The benefit-risk profile of pertuzumab , trastuzumab , and docetaxel supports this regimen as the first-line therapy for patients with HER@-positive metastatic breast cancer from all geographic regions .


The purpose of this study was to assess the feasibility of an endoscopic , optical-fiber-based , laser delivery system ( LDS ) developed to perform sole-therapy transmyocardial revascularization ( TMR ) in a totally endoscopic , robotically assisted operation .


Forty-two patients were enrolled in a multicenter , prospective , single-arm clinical trial conducted at four US centers between @ and @ .


Transmyocardial revascularization was performed completely endoscopically with robotic assistance , introducing the Holmium : Yttrium aluminum garnet ( YAG ) LDS via a @-mm port .


Completion of the operation endoscopically defined procedural success .


Clinical data were recorded before , during , and at least @ days after the procedure .


All patients had Canadian Cardiovascular Score angina class IV at baseline .


The mean ejection fraction was @ % ( range -LSB- R -RSB- , @-@ ) , the mean age was @ years ( R , @-@ ) , @ % ( @/@ ) were men , @ % ( @/@ ) underwent previous coronary artery bypass grafting surgery , and @ % ( @/@ ) underwent prior coronary stenting .


Procedural success was accomplished in @ % ( @/@ ) .


For the procedural successes , the mean number of TMR channels was @ ( R , @-@ ) , the median operative time was @ minutes ( R , @-@ minutes ) , and the median length of stay postoperatively was @ days ( R , @-@ ) .


There was no operative or @-day mortality , and no patient received any transfusion .


At @ days , freedom from major adverse cardiac events was @ % ( two patients had transient congestive heart failure ) .


At the median @-month follow-up ( single-center data , n = @ ) , the mean ( SD ) Canadian Cardiovascular Score angina score was @ ( @ ) ( P < @ vs baseline ) .


Robotically assisted TMR can be performed using an endoscopic , optical-fiber-based LDS , with high procedural success , avoidance of early adverse clinical events , and potential for successful angina relief .


DBCare ( Ace Continental Exports Inc. , London , UK ) is a traditional Indian herbal food supplement marketed as an antidiabetes remedy .


This study evaluated the efficacy and safety of DBCare in patients with inadequately controlled type @ diabetes mellitus ( T@DM ) despite oral hypoglycemic treatment .


A @-week randomized double-blind placebo-controlled trial was conducted .


Patients with T@DM on oral hypoglycemic agents with HbA@C > @ % were randomized to receive DBCare or placebo tablets .


Thirty-five patients ( @ male/@ female ; mean age @ @ years ) , with a mean baseline HbA@C of @ % @ % , received DBCare ( N = @ ) or placebo ( N = @ ) .


During the study period , HbA@C declined @ @ % in the DBCare group and @ % @ % in the placebo group ( p = @ ) .


No significant changes occurred in fasting plasma glucose , lipid profile , or homeostasis model assessment throughout the study or in body mass index , waist circumference , or blood pressure values .


Hypoglycemic episodes ( glucose < @ mg/dL ) were more frequent in the treatment group ( @ vs @ , p = @ ) , necessitating a decrease in other hypoglycemic medications in @ patients .


DBCare was generally well tolerated , with mild side effects that were not different from those of the placebo group .


This preliminary study did not demonstrate that DBCare was efficacious in improving glycemic control in inadequately controlled patients with T@DM on oral hypoglycemics .


A trend toward improved glycemic control was noted in the DBCare group , which correlates with more frequent hypoglycemic episodes .


Further studies are needed to elucidate DBCare 's hypoglycemic effect in patients with T@DM in general and in specific clinical settings , such as HbA@C @ % , short ( @-year ) duration of diabetes , or young age in particular .


Postprandial hypoglycemia after gastric bypass surgery is a serious problem .


Available treatments are often ineffective .


The objective was to test the hypotheses that injection of rapid-acting insulin before a high-carbohydrate meal or replacement of other carbohydrates with fructose in the meal would prevent hypoglycemia .


This was a randomized , crossover trial comparing a high-carbohydrate meal with premeal saline injection ( control ) , a high-carbohydrate meal with premeal insulin injection , and a high-fructose meal with total carbohydrate content similar to the control meal .


The setting was an academic medical center .


Ten patients with post-gastric bypass hyperinsulinemic hypoglycemia participated .


Interventions included lispro insulin injected before test meals and replacement of other carbohydrates with fructose in test meals .


The main outcome measure was plasma glucose < @ mg/dL after test meals .


After the control meal , mean peak glucose and insulin were @ @ mg/dL and @ @ mU/L , respectively ; mean glucose nadir was @ @ mg/dL ; and eight of @ subjects demonstrated glucose < @ mg/dL .


Five subjects demonstrated a glucose nadir < @ mg/dL .


There were no significant differences in the corresponding values after premeal insulin treatment , except that the mean glucose nadir of @ @ mg/dL was lower ( P < @ ) .


After the fructose meal , mean peak postprandial glucose and insulin were @ @ mg/dL and @ @ mU/L , respectively ( both P < @ for comparison with control ) , mean glucose nadir was @ @ mg/dL ( P < @ ) , and two of @ subjects demonstrated glucose < @ mg/dL ( P < @ ) .


People with post-gastric bypass hypoglycemia can consume a meal sweetened with fructose with little risk of hypoglycemia .


Treatment with rapid-acting insulin before a carbohydrate-containing meal did not prevent hypoglycemia .


Randomised controlled trials have shown that bariatric surgery is more effective than conventional treatment for the short-term control of type-@ diabetes .


However , published studies are characterised by a relatively short follow-up .


We aimed to assess @ year outcomes from our randomised trial designed to compare surgery with conventional medical treatment for the treatment of type @ diabetes in obese patients .


We did our open-label , randomised controlled trial at one diabetes centre in Italy .


Patients aged @-@ years with a body-mass index of @ kg/m ( @ ) or more and a history of type @ diabetes lasting at least @ years were randomly assigned ( @:@:@ ) , via a computer-generated randomisation procedure , to receive either medical treatment or surgery by Roux-en-Y gastric bypass or biliopancreatic diversion .


Participants were aware of treatment allocation before the operation and study investigators were aware from the point of randomisation .


The primary endpoint was the rate of diabetes remission at @ years , defined as a glycated haemaglobin A@c ( HbA@c ) concentration of @ % or less ( @ mmol/mol ) and a fasting glucose concentration of @ mmol/L or less without active pharmacological treatment for @ year .


Here we analyse glycaemic and metabolic control , cardiovascular risk , medication use , quality of life , and long-term complications @ years after randomisation .


Analysis was by intention to treat for the primary endpoint and by per protocol for the @ year follow-up .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between April @ , @ , and Oct @ , @ , we randomly assigned @ patients to receive either medical treatment ( n = @ ) or surgery by gastric bypass ( n = @ ) or biliopancreatic diversion ( n = @ ) ; @ ( @ % ) patients completed @ years ' follow-up .


Overall , @ ( @ % ) of the @ surgical patients ( seven -LSB- @ % -RSB- of @ in the gastric bypass group and @ -LSB- @ % -RSB- of @ in the bilipancreatic diversion group ) maintained diabetes remission at @ years , compared with none of the @ medically treated patients ( p = @ ) .


We recorded relapse of hyperglycaemia in eight ( @ % ) of the @ patients who achieved @ year remission in the gastric bypass group and seven ( @ % ) of the @ patients who achieved @ year remission in the biliopancreatic diversion group .


Eight ( @ % ) patients who underwent gastric bypass and @ ( @ % ) patients who underwent biliopancreatic diversion had an HbA@c concentration of @ % or less ( @ mmol/mol ) with or without medication , compared with four ( @ % ) medically treated patients ( p = @ ) .


Surgical patients lost more weight than medically treated patients , but weight changes did not predict diabetes remission or relapse after surgery .


Both surgical procedures were associated with significantly lower plasma lipids , cardiovascular risk , and medication use .


Five major complications of diabetes ( including one fatal myocardial infarction ) arose in four ( @ % ) patients in the medical group compared with only one complication in the gastric bypass group and no complications in the biliopancreatic diversion group .


No late complications or deaths occurred in the surgery groups .


Nutritional side-effects were noted mainly after biliopancreatic diversion .


Surgery is more effective than medical treatment for the long-term control of obese patients with type @ diabetes and should be considered in the treatment algorithm of this disease .


However , continued monitoring of glycaemic control is warranted because of potential relapse of hyperglycaemia .


Lipoabdominoplasty is nearly a daily aesthetic procedure .


Despite the emergence of laser-assisted liposuction , to date , it has not been clearly evaluated combined with abdominoplasty .


This prospective study aimed to evaluate the effectiveness and safety of laser-assisted liposuction relative to traditional liposuction combined with high-lateral-tension abdominoplasty .


This study investigated @ consecutive female patients who underwent high-lateral-tension abdominoplasty combined with liposuction of the upper central abdomen and both flanks .


The patients were divided into three equal groups based on the technique used for liposuction .


Group @ underwent conventional liposuction with abdominoplasty .


Group @ underwent a mixture of conventional and laser-assisted liposuction with abdominoplasty .


Group @ underwent laser-assisted liposuction with abdominoplasty .


The patients in groups @ and @ had a better aesthetic outcome than those in group @ with regard to abdominal contour and skin tightness .


No major complications were observed in groups @ and @ .


The patients in group @ had a higher incidence of complications ( @ seromas , @ central necroses and dehiscence ) , and one patient underwent secondary sutures .


Laser-assisted liposuction combined with abdominoplasty in the lateral abdomen seems to be a safe technique with good aesthetic outcomes .


Although the combined use of laser-assisted liposuction in the lateral and central abdomen can achieve relatively better aesthetic results , it is associated with significant complications , and its use can not be supported .


Proper laser parameters in the central abdominal area still need further study .


This journal requires that authors assign a level of evidence to each article .


For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/@ .


This study was performed to compare patient outcomes after Reamer-Irrigator-Aspirator ( RIA ) - harvested bone grafting with the current gold standard , either anterior or posterior iliac crest bone graft ( ICBG ) .


Prospective randomized controlled trial .


Multicenter study at @ geographically separate Level @ trauma centers .


One hundred thirty-three patients with nonunion or posttraumatic segmental bone defect requiring operative intervention .


Patients were prospectively randomized to receive ICBG or RIA autograft .


Supplemental internal fixation was performed per surgeon preference .


Operative data included amount of graft , time of harvest , and associated surgical costs .


The Short Musculoskeletal Functional Assessment and the Visual Analog Scale were used to document baseline and postoperative function and pain .


Clinical and radiographic union was the defined end point ; patients considered to have failed treatment if they either developed an infection requiring operative treatment or had a persistent nonunion of the grafted extremity .


One hundred thirteen of the @ enrolled patients were followed until union and included in the final analysis .


Intraoperative data showed anterior ICBG to yield @ @ ( @-@ ) cm of autograft with an average harvest time of @ @ minutes , posterior ICBG yielded @ @ ( @-@ ) cm of autograft in @ @ minutes , and RIA yielded @ @ ( @-@ ) cm in @ @ minutes .


Anterior ICBG produced significantly less bone graft than either RIA or posterior ICBG ( P < @ ) .


The RIA harvest was completed in significantly less operative time compared with posterior ICBG ( P = @ ) .


At $ @ , the RIA setup was considerably more expensive than the $ @ cost of a bone graft tray ; however , when compared with posterior ICBG , the longer operative time required for a posterior harvest came at an additional incremental cost of $ @-@ , making RIA the less expensive option .


Patients were followed for an average of @ @ ( @-@ ) weeks .


Forty-nine of @ patients ( @ % ) who received ICBG united in an average of @ @ weeks ; @ of @ patients ( @ % ) who received RIA healed in an average of @ @ weeks .


Union rates and time to union were comparable between the @ procedures .


There was no difference in complications requiring reoperation for persistent nonunion or infection at the grafted site , nor there was any difference in donor-site complications .


Postoperative follow-up showed that RIA patients had significantly lower donor-site pain scores throughout follow-up .


When compared with autograft obtained from the iliac crest , autograft harvested using the RIA technique achieves similar union rates with significantly less donor-site pain .


RIA also yields a greater volume of graft compared with anterior ICBG and has a shorter harvest time compared with posterior ICBG .


For larger volume harvests , cost analysis favors using RIA .


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


The early biological impact of short-term mechanical ventilation on healthy lungs is unknown .


The authors aimed to characterize the immediate tidal volume ( VT ) - related changes on lung injury biomarkers in patients with healthy lungs and low risk of pulmonary complications .


Twenty-eight healthy patients for knee replacement surgery were prospectively randomized to volume-controlled ventilation with VT @ ( VT@ ) or @ ( VT@ ) ml/kg predicted body weight .


General anesthesia and other ventilatory parameters ( positive end-expiratory pressure , @ cm H@O , FIO@ , @ , respiratory rate titrated for normocapnia ) were managed similarly in the two groups .


Exhaled breath condensate and blood samples were collected for nitrite , nitrate , tumor necrosis factor - , interleukins-@ , -@ , -@ , -@ , -@ , neutrophil elastase , and Clara Cell protein @ measurements , at the onset of ventilation and @ min later .


No significant differences in biomarkers were detected between the VT groups at any time .


The coefficient of variation of exhaled breath condensate nitrite and nitrate decreased in the VT@ but increased in the VT@ group after @-min ventilation .


Sixty-minute ventilation significantly increased plasma neutrophil elastase levels in the VT@ ( @ @ vs. @ @ ng/ml , P = @ ) and Clara Cell protein @ levels in the VT@ group ( @ @ vs. @ @ ng/ml , P = @ ) .


Exhaled breath condensate nitrite correlated with plateau pressure ( r = @ , P = @ ) and plasma neutrophil elastase ( r = @ , P = @ ) .


Plasma Clara Cell protein @ correlated with compliance ( r = @ , P = @ ) .


No tidal volume-related changes were observed in the selected lung injury biomarkers of patients with healthy lungs after @-min ventilation .


Plasma neutrophil elastase and plasma Clara Cell protein @ might indicate atelectrauma and lung distention , respectively .


Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis .


We aimed to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of multiple sclerosis .


In this randomised , double-blind , placebo-controlled , parallel-group study , we enrolled patients aged @-@ years with clinically isolated syndrome ( defined as a neurological event consistent with demyelination , starting within @ days of randomisation , and two or more T@-weighted MRI lesions @ mm in diameter ) from @ centres ( mostly hospitals ) in @ countries .


Participants were randomly assigned ( @:@:@ ) in a double-blind manner ( by an interactive voice response system ) to once-daily oral teriflunomide @ mg , teriflunomide @ mg , or placebo , for up to @ weeks .


Patients , staff administering the interventions , and outcome assessors were masked to treatment assignment .


The primary endpoint was time to relapse ( a new neurological abnormality separated by @ days from a preceding clinical event , present for @ h in the absence of fever or known infection ) , which defined conversion to clinically definite multiple sclerosis .


The key secondary endpoint was time to relapse or new gadolinium-enhancing or T@ lesions on MRI , whichever occurred first .


The primary outcome was analysed for the modified intention-to-treat population ; safety analyses included all randomised patients who were exposed to the study drug , as treated .


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


Between Feb @ , @ , and Aug @ , @ , @ patients were enrolled and randomly assigned to teriflunomide @ mg ( n = @ ) , teriflunomide @ mg ( n = @ ) , or placebo ( n = @ ) .


Two patients in each of the teriflunomide groups did not receive the study drug , so the modified intention-to-treat population comprised @ patients in the teriflunomide @ mg group , @ in the teriflunomide @ mg group , and @ in the placebo group .


Compared with placebo , teriflunomide significantly reduced the risk of relapse defining clinically definite multiple sclerosis at the @ mg dose ( hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- ; p = @ ) and at the @ mg dose ( @ -LSB- @-@ -RSB- ; p = @ ) .


Teriflunomide reduced the risk of relapse or a new MRI lesion compared with placebo at the @ mg dose ( HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) and at the @ mg dose ( @ -LSB- @-@ -RSB- ; p = @ ) .


During the study , six patients who were randomly assigned to placebo accidently also received teriflunomide at some point : four received @ mg and two received @ mg .


Therefore , the safety population comprised @ patients on teriflunomide @ mg , @ on teriflunomide @ mg , and @ on placebo .


Adverse events that occurred in at least @ % of patients in either teriflunomide group and with an incidence that was at least @ % higher than that with placebo were increased alanine aminotransferase ( @ -LSB- @ % -RSB- of @ patients in the @ mg group , @ -LSB- @ % -RSB- of @ in the @ mg group vs @ -LSB- @ % -RSB- of @ in the placebo group ) , hair thinning ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , diarrhoea ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , paraesthesia ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and upper respiratory tract infection ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


The most common serious adverse event was an increase in alanine aminotransferase ( four -LSB- @ % -RSB- and five -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) .


TOPIC is to our knowledge the first study to report benefits of an available oral disease-modifying therapy in patients with early multiple sclerosis .


These results extend the stages of multiple sclerosis in which teriflunomide shows a beneficial effect .


ABT-@ , a highly selective histamine-@ receptor antagonist , demonstrated efficacy across several preclinical cognitive domains , and safety in healthy subjects and elderly volunteers .


Evaluate the efficacy and safety of ABT-@ in subjects with mild-to-moderate Alzheimer 's dementia .


The study used a randomized , double-blind , placebo - and active-controlled , parallel group design with pre-defined futility criteria to permit early study termination .


A total of @ subjects were randomized in an equal ratio to ABT-@ @ mg or @ mg , donepezil @ mg , or placebo once daily for @ weeks .


The primary efficacy endpoint was the change from baseline to final evaluation on the @-item Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-Cog ) total score .


The study was prematurely terminated because futility criteria were met .


Point estimates on the ADAS-Cog scores for both ABT-@ dose groups were numerically inferior to placebo but no statistical differences were detected .


Donepezil demonstrated statistically significant improvement .


Adverse events were generally mild and self-limiting .


ABT-@ did not demonstrate efficacy in the symptomatic treatment of Alzheimer 's dementia .


Failure in complete healing of the wound is one of the probable complications of cesarean .


The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound .


This prospective randomized double-blind clinical trial was conducted on @ women who had undergone cesarean operation in Amir-al-Momenin hospital ( Gerash , Iran ) .


The participants were randomly divided into two groups each containing @ patients .


In one group , the wound was dressed with aloe vera gel , while simple dressing was used in the control group .


Wound healing was assessed @ hours and @ days after the cesarean operation using REEDA scale .


The data were analyzed through Chi-square and t-test .


The participants ' mean age was @ in the aloe vera group and @ in the control group , but the difference was not statistically significant .


However , a significant difference was found between the two groups concerning body mass index , heart rate , and systolic blood pressure ( P < @ ) .


Also , a significant difference was observed between the two groups with respect to the wound healing score @ hours after the operation ( P = @ ) .


After @ days , however , the difference in the wound healing score was not significant ( P = @ ) .


Overall , @ participants in the aloe vera group and @ ones in the control group had obtained a zero score @ hours after the operation .


These measures were respectively obtained as @ and @eight days after the operation .


According to the findings of this study , the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel .


To determine the protective effect of zero-balanced ultrafiltration and modified ultrafiltration on infants ' pulmonary function after cardiac surgery .


Sixty infants with congenital heart diseases were randomly divided into @ groups : a zero-balanced ultrafiltration group ( Z group ) , a modified ultrafiltration group ( M group ) and a zero-balanced ultrafiltration with modified ultrafiltration group ( Z+M group ) .


Oxygenation index ( OI ) , difference of alveoli-arterial oxygen pressure ( P ( A - ) O@ ) , static lung compliance ( Cstat ) , and airway resistance ( Raw ) were measured before caridopulmonary bypass ( CPB , T@ ) , @ minutes after the CPB ( T@ ) , @ h after the operation ( T@ ) , @ h after the operation ( T@ ) and @ h after the operation ( T@ ) .


The time of mechanical ventilation was also monitored .


After the CPB , OI and Cstat in all groups decreased significantly , while Raw and P ( A - ) O@ increased significantly .


At T@ , T@ and T@ , OI and Cstat in the Z+M group were significantly higher than those in the Z group and the M group ( P < @ ) , Raw and P ( A - ) O@ in the Z+M group were significantly lower than those in the Z group and the M group ( P < @ ) .


The ventilation time in the Z+M group was significantly shorter than that in the Z group and the M group ( P < @ ) .


Zero-balanced ultrafiltration and modified ultrafiltration can effectively promote the pulmonary function after cardiac surgery in infants .


Exposure to ozone has acute respiratory effects , but few human clinical studies have evaluated cardiovascular effects .


We hypothesized that ozone exposure alters pulmonary and systemic vascular function , and cardiac function , with more pronounced effects in subjects with impaired antioxidant defense from deletion of the glutathione-S-transferase M@ gene ( GSTM@ null ) .


Twenty-four young , healthy never-smoker subjects ( @ GSTM@ null ) inhaled filtered air , @ppb ozone and @ppb ozone for @h , with intermittent exercise , in a double-blind , randomized , crossover fashion .


Exposures were separated by at least @ weeks .


Vital signs , spirometry , arterial and venous blood nitrite levels , impedance cardiography , peripheral arterial tonometry , estimation of pulmonary capillary blood volume ( Vc ) , and blood microparticles and platelet activation were measured at baseline and during @h after each exposure .


Ozone inhalation decreased lung function immediately after exposure ( meanstandard error change in FEV@ , air : -@ L ; @ppb ozone : -@ L ; p < @ ) .


The immediate post-exposure increase in blood pressure , caused by the final @-min exercise period , was blunted by @ppb ozone exposure ( meanstandard error change for air : @ mmHg ; @ppb ozone : @ mmHg ; @ppb ozone : @ mmHg ; p = @ ) .


We found no consistent effects of ozone on any other measure of cardiac or vascular function .


All results were independent of the GSTM@ genotype .


We did not find convincing evidence for early acute adverse cardiovascular consequences of ozone exposure in young healthy adults .


The ozone-associated blunting of the blood pressure response to exercise is of unclear clinical significance .


To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery .


Inadequate children 's postoperative pain management remains a global problem .


Parents are required to be involved in their child 's pain assessment and management , yet they often lack relevant knowledge and skills .


Education is an effective strategy for enhancing a person 's knowledge , attitudes and behaviour .


However , few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery .


Randomized controlled trial and embedded qualitative process evaluation .


One hundred and sixty-two pairs of participants ( each comprised of one parent and his/her child undergoing inpatient elective surgery ) will be recruited ( protocol approved in January @ ) .


Participants will be randomized to either a Control group ( routine care ) , an Intervention group @ ( routine care and an educational intervention with face-to-face teaching ) , or an Intervention group @ ( routine care and an educational intervention without face-to-face teaching ) .


Outcome measures will include parents ' knowledge , attitude and behaviour related to postoperative pain management ; their child 's postoperative pain ; and parents ' satisfaction with their child 's pain management at baseline and around @ , @ and @ hours after the operation .


A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents ' knowledge , attitude and behaviour related to postoperative pain management and reduce their child 's postoperative pain .


Urolithiasis ( kidney stones ) is a common reason for Emergency Department ( ED ) visits , accounting for nearly @ % of all visits in the United States .


Computed tomography ( CT ) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound .


This paper describes the rationale and methods of STONE ( Study of Tomography Of Nephrolithiasis Evaluation ) , a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis .


STONE is a multi-center , non-blinded pragmatic randomized comparative effectiveness trial of patients between ages @ and @ with suspected nephrolithiasis seen in an ED setting .


Patients were randomized to one of three initial imaging examinations : point-of-care ultrasound , ultrasound performed by a radiologist or CT. .


Participants then received diagnosis and treatment per usual care .


The primary aim is to compare the rate of severe SAEs ( Serious Adverse Events ) between the three arms .


In addition , a broad range of secondary outcomes was assessed at baseline and regularly for six months post-baseline using phone , email and mail questionnaires .


Excluding @ patients who withdrew after randomization , a total of @ patients were randomized and completed a baseline questionnaire ( n = @ , @ and @ in the point-of-care ultrasound , radiology ultrasound and radiology CT arms , respectively ) .


Follow-up is complete , and full or partial outcomes were assessed on over @ % of participants .


The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting .


To assess pain intensity with and without subcutaneous local anesthesia prior to intraarticular administration of contrast medium for magnetic resonance arthrography ( MRa ) of the shoulder .


This single-center study was conducted after an IRB waiver of authorization , between January @ and December @ .


All patients provided written , informed consent for the procedure .


Our prospectively populated institutional database was searched , based on our inclusion criteria .


There were @ outpatients ( @ men and @ women ; mean age , @ years @ ; range , @-@ ) who underwent MRa and were enrolled in this study .


Patients were excluded if they had received surgery of the shoulder before MRa , had undergone repeated MRa of the same shoulder , and/or had undergone MRa of both shoulders on the same day .


Patients were randomly assigned into one of three groups .


Patients in group A ( n = @ ) received skin infiltration with local anesthesia .


Patients in control group B ( n = @ ) and group C ( n = @ ) did not receive local anesthesia .


Pain levels were immediately assessed after the injection for MRa using a horizontal visual analog scale ( VAS ) that ranged from @ to @ .


To compare the pain scores of the three groups for male and female patients , a two-way analysis of variance was used .


A p-value equal to or less than @ was considered to indicate a significant result .


Patients who received local anesthesia ( group A ) showed a mean pain level on the VAS of @ @ .


In patients who did not receive local anesthetics ( groups B and C ) , a mean pain level on the VAS of @ @ and @ @ were detected , respectively .


Between the three groups , no statistically significant difference in pain intensity was detected ( p = @ ) .


There were significant differences in subjective pain perception between men and women ( p = @ ) .


Moreover , the sex difference in all three groups was equal ( p = @ ) .


Local anesthesia is not required to lower a patient 's pain intensity when applying intra-articular contrast media for MR arthrography of the shoulder .


This could result in reduced costs and a reduced risk of adverse reactions , without an impact on patient comfort .


To observe the difference in the efficacy on traumatic nerve injury among electroacupuncture , warm needling therapy and electroacupuncture plus warm needling therapy and explore the better therapeutic method .


The electromyography ( EMG ) and electroneurography ( ENG ) of @ cases showed traumatic nerve injury of moderate damage .


According to the single blind randomization principle , they were divided into an electroacupuncture ( EA ) group , a warm needling therapy ( WN ) group and an EA plus WN group , @ cases in each one .


The main acupoints were selected from Yangming Meridian and Shaoyang Meridian corresponding to the distribution of damaged nerves .


EA , WN and EA plus WN were applied separately .


The treatment was given once every day , @ treatments made one session .


After @ sessions of treatment ( @ treatments in total ) , EMG and ENG were re-checked and the results were analyzed statistically .


Regarding the total effective rate and effective rate , it was @ % ( @/@ ) in the EA plus WN group , which was better than @ % ( @/@ ) in the EA group and @ % ( @/@ ) in the WN group ( P < @ ) .


Concerning to the improvements of EMG , the result in the EA plus WN group was @ % ( @/@ ) , which was better than the other two groups -LSB- @ % ( @/@ ) ,@ % ( @/@ ) -RSB- ( P < @ ) .


In terms of the recovery of nerve conduction and amplitude , the results in EA plus WN group -LSB- ( @ + / -@ ) m/s , ( @ + / -@ ) , microVx@ @ -RSB- were better than the other two groups -LSB- ( @ + / -@ ) m/s , ( @ + / -@ ) microV X @ @ , ( @ + / -@ ) m/s , ( @ + / -@ ) microV X @ @ -RSB- ( P < @ ) .


EA combined with WN is a better therapy of acupuncture and moxibustion in the treatment of traumatic nerve injury .


The aim of this study was to compare the skeletal and dental effects of the EVAA appliance with those of an activator appliance in growing children with skeletal Class II anomalies .


A total of @ subjects with Class II anomalies were recruited for this study .


They were divided into three groups : the EVAA group ( n = @ ; mean chronological age : @ years @ months ) , activator group ( n = @ ; mean chronological age : @ years @ months ) and control group ( n = @ ; mean chronological age : @ years @ months ) .


Lateral cephalometric radiographs were taken at the beginning and end of functional therapy .


Fixed orthodontic treatment was completed in the EVAA group .


A statistical software program ( SPSS @ ) was used for one-way analysis of variance and multiple comparisons with the Duncan test .


We observed a significant decrease in the ANB , convexity , and @NA ( ) , while a significant increase appeared in upper anterior facial height , posterior facial height , @NB ( mm ) , SN-lower occlusal plane values in the EVAA and activator groups after treatment ( p < @ ) .


No significant difference in study parameters in the control group during the treatment period except for the increase in SNA and @NA ( mm ) values ( p < @ ) were observed .


There were no significant differences between EVAA and activator treatment groups in terms of study parameters except for the articular angle , which was significantly higher in the EVAA group after therapy ( p < @ ) .


The effects of EVAA appliances were similar to those of activator treatment .


The objectives of this study were to present the rationale for the main aspects of the study design and describe the trial methodology for the Idiopathic Intracranial Hypertension Treatment Trial ( IIHTT ) .


Eligible candidates with mild visual field loss ( automated perimetric mean deviation -LSB- PMD -RSB- -@ to -@ dB ) were randomized to receive either acetazolamide or matching placebo tablets .


Randomized participants were offered participation in a supervised dietary program .


The primary outcome variable , PMD , was measured at @ months .


Additionally , cerebrospinal fluid from subjects and serum from study participants and matched controls were collected for genetic analysis and vitamin A studies .


An ancillary optical coherence substudy was added to investigate the changes of papilledema in the optic nerve head and retina that correlate with Frisn grading , visual field deficits , and low-contrast visual acuity .


The randomized trial entered @ participants from March @ , @ , through November @ , @ , from the United States and Canada .


The primary outcome ( month @ ) visits were successfully completed by June @ , @ .


Blood specimens were obtained from @ controls without IIH to investigate vitamin A metabolism and genetic markers of potential risk factors for IIH .


The IIHTT is the first randomized , double-masked placebo-controlled trial to study the effectiveness of medical treatment for patients with IIH .


The aim of this study was to assess the efficacy of a @-month prevention program conducted in @ community pharmacies in reducing the risk for diabetes .


In a cluster-randomized controlled trial in @,@ participants , mean change in the risk for diabetes ( indicated by the Finnish Diabetes Risk Score -LSB- FINDRISC -RSB- ) between intervention and control groups was calculated .


In the intervention program GLICEMIA , three appointments with individual counseling and five educational group sessions were combined , whereas in the control group , only information about the participants ' health was obtained in three assessments .


After adjusting for cluster structure and differences in baseline characteristics , improvement in FINDRISC in the intervention group was @ points ( @ % CI @-@ @ ) above the control group .


The GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over @ year .


Telavancin is approved in Europe for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus when other alternatives are not suitable .


The approved European prescribing information contraindicates the use of telavancin in patients with severe renal impairment ( creatinine clearance < @ mL/min , including patients on haemodialysis ) and pre-existing acute renal failure owing to the higher observed mortality in these patients .


Data from the ATTAIN studies were reanalysed , excluding patients with these contraindicating conditions at baseline .


( At the time of submission of this article , the European marketing authorization of telavancin for the treatment of nosocomial pneumonia was suspended pending evidence of a new European Medicines Agency-approved supplier .


Clinigen Healthcare Ltd , Theravance 's commercialization partner for telavancin in Europe , is in the process of seeking approval of a new manufacturing source . )


A post hoc analysis of data from two Phase @ ATTAIN trials of telavancin for the treatment of Gram-positive nosocomial pneumonia assessing clinical outcomes and safety .


The all-treated population for this analysis represented @ % ( @/@ ) of the ATTAIN all-treated population .


The cure rates in the clinically evaluable population were similar in the telavancin ( @ % , @/@ ) and vancomycin ( @ % , @/@ ) groups -LSB- treatment difference ( @ % CI ) : @ % ( -@ % to @ % ) -RSB- , and were consistent with the overall ATTAIN study results .


The cure rate was higher in the telavancin than the vancomycin treatment group in microbiologically evaluable patients with only Gram-positive pathogens isolated at baseline -LSB- @ % ( @/@ ) versus @ % ( @/@ ) , respectively ; treatment difference ( @ % CI ) : @ % ( @ % -@ % ) -RSB- .


The incidences of adverse events were similar between treatment groups and consistent with the overall findings of the ATTAIN study .


This analysis demonstrated that in the subset of patients without severe renal impairment or pre-existing acute renal failure , clinical and safety outcomes were similar in the telavancin and vancomycin treatment groups .


To evaluate the safety and efficacy of adjuvant intensity-modulated radiotherapy ( IMRT ) with concurrent paclitaxel and cisplatin ( TP ) in early stage cervical cancer patients with high risk factors after radical hysterectomy .


Patients who underwent radical hysterectomy for FIGO stage IB-IIA cervical cancer and had high risk factors for recurrence were recruited .


One cycle of TP was delivered before and after concurrent chemoradiotherapy , respectively .


Concurrent chemoradiotherapy began @ days after the start of the initial cycle of the chemotherapy with two cycles of TP delivered on day @ and day @ of radiotherapy .


Primary endpoints were overall survival ( OS ) and relapse-free survival ( RFS ) , with toxicities , local-regional control ( LC ) and distant failure ( DF ) rate as secondary endpoints .


Between @ and @ , @ patients were evaluable .


The @ and @-year RFS rates were @ % and @ % .


Corresponding OS rates were @ % , and @ % , respectively .


The @-year LC and DF rates were @ % and @ % , respectively .


Grade @-@ acute leucopenia , neutropenia and thrombocytopenia occurred in @ % , @ % and @ % of patients , respectively .


There were @ % and @ % patients experienced acute vomiting and diarrhea , but only @ % and @ % patients were grade @ , respectively .


No case of chronic toxicity exceeded grade @ .


Adjuvant concurrent IMRT with paclitaxel plus cisplatin are safe and effective in early stage cervical cancer patients with high risk factors for recurrence following radical hysterectomy .


To observe the effection of immune reconstitution efficiency and the immune function on Immune @ with HAART to HIV/AIDS patients which poor immune reconstitution after HAART .


Two hundred and sixty four patients failure to immune reconstitution after HAART were randomly divided into treatment group ( @ cases ) and control group ( @ cases ) , respectively , using Immune @ plus HAART and placebo combined with HAART for @ months .


the CD@ , CD@ , CD@RA , CD@RO , CD@CD@ , CD@CD@ , CD@CD@ , HLA-DR and CD@CD@ were observed in order to evaluate the immune reconstitution efficiency .


After the intervention for @ months , the effective rate of treatment group ( @ % ) was significantly superior to the control group ( @ % ) ( P = @ ) .


Treated group could significantly increased the CD@ , CD@RA , CD@RO cell counts compared with control group ( P < @ ) ; CD@ , CD@ , CD@CD@ absolute count comparison between the two groups had no significant difference ; CD@CD@ relative counting the treatment group group significantly increased ( P < @ ) compared to the control ; CD@CD@ , CD@CD@ , CD@DR , CD@CD@ relative counting groups showed no significant difference .


Immune @ can effectively improve the immune reconstitution efficiency , CD@ counts , CD@RA counts and CD@RO counts of patients after HAART , therefore promoting immune reconstitution .


The purpose of this study was to compare the analgesic properties of levobupivacaine with or without fentanyl for patient-controlled epidural analgesia after Cesarean section in a randomized , double-blinded study .


We enrolled American Society of Anesthesiologists class I/II , full-term pregnant women at National Taiwan University Hospital who received patient-controlled epidural analgesia after Cesarean section between @ and @ .


Eighty women were randomly assigned into two groups .


In group A , the @ subjects received drug solutions made of @ mg/ml levobupivacaine plus @mcg/ml fentanyl , and in group B the @ subjects received @mg/ml levobupivacaine .


Maintenance was self-administered boluses and a continuous background infusion .


There were no significant differences in the resting and dynamic pain scales and total volume of drug used between the two groups .


Patient satisfaction was good in both groups .


Our study showed that pure epidural levobupivacaine can provide comparative analgesic properties to the levobupivacaine-fentanyl combination after Cesarean section .


Pure levobupivacaine may serve as an alternative pain control regimen to avoid opioid-related adverse events in parturients .


To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy ( CP ) .


A prospective randomized cross-over design study compared the effect of regular physiotherapy ( baseline ) with blocks of physiotherapy alternating with no physiotherapy over one year .


Thirty-nine institutionalized children with CP and clinically similar syndromes ( @-@ years old , Gross Motor Function Classification Scale II-IV ) were included .


During the first scholastic year , group A received regular physiotherapy , group B blocks of physiotherapy and vice versa in the second year .


The Gross Motor Function Measure @ ( GMFM-@ ) was the outcome measure .


Thirteen children in each group completed the study .


GMFM-@ improved ( p < @ ) over the study period in both groups in total ; changes ( p < @ ) were seen only in dimension D ( group B ) and E ( both groups ) during regular therapy .


Physiotherapy may be more effective when provided regularly rather than in blocks .


To investigate the effectiveness of a combined social and physical environmental intervention as well as the effectiveness of both separate interventions .


In a @ @ factorial design , @ office employees were allocated to the combined social and physical environmental intervention , to the social environmental intervention only , to the physical environmental intervention only , or were part of the control group .


Data on presenteeism , absenteeism , work performance , and work engagement were obtained with questionnaires at baseline , @ , and @ months .


Multilevel analyses were performed .


The combined intervention showed a decrease in contextual performance and dedication .


The social environmental intervention showed an improvement in task performance .


The physical environmental intervention revealed an improvement in absorption .


Although the study showed some promising results , it is not recommended to implement the current interventions .


We examine the cross-sectional associations between baseline characteristics and sexual function and the longitudinal associations between change in lower urinary tract symptoms and change in sexual function among men with benign prostatic hyperplasia .


We studied lower urinary tract symptoms assessed by the AUA-SI and sexual function determined by the BMSFI in men enrolled in the MTOPS study .


The cross-sectional cohort included @,@ men who completed the BMSFI at baseline .


The longitudinal cohort included @ men who were randomized to placebo and had completed the BMSFI at baseline and at least once during a @-year followup .


Multiple adjusted linear modeling for each domain of the BMSFI was performed to assess associations of sexual function with lower urinary tract symptoms .


After adjustment for baseline demographic and clinical characteristics , increased age , less education , obesity and severe lower urinary tract symptoms were each significantly associated with poorer sexual drive , erectile function , ejaculatory function , sexual problem assessment and overall satisfaction in the cross-sectional cohort .


However , none of these baseline characteristics predicted change in sexual function in the longitudinal cohort .


Decline in sexual function in all sexual function domains associated with worsening of lower urinary tract symptoms in this group was small .


Increased age , less education , obesity and more severe lower urinary tract symptoms were individually associated cross-sectionally , but not longitudinally , with poorer sexual function in men with lower urinary tract symptoms/benign prostatic hyperplasia .


The decline in sexual function associated with worsening of lower urinary tract symptoms in men assigned to placebo was small .


This study was conducted to compare and evaluate the effect of adding lornoxicam or nitroglycerine as adjuncts to lidocaine in intravenous regional anesthesia ( IVRA ) .


@ patients were randomly separated into three groups , lidocaine group ( group L ) , lidocaine + lornoxicam group ( group LL ) , and lidocaine + lornoxicam + transdermal nitroglycerine group ( group LL-N ) .


Hemodynamic parameters , sensory and motor blocks onset , and recovery times were recorded .


Analgesic consumption for tourniquet pain and postoperative period were recorded .


Sensory block onset times and motor block onset times were shorter in the LL-N and LL groups compared with L group .


Sensory block recovery time and motor block recovery time were prolonged in the LL and LL-N groups compared with group L.


The amount of fentanyl required for tourniquet pain was less in group LL and group LL-N when compared with group L. VAS scores of tourniquet pain were higher in group L compared with the other study groups .


Postoperative VAS scores were higher for the first @ hours in group L compared with the other study groups .


The adjuvant drugs ( lornoxicam or TNG ) when added to lidocaine in IVRA were effective in improving the overall quality of anesthesia , reducing tourniquet pain , increasing tourniquet tolerance , and improving the postoperative analgesia .


To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant ( HSCT ) for adolescents/young adults ( AYAs ) , we examined efficacy of a therapeutic music video ( TMV ) intervention delivered during the acute phase of HSCT to : @ ) increase protective factors of spiritual perspective , social integration , family environment , courageous coping , and hope-derived meaning ; @ ) decrease risk factors of illness-related distress and defensive coping ; and @ ) increase outcomes of self-transcendence and resilience .


This was a multisite randomized , controlled trial ( COG-ANUR@ ) conducted at @ Children 's Oncology Group sites involving @ AYAs aged @-@ years undergoing myeloablative HSCT .


Participants , randomized to the TMV or low-dose control ( audiobooks ) group , completed @ sessions over @ weeks with a board-certified music therapist .


Variables were based on Haase 's Resilience in Illness Model ( RIM ) .


Participants completed measures related to latent variables of illness-related distress , social integration , spiritual perspective , family environment , coping , hope-derived meaning , and resilience at baseline ( T@ ) , postintervention ( T@ ) , and @ days posttransplant ( T@ ) .


At T@ , the TMV group reported significantly better courageous coping ( Effect Size -LSB- ES -RSB- , @ ; P = @ ) .


At T@ , the TMV group reported significantly better social integration ( ES , @ ; P = @ ) and family environment ( ES , @ ; P = @ ) , as well as moderate nonsignificant effect sizes for spiritual perspective ( ES , @ ; P = @ ) and self-transcendence ( ES , @ ; P = @ ) .


The TMV intervention improves positive health outcomes of courageous coping , social integration , and family environment during a high-risk cancer treatment .


We recommend the TMV be examined in a broader population of AYAs with high-risk cancers .


To report the @-month results of the first head-to-head comparison of a dexamethasone implant ( Ozurdex ; Allergan , Inc. , Irvine , CA ) versus bevacizumab ( Avastin ; Genentech , South San Francisco , CA ) for center-involving diabetic macular edema ( DME ) .


Phase @ , prospective , multicenter , randomized , single-masked clinical trial ( clinicaltrials.gov identifier NCT@ ) .


We enrolled @ eyes of @ patients with center-involving DME .


Forty-two eyes were randomized to receive bevacizumab every @ weeks and @ eyes were randomized to receive a dexamethasone implant every @ weeks , both pro re nata .


Results were analyzed using linear regression with generalized estimation equation methods to account for between-eye correlation .


The primary outcome was the proportion of eyes that improved vision by @ logarithm of minimum angle of resolution letters .


Secondary outcomes included mean change in best-corrected visual acuity ( BCVA ) , change in central macular thickness ( CMT ) , injection frequency , and adverse events .


Patient-reported outcomes were measured using the Impact of Vision Impairment ( IVI ) questionnaire .


Improvement in BCVA of @ or more letters was found in @ of @ eyes ( @ % ) treated with bevacizumab compared with @ of @ dexamethasone implant-treated eyes ( @ % ; P = @ ) .


None of the @ bevacizumab eyes lost @ letters or more , whereas @ of @ ( @ % ) dexamethasone implant eyes did , mostly because of cataract .


Mean CMT decreased by @ m for bevacizumab eyes and by @ m for dexamethasone implant eyes ( P = @ ) .


Bevacizumab-treated eyes received a mean of @ injections compared with @ injections for dexamethasone implant eyes .


Significant improvement in IVI scores occurred for both treatment groups .


Dexamethasone implant achieved similar rates of visual acuity improvement compared with bevacizumab for DME , with superior anatomic outcomes and fewer injections .


Both treatments were associated with improvement in visual quality-of-life scores .


However , more dexamethasone implant-treated eyes lost vision , mainly because of cataract .


As tau aggregation pathology correlates with clinical dementia in Alzheimer 's disease ( AD ) , a tau aggregation inhibitor ( TAI ) could have therapeutic utility .


Methylthioninium ( MT ) acts as a selective TAI in vitro and reduces tau pathology in transgenic mouse models .


To determine the minimum safe and effective dose of MT required to prevent disease progression on clinical and functional molecular imaging outcomes .


An exploratory double-blind , randomized , placebo-controlled , dose-finding trial of MT ( @ , @ , and @ mg/day ) was conducted in @ mild/moderate AD subjects .


The primary outcome was change on the Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-cog ) at @ weeks relative to baseline severity .


Effect of treatment on regional cerebral blood flow decline was determined in a sub-study in @ subjects .


After @ weeks , subjects were re-consented to enter sequential @ - and @-month blinded extension phases .


Registered with ClinicalTrials.gov ( NCT@ ) .


At @ weeks , there were significant treatment benefits in two independent populations at the @ mg/day dose : in moderate subjects on the ADAS-cog scale ( treatment effect : -@ units , corrected p = @ ) and two other clinical scales ; in mild subjects on the more sensitive regional cerebral blood flow measure ( treatment effect : @ % , corrected p < @ ) .


With continued treatment for @ weeks , benefit was seen on the ADAS-cog scale in both mild and moderate subjects .


The delivery of the highest dose was impaired due to dose-dependent dissolution and absorption limitations .


The minimum safe and effective daily MT dose is @ mg and suggests that further study of MT is warranted in AD .


Infarct size and location are thought to correlate with different mechanisms of lacunar infarcts .


We examined the relationship between the size and shape of lacunar infarcts and vascular risk factors and outcomes .


We studied @ participants in the Secondary Prevention of Small Subcortical Stroke trial with a lacunar infarct visualized on diffusion-weighted imaging .


Infarct volume was measured planimetrically , and shape was classified based on visual analysis after @-dimensional reconstruction of axial MRI slices .


Infarct shape was ovoid/spheroid in @ % , slab in @ % , stick in @ % , and multicomponent in @ % .


Median infarct volume was smallest in ovoid/spheroid relative to other shapes : @ , @ , @ , and @ mL , respectively ( P < @ ) .


Distributions of vascular risk factors were similar across the @ groups except that patients in the ovoid/spheroid and stick groups were more often diabetic and those with multicomponent had significantly higher blood pressure at study entry .


Intracranial stenosis did not differ among groups ( P = @ ) .


Infarct volume was not associated with vascular risk factors .


Increased volume was associated with worse functional status at baseline and @ months .


Overall , @ recurrent strokes occurred during an average of @ years of follow-up with no difference in recurrent ischemic stroke rate by shape or volume .


In patients with recent lacunar stroke , vascular risk factor profile was similar among the different infarct shapes and sizes .


Infarct size correlated with worse short-term functional outcome .


Neither shape nor volume was predictive of stroke recurrence .


To develop a model to predict EuroQol five-dimensional questionnaire ( EQ-@D ) values from clinical chronic obstructive pulmonary disease ( COPD ) questionnaire ( CCQ ) scores .


We used data from three clinical trials ( the Randomized Clinical Trial on Effectiveness of Integrated COPD Management in Primary Care -LSB- RECODE -RSB- , the Assessment Of Going Home Under Early Assisted Discharge -LSB- GO-AHEAD -RSB- , and the Health Status Guided COPD Care -LSB- MARCH -RSB- ) .


Data were randomly split into an estimation sample and a validation sample .


The conceptual similarity between patient-reported CCQ and preference-based EQ-@D scores was assessed using correlation and principal-component analysis .


Different types of models were estimated with increasing complexity .


We selected the final models on the basis of mean absolute error and root mean square error when comparing predicted and observed values from the same population ( internal validity ) and from different trial populations ( external validity ) .


We also developed models for different country-specific EQ-@D value sets .


The principal-component analysis showed that the CCQ domains functional state and mental state are associated with four dimensions of the EQ-@D .


The EQ-@D dimension pain/discomfort formed a separate construct on which no CCQ item loaded .


The mean observed EQ-@D values were not significantly different from the mean predicted EQ-@D values in internal validation samples but did significantly differ in external validation samples .


The models underestimated EQ-@D values in milder health states and overestimated them in more severe health states .


The predictive ability of the models was similar across different EQ-@D value sets .


The models can predict mean EQ-@D values that are similar to observed mean values in a similar population .


The overestimating/underestimating of the low/high EQ-@D values , however , limits its use in Markov models .


Therefore , mapping should be used cautiously .


To evaluate quetiapine XR in patients with anxious depression , as defined by HAM-A total and HAM-D anxiety/somatisation factor scores .


Post hoc analyses of pooled data from two @-week , double-blind , randomised , placebo-controlled studies of adjunctive quetiapine XR ( @ or @ mg/day ) in patients with MDD and inadequate response to antidepressants .


Patients were stratified in a primary analysis using HAM-A ( HAM-A total score at baseline @ -LSB- `` high '' -RSB- or < @ -LSB- `` low '' -RSB- ) and a secondary analysis using HAM-D ( anxious depression defined as HAM-D anxiety/somatisation factor score @ ) .


Outcomes included change in MADRS total score .


In patients with high anxiety levels ( HAM-A total score @ ) , reductions in MADRS total score were -@ ( P = @ ) and -@ ( P < @ ) for quetiapine XR @ and @ mg/day , respectively , vs. placebo ( -@ ) .


In patients with low levels of anxiety ( HAM-A total score < @ ) , both quetiapine XR doses ( P < @ ) improved MADRS total scores vs. placebo .


In the secondary analysis , quetiapine XR @ ( P < @ ) and @ mg/day ( P < @ ) improved MADRS total score vs. placebo in patients with HAM-D anxiety/somatisation factor score @ .


Adjunct quetiapine XR demonstrates efficacy in patients with anxious and non-anxious depression , assessed using HAM-A total score , and anxious depression assessed using HAM-D anxiety/somatisation factor score .


To develop a population pharmacokinetic model for intravenous omeprazole in critically ill children .


One hundred eighty-six omeprazole concentration-time data from @ critically ill children were analyzed using the nonlinear mixed-effects approach with the nonlinear mixed-effects modeling software , version @ software .


Patients were randomized into @ groups and received intravenous omeprazole at a dose of @ or @ mg/kg twice daily .


Blood samples were drawn at @ , @ , @ , @ , @ , and @ hours after the first infusion .


The pharmacokinetic profile was best described by a @-compartment model with a first-order elimination process .


Between-patient variability could only be associated with plasma clearance ( CL ) .


The typical values for plasma CL were @ Lh@ kg ( @ % ) , with a distributional clearance of @ Lh@ kg ( @ % ) and central and peripheral compartment distribution volumes of @ L/@ kg ( @ % ) and @ L/@ kg ( @ % ) , respectively .


Allometric size models seemed to predict changes adequately in all the pharmacokinetic parameters .


High values of between-patient variability of CL -LSB- @ % ( @ % ) -RSB- and residual variability -LSB- @ % ( @ % ) -RSB- were still found in the final model .


Model-based simulations suggested that the most suitable dose was @ mg/kg because this yielded similar exposure ( defined by the area under the concentration-time curve ) to that obtained in adults after a @-mg dose of omeprazole intravenously .


An allometric size model allows changes to be predicted in all the pharmacokinetic parameters , making dose adjustment by body weight important to achieve the most effective omeprazole exposure .


This is the first step toward a population pharmacokinetic study , including more data to develop a predictable model to be used during therapeutic drug monitoring .


Instructor feedback reduces the number of repetitions and time to reach proficiency during laparoscopic simulator training .


The objective of this study was to examine the effect of instructor feedback on long-term skill retention .


A @-month follow-up of a randomized trial .


Participants were surgical novices ( medical students ) .


All participants ( n = @ ) initially practiced a laparoscopic salpingectomy on the LapSim virtual reality simulator to proficiency .


The intervention group could request instructor feedback , whereas the control group could not .


After @ months , the participants ( n = @ ) practiced on the simulator until they reached proficiency again .


The primary outcomes were the total time and the number of repetitions .


Initially , the intervention group used significantly fewer repetitions ( @ vs @ , p < @ ) and less total training time ( @ vs @ min , p < @ ) than the control group to reach the proficiency level .


At follow-up , both the groups used an equal number of repetitions ( @ vs @ , p = @ ) and time ( @ vs @ min , p = @ ) to reach the same proficiency level .


Instructor feedback during proficiency-based laparoscopic simulator training does not affect the long-term retention of skills .


To assess the effect of food on the pharmacokinetics ( PK ) of canagliflozin and metformin following administration of a canagliflozin/metformin ( @/@ ,@ mg ) immediate-release ( IR ) fixed-dose combination ( FDC ) tablet .


A randomized , open-label , singlecenter , single-dose , @-period , @-sequence crossover study was conducted in healthy participants .


Participants were randomized to @ sequences of fasted and fed ( or vice versa ) administration of one @/@ ,@ mg canagliflozin/metformin IR FDC , with @-@ day washout between treatments PK parameters ( AUC , Cmax , tmax , t@/@ ) were assessed for canagliflozin and metformin .


Safety was evaluated .


When comparing the IR FDC tablet administered with and without food , PK parameters of canagliflozin were bioequivalent as the @ % confidence intervals ( CIs ) for log-transformed AUClast , AUC , and Cmax were within the bioequivalence limits of @-@ % .


For metformin , overall exposure was similar under fed and fasted conditions as geometric mean ratios for AUC and associated @ % CI were contained within the bioequivalence limits , but geometric mean Cmax decreased by @ % in the fed compared to fasted state .


Both treatments were well tolerated with similar adverse events and most common were gastrointestinal events , generally attributed to metformin .


Food did not affect canagliflozin bioavailability parameters ( Cmax and AUCs ) or AUCs of metformin .


The Cmax of metformin was decreased by @ % , which is not considered clinically meaningful .


The canagliflozin/metformin FDC tablet is recommended to be taken with meals to reduce the symptoms of gastrointestinal intolerability associated with metformin .


Routine prophylaxis with replacement factor VIII ( FVIII ) - the standard of care for severe hemophilia A - often requires frequent intravenous infusions ( three or four times weekly ) .


An FVIII molecule with an extended half-life could reduce infusion frequency .


The A-LONG study established the safety , efficacy and prolonged pharmacokinetics of recombinant FVIII Fc fusion protein ( rFVIIIFc ) in previously treated adolescents and adults with severe hemophilia A.


In this post hoc analysis , we investigated the relationship between subjects ' prestudy ( FVIII ) and on-study ( rFVIIIFc ) regimens .


We analyzed two subgroups of subjects : prior prophylaxis and on-study individualized prophylaxis ( n = @ ) , and prior episodic treatment and on-study weekly prophylaxis ( n = @ ) .


Subjects ' prestudy dosing regimens and bleeding rates were compared with their final rFVIIIFc regimens and annualized bleeding rates ( ABRs ) in the last @ months on-study .


Dosing regimen simulations based on population pharmacokinetics models for rFVIII and rFVIIIFc were performed .


As compared with their prestudy regimen , @ of @ ( @ % ) subjects on individualized rFVIIIFc prophylaxis decreased their infusion frequency .


Overall ABRs were low , with comparable factor consumption .


Longer dosing intervals , including @-day dosing , were associated with higher baseline von Willebrand factor antigen levels .


Simulated dosing regimens predicted a greater proportion of subjects with steady-state FVIII activity trough levels of @ IU dL ( -@ ) ( @ % ) with rFVIIIFc than with equivalent rFVIII regimens .


These results suggest that patients on rFVIIIFc prophylaxis can reduce their infusion frequency as compared with their prior FVIII regimen while maintaining low bleeding rates , affording more patients trough levels of @ IU dL ( -@ ) than with rFVIII products requiring more frequent dosing regimens .


Compared to other children , those with disability have additional challenges to being physically active .


Prader-Willi Syndrome is a genetic form of childhood obesity that is characterized by hypotonia , growth hormone deficiency , behavioral , and cognitive disability .


In children , the low prevalence of this syndrome ( @ in @,@ to @,@ live births ) makes group-based physical activity interventions difficult .


In contrast , the home environment presents a natural venue to establish a physical activity routine for this population .


This manuscript describes the design of a parent-led physical activity intervention incorporating playground and interactive console-based games to increase physical activity participation in youth with and without Prader-Willi Syndrome .


The study participants will be @ youth ages @-@ y ( @ with the syndrome and @ without the syndrome but categorized as obese ) .


The study will use a parallel design with the control group receiving the intervention after serving as control .


Participants will be expected to complete a physical activity curriculum @ days a week for @ months including playground games @ days a week and interactive console games @ days a week .


Parents will be trained at baseline and then provided with a curriculum and equipment to guide their implementation of the program .


Tips related to scheduling and coping with barriers to daily program implementation will be provided .


Throughout , parents will be contacted by phone once a week ( weeks @-@ ) and then every other week to receive support in between visits .


Measurements of children and parents will be obtained at baseline , @ weeks , and at the end ( week @ ) of the intervention .


Children main outcomes include physical activity ( accelerometry ) , body composition ( dual x-ray absorptiometry ) , motor proficiency ( Bruininks-Oseretsky Test of Motor Proficiency ) , quality of life and physical activity self-efficacy ( questionnaires ) .


Intervention compliance will be monitored using mail-in daily self-report checklists .


This parent-guided physical activity intervention aims to increase physical activity by using a curriculum that builds physical activity related self-confidence through the development and/or enhancement of motor skill competency .


Ultimately , helping children develop these skills as well as joy in being physically active will translate into sustained behavior change .


Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints .


The Physical Activity during Cancer Treatment ( PACT ) study was designed to primarily examine the effects of an @-week exercise intervention , offered in the daily clinical practice setting and starting within @ weeks after diagnosis , on preventing an increase in fatigue .


This multi-centre controlled trial randomly assigned @ breast cancer patients to usual care ( n = @ ) or supervised aerobic and resistance exercise ( n = @ ) .


By design , all patients received chemotherapy between baseline and @ weeks .


Fatigue ( i.e. , primary outcome at @ weeks ) , quality of life , anxiety , depression , and physical fitness were measured at @ and @ weeks .


Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control ( mean between-group differences at @ weeks : -@ ; @ % CI -@ to -@ ; effect size -@ ) .


Results for general fatigue were comparable but did not reach statistical significance ( -@ , @ % CI -@ ; @ ; effect size -@ ) .


At @ weeks , submaximal cardiorespiratory fitness and several muscle strength tests ( leg extension and flexion ) were significantly higher in the intervention group compared to control , whereas peak oxygen uptake did not differ between groups .


At @ weeks these differences were no longer statistically significant .


Quality of life outcomes favoured the exercise group but were not significantly different between groups .


A supervised @-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue , submaximal cardiorespiratory fitness , and muscle strength .


Exercise early during treatment of breast cancer can be recommended .


At @ weeks , these effects were no longer statistically significant .


This might have been caused by the control participants ' high physical activity levels during follow-up .


In @-@ , a psychosocial intervention conducted in New York City significantly improved outcomes for parents living with HIV and their adolescent children over six years .


We examine if the intervention benefits are similar for adolescents of mothers living with HIV ( MLH ) in @-@ in Los Angeles when MLH 's survival had increased substantially .


Adolescents of MLH in Los Angeles ( N = @ ) aged @-@ years old were randomized with their MLH to either : @ ) a standard care condition ( n = @ adolescent-MLH dyads ) ; or @ ) an intervention condition consisting of small group activities to build coping skills ( n = @ adolescent-MLH dyads , @ % attended the intervention ) .


At @ months , @ % of adolescents were reassessed .


Longitudinal structural equation modeling examined if intervention participation impacted adolescents ' relationships with parents and their sexual risk behaviors .


Compared to the standard care , adolescents in the intervention condition reported significantly more positive family bonds @ months later .


Greater participation by MLH predicted fewer family conflicts , and was indirectly associated with less adolescent sexual risk behavior at the @ month follow-up assessment .


Anticipated developmental patterns were observed -- sexual risk acts increased with age .


Reports were also consistent with anticipated gender roles ; girls reported better bonds with their mothers at @ months , compared to boys .


Adolescents of MLH have better bonds with their mothers as a function of participating in a coping skills intervention and reduced sexual risk-taking as a function of MLH intervention involvement .


To assess the effectiveness of supportive counselling after miscarriage .


Randomised controlled trial .


University hospital .


Two hundred and eighty women with miscarriage .


Women were randomised to receive supportive counselling from a nurse ( at diagnosis and @ weeks later ) or routine care .


Psychological wellbeing was measured with the General Health Questionnaire ( GHQ-@ ) and Beck Depression Inventory ( BDI ) .


Primary outcome measured the proportion of women suffering psychological distress ( GHQ-@ score @ ) at @ months after miscarriage .


Secondary outcomes were GHQ-@ and BDI scores at @ weeks , @ and @ months .


There was no difference in the proportion of women suffering psychological distress at @ months after miscarriage ( @ % in counselling group versus @ % in control group ; @ % CI -@ to @ ; P = @ ) .


However , for the subgroup of women ( n = @ ) with high baseline GHQ-@ scores , the median GHQ-@ score in the counselling group was significantly lower than the control group at @ weeks ( median score @ versus @ in counselling and control groups ; P = @ ) and @ months ( median score @ versus @ in counselling and control groups ; P = @ ) .


Similarly , for women with high baseline BDI scores ( BDI > @ ) , the proportion for women continuing to score high was significantly lower in the counselling group @ weeks after miscarriage ( @ versus @ % in counselling group and control group ; P = @ ) .


Although the results of current study do not justify routine counselling of all women following miscarriage , a supportive counselling programme for selected women with high levels of psychological distress is promising and merits further investigation .


The susceptibility to type @ diabetes of people of south Asian descent is established , but there is little trial-based evidence for interventions to tackle this problem .


We assessed a weight control and physical activity intervention in south Asian individuals in the UK .


We did this non-blinded trial in two National Health Service ( NHS ) regions in Scotland ( UK ) .


Between July @ , @ , and Oct @ , @ , we recruited men and women of Indian and Pakistani origin , aged @ years or older , with waist circumference @ cm or greater in men or @ cm or greater in women , and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test .


Families were randomised ( using a random number generator program , with permuted blocks of random size , stratified by location -LSB- Edinburgh or Glasgow -RSB- , ethnic group -LSB- Indian or Pakistani -RSB- , and number of participants in the family -LSB- one vs more than one -RSB- ) to intervention or control .


Participants in the same family were not randomised separately .


The intervention group received @ visits from a dietitian over @ years and the control group received four visits in the same period .


The primary outcome was weight change at @ years .


Analysis was by modified intention to treat , excluding participants who died or were lost to follow-up .


We used linear regression models to provide mean differences in baseline-adjusted weight at @ years .


This trial is registered , number ISRCTN@ .


Of @ people who were screened with an oral glucose tolerance test , @ ( @ % ) had impaired glucose tolerance or impaired fasting glucose and @ entered the trial .


Participants were in @ family clusters that were randomised ( @ families with @ participants were allocated to intervention ; @ families with @ participants were allocated to control ) .


@ ( @ % ) participants in @ families completed the trial .


Mean weight loss in the intervention group was @ kg ( SD @ ) , compared with a mean weight gain of @ kg ( @ ) in the control group , an adjusted mean difference of -@ kg ( @ % CI -@ to -@ ) .


Modest , medium-term changes in weight are achievable as a component of lifestyle-change strategies , which might control or prevent adiposity-related diseases .


Neurobiologically , panic disorder ( PD ) is supposed to be characterised by cerebral hypofrontality .


Via functional near-infrared spectroscopy ( fNIRS ) , we investigated whether prefrontal hypoactivity during cognitive tasks in PD-patients compared to healthy controls ( HC ) could be replicated .


As intermittent theta burst stimulation ( iTBS ) modulates cortical activity , we furthermore investigated its ability to normalise prefrontal activation .


Forty-four PD-patients , randomised to sham or verum group , received @ iTBS-sessions above the left dorsolateral prefrontal cortex ( DLPFC ) in addition to psychoeducation .


Before first and after last iTBS-treatment , cortical activity during a verbal fluency task was assessed via fNIRS and compared to the results of @ HC .


At baseline , PD-patients showed hypofrontality including the DLPFC , which differed significantly from activation patterns of HC .


However , verum iTBS did not augment prefrontal fNIRS activation .


Solely after sham iTBS , a significant increase of measured fNIRS activation in the left inferior frontal gyrus ( IFG ) during the phonological task was found .


Our results support findings that PD is characterised by prefrontal hypoactivation during cognitive performance .


However , verum iTBS as an `` add-on '' to psychoeducation did not augment prefrontal activity .


Instead we only found increased fNIRS activation in the left IFG after sham iTBS application .


Possible reasons including task-related psychophysiological arousal are discussed .


To compare the outcomes of phacoemulsification with either a @-mm clear corneal incision and a foldable intraocular lens ( IOL ) or a @-mm sclerocorneal tunnel incision and a rigid polymethyl methacrylate ( PMMA ) IOL .


In a prospective , randomised clinical trial of phacoemulsification cataract surgery , @ patients received either a foldable hydrophilic acrylic IOL through a @-mm corneal incision or an inexpensive rigid PMMA IOL via a @-mm sclerocorneal tunnel .


Intra - and post-operative data and visual acuity at discharge , @ weeks , and @ year follow-up were analysed .


At @ year after surgery , @ ( @ % ) patients were followed up with an uncorrected visual acuity of @/@ or better in @ % of the foldable and @ % in the rigid IOL group ( risk ratio ( RR ) @ , @ % confidence intervals ( CI ) @-@ @ ) .


Poor outcome ( best-corrected acuity @/@ or worse ) occurred in @ % and @ % , respectively ( RR @ , @ % CI @-@ @ ) .


The surgical cost of consumables and overall surgical time were similar in both groups ; however , the cost of the foldable IOL was eight times higher than the PMMA IOL .


Posterior capsule opacification was more common in the rigid IOL group at @ months ( @ % vs @ % ) ; however , this did not affect post-operative vision .


In the hands of experienced cataract surgeons , phacoemulsification with implantation of a foldable or a rigid IOL gives excellent results .


Using an inexpensive rigid PMMA IOL will make phacoemulsification more affordable for poor patients in low - and middle-income countries .


Calcium folinate ( leucovorin ) , which is converted in vivo into biologically active folate , enhances the potency of @-fluorouracil ( @-FU ) - based chemotherapy in colorectal cancer .


A common dosage of leucovorin in adjuvant and palliative settings is @mg/m ( @ ) .


The aim was to determine the levels of tetrahydrofolate ( THF ) , @,@-methylenetetrahydrofolate ( methyleneTHF ) , and @-methyltetrahydrofolate ( methylTHF ) in tumour and mucosa of colorectal cancer patients who received different dosages of leucovorin intravenously at time of surgery .


Eighty patients scheduled for colorectal resection with indication of colorectal cancer were randomised into four groups to receive leucovorin at @ , @ , @ , or @mg/m ( @ ) , respectively .


Blood samples were taken @ and @min after leucovorin administration .


Biopsy samples from tumour and mucosa were collected and snap-frozen at surgery .


The levels of THF , methyleneTHF , and methylTHF in tumour and mucosa were assessed by liquid chromatography electrospray ionisation tandem mass spectrometry ( LC-MS/MS ) and the results were related to clinical diagnosis and therapeutic regimens .


The folate levels in tissue revealed extensive inter-individual variability .


The mean methyleneTHF value for the four treatment groups were @ , @,@ , @,@ and @,@ pmol/gww .


Only half of the patients who received @mg/m ( @ ) leucovorin had higher levels of methyleneTHF in tumour than patients who received @mg/m ( @ ) leucovorin .


Rectal cancer patients had significantly lower levels of methyleneTHF compared with colon cancer patients .


There was a large inter-patient variability of tissue folate levels in colorectal cancer patients after supplementation with leucovorin at standardised dosage .


High leucovorin doses were needed to exceed baseline methyleneTHF values , especially in rectal cancer patients .


The results indicate that the standardised leucovorin dose may be insufficient to attain the full antitumour effect of @-FU .


Further studies are needed to establish whether higher dosage yields a better treatment response .


Evaluate baseline factors that may explain the influence of study site on decisional conflict ( DC ) in men from the Personal Patient Profile : Prostate ( P@P ) randomized trial .


@ cases from @ P@P sites were included .


Participants completed baseline demographic assessments , @ subscales of the DC scale at baseline ( uncertainty , informed , values clarity , and support ) , the Expanded Prostate Cancer Index Composite ( short form ) and the State-Trait Anxiety Inventory .


Site data regarding typical practices were collected .


Linear regressions were used to model the relation between baseline DC scores and study site adjusting for the list of variables .


Baseline decisional uncertainly ( p = @ ) and informed ( p = @ ) subscales were significantly different across sites .


Participant demographic and baseline measures were significantly different ( p < @ ) between sites except for trait anxiety .


We identified participant level factors that explained study site differences at baseline for the decisional uncertainty and values clarity subscales : a preferred treatment choice at study entry , whether the study program was accessed at home vs. in clinic , number of doctors consulted pre-study , working status , state anxiety , information from the media or a health care provider , and perceived knowledge level .


State anxiety was associated with higher DC across all subscales .


Individual characteristics of men seeking consultation for LPC were associated with DC at baseline , not the site alone ; anxiety contributed to higher conflict .


These findings will inform future development and implementation of the P@P and other decision support interventions .


An immune function assay shows promise for identifying solid organ recipients at risk for infection or rejection .


The following randomized prospective study was designed to assess the clinical benefits of adjusting immunosuppressive therapy in liver recipients based on immune function assay results .


Adult liver recipients were randomized to standard practice ( control group ; n = @ ) or serial immune function testing ( interventional group ; n = @ ) performed with a commercially available in vitro diagnostic assay ( ImmuKnow ; Viracor-IBT Laboratories , Lee 's Summit , MO ) before transplantation , immediately after surgery and at day @ , weeks @ to @ , @ , and @ , and months @ to @ , @ , and @ .


The assay was repeated within @ days of suspected/confirmed rejection/infection and within @ week after event resolution .


Based on immune function values , tacrolimus doses were reduced @ % when values were less than @ ng/mL adenosine triphosphate ( low immune cell response ) and increased @ % when values were greater than @ ng/mL adenosine triphosphate ( strong immune cell response ) .


The @-year patient survival was significantly higher in the interventional arm ( @ % vs @ % ; P < @ ) and the incidence of infections longer than @ days after transplantation was significantly lower among patients in the interventional arm ( @ % vs. @ % , P < @ ) .


The difference in infection rates was because of lower bacterial ( @ % vs @ % ; P < @ ) and fungal infection ( @ % vs @ % ; P < @ ) .


Among recipients without adverse events , the study group had lower tacrolimus dosages and blood levels .


Immune function testing provided additional data which helped optimize immunosuppression and improve patient outcomes .


There are scarce reports regarding the prognosis of a second course of antithyroid drug ( ATD ) therapy on recurrent Graves ' disease ( GD ) .


The aim of this study was to assess the long-term remission rate after a second ATD therapy and verify significant clinical predictors of a remission .


A prospective randomized clinical trial with long-term follow-up was conducted to evaluate the effects of a second course of ATD therapy .


A total of @ recurrent GD patients who had finished a first regular ATD therapy were enrolled in this study , and prescribed methimazole ( MMI ) treatment with titration regimen .


The patients were randomly assigned to two groups when the drug doses were reduced to @ mg daily ( qd ) .


Group @ was discontinued with @ mg qd after about @ months .


Group @ was continuously reduced to @ mg every other day ( qod ) after @ months and then discontinued with @ mg qod after about a further @ months .


The patients were followed for @ months after drug withdrawal .


Of the total number of patients , @ cases ( @ % ) achieved permanent remission at the end of follow-up , with the recurrence of @ cases ( @ % ) .


The remission rate of group @ ( @ % ) was significantly higher than that of group @ ( @ % ) ( P = @ ) .


Cox regression showed that the hazard ratio for recurrence decreased under a high or high normal TSH level at drug withdrawal .


A second course of ATD therapy can bring about a satisfying long-term remission on recurrent GD .


The drug dose of @ mg qod and a high or high normal TSH level at drug withdrawal may increase the likelihood of permanent remission .


Kidney stones are one of the most common disorders of the urinary tract and cause a great deal of morbidity and economic loss .


Because of the side effects and costs of current interventional procedures , researchers are interested in finding medicinal therapies .


In this regard , some reports have focused on traditional medicines as a drug discovery resource .


Iranian scholars in the medieval era recommended Lapis judaicus for the prevention and treatment of kidney stones .


The present study assessed the efficacy and safety of Lapis judaicus on the size of calcium kidney stones and some related biochemical factors in blood and urine .


Sixty patients with kidney stone disease were included in this double-blind randomized clinical study .


Thirty patients received @g of Lapis judaicus powder in hard capsules per day for @ weeks , and another @ patients received a placebo for the same period .


Ultrasonography was performed on patients , and blood and urine samples were collected before and after the study to evaluate the efficacy and safety of Lapis judaicus in calcium kidney stone patients .


The size of the kidney stones was reduced significantly ( p < @ ) in the drug group .


In @ patients from the drug group , the stone was completely dissolved .


Moreover , urine calcium concentration and specific gravity were reduced and urine magnesium was increased ( p < @ ) .


Lapis judaicus did not affect BUN , creatinine , ALT , or AST .


Contrary to the placebo group , the size of kidney stones was reduced significantly in the treatment group after oral administration of Lapis judaicus .


This preliminary study confirms traditional knowledge of the efficacy and safety of Lapis judaicus in kidney stone diseases and suggests a new method to treat calcium kidney stones .


Further detailed in vitro and in vivo studies aimed at discovering the mechanism of action of Lapis judaicus and clinical studies involving a larger population of patients will be necessary to fully explain and confirm the results obtained in the present study .


Hydration with topical emollients forms the backbone of treatment for mild atopic dermatitis ( AD ) , but few randomized controlled trials have assessed their efficacy in young children .


Assess the efficacy and tolerability of long-term emollient therapy in the treatment of moderate to severe xerosis in young children with AD .


This was a phase III , multicentre , double-blind , randomized , vehicle-controlled trial .


Children ( n = @ ) aged @-@years with AD-associated xerosis were randomized @:@ to a @-day treatment with an emollient combining glycerol and paraffin or its vehicle .


Non-responders at the end of the double-blind period were treated open label with emollient until day @ .


Responders stopped treatment until reassessment on day @ .


Those who relapsed after stopping treatment were treated open label with emollient until day @ .


During the double-blind period , xerosis score ( XS ) of the scoring atopic dermatitis ( SCORAD ) index , objective SCORAD and visual analogue score decreased and skin hydration increased more in the emollient group than in the vehicle group ( P < @ for all measures ) .


More patients were responders with emollient than with vehicle ( @ % vs. @ % , P < @ ) .


During the open-label period , stopping emollient treatment led to relapse but improvement returned if treatment was restarted with emollient .


Regular use of the emollient also yielded improvement in children who did not initially respond .


Adverse events were similar in the two groups , and no treatment-related severe adverse events were reported .


Long-term therapy with emollient is effective and well tolerated for the treatment of xerosis in children with atopic dermatitis .


Adequate calcium intakes may enhance bone mineral accumulation during childhood .


Little is known about the optimal calcium intake in Chinese adolescents .


We examined the effects of three levels of calcium intake on bone mineral accretion in adolescents .


This was a @-year randomized , double-blind , controlled trial .


The subjects were randomly assigned to receive @ g of milk powder containing @ mg of calcium and @ IU of vitamin D ( Low-Ca group ) , or same milk powder additionally fortified with @ mg of calcium ( Mid-Ca group ) or @ mg of calcium ( High-Ca group ) for @ years .


The subjects ' bone mineral density ( BMD ) and bone mineral content ( BMC ) at the total body , lumbar spine and left hip were determined by dual-energy X-ray absorptiometry at baseline and after the second year of treatment .


Of the @ girls and @ boys ( aged @-@ years ) enrolled , @ girls and @ boys completed the trial .


The girls in the High-Ca group ( @,@ mg/d ) had @ % , @ % and @ % greater BMD accretion at the total hip , femoral neck and shaft ( P < @ ) but not at total body less head and spine than those in the Low-Ca group ( @ mg/d ) .


A significant effect of higher calcium intake was also observed for percentage change of size-adjusted BMC at femur neck ( P = @ ) .


Bonferroni tests indicated no significant differences in the percentage changes in BMD , BMC or size-adjusted BMC between the Mid - and Low-Ca groups and between the High - and Mid-Ca groups .


Extra calcium had no observable additional effect in the boys ( P > @ ) .


An intake of @ mg/d or more might be helpful in maximizing bone mineral accretion in the hip for girls .


But further large studies are required to identify its long-term effects and the optimal calcium intake for boys .


Acute musculoskeletal trauma , including strains , sprains or contusions , occur frequently .


Pain management is a crucial component of treatment .


However , there is no convincing evidence which drug is superior in managing pain in these patients .


The aim of the PanAM Study is to compare analgesic efficacy of three strategies of pain management : paracetamol , diclofenac , or a combination of both in patients with acute musculoskeletal trauma .


The PanAM Study is a multi-center , double blind randomized controlled trial with non-inferiority design .


Included are adult patients presenting to an academic , urban Emergency Department or to a General Practice with acute , blunt , traumatic limb injury .


In total , @ patients will be included using a predefined list of exclusion criteria , to be allocated by randomization to treatment with paracetamol + placebo diclofenac , diclofenac + placebo paracetamol or paracetamol + diclofenac .


The hypothesis is that paracetamol will not be inferior to treatment with diclofenac , or the combination of both .


Primary outcome will be between-group differences in decrease in pain , measured with Numerical Rating Scales at baseline and at @minutes after study drug administration .


Secondary outcomes are Numerical Rating Scales at @ and @minutes and measured frequently during three consecutive days after discharge ; occurrence of adverse effects ; patient satisfaction and an analysis of quality of life and cost-effectiveness .


Recruitment started July @ and is expected to last a year .


With this multi-center randomized clinical trial we will investigate whether treatment with paracetamol alone is not inferior to diclofenac alone or a combination of both drugs in adult patients with acute musculoskeletal trauma .


The main relevance of the trial is to demonstrate the benefits and risks of three commonly used treatment regimens for musculoskeletal trauma .


Data that lead to the prevention of severe Non-Steroidal Anti-Inflammatory Drugs-related adverse effects might be gathered .


Nilotinib inhibits the tyrosine kinase activity of ABL@/BCR-ABL @ and KIT , platelet-derived growth factor receptors ( PDGFRs ) , and the discoidin domain receptor .


Gain-of-function mutations in KIT or PDGFR are key drivers in most gastrointestinal stromal tumours ( GISTs ) .


This trial was designed to test the efficacy and safety of nilotinib versus imatinib as first-line therapy for patients with advanced GISTs .


In this randomised , open-label , multicentre , phase @ trial ( ENESTg@ ) , participants from academic centres were aged @ years or older and had previously untreated , histologically confirmed , metastatic or unresectable GISTs .


Patients were stratified by previous adjuvant therapy and randomly assigned ( @:@ ) via a randomisation list to receive oral imatinib @ mg once daily or oral nilotinib @ mg twice daily .


The primary endpoint was centrally reviewed progression-free survival .


Efficacy endpoints were assessed by intention-to-treat .


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


Because the futility boundary was crossed at a preplanned interim analysis , trial accrual terminated in April , @ .


Between March @ , @ , and April @ , @ , @ patients were enrolled ; of whom @ were allocated nilotinib and @ were allocated imatinib .


At final analysis of the core study ( data cutoff , October , @ ) , @-year progression-free survival was higher in the imatinib group ( @ % -LSB- @ % CI @-@ -RSB- ) than in the nilotinib group ( @ % -LSB- @-@ -RSB- ; hazard ratio @ -LSB- @ % CI @-@ -RSB- ) .


In the imatinib group , the most common grade @-@ adverse events were hypophosphataemia ( @ -LSB- @ % -RSB- ) , anaemia ( @ -LSB- @ % -RSB- ) , abdominal pain ( @ ; @ % ) , and elevated lipase level ( @ ; @ % ) , and in the nilotinib group were anaemia ( @ ; @ % ) , elevated lipase level ( @ ; @ % ) , elevated alanine aminotransferase concentration ( @ ; @ % ) , and abdominal pain ( @ ; @ % ) .


The most common serious adverse event in both groups was abdominal pain ( @ -LSB- @ % -RSB- in the imatinib group , @ -LSB- @ % -RSB- in the nilotinib group ) .


Nilotinib can not be recommended for broad use to treat first-line GIST .


However , future studies might identify patient subsets for whom first-line nilotinib could be of clinical benefit .


To examine the health-related quality of life ( HRQOL ) in patients with transient ischemic attack ( TIA ) or minor stroke and assess the impact of recurrent stroke on HRQOL .


Health-related quality of life data on patients participated in the Clopidogrel in High-risk patients with Acute Nondisabling Cerebrovascular Events ( CHANCE ) trial were analyzed .


The available @-day EuroQoL data ( EQ-@D ) were used to calculate EQ-@D index score .


Poor HRQOL was defined as an EQ-@D index score @ .


The characteristics of HRQOL and factors predicting poor HRQOL in these patients were then explored .


Among the total @ patients enrolled , @-day HRQOL data were obtained from @ patients for analysis .


The mean EQ-@D index score at day @ was @ @ for all patients , but only @ @ for those with recurrent strokes .


Poor @-day HRQOL was found in @ ( @ % ) patients .


Patients with poor HRQOL had more strokes during follow-up than patients with good HRQOL ( @ vs. @ % , P < @ ) .


Age , history of hypertension and diabetes , and NIHSS at baseline were independent risk factors for predicting poor HRQOL .


Stroke recurrence , NIHSS at baseline , age , and minor stroke on admission became independent risk factors once stroke recurrence was added into the model .


Stroke recurrence was associated with poor HRQOL in patients with TIA or minor strokes .


Interventions focusing on controlling risk factors and prevention of worsening of neurological function may prevent poor HRQOL in these patients .


Comparing the effectivity of prilocaine and prilocaine alkalinized with @ % NaHCO@ in terms of sensory and motor block onset and termination durations in RIVA technique considering patients ' satisfaction and tolerance with application of tourniquet undergoing hand-wrist surgery .


@ patients were randomised into two groups .


First group ( Group P ) was administered prilocaine and second group ( Group PN ) was administered prilocaine + % @ NaHCO@ .


Sensory and motor block onset and termination times and onset of tourniquet pain were recorded .


No significant difference was found between the two groups in terms of onset and termination of sensory block and the onset of motor block .


The duration of the motor block was longer in Group PN than in Group P ( P < @ ) .


Tourniquet pain was more intense in Group P ( P = @ ) .


In Group PN , the use of additional drugs was recorded at a lower rate and patients ' satisfaction was higher than Group P.