HbA1C level in groups B and C significantly ( P < 0.05 ) decreased as compared with group A at week 12 .


Addition of bromocriptine to metformin also significantly ( P < 0.05 ) decreased FPG and PPPG levels in a dose-dependent manner as compared with metformin alone .


Intergroup analysis did not show any statistically significant change in weight of study subjects at different intervals .


The combination of bromocriptine with metformin significantly decreased FPG , PPPG , and HbA1C compared with metformin alone in type 2 DM patients in a dose-dependent manner .


Nowadays , conventional analgesic agents , which are widely used for pain relief after cesarean section , provide suboptimal analgesia with occasional serious side effects .


We designed a randomized , double-blind , placebo-controlled study to evaluate the analgesic efficacy of intrathecal ketamine added to bupivacaine after cesarean section .


Sixty patients scheduled for cesarean section under spinal anesthesia were randomly allocated to one of the two groups to receive either bupivacaine 10 mg combined with 0.1 mg/kg ketamine , or bupivacaine 10 mg combined with 0.5 mL distilled water intrathecally .


The time to the first analgesic request , analgesic requirement in the first 24 hours after surgery , onset times of sensory and motor blockades , the durations of sensory and motor blockades , and the incidences of adverse effects such as hypotension , ephedrine requirement , bradycardia , and hypoxemia , were recorded .


Patients who received ketamine had a significantly prolonged duration of anesthesia compared with those who did not in the control group [ 95 % confidence intervals ( CI ) 195-217 ; p = 0.001 ] .


The mean time to the first analgesic request was also significantly longer in ketamine group ( 95 % CI 252.5-275 ; p < 0.001 ) .


The total analgesic consumption in the 24 hours following surgery significantly lessened in the ketamine group compared with that of the control group ( 95 % CI 2-2 .5 ; p < 0.001 ) .


The two groups did not differ significantly in intraoperative and postoperative side effects .


Intrathecal ketamine 0.1 mg/kg co-administered with spinal bupivacaine elongated the time to the first analgesic request and lessened the total analgesic consumption in the first 24 postoperative hours in comparison with bupivacaine alone in the control group following elective cesarean delivery .


To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students ' subsequent presentations .


We conducted a single-blind , 3-arm , cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine , University of Maryland School of Medicine , Oregon Health & Science University , and Case Western Reserve University School of Medicine .


Blocks of students at each school were randomly assigned to experience either ( 1 ) no formal presentation feedback ( control ) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a ( 2 ) single-item ( simple ) or ( 3 ) 18-item ( detailed ) evaluation form .


At the clerkship end , overall quality of subjects ' presentations was rated by faculty blinded to randomization status , and subjects reported whether their presentations had improved .


Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school .


A total of 476 participants were evenly divided into the 3 arms , which had similar characteristics .


Compared with controls , presentation quality was significantly associated with participating in detailed ( coefficient : 0.38 ; 95 % confidence interval [ CI ] : 0.07-0 .69 ) but not simple ( coefficient : 0.16 ; 95 % CI : -0.12 -0.43 ) feedback sessions .


Similarly , student self-report of presentation improvement was significantly associated with participating in detailed ( odds ratio : 2.16 ; 95 % CI : 1.11-4 .18 ] but not simple ( odds ratio : 1.89 ; 95 % CI : 0.91-3 .93 ) feedback sessions .


Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls .


Stroke is a major cause of death and disability in the world , and the prevalence of stroke tends to increase with age .


Despite advances in acute care and secondary preventive strategies , primary prevention should play the most significant role in the reduction of the burden of stroke .


As an important component of traditional Chinese Qigong , Baduanjin exercise is a simple , safe exercise , especially suitable for older adults .


However , current evidence is insufficient to inform the use of Baduanjin exercise in the prevention of stroke.The aim of this trail is to systematically evaluate the prevention effect of Baduanjin exercise on ischemic stroke in the community elder population with high risk factors .


A total of 170 eligible participants from the community elder population will be randomly allocated into the Baduanjin exercise group and usual physical activity control group in a 1:1 ratio .


Besides usual physical activity , participants in the Baduanjin exercise group will accept a 12-week Baduanjin exercise training with a frequency of five days a week and 40 minutes a day .


Primary and secondary outcomes will be measured at baseline , 13 weeks ( at end of intervention ) and 25 weeks ( after additional 12-week follow-up period ) .


This study will be the randomized trial to evaluate the effectiveness of Baduanjin exercise for primary prevention of stroke in community elder population with high risk factors of stroke .


The results of this trial will help to establish the optimal approach for primary prevention of stroke .


Chinese Clinical Trial Registry : ChiCTR-TRC-13003588 .


Registration date : 24 July , 2013 .


Oak moss absolute , an extract from the lichen Evernia prunastri , is a valued perfume ingredient but contains extreme allergens .


To compare the elicitation properties of two preparations of oak moss absolute : ` classic oak moss ' , the historically used preparation , and ` new oak moss ' , with reduced contents of the major allergens atranol and chloroatranol .


The two preparations were compared in randomized double-blinded repeated open application tests and serial dilution patch tests in 30 oak moss-sensitive volunteers and 30 non-allergic control subjects .


In both test models , new oak moss elicited significantly less allergic contact dermatitis in oak moss-sensitive subjects than classic oak moss .


The control subjects did not react to either of the preparations .


New oak moss is still a fragrance allergen , but elicits less allergic contact dermatitis in previously oak moss-sensitized individuals , suggesting that new oak moss is less allergenic to non-sensitized individuals .


This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents ( EES ) and paclitaxel-eluting stents ( PES ) in patients with obstructive coronary artery disease .


The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI .


However , there have been concerns regarding the durability of these benefits over longer-term follow-up .


SPIRIT III was a prospective , multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES .


Endpoints included ischemia-driven target vessel failure ( TVF ) ( death , myocardial infarction ( MI ) , or ischemia-driven target vessel revascularization [ TVR ] ) , the pre-specified primary endpoint ) , target lesion failure ( TLF ) ( cardiac death , target-vessel MI , or ischemia-driven target lesion revascularization [ TLR ] ) , major adverse cardiac events ( MACE ) ( cardiac death , MI , or ischemia-driven TLR ) , their individual components and stent thrombosis .


Five-year follow-up was available in 91.9 % of patients .


Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF ( 19.3 % vs. 24.5 % , p = 0.05 ) , TLF ( 12.7 % vs. 19.0 % , p = 0.008 ) , and MACE ( 13.2 % vs. 20.7 % , p = 0.007 ) .


EES also resulted in reduced rates of all-cause death ( 5.9 % vs. 10.1 % , p = 0.02 ) , with nonsignificantly different rates of MI , stent thrombosis , and TLR , and no evidence of late catch-up of TLR over time .


At 5 years after treatment , EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality .


Additionally , the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up .


Neuropeptide S Receptor ( NPSR1 ) gene has been associated with multiple allergic phenotypes in several patient populations .


We analysed the effect of the NPSR1 genotypes in the development of asthma , rhinitis , eczema , or food allergy in children randomly receiving either probiotic or placebo treatment .


796 children born to families at high risk for allergic diseases were examined by a paediatrician at the age of three months , six months , two years , and five years .


Asthma , rhinitis , eczema , and food allergy were diagnosed according to international guidelines .


Treatment with probiotics ( double-blinded and placebo controlled ) was begun with mothers at 35 weeks of gestation age and continued after the birth of infants up to the age of six months .


Association and additive inheritance models were used in genetic analyses .


Distribution of the hopo546333 was suggestive in the group of patients with atopic eczema at two years .


The hopo546333_G was found more often in those with eczema in the placebo group ( p = 0.048 , after Bonferroni correction ) and the hopo546333_A was found more often in those with eczema and probiotics compared to those with eczema and placebo treatment .


None of the NPSR1 tagging SNPs was associated with asthma , IgE-mediated asthma , or sensitisation .


Allergic disease in both parents doubled the risk for IgE-mediated allergic disease ( OR 2.1 ) .


The NPSR1 gene SNP hopo546333 showed a suggestive association for high IgE-associated atopic eczema at two years .


Abundant literature regarding the use of intravenous tranexamic acid ( TXA ) in primary total knee replacement is available .


Randomized controlled trials have confirmed the efficacy of topical TXA compared with placebo , but the comparison between topical and intravenous TXA is unclear .


The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary total knee replacement with cemented implants .


A Phase-III , single-center , double-blind , randomized , controlled clinical trial was performed to compare topical intra-articular TXA ( 3 g of TXA in 100 mL of physiological saline solution ) with two intravenous doses of TXA ( 15 mg/kg in 100 mL of physiological saline solution , one dose before tourniquet release and another three hours after surgery ) in a multimodal protocol for blood loss prevention .


The primary outcome was the blood transfusion rate , and the secondary outcomes included visible blood loss ( as measured in the drain ) at twenty-four hours postoperatively and invisible blood loss ( as estimated from the Nadler formula ) at forty-eight hours postoperatively .


The sample size of seventy-eight patients was calculated to give a statistical power of 99 % for demonstrating noninferiority .


Thirty-nine patients each were allocated to receive topical intra-articular TXA ( the experimental group ) and intravenous TXA ( the control group ) ; there were no significant differences in demographics or preoperative laboratory values between the groups .


Noninferiority was estimated by comparing the confidence intervals with a delta of 10 % .


Student t and Mann-Whitney tests were used to assess the significance of any differences .


The transfusion rate was zero in both groups ; thus , noninferiority was demonstrated for the primary efficacy end point , suggesting equivalence .


Noninferiority was also demonstrated for the secondary efficacy end points .


Drain blood loss at twenty-four hours was 315.6 mL ( 95 % confidence interval [ CI ] , 248.5 to 382.7 mL ) in the experimental group and 308.1 mL ( 95 % CI , 247.6 to 368.5 mL ) in the control group ( p = 0.948 , Mann-Whitney ) .


Also , estimated blood loss at forty-eight hours was 1259.0 mL ( 95 % CI , 1115.6 to 1402.3 mL ) in the experimental group and 1317.9 mL ( 95 % CI , 1175.4 to 1460.4 mL ) in the control group ( p = 0.837 , Mann-Whitney ) .


No significant safety differences were seen between groups .


Topical administration of TXA according to the described protocol demonstrated noninferiority compared with intravenous TXA , with no safety concerns .


This randomized controlled trial supports the topical intra-articular administration of TXA in primary total knee replacement with cemented implants .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Nutritional anemia is a public health problem among Ghanaian schoolchildren .


There is need to employ dietary modification strategies to solve this problem through school and household feeding programs .


To evaluate the effectiveness of cowpea-based food containing fish meal served with vitamin C-rich drink to improve iron stores and hemoglobin concentrations in Ghanaian schoolchildren .


The study involved cross-sectional baseline and nutrition intervention phases .


There were 150 participants of age 6 to 12 years .


They were randomly assigned to 3 groups , fish meal - vitamin C ( n = 50 ) , vitamin C ( n = 50 ) , and control ( n = 50 ) , and given different cowpea-based diets for a 6-month period .


Height and weight measurements were done according to the standard procedures , dietary data were obtained by 24-hour recall and food frequency questionnaire , hemoglobin concentrations were determined by Hemocue Hemoglobinometer , and serum ferritin and complement-reactive protein ( CRP ) were determined by enzyme-linked immunosorbent assay .


Participants ' blood samples were examined for malaria parasitemia and stools for helminthes using Giemsa stain and Kato-Katz techniques , respectively .


Mean ferritin concentration was not significantly different among groups .


End line mean or change in hemoglobin concentrations between fish meal-vitamin C group ( 128.4 7.2 / 8.3 10.6 g/L ) and control ( 123.1 6.6 / 4.2 10.4 g/L ) were different , P < .05 .


Change in prevalence of anemia in fish meal-vitamin C group ( 19.5 % ) was different compared to those of vitamin C group ( 9.3 % ) and the control ( 12.2 % ) .


Levels of malaria parasitemia and high CRP among study participants at baseline and end line were 58 % and 80 % then 55 % and 79 % , respectively .


Level of hookworm infestation was 13 % .


Cowpea-based food containing 3 % fish meal and served with vitamin C-rich drink improved hemoglobin concentration and minimized the prevalence of anemia among the study participants .


Mild cognitive impairment ( MCI ) increases dementia risk with no pharmacologic treatment available .


The Study of Mental and Resistance Training was a randomized , double-blind , double-sham controlled trial of adults with MCI .


Participants were randomized to 2 supervised interventions : active or sham physical training ( high intensity progressive resistance training vs seated calisthenics ) plus active or sham cognitive training ( computerized , multidomain cognitive training vs watching videos/quizzes ) , 2-3 days/week for 6 months with 18-month follow-up .


Primary outcomes were global cognitive function ( Alzheimer 's Disease Assessment Scale-cognitive subscale ; ADAS-Cog ) and functional independence ( Bayer Activities of Daily Living ) .


Secondary outcomes included executive function , memory , and speed/attention tests , and cognitive domain scores .


One hundred adults with MCI [ 70.1 ( 6.7 ) years ; 68 % women ] were enrolled and analyzed .


Resistance training significantly improved the primary outcome ADAS-Cog ; [ relative effect size ( 95 % confidence interval ) -0.33 ( -0.73 , 0.06 ) ; P < .05 ] at 6 months and executive function ( Wechsler Adult Intelligence Scale Matrices ; P = .016 ) across 18 months .


Normal ADAS-Cog scores occurred in 48 % ( 24/49 ) after resistance training vs 27 % ( 14/51 ) without resistance training [ P < .03 ; odds ratio ( 95 % confidence interval ) 3.50 ( 1.18 , 10.48 ) ] .


Cognitive training only attenuated decline in Memory Domain at 6 months ( P < .02 ) .


Resistance training 18-month benefit was 74 % higher ( P = .02 ) for Executive Domain compared with combined training [ z-score change = 0.42 ( 0.22 , 0.63 ) resistance training vs 0.11 ( -0.60 , 0.28 ) combined ] and 48 % higher ( P < .04 ) for Global Domain [ z-score change = .0.45 ( 0.29 , 0.61 ) resistance training vs 0.23 ( 0.10 , 0.36 ) combined ] .


Resistance training significantly improved global cognitive function , with maintenance of executive and global benefits over 18 months .


We performed a randomized , non-comparative phase II study evaluating docetaxel in combination with either daily continuous ( protracted IV ) 5-fluorouracil or cisplatin administered weekly , concurrent to radiotherapy in the treatment of locally advanced pancreatic carcinoma .


Results of the docetaxel plus cisplatin regimen are reported .


Forty chemotherapy-naive patients with locally advanced pancreatic carcinoma were randomly assigned to receive 5-fluorouracil and docetaxel or docetaxel 20mg/m ( 2 ) and cisplatin 20mg/m ( 2 ) / week , plus concurrent radiotherapy for 6 weeks .


The radiation dose to the primary tumour was 54Gy in 30 fractions .


The trial 's primary endpoint was the 6-month crude non-progression rate .


51 patients from 7 centres were included in the docetaxel-cisplatin treatment group .


Six-month non-progression rate was 39 % ( 95 % confidence interval : 26-53 ) .


Median overall survival was 9.6 months ( 95 % confidence interval : 2.4-60 .7 ) ; 6 complete and 8 partial responses were obtained .


Six patients survived more than 2 years after their inclusion in the trial .


Grade 3 toxicity was reported in 63 % of patients ; no treatment-related death occurred .


Severe toxicities were mainly anorexia ( 22 % ) , vomiting ( 20 % ) and fatigue ( 24 % ) .


Despite inadequate efficacy according to the main end point , this regimen gave a satisfactory rate of objective response ( 27 % ) with tolerable toxicity .


Recombinant granulocyte colony-stimulating factor ( G-CSF ) is widely used to mobilize haematopoietic stem cells .


We compared the efficacy and safety of a biosimilar G-CSF ( Zarzio ( ) , Sandoz Biopharmaceuticals ) with the originator G-CSF ( Neupogen ( ) , Amgen ) in patients with haematological malignancies .


A total of 108 patients were included in this study , 59 of whom were female ( 49 male ) , with an overall median age of 51 years ( range 19-69 ) .


Patients had multiple myeloma ( n = 46 ) , non-Hodgkin 's lymphoma ( n = 28 ) , Hodgkin 's lymphoma ( n = 26 ) , or other diagnosis ( n = 8 ) .


After administration of mobilizing regimens ( primarily high-dose etoposide , high-dose cyclophosphamide , intermediate-dose Ara-C or ESHAP ) , patients were randomized to a standard daily 10 g/kg dose of biosimilar G-CSF ( n = 54 ) or originator G-CSF ( n = 54 ) .


Median duration of G-CSF administration was 8 days with both biosimilar G-CSF ( range 4-17 ) and originator G-CSF ( range 4-14 ) .


Both groups had a median of one apheresis with a median time until first apheresis of 11 days .


There were no statistically significant differences between groups in the mean SD number of mobilized CD34 + cells/L in peripheral blood or the number of CD34 + cells/kg body weight .


Five patients ( 9 % ) in the originator G-CSF group and six patients in the biosimilar G-CSF group ( 11 % ) did not mobilize sufficient CD34 + cells .


The adverse event profile was similar between groups .


A biosimilar G-CSF ( Zarzio ( ) ) demonstrated similar efficacy and safety as the reference originator G-CSF ( Neupogen ( ) ) in hematopoietic stem cell mobilization in patients with haematological malignancies .


The standardized patient approach has proved to be an effective training tool for medical educators .


This article explains the process of employing standardized patients in an HIV stigma reduction intervention in healthcare settings in China .


The study was conducted in 40 hospitals in two provinces of China .


One year after the stigma reduction intervention , standardized patients made unannounced visits to participating hospitals , randomly approached service providers on duty and presented symptoms related to HIV and disclosed HIV-positive test results .


After each visit , the standardized patients evaluated their providers ' attitudes and behaviours using a structured checklist .


Standardized patients also took open-ended observation notes about their experience and the evaluation process .


Seven standardized patients conducted a total of 217 assessments ( 108 from 20 hospitals in the intervention condition ; 109 from 20 hospitals in the control condition ) .


Based on a comparative analysis , the intervention hospitals received a better rating than the control hospitals in terms of general impression and universal precaution compliance as well as a lower score on stigmatizing attitudes and behaviours toward the standardized patients .


Standardized patients are a useful supplement to traditional self-report assessments , particularly for measuring intervention outcomes that are sensitive or prone to social desirability .


Anecdotal reports have demonstrated the feasibility of needle aspiration to deflate a distended bowel , but we do not know of any prospective study that has evaluated this technique .


We designed a controlled study to evaluate the use of the selective transperitoneal needle aspiration of a bowel loop ( STAB ) in infants .


Candidates were patients of less than 6 months of age , scheduled for laparoscopic Nissen fundoplication , in whom severe colonic distension was observed .


We randomized the patients to the study drug or placebo in a 1:1 mode .


The treatment group received STAB , whereas the control group was subject to conventional maneuvers .


We performed 403 Nissen procedures laparoscopically : 102 were in infants 6 months old , but only 44 presented severe transverse colonic distension .


STAB facilitated the surgical procedure and drastically reduced surgical time .


Thus , we calculated our sample size with use of the following inputs : 90 % power , a critical P value of .05 , and 50 % reduction in surgical time .


This resulted in a necessary sample size of 21 subjects per group , for a total required sample size of 42 subjects .


STAB procedures were done in 23 patients , and conventional measures were used in 21 .


STAB was attempted a total of 45 times .


Mean operative time was shorter in the STAB group .


We propose the use of STAB as alternative therapy to decompress a dilated large-bowel loop during laparoscopic surgery .


This maneuver is simple and efficient and has no clinical complications .


Future studies are required to evaluate its role in the subset of other patients or procedures .


The traditional oxygen delivery methods for oxygen therapy are continuous flow oxygen ( CFO ) and demand oxygen delivery ( DOD ) ; however , oxygen waste is considerable in CFO , while DOD is uncomfortable for patients .


Synchronized DOD ( SDOD ) , which was designed to overcome the drawbacks of both CFO and DOD , supplies oxygen according to the patient 's breathing pattern and the desired oxygen saving .


This study was conducted to examine the overall performance of SDOD in terms of oxygen saturation ( SpO2 ) , patients ' comfort , and oxygen saving ratio ( SR ) .


Study subjects were patients who required oxygen for COPD or pneumonia .


Patients received oxygen through nasal prongs by CFO and SDOD for 30 min each .


SpO2 was measured every 10 min by pulse oximetry , and subjects recorded their level of comfort after 30 min .


The flow of discharged oxygen was recorded to calculate SR. .


Ten subjects ( median age , 68 y ; range , 56-86 y ) were enrolled .


The SpO2 of patients during SDOD ( 97 2 % ) was similar to that during CFO ( 96 3 % ) with no statistically significant difference ( P = .53 ) .


Subjects reported SDOD to be more comfortable than CFO .


The comfort score of subjects treated with SDOD was 7.05 2.07 ( 0 : very uncomfortable , 10 : very comfortable ) ; this was significantly higher ( P = .02 ) than the comfort score ( 5.20 1.83 ) of subjects treated with CFO .


The SR values set by clinicians were very similar to calculated SR values .


SDOD appears to be more suitable for oxygen therapy than CFO when considering SpO2 , patients ' comfort , and SR. .


In Haiti and other countries , large-scale investments in school feeding programs have been made with marginal evidence of nutrition outcomes .


We aimed to examine the effectiveness of a fortified ready-to-use supplementary food ( RUSF ) , Mamba , on reduced anemia and improved body composition in school-aged children compared to an unfortified cereal bar , Tablet Yo , and control groups .


A cluster , randomized trial with children ages 3-13 y ( n = 1167 ) was conducted in the north of Haiti .


Six schools were matched and randomized to the control group , Tablet Yo group ( 42 g , 165 kcal ) , or Mamba group ( 50 g , 260 kcal , and > 75 % of the RDA for critical micronutrients ) .


Children in the supplementation groups received the snack daily for 100 d , and all were followed longitudinally for hemoglobin concentrations , anthropometry , and bioelectrical impedance measures : baseline ( December 2012 ) , midline ( March 2013 ) , and endline ( June 2013 ) .


Parent surveys were conducted at baseline and endline to examine secondary outcomes of morbidities and dietary intakes .


Longitudinal regression modeling using generalized least squares and logit with random effects tested the main effects .


At baseline ,14.0 % of children were stunted , 14.5 % underweight , 9.1 % thin , and 73 % anemic .


Fat mass percentage ( mean SD ) was 8.1 % 4.3 % for boys and 12.5 % 4.4 % for girls .


In longitudinal modeling , Mamba supplementation increased body mass index z score ( regression coefficient SEE ) 0.25 0.06 , fat mass 0.45 0.14 kg , and percentage fat mass 1.28 % 0.27 % compared with control at each time point ( P < 0.001 ) .


Among boys , Mamba increased fat mass ( regression coefficient SEE ) 0.73 0.19 kg and fat-free mass 0.62 0.34 kg compared with control ( P < 0.001 ) .


Mamba reduced the odds of developing anemia by 28 % compared to control ( adjusted OR : 0.72 ; 95 % CI : 0.57 , 0.91 ; P < 0.001 ) .


No treatment effect was found for hemoglobin concentration .


To our knowledge , this is the first study to give evidence of body composition effects from an RUSF in school-aged children .


To examine the effect of incentive spirometry in pulmonary rehabilitation of chronic obstructive pulmonary disease ( COPD ) patients and compare its efficacy with inspiratory resistive muscle training ( IMT ) technique .


Randomized controlled trial .


Thirty patients with COPD , from a general hospital in Mashhad , Iran , were randomly assigned to two study groups .


All subjects trained daily in two 15-minute sessions , 4 days a week , for 4 weeks .


Respiratory function tests were compared before interventions and at the end of weeks 2 and 4 .


Both techniques improved the mean values of all respiratory function tests ( p. 01 ) .


The IMT technique was more effective to improve MVV and PImax ( p. 05 ) .


PEFR was better improved in the incentive spirometry group ( p. 05 ) .


There was no significant difference for other spirometric parameters between two groups .


Incentive spirometry can be considered as an effective component for pulmonary rehabilitation in COPD patients .


Secukinumab , a fully human anti-interleukin-17A monoclonal antibody , exhibited promising activity in a proof-of-concept study when administered in intravenous ( IV ) doses to patients with active , chronic , noninfectious uveitis .


This study compared the efficacy and safety of different IV and subcutaneous ( SC ) doses of secukinumab in patients with noninfectious uveitis .


Multicenter , randomized , double-masked , dose-ranging , phase 2 clinical trial .


Thirty-seven patients with active noninfectious intermediate uveitis , posterior uveitis , or panuveitis who required corticosteroid-sparing immunosuppressive therapy .


Patients were randomized to secukinumab 300 mg SC every 2 weeks for 4 doses , secukinumab 10 mg/kg IV every 2 weeks for 4 doses , or secukinumab 30 mg/kg IV every 4 weeks for 2 doses .


Intravenous or SC saline was administered to maintain masking .


Efficacy was assessed on day 57 ( 2-4 weeks after last dose ) .


Percentage of patients with treatment response , defined as ( 1 ) at least a 2-grade reduction in vitreous haze score or trace or absent vitreous haze in the study eye without an increase in corticosteroid dose and without uveitis worsening or ( 2 ) reduction in corticosteroid dosages to prespecified levels without uveitis worsening .


Percentage of patients with remission , defined as anterior chamber cell and vitreous haze scores of 0 or 0.5 + in both eyes without corticosteroid therapy or uveitis worsening .


Secukinumab 30 mg/kg IV and 10 mg/kg IV , compared with the 300 mg SC dose , produced higher responder rates ( 72.7 % and 61.5 % vs. 33.3 % , respectively ) and remission rates ( 27.3 % and 38.5 % vs. 16.7 % , respectively ) .


Statistical and clinical superiority for the 30 mg/kg IV dose compared with the 300 mg SC dose was established in a Bayesian probability model .


Other measures , including time to response onset , change in visual acuity , and change in vitreous haze score , showed numeric trends favoring IV dosing .


Secukinumab , administered in IV or SC formulations , appeared safe and was well tolerated .


Intravenous secukinumab was effective and well tolerated in noninfectious uveitis requiring systemic corticosteroid-sparing immunosuppressive therapy .


Greater activity with IV dosing suggests that patients may not receive sufficient drug with SC administration .


High-dose IV secukinumab may be necessary to deliver secukinumab in therapeutic concentrations .


To explore the effects of walking exercise during late trimester on pregnancy outcome of low-risk primipara .


A prospective randomized controlled study was conducted for 123 cases of low-risk primipara who had regular prenatal care at Shengjing Hospital , China Medical University from July 2012 to June 2013 .


And informed consent was obtained .


The control group included 116 cases of other low-risk primipara in the same period .


Except that the experimental group had regular structured walking exercise from 34 weeks of gestational age to delivery , other consulting guidance were the same as the control group .


The inter-group differences , such as delivery mode , mean body weight gain per week after 34 weeks of gestation , duration of labor , labor pain perception , neonatal weight and neonatal birth condition , were detected and analyzed .


Finally there were 13 and 8 dropouts in experimental and control groups respectively .


For two groups , the rate of caesarean section was 12.7 % and 18.5 % , the mean body weight gain per week after 34 weeks of gestational age ( 0.41 0.13 ) and ( 0.56 0.09 ) kg , the labor pain score are 6.1 1.9 and 7.6 2.3 , the duration of labor ( 12 4 ) and ( 15 6 ) h , the neonatal birth weight ( 3.4 0.3 ) and ( 3.7 0.6 ) kg and the rate of macrosomia 4.5 % and 7.4 % respectively .


The differences had statistical significance ( P < 0.05 ) .


The rate of preterm birth was 5.5 % and 4.6 % , the rate of premature rupture of membrane 15.5 % and 13.9 % and the rate of neonatal asphyxia 2.7 % and 3.7 % respectively .


The differences had no statistical significance ( all P > 0.05 ) .


Simple , safe and effective , walking exercise during late trimester may improve the pregnancy outcomes of low-risk primipara .


Visceral adipose tissue ( VAT ) is associated with an increased risk of metabolic syndrome ( MetS ) .


Recent studies have suggested that VAT negatively affects bone .


However , MetS has also been associated with higher estradiol ( E2 ) levels , which is bone protective .


We therefore investigated the impact of VAT and E2 levels on bone density , structural parameters , and strength estimates .


A cross-sectional study was conducted in 72 obese men with MetS to investigate the impact of VAT and E2 levels on bone .


Bone parameters were assessed by dual-energy X-ray absorptiometry ( DXA ) , quantitative computed tomography ( QCT ) , and high-resolution peripheral QCT ( HRpQCT ) at lumbar spine , proximal femur , radius , and tibia .


VAT volume was measured by magnetic resonance imaging ( MRI ) and sexual hormones were measured in blood samples .


Men with high VAT had a lower bone density at the hip ( P < 0.05 ) , lower cortical thickness , and higher buckling ratio at femoral neck ( FN ) ( P = 0.008 and P = 0.02 ) , compared with men with low VAT , despite a similar body weight and BMI .


Generally , E2 levels were low ( median 43pmol/l ) , and men with E2 levels below median had reduced bone density at lumbar spine ( P = 0.04 ) , and impaired structural parameters at radius and tibia , compared with men with E2 levels above median .


At the hip , VAT volume and E2 levels affected bone density independently and additively , and 50 % of men with high VAT and low E2 levels had osteopenia with significantly lower T-score at FN ( P = 0.004 ) .


High VAT and low E2 negatively affect bone in obese men with MetS .


VAT and E2 affect bone density at the hip independently and additively , revealing an unexpected high prevalence of osteopenia in middle-aged men with MetS .


Thromboxane prostaglandin receptors have been implicated to be involved in the atherosclerotic process .


We assessed whether Terutroban , a thromboxane prostaglandin receptor antagonist , affects the progression of atherosclerosis , as measured by common carotid intima-media thickness and carotid plaques .


A substudy was performed among 1141 participants of the aspirin-controlled Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin with Terutroban in Patients with a History of Ischemic Stroke or Transient Ischemic Attack ( PERFORM ) trial .


Common carotid intima-media thickness and carotid plaque occurrence was measured during a 3-year period .


Baseline characteristics did not differ between Terutroban ( n = 592 ) and aspirin ( n = 549 ) treated patients and were similar as in the main study .


Mean study and treatment duration were similar ( 28 and 25 months , respectively ) .


In the Terutroban group , the annualized rate of change in common carotid intima-media thickness was 0.006 mm per year ( 95 % confidence interval , -0.004 to 0.016 ) and -0.005 mm per year ( 95 % confidence interval , -0.015 to 0.005 ) in the aspirin group .


There was no statistically significant difference between the groups in the annualized rate of change of common carotid intima-media thickness ( 0.011 mm per year ; 95 % confidence interval , -0.003 to 0.025 ) .


At 12 months of follow-up , 66 % of Terutroban patients had no emergent plaques , 31 % had 1 to 2 emergent plaques , and 3 % had 3 emergent plaques .


In the aspirin group , the corresponding percentages were 64 % , 32 % , and 4 % .


Over time , there was no statistically significant difference in the number of emergent carotid plaques between treatment modalities ( rate ratio , 0.91 ; 95 % confidence interval , 0.77-1 .07 ) .


Compared with aspirin , Terutroban did not beneficially affect progression of carotid atherosclerosis among well-treated patients with a history of ischemic stroke or transient ischemic attacks with an internal carotid stenosis < 70 % .


http://www.controlled-trials.com .


Unique identifier : ISRCTN66157730 .


The objectives of the study were to evaluate the image quality and diagnostic performance of sinogram-affirmed iterative reconstruction ( SAFIRE ) for detecting hepatic metastasis and to estimate the potential radiation dose reduction at abdominal computed tomography ( CT ) .


Fifty-nine consecutive patients ( mean age , 59.2 years ; range , 42-81 years ) who had hepatic metastasis and who underwent dual-source abdominal CT were enrolled in this study .


The image noise of the liver was compared between full-dose filtered back projection images ( FD-FBP ) and simulated half-dose images , which used only single-source projection data , and reconstructed with different strengths of SAFIRE ( HD-SAFIRE ( 1-5 ) ) by 1-way analysis of variance with Bonferroni correction .


The diagnostic performance for hepatic metastasis was compared by logistic regression with the weighted least squares method and noninferiority test between the FD-FBP images and the half-dose sinogram-affirmed iterative reconstruction ( HD-SAFIRE ) images .


As the SAFIRE strength increased , image noise decreased ( P < 0.001 ) .


The images of HD-SAFIRE ( 2 ) showed similar image noise for liver parenchyma ( 13.4 Hounsfield unit [ HU ] ) , signal-to-noise ratio for liver parenchyma ( 9.2 ) , and lesion-to-liver contrast-to-noise ratio ( 4.5 ) , compared with the FD-FBP images ( 12.6 HU , P = 0.668 ; 9.6 , P > 0.999 ; and 4.5 , P > 0.999 , respectively ) .


The diagnostic accuracy for hepatic metastasis with the HD-SAFIRE ( 2 ) images ( 87.5 % ) was not different from that of the FD-FBP images ( 87.5 % , P > 0.999 ) .


The diagnostic performance of the HD-SAFIRE ( 2 ) images was also noninferior to that of the FD-FBP images ( 95 % confidence interval lower limit difference [ -9.16 % ] excluding the -10 % clinical noninferiority limit ) .


The mean ( SD ) volume CT dose index of FD-FBP was 11.26 ( 2.66 ) mGy , and the mean ( SD ) radiation dose equivalent associated with HD-SAFIRE was estimated to be 5.63 ( 1.33 ) mGy .


By applying SAFIRE2 , the radiation dose could be reduced by up to 50 % compared with the standard-of-care abdominal CT protocol without increasing image noise and without deteriorating diagnostic performance for the detection of hepatic metastasis .


Shoulder arthroscopic surgeries evolve with intense postoperative pain .


Several analgesic techniques have been advocated .


The aim of this study was to compare suprascapular and axillary nerve blocks in shoulder arthroscopy using the interscalene approach to brachial plexus blockade .


According to the technique used , sixty-eight patients were allocated into two groups : interscalene group ( IG , n = 34 ) and selective group ( SG , n = 34 ) , with neurostimulation approach used for both techniques .


After appropriate motor response , IG received 30 mL of 0.33 % levobupivacaine in 50 % enantiomeric excess with adrenalin 1:200,000 .


After motor response of suprascapular and axillary nerves , SG received 15 mL of the same substance on each nerve .


General anesthesia was then administered .


Variables assessed were time to perform the blocks , analgesia , opioid consumption , motor block , cardiovascular stability , patient satisfaction and acceptability .


Time for interscalene blockade was significantly shorter than for selective blockade .


Analgesia was significantly higher in the immediate postoperative period in IG and in the late postoperative period in SG .


Morphine consumption was significantly higher in the first hour in SG .


Motor block was significantly lower in SG .


There was no difference between groups regarding cardiocirculatory stability and patient satisfaction and acceptability .


Failure occurred in IG ( 1 ) and SG ( 2 ) .


Both techniques are safe , effective , and with the same degree of satisfaction and acceptability .


The selective blockade of both nerves showed satisfactory analgesia , with the advantage of providing motor block restricted to the shoulder .


To explore the effects of pri ming rocuronium on neuromuscular blockade produced by mivacurium .


Ethical approval was granted by the medical ethics committee of our hospital with a reference number of C-2013-018-01 .


A total of 120 ASA physical status I and II patients undergoing selective otorhinolaryngologic surgery under general anesthesia signed the form of informed consent .


And they were randomly divided by a random number table into 4 groups .


After a standardized imidazole-propofol-fentanyl induction , they received a saline placebo injection ( GroupI ) and a pri ming dose of rocuronium 0.06 mg/kg ( GroupII ) , rocuronium 0.075 mg/kg ( Group III ) and rocuronium 0.1 mg/kg ( Group IV ) .


An intubating dose of mivacurium 0.15 mg/kg was offered 3 minutes later .


Anesthesia was maintained with propofol and remifentanyl continuous infusion .


Neuromuscular block was monitored with train of four ( TOF ) stimulation .


The onset time , reappearance of T1 ( DUR TOFc 1 ) , times of T1 25 % and 75 % recovery , recovery index and times of TOF25 % , 75 % and 90 % recovery were recorded .


The onset time of mivacurium was significantly shorter and the times of T1 25 % and 75 % recovery were significantly longer in groups of II , III and IV than those in groupI .


No significant difference existed in recovery index among 4 groups .


The onset time of mivacurium became progressively shorter with the growing pri ming dose of rocurium among three experiment groups .


And it was not statistically significant .


Pri ming rocuronium decreases the onset and intubating times of mivacurium without effect on recovery index .


No significant difference exists in drug effect among 3 experiment groups .


Oxidative stress and inflammation are two key mechanisms suggested to be involved in the pathogenesis of Alzheimer 's disease ( AD ) .


Omega-3 fatty acids ( -3 FAs ) found in fish and fish oil have several biological properties that may be beneficial in AD .


However , they may also auto-oxidize and induce in vivo lipid peroxidation .


The objective of this study was to evaluate systemic oxidative stress and inflammatory biomarkers following oral supplementation of dietary -3 FA .


Forty patients with moderate AD were randomized to receive 1.7 g DHA ( 22:6 ) and 0.6 g EPA ( 20:5 ) or placebo for 6 months .


Urinary samples were collected before and after supplementation .


The levels of the major F2-isoprostane , 8-iso-PGF2 , a consistent in vivo biomarker of oxidative stress , and 15-keto-dihydro-PGF2 , a major metabolite of PGF2 and biomarker of inflammatory response , were measured .


F2-isoprostane in urine increased in the placebo group after 6 months , but there was no clear difference in treatment effect between supplemented and non-supplemented patients on the urinary levels of F2-isoprostanes and 15-keto-dihydro-PGF2 .


At baseline , the levels of 15-keto-dihydro-PGF2 showed negative correlative relationships to -3 FAs , and a positive correlation to linoleic acid .


8-iso-PGF2 correlated negatively to the -6 FA arachidonic acid .


The findings indicate that supplementation of -3 FAs to patients with AD for 6 months does not have a clear effect on free radical-mediated formation of F2-isoprostane or cyclooxygenase-mediated formation of prostaglandin F2 .


The correlative relationships to FAs indicate a potential role of FAs in immunoregulation .


Morning dose or twice-daily proton pump inhibitor ( PPI ) use is often prescribed to heal severe reflux esophagitis .


Compare the effect of single dose morning ( control arm ) versus nighttime ( experimental arm ) omeprazole/sodium bicarbonate ( Zegerid ( ) ) ( IR-OME ) on esophagitis and gastroesophageal reflux symptoms .


Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective , randomized , parallel design , single center study .


Esophagogastroduodenoscopy ( EGD ) and validated self-report symptom questionnaires were completed at baseline and follow-up .


Intention-to-treat and per-protocol analyses were performed .


Ninety-two of 128 ( 72 % ) eligible subjects participated [ 64 ( 70 % ) male , mean age 58 ( range 19-86 ) , median BMI 29 ( range 21-51 ) , 58 C :34 D ] .


Overall , 81 ( 88 % ) subjects healed [ n = 70 ( 76 % ) ] or improved [ n = 11 ( 12 % ) ] erosions .


There was no significant difference ( morning vs. night ) in mucosal healing [ 81 vs. 71 % , ( p = 0.44 ) ] or symptom resolution [ heartburn ( 77 vs. 65 % , p = 0.12 ) , acid regurgitation ( 82 vs. 73 % , p = 0.28 ) ] .


Prevalence of newly identified Barrett 's esophagus was 14 % with half diagnosed only after treatment .


Once-daily IR-OME ( taken morning or night ) effectively heals severe reflux esophagitis and improves GERD symptoms .


Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett 's esophagus .


Alerts embedded in electronic health records ( EHRs ) are designed to improve processes at the point of care .


The aim of this study was to determine if an EHR alert-at emergency department ( ED ) triage-increases the ED triage nurse 's utilization of triage protocols .


ED triage nurses were randomized to receive either a passive EHR alert or no intervention for patients with the following complaints : minor trauma with extremity injuries or female patients with abdominal pain .


The EHR alert notified the nurse that the patient was eligible for diagnostic testing : radiographs for patients with injured extremities or urinalysis for female patients with abdominal pain .


Twenty-eight nurses triaged 20,410 patients in the 6 months before the intervention and 19,157 in the 6 months after the intervention .


Before the intervention , the urinalysis protocol was implemented in 101/624 ( 16.2 % ) patients triaged by the intervention group and 116/711 ( 16.3 % ) triaged by the control group .


After the intervention , the urinalysis protocol was implemented in 146/530 ( 27.6 % ) patients triaged by the intervention group and 174/679 ( 25.6 % ) triaged by the control group .


Before the intervention , the radiograph protocol was implemented in 58/774 ( 7.5 % ) patients triaged by the intervention group and 45/684 ( 6.6 % ) triaged by the control group .


After the intervention , the radiograph protocol was implemented in 78/614 ( 12.7 % ) patients triaged by the intervention group and 79/609 ( 13.0 % ) triaged by the control group .


The use of a passive EHR alert to promote ED triage protocols showed little benefit .


Before the widespread implementation of EHR alerts for patient care , rigorous studies are required to determine the best alert methods and the impacts of such interventions .


Hemolysis reaction is a rare class effect of therapy with intravenously administered human normal immunoglobulin ( IVIG ) .


Anti-A/B isoagglutinins ( isohemagglutinins ) originating from donor plasma are considered a probable risk factor for hemolysis .


We hypothesized that screening and exclusion of plasma obtained from donors with high isoagglutinin titers from the manufacturing process would produce a meaningful reduction of anti-A/B isoagglutinin titers of the final IVIG product .


A donor screening method for anti-A isoagglutinins using an automated indirect agglutination test ( IAT ) in gel cards was developed .


Industry-scale donor plasma pools and final IVIG product were prepared according to the manufacturing process of Privigen ( human 10 % liquid IVIG ) .


Anti-A/B isoagglutinin levels were measured by IAT , direct agglutination test , and a flow cytometry-based assay .


Screening of plasma from 705 randomly selected donors identified 6.8 % donors with high anti-A isoagglutinin titers in plasma .


Exclusion of plasma from these donors resulted in a one-titer-step reduction of anti-A isoagglutinin in laboratory-scale pooled plasma .


The same donor screening method applied to industry-scale production resulted in exclusion of 5.1 % of donors and produced a one-titer-step reduction of both anti-A and anti-B isoagglutinin titers in the final IVIG product .


Anti-A/B isoagglutinin titers in IVIG products can be reduced on an industrial scale through implementation of anti-A donor screening , which may lower the risk of hemolysis after IVIG therapy .


Rectus sheath block can provide analgesia following umbilical hernia repair .


However , conflicting reports on its analgesic effectiveness exist .


No study has investigated plasma local anesthetic concentration following ultrasound-guided rectus sheath block ( USGRSB ) in children .


Compare the effectiveness and bupivacaine absorption following USGRSB or wound infiltration ( WI ) for umbilical hernia repair in children .


A randomized blinded study comparing WI with USGRSB in 40 children undergoing umbilical hernia repair was performed .


Group WI ( n = 20 ) received wound infiltration 1 mgkg ( -1 ) 0.25 % bupivacaine .


Group RS ( n = 20 ) received USGRSB 0.5 mgkg ( -1 ) 0.25 % bupivacaine per side in the posterior rectus sheath compartment .


Pain scores and rescue analgesia were recorded .


Blood samples were drawn at 0 , 10 , 20 , 30 , 45 , and 60 min .


Patients in the WI group had a twofold increased risk of requiring morphine ( hazard ratio 2.06 , 95 % CI 1.01 , 4.20 , P = 0.05 ) .


When required , median time to first morphine dose was longer in the USGRSB group ( 65.5 min vs. 47.5 min , P = 0.049 ) .


Peak plasma bupivacaine concentration was higher following USGRSB than WI ( median : 631.9 ngml ( -1 ) IQR : 553.9-784 .1 vs. 389.7 ngml ( -1 ) IQR : 250.5-502 .7 , P = 0.002 ) .


Tmax was longer in the USGRSB group ( median 45 min IQR : 30-60 vs. 20 min IQR : 20-45 , P = 0.006 ) .


USGRSB provides more effective analgesia than WI for umbilical hernia repair .


USGRSB with 1 mgkg ( -1 ) 0.25 % bupivacaine is associated with safe plasma bupivacaine concentration that peaks higher and later than WI .


Caution against using larger volumes of higher concentration local anesthetic for USGRSB is advised .


Drug-drug interactions between canagliflozin , a sodium glucose co-transporter 2 inhibitor approved for the management of type-2 diabetes mellitus , and an oral contraceptive ( OC ) , warfarin , and digoxin were evaluated in three phase 1 studies in healthy participants .


All studies were open-label ; study 1 included a fixed-sequence design , and studies 2 and 3 used a crossover design .


Regimens were : study 1 : OC ( levonorgestrel ( 150 g ) + ethinyl estradiol ( 30 g ) ) / day ( day 1 ) , canagliflozin 200 mg/day ( days 4 - 8 ) , and canagliflozin with OC ( day 9 ) ; study 2 : canagliflozin 300 mg/day ( days 1 - 12 ) with warfarin 30 mg/day ( day 6 ) in period 1 , and only warfarin 30 mg/day ( day 1 ) in period 2 , or vice versa ; study 3 : digoxin alone ( 0.5 mg/day ( day 1 ) + 0.25 mg/day ( days 2 - 7 ) ) in period 1 , and with canagliflozin 300 mg/day ( days 1 - 7 ) in period 2 , or vice versa .


Pharmacokinetics ( PK ) were assessed at prespecified intervals ; OC : days 1 and 9 , canagliflozin : days 8 - 9 ( study 1 ) ; warfarin : days 6 ( period 1 ) and 1 ( period 2 ) ( study 2 ) ; and digoxin : days 5 - 7 ( periods 1 and 2 ) ( study 3 ) .


Warfarin 's pharmacodynamics ( PD ; International Normalized Ratio ( INR ) ) was assessed on days 6 ( period 1 ) and 1 ( period 2 ) .


Canagliflozin increased the plasma exposure of OC ( maximum plasma concentration ( Cmax ) : 22 % , area under the curve ( AUC ) : 6 % ) and digoxin ( Cmax : 36 % , AUC : 20 % ) ; but did not alter warfarin 's PK and PD .


No clinically relevant safety findings ( including hypoglycemia ) were noted .


Canagliflozin can be coadministered with OC , warfarin , or digoxin without dose adjustments .


All treatments were well-tolerated .


This study aimed to determine during 36 months of follow-up the ( 1 ) clinical outcomes and ( 2 ) influence of high-risk human papillomavirus ( HPV ) status on the risk of progression to cervical intraepithelial neoplasia 2 + ( CIN 2 + ) , among women with histologically proven CIN 1 .


This is an ad hoc analysis of women with CIN 1 within TOMBOLA , a randomized trial of the management of women with low-grade cervical cytology .


Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included .


Sociodemographic data and a sample for HPV testing were collected at recruitment .


Data on the sample women were extracted to calculate the cumulative incidence of CIN 2 + and the performance characteristics of the baseline HPV test .


Detection of CIN 2 or worse ( CIN 2 + ) during follow-up or at exit colposcopy was analyzed .


A total of 171 women were included .


Their median age was 29 years .


Fifty-two percent were high-risk HPV positive , 17 % were HPV-16 positive , and 11 % were HPV-18 positive .


Overall , 21 women ( 12 % ) developed CIN 2 + , with a median time to detection of 25 months .


Factors associated with progression to CIN 2 + were presence of HPV-18 ( relative risk = 3.04 ; 95 % CI = 1.09-8 .44 ) and HPV-16 and/or HPV-18 at recruitment ( relative risk = 3.98 ; 95 % CI = 1.60-9 .90 ) .


The sensitivity and specificity of a combined HPV-16 / HPV-18 test for the detection of CIN 2 + during 3 years were 58 % and 78 % , respectively .


Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years .


Because the median time to progression was 25 months , conservative management could recommend the next repeat cytology at 2 years .


To determine longitudinal changes in angle configuration in the eyes of primary angle-closure suspects ( PACS ) treated by laser peripheral iridotomy ( LPI ) and in untreated fellow eyes .


Longitudinal cohort study .


Primary angle-closure suspects aged 50 to 70 years were enrolled in a randomized , controlled clinical trial .


Each participant was treated by LPI in 1 randomly selected eye , with the fellow eye serving as a control .


Angle width was assessed in a masked fashion using gonioscopy and anterior segment optical coherence tomography ( AS-OCT ) before and at 2 weeks , 6 months , and 18 months after LPI .


Angle width in degrees was calculated from Shaffer grades assessed under static gonioscopy .


Angle configuration was also evaluated using angle opening distance ( AOD250 , AOD500 , AOD750 ) , trabecular-iris space area ( TISA500 , TISA750 ) , and angle recess area ( ARA ) measured in AS-OCT images .


No significant difference was found in baseline measures of angle configuration between treated and untreated eyes .


At 2 weeks after LPI , the drainage angle on gonioscopy widened from a mean of 13.5 at baseline to a mean of 25.7 in treated eyes , which was also confirmed by significant increases in all AS-OCT angle width measures ( P < 0.001 for all variables ) .


Between 2 weeks and 18 months after LPI , a significant decrease in angle width was observed over time in treated eyes ( P < 0.001 for all variables ) , although the change over the first 5.5 months was not statistically significant for angle width measured under gonioscopy ( P = 0.18 ) , AOD250 ( P = 0.167 ) and ARA ( P = 0.83 ) .


In untreated eyes , angle width consistently decreased across all follow-up visits after LPI , with a more rapid longitudinal decrease compared with treated eyes ( P values for all variables 0.003 ) .


The annual rate of change in angle width was equivalent to 1.2 / year ( 95 % confidence interval [ CI ] , 0.8-1 .6 ) in treated eyes and 1.6 / year ( 95 % CI , 1.3-2 .0 ) in untreated eyes ( P < 0.001 ) .


Angle width of treated eyes increased markedly after LPI , remained stable for 6 months , and then decreased significantly by 18 months after LPI .


Untreated eyes experienced a more consistent and rapid decrease in angle width over the same time period .


Chronic pain and progressive loss of physical function with AS may adversely affect health-related quality of life ( HRQoL ) .


The objective of this study was to assess the 5-year data regarding spinal mobility , physical function and HRQoL in patients with AS who participated in the Adalimumab Trial Evaluating Long-term Efficacy and Safety for AS ( ATLAS ) study .


Patients received blinded adalimumab 40 mg or placebo every other week for 24 weeks , then open-label adalimumab for up to 5 years .


Spinal mobility was evaluated using linear BASMI ( BASMIlin ) .


BASDAI , total back pain , CRP , BASFI , Short Form-36 and AS quality of life ( ASQoL ) were also assessed .


Correlations between BASMIlin and clinical , functional and ASQoL outcomes after 12 weeks and after 5years of adalimumab exposure were evaluated using Spearman 's rank correlation .


Associations were further analysed using multivariate regression .


Three hundred and eleven patients received 1 dose of adalimumab ; 125 of the 208 patients originally randomized to adalimumab received treatment for 5 years .


Improvements in BASMIlin were sustained through 5 years , with a mean change of -0.6 from baseline in the population who completed 5 years of treatment with adalimumab .


Improvements in disease activity , physical function and ASQoL were also sustained through 5 years .


BASMIlin was significantly correlated with all evaluated clinical outcomes ( P < 0.001 ) .


The highest correlation was with BASFI at 12 weeks ( r = 0.52 ) and at 5 years ( r = 0.65 ) .


Multivariate regression analysis confirmed this association ( P < 0.001 ) .


Treatment with adalimumab for up to 5 years demonstrated sustained benefits in spinal mobility , disease activity , physical function and HRQoL in patients with active AS .


Spinal mobility was significantly associated with short - and long-term physical function in these patients .


Clinicaltrials.gov ; https://clinicaltrials.gov/NCT00085644 .


The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss .


The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding .


A longitudinal multicenter study was conducted in patients with body mass index ( BMI ) > 35 kg/m ( 2 ) who underwent gastric banding with the BioEnterics Intragastric Balloon ( BIB ) .


After balloon removal ( 6 mo ) , patients were allocated into 2 group according to their percentage of excess weight loss ( % EWL ) : group > 25 ( % EWL > 25 % ) and group < 25 ( % EWL < 25 % ) .


Patients from both group underwent laparoscopic adjustable gastric banding ( LAGB ) 1-3 months after BIB removal .


The LAP-BAND AP band was placed in all patients via pars flaccida .


Weight loss parameters were considered in both groups .


From January 2005 to December 2009 , 1357 patients were enrolled in this study .


Mean BMI at time of BIB positioning was 44.98.4 ( range 29-82 .5 ) .


After 6 months , at time of removal , mean BMI was 39.47.3 .


According to the cutoff , patients were allocated into group A ( n = 699 ) and group B ( n = 658 ) .


At this time the mean BMI was 36.46.4 and 42.76.9 ( P = .001 ) in groups A and B , respectively .


At 1-year follow-up from LAGB , mean BMI was 35.86.5 and 40.07.4 ( P < .001 ) in groups A and B , respectively .


This significant difference was confirmed at 3 - and 5-year follow-ups .


A similar pattern was observed with the % EWL .


Satisfactory results with BIB are predictive of a positive outcome of LASB at 1 , 3 , and 5 years after the procedure , and poor results do not inevitably indicate a negative outcome for gastric banding .


Calcitonin gene-related peptide ( CGRP ) is crucial in the pathophysiology of migraine .


We assessed the safety , tolerability , and efficacy of ALD403 , a genetically engineered humanised anti-CGRP antibody , for migraine prevention .


In this randomised , double-blind , placebo-controlled , exploratory , proof-of-concept phase 2 trial , patients aged 18-55 years with five to 14 migraine days per 28-day period were randomly assigned ( 1:1 ) via an interactive web response system to receive an intravenous dose of ALD403 1000 mg or placebo .


Site investigators , patients , and the sponsor were masked to treatment allocation during the study .


The primary objective was to assess safety at 12 weeks after infusion .


The primary efficacy endpoint was the change from baseline to weeks 5-8 in the frequency of migraine days , as recorded in patient electronic diaries .


Patients were followed up until 24 weeks for exploratory safety and efficacy analyses .


Safety and efficacy analyses were done by intention to treat .


This study is registered with ClinicalTrials.gov , NCT01772524 .


Between Jan 28 , 2013 , and Dec 23 , 2013 , of 174 patients randomly assigned at 26 centres in the USA , 163 received either ALD403 ( n = 81 ) or placebo ( n = 82 ) .


Adverse events were experienced by 46 ( 57 % ) of 81 patients in the ALD403 group and 43 ( 52 % ) of 82 in the placebo group .


The most frequent adverse events were upper respiratory tract infection ( placebo 6 [ 7 % ] patients vs ALD403 7 [ 9 % ] patients ) , urinary tract infection ( 4 [ 5 % ] vs 1 [ 1 % ] ) , fatigue ( 3 [ 4 % ] vs 3 [ 4 % ] ) , back pain ( 4 [ 5 % ] vs 3 [ 4 % ] ) , arthralgia ( 4 [ 5 % ] vs 1 [ 1 % ] ) , and nausea and vomiting ( 2 [ 2 % ] vs 3 [ 4 % ] ) .


Six serious adverse events were reported by three patients and were judged to be unrelated to study drug : in the ALD403 group , one patient had four serious adverse events and one had one serious adverse event , and in the placebo group , one patient had one serious adverse event .


There were no differences in vital signs or laboratory safety data between the two treatment groups .


The mean change in migraine days between baseline and weeks 5-8 was -56 ( SD 30 ) for the ALD403 group compared with -46 ( 36 ) for the placebo group ( difference -10 , 95 % CI -20 to 01 ; one-sided p = 00306 ) .


No safety concerns were noted with an intravenous dose of ALD403 1000 mg .


This study also provides preliminary evidence for the efficacy of ALD403 in the preventive treatment of migraine in patients with a high monthly frequency of migraine days .


Alder Biopharmaceuticals .


Polycystic liver disease ( PLD ) , the most common extrarenal manifestation of autosomal-dominant polycystic kidney disease ( ADPKD ) , has become more prevalent as a result of increased life expectancy , improved renal survival , reduced cardiovascular mortality , and renal replacement therapy .


No studies have fully characterized PLD in large cohorts .


We investigated whether liver and cyst volumes are associated with volume of the hepatic parenchyma , results from liver laboratory tests , and patient-reported outcomes .


We performed a cross-sectional analysis of baseline liver volumes , measured by magnetic resonance imaging , and their association with demographics , results from liver laboratory and other tests , and quality of life .


The data were collected from a randomized , placebo-controlled trial underway at 7 tertiary-care medical centers to determine whether the combination of an angiotensin I-converting enzyme inhibitor and angiotensin II-receptor blocker was superior to the inhibitor alone , and whether low blood pressure ( < 110/75 mm Hg ) was superior to standard blood pressure ( 120-130/70 -80 mm Hg ) , in delaying renal cystic progression in 558 patients with ADPKD , stages 1 and 2 chronic kidney disease , and hypertension ( age , 15-49 y ) .


We found hepatomegaly to be common among patients with ADPKD .


Cysts and parenchyma contributed to hepatomegaly .


Cysts were more common and liver and cyst volumes were greater in women , increasing with age .


Patients with advanced disease had a relative loss of liver parenchyma .


We observed small abnormalities in results from liver laboratory tests , and that splenomegaly and hypersplenism were associated with PLD severity .


Higher liver volumes were associated with a lower quality of life .


Hepatomegaly is common even in early stage ADPKD and is not accounted for by cysts alone .


Parenchymal volumes were larger , compared with liver volumes of patients without ADPKD or with those predicted by standardized equations , even among patients without cysts .


The severity of PLD was associated with altered biochemical and hematologic features , as well as quality of life .


ClinicalTrials.gov identifier : NCT00283686 .


Peripancreatic fluid collections ( PFCs ) have been adequately drained using multiple plastic stents placed in a single-step endoscopic ultrasound ( EUS ) procedure .


Recent reports have presented the usefulness of metal stents for this procedure ; however , there has been no prospective comparative study on their effectiveness and safety .


We conducted a prospective randomized study to compare multiple plastic stents with fully covered , self-expanding metal stents ( FCSEMSs ) for the drainage of PFCs .


Between January 2012 and May 2013 , patients with PFCs demonstrated by various modalities were enrolled in our study .


Patients were randomly assigned to receive either a FCSEMS or plastic stents for EUS-guided PFC drainage .


The procedure time , technical success rate , and adverse event rates of the PFCs were evaluated .


50 patients ( 41 men ) were included and randomly assigned to either the FCSEMS group ( n = 25 ) or the plastic stent group ( n = 25 ) .


The median procedure time with FCSEMS was significantly shorter than with plastic stents ( 15.0 min vs. 29.5 min , P < 0.01 ) .


The technical success rate was 100 % for both groups .


The clinical success rate was 20 out of 23 for FCSEMS and 20 out of 22 for plastic stents ( P = 0.97 ) .


No adverse events occurred in the FCSEMS group , while adverse events occurred in two patients in the plastic stent group ( P = 0.16 ) .


One recurrence was observed during follow-up in the FCSEMS group and none in the plastic stent group ( P = 0.15 ) .


EUS-guided PFC drainage with FCSEMSs is comparable to such drainage with plastic stents in terms of technical feasibility , efficacy , and safety ; however , the use of FCSEMSs may also simplify and shorten the procedure .


KCT0000766 ( https://cris.nih.go.kr ) .


It is projected that in Australia there will be between 28 % and 48 % of palliative care patients living alone by the year 2031 .


As such , it will become increasingly important to provide appropriate home-based care in order to support these patients to be cared for and die at home .


This study explored the experiences of community-based palliative care cancer patients who live alone without a caregiver and what psychosocial issues they face .


Face-to-face semistructured interviews were conducted with eight participants , and constant comparison was used for the analysis .


Four main themes emerged : ( 1 ) loss of social networks ; ( 2 ) maintaining independence ; ( 3 ) balancing independence and the need for assistance ; and ( 4 ) planning for the end of life .


Participants balanced independence with the need to accept help in order to maintain independence .


Participants became more flexible about their preferred place of death .


The practice implications for working with people close to death who are living alone are that supports and assistance may be needed to maintain social networks and also a sense of independence .


The timely publication of findings in peer-reviewed journals is a primary goal of clinical research .


In clinical trials , the processes leading to publication can be complex from choice and prioritization of analytic topics through to journal submission and revisions .


As little literature exists on the publication process for multicenter trials , we describe the development , implementation , and effectiveness of such a process in a multicenter trial .


The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis ( HALT-C ) trial included a data coordinating center ( DCC ) and clinical centers that recruited and followed more than 1,000 patients .


Publication guidelines were approved by the steering committee , and the publications committee monitored the publication process from selection of topics to publication .


A total of 73 manuscripts were published in 23 peer-reviewed journals .


When manuscripts were closely tracked , the median time for analyses and drafting of manuscripts was 8months .


The median time for data analyses was 5months and the median time for manuscript drafting was 3months .


The median time for publications committee review , submission , and journal acceptance was 7months , and the median time from analytic start to journal acceptance was 18months .


Effective publication guidelines must be comprehensive , implemented early in a trial , and require active management by study investigators .


Successful collaboration , such as in the HALT-C trial , can serve as a model for others involved in multidisciplinary and multicenter research programs .


The HALT-C Trial was registered with clinicaltrials.gov ( NCT00006164 ) .


Several evidences have supported the benefits of home blood pressure monitoring ( HBPM ) in improving hypertension awareness and control .


However , little was known about the use of HBPM by hypertensive patients in primary care in China .


A cross-sectional questionnaire survey on HBPM use was conducted on 1915 hypertensive patients in Xinzhuang County Hospital in Shanghai , and the factors related to regular use of HBPM were also determined .


Overall , 1011 of the 1915 participants engaged in using HBPM , among whom 786 individuals used HBPM more than once a month .


Of the 1011 HBPM users , 25.42 % chose a mercury sphygmomanometer , 33.55 % used wrist-cuff electronic devices , and 46.5 % selected arm-cuff electronic devices .


In addition , 73 % of HBPM users reported HBP readings to their general practitioners .


Compared with the less frequent users , patients who used HBPM daily were likely to report their blood pressure ( BP ) values to the doctors depending on notebook or mechanical memory than on their own memories ( P < 0.001 ) .


Moreover , patients with college education were 2.7 times more likely than those with middle school education or less to engage in frequent HBPM use ( odds ratio = 2.71 , 95 % confidence interval = 2.03-3 .61 ) .


This local community survey showed that 40 % of hypertension patients used HBPM frequently in primary care in China .


However , certain patients chose the improper BP monitoring device or questionable reporting methods .


Therefore , the use of arm-cuff electric devices with multiple memory storage or a home BP telemonitoring system should be promoted by health education targeted at hypertensive patients .


Use of rehabilitation technology , such as ( electro ) mechanical devices or robotics , could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke .


Arm support ( AS ) training showed improvement of unsupported arm function in chronic stroke .


To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity , compared with dose-matched conventional reach training in subacute stroke patients .


In a single-blind , multicenter , randomized controlled trial , 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training ( CON ) .


Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment ( FM ) , maximal reach distance , Stroke Upper Limb Capacity Scale ( SULCS ) , and arm pain via Visual Analogue Scale , in addition to perceived motivation by Intrinsic Motivation Inventory posttraining .


FM and SULCS scores and reach distance improved significantly within both groups .


These improvements and experienced pain did not differ between groups .


The AS group reported higher interest/enjoyment during training than the CON group .


AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation , when applied at the same dose .


Rates of retention in care of HIV-positive pregnant women in care programs in Nigeria remain generally poor with rates around 40 % reported for specific programs .


Poor quality of services in health facilities and long waiting times are among the critical factors militating against retention of these women in care .


The aim of the interventions in this study is to assess whether a continuous quality improvement intervention using a Breakthrough Series approach in local district hospitals and primary health care clinics will lead to improved retention of HIV-positive women and mothers .


A cluster randomized controlled trial with 32 health facilities randomized to receive a continuous quality improvement/Breakthrough Series intervention or not .


The care protocol for HIV-infected pregnant women and mothers is the same in all sites .


The quality improvement intervention started 4 months before enrollment of individual HIV-infected pregnant women and initially focused on reducing waiting times for women and also ensuring that antiretroviral drugs are dispensed on the same day as clinic attendance .


The primary outcome measure is retention of HIV-positive mothers in care at 6 months postpartum .


Results of this trial will inform whether quality improvement interventions are an effective means of improving retention in prevention of mother-to-child transmission of HIV programs and will also guide where health system interventions should focus to improve the quality of care for HIV-positive women .


This will benefit policymakers and program managers as they seek to improve retention rates in HIV care programs .


Determine prevalence of diabetes , and describe use of blood glucose lowering ( BGL ) drugs and glycemic control in Norwegian nursing homes .


In this cross-sectional study we collected details of BGL drugs , capillary blood glucose measurements ( CBGM ) in the last four weeks and HbA1c measurements in the last 12 months from the medical records of patients with diabetes , within a population of 742 long-term care patients from 19 randomly selected nursing homes in Western Norway .


Descriptive statistics were applied , and Pearson 's chi-squared ( P0 .05 ) or non-overlapping 95 % confidence intervals were interpreted as significant effects .


116 patients ( 16 % ) had diabetes , 100 of these gave informed consent and medical data were available .


BGL treatment was as follows : ( 1 ) insulin only ( 32 % ) , ( 2 ) insulin and oral antidiabetics ( OADs ) ( 15 % ) , ( 3 ) OADs only ( 27 % ) and ( 4 ) no drugs ( 26 % ) .


Patients with cognitive impairment were less likely to receive medical treatment ( P = 0.04 ) .


CBGM and HbA1c measurements were performed for 73 % and 77 % of patients , respectively .


Mean HbA1c was 7.3 % ( 57 mmol/mol ) , 46 % of patients had an HbA1c < 7.0 % ( 53 mmol/mol ) , and CBGM consistent with risk of hypoglycemia was found for 60 % of these patients .


Prevalence of diabetes and BGL treatment in Norwegian nursing homes is comparable to other European countries .


Although special care seems to be taken when choosing treatment for patients with cognitive impairment , there are signs of overtreatment in the population as a whole .


The strict glycemic control unveiled may negatively affect these frail patients ' quality of life and increase the risk of early death .


To investigate whether the negative quality of life result of a large randomized exercise intervention study ( BREX ) was due to considerable spontaneous recovery after adjuvant treatments .


The change in QoL was studied in the control patients of the BREX study ( Group 1 ) and a group of similar follow-up patients that did not participate in any intervention study ( Group 2 ) .


QoL was measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 with the breast cancer module supplement 6 and 12 months after surgery .


QoL improved in both groups between 6 and 12 months after surgery .


The improvement was similar in both groups for global QoL and for most of the QoL sub-scales .


No evidence was found to support the hypothesis that participation in an exercise intervention per se significantly improves QoL .


Spontaneous improvement in QoL began during the first six months after the primary treatments , which might have confounded the results of the intervention of the BREX study .


Cranial electrotherapy stimulation ( CES ) is used as a treatment for depression and anxiety , and as an adjunctive intervention for pain management .


This prospective study investigated whether CES could decrease preoperative anxiety , the injection pain of rocuronium , postoperative pain and stress hormone levels .


Female patients undergoing thyroidectomy were randomly assigned to two groups , to receive either no pretreatment ( control group ) or CES pretreatment .


Anxiety score , withdrawal response on rocuronium injection , and pain scores at 1 , 4 , 12 and 24 h post surgery were evaluated .


Adrenocorticotrophic hormone ( ACTH ) , cortisol and glucose levels were measured .


Patients were blinded to the treatment condition .


Fifty patients entered the study ( n = 25 per group ) .


Anxiety score and withdrawal responses during rocuronium injection were significantly reduced in the CES group compared with the control group .


Pain score was significantly lower in the CES group than in the control group , 1 h and 4 h post surgery .


There were no significant differences in ACTH , cortisol and glucose levels .


CES pretreatment appears to reduce the level of preoperative anxiety , injection pain of rocuronium and postoperative pain .


However , CES pretreatment did not affect stress hormone responses .


To compare visual outcomes following photorefractive keratectomy ( PRK ) , PRK with mitomycin C ( MMC-PRK ) , and LASEK in moderate and high myopia in military personnel .


This prospective , randomized contralateral eye study included 167 patients 21 years or older with manifest spherical equivalent -5.99 1.40 diopters ( D ) ( range : -3.88 to -9.38 D ) randomized to either MMC-PRK or LASEK treatment in their dominant eye and conventional PRK without MMC in the fellow eye .


All procedures were performed using the LADARVision 4000 Excimer Laser System ( Alcon Surgical Inc. , Ft. Worth , TX ) .


High - and low-contrast visual acuities , manifest refraction , endothelial cell count , and corneal haze were evaluated up to 12 months postoperatively .


At 12 months postoperatively , visual outcomes were comparable among the treatment groups .


Corneal haze of any grade was less common in MMC-PRK compared to PRK at 1 month ( 21.4 % vs 31.0 % ; P < .01 ) and 3 months ( 12.8 % vs 35.9 % ; P = .03 ) postoperatively ; it was also less common in MMC-PRK compared to LASEK at 1 month ( 21.4 % vs 55.9 % ; P < .01 ) , 3 months ( 12.8 % vs 42.4 % ; P < .01 ) , and 6 months ( 12.2 % vs 36.4 % ; P = .03 ) postoperatively .


Haze rate ( grade 0.5 or higher ) was comparable between LASEK and PRK .


Clinically significant haze ( grade 2 or higher ) developed after PRK ( 4 eyes ) and LASEK ( 2 eyes ) , but not after MMC-PRK .


MMC-PRK showed some benefits in minimizing corneal haze formation .


One year after surgery , there was no discernible difference in the postoperative refractive outcomes among the three methods .


To establish the relative bioavailability ( rBA ) between two p.o. 5-mg levomethadone hydrochloride formulations , i.e. , L-Polamidon 5 mg tablets ( test ) vs. L-Polamidon solution for substitution ( reference ) .


To assess the safety and tolerability of both formulations .


A total of 33 healthy male subjects , aged 29 6 years ( BMI : 23.9 2.5 kg/m2 ) completed this single center , open-label , randomized , 2-period cross-over study with single dose administrations under fasting conditions and coadministration with naltrexone for safety reasons .


Administrations of both investigational products were separated by a washout period of at least 2 weeks , i.e. , 13 treatmentfree days .


The total dose for each subject was 2 x 5 mg resulting in 10 mg levomethadone hydrochloride .


For pharmacokinetic evaluation , blood samples were withdrawn until 72 hours postdose .


A validated non-stereoselective liquid chromatography-tandem mass spectroscopy method ( LC-MS/MS ) was applied for the determination of levomethadone in plasma .


The lower limit of quantitation was 0.100 ng/mL .


Adverse events were descriptively analyzed in the study population .


The geometric means of the parameters related with the extent of total exposure of levomethadone , i.e. , AUC ( 0-tlast ) and AUC ( 0 - ) , were 244.422 ng x h/mL and 332.999 ng x h/mL for test and 246.837 ng x h/mL and 329.467 ngh/mL for reference , respectively .


The geometric means of the peak exposure for levomethadone , i.e. , Cmax , were 8.923 ng/mL for test and 8.635 ng/mL for reference .


The point estimates ( PEs ) of the Test/Reference ( T/R ) adjusted geometric mean ratios of AUC ( 0-last ) , AUC ( 0 - ) , and C ( max ) were 99.20 % , 101.42 % , and 104.11 % , respectively , and all of them showed 90 % - confidence intervals ( CIs ) within the range of 80.00 - 125.00 % as suggested by regulatory requirements for bioequivalence assessment In total , 21 subjects experienced 55 AEs during the study , the most frequently reported AE , i.e. , headache , accounted for 13 out of the total 55 AEs ( 23.6 % ) and no AEs of severe intensity were reported .


Bioequivalence could be demonstrated in terms of rate and extent of absorption after administration of test and reference products under naltrexone protection .


Concerning the safety evaluation , no negative implications on the possible use of the test formulation could be determined .


Vincristine causes known side effects of peripheral sensory , motor , autonomic and cranial neuropathies .


No preventive interventions are known .


We performed a randomized , placebo-controlled , double-blind trial of oral glutamic acid as a preventive agent in pediatric patients with cancer who would be receiving vincristine therapy for at least 9 consecutive weeks ( Stratum 1 = Wilms tumor and rhabdomyosarcoma ) or 4 consecutive weeks in conjunction with steroids ( Stratum 2 = Acute lymphoblastic leukemia and non-Hodgkin lymphoma ) .


At designated time points , a scored neurologic exam using the Modified Balis Pediatric Scale of Peripheral Neuropathies was performed to document neurologic toxicity .


Between 2007 and 2012 , 250 patients were enrolled ( Stratum 1 = 50 , Stratum 2 = 200 ) .


The glutamic acid treated group did not have a significantly lower percentage of neurotoxicity compared to placebo treated group either overall or within stratum or age subgroups .


The only subgroup which was suggestive of treatment effect was for age .


Patients 13 years or older showed a larger benefit in favor of glutamic acid ( P = 0.055 ) compared to patients less than 13 years ( P = 1.00 ) .


Constipation was the most frequently reported ( 14 % ) Grade II or higher neurotoxicity .


Vincristine-associated neurotoxicity in pediatric oncology remains a frequent complication of chemotherapy for multiple diagnoses with an approximate 30 % of patients affected .


Glutamic acid is not effective for prevention in pre-adolescents .


There is a suggestion of benefit in patients 13 years or older , but the study was not designed to provide adequate power to test the treatment effect within this age group alone .


To evaluate retinal sensitivity in patients with diabetic macular edema who received intravitreal aflibercept injection ( IAI ) or laser .


A substudy included 46 patients from DA VINCI ( a randomized , double-masked Phase 2 study ) receiving either laser , 0.5 mg IAI every 4 weeks , 2 mg IAI every 4 weeks , 2 mg IAI every 8 weeks after 3 monthly doses ( 2q8 ) , or 2 mg IAI as-needed after 3 monthly doses for 52 weeks .


Retinal sensitivity was measured in one ( central ) , five ( one central and four inner ) , and eight ( four inner and four outer ) optical coherence tomography subfields .


Mean best-corrected visual acuity improvement in the subgroup at Week 52 was 3.3 letters with laser and ranged from 5.4 to 16.3 letters in the IAI groups .


Retinal sensitivity of laser patients at Week 52 was comparable with baseline in the central optical coherence tomography subfield but decreased in the five and eight optical coherence tomography subfields .


Compared with laser , retinal sensitivity significantly increased with IAI in the 2q8 and pooled IAI groups in the 5 and 8 optical coherence tomography subfields at Week 52 ( P < 0.05 ) .


Intravitreal aflibercept injection improved best-corrected visual acuity and retinal sensitivity in this subgroup of patients .


Laser may cause a deterioration of macular function that is not detectable with best-corrected visual acuity testing .


Prediction of radiographic progression ( RP ) in early rheumatoid arthritis ( eRA ) would be very useful for optimal choice among available therapies .


We evaluated a multi-biomarker disease activity ( MBDA ) score , based on 12 serum biomarkers as a baseline predictor for 1-year RP in eRA .


Baseline disease activity score based on erythrocyte sedimentation rate ( DAS28-ESR ) , disease activity score based on C-reactive protein ( DAS28-CRP ) , CRP , MBDA scores and DAS28-ESR at 3months were analysed for 235 patients with eRA from the Swedish Farmacotherapy ( SWEFOT ) clinical trial .


RP was defined as an increase in the Van der Heijde-modified Sharp score by more than five points over 1year .


Associations between baseline disease activity measures , the MBDA score , and 1-year RP were evaluated using univariate and multivariate logistic regression , adjusted for potential confounders .


Among 235 patients with eRA , 5 had low and 29 moderate MBDA scores at baseline .


None of the former and only one of the latter group ( 3.4 % ) had RP during 1year , while the proportion of patients with RP among those with high MBDA score was 20.9 % ( p = 0.021 ) .


Among patients with low/moderate CRP , moderate DAS28-CRP or moderate DAS28-ESR at baseline , progression occurred in 14 % , 15 % , 14 % and 15 % , respectively .


MBDA score was an independent predictor of RP as a continuous ( OR = 1.05 , 95 % CI 1.02 to 1.08 ) and dichotomised variable ( high versus low/moderate , OR = 3.86 , 95 % CI 1.04 to 14.26 ) .


In patients with eRA , the MBDA score at baseline was a strong independent predictor of 1-year RP .


These results suggest that when choosing initial treatment in eRA the MBDA test may be clinically useful to identify a subgroup of patients at low risk of RP .


WHO database at the Karolinska Institute : CT20080004 ; and clinicaltrials.gov : NCT00764725 .


Results of an exploratory phase 2 study showed that insulin degludec , a basal insulin with an action profile of longer than 42 h , provided similar glycaemic control when injected three times a week ( IDeg 3TW ) to once-daily insulin glargine ( IGlar OD ) .


To provide further evidence , we did two phase 3 trials to compare the efficacy and safety of IDeg 3TW with IGlar OD in insulin-naive patients with type 2 diabetes .


In two 26 week , randomised , open-label , parallel group , non-inferiority trials IDeg was injected Monday , Wednesday , and Friday before breakfast ( IDeg 3TW ( AM ) ) in the AM trial ( 94 sites in seven countries ) or with the evening meal ( IDeg 3TW ( PM ) ) in the PM trial ( 89 sites in seven countries ) , and compared with IGlar OD .


Adults with type 2 diabetes ( HbA ( 1c ) 7.0-10 .0 % ; body-mass index 45 kg/m ( 2 ) ) were randomly allocated ( 1:1 ) without stratification by a central interactive response system to IDeg 3TW or IGlar OD .


Both groups continued taking metformin with or without dipeptidyl peptidase-4 inhibitors .


Insulin was titrated to achieve a prebreakfast self-monitored blood glucose ( SMBG ) concentration of between 3.9 and less than 5.0 mmol/L .


The primary outcome was non-inferiority of IDeg 3TW compared with IGlar OD , as assessed by change in HbA ( 1c ) from baseline to 26 weeks ( non-inferiority limit of 0.4 % ) by ANOVA in an intent-to-treat analysis ( full analysis set ) .


These trials are registered with ClinicalTrials.gov , numbers NCT01068678 and NCT01076647 .


We recruited 460 patients for the AM trial ( IDeg 3TW ( AM ) , n = 230 ; IGlar OD , n = 230 ) and 467 patients for the PM trial ( IDeg 3TW ( PM ) , n = 233 ; IGlar OD , n = 234 ) .


After 26 weeks , mean HbA decreased by 0.9 % ( IDeg 3TW ( AM ) ) and 1.3 % ( IGlar OD ) in the AM trial , and by 1.1 % ( IDeg 3TW ( PM ) ) and 1.4 % ( IGlar OD ) in the PM trial .


Non-inferiority was not confirmed in either trial ( estimated treatment difference [ IDeg 3TW ( AM ) - IGlar OD ] 0.34 % , 95 % CI 0.18-0 .51 ; [ IDeg 3TW ( PM ) - IGlar OD ] 0.26 % , 0.11-0 .41 ) .


Across the two trials , rates of confirmed hypoglycaemia ( SMBG < 3.1 mmol/L or severe [ needing assistance ] ) ranged from 1.0 to 1.6 episodes per patient-year and were similar for IDeg 3TW ( AM ) and IGlar OD ( estimated rate ratio [ ERR ] 1.04 , 95 % CI 0.69-1 .55 ) , but higher for IDeg 3TW ( PM ) than for IGlar OD ( ERR 1.58 , 1.03-2 .43 ) .


The rate of nocturnal confirmed hypoglycaemia was higher for IDeg 3TW ( AM ) than for IGlar OD ( ERR 2.12 , 1.08-4 .16 ) ; we noted no significant difference between IDeg 3TW ( PM ) and IGlar OD ( ERR 0.60 , 0.21-1 .69 ) .


The inferior glycaemic control and increased risk of hypoglycaemia with IDeg 3TW compared with IGlar OD do not support a three-times-weekly dosing regimen .


Novo Nordisk .


To evaluate the efficacy of two office-based treatments designed to prevent deterioration in glycemic control in young adolescents with type 1 diabetes in a randomized clinical trial .


An individualized , more intensive family teamwork Coping skills program was compared with a diabetes Education treatment .


A baseline assessment was followed by four brief treatment sessions and immediate posttesting over the course of 1.5 years .


Families of 226 early adolescents ( ages 11-14 ) were randomized to receive either individualized coping skills education or diabetes education as adjunctive treatment to quarterly medical appointments .


Continued follow-up occurred at 3.5-month intervals for a long-term follow-up of up to 3 years .


A post hoc Usual Care group facilitated comparisons of glycemic control .


Growth curve analysis showed that both treatment groups successfully prevented deterioration in adolescent disease care and simultaneously improved adolescent and parent quality of life that included indicators of more effective communication and reduced adherence barriers-without a concomitant increase in diabetes-related or general family conflict .


However , contrary to expectation , the Education group was more efficacious than the Coping group in improvement of disease adherence and glycemic control over a 3-year follow-up .


Low-intensity office-based quarterly treatment can maintain or improve disease care adherence in early adolescence when provided to adolescent/parent dyads .


Better outcomes are achieved when treatment goals and techniques match the needs of the targeted population .


In spinal anaesthesia for a Caesarean delivery , it is important to limit anaesthesia only at the surgical area , and to resolve fast motor block .


We compared the intraoperative effectiveness , hemodynamic effects , anaesthetic recovery times and patients satisfaction after isobaric levobupivacaine ( L ) 0.25 % versus L0 .50 % spinal anaesthesia during elective Caesarean deliveries performed with the Stark technique .


In this double-blinded prospective study , seventy women undergoing elective caesarean delivery were randomized to receive either intrathecal 7.5 mg Levobupivacaine 0.25 % plus sufentanil 2.5 g ( Group L0 .25 ) , or intrathecal 7.5 mg L 0.50 % plus sufentanil 2.5 g ( GroupControl ) .


The onset time , duration of anaesthesia , analgesia and sensory and motor block and hemodynamic parameters were measured from the beginning of spinal anaesthesia until four hours after spinal anaesthesia ( T240 ) .


Onset time , duration of anaesthesia and haemodynamic variations were similar in the two groups .


No patients required general anesthesia to complete surgery .


Motor block vanished faster in Group L0 .25 as compared with GroupControl ( p < .01 ) .


The cephalad spread of the 0.50 % solution was higher than that of the 0.25 % solution : no patient in Group L0 .25 experienced paresthesia of the upper limbs vs 14 % in GroupControl ( p < .05 ) .


In GroupControl anaesthesia reached the dermatome T1 in 15 % of cases .


Maternal and surgeon satisfaction was good in every patient .


Levobupivacaine 7.5 milligrams at 0.25 % may be used as a suitable alternative to L 0.50 % for spinal anaesthesia for caesarean deliveris with the Stark technique with good maternal satisfaction .


In Group L0 .25 a lower appearance of nausea and hypotension were observed and motor and sensitive block developed and diminished faster while no clinically significant differences in hemodynamic behavior was observed between groups .


To compare functional and morphological outcomes of femtosecond laser clear corneal incision ( CCI ) versus manual CCI during cataract surgery .


Sixty eyes of 60 patients who underwent CCI during cataract surgery were randomized into two groups : femtosecond laser CCI ( 30 eyes ) and manual CCI ( 30 eyes ) .


There were no significant between-group differences in uncorrected distance visual acuity , corrected distance visual acuity , surgically induced astigmatism , and corneal aberrations .


Keratometric astigmatism was significantly lower in the femtosecond laser CCI group compared to the manual CCI group at 30 and 180 days ( P < .05 ) .


Central endothelial cell count was significantly higher in the femtosecond laser CCI group compared to the manual CCI group at 7 and 30 days postoperatively ( P < .05 ) .


A lower increase of corneal thickness at the incision site was observed at 30 and 180 days postoperatively in the femtosecond laser CCI group compared to the manual CCI group ( P < .05 ) .


In addition , femtosecond laser CCI showed a better morphology ( lower percentage of endothelial and epithelial gaping and endothelial misalignment ) compared to manual CCI at different time points .


Total phacoemulsification time was significantly lower in the femtosecond laser CCI group ( P < .05 ) .


The femtosecond laser procedure was safe , efficient , and less damaging , as evidenced by lower central endothelial cell loss , lower increase of corneal thickness at the incision site , and better tunnel morphology compared to the manual technique .


The aim of this study was to compare the duration of postoperative analgesia and possible adverse effects produced by caudal bupivacaine 0.25 % at 1 ml/kg with or without 1.5 ug/kg of neostigmine in children undergoing unilateral herniotomy .


Sixty-six children aged 1-6 years , of ASA physical status classes I or II for elective unilateral herniotomy under general anaesthesia without premedication were studied .


The patients were randomly allocated into two groups of 33 each .


Group B received caudal analgesia with plain bupivacaine 0.25 % at 1 ml/kg alone , while group BN received caudal analgesia using a mixture of plain bupivacaine 0.25 % at 1 ml/kg and neostigmine 1.5 ug / kg .


Postoperatively , monitoring of pain scores and time to first analgesic request and , total dose of analgesics administered in the first 24 hours were recorded .


All the patients participated throughout the study .


There were no differences in the demographic characteristics ( age , weight , ASA status ) between the two groups .


The mean duration of effective analgesia was significantly longer in group BN , 460 60.2 min .


compared to group B , 286.4 47.8 mins , ( p < 0.001 ) .


The analgesic requirement within the first 24 hours postoperatively was also significantly reduced in group BN , p < 0.001 .


The study shows that the addition of low dose neostigmine to caudal isobaric bupivacaine significantly prolonged the time to first analgesic request and hence significantly reduced postoperative analgesic requirement .


The American College of Surgeons Oncology Group Z0011 trial has been lauded as practice changing .


We sought to identify its impact on breast cancer surgery in the community hospital setting .


A retrospective review was performed from 8 community hospitals identifying patients with invasive breast cancer meeting the Z0011 criteria .


The primary outcome measures were the rate of completion axillary lymph node dissection ( ALND ) and performance of intraoperative sentinel lymph node ( SLN ) analysis over time .


A total of 1,125 lumpectomies with SLN biopsies were performed with 180 subjects meeting inclusion criteria .


Performance of ALND ( P < .0001 ) and intraoperative SLN analysis ( P < .0001 ) declined during each time period .


Patients more likely to undergo ALND included those with extracapsular extension ( odds ratio [ OR ] 12.8 , 95 % confidence interval [ CI ] 2.5 to 67.1 ) and those who underwent reoperative surgery ( OR 10.8 , 95 % CI 2.6 to 44.4 ) or intraoperative SLN analysis ( OR 5.1 , 95 % CI 1.2 to 21.9 ) .


American College of Surgeons Oncology Group Z0011 trial has been rapidly practice changing in the community hospital setting .


Indomethacin is a potent analgesic that , similar to other nonsteroidal anti-inflammatory drugs , is associated with serious dose-related adverse events .


There is a need for newer nonsteroidal anti-inflammatory drug products with improved tolerability .


Low-dose submicron indomethacin was developed using SoluMatrix Fine Particle Technology to enable treatment at lower doses than commercially available indomethacin drug products .


This study evaluated the pharmacokinetics and safety of submicron indomethacin 20 and 40 mg compared with indomethacin 50-mg capsules .


This was a phase 1 , randomized , open-label , 4-period , 4-sequence , single-dose crossover study .


Forty healthy volunteers received low-dose submicron indomethacin 20 - or 40-mg capsules , or indomethacin 50-mg capsules under fasting or fed conditions .


Pharmacokinetic parameters and safety were assessed .