We sought to determine if there is improved success in obtaining ultrasound-guided PIV using a BP cuff vs a tourniquet in `` difficult stick '' patients .


This is a prospective , randomized , single-blinded trial .


Adult patients requiring PIV with at least 2 prior failed attempts were enrolled .


Patients were assigned to tourniquet or BP cuff for target vein dilation randomly .


Nurses prepared the patient for PIV attempt by either placing a BP cuff inflated to 150 mm Hg or placing a tourniquet on the chosen extremity .


The extremity was draped to blind the physician to assignment .


Physicians then attempted ultrasound-guided PIV .


Failures were defined as IVs requiring greater than 3 ultrasound-guided attempts or 30 minutes , or patient intolerance .


If failure occurred , the physician was unblinded ; and the patient could be crossed over and reattempted .


Thirty-eight patients were enrolled .


The success rate for the tourniquet group ( n = 17 ) and BP cuff group ( n = 21 ) was 82.4 % and 47.6 % , respectively ( P = .04 ) .


There were no differences between groups for vessel depth , diameter , or procedure time .


Six in the BP cuff group were crossed over and had successful PIV obtained with tourniquet .


Tourniquet is superior to BP cuff for target vein dilation in ultrasound-guided PIV .


To compare the efficacy and safety of dulaglutide , a once-weekly GLP-1 receptor agonist , with placebo and exenatide in type 2 diabetic patients .


The primary objective was to determine superiority of dulaglutide 1.5 mg versus placebo in HbA1c change at 26 weeks .


This 52-week , multicenter , parallel-arm study ( primary end point : 26 weeks ) randomized patients ( 2:2:2:1 ) to dulaglutide 1.5 mg , dulaglutide 0.75 mg , exenatide 10 g , or placebo ( placebo-controlled period : 26 weeks ) .


Patients were treated with metformin ( 1,500-3 ,000 mg ) and pioglitazone ( 30-45 mg ) .


Mean baseline HbA1c was 8.1 % ( 65 mmol/mol ) .


Least squares mean SE HbA1c change from baseline to the primary end point was -1.51 0.06 % ( -16.5 0.7 mmol/mol ) for dulaglutide 1.5 mg , -1.30 0.06 % ( -14.2 0.7 mmol/mol ) for dulaglutide 0.75 mg , -0.99 0.06 % ( -10.8 0.7 mmol/mol ) for exenatide , and -0.46 0.08 % ( -5.0 0.9 mmol/mol ) for placebo .


Both dulaglutide doses were superior to placebo at 26 weeks ( both adjusted one-sided P < 0.001 ) and exenatide at 26 and 52 weeks ( both adjusted one-sided P < 0.001 ) .


Greater percentages of patients reached HbA1c targets with dulaglutide 1.5 mg and 0.75 mg than with placebo and exenatide ( all P < 0.001 ) .


At 26 and 52 weeks , total hypoglycemia incidence was lower in patients receiving dulaglutide 1.5 mg than in those receiving exenatide ; no dulaglutide-treated patients reported severe hypoglycemia .


The most common gastrointestinal adverse events for dulaglutide were nausea , vomiting , and diarrhea .


Events were mostly mild to moderate and transient .


Both once-weekly dulaglutide doses demonstrated superior glycemic control versus placebo and exenatide with an acceptable tolerability and safety profile .


Alcohol accelerates the course of hepatitis C ( HCV ) infection and liver damage .


Little is known about recency of alcohol use among patients with HCV .


Alcohol consumption recency was compared among HCV patients with and without alcohol use disorders and current and lifetime alcohol use histories .


Patients considering antiviral treatment for HCV ( n = 309 ) recruited from university-affiliated and VA liver and infectious disease clinics were assessed for lifetime and current-year psychiatric disorders and alcohol-use patterns .


Full diagnostic interviews , self-report surveys , medical record review , and urine screening for recent alcohol and drug use were conducted .


60 % used alcohol in the last year .


Besides alcohol history , those who stopped using alcohol in the past year differed from those with no lifetime use only in gender ( 60 % vs. 22 % ) ; however , patients no longer using alcohol in the last year were less likely than those still using to have a current drug use disorder ( 16 % vs. 3 % ) or last-month drug use ( 52 % vs. 30 % ) , and had fewer current risky behaviors ( 1.3 vs. 0.6 ) .


Among patients with last-year alcohol use , those with past alcohol use disorders differed from those without only by higher prevalence of drug use disorder ( 84 % vs. 47 % ) and drug use after HCV diagnosis ( 67 % vs. 43 % ) .


Patients who had stopped using alcohol for at least a year were much like those who never used alcohol in regard to other drug use , psychiatric history , smoking , and risky behaviors .


These findings indicate that HCV patients with at least a year of abstinence from alcohol , including those with a history of alcohol use disorder , should be considered HCV treatment candidates .


Telephone triage is increasingly used to manage workload in primary care ; however , supporting evidence for this approach is scarce .


We aimed to assess the effectiveness and cost consequences of general practitioner - ( GP ) - led and nurse-led telephone triage compared with usual care for patients seeking same-day consultations in primary care .


We did a pragmatic , cluster-randomised controlled trial and economic evaluation between March 1 , 2011 , and March 31 , 2013 , at 42 practices in four centres in the UK .


Practices were randomly assigned ( 1:1:1 ) , via a computer-generated randomisation sequence minimised for geographical location , practice deprivation , and practice list size , to either GP-led triage , nurse-led computer-supported triage , or usual care .


We included patients who telephoned the practice seeking a same-day face-to-face consultation with a GP .


Allocations were concealed from practices until after they had agreed to participate and a stochastic element was included within the minimisation algorithm to maintain concealment .


Patients , clinicians , and researchers were not masked to allocation , but practice assignment was concealed from the trial statistician .


The primary outcome was primary care workload ( patient contacts , including those attending accident and emergency departments ) in the 28 days after the first same-day request .


Analyses were by intention to treat and per protocol .


This trial was registered with the ISRCTN register , number ISRCTN20687662 .


We randomly assigned 42 practices to GP triage ( n = 13 ) , nurse triage ( n = 15 ) , or usual care ( n = 14 ) , and 20,990 patients ( n = 6695 vs 7012 vs 7283 ) were randomly assigned , of whom 16,211 ( 77 % ) patients provided primary outcome data ( n = 5171 vs 5468 vs 5572 ) .


GP triage was associated with a 33 % increase in the mean number of contacts per person over 28 days compared with usual care ( 265 [ SD 174 ] vs 191 [ 143 ] ; rate ratio [ RR ] 133 , 95 % CI 130-136 ) , and nurse triage with a 48 % increase ( 281 [ SD 168 ] ; RR 148 , 95 % CI 144-152 ) .


Eight patients died within 7 days of the index request : five in the GP-triage group , two in the nurse-triage group , and one in the usual-care group ; however , these deaths were not associated with the trial group or procedures .


Although triage interventions were associated with increased contacts , estimated costs over 28 days were similar between all three groups ( roughly 75 per patient ) .


Introduction of telephone triage delivered by a GP or nurse was associated with an increase in the number of primary care contacts in the 28 days after a patient 's request for a same-day GP consultation , with similar costs to those of usual care .


Telephone triage might be useful in aiding the delivery of primary care .


The whole-system implications should be assessed when introduction of such a system is considered .


Health Technology Assessment Programme UK National Institute for Health Research .


To explore the effectiveness and participant experience of web-based physiotherapy for people moderately affected with Multiple Sclerosis ( MS ) and to provide data to establish the sample size required for a fully powered , definitive randomized controlled study .


A randomized controlled pilot study .


Rehabilitation centre and participants ' homes .


Thirty community dwelling adults moderately affected by MS ( Expanded Disability Status Scale 5-6 .5 ) .


Twelve weeks of individualised web-based physiotherapy completed twice per week or usual care ( control ) .


Online exercise diaries were monitored ; participants were telephoned weekly by the physiotherapist and exercise programmes altered remotely by the physiotherapist as required .


The following outcomes were completed at baseline and after 12 weeks ; 25 Foot Walk , Berg Balance Scale , Timed Up and Go , Multiple Sclerosis Impact Scale , Leeds MS Quality of Life Scale , MS-Related Symptom Checklist and Hospital Anxiety and Depression Scale .


The intervention group also completed a website evaluation questionnaire and interviews .


Participants reported that website was easy to use , convenient , and motivating and would be happy to use in the future .


There was no statistically significant difference in the primary outcome measure , the timed 25ft walk in the intervention group ( P = 0.170 ) , or other secondary outcome measures , except the Multiple Sclerosis Impact Scale ( P = 0.048 ) .


Effect sizes were generally small to moderate .


People with MS were very positive about web-based physiotherapy .


The results suggested that 80 participants , 40 in each group , would be sufficient for a fully powered , definitive randomized controlled trial .


Botulinum toxin injections are used to treat spasticity in stroke .


Although this treatment is effective on muscle tone , its effect on functional gait-related activities remains uncertain .


The aim of this randomized controlled trial was to determine the effect of a self-rehabilitation programme as an adjunct to botulinum toxin injections on gait-related activities in patients with chronic hemiparesis .


Thirty-five outpatients were included .


Each patient was randomized to 1 of 2 groups : botulinum toxin + standardized self-rehabilitation programme ( R group , n = 19 ) or botulinum toxin alone ( C group , n = 16 ) .


Each patient was evaluated with the following tests before botulinum toxin injections and one month afterwards : 10-m timed walk , Timed Up and Go , distance covered in 6 min over an ecological circuit , and the stair test .


There were significant improvements in the R group compared with the C group : maximal gait speed improved by 8 % ( p = 0.003 ) ; distance covered in 6 min over an ecological circuit increased by 7.1 % ( p = 0.01 ) ; and time to ascend and to descend a flight of stairs decreased by 9.8 % ( p = 0.003 ) and 6.6 % ( p = 0.009 ) , respectively .


The self-rehabilitation programme was well tolerated and safe .


These results strongly suggest that a standardized self-rehabilitation programme constitutes a useful adjunct to botulinum toxin injections in order to improve gait-related activities .


Headache is a common health problem in adolescents .


There are a number of risk factors for headache in adolescents that are amenable to intervention .


The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors .


In all , 1674 students in 8th-10th grade at 12 grammar schools in greater Munich , Germany , were cluster randomized into intervention and control groups .


A standardized 60-min prevention lesson focusing on preventable risk factors for headache ( physical inactivity , coffee consumption , alcohol consumption and smoking ) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting .


Seven months later , students were reassessed .


The main outcome parameter was headache cessation .


Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated .


Nine hundred students ( intervention group N = 450 , control group N = 450 ) with headache at baseline and complete data for headache and confounders were included in the analysis .


Headache cessation was observed in 9.78 % of the control group compared with 16.22 % in the intervention group ( number needed to treat = 16 ) .


Accounting for cluster effects and confounders , the probability of headache cessation in the intervention group was 1.77 ( 95 % confidence interval = [ 1.08 ; 2.90 ] ) higher than in the control group .


The effect was most pronounced in adolescents with tension-type headache : odds ratio = 2.11 ( 95 % confidence interval = [ 1.15 ; 3.80 ] ) .


Our study demonstrates the effectiveness of a one-time , classroom-based headache prevention programme .


To investigate the associations of NOS1AP rs12742393 polymorphism with the risk of type 2 diabetes mellitus ( T2DM ) and repaglinide therapeutic efficacy in Chinese patients with T2DM .


Prospective case-control study .


Academic medical center .


A total of 300 patients with T2DM and 200 healthy volunteers were enrolled to identify NOS1AP rs12742393 genotypes using the polymerase chain reaction-restriction fragment length polymorphism assay .


Eighty-four patients with various genotypes were randomly selected to receive oral repaglinide as a single-agent therapy ( 3mg/day ) for 8weeks .


Anthropometric measurements and fasting plasma glucose ( FPG ) , postprandial plasma glucose , hemoglobin A1c , fasting serum insulin ( FINS ) , postprandial serum insulin , homeostasis model assessment for insulin resistance ( HOMA-IR ) , triglyceride , total cholesterol , low-density lipoprotein-cholesterol , and high-density lipoprotein-cholesterol tests were obtained before and after repaglinide treatment .


The risk C allelic frequency of NOS1AP rs12742393 was higher in patients with T2DM than in healthy volunteers ( p < 0.001 ) .


Patients with T2DM and genotypes AA and AC at NOS1AP rs12742393 had a significant reduction in FPG ( mmol/l ) compared with those with genotype CC ( p < 0.01 ) .


Patients with CC homozygotes and AC heterozygotes had a greater increase in FINS ( mU/l ) than those with wild-type AA ( p < 0.05 ) .


In addition , the carriers of genotype CC at NOS1AP rs12742393 had higher differential values of HOMA-IR compared with genotypes AC and AA carriers ( p < 0.001 ) .


The effects of repaglinide treatment on FPG ( p < 0.01 ) , FINS ( p < 0.05 ) and HOMA-IR ( p < 0.001 ) were reduced in patients with T2DM carrying the NOS1AP rs12742393 risk C allele compared with the AA genotype carriers .


The NOS1AP rs12742393 polymorphism is associated with therapeutic efficacy of repaglinide in Chinese T2DM patients .


Lactoferrin ( LF ) , a non-haem iron binding glycoprotein , shares antimicrobial properties with innate immune system components influencing proinflammatory release of cytokines involved in psoriatic plaque development .


The objective of the study was to verify if LF could provide a therapeutic application in psoriasis .


An open-label , two arms , 4-week trial was designed on 30 subjects affected by mild to moderate plaque psoriasis .


All patients received oral bovine LF 100 mg .


Fifteen patients ( group A ) were topically treated with 10 % LF ointment , 15 patients ( group B ) with 20 % LF ointment .


All patients applied only ointment vehicle on contra lateral target lesion as intra-patient side to side control .


Efficacy was assessed by Target Lesion Score .


Twenty-two patients completed the study .


Improvement in elevation , redness and scaling was observed on LF treated psoriatic target lesions comparing to the controlateral controls ( P < 0.05 ) .


There was no additional efficacy for 20 % versus 10 % topical applications .


Oral drug alone did not exert any improvement on the control plaques receiving topical placebo .


Our clinical results suggest that LF could be included as a possible safe topical therapeutic option in the treatment of psoriatic plaque .


The negative impact of rising progesterone levels on pregnancy rates is well known , but data on mature oocyte yield are conflicting .


We examined whether delaying the oocyte maturation trigger in IVF/ICSI affected the number of mature oocytes and investigated the potential influence of serum progesterone levels in this process .


Between January 31 , 2011 , and December 31 , 2011 , 262 consecutive patients were monitored using ultrasound plus hormonal evaluation .


Those with > = 3 follicles with a mean diameter of > = 18 mm were divided into 2 groups depending on their serum progesterone levels .


In cases with a progesterone level < = 1 ng/ml , which was observed in 59 patients , 30-50 % of their total number of follicles ( only counting those larger than 10 mm ) were at least 18 mm in diameter .


These patients were randomised into 2 groups : in one group , final oocyte maturation was triggered the same day ; for the other , maturation was triggered 24 hours later .


Seventy-two patients with progesterone levels > 1 ng/ml were randomised in the same manner , irrespective of the percentage of larger follicles ( > = 18 mm ) .


The number of metaphase II oocytes was our primary outcome variable .


Because some patients were included more than once , correction for duplicate patients was performed .


In the study arm with low progesterone ( < = 1 ng/ml ) , the mean number of metaphase II oocytes ( + / - SD ) was 10.29 ( + / -6.35 ) in the group with delayed administration of the oocyte maturation trigger versus 7.64 ( + / -3.26 ) in the control group .


After adjusting for age , the mean difference was 2.41 ( 95 % CI : 0.22-4 .61 ; p = 0.031 ) .


In the study arm with elevated progesterone ( > 1 ng/ml ) , the mean numbers of metaphase II oocytes ( + / - SD ) were 11.81 ( + / -9.91 ) and 12.03 ( + / -7.09 ) for the delayed and control groups , respectively .


After adjusting for PCOS ( polycystic ovary syndrome ) and female pathology , the mean difference was -0.44 ( 95 % CI : -3.65 -2.78 ; p = 0.79 ) .


Delaying oocyte maturation in patients with low progesterone levels yields greater numbers of mature oocytes .


Calcium dobesilate is an antioxidant drug and this study is aimed to investigate the effects of calcium dobesilate on gentamicin-induced nephrotoxicity .


This experimental study was conducted on 40 male Sprague-Dawley rats .


The rats were randomly divided into the following 5 groups : control , sham , gentamicin ( 100 mg/kg/d , intraperitoneal ) , gentamicin and calcium dobesilate ( 50 mg/kg body weight ) , gentamicin and calcium dobesilate ( 50 mg/kg body weight ) .


Treatment was provided once a day in a 7-day period .


At the end of the 7th day , plasma and urine samples were taken and the concentrations of creatinine , urea nitrogen , sodium , potassium , and osmolarity were measured in both samples .


The level of oxidative stress in the left kidney tissue samples was also assessed by measuring malondialdehyde and ferric reducing antioxidant power .


Calcium dobesilate intake with both doses led to a significant decrease in the elevated concentration of creatinine , urea nitrogen , and fractional excretion of sodium by gentamicin , and an increase in creatinine clearance and absolute excretion of potassium as compared to the gentamicin group .


Furthermore , calcium dobesilate decreased tissue malondialdehyde and increased tissue ferric reducing antioxidant power at both doses , in comparison to those in the gentamicin group .


Calcium dobesilate is capable of protecting rats against gentamicin-induced nephrotoxicity .


This protective effect of calcium dobesilate is probably dependent on its antioxidant properties .


To compare postoperative pain following laser-assisted subepithelial keratectomy ( LASEK ) and transepithelial photorefractive keratectomy ( T-PRK , two-step surgery ) and alleviate postoperative subjective pain .


Thirty patients ( 60 eyes ) with myopia or myopic astigmatism were consecutively recruited into this prospective , randomized paired study .


Patients underwent LASEK in one eye , and T-PRK in the other .


The degree of pain was rated on a scale of 0-10 on postoperative days 1 , 2 and 3 .


Uncorrected visual acuity ( UCVA ) and subepithelial corneal haze were assessed at postoperative 1 and 3 months .


The pain was relieved on the 4th postoperative day in all patients , healing of corneal epithelium was observed at 4-5 days after surgery and contact lenses were removed promptly .


At postoperative 1 day , the mean subjective pain score in the LASEK group was 3.2 1.88 and 4.43 1.61 in T-PRK group ( P = 0.008 ) .


No significant difference was found between two groups on postoperative 2 and 3 days .


At postoperative 3 months , the percentage of UCVA 0.8 in the LASEK group was 100 % and 96.7 % in the T-PRK group ( P = 0.24 ) , 93.3 % of patients in the LASEK with UCVA 1.0 and 90 % in the T-PRK group ( P = 0.64 ) .


In the LASEK group , the value of corneal haze was 0.26 0.21 and 0.27 0.25 in the T-PRK group ( P = 0.877 ) .


Good visual acuity was obtained in both groups at postoperative 3 months .


Compared with those in the T-PRK group , patients undergoing had less discomfort in the LASEK group , which may be associated with corneal epithelial activity .


The changing curve of subjective pain in the T-PRK group was relatively flat and stable at postoperative 3 days .


Obesity affects 25 % of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease .


Some effective weight loss treatments exist but there is no nationally available National Health Service ( NHS ) treatment service , and general practitioners ( GPs ) rarely discuss weight management with patients or support behavior change .


Evidence shows that commercial weight management services , that most primary care trusts have ` on prescription ' , are more effective than primary care treatment .


We propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress , or advice to lose weight on medical grounds .


The primary outcome will be weight change at 12-months .


Other questions are : what actions do people take to manage their weight in response to the two GP intervention types ?


How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type ?


How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention ?


What is the cost per kg/m2 lost for each intervention ?


Research assistants visiting GP practices in England ( n = 60 ) would objectively measure weight and height prior to GP consultations and randomize willing patients ( body mass index 30 + , excess body fat , 18 + years ) using sealed envelopes .


Full recruitment ( n = 1824 ) is feasible in 46weeks , requiring six sessions of advice-giving per GP .


Participants will be contacted at 3months ( postintervention ) via telephone to identify actions they have taken to manage their weight .


We will book appointments for participants to be seen at their GP practice for a 12-month follow-up .


Trial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service .


Likewise , the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide .


Current Controlled Trials ISRCTN26563137 .


Anorexia nervosa is a serious illness with significant morbidity .


The evidence base for existing psychological and pharmacological interventions to manage anorexia nervosa is not strong , and use of new adjunctive therapies that improve the effectiveness of existing treatments , and lead to improved mental health outcomes for this patient group is highly desirable .


This study investigates the views of patients with anorexia nervosa receiving an acupuncture or acupressure intervention .


A randomised controlled trial was conducted in Sydney , Australia .


Twenty-six inpatients with a diagnosis of anorexia nervosa were randomised to a six week intervention of acupuncture or acupressure with light massage .


Treatment was administered twice weekly for three weeks , then weekly for three weeks .


A post treatment questionnaire was administered to explore participant views , of the study consultation .


Questions examined important aspects of the clinical encounter including the , patient 's perception of the practitioners ' relational empathy ( CARE ) , treatment perceptions and the , therapeutic relationship .


Participants in both groups scored highly on the CARE scale assessing empathy and the , therapeutic relationship .


There was no difference in the mean CARE scores for the acupuncture group ( 50 ( SD 0.0 ) ) and the acupressure group ( 49.5 ( SD 0.8 ) ) .


Participants highly valued the therapeutic , encounter and in particular the characteristics of empathy , positive regard , acceptance , non , judgmental responses and trust .


Having someone to talk to , being less stressed/relaxed and contact , with the study staff were also perceived to be important .


Study participants perceive the therapeutic relationship and empathy as important qualities of the acupuncture or acupressure intervention as an adjunct therapy for the treatment of anorexia nervosa .


Delcasertib is a selective inhibitor of delta-protein kinase C ( delta-PKC ) , which reduced infarct size during ischaemia/reperfusion in animal models and diminished myocardial necrosis and improved reperfusion in a pilot study during primary percutaneous coronary intervention ( PCI ) for ST elevation myocardial infarction ( STEMI ) .


A multicentre , double-blind trial was performed in patients presenting within 6 h and undergoing primary PCI for anterior ( the primary analysis cohort , n = 1010 patients ) or inferior ( an exploratory cohort , capped at 166 patients ) STEMI .


Patients with anterior STEMI were randomized to placebo or one of three doses of delcasertib ( 50 , 150 , or 450 mg/h ) by intravenous infusion initiated before PCI and continued for 2.5 h.


There were no differences between treatment groups in the primary efficacy endpoint of infarct size measured by creatine kinase MB fraction area under the curve ( AUC ) ( median 5156 , 5043 , 4419 , and 5253 ng h/mL in the placebo , delcasertib 50 , 150 , and 450 mg/mL groups , respectively ) in the anterior STEMI cohort .


No treatment-related differences were seen in secondary endpoints of infarct size , electrocardiographic ST-segment recovery AUC or time to stable ST recovery , or left ventricular ejection fraction at 3 months .


No differences in rates of adjudicated clinical endpoints ( death , heart failure , or serious ventricular arrhythmias ) were observed .


Selective inhibition of delta-PKC with intravenous infusion of delcasertib during PCI for acute STEMI in a population of patients treated according to contemporary standard of care did not reduce biomarkers of myocardial injury .


The aim of this study was to compare lung deposition and assess the bioequivalence of two formulations containing budesonide and formoterol and being delivered via Elpenhaler and Turbuhaler , respectively .


A pharmacokinetic ( PK ) study was conducted .


An open , randomized , two-sequence , two-period , crossover , single-dose study in 100 asthmatic patients under fasting conditions was performed .


Wash out period was 6 days .


Equivalence in lung deposition was assessed after a single inhalation of each treatment with concomitant oral administration of activated charcoal ( 40g ) to prevent gastrointestinal absorption of the drugs .


Several PK parameters were estimated , the area under the drug concentration in plasma versus time curve ( AUC0-t ) and the maximum drug concentration in plasma ( Cmax ) being the primary response variables .


Equivalent lung deposition was concluded if the 90 % confidence interval ( CI ) for the Elpenhaler/Turbuhaler geometric mean ratio of AUC0-t and Cmax , for both drug substances fell within the regulatory limits ( 0.80-1 .25 ) .


Acceptance criteria were met .


Equivalent lung deposition can be concluded .


No statistically significant differences between treatments in the incidence of adverse events were found .


The formulations are bioequivalent regarding both rate and extent of absorption .


The treatments were also well tolerated by the participating subjects .


To evaluate the effect of Dexmedetomidine and Midazolam on respiratory and circulation in patients experiencing open heart surgery under acupuncture-assisted general anesthesia .


Sixty patients undergoing open heart surgery ( cardiac valve replacement surgery and aortic valve replacement surgery ) were randomly and equally divided into Dexmedetomidine ( D ) and Midazolam ( M ) groups .


Electroacupuncture ( EA ) was applied to bilateral Yunmen ( LU 2 ) , Zhongfu ( LU1 ) , Lieque ( LU7 ) and Neiguan ( PC6 ) .


For patients of group D , Dexmedetomidine ( i.v. , loading dose : 1 microg/kg , and succedent dose : 0.2-1 microg x kg ( -1 ) x h ( -1 ) ) was given .


For patients of group M , Midazolam ( i.v. , loading dose : 0.05 mg/kg , succedent dose : 0.01-0 .03 mg x kg ( -1 ) x h ( -1 ) ) was given .


Arterial oxygen pressure ( PaO2 ) , arterial carbondioxide tension ( PaCO2 ) , O2 saturation ( SPO2 ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , anesthetic effect , time of spontaneous breathing recovery , and time of resuscitation were recorded before operation ( T0 ) , immediately after skin incision ( T1 ) , immediately after sternotomy ( T2 ) , before suspension of cardiopulmonary bypass ( CPB , T3 ) , immediately after cardiac re-beating ( T4 ) , immediately after CPB cessation ( T5 ) , and at the end of surgery ( T6 ) .


Before operation , no significant differences were found between the group D and M in the levels of PaO2 , PaCO2 and SPO2 ( P > 0.05 ) .


The PaO2 and SPO2 levels after skin incision , sternotomy , before suspension of CPB and at the end of surgery were significantly lower in group M than in group D ( P < 0.05 ) , while the le - vels of PaCO2 after skin incision , sternotomy , before suspension of CPB and at the end of surgery , and HR after skin incision , sternotomy , before suspension of CPB , after heart re-beating , after CPB cessation and at the end of surgery in group M were considerably higher than those in group D ( P < 0.05 ) .


In addition , the time of spontaneous breathing recovery of group M was significantly later than that of group D ( P < 0.05 ) .


No significant differences were found between the two groups in MAP levels at the 6 time-points during surgery , in the PaO2 , PaCO2 and SPO2 levels at the time-points of post-cardiac re-beating , and after CPB cessation ( P > 0.05 ) .


It suggested that the respiration and circulation states in group D were more smoothly than those in group M.


There was no significant difference between the two groups in the time of resuscitation ( P > 0.05 ) .


Dexmedetomidine is superior to Midazolam in analgesia , and improving respiration and circulation functions for open heart surgery patients under acupuncture-assisted general anesthesia .


We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry .


During a 2-year period at four centers in Catalonia , Spain , we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy ( including intravenous alteplase when eligible ) and endovascular therapy with the Solitaire stent retriever ( thrombectomy group ) or medical therapy alone ( control group ) .


All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging .


In all study patients , the use of alteplase either did not achieve revascularization or was contraindicated .


The primary outcome was the severity of global disability at 90 days , as measured on the modified Rankin scale ( ranging from 0 [ no symptoms ] to 6 [ death ] ) .


Although the maximum planned sample size was 690 , enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials .


Thrombectomy reduced the severity of disability over the range of the modified Rankin scale ( adjusted odds ratio for improvement of 1 point , 1.7 ; 95 % confidence interval [ CI ] , 1.05 to 2.8 ) and led to higher rates of functional independence ( a score of 0 to 2 ) at 90 days ( 43.7 % vs. 28.2 % ; adjusted odds ratio , 2.1 ; 95 % CI , 1.1 to 4.0 ) .


At 90 days , the rates of symptomatic intracranial hemorrhage were 1.9 % in both the thrombectomy group and the control group ( P = 1.00 ) , and rates of death were 18.4 % and 15.5 % , respectively ( P = 0.60 ) .


Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals .


Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset , stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence .


( Funded by Fundaci Ictus Malaltia Vascular through an unrestricted grant from Covidien and others ; REVASCAT ClinicalTrials.gov number , NCT01692379 . )


Pain is the most encountered complication following third molar surgery .


Although nonsteroidal anti-inflammatory drugs are often used for pain control , the effect of preemptive lornoxicam has not been detailed .


We compare the analgesic efficacy of preemptive lornoxicam versus postoperative lornoxicam .


Forty-three participants aged 18 to 33 years who had bilateral , symmetrical third molars were included in this double-blind , randomized , placebo-controlled study .


All participants took part in each of the 2 groups for a 1-month interval ( crossover design ) .


Group Pre received lornoxicam 8 mg intravenously 25 minutes before surgery and 2 mL serum saline postoperatively .


Group Post was given the opposite protocol .


Pain was evaluated by visual analog scale in the first 12 hours .


We observed statistically significant differences in the reduction of the pain level in group Pre ( P < .05 ) .


These participants felt less pain in the first 5 postoperative hours and needed fewer analgesics in the first 12 postoperative hours .


Preemptive lornoxicam is effective for postoperative pain control .


The objective of this study was to test the effect of sugar-free chewing gum sweetened with xylitol or maltitol compared to the use of a gum base or no gum on gingivitis and plaque scores under both brushing and non-brushing circumstances .


The design of the study was a four-group , double-blinded , randomized controlled study with a 3-week duration .


In each group , the participants did not brush the teeth in the lower jaw designated to develop experimental gingivitis , while maintaining normal oral hygiene procedures in the upper jaw .


After professional dental prophylaxis , the participants were allocated into one of four groups ( xylitol , maltitol , gum base or no gum ) .


Chewing gum was used five times a day for 10 min .


220 participants completed the study and provided evaluable data .


The increase in bleeding on marginal probing ( BOMP ) and plaque scores ( PS ) in the non-brushed ( lower ) jaw with experimental gingivitis was significant in all groups ( P < 0.001 ) .


As compared to the gum base , the increase in BOMP in the xylitol and maltitol group was significantly lower .


In the brushed upper jaw , no significant changes for BOMP were observed from the baseline to the end point of the study , and there were no significant differences in BOMP and PS between the groups .


In circumstances where regular brushing is performed , no effect of chewing gum was observed on bleeding and plaque scores .


In the absence of brushing , chewing xylitol or maltitol gum provided a significant inhibitory effect on gingivitis scores compared to chewing gum base .


The difference when compared to the group not using gum was not significant .


Due to structural differences , bioavailability of krill oil , a phospholipid based oil , could be higher than fish oil , a triglyceride-based oil , conferring properties that render it more effective than fish oil in increasing omega-3 index and thereby , reducing cardiovascular disease ( CVD ) risk .


The objective was to assess the effects of krill oil compared with fish oil or a placebo control on plasma and red blood cell ( RBC ) fatty acid profile in healthy volunteers .


Twenty four healthy volunteers were recruited for a double blinded , randomized , placebo-controlled , crossover trial .


The study consisted of three treatment phases including krill or fish oil each providing 600 mg of n-3 polyunsaturated fatty acids ( PUFA ) or placebo control , corn oil in capsule form .


Each treatment lasted 4 wk and was separated by 8 wk washout phases .


Krill oil consumption increased plasma ( p = 0.0043 ) and RBC ( p = 0.0011 ) n-3 PUFA concentrations , including EPA and DHA , and reduced n-6 : n-3 PUFA ratios ( plasma : p = 0.0043 , RBC : p = 0.0143 ) compared with fish oil consumption .


Sum of EPA and DHA concentrations in RBC , the omega-3 index , was increased following krill oil supplementation compared with fish oil ( p = 0.0143 ) and control ( p < 0.0001 ) .


Serum triglycerides and HDL cholesterol concentrations did not change with any of the treatments .


However , total and LDL cholesterol concentrations were increased following krill ( TC : p = 0.0067 , LDL : p = 0.0143 ) and fish oil supplementation ( TC : p = 0.0028 , LDL : p = 0.0143 ) compared with control .


Consumption of krill oil was well tolerated with no adverse events .


Results indicate that krill oil could be more effective than fish oil in increasing n-3 PUFA , reducing n-6 : n-3 PUFA ratio , and improving the omega-3 index .


ClinicalTrials.gov , NCT01323036 .


R-CHOP ( rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone ) is standard care for aggressive B-cell lymphoma .


A prospective trial was conducted to investigate the role of additive radiotherapy ( RT ) to bulky and extralymphatic disease .


The best arm of the RICOVER-60 trial ( 6R-CHOP-14 +2 R [ R-CHOP administered once every 2 weeks plus two additional applications of rituximab ] plus involved-field RT [ 36 Gy ] to sites of initial bulky [ 7.5 cm ] disease and extralymphatic involvement ) was compared with a cohort receiving the same immunochemotherapy but without RT in an amendment to the RICOVER-60 trial ( RICOVER-noRTh ) in a prospective fashion .


After a median observation time of 39 months , 164 of 166 RICOVER-noRTh patients were evaluable .


In a multivariable analysis of the intention-to-treat population adjusting for International Prognostic Index risk factors and age ( > 70 years ) , event-free survival ( EFS ) of patients with bulky disease was inferior without additive RT ( hazard ratio [ HR ] , 2.1 ; 95 % CI , 1.3 to 3.5 ; P = .005 ) , with trends for inferior progression-free ( PFS ; HR , 1.8 ; 95 % CI , 1.0 to 3.3 ; P = .058 ) and overall survival ( OS ; HR , 1.6 ; 95 % CI , 0.9 to 3.1 ; P = .127 ) .


In a per-protocol analysis with 11 patients in RICOVER-noRTh excluded for receiving unplanned RT , multivariable analysis revealed HRs of 2.7 ( 95 % CI , 1.3 to 5.9 ; P = .011 ) for EFS , 4.4 ( 95 % CI , 1.8 to 10.6 ; P = .001 ) for PFS , and 4.3 ( 95 % CI , 1.7 to 11.1 ; P = .002 ) for OS for patients not receiving RT to bulky disease .


Additive RT to bulky sites abrogates bulky disease as a risk factor and improves outcome of elderly patients with aggressive B-cell lymphoma .


Whether RT can be spared in patients with ( metabolic ) complete remission after immunochemotherapy must be addressed in appropriately designed prospective trials .


The purpose of this study was to investigate the role of ( hyperopic or myopic ) spectacle correction in reading speed of 9 - to 10-year-old children .


Subjects were recruited at their schools .


Initial selection was based on reduced distance acuity and/or a positive blur test .


Final inclusion depended on cycloplegic refraction .


Forty-three myopes were prescribed glasses .


Sixty-five hyperopes were randomized to three groups : ( 1 ) no glasses , ( 2 ) +0.5 DS for both eyes , and ( 3 ) full correction .


Before and 4 to 6 months after prescription of glasses , reading speed was tested : One-Minute Test ( reading speed of genuine words ) and the Klepel ( reading speed of nonwords ) .


Data for this second reading test were obtained in 34 myopes and 48 hyperopes .


At baseline , myopes had about 11 % higher One-Minute scores ( p = 0.005 ) and about 9 % higher Klepel scores ( p = 0.066 ) than hyperopes .


At follow-up , the hyperopia-full correction group improved its One-Minute score by about 13 % more than both the no-glasses group ( p = 0.012 ) and +0.5 DS group ( p = 0.019 ) .


Spectacles did not , or only slightly , improve reading scores of myopes ( One-Minute scores , p = 0.068 ; Klepel scores , p = 0.021 ) .


Correction of hyperopia may increase speed of reading ( as reflected by the One-Minute score ) .


The fact that reading speed of nonwords does not increase after correction suggests that hyperopia affects speed of recognition but not decoding per se .


Attention-deficit/hyperactivity disorder ( ADHD ) is associated with difficulties in learning , behaviour and psychosocial adjustment that persist into adulthood .


Decreased omega-3 fatty acids and increased inflammation or oxidative stress may contribute to neuro-developmental and psychiatric disorders such as ADHD .


The aim of this study was to determine the effect of n-3 supplementation on hyperactivity , oxidative stress and inflammatory mediators in children with ADHD .


In this double blind study , 103 children ( 6-12 years ) with ADHD receiving maintenance therapy were assigned randomly into two groups .


The n-3 group received n-3 fatty acids ( 635 mg eicosapentaenoic acid ( EPA ) , 195 mg docosahexaenoic acid ( DHA ) ) , and the placebo group received olive oil capsules which were visually similar to the n-3 capsules .


The duration of supplementation was 8 weeks .


Plasma C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) and the activity of glutathione reductase ( GR ) , catalase ( CAT ) and superoxide dismutase ( SOD ) were determined before and after the intervention .


Likewise the Conners ' Abbreviated Questionnaires ( ASQ-P ) was applied .


After 8-week intervention , a significant reduction was observed in the levels of CRP ( P < 0.05 , 95 % CI = 0.72-2 .02 ) and IL-6 ( P < 0.001 , 95 % CI = 1.93-24 .33 ) in the n-3 group .


There was also a significant increase in activity of SOD and GR ( P < 0.001 ) .


A significant improvement was seen in the ASQ-P scores in the n-3 group ( P < 005 ) .


Eight weeks of EPA and DHA supplementation decreased plasma inflammatory mediators and oxidative stress in the children with ADHD .


These results suggest that n-3 fatty acid supplementation may offer a safe and efficacious treatment for children with ADHD .


To compare the fitting time requirements and the efficiency in achieving improvements in speech perception during the first 6 months after initial stimulation of computer-assisted fitting with the Fitting to Outcome eXpert ' ( FOX ) and a standard clinical fitting procedure .


Twenty-seven post-lingually deafened adults , newly implanted recipients of the Advanced Bionics HiRes 90K cochlear implant from Germany , the UK , and France took part in a controlled , randomized , clinical study .


Speech perception was measured for all participants and fitting times were compared across groups programmed using FOX and conventional programming methods .


The fitting time for FOX was significantly reduced at 14 days ( P < 0.001 ) but equivalent over the 6-month period .


The groups were not well matched for duration of deafness ; therefore , speech perception could not be compared across groups .


Despite including more objective measures of performance than a standard fitting approach and the adjustment of a greater range of parameters during initial fitting , FOX did not add to the overall fitting time when compared to the conventional approach .


FOX significantly reduced the fitting time in the first 2 weeks and by providing a standard fitting protocol , reduced variability across centres .


FOX computer-assisted fitting can be successfully used at switch on , in different clinical environments , reducing fitting time in the first 2 weeks and is efficient at providing a usable program .


Glomerular filtration rate ( GFR ) declines during long-term dialysis treatment .


In peritoneal dialysis , blockade of the renin-angiotensin-aldosterone system reduces GFR decline .


Observational studies suggest that similar treatment may preserve kidney function in hemodialysis ( HD ) .


A multicenter , randomized , placebo-controlled , double-blinded trial , with 1-year follow-up .


Adult HD patients with urine output > 300mL/24h , HD vintage less than 1 year , and cardiac ejection fraction > 30 % .


Patients were included from 6 HD centers .


Patients were randomly assigned to placebo or the angiotensin II receptor blocker irbesartan , 300mg daily .


Target systolic blood pressure ( BP ) was 140mm Hg .


Primary outcomes were change in GFR measured as the mean of creatinine and urea renal clearance together with urine volume .


Secondary outcomes were change in albuminuria , renin-angiotensin II-aldosterone hormone plasma levels , and time to anuria .


Of 82 patients randomly assigned ( 41 patients in each group ) , 56 completed 1 year of treatment .


The placebo and irbesartan groups were comparable at baseline in terms of sex balance ( 26 vs 30 men ) , mean age ( 62 vs 61 years ) , median HD vintage ( 137 vs 148 days ) , mean HD time ( 10 vs 11h/wk ) , median urine volume ( 1.19 vs 1.26 L/d ) , and mean GFR ( 4.8 vs 5.7 mL/min/1 .73 m ( 2 ) ) .


The target BP level was reached in both groups and BP did not differ significantly between groups over time .


Adverse-event rates were similar .


GFR declined by a mean of 1.7 ( 95 % CI , 1.2-2 .3 ) and 1.8 ( 95 % CI , 1.1-2 .4 ) mL/min/1 .73 m ( 2 ) per year in the placebo and irbesartan groups , respectively .


Mean difference ( baseline values minus value at 12 months ) between groups was-0 .0 ( 95 % CI,-0 .8 to 0.8 ) .


In each group , 4 patients became anuric .


GFR decline rates were lower than expected , reducing the power .


At equal BP levels , we found that irbesartan treatment did not affect the decline in GFR or urine volume significantly during 1 year of treatment in HD patients .


Irbesartan treatment was used safely in the studied population .


Short interpregnancy intervals are associated with adverse perinatal outcomes .


Increased postpartum use of long-acting reversible contraception ( LARC ) could reduce short interpregnancy intervals .


Therefore , the primary objective of our study was to evaluate if a postpartum educational script about LARC ( LARC script ) could increase postpartum LARC utilization at the 6-week postpartum visit .


We completed a randomized controlled trial ( 1:1 ) of 800 postpartum women in Raleigh , North Carolina .


Women were recruited from the postpartum unit and randomized to receive ( intervention ) or not receive ( control ) the LARC script prior to hospital discharge .


We conducted follow-up phone interviews to assess LARC use after their 6-week postpartum visit .


We used Pearson 's chi-squared test to compare LARC use between arms .


Between May 2011 and January 2012 , 400 women were randomized to each arm .


Three hundred sixty-nine women ( 92.3 % ) in each arm were successfully contacted after their 6-week postpartum visit .


LARC use was reported by 17.6 % and 13.3 % of women in the intervention and control arms , respectively ( p = .103 ) .


The LARC script did not increase LARC utilization at the 6-week postpartum visit .


Future studies should evaluate interventions that address both educational and systematic barriers to postpartum LARC uptake .


Use of a postpartum educational script focused on the intrauterine device and contraceptive implant did not increase their utilization after the 6-week postpartum visit .


Future studies should evaluate interventions that address both educational and systematic barriers to postpartum contraceptive uptake .


Although depression is a risk and prognostic factor for cardiovascular disease ( CVD ) , depression trials involving cardiac patients have not observed the anticipated cardiovascular benefits .


To test our hypothesis that depression treatment delivered before clinical CVD onset reduces risk of CVD events , we conducted an 8-year follow-up study of the Indiana sites of the Improving Mood-Promoting Access to Collaborative Treatment ( IMPACT ) randomized controlled trial .


Participants were 235 primary care patients 60 years or older with major depression or dysthymia who were randomized to a 12-month collaborative care program involving antidepressants and psychotherapy ( 85 without and 35 with baseline CVD ) or usual care ( 83 without and 32 with baseline CVD ) .


Hard CVD events ( fatal/nonfatal ) were identified using electronic medical record and Medicare/Medicaid data .


A total of 119 patients ( 51 % ) had a hard CVD event .


As hypothesized , the treatment baseline CVD interaction was significant ( p = .021 ) .


IMPACT patients without baseline CVD had a 48 % lower risk of an event than did usual care patients ( 28 % versus 47 % , hazard ratio = 0.52 , 95 % confidence interval = 0.31-0 .86 ) .


The number needed to treat to prevent one event for 5 years was 6.1 .


The likelihood of an event did not differ between IMPACT and usual care patients with baseline CVD ( 86 % versus 81 % , hazard ratio = 1.19 , 95 % confidence interval , 0.70-2 .03 ) .


Collaborative depression care delivered before CVD onset halved the excess risk of hard CVD events among older , depressed patients .


Our findings raise the possibility that the IMPACT intervention could be used as a CVD primary prevention strategy .


clinicaltrials.gov Identifier : NCT01561105 .


Preeclampsia is a unique disease of pregnancy .


Delivery via caesarean section is the most important way of terminating the pregnancy and treating preeclampsia .


Perioperative fluid therapy is performed to maintain the circulatory volume and reduce tissue edema .


This study evaluated the effects of hypertonic sodium chloride hydroxyethyl starch 40 ( HSH40 ) as perioperative fluid therapy for preeclampsia patients .


Forty preeclamptic women were randomly divided into two groups : the Ringer 's solution group and the HSH40 group .


Their ECG , HR , MAP , and SPO2 were monitored .


Their MVP and HR were recorded at five , eight , and ten minutes after anesthesia induction and at the end of the caesarean section .


The corresponding volume of infusion , blood loss , and urine output during the operation were also recorded .


Venous samples were collected before HSH40 infusion and 30 min after infusion to measure the plasma concentrations of ET , TXB2 , 6-keto-PGF1 , and ANP via a radioimmunoassay .


HSH40 infusion significantly decreased the plasma ET levels ( p < 0.01 ) , significantly changed the plasma ANP and TXB2 levels ( p < 0.05 ) , and significantly increased the plasma 6-keto-PGF1 levels ( p < 0.01 ) in the experimental group compared with those before infusion .


The plasma levels of ET , ANP , TXB2 , and 6-keto-PGF1 did not significantly change in the control group .


Compared with T1 , MAP decreased significantly at T2 , T3 , T4 , and T5 within groups ( p < 0.05 ) and between the two groups .


MAP significantly changed at T2 , T3 , T4 , and T5 ( p < 0.05 ) .


HR did not significant change at T1 , T2 , T3 , T4 , and T5 within or between groups .


Volume of infusion and urine volume significantly differed between groups ( p < 0.05 ) .


Low-dose HSH40 lowers the plasma levels of vasoconstrictor substances ( ET and TXB2 ) and increases the levels of vasodilator substances ( 6-keto-PGF1 and ANP ) during preeclampsia .


It effectively maintains and stabilizes the circulating blood volume , increasing renal blood flow , which improves renal function and increases urine output .


To compare percutaneous nephrostomy ( PCN ) tube vs JJ ureteric stenting as the initial urinary drainage method in children with obstructive calcular anuria ( OCA ) and post-renal acute renal failure ( ARF ) due to bilateral ureteric calculi , to identify the selection criteria for the initial urinary drainage method that will improve urinary drainage , decrease complications and facilitate the subsequent definitive clearance of stones , as this comparison is lacking in the literature .


A series of 90 children aged 12 years presenting with OCA and ARF due to bilateral ureteric calculi were included from March 2011 to September 2013 at Cairo University Pediatric Hospital in this randomised comparative study .


Patients with grade 0-1 hydronephrosis , fever or pyonephrosis were excluded .


No patient had any contraindication for either method of drainage .


Stable patients ( or patients stabilised by dialysis ) were randomised ( non-blinded , block randomisation , sealed envelope method ) into PCN-tube or bilateral JJ-stent groups ( 45 patients for each group ) .


Initial urinary drainage was performed under general anaesthesia and fluoroscopic guidance .


We used 4.8-6 F JJ stents or 6-8 F PCN tubes .


The primary outcomes were the safety and efficacy of both groups for the recovery of renal functions .


Both groups were compared for operative and imaging times , complications , and the period required for a return to normal serum creatinine levels .


The secondary outcomes included the number of subsequent interventions needed for clearance of stones .


Additional analysis was done for factors affecting outcome within each group .


All presented patients completed the study with intention-to-treat analysis .


There was no significant difference between the PCN-tube and JJ-stent groups for the operative and imaging times , period for return to a normal creatinine level and failure of insertion .


There were significantly more complications in the PCN-tube group .


The stone size ( > 2cm ) was the only factor affecting the rates of mucosal complications , operative time and failure of insertion in the JJ-stent group .


The degree of hydronephrosis significantly affected the operative time for PCN-tube insertion .


Grade 2 hydronephrosis was associated with all cases of insertion failure in the PCN-tube group .


The total number of subsequent interventions needed to clear stones was significantly higher in the PCN-tube group , especially in patients with bilateral stones destined for chemolytic dissolution ( alkalinisation ) or extracorporeal shockwave lithotripsy ( ESWL ) .


We recommend the use of JJ stents for initial urinary drainage for stones that will be subsequently treated with chemolytic dissolution or ESWL , as this will lower the total number of subsequent interventions needed to clear the stones .


This is also true for stones destined for ureteroscopy ( URS ) , as JJ-stent insertion will facilitate subsequent URS due to previous ureteric stenting .


Mild hydronephrosis will prolong the operative time for PCN-tube insertion and may increase the incidence of insertion failure .


We recommend the use of PCN tube if the stone size is > 2cm , as there was a greater risk of possible iatrogenic ureteric injury during stenting with these larger ureteric stones in addition to prolongation of operative time with an increased incidence of failure .


Hamstring strain is a common injury in sprinters and jumpers , and therefore time to return to sport and secondary prevention become of particular concern .


To compare the effectiveness of two rehabilitation protocols after acute hamstring injury in Swedish elite sprinters and jumpers by evaluating time needed to return to full participation in the training process .


Prospective randomised comparison of two rehabilitation protocols .


Fifty-six Swedish elite sprinters and jumpers with acute hamstring injury , verified by MRI , were randomly assigned to one of two rehabilitation protocols .


Twenty-eight athletes were assigned to a protocol emphasising lengthening exercises , L-protocol , and 28 athletes to a protocol consisting of conventional exercises , C-protocol .


The outcome measure was the number of days to return to full training .


Re-injuries were registered during a period of 12 months after return .


Time to return was significantly shorter for the athletes in the L-protocol , mean 49 days ( 1SD26 , range 18-107 days ) , compared with the C-protocol , mean 86 days ( 1SD34 , range 26-140 days ) .


Irrespective of protocol , hamstring injuries where the proximal free tendon was involved took a significantly longer time to return than injuries that did not involve the free tendon , L-protocol : mean 73 vs 31 days and C-protocol : mean 116 vs 63 days , respectively .


Two reinjuries were registered , both in the C-protocol .


A rehabilitation protocol emphasising lengthening type of exercises is more effective than a protocol containing conventional exercises in promoting time to return in Swedish elite sprinters and jumpers .


To evaluate the efficacy of autologous serum ( AS ) eye drops for the symptomatic relief of severe dry eye syndrome ( DES ) , as compared to conventional preservative-free artificial tears ( PFAT ) .


This prospective double-blind randomized crossover study used the Ocular Surface Disease Index ( OSDI ) , tear film break-up time ( TBUT ) , Schirmer 's Test , and OXFORD Scale at baseline and after each of two 1-month treatment periods to measure the effect of 20 % diluted AS eye drops vs. PFAT in 20 consecutive severe DES patients that were refractory to conventional treatment .


The study included 20 ( 18 female and two male ) severe DES patients ( 40 eyes ) .


Significantly higher TBUT ( P < 0.001 , Wilcoxon signed-rank test ) and a greater decrease in OSDI score ( 55.18 % decrease in the AS treatment group vs. 19.50 % decrease in the PFAT treatment group ) ( P < 0.001 , Student 's paired samples t-test ) were observed in the AS treatment group after 1 month of treatment .


There was n't a significant difference in Schirmer 's test and OXFORD conjunctival and corneal vital dying grading scores between the two treatment groups after 1 month of treatment ( P > 0.05 [ Mann-Whitney U test ] ) .


AS eye drops were more effective than conventional eye drops for improving tear film stability and subjective comfort in patients with severe DES .


The maximum plasma concentration ( Cmax ) of oxymorphone extended release ( ER ) 20mg and 40mg is approximately 50 % higher in fed than in fasted subjects , with most of the difference in area-under-the-curve ( AUC ) occurring in the first 4 hours post-dose .


Hence , the US FDA recommends in the approved labeling that oxymorphone ER is taken at least 1 hour before or 2 hours after eating .


In order to determine the potential impact on cognitive performance of the increased absorption of oxymorphone ER , fed versus fasting , we conducted a randomized , rater-blinded , crossover study in 30 opioid-tolerant subjects , using tests from the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) .


The subjects randomly received 40mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal or after fasting for 8-12 hours , and were tested 1 hour and 3 hours post-dose .


The CANTAB tests , Spatial Recognition Memory ( SRM ) and Spatial Working Memory ( SWM ) , showed no statistically significant differences between the fed and fasting conditions .


However , sustained attention , as measured by the Rapid Visual Information Processing ( RVP ) CANTAB test , showed a statistically significant interaction of fed versus fasting and post-dose time of testing ( F [ 1,28 ] = 6.88 , P = 0.01 ) , suggesting that 40mg oxymorphone ER after a high-fat meal versus fasting mitigates the learning effect in this particular cognition domain from 1 hour to 3 hours post-dose .


Oxymorphone 40mg ER affected cognitive performance similarly within 3 hours post-dose , whether given on an empty stomach or after a high-fat meal , suggesting that the effect of food on plasma concentration may not be relevant in the medication 's impact on cognition .


Supplementation of vitamin A in children aged 6-59 months improves child survival and is implemented as global policy .


Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results .


We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days ( 6 months ) .


We did an individually randomised , double-blind , placebo-controlled trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania .


Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dar es Salaam .


In Kilombero , Ulanga , and Kilosa districts , women were seen at home as part of the health and demographic surveillance system .


Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months .


We randomly assigned infants to receive one dose of 50,000 IU of vitamin A or placebo in the first 3 days after birth .


Infants were randomly assigned in blocks of 20 , and investigators , participants ' families , and data analysis teams were masked to treatment assignment .


We assessed infants on day 1 and day 3 after dosing , as well as at 1 , 3 , 6 , and 12 months after birth .


The primary endpoint was mortality at 6 months , assessed by field interviews .


The primary analysis included only children who were not lost to follow-up .


This trial is registered with the Australian New Zealand Clinical Trials Registry ( ANZCTR ) , number ACTRN12610000636055 .


Between Aug 26 , 2010 , and March 3 , 2013 , 31,999 newborn babies were randomly assigned to receive vitamin A ( n = 15,995 ) or placebo ( n = 16,004 ; 15,428 and 15,464 included in analysis of mortality at 6 months , respectively ) .


We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months ( 26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group ; risk ratio 110 , 95 % CI 095-126 ; p = 0193 ) .


There was no evidence of a differential effect for vitamin A supplementation on mortality by sex ; risk ratio for mortality at 6 months for boys was 108 ( 090-129 ) and for girls was 112 ( 091-139 ) .


There was also no evidence of adverse effects of supplementation within 3 days of dosing .


Neonatal vitamin A supplementation did not result in any immediate adverse events , but had no beneficial effect on survival in infants in Tanzania .


These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation .


Bill & Melinda Gates Foundation to WHO .


To estimate the effectiveness of different strategies involving delayed antibiotic prescription for acute respiratory tract infections .


Open , pragmatic , parallel group , factorial , randomised controlled trial .


Primary care in the United Kingdom .


889 patients aged 3 years and over with acute respiratory tract infection , recruited between 3 March 2010 and 28 March 2012 by 53 health professionals in 25 practices .


Patients judged not to need immediate antibiotics were randomised to undergo four strategies of delayed prescription : recontact for a prescription , post-dated prescription , collection of the prescription , and be given the prescription ( patient led ) .


During the trial , a strategy of no antibiotic prescription was added as another randomised comparison .


Analysis was intention to treat .


Mean symptom severity ( 0-6 scale ) at days 2-4 ( primary outcome ) , antibiotic use , and patients ' beliefs in the effectiveness of antibiotic use .


Secondary analysis included comparison with immediate use of antibiotics .


Mean symptom severity had minimal differences between the strategies involving no prescription and delayed prescription ( recontact , post-date , collection , patient led ; 1.62 , 1.60 , 1.82 , 1.68 , 1.75 , respectively ; likelihood ratio test ( 2 ) 2.61 , P = 0.625 ) .


Duration of symptoms rated moderately bad or worse also did not differ between no prescription and delayed prescription strategies combined ( median 3 days v 4 days ; 4.29 , P = 0.368 ) .


There were modest and non-significant differences in patients very satisfied with the consultation between the randomised groups ( 79 % , 74 % , 80 % , 88 % , 89 % , respectively ; likelihood ratio test ( 2 ) 2.38 , P = 0.667 ) , belief in antibiotics ( 71 % , 74 % , 73 % , 72 % , 66 % ; 1.62 , P = 0.805 ) , or antibiotic use ( 26 % , 37 % , 37 % , 33 % , 39 % ; 4.96 , P = 0.292 ) .


By contrast , most patients given immediate antibiotics used antibiotics ( 97 % ) and strongly believed in them ( 93 % ) , but with no benefit for symptom severity ( score 1.76 ) or duration ( median 4 days ) .


Strategies of no prescription or delayed antibiotic prescription result in fewer than 40 % of patients using antibiotics , and are associated with less strong beliefs in antibiotics , and similar symptomatic outcomes to immediate prescription .


If clear advice is given to patients , there is probably little to choose between the different strategies of delayed prescription .


ISRCTN38551726 .


To our knowledge , this is the first study to assess the potential to pharmacologically improve auditory function in adults with age-related sensorineural hearing loss .


To explore the potential for the - amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid potentiator mechanism to affect auditory function in individuals with mild to moderate age-related sensorineural hearing loss .


A randomized , double-blind , placebo-controlled , single-dose , 3-way crossover study was conducted in 3 academic ear , nose , and throat clinics and 2 private clinical research centers between December 22 , 2011 , and February 26 , 2013 .


Participants were 50 - to 75-year-old men and women of nonchildbearing potential with mild to moderate sensorineural hearing loss .


Three single doses of PF-04958242 , an - amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid glutamate-positive allosteric modulator , and placebo .


Pure-tone average , speech discrimination score , and speech in noise testing change from baseline at 1 and 5 hours after a single dose of PF-04958242 .


The treatment was safe and well tolerated .


The estimates for the primary end point change from baseline in pure-tone average compared with placebo at 1 hour were -0.77 ( 95 % CI , -2.14 to 0.59 ) and 0.37 ( 95 % CI , -0.97 to 1.72 ) for 0.27 and 0.35 mg , respectively .


At 5 hours the estimates were -0.57 ( 95 % CI , -2.43 to 1.29 ) and -0.56 ( 95 % CI , -2.45 to 1.33 ) for 0.27 and 0.35 mg , respectively .


No significant change from baseline was demonstrated compared with placebo in the primary or secondary study end points at 1 or 5 hours after receiving treatment .


To our knowledge , this clinical trial is the first study of a pharmacologic treatment for age-related sensorineural hearing loss and provides information with regard to study design , end points , variability , data characteristics , and operational feasibility to guide the design of future hearing loss trials .


clinicaltrials.gov Identifier : NCT01518920 .


Kendall suggests testing the rotator cuff muscles in their maximally shortened position , since one-joint muscles are thought to be strongest .


We found little evidence to support this concept .


The purpose of this study was to determine if the shoulder internal rotator ( IR ) and external rotator ( ER ) muscles are strongest when placed in their shortened length position .


Fifty-three subjects participated .


Glenohumeral joint internal rotation and external rotation motion was measured .


Muscle strength was then tested using a hand-held dynamometer in four positions : ( 1 ) end-range ER ; ( 2 ) neutral 0 ; ( 3 ) glenohumeral joint mid-range and ( 4 ) end-range IR .


Data were analyzed using two repeated measures ANOVA 's .


The results suggest that rotator muscle strength is dependent on muscle length .


IR strength was weakest at end-range IR in its shortest length ; ER muscle strength was weakest at end-range ER in its shortest length .


Muscle strength of the IR or ER was not significantly different when comparing neutral 0 to the mid-range position and at their most lengthened position .


The IR and ER muscles were found to be weakest when placed in a position of shortest muscle length , while the neutral 0 and mid-range positions were the strongest positions .


To compare the anesthetic effectiveness of topical proparacaine drops , subconjunctival lidocaine , and 2 % lidocaine gel .


Ninety-two patients undergoing intravitreal injections were randomized to 1 of 3 groups : proparacaine 0.5 % drops ( Group Drops ) , proparacaine 0.5 % drops plus subconjunctival lidocaine ( Group SC ) , or 2 % lidocaine gel ( Group Gel ) .


Patients were asked to score their pain experience using a visual analog scale of 0 to 10 immediately following the injections and 10 min , 1 h , 6 h , and 24 h after the injections .


Patients also graded the overall injection experience as Excellent , Very Good , Fair , Poor , or Awful .


The physician evaluated the patients ' eye movement during intravitreal injection on 3 levels : ( 0 ) none or minimal , ( 1 ) not compromising the injection , and ( 2 ) compromising the injection .


The patients in Group Drops had the worst mean pain scores during the injection and 10 min after , with the highest occurrence of movements compromising the procedure ( Grade 2 ; 38.7 % ) .


The patients in Group SC had a higher percentage of good experiences ( 37.9 % ) but a higher incidence of chemosis ( 16.7 % ) .


The patients in Group Gel had similar overall pain scores to Group Drops patients but a higher incidence of keratitis ( 19.4 % ) .


There was no statistically significant correlation between the use of aspirin or anticoagulants and the occurrence of hyperemia or hyposphagma .


Subconjunctival lidocaine was most effective in preventing pain and eye movements during intravitreal injections .


Although 2 % lidocaine gel produced a good overall experience for the patients , the incidence of keratitis was very high ( 19.4 % ) .


Therefore , we do not recommend 2 % lidocaine gel as the first anesthetic choice for intravitreal injections .


There is no evidence to suspend the use of aspirin or other anticoagulants drugs prior to intravitreal injections .


Oral flora , blood-borne pathogens , and bacterial contamination pose a direct risk of infection to patients and health care workers .


We conducted a study in a simulated operating room using a newly validated technology to determine whether the use of 2 sets of gloves , with the outer set removed immediately after endotracheal intubation , may reduce this risk .


Forty-one anesthesiology residents ( PGY 2-4 ) were enrolled in a study consisting of individual or group simulation sessions .


On entry to the simulated operating room , the residents were asked to perform an anesthetic induction and tracheal intubation timed to approximately 6 minutes ; they were unaware of the study design .


Of the 22 simulation sessions , 11 were conducted with the intubating resident wearing single gloves , and 11 with the intubating resident using double gloves with the outer pair removed after verified intubation .


Before the start of the scenario , we coated the lips and inside of the mouth of the mannequin with a fluorescent marking gel as a surrogate pathogen .


After the simulation , an observer examined 40 different sites using a handheld ultraviolet light in the operating room to determine the transfer of surrogate pathogens to the patient and the patient 's environment .


Residents who wore double gloves were instructed by a confederate nurse to remove the outer set immediately after completion of the intubation .


Forty sites of potential intraoperative pathogen spread were identified and assigned a score .


The difference in the rate of contamination between anesthesiology residents who wore single gloves versus those with double gloves was clinically and statistically significant .


The number of sites that were contaminated in the operating room when the intubating resident wore single gloves was 20.3 1.4 ( mean SE ) ; the number of contaminated sites when residents wore double gloves was 5.0 0.7 ( P < 0.001 ) .


The results of this study suggest that when an anesthesiologist wears 2 sets of gloves during laryngoscopy and intubation and then removes the outer set immediately after intubation , the contamination of the intraoperative environment is dramatically reduced .


Little is known about thermoregulation of the newborn while bonding on the mother 's chest immediately after cesarean delivery .


Newborn hypothermia is associated with serious complications and should be avoided .


Therefore , we evaluated whether newborns develop hypothermia during intraoperative bonding while positioned on their mothers ' chests and investigated the effects of active cutaneous warming of the mothers and babies during a 20-minute intraoperative bonding period .


We enrolled 40 parturients scheduled for elective cesarean delivery under spinal anesthesia .


Mothers and their newborns were randomized to receive either passive insulation or forced-air skin-surface warming during the surgical procedure and bonding period .


The primary outcome was neonatal core temperature at the end of the bonding period .


Core temperatures of the newborns were measured with a rectal probe .


Body temperatures of the mothers were assessed by sublingual measurements .


Skin temperatures , thermal comfort of the mothers , and perioperative shivering were evaluated .


Without active warming from the beginning of the surgical procedure until the end of the bonding period , the mean ( SD ) neonatal core temperature decreased to 35.9 ( 0.6 ) C. Seventeen of 21 ( 81 % ) newborns became hypothermic ( defined as a core temperature below 36.5 C ) .


Active skin-surface warming from the beginning of the surgical procedure until the end of the bonding period resulted in a neonatal core temperature of 37.0 ( 0.2 ) C and a decreased incidence of hypothermia ( 1 of 19 ( 5 % ) newborns ( P < 0.0001 ) ) .


In addition , active warming increased the mean skin temperatures of the infants , maternal core and skin temperatures , maternal thermal comfort , and reduced perioperative shivering .


Active forced-air warming of mothers and newborns immediately after cesarean delivery reduces the incidence of infant and maternal hypothermia and maternal shivering , and increases maternal comfort .


Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease , and some of these studies show that telehealthcare may even lower healthcare costs .


However , the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone .


The present study is known as ` TeleCare North ' in Denmark .


It seeks to address these doubts by implementing a large-scale , pragmatic , cluster-randomized trial with nested economic evaluation .


The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice .


General practitioners will be responsible for recruiting eligible participants ( 1,200 participants are expected ) for the trial in the geographical area of the North Denmark Region .


Twenty-six municipality districts in the region define the randomization clusters .


The primary outcomes are changes in health-related quality of life , and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months .


Secondary outcomes are changes in mortality and physiological indicators ( diastolic and systolic blood pressure , pulse , oxygen saturation , and weight ) .


There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research .


This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial .


Clinicaltrials.gov , http://NCT01984840 , November 14 , 2013 .


Choosing the right infusion set site can be an important factor in obtaining good glycemic control , especially in very young children .


In an attempt to identify the best infusion site , we performed a crossover study in six preschool children with type 1 diabetes using insulin pump therapy .


We enrolled six patients 5.20.7 years old ( range , 4-6 years ) , with type 1 diabetes for more than 1.5 years , using insulin pump therapy for at least 6 months .


For each patient , body mass index , glycated hemoglobin , and all data downloaded from the system were evaluated on two occasions : the first with the infusion set placed on the buttock and the second on the abdomen , each for 3 days .


The order of infusion set placement was randomized .


Mean capillary blood glucose , mean continuous glycemia , mean area under the curve ( AUC ) using the trapezoidal rule for both > 140mg/dL and < 70mg/dL , insulin daily dose , carbohydrate/insulin ratio , total basal insulin , total bolus insulin , and mean amplitude of glucose excursions ( MAGE ) were evaluated .


Mean glycemic values , mean AUC > 140mg/dL , and MAGE were significantly lower when the infusion set was placed on the buttock versus the abdomen ( 144.631.9 mg/dL vs. 166.034.8 mg/dL [ P = 0.000 ] , 28.418.3 % vs. 48.828.2 % [ P = 0.000 ] , and 3210 vs. 6015mg/dL [ P < 0.001 ] , respectively ) , whereas mean AUC < 70mg/dL was higher ( 1.472.77 % vs. 0.871.03 % [ P < 0.001 ] ) .


The present findings suggest that preschool children with type 1 diabetes using insulin pump therapy could benefit from inserting the infusion set in the buttock instead of the abdomen .


To evaluate risk factors for GI adverse events ( AEs ) within a phase III trial of bevacizumab in first-line ovarian cancer therapy .


Women with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles ( C ) 2 to C22 ( R1 ) ; chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 ( R2 ) ; or chemotherapy plus bevacizumab C2 to C22 ( R3 ) .


Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade 2 perforation , fistula , necrosis , or hemorrhage .


Of 1,873 patients enrolled , 1,759 ( 94 % ) were evaluable , and 2.8 % ( 50 of 1,759 ) experienced a GI AE : 10 of 587 ( 1.7 % , R1 ) , 20 of 587 ( 3.4 % , R2 ) , and 20 of 585 ( 3.4 % , R3 ) .


Univariable analyses indicated that previous treatment of inflammatory bowel disease ( IBD ; P = .005 ) and small bowel resection ( SBR ; P = .032 ) or large bowel resection ( LBR ; P = .012 ) at primary surgery were significantly associated with a GI AE .


The multivariable estimated relative odds of a GI AE were 13.4 ( 95 % CI , 3.44 to 52.3 ; P < .001 ) for IBD ; 2.05 ( 95 % CI , 1.09 to 3.88 ; P = .026 ) for LBR ; 1.95 ( 95 % CI , 0.894 to 4.25 ; P = .093 ) for SBR ; and 2.15 for bevacizumab exposure ( aggregated 95 % CI , 1.05 to 4.40 ; P = .036 ) .


History of treatment for IBD , and bowel resection at primary surgery , increase the odds of GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer .


After accounting for these risk factors , concurrent bevacizumab doubles the odds of a GI AE , but is not appreciably increased by continuation beyond chemotherapy .


Compliance with immunosuppressive regimens may affect clinical outcomes in renal transplant recipients .


The aim of this study was to assess the safety and efficacy of standard-dose tacrolimus modified-release ( TAC-MR ) once daily versus tacrolimus ( TAC ) twice daily in stable renal transplant recipients .


Ninety-nine stable renal transplant recipients were randomized to receive standard-dose tacrolimus twice daily or standard-dose modified-release tacrolimus once daily on a 1:1 ( mg : mg ) basis .


The primary end point was the incidence of adverse events ( AEs ) in both groups .


Secondary end points included biopsy-proven acute rejection , graft survival , patient survival , clinical indicators , and change in score of questionnaire .


The incidence of AEs was not different between the TAC and TAC-MR groups ( 56.0 % vs 53.1 % , P > .05 ) .


There were no significant differences in mean calculated glomerular filtration rate , blood pressure , glycosylated hemoglobulin ( HbA1c ) , blood concentration of tacrolimus , and drug compliance .


The scores of all items in the 36-item short form health survey ( SF-36 ) were not different between groups , except for vitality .


With respect to the subject questionnaire , there was no difference in question scores between the two treatment groups .


A regimen of TAC-MR once daily can be considered as an effective and safe alternative formulation of tacrolimus in stable renal transplant patients .


To evaluate the possible renal and hepatic toxicity of tepoxalin in dogs exposed to hypotension during isoflurane anesthesia .


Prospective , randomized experimental study .


Twenty adult mixed-breed dogs , weighing 18.82.8 kg .


The animals received 10mgkg ( -1 ) tepoxalin orally 2hours before the anesthetic procedure ( PRE ; n = 6 ) , or 30minutes after anesthesia ( POST ; n = 6 ) , along with a control group ( CON ; n = 8 ) , which were only anesthetized .


The PRE and POST groups also received the same dose of tepoxalin for 5days post-procedure .


All dogs were anesthetized with propofol and maintained with isoflurane and the end-tidal isoflurane ( Fe'Iso ) was increased until mean arterial pressure decreased to 50-60mmHg .


These pressures were maintained for 60minutes .


Heart rate , arterial pressures and Fe'Iso were recorded at 0 , 10 and every 10minutes up to 60minutes of hypotension .


Blood gases , pH , electrolytes and bleeding time were analyzed before and at 30 and 60minutes of hypotension .


Renal and hepatic changes were quantified by serum and urinary biochemistry and creatinine clearance .


Serum concentrations of alanine amino transferase ( ALT ) , alkaline phosphatase ( ALP ) and - glutamyl transferase ( GGT ) , blood urea nitrogen ( BUN ) and creatinine ( Cr ) , and urinary output , urinary Cr , Cr clearance , and GGT : Cr ratio remained stable throughout the evaluations .


During the anesthetic procedure there were no important variations in the physiological parameters .


No side effects were observed in any of the groups .


Tepoxalin did not cause significant effects on renal function or cause hepatic injury in healthy dogs exposed to hypotension with isoflurane , when administered pre - or postanesthetic and continued for five consecutive days .


An exploratory analysis of the German Off Pump Coronary Artery Bypass Grafting in Elderly Patients ( GOPCABE ) trial was performed to investigate the effect of off-pump coronary artery bypass grafting ( CABG ) on kidney function after the operation .


Data on kidney function were available from 1,612 patients , representing 67 % of the study population .


Preoperative kidney function was graded according to the glomerular filtration rate .


Acute kidney injury ( AKI ) within the first week after the operation was defined and classified according to the Acute Kidney Injury Network ( AKIN ) criteria .


The incidence and severity of AKI was compared between patients operated on on-pump or off-pump .


Impaired kidney function was seen in 642 patients ( 40 % ) , and 19 patients had preexisting end-stage kidney disease .


AKI of any severity occurred in half of all patients undergoing CABG , with AKIN stage 1 accounting for most of the cases .


The incidence and severity of AKI in patients undergoing on-pump vs off-pump CABG was AKIN stage 1 : 298 ( 37 % ) vs 329 ( 42 % ) ; AKIN stage 2 : 38 ( 5 % ) vs 43 ( 5 % ) ; and AKIN stage 3 : 44 ( 6 % ) vs 44 ( 6 % ) , which did not differ significantly ( p = 0.174 ) .


New renal replacement therapy was necessary in 3.2 % ( on-pump ) and in 2.7 % ( off-pump ) of all patients .


Stratification according to preoperative kidney function yielded comparable frequencies of AKI for on-pump and off-pump CABG .


AKI was common in elderly patients undergoing CABG , but deterioration of kidney function requiring renal replacement therapy was a rare event .


Off-pump CABG was not associated with decreased rates or reduced severity of AKI in elderly patients .


Obstructive sleep apnea ( OSA ) diagnosis using simplified methods such as portable sleep monitoring ( PM ) is only recommended in patients with a high pretest probability .


The aim is to determine the diagnostic efficacy , consequent therapeutic decision-making , and costs of OSA diagnosis using polysomnography ( PSG ) versus three consecutive studies of PM in patients with mild to moderate suspicion of sleep apnea or with comorbidity that can mask OSA symptoms .


Randomized , blinded , crossover study of 3 nights of PM ( 3N-PM ) versus PSG .


The diagnostic efficacy was evaluated with receiver operating characteristic ( ROC ) curves .


Therapeutic decisions to assess concordance between the two different approaches were performed by sleep physicians and respiratory physicians ( staff and residents ) using agreement level and kappa coefficient .


The costs of each diagnostic strategy were considered .


Fifty-six patients were selected .


Epworth Sleepiness Scale was 10.1 ( 5.3 ) points .


Bland-Altman plot for apnea-hypopnea index ( AHI ) showed good agreement .


ROC curves showed the best area under the curve in patients with PSG AHI 5 [ 0.955 ( confidence interval = 0.862-0 .993 ) ] .


For a PSG AHI 5 , a PM AHI of 5 would effectively exclude and confirm OSA diagnosis .


For a PSG AHI 15 , a PM AHI 22 would confirm and PM AHI < 7 would exclude OSA .


The best agreement of therapeutic decisions was achieved by the sleep medicine specialists ( 81.8 % ) .


The best cost-diagnostic efficacy was obtained by the 3N-PM .


Three consecutive nights of portable monitoring at home evaluated by a qualified sleep specialist is useful for the management of patients without high pretest probability of obstructive sleep apnea or with comorbidities .


http://www.clinicaltrials.gov , registration number : NCT01820156 .


Guerrero A , Embid C , Isetta V , Farre R , Duran-Cantolla J , Parra O , Barb F , Montserrat JM , Masa JF .


Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring .


Low high-density lipoprotein cholesterol ( HDL-C ) is a risk factor for coronary artery disease .


Investigating mechanisms underlying acquired severe HDL deficiency in noncritically ill patients ( `` disappearing HDL syndrome '' ) could provide new insights into HDL metabolism .


To determine the cause of low HDL-C in patients with severe acquired HDL deficiency .


Patients with intravascular large B-cell lymphoma ( n = 2 ) , diffuse large B-cell lymphoma ( n = 1 ) , and autoimmune lymphoproliferative syndrome ( n = 1 ) presenting with markedly decreased HDL-C , low low-density lipoprotein cholesterol ( LDL-C ) , and elevated triglycerides were identified .


The abnormal lipoprotein profile returned to normal after therapy in all 4 patients .


All patients were found to have markedly elevated serum interleukin-10 ( IL-10 ) levels that also normalized after therapy .


In a cohort of autoimmune lymphoproliferative syndrome patients ( n = 93 ) , IL-10 showed a strong inverse correlation with HDL-C ( R ( 2 ) = 0.3720 , P < .0001 ) .


A direct causal role for increased serum IL-10 in inducing the observed changes in lipoproteins was established in a randomized , placebo-controlled clinical trial of recombinant human IL-10 in psoriatic arthritis patients ( n = 18 ) .


Within a week of initiating subcutaneous recombinant human IL-10 injections , HDL-C precipitously decreased to near-undetectable levels .


LDL-C also decreased by more than 50 % ( P < .0001 ) and triglycerides increased by approximately 2-fold ( P < .005 ) .


All values returned to baseline after discontinuing IL-10 therapy .


Increased IL-10 causes severe HDL-C deficiency , low LDL-C , and elevated triglycerides .


IL-10 is thus a potent modulator of lipoprotein levels , a potential new biomarker for B-cell disorders , and a novel cause of disappearing HDL syndrome .


The aim of this study was to investigate whether baseline lesion complexity affects drug-eluting stent ( DES ) outcomes according to diabetic status .


Previous studies have reported conflicting results regarding DES safety and efficacy in patients with and without diabetes mellitus ( DM ) .


Patient-level data from 18 prospective randomized trials were pooled .


DES treatment outcomes in patients with versus without DM were analyzed in 2 propensity score-matched groups further stratified according to lesion complexity ( American College of Cardiology and American Heart Association class A/B1 vs. B2/C ) .


Remaining baseline differences were adjusted for by multivariate analysis .


DM was present in 3,467 of 18,441 patients ( 18.8 % ) .


DM was a predictor of 1-year repeat revascularization ( target lesion revascularization : hazard ratio : 1.34 ; 95 % confidence interval : 1.05 to 1.70 ; target vessel revascularization : hazard ratio : 1.40 ; 95 % confidence interval : 1.15 to 1.72 ) and cardiac death or myocardial infarction ( hazard ratio : 1.40 ; 95 % confidence interval : 1.09 to 1.81 ) .


Rates of target lesion and target vessel revascularization were significantly higher in patients with versus those without DM with type B2/C lesions ( 8.0 % vs. 4.5 % and 10.6 % vs. 5.9 % , respectively , p < 0.0001 for both ) , but not in patients with only type A/B1 lesions ( 4.6 % vs. 4.8 % , p = 0.87 , and 7.4 % vs. 6.8 % , p = 0.47 , respectively ) , with a significant interaction between DM and lesion type observed for both endpoints ( p = 0.01 and p = 0.02 , respectively ) .


No interaction was observed for death or myocardial infarction ( p = 0.28 ) .


In the DES era , patients with DM remain at increased risk for cardiac death or myocardial infarction .


However , DM is a risk factor for repeat revascularization only in those patients with complex lesions ; patients with DM and noncomplex lesions have similar rates of 1-year freedom from repeat revascularization as do patients without DM .


Data on the benefits of synbiotics in functional constipation are conflicting .


The aim of this study was to assess whether the administration of the synbiotic supplement Psyllogel Megafermenti ( ) normalized stool consistency and decreased intestinal transit time ( ITT ) in patients with severe functional constipation , based on its ability to impact on the gut microbiota .


We conducted a pilot randomized , double-blind , controlled trial .


After a 2-week run-in period , patients from a tertiary care setting with severe functional constipation fulfilling the Rome III Diagnostic Criteria in the past year were randomly assigned to receive by mouth 2 bags/day of Psyllogel Megafermenti ( ) ( Group A ) or 2.8 g of maltodextrin twice daily ( Group B ) for 8 weeks .


Primary endpoints were increase of bowel evacuations with normal stool consistency and volume , and ITT reduction .


Secondary endpoints included symptom improvement according to the Rome III Diagnostic Criteria , reduction of the Agachan-Wexner score and changes in gut microbiota composition .


Twenty-nine patients completed the study : 17 were allocated to Group A and 12 to Group B.


A statistically significant increase in stools with normal consistency was observed only in Group A ( p = 0.001 ) , even when considering patients with normal stools 50 % of time at baseline .


In Group A , a significant reduction in ITT was also found ( p = 0.022 ) .


According to polymerase chain reaction-denaturing gradient gel electrophoresis profiling of stool samples , 50 % of the patients treated with synbiotics harbored all the probiotic species of the study product .


An 8-week treatment with Psyllogel Megafermenti ( ) improved the main clinical parameters of functional constipation in patients extremely homogeneous for disorder severity and underlying pathophysiology ( Eudract.ema.europa.eu , No. 2008-000913-30 ) .


In orthodontics , adding restorative materials on occlusal or lingual surfaces is a common method to create a mini-biteplane to increase patients ' vertical dimension temporarily to facilitate several treatment procedures .


However , this method transmits excessive occlusal forces through the periodontal ligament and causes trauma .


In this prospective randomized clinical trial , we measured and compared quantitatively the volumes of root resorption after 4 weeks of occlusal trauma .


Forty-eight maxillary and mandibular first premolars of 12 patients ( 6 girls , 6 boys ) comprised the sample for this study .


One side of each patient was randomly selected as the control .


On the contralateral side , a light-cured glass ionomer cement ( Transbond Plus Light Cure Band Adhesive ; 3M Unitek , Monrovia , Calif ) was bonded onto the occlusal surface of the mandibular first premolar so that the cement was in contact with the maxillary first premolar .


After 4 weeks , both first premolars were extracted .


Each sample was imaged using a microcomputed tomography system ( 1172 ; SkyScan , Aartselaar , Belgium ) and analyzed with specially designed software for volumetric measurements of resorption craters .


Furthermore , pain was evaluated with a visual analog scale for 7 days .


There were significant differences in the amounts of root resorption between the control and the experimentally traumatized teeth .


No significant difference among the buccal , lingual , mesial , and distal surfaces was found in either jaw .


Furthermore , no significant difference existed in the amount of root resorption among the cervical , middle , and apical thirds of both jaws .


There was no correlation between age , sex , volume of the root resorption craters , and pain .


Restorative buildups , used to increase the vertical dimension by 2 mm for 4 weeks , caused root resorption along the sides of the teeth during the active bite-increase period .


The effect profile of differing antihypertensive agents is well studied , but minimal data regarding the interaction between hemodynamic response and presenting blood pressure ( BP ) exist .


Achievement of target BP is less likely in patients with higher initial BPs .


This is a substudy of the multicenter safety and efficacy Evaluation of intravenous Cardene ( nicardipine ) and Labetalol Use in the Emergency department ( CLUE ) trial that randomized patients to Food and Drug Administration-recommended intravenous dosing of nicardipine or labetalol to reach a physician predefined systolic BP ( SBP ) and target range ( TR ) of 20 mm Hg within 30 minutes .


The proportion achieving TR was assessed as a function of initial SBP , and dichotomized comparisons were made using median SBP .


Likelihood of a final BP within TR was modeled using logistic regression with forced inclusion of initial BP as a categorical variable .


A total 223 patients were enrolled ; 115 ( 51.6 % ) had an initial SBP greater than the median 202 mm Hg .


The median SBP ( interquartile range ) of the high BP group was 218 ( 210-228 ) mm Hg vs the low BP group 190 ( 182-197 ) mm Hg ( P < 0.0001 ) .


No groupwise differences existed except that the high group had higher mean ( SD ) serum creatinine level at baseline ( 3.1 [ 3.9 ] vs 1.9 [ 2.3 ] , P = .008 ) .


The proportion of patients achieving SBP within TR at 30 minutes did not differ ( 85.2 % [ 98 of 115 ] vs 88.9 % [ 96 of 108 ] , P = .42 ) .


Randomization to nicardipine ( odds ratio = 2.85 ; 95 % confidence interval , 1.16-7 .01 ) , but not initial SBP ( odds ratio = 0.60 ; 95 % confidence interval , 0.25-1 .44 ) , was associated with achievement of target SBP at 30 minutes .


Initial SBP is not a predictor of the ability to achieve a prespecified target range SBP within 30 minutes .


High-density lipoproteins ( HDLs ) from type 2 diabetic patients are unable to counteract the inhibitory effect of oxidized low-density lipoproteins ( ox-LDLs ) on vasorelaxation .


We hypothesized that glitazones , which improve glycemic control and dyslipidemia , could correct this abnormality .


We compared the ability of HDL from controls ( n = 12 ) and from type 2 diabetic patients before and after 6 months of treatment with either rosiglitazone ( n = 11 ) or pioglitazone ( n = 8 ) to counteract the inhibitory effect of ox-LDL on vasodilatation of rabbit aorta rings .


Rosiglitazone induced a decrease in hemoglobin A1c ( 7.7 % 1.1 % vs 9.8 % 1.0 % , P = .003 ) and an increase in HDL cholesterol ( 1.14 0.32 vs 0.98 0.24 mmol/L , P = .033 ) .


Pioglitazone induced a decrease in hemoglobin A1c ( 8.3 % 2.5 % vs 9.5 % 3.2 % , P = .068 ) and serum triglycerides ( 1.58 0.89 vs 2.03 0.70 mmol/L , P = .069 ) and an increase in HDL cholesterol ( 1.39 0.22 vs 1.14 0.22 mmol/L , P = .018 ) .


The triglyceride content of HDL was unchanged by rosiglitazone and was decreased by 25 % ( P = .068 ) by pioglitazone .


HDL from controls counteracted the inhibitory effect of ox-LDL on vasodilatation ( maximal relaxation [ Emax ] = 74.4 % 3.5 % vs 51.9 % 3.3 % , P = .0029 ) , whereas HDL from type 2 diabetic patients did not ( Emax = 51.7 % 5.8 % vs 52.3 % 4.6 % [ P = .66 ] and 52.7 % 5.5 % vs 51.9 % 4.5 % [ P = .78 ] for the rosiglitazone and pioglitazone group , respectively ) .