatitis relative to the observation period .


The incidence of Grade @ dermatitis did not differ between the two groups .


However , as secondary endpoints of this study , the incidence of Grade @ dermatitis was lower in Group A than B ( @ vs. @ % ; P < @ ) , and the duration of Grade @ dermatitis was shorter in Group A than B ( @ vs. @ % ; P < @ ) , as was the duration of Grade @ dermatitis ( @ vs. @ % ; P < @ ) .


Our study indicated that beta-hydroxy-beta-methylbutyrate / arginine/glutamine supplementation was potentially effective in the prevention of radiation dermatitis in head and neck cancer patients .


Applied Kinesiology ( AK ) is a diagnostic technique widely used within the Integrative Medical community .


In essence , it posits that a question can be mentally held in a person 's mind , sometimes while they are holding a substance like a vitamin , or a food sample , and by measuring relative muscular weakness an answer as to whether the substance or the condition represented by the question is good for that person can be obtained .


This AK is presumed to have a diagnostic capability .


That being presumed , this study asks the following questions : ( @ ) Is there a difference in muscular strength when an individual holds a substance that is inimical to life processes ( a poison solution ) , as compared to a substance that is essential for life ( normal saline ) ?


( @ ) Is this effect a transaction involving input from both the person being measured and the kinesiologist doing the measurement or is it only the person being measured ?


( @ ) As an extension of question @ , is the result the same when different kinesiologists take the measurement or when no kinesiologist is involved ?


( @ ) Does belief , expectation , gender , or time cognition play a role in determining response ?


To answer these questions , which would help to define the parameters of the AK process , @ participants were tested during three trials each , first by one kinesiologist , then by another , and finally , with no kinesiologist present by grip strength indicated using a hand dynamometer .


Grip strength being a self-administered AK test of relative muscular strength .


For each trial , a pair of randomly numbered sealed vials , each pair in a randomly numbered plastic bag , were used as the objects of the trial .


In each bag , one vial contained saline solution while the other was filled with a slightly smaller amount of saline solution to which had been added ionic hydroxylamine hydrochloride ( NH@OH ) ( + ) , producing a toxic solution of @mg/ml .


Each trial consisted of a separate muscle test for each vial .


All present at the trials were blind as to which vial contained the toxin .


And all who prepared the vials were blind to the trials .


The force used by the kinesiologists in each of their trials was measured via a pressure pad system .


The hand dynamometer trials were conducted with no kinesiologist present .


Of the @ sets of trials , the toxic vial was identified correctly in @ of them ( @ % ) , resulting in a one-tailed exact binomial P-value of @ .


Results for two of the kinesiologists were almost exactly at chance .


For the third kinesiologist , there was a one-tailed exact binomial P-value of @ ( unadjusted for multiple testing ) .


Results for the dynamometer were also almost exactly at chance .


Testing whether there was a significant difference in proportions for whom the AK test worked based on belief about whether it would work resulted in non-significant ( @ ) values of @ ( P = @ ) for the trials with one kinesiologist and @ ( P = @ ) for the hand dynamometer trials .


The final variable examined was gender .


While there was no significant difference in performance for males and females for the trials of the male kinesiologist or the hand dynamometer , the combined data for the two female kinesiologists did reveal a difference .


Of the @ sessions with females , only @ were successful ( @ % ) , while for the @ sessions with males , @ were successful ( @ % ) , resulting in a ( @ ) statistic of @ , P = @ .


However , given all of the ( @ ) tests performed in this section , the results must be interpreted with caution because of multiple testing .


Results indicate belief in whether the AK test will work was not significantly related to whether it actually did work .


A ( @ ) test of the relationship between time perception and correct vial choice showed no significant relationships .


The ( @ ) statistic for the relationship using the hand dynamometer data was @ , P = @ .


The data in this study , particularly when seen in the larger context of a review of the literature from the AK field itself by Klinkoski and Leboeuf ( @ ) , which considered @ papers published between @ and @ by the International College of Applied Kinesiology , and the survey by Hall , Lewith , Brien , and Little ( @ ) , using standard evaluation criteria -LSB- quality assessment tool for studies of diagnostic accuracy included in systematic reviews ( QUADAS ) , Standards for Reporting of Diagnostic Studies ( STARD ) , JADAD , and Consolidated Standards of Reporting Trials ( CONSORT ) -RSB- , for research methodology , as well as six prior non-clinical studies by Radin ( @ ) , Quintanar and Hill ( @ ) , Braud ( @ ) , Arnett et al. ( @ ) , Ludtke ( @ ) , and Kendler and Keating ( @ ) , all together suggest the following : The research published by the Applied Kinesiology field itself is not to be relied upon , and in the experimental studies that do meet accepted standards of science , Applied Kinesiology has not demonstrated that it is a useful or reliable diagnostic tool upon which health decisions can be based .


The phosphodiesterase type @ inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia ( BPH ) .


While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH ( LUTS/BPH ) , improvements in nocturia were not significant in individual studies .


We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies .


Data were integrated from four randomized , placebo-controlled , double-blind , @-week registrational studies of tadalafil for LUTS/BPH .


Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question @ ( IPSS Q@ ) .


Efficacy results were analyzed using analysis of covariance .


For the tadalafil @ mg once daily ( N = @ ) and placebo ( N = @ ) groups , baseline characteristics were well balanced , and the overall severity of nocturia per mean IPSS Q@ was @ @ .


The mean treatment change was -@ with placebo and -@ with tadalafil ; the least-squares mean ( standard error ) treatment difference was -@ ( @ ) , p = @ .


For patients receiving placebo and tadalafil , respectively , the proportion with improved nocturnal frequency was @ and @ % , with no change was @ and @ % , and with worsening was @ and @ % .


A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo ; however , the treatment difference was small and not considered clinically meaningful .


Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH .


To evaluate whether @-mm long implants could be a suitable alternative to longer implants placed in vertically augmented atrophic posterior mandibles .


Sixty partially edentulous patients having @ to @ mm of residual crestal height and at least @ mm thickness measured on CT scans above the mandibular canal were randomised according to a parallel group design .


They were either to receive @ to @ submerged @-mm long implants or @ mm or longer implants ( @ patients per group ) placed in vertically augmented bone .


Bone was augmented with interpositional anorganic bovine bone blocks covered by resorbable barriers .


Grafts were left to heal for @ months before implant placement .


Four months after provisional acrylic prostheses were delivered , they were replaced , after @ months , by definitive metal-ceramic prostheses .


Outcome measures were : prosthesis and implant failures ; complications ; and radiographic peri-implant marginal bone level changes .


All patients were followed up to @ years after loading .


Five years after loading , @ patients dropped out : @ from the short implant group and @ from the augmented group .


The augmentation procedure failed in @ patients and only @-mm long implants could be inserted .


There were no statistically significant differences for prosthesis and implant failures .


Five prostheses failed in @ patients of the short implant group versus @ prostheses in @ patients in the augmented group ( Fishers exact test P = @ ; difference in proportions = @ ; @ % CI -@ to @ ) .


Five short implants failed in @ patients versus @ long implants in @ patients ( Fishers exact test P = @ difference in proportions = @ ; @ % CI -@ to @ ) .


There were statistically more complications in augmented patients ( @ complications in @ augmented patients versus @ complications in @ patients of the short implant group ) ( Fishers exact test P < @ ; difference in proportions = @ ; @ % CI @ , @ ) .


Both groups gradually lost peri-implant bone in a statistically significant way .


Five years after loading , short implant group patients lost an average of @ mm peri-implant bone compared with @ mm in the augmented group .


Short implants experienced statistically significantly less bone loss ( @ mm , @ % CI @ ; @ , P < @ ) than long implants .


When residual bone height over the mandibular canal is between @ to @ mm , @ mm short implants could be an interesting alternative to vertical augmentation in posterior atrophic mandibles since the treatment is faster , cheaper and associated with less morbidity .


Longer follow-ups may still be needed to confirm these results , however the medium-term prognosis ( @ years after loading ) of short implants is at least as good as those of longer implants placed vertically in augmented mandibles .


Pilonidal sinus disease is associated with significant morbidity after surgical treatment with regard to wound healing .


Recent case studies suggested that negative-pressure wound therapy as primary treatment following surgical excision may shorten the duration of wound healing .


The purpose of this randomized controlled trial was to evaluate the role of vacuum therapy in pilonidal sinus disease : negative-pressure wound therapy versus standard open wound care after surgical excision .


Patients were randomly assigned to either negative-pressure wound therapy for @ weeks or standard open wound healing .


The primary end point of the study was the time to complete wound healing .


Secondary end points were visual analog scale score , wound size ratio at day @ ( ie , wound healing rate ) , time to resume daily activities , and recurrence within @ months after wound closure .


Forty-nine patients were included in the study : @ patients were treated with vacuum therapy , and @ patients underwent standard open wound care .


Complete wound healing was achieved at a median of @ days in the vacuum therapy group versus @ days in control patients ( p = @ ) .


The wound size ratio was significantly lower in the vacuum therapy group ( @ versus @ , p = @ ) , ie , higher wound healing rate in the first @ weeks .


There was no difference in visual analog scale scores and disease recurrence between both groups .


The time to resume full daily activities after surgery was @ days in the patients undergoing vacuum therapy and @ days in the control patients ( p = @ ) .


This study is limited by the small number of patients , the lack of blinding to patients and doctors , and the absence of patient quality-of-life evaluation .


It is feasible to apply vacuum therapy in the treatment of pilonidal sinus disease , and it has a positive effect on wound size reduction in the first @ weeks .


However , there is no difference in time to complete wound healing and time to resume daily life activities .


Plasmodium falciparum malaria is treated with @ mg/kg of chloroquine ( CQ ) irrespective of age .


Theoretically , CQ should be dosed according to body surface area ( BSA ) .


The effect of dosing CQ according to BSA has not been determined but doubling the dose per kg doubled the efficacy of CQ in children aged < @ years infected with P. falciparum carrying CQ resistance causing genes typical for Africa .


The study aim was to determine the effect of age on CQ concentrations .


Day @ whole blood CQ concentrations were determined in @ and @ children treated with @ and @ mg/kg , respectively , in previously conducted clinical trials .


CQ concentrations normalised for the dose taken in mg/kg of CQ decreased with decreasing age ( p < @ ) .


CQ concentrations normalised for dose taken in mg/m ( @ ) were unaffected by age .


The median CQ concentration in children aged < @ years taking @ mg/kg and in children aged @-@ years taking @ mg/kg were @ ( @ % confidence interval -LSB- CI -RSB- @-@ ) and @ ( @ % CI @-@ ) nmol/l , respectively ( p = @ ) .


The median CQ concentration in children aged @-@ taking @ mg/kg and children aged @-@ taking @ mg/kg were @ and @ nmol/l .


Adverse events were not age/concentration dependent .


CQ is under-dosed in children and should ideally be dosed according to BSA .


Children aged < @ years need approximately double the dose per kg to attain CQ concentrations found in children aged @-@ years .


Clinical trials assessing the efficacy of CQ in Africa are typically performed in children aged < @ years .


Thus the efficacy of CQ is typically assessed in children in whom CQ is under dosed .


Approximately @ fold higher drug concentrations can probably be safely given to the youngest children .


As CQ resistance is concentration dependent an alternative dosing of CQ may overcome resistance in Africa .


To compare the safety and efficacy of fibrin glue and cyanoacrylate glue for refixating the recessed muscle to the sclera in patients undergoing strabismus surgery .


In this prospective , randomized , and interventional case series , there were @ patients in each group .


Two different types of glue were used for refixating the muscle to the sclera after its recession : fibrin glue ( fibrin group ) and cyanoacrylate glue ( cyanoacrylate group ) .


Resection was performed as usual with a @-@ polyglactin suture .


The conjunctiva was closed with the same glue that was used for muscle recession .


Average time required per muscle attachment was @ minutes in the fibrin group and @ minutes in the cyanoacrylate group .


There was no significant difference in pain at all postoperative visits in both groups .


Significantly more chemosis was observed in the cyanoacrylate group at postoperative @ weeks .


At all other postoperative visits , there was no significant difference in chemosis in both groups .


There was significantly more conjunctival reaction in the cyanoacrylate group at @ and @ weeks and @ months ; the difference was highly significant at @ months ( P = @ ) .


Total inflammatory score was significantly high in the cyanoacrylate group at @ week , @ weeks , and @ months .


Both fibrin and cyanoacrylate glue are equally efficacious for muscle reattachment ; however , fibrin glue is more biotolerant compared to cyanoacrylate glue and results in less postoperative inflammation , and is thus recommended for recession in strabismus surgery .


Stratification of patients for treatment of ductal carcinoma in situ ( DCIS ) is suboptimal , with high systemic overtreatment rates .


A training set of @ tumours from women with pure DCIS were immunostained for proteins involved in cell survival , hypoxia , growth factor and hormone signalling .


A generalised linear regression with regularisation and variable selection was applied to a multiple covariate Cox survival analysis with recurrence-free survival @-fold cross-validation and leave-one-out iterative approach were used to build and test the model that was validated using an independent cohort of @ patients with pure DCIS .


The clinical role of a COX-@-targeting agent was then tested in a proof-of-concept neoadjuvant randomised trial in ER-positive DCIS treated with exemestane @ mg day ( -@ ) celecoxib @ mg day ( -@ ) .


The COX-@ expression was an independent prognostic factor for early relapse in the training ( HR @ ( @ % CI : @-@ @ ) P = @ ) and independent validation cohort ( HR @ ( @ % CI : @-@ @ ) P = @ ) .


There was no significant interaction with other clinicopathological variables .


A statistically significant reduction of Ki-@ expression after treatment with exemestane celecoxib was observed ( P < @ ) with greater reduction in the combination arm ( P < @ ) .


Concomitant reduction in COX-@ expression was statistically significant in the exemestane and celecoxib arm ( P < @ ) only .


In patients with DCIS , COX-@ may predict recurrence , aiding clinical decision making .


A combination of an aromatase inhibitor and celecoxib has significant biological effect and may be integrated into treatment of COX@-positive DCIS at high risk of recurrence .


The objective of the present study was to investigate the effect of probiotic Lactobacillus casei Shirota on the values of mutans streptococci counts in saliva .


@ children were included in this double blinded study .


Study design included @ periods which consisted of a run in period , two intervention periods and a washout period .


During the intervention periods children were either given probiotic milk or control milk for @ days .


Pre and post intervention salivary samples were subjected to microbiological evaluation .


Then numbers of mutans streptococci were taken by identifying colony morphology .


A statistically significant reduction of mutans streptococci colony count was noted in the probiotic group ( p = @ ) .


The reduction in children with higher levels of mutans streptococci ( @ ) after intervention was @ % in the probiotic group .


Daily consumption of milk containing probiotic bacteria can reduce the levels of mutans streptococci and may contribute to the prevention of dental caries .


This study introduces a new device to facilitate perforation size measurement during `` butterfly '' myringoplasty .


The purpose of this study is to evaluate the use of ` otological compass ' on short-term results of inlay cartilaginous ` butterfly ' tympanoplasty technique in adult patients .


Prospective , randomized , controlled , blinded .


This study included @ patients who underwent inlay cartilage myringoplasty .


All operations were performed under general anesthesia by the same surgeon with a microscope-assisted approach .


The patients were divided randomly and consecutively into two groups : Group @ ( n = @ ) had perforation dimensions and shape measured using the Otologic Compass ( OC ) and the control group ( n = @ ) had perforation measured by means of a Fisch elevator .


The duration of surgery , number of trials for correct placement of the cartilage graft , results and complications of the surgery were evaluated and compared .


The mean follow-up duration was @ months .


Groups were similar in terms of age and perforation diameters ( p > @ ) .


Average number of cartilage shaping before satisfactory graft fitting was significantly fewer in the OC group : @ @ and @ @ trials for OC and control groups , respectively ( p < @ ) .


Mean duration of preparation and satisfactory graft fitting was @ @ minutes in the OC group whereas it was @ @ minutes for the control group .


Operative duration was significantly shorter in the OC group ( p < @ ) .


At the end of the follow-up period , successful closure occurred @ % and @ % patients in the OC and control groups , respectively ( p > @ ) .


The mean preoperative to postoperative three-tone air-bone gap improved @ dB and @ dB in OC and control groups , respectively ( p > @ ) .


This study shows that OC presents as a useful tool that expedites and refines butterfly myringoplasty procedure .


The number of cartilage shaping prior to satisfactory graft fitting revealed significantly better results : almost all surgeries in the OC group were complete after a single cartilage shaping attempt .


Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem .


In the absence of a simulation study , the drinking outcomes among those who are lost to follow-up are not known .


Individuals who drop out of treatment and continue to provide drinking data , however , may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up .


We used data from the COMBINE study , a multisite , randomized clinical trial , to examine drinking during the @months of treatment among individuals who dropped out of treatment but continued to provide drinking data ( i.e. , `` treatment dropouts ; '' n = @ ) .


First , we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers ( n = @ ) and treatment dropouts ( n = @ ; total N = @,@ ) , as well as the observed treatment effect size among just those who dropped out of treatment ( n = @ ) .


In both the total sample ( N = @,@ ) and the dropout sample ( n = @ ) , we then deleted the drinking data after treatment dropout from those @ individuals to simulate missing data .


Using the deleted data sets , we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using @ methods to handle missing data ( last observation carried forward , baseline observation carried forward , placebo mean imputation , missing = heavy drinking days , multiple imputation ( MI ) , and full information maximum likelihood -LSB- FIML -RSB- ) .


MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses , while missing = heavy drinking days performed the worst .


Although missing drinking data should be avoided whenever possible , MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial .


There is evidence that neurofibrillary tangle ( NFT ) burden is associated with psychotic symptoms in Alzheimer disease ( AD ) .


However , it is not clear whether this association is direct or mediated through the increased cognitive impairment associated with NFTs .


We sought to determine whether the extended MAPT haplotype was associated with the worsening of delusions and hallucinations in a combined cohort of @ patients who participated in @ clinical trials of treatment with memantine .


After controlling for baseline dementia severity , exposure to memantine , and antipsychotics , analysis shows that carriers of at least one H@ allele had a @-fold ( P = @ ) increased risk of worsening hallucinations .


There was some evidence of association with worsening delusions but only in analysis by allele .


These results are the first to indicate that the H@ allele of the extended MAPT haplotype negatively affects the course of psychotic symptoms in AD independently of disease severity .


It will be important for future research to examine MAPT transcription in people with AD with and without psychotic symptoms to understand the exact mechanisms underlying these findings .


We introduced an initial large dose of modified St. Thomas ' Hospital cardioplegic solution with the aim of providing both myocardial protection as well as a smooth intraoperative process .


In @ cases of isolated aortic valve replacement , we used the modified technique of cardioplegia in @ ( group S ) and conventional administration of glucose-insulin-potassium solution in @ ( group G ) .


The patients were selected at random .


In group S , we added @ mEq of potassium to the original St. Thomas ' Hospital solution and administered @mLkg ( -@ ) as an initial dose .


The temperature was decreased to @ .


The mean of reperfusion time after declamping in group S was significantly shorter ( @ @ vs. @ @ min ; p = @ ) .


The average of postoperative maximum creatine kinase-MB was significantly lower in group S ( @ @ vs. @ @ IUL ( -@ ) ; p = @ ) .


On multivariate analysis , use of the modified cardioplegia and aortic crossclamp time were significantly associated with creatine kinase-MB level and reperfusion time after declamping .


This modified technique was an acceptable option that provided a bloodless operative field and avoided multiple cardioplegic administrations .


Vitamin D and its metabolites have potent immunomodulatory effects in vitro , including up-regulation of cathelicidin , a critical antimicrobial protein .