Change in HSDS per GH mg/kg/day dose ( HSDS/GH dose ratio ) and proportion of IGF-I levels above +@ SDS at the end of @ years .


GH dosing titrated to an IGF-I target of @ SDS was the most dose-sparing treatment regimen for GHD or ISS children ( meanSE HSDS/GH dose ratios @ @ and @ @ , respectively ) compared with conventional dosing ( @ @ and @ @ , respectively ; P = @ , P = @ ) and IGF@T ( @ @ and @ @ , respectively ; P = @ , P < @ ) .


IGF@T also resulted in the fewest IGF-I excursions above +@ SDS ( @ % vs @ % for conventional dosing ; P < @ ) .


IGF-I-based GH dosing , targeted to age - and gender-adjusted means , may offer a more dose-sparing and potentially safer mode of therapy than traditional weight-based dosing .


To compare the clinical benefit of a periodontal dressing applied after a one-stage full-mouth disinfection ( OSFMD ) in patients with chronic periodontitis up to @months after therapy .


This randomized , controlled split-mouth study included @ patients .


After OSFMD , a test and a control side were selected by means of a computer-generated randomization list .


Test sides received a periodontal dressing ( Coepak ( ) ) for @days and the control sides received no periodontal dressing .


After @days the periodontal dressing was removed and the pain experience was recorded .


After @months , the clinical periodontal parameters were recorded .


The periodontal dressing group showed a significant ( p < @ ) additional pocket depth reduction and additional clinical attachment gain for the moderate pockets of single - and multi-rooted teeth compared with the control group .


A significant ( p < @ ) lower percentage of sites with probing pocket depth @mm were shown for the periodontal dressing group compared with the control group ( @ % versus @ % ) .


The pain intensity was significantly reduced when using a periodontal dressing ( @ versus @ ) .


The use of a periodontal dressing for @days after a OSFMD offers an additional short-term clinical improvement and lowers the pain intensity .


It was hypothesized that a mobile health ( mHealth ) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at @weeks , which would be better maintained over @weeks , compared to the active control intervention .


Eligible participants ( @ metabolic syndrome risk factors ) were randomized to the mHealth intervention ( n = @ ) or the active control group ( n = @ ) .


Blood pressure and other cardiometabolic risk factors were measured at baseline and at @ , @ and @weeks .


Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity .


Analyses were conducted on @ participants in the intervention group ( aged @ years ; @ % female ) and @ participants in the active control group ( aged @ years ; @ % female ) .


At @weeks , baseline adjusted mean change in systolic blood pressure ( primary outcome ) was greater in the active control group compared to the intervention group ( -@ mmHg ; @ % CI -@ to -@ mmHg ; p = @ ) , but there were no differences between groups in mean change for secondary outcomes .


Over @-weeks , the difference in mean change for systolic blood pressure was no longer apparent between groups , but remained significant across the entire population ( time : p < @ ) .


In participants with increased cardiometabolic risk , exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention , though over @weeks , improvements were equal between interventions .


Physicians play a critical role in addressing tobacco dependence , yet report limited training .


Tobacco dependence treatment curricula for medical students could improve performance in this area .


This study identified student and medical school tobacco treatment curricula characteristics associated with intentions and use of the @As for tobacco treatment among @rd year U.S. medical students .


Third year medical students ( N = @ , @ % male ) from @ U.S. medical schools completed a survey in @-@ assessing student characteristics , including demographics , tobacco treatment knowledge , and self-efficacy .


Tobacco curricula characteristics assessed included amount and type of classroom instruction , frequency of tobacco treatment observation , instruction , and perception of preceptors as role models .


Greater tobacco treatment knowledge , self-efficacy , and curriculum-specific variables were associated with @A intentions , while younger age , tobacco treatment self-efficacy , intentions , and each curriculum-specific variable were associated with greater @A behaviors .


When controlling for important student variables , greater frequency of receiving @A instruction ( OR = @ ; @ % CI @-@ @ ) and perception of preceptors as excellent role models in tobacco treatment ( OR = @ ; @ % CI @-@ @ ) were significant curriculum predictors of @A intentions .


Greater @A instruction ( B = @ ( @ ) ; p < @ ) and observation of tobacco treatment ( B = @ ( @ ) ; p < @ ) were significant curriculum predictors of greater @A behaviors .


Greater exposure to tobacco treatment teaching during medical school is associated with both greater intentions to use and practice tobacco @As .


Clerkship preceptors , or those physicians who provide training to medical students , may be particularly influential when they personally model and instruct students in tobacco dependence treatment .


The aim of the study was to compare the effects of aerobic exercise training and yoga on the functional capacity , peripheral muscle strength , quality of life ( QOL ) , and fatigue in breast cancer survivors .


A total of @ patients with a diagnosis of breast cancer were included in the study .


The patients were randomly assigned to @ groups : aerobic exercise ( n = @ ) and yoga added to aerobic exercise ( n = @ ) .


Both groups participated in submaximal exercise @ minutes/d , @ d/wk for @ weeks .


The second group participated in a @-hour yoga program in addition to aerobic exercise training .


Functional capacity was assessed by the @-Minute Walk Test ( @MWT ) .


Peripheral muscle strength was evaluated with a hand-held dynamometer .


The fatigue severity level was assessed with the Fatigue Severity Scale ( FSS ) .


The QOL was determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire .


There were statistically significant increases in peripheral muscle strength , the @MWT distance , and the perception of QOL in both groups ( P < @ ) .


Additionally , the group with aerobic exercise and yoga showed marked improvement compared with the aerobic exercise group in fatigue perception ( P < @ ) .


According to the data from this study , aerobic exercise training and yoga improved the functional capacity and QOL of breast cancer patients .


Aerobic exercise programs can be supported by body mind techniques , such as yoga , in the rehabilitation of cancer patients for improving functional recovery and psychosocial wellness .


A very high percentage of patients with severe pelvic endometriosis develop adhesions after laparoscopic surgery .


The objective of this trial was to evaluate the role of ovarian suspension performed during surgery for severe endometriosis on ovarian adhesions and postoperative pelvic pain .


A randomized controlled trial ( Canadian Task Force classification I ) .


The tertiary care University Hospital of Bologna , Bologna , Italy .


Eighty patients with ovarian and posterior deep infiltrating endometriosis were included in the study .


Patients underwent laparoscopic surgery for endometriosis and were randomized sequentially into @ groups : transient ovarian suspension was performed in the treatment group ( n = @ ) , whereas in the control group ( n = @ ) ovaries were left free in the pelvis .


Symptom intensity ( dysmenorrhea , chronic pelvic pain , dyspareunia , dyschezia , and dysuria ) were ranked using a visual analog scale .


Postsurgical ovarian adhesions were evaluated using transvaginal ultrasonographic scans performed by an ultrasound operator who was blinded to the details of the operative procedure and women 's randomization allocation .


Complications , lesion localization , endometrioma diameter , and surgery time were recorded .


At follow-up , a significantly lower rate of ultrasound-detectable ovarian adhesions with the uterus and the bowel was observed in the treatment group , respectively ( @ % vs @ % , p = @ and @ % vs @ % , p < @ ) .


Patients in the control group showed a higher percentage of fixed ovaries with moderate and severe adhesions than the treatment group , respectively ( @ % vs @ % , p = @ and @ % vs @ % , p = @ ) .


No differences between the @ groups were found regarding complications and pelvic pain .


Ovarian suspension seems to be an additional effective surgical procedure associated with an increased ovarian mobility in women treated for severe endometriosis .


Moreover , it is feasible , safe , simple , and fast .


Hence , it should be routinely used during laparoscopic surgery for endometriosis .


Insulin therapy should be strongly considered in newly diagnosed type @ diabetic ( T@D ) patients with severe hyperglycemia .


However , whether insulin be continued or patients switched to an oral antidiabetic drug ( OAD ) after short-term intensive insulin therapy ( ITT ) is not clear .


After ITT for @-@ days , @ patients were randomized into either a glargine ( n = @ ) or metformin-based OAD ( n = @ ) group for a @-month intervention .


After these @ months , patients in the glargine group were switched to metformin-based OAD therapy , whereas treatment in the OAD group was unchanged .


Patients were followed-up for another @ months .


At the end of the @-month intervention , HbA@c was similarly reduced in both the glargine ( from @ % to @ % ; P < @ ) and OAD ( from @ % to @ % ; P < @ ) groups .


At the end of @ months , HbA@c was at comparable and near optimal levels in both groups .


Similar increases were seen in homeostatic model assessment of - cell function in the two groups after @ months .


There were no significant differences between the two groups in insulin sensitivity improvement , hypoglycemic episodes , weight change , treatment satisfaction and quality of life after the @-month intervention .


The effects of metformin-based OAD therapy on glycemic control and improvements in - cell function are not inferior to glargine in newly diagnosed T@D patients with severe hyperglycemia after short-term ITT .


Considering the superiority of metformin in terms of safety , cost , and convenience , metformin-based OAD therapy is strongly recommended for these patients .


Group psychosocial interventions including mindfulness-based cancer recovery ( MBCR ) and supportive-expressive group therapy ( SET ) can help breast cancer survivors decrease distress and influence cortisol levels .


Although telomere length ( TL ) has been associated with breast cancer prognosis , the impact of these two interventions on TL has not been studied to date .


The objective of the current study was to compare the effects of MBCR and SET with a minimal intervention control condition ( a @-day stress management seminar ) on TL in distressed breast cancer survivors in a randomized controlled trial .


MBCR focused on training in mindfulness meditation and gentle Hatha yoga whereas SET focused on emotional expression and group support .


The primary outcome measure was relative TL , the telomere/single-copy gene ratio , assessed before and after each intervention .


Secondary outcomes were self-reported mood and stress symptoms .


Eighty-eight distressed breast cancer survivors with a diagnosis of stage I to III cancer ( using the American Joint Committee on Cancer ( AJCC ) TNM staging system ) who had completed treatment at least @ months prior participated .


Using analyses of covariance on a per-protocol sample , there were no differences noted between the MBCR and SET groups with regard to the telomere/single-copy gene ratio , but a trend effect was observed between the combined intervention group and controls ( F -LSB- @,@ -RSB- , @ ; P = @ ; ( @ ) = @ ) ; TL in the intervention group was maintained whereas it was found to decrease for control participants .


There were no associations noted between changes in TL and changes in mood or stress scores over time .


Psychosocial interventions providing stress reduction and emotional support resulted in trends toward TL maintenance in distressed breast cancer survivors , compared with decreases in usual care .


To evaluate the influence of perioperative intravenous administration of ambroxol on pulmonary function , postoperative complications , postoperative hospital stay , and cost after video-assisted thoracic surgery lobectomy for lung cancer .


Sixty patients who underwent video-assisted thoracic surgery lobectomy for lung cancer in Xiangya Hospital , Central South University between May @ and May @ were randomly assigned into @ groups : An ambroxol group ( n = @ ) and a control group ( n = @ ) .


In the ambroxol group , patients were given ambroxol ( @ @ mg/d ) on the day of operation and on the first @ postoperative days .


In control group , placebo was given .


The pulmonary function tests , arterial blood gases , incidence of perioperative morbidity , postoperative mechanical ventilation time , duration of ICU stay , length and costs of postoperative hospital stay were compared between the @ groups .


The @ groups were well matched for demographics and operative variables .


The ambroxol group showed better the percent predicted forced expiratory volume in @ second ( FEV@ % ) , the ratio of forced expiratory volume in @ second to forced vital capacity ( FEV@/FVC % ) , the percent predicted diffusing capacity of the lung for carbon monoxide ( DLCO % ) and arterial oxygen pressure than the control group .


The postoperative pulmonary complications was significantly reduced , the duration of mechanical ventilation and the length of ICU stay were shortened , and the length and costs of postoperative hospital stay were significantly decreased in the ambroxol group compared with the control group ( all P < @ ) .


Perioperative intravenous administration of ambroxol can improve the postoperative lung function , reduce the incidence of pulmonary complications , shorten the length of postoperative hospital stay , and lower the total cost of hospitalization after video-assisted thoracic surgery lobectomy for lung cancer .


Several agents have been tried in the management of mastalgia .


Centchroman ( Ormeloxifene ) , a novel non-steroidal selective estrogen receptor modulator ( SERM ) , has also been recently used in the management of mastalgia .


Eligible patients , who had mastalgia for more than @ months , were randomized into two groups - Group A received centchroman @ mg daily and Group B received tamoxifen @ mg daily .


Treatment was continued for a total of @ weeks ; thereafter , patients were followed for another @ weeks without medication to assess the continuum of relief .


Pain severity was measured with VAS score .


Patients were considered to have complete pain relief if their VAS score decreased to @ or less .


Patients , in both the groups , showed gradual improvement in mastalgia with passage of time up to @ weeks .


Following cessation of treatment at @ weeks , partial relapse of pain was observed at @ weeks .


There was no significant difference between Group A and Group B in terms of mean VAS Score and proportion of women reporting pain relief at @ , @ , @ , and @ weeks .


Fifteen patients in Group A had side effects namely dizziness , menstrual irregularities and development of ovarian cysts .


There was no side effect noted in group B.


Centchroman and tamoxifen were found to be of similar effectiveness in providing pain relief in mastalgia .


High frequency of side effects , particularly development of ovarian cyst , in patients receiving centchroman is a matter of concern .


Nasoalveolar molding became increasingly popular in the @s as a means of easing surgery and improving nasal outcomes for cleft lip repairs .


In the late @s , three orthodontists from our center underwent nasoalveolar molding training : two at the Rush Craniofacial Center , in Chicago ; and one at New York University Craniofacial Center .


They brought two different nasoalveolar molding techniques back to Chang Gung Craniofacial Center : the modified Figueroa and the modified Grayson techniques .


Outcomes following use of these techniques have not previously been compared prospectively .


Between May of @ and March of @ , a randomized , prospective , single-blind trial was conducted to compare the number of clinical visits , total costs , complications , and nasal symmetry between the two nasoalveolar molding techniques in @ patients with unilateral complete cleft lip .


There were no differences between nasoalveolar molding techniques in the number of clinical visits , total costs , nostril height , or nostril area ratio .


Preoperatively but after nasoalveolar molding , the nostril width ratio was wider for the Figueroa group than for the Grayson group .


Six months after surgical correction , there were no differences in nostril height , nostril width , nasal sill height , or nostril area ratio between nasoalveolar molding methods .


Alveolar ulceration occurred more frequently in the Grayson group .


The modified Grayson technique reduced nostril width more efficiently , but alveolar ulceration was more frequent and no differences in nostril width were found following surgery .


Overall , the two nasoalveolar molding techniques produced similar nasal outcomes .


Therapeutic , II .


This analysis compared the quality-adjusted survival and clinical outcomes of albumin-bound paclitaxel + carboplatin ( nab-PC ) vs solvent-based paclitaxel + carboplatin ( sb-PC ) as first-line therapy in advanced non-small-cell lung cancer ( NSCLC ) in older patients .


Using age-based subgroup data from a randomised Phase-@ clinical trial , nab-PC and sb-PC were compared with respect to overall response rate ( ORR ) , overall survival ( OS ) , progression-free survival ( PFS ) , quality of life ( QoL ) , safety/toxicity , and quality-adjusted time without symptoms or toxicity ( Q-TWiST ) with ages @ and @ years as cut points .


Among patients aged @ years ( N = @ ) , nab-PC ( N = @ ) significantly increased ORR and prolonged OS , despite a non-significant improvement in PFS , vs sb-PC ( N = @ ) .


Nab-PC improved QoL and was associated with less neuropathy , arthralgia , and myalgia but resulted in more anaemia and thrombocytopenia .


Nab-PC yielded significant Q-TWiST benefits ( @ vs @ months ; @ % CI of gain : @-@ @ ) , with a relative Q-TWiST gain of @ % ( ranging from @ % to @ % in threshold analysis ) .


In the @ years age group , nab-PC showed similar , but non-significant , ORR , PFS , and Q-TWiST benefits and significantly improved OS and QoL .


Nab-PC as first-line therapy in older patients with advanced NSCLC increased ORR , OS , and QoL and resulted in quality-adjusted survival gains compared with standard sb-PC .


To test the use of three lead monitoring as a screening tool for atrial fibrillation ( AF ) in general practice .


AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs .


@ randomly selected general practices identified @ randomly selected patients aged @ or older from their database and excluded those known to have AF , those with clinical issues or who had not attended for three years .


Up to @ eligible patients/practice were invited to attend for screening .


A @min three-lead ECG was recorded and collected centrally for expert cardiology assessment .


Risk factor data was gathered .


( i ) point prevalence of AF , ( ii ) proportion of ECG tracings which were adequate for interpretation , ( iii ) uptake rate by patients and ( iv ) acceptability of the screening process to patients and staff ( reported separately ) .


Of @ current patients , @ were eligible for inclusion , @ ( @ % ) agreed to take part in screening and @ ( @ % ) completed screening .


The point prevalence rate for AF was @ % -@ % new cases ( @ of @ who were screened ) and @ % existing cases ( @ of @ eligible patients ) .


Only four of @ ( @ % ) screening visits did not record a usable ECG and @ ( @ % ) three lead ECGs required a clarifying @ lead ECG .


Three lead screening for AF is feasible , effective and offers an alternative to pulse taking or @ lead ECGs .


The availability of this technology may facilitate more effective screening , leading to reduced stroke incidence .


Prehospital identification of acute stroke increases the possibility of early treatment and good outcome .


To increase identification of stroke , the Face Arm Speech Time ( FAST ) test was introduced in the Emergency Medical Communication Center ( EMCC ) .


This substudy aims to evaluate the implementation of the FAST test in the EMCC and the ambulance service .


The study was conducted in the region of Stockholm , Sweden during @ months .


The study population consisted of all calls to the EMCC concerning patients presenting at least one FAST symptom or a history/finding making the EMCC or ambulance personnel to suspect stroke within @ h. Positive FAST was compared to diagnosis at discharge .


Positive predictive values ( PPV ) for a stroke diagnosis at discharge were calculated .


In all , @ patients with a median age of @ years were enrolled , @ ( @ % ) by the EMCC and @ ( @ % ) by the ambulances .


At discharge , @ patients ( @ % ) were diagnosed with stroke/transient ischemic attack ( TIA ) , @ identified by the EMCC ( @ % ) and @ ( @ % ) by the ambulances .


The PPV for a discharge diagnosis of stroke/TIA was @ % ( CI @-@ % ) in EMCC-enrolled and @ % ( CI @-@ % ) in ambulance-enrolled patients .


With a positive FAST the PPV of a correct stroke/TIA diagnosis increased to @ % ( CI @-@ % ) and @ % ( CI @-@ % ) in EMCC - and ambulance-enrolled patients , respectively .


Positive FAST from EMCC was also found in @ % of patients with a nonstroke diagnosis at discharge .


A stroke/TIA diagnosis at discharge but negative FAST was found in @ and @ patients enrolled by the EMCC and ambulances , respectively .


The PPV of FAST is higher when used on the scene by ambulance than by EMCC .


FAST may be a useful prehospital tool to identify stroke/TIA but has limitations as the test can be negative in true strokes , can be positive in nonstrokes , and FAST symptoms may be present but not identified in the emergency call .


For the prehospital care situation better identification tools are needed .


Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings .


Women completing @-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a @-year observational cohort .


The primary outcome , treatment success , was defined as no re-treatment or self-reported stress incontinence symptoms .


Secondary outcomes included urinary symptoms and quality of life , satisfaction , sexual function and adverse events .


Of @ women @ ( @ % ) from the original trial enrolled in the study .


Five years after surgical treatment success was @ % greater in women assigned to the retropubic sling compared to the transobturator sling ( @ % vs @ % , @ % CI -@ , @ ) , not meeting prespecified criteria for equivalence .


Satisfaction decreased during @ years but remained high and similar between arms ( retropubic sling @ % vs transobturator sling @ % , p = @ ) .


Urinary symptoms and quality of life worsened with time ( p < @ ) , and women with a retropubic sling reported greater urinary urgency ( p = @ ) , more negative impact on quality of life ( p = @ ) and worse sexual function ( p = @ ) .


There was no difference in the proportion of women experiencing at least @ adverse event ( p = @ ) .


Seven new mesh erosions were noted ( retropubic sling @ , transobturator sling @ ) .


Treatment success decreased during @ years for retropubic and transobturator slings , and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit .


However , satisfaction remained high in both arms .


Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function .


New mesh erosions occurred in both arms over time , although at a similarly low rate .


More than @,@ surgeries are performed annually in the United States for pelvic organ prolapse .


Sacrospinous ligament fixation ( SSLF ) and uterosacral ligament suspension ( ULS ) are commonly performed transvaginal surgeries to correct apical prolapse .


Little is known about their comparative efficacy and safety , and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training ( BPMT ) improves outcomes of prolapse surgery .


To compare outcomes between ( @ ) SSLF and ULS and ( @ ) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence .


Multicenter , @ factorial , randomized trial of @ women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between @ and @ at @ US medical centers .


Two-year follow-up rate was @ % .


The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF ( n = @ ) or ULS ( n = @ ) ; the behavioral intervention was randomization to receive perioperative BPMT ( n = @ ) or usual care ( n = @ ) .


The primary outcome for the surgical intervention ( surgical success ) was defined as ( @ ) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen ( anatomic success ) , ( @ ) no bothersome vaginal bulge symptoms , and ( @ ) no re-treatment for prolapse at @ years .


For the behavioral intervention , primary outcome at @ months was urinary symptom scores ( Urinary Distress Inventory ; range @-@ , higher scores worse ) , and primary outcomes at @ years were prolapse symptom scores ( Pelvic Organ Prolapse Distress Inventory ; range @-@ , higher scores worse ) and anatomic success .


At @ years , surgical group was not significantly associated with surgical success rates ( ULS , @ % -LSB- @/@ -RSB- vs SSLF , @ % -LSB- @/@ -RSB- ; unadjusted difference , -@ % ; @ % CI , -@ % to @ % ; adjusted odds ratio -LSB- OR -RSB- , @ ; @ % CI , @ to @ ) or serious adverse event rates ( ULS , @ % -LSB- @/@ -RSB- vs SSLF , @ % -LSB- @/@ -RSB- ; unadjusted difference , -@ % ; @ % CI , -@ % to @ % ; adjusted OR , @ ; @ % CI , @ to @ ) .


Perioperative BPMT was not associated with greater improvements in urinary scores at @ months ( adjusted treatment difference , -@ ; @ % CI , -@ to @ ) , prolapse scores at @ months ( adjusted treatment difference , -@ ; @ % CI , -@ to @ ) , or anatomic success at @ months .


Two years after vaginal surgery for prolapse and stress urinary incontinence , neither ULS nor SSLF was significantly superior to the other for anatomic , functional , or adverse event outcomes .


Perioperative BPMT did not improve urinary symptoms at @ months or prolapse outcomes at @ years .


Minocycline and lymecycline are used in the treatment of acne , but there is not enough evidence to support superior efficacy of one of them .


@ participants from @ to @ years old with mild to moderate facial acne vulgaris were recruited .


@ had @ mg of minocycline in a single daily dose for @ weeks and @ had @ mg of lymecycline in a single daily dose for @ weeks .


Participants were evaluated at baseline , week @ and week @ .


@ minocycline and @ lymecycline patients were evaluable .


The last observation carried forward for the count of non-inflammatory lesions changed from @ @ to @ @ in the minocycline group and from @ @ to @ @ in the lymecycline group ( no significant changes ) ; corresponding changes in inflammatory lesions were from @ @ to @ @ in the minocycline group and from @ @ to @ @ in lymecycline group ( P < @ comparing baseline vs. final in both groups ) .


Porphyrin counts varied from @ @ to @ @ in the minocycline group and from @ @ to @ @ in the lymecycline group ( P < @ between the groups at study end ) .


@ ( @ % ) patients receiving minocycline suffered @ adverse events ( @ of them gastrointestinal ) , while @ ( @ % ) lymecycline patients had @ adverse events ( @ of them gastrointestinal ) .


One patient in the lymecycline group withdrew the study due to gastritis , and one more patient in the same group experienced eosinophilia .


There were no differences between the groups in non-inflammatory and inflammatory lesion counts , and in the safety profile .


Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline ( ClinicalTrials.gov number , NCT@ ) .


Experimental studies have shown that liposomal curcumin can exert a reduction in tumor growth in pancreatic and colorectal cancer .


In this phase I clinical trial we investigated the pharmacokinetics , safety , and tolerability of intravenously administered liposomal curcumin in healthy subjects .


@ male and female participants were included in this randomized , placebo-controlled double-blind phase I dose escalation study .


Subjects received a single dose of liposomal curcumin ( @ - @ mg/m@ ; n = @ - @ per group ) or placebo over @ hours intravenously .


Dose-dependent increases in the plasma concentrations of curcumin and its metabolite tetrahydrocurcumin ( THC ) were detected .


After the end of drug infusion , curcumin and THC plasma concentrations decreased within @ - @ minutes below the limit of quantification .


Mean urinary excretion was ~ @ % of total systemic clearance .


Liposomal curcumin was tolerated well , but a transient red blood cell echinocyte formation with concomitant increase in mean cellular volume was observed at dosages @ mg/m@ .


Short-term intravenous dosing of liposomal curcumin appears to be safe up to a dose of @ mg/m@ .


Changes in red blood cell morphology may represent a dose limiting sign of toxicity .


The effectiveness and tolerability of tapentadol extended release ( ER ) , a centrally acting analgesic with - opioid receptor agonist and norepinephrine ( noradrenaline ) reuptake inhibitor activities , have been demonstrated in patients with chronic pain , including those switching directly from prior opioid therapy .


The objective of the current study was to evaluate the effectiveness and safety of conversion to oral tapentadol ER ( @-@ mg twice daily ) from previous around-the-clock strong opioid therapy in patients with moderate to severe , chronic malignant tumor-related cancer pain that was well-controlled .


This randomized , open-label , phase III study , which was conducted in Japan , included a @ - to @-week screening period ( on previous opioid ) and an @-week , open-label treatment period .


Eligible patients , who were taking a strong opioid analgesic and had a mean pain intensity score < @ during the @ days prior to randomization ( adequate pain control on previous strong opioid ) , were randomized ( @:@ ) to receive twice-daily treatment with tapentadol ER ( @-@ mg/day ) or morphine sustained release ( SR ; @-@ mg/day ; reference for assay sensitivity ) .


Initial doses were estimated based on the conversion ratio of tapentadol ER : oxycodone : morphine : fentanyl = @:@:@:@ .


The primary effectiveness endpoint was the proportion of patients who maintained pain control -LSB- change from baseline in mean pain intensity ( @-point numerical rating scale ) less than +@ for @ consecutive days and no more than two doses of rescue medication per day for @ consecutive days ) during the first week of open-label treatment .


In the tapentadol ER group ( n = @ ) , @ % of patients ( @/@ ; @ % CI , @-@ @ ) maintained pain control during Week @ .


On the Patient Global Impression of Change , @ % ( @/@ ) , @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) of patients in the tapentadol ER group reported that their overall condition was `` very much improved , '' `` much improved , '' `` minimally improved , '' and `` not changed , '' respectively , at Week @ compared with @ % , @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) reporting these ratings at Week @ .


The sensitivity of effectiveness analyses was validated based on results using morphine SR ; @ % ( @/@ ; @ % CI , @-@ @ ) of patients in the morphine SR group maintained pain control after @ week of treatment .


The overall safety profile was similar to that demonstrated in previous studies ; tapentadol ER was associated with a lower incidence of gastrointestinal treatment-emergent adverse events than morphine SR -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) -RSB- , including constipation -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) -RSB- and vomiting -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) -RSB- .


Overall , results indicate that conversion from previous strong opioids to tapentadol ER ( @-@ mg twice daily ) was successful and resulted in safe and effective pain control with improved gastrointestinal tolerability versus morphine SR in patients with moderate to severe cancer-related pain that was well-controlled on their previous opioid .


Antipsychotic drugs frequently cause amenorrhoea and galactorrhoea .


Jasmine flowers used topically were as effective as oral Bromocriptine in suppressing puerperal lactation .


This study aims to evaluate the efficacy and safety of intranasal jasmine flower extract ( JFE ) to reduce prolactin levels of patients on stable doses of antipsychotic drugs .


This is a randomized , double blind , crossover clinical trial .


An aqueous-ethanol extract of jasmine flowers was prepared and used as nasal drops .


A decrease in serum prolactin of @ng/mL was considered a significant response .


Ten out of @ women had a significant drop in the serum prolactin while on the JFE .


The non-responders to JFE were on higher doses of antipsychotic drugs .


The main side effect was a transient and mild burning sensation in the nose .


A cost analysis favoured JFE over dopamine agonists .


JFE contains a prolactin-lowering substance which needs further characterisation .


To evaluate the recurrence of common bile duct stones and risk factors for recurrence following routine endoscopic sphincterotomy ( EST ) versus small-incision endoscopic sphincterotomy plus endoscopic papillary balloon dilation ( EST-EPBD ) .


Three hundred patients who were hospitalized between June @ and June @ with common bile duct stones > @ mm in diameter were randomly assigned to the EST or EST-EPBD group .


We compared the short-term ( @ years ) and long-term ( > @ years ) recurrence of ductal stones in the two groups over a @-month follow-up period .


Potential risk factors were evaluated using a logistic regression analysis .


A total of @ patients completed the study .


The short-term recurrence rate in the EST group was not significantly higher than that in the EST-EPBD group ( P > @ ) .


The long-term recurrence rate for the EST group was significantly higher than that for the EST-EPBD group ( P < @ ) .


The serum level of cholesterol , body mass index , gallstones , maximum stone diameter , number of stones , and mechanical lithotripsy were risk factors for the recurrence of ductal stones .


Minimal size of the duodenal papilla incision was a protective factor with regard to the recurrence of ductal stones .


Cholecystectomy , sex , and age were not associated with the recurrence of ductal stones .


Small-incision EST-EPBD has a similar overall success rate and a significantly lower rate of the recurrence of ductal stones , compared with those of EST alone .


Thus , the curative effect of EST-EPBD is better than that of EST alone .


Minimal size of the duodenal papilla incision protects against the recurrence of ductal stones .


To find out whether in varicocele embolization the copolymer cyanoacrylate glue ( NBCA-MS ) has a better patient tolerance compared to the monomer n-butyl-@-cyanoacrylate ( NBCA ) .


N = @ insufficient spermatic veins ( left sided N = @ , right sided N = @ ) diagnosed in N = @ adult males were prospectively randomized for blinded embolization with either NBCA N = @ ( Histoacryl ) or with NBCA-MS N = @ ( Glubran@ ) .


Before , during and up to one week after embolization , patient discomfort was assessed by a standardized pain scale .


Type , location and side of discomfort were noted .


Statistical analysis was performed with the Mann-Whitney U-test , the McNemar test and the Fisher 's exact test .


Embolization caused discomfort in N = @/@ ( @ % ) spermatic veins , comprising N = @/@ ( @ % ) in the NBCA group and N = @/@ ( @ % ) in the NBCA-MS group .


During the week after embolization , the overall number of discomfort reports rose to N = @/@ ( @ % ) , with an increase to N = @/@ ( @ % ) in the NBCA group and to N = @/@ ( @ % ) in the NBCA-MS group .


The number of immediate grade @ to @ pain reactions was N = @/@ ( @ % ) , and rose to N = @/@ ( @ % ) after one week .


No difference in discomfort during embolization and at @ week after treatment was noted .


Characteristics , severity grading , and location of discomfort were similar in both NBCA groups , regardless the time point of observation .


Discomfort after glue embolization of varicocele is a common side effect , which might evolve to pain .


The assumed lower inflammatory reaction on NBCA-MS was not translated in an improved tolerance .


The aim of this prospective clinical study was to compare the mean durability and the failure rates of two types of orthodontic retainers .


Orthodontic patients ( @ ) aged between @ and @ years were recruited in this study .


The polyethylene woven ribbon ( Ribbond , Seattle , WA , USA ) retainer was compared with a @-in flexible spiral wire ( Respond , Ormco , Glendora , CA , USA ) retainer .


When treatment was completed , the retainers were bonded from canine to canine in the maxillary and the mandibular arches of the participants .


In the follow-up visits , the patients were re-evaluated every @ months over a period of @ months .


The time taken for the retainers to remain without any fracture was appraised .


Kaplan-Meier analysis and the logrank test were employed to identify significant differences in the survival functions between the groups .


The rates of the retainers ' failure between the groups were analyzed using Chi-square test .


It was revealed that the mean survival of the flexible spiral wire retainer was @ and @ months in the maxillary and mandibular arches , respectively .


The mean survival of the ribbon retainer was @ and @ months in the maxillary and mandibular arches , respectively .


Ribbon retainers showed a failure rate of @ % in the maxillary and @ % in the mandibular arches .


Flexible spiral retainers showed a failure rate of @ % in the maxillary and @ % in the mandibular arches .


The differences were not statistically significant .


Regarding the evaluation period , the differences had limited clinical significance .


The mean survival time and the failure rates of the polyethylene woven ribbon retainer were comparable to the flexible spiral wire retainer during the @ months after orthodontic treatment .


Low-glycemic index ( GI ) diets have been proven to have beneficial effects in such chronic conditions as type @ diabetes , ischemic heart disease , and some types of cancer , but the effect of low-GI diets on weight loss , satiety , and inflammation is still controversial .


We assessed the efficacy of @ moderate-carbohydrate diets and a low-fat diet with different GIs on weight loss and the modulation of satiety , inflammation , and other metabolic risk markers .


The GLYNDIET study is a @-mo randomized , parallel , controlled clinical trial conducted in @ overweight and obese adults .


Participants were randomly assigned to one of the following @ isocaloric energy-restricted diets for @ mo : @ ) a moderate-carbohydrate and high-GI diet ( HGI ) , @ ) a moderate-carbohydrate and low-GI diet ( LGI ) , and @ ) a low-fat and high-GI diet ( LF ) .


At weeks @ and @ and the end of the intervention , changes in body mass index ( BMI ; in kg/m ( @ ) ) differed significantly between intervention groups .


Reductions in BMI were greater in the LGI group than in the LF group , whereas in the HGI group , reductions in BMI did not differ significantly from those in the other @ groups ( LGI : -@ @ ; HGI : -@ @ ; LF : -@ @ ; F = @ , P = @ ; pairwise comparisons : LGI compared with HGI , P = @ ; LGI compared with LF , P = @ ; HGI compared with LF , P = @ ) .


The decrease in fasting insulin , homeostatic model assessment of insulin resistance , and homeostatic model assessment of cell function was also significantly greater in the LGI group than in the LF group ( P < @ ) .


Despite this tendency for a greater improvement with a low-GI diet , the @ intervention groups were not observed to have different effects on hunger , satiety , lipid profiles , or other inflammatory and metabolic risk markers .


A low-GI and energy-restricted diet containing moderate amounts of carbohydrates may be more effective than a high-GI and low-fat diet at reducing body weight and controlling glucose and insulin metabolism .


This trial was registered at Current Controlled Trials ( www.controlled-trials.com ) as ISRCTN@ .


Although repair augmented with mesh has been proved its priority in anatomical and functional recovery after anterior compartment reconstruction , the data about posterior compartment are scarce .


The aim of this study was to compare bowel functional outcome of posterior vaginal compartment repair with and without mesh in patients with pelvic organ prolapse ( POP ) .


This was a prospective , double-blind , clinical pilot study of @ postmenopausal women with symptomatic POP ( overall POP-quantification -LSB- POP-Q -RSB- Stage III-IV ) who underwent total pelvic floor reconstruction .


Patients were grouped according to the use of mesh for posterior vaginal compartment repair : A mesh group and a nonmesh group .


POP-Q stage , the pelvic floor impact questionnaire short form-@ ( PFIQ-@ ) and anorectal manometry were evaluated before and @ months after surgery .


Anatomical success was defined as POP-Q Stage II or less .


A t-test was used to compare preoperative with postoperative data in the two groups .


Totally , @ ( @ % ) were available for the follow-up .


POP-Q measurements improved significantly compared to baseline ( P < @ ) in both groups .


No recurrence was observed .


Subjects in both groups reported improvement in pelvic floor symptoms , and there was no significant difference in the PFIQ-@ score between groups at follow-up ( P > @ ) .


Compared with baseline , the nonmesh group exhibited a statistically significant decrease in anal residual pressure , a significant increase in the anorectal pressure difference during bowel movement , and a reduced rate of dyssynergia defecation pattern ( P < @ ) .


Provided there is sufficient support for the anterior wall and apex of vagina with mesh , posterior compartment repair without mesh may be as effective as repair with mesh for anatomical recovery while providing better anorectal motor function .


Long-lasting insecticide-treated net ( LLIN ) window and door curtains alone or in combination with LLIN water container covers were analysed regarding effectiveness in reducing dengue vector density , and feasibility of the intervention .


A cluster randomised trial was conducted in an urban area of Colombia comparing @ randomly selected control and @ intervention clusters .


In control clusters , routine vector control activities were performed .


The intervention delivered first , LLIN curtains ( from July to August @ ) and secondly , water container covers ( from October to March @ ) .


Cross-sectional entomological surveys were carried out at baseline ( February @ to June @ ) , @ weeks after the first intervention ( August to October @ ) , and @-@ weeks after the second intervention ( March to April @ ) .


Curtains were installed in @ households and water container covers in @ households .


The Breteau index ( BI ) fell from @ to @ in the intervention group and from @ to @ in the control group .


The additional intervention with LLIN covers for water containers showed a significant reduction in pupae per person index ( PPI ) ( p = @ ) .


In the intervention group , the PPI index showed a clear decline of @ % compared with @ % in the control group .


Costs were high but options for cost savings were identified .


Short term impact evaluation indicates that the intervention package can reduce dengue vector density but sustained effect will depend on multiple factors .


There is no consensus as to which bariatric procedure is preferred to reduce weight and improve health in patients with a body mass index higher than @ .


To compare @-year outcomes after Roux-en-Y gastric bypass ( gastric bypass ) and biliopancreatic diversion with duodenal switch ( duodenal switch ) .


Randomized clinical open-label trial at Oslo University Hospital , Oslo , Norway , and Sahlgrenska University Hospital , Gothenburg , Sweden .


Participants were recruited between March @ , @ , and August @ , @ , and included @ patients aged @ to @ years with a body mass index of @ to @ .


The current study provides the @-year follow-up analyses by intent to treat , excluding one participant accepted for inclusion who declined being operated on prior to knowing to what group he was randomized .


Laparoscopic gastric bypass and laparoscopic duodenal switch .


Body mass index and secondary outcomes including anthropometric measures , cardiometabolic risk factors , pulmonary function , vitamin status , gastrointestinal symptoms , health-related quality of life , and adverse events .


Sixty patients were randomly assigned and operated on with gastric bypass ( n = @ ) and duodenal switch ( n = @ ) .


Fifty-five patients ( @ % ) completed the study .


Five years after surgery , the mean reductions in body mass index were @ ( @ % CI , @-@ @ ) and @ ( @ % CI , @-@ @ ) after gastric bypass and duodenal switch , respectively .


The mean between-group difference was @ ( @ % CI , @-@ @ ; P < @ ) .


Remission rates of type @ diabetes mellitus and metabolic syndrome and changes in blood pressure and lung function were similar between groups .


Reductions in total cholesterol , low-density lipoprotein cholesterol , triglycerides , and fasting glucose were significantly greater after duodenal switch compared with gastric bypass .


Serum concentrations of vitamin A and @-hydroxyvitamin D were significantly reduced after duodenal switch compared with gastric bypass .


Duodenal switch was associated with more gastrointestinal adverse effects .


Health-related quality of life was similar between groups .


Patients with duodenal switch underwent more surgical procedures related to the initial procedure ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- patients ; P = @ ) and had significantly more hospital admissions compared with patients with gastric bypass .


In patients with a body mass index of @ to @ , duodenal switch resulted in greater weight loss and greater improvements in low-density lipoprotein cholesterol , triglyceride , and glucose levels @ years after surgery compared with gastric bypass while improvements in health-related quality of life were similar .


However , duodenal switch was associated with more surgical , nutritional , and gastrointestinal adverse effects .


We present the results of a previously unpublished hemoglobin-based oxygen carrier ( HBOC ) study conducted in @-@ .


In a multicenter , randomized , single-blind , comparative study of HBOC-@ versus allogeneic red blood cell ( RBC ) transfusions , no-cardiac surgery patients received HBOC-@ to a maximum of @ units ( n = @ ) or RBCs ( n = @ ) .


Patients could be switched to RBCs for safety or any other reason .


The efficacy end points were elimination and/or reduction of allogeneic RBC transfusions for @ days .


The proportion of patients in the HBOC-@ group that avoided RBC transfusion was @ ( @ % confidence interval , @-@ @ ) .


Subjects in the HBOC-@ group received on average @ units of RBCs versus @ units in the control arm ( P = @ ) .


Seventy-nine ( @ % ) subjects in the HBOC-@ group and @ ( @ % ) in the RBC group experienced adverse events ( AEs ) , judged to be associated with study treatment in @ ( @ % ) and @ ( @ % ) subjects , respectively .


Thirty-day mortality , @ ( @ % ) vs @ ( @ % ) patients ( P = @ ) , incidence of serious AEs , @ ( @ % ) vs @ ( @ % ) ( P = @ ) , or time to intensive care unit ( log-rank P = @ ) or hospital discharge ( log-rank P = @ ) were similar for the HBOC-@ and RBC groups , respectively .


Up to @ units of HBOC-@ infused over the course of @ days resulted in RBC transfusion avoidance in @ % of patients .


There were no notable differences in mortality and serious AEs incidence .


The use of HBOC-@ was associated with a notable excess of nonserious AEs .


Early , safe , effective , and durable evidence-based interventions for children and adolescents with chronic migraine do not exist .


To determine the benefits of cognitive behavioral therapy ( CBT ) when combined with amitriptyline vs headache education plus amitriptyline .


A randomized clinical trial of @ youth ( @ % female ) aged @ to @ years diagnosed with chronic migraine ( @ days with headache/month ) and a Pediatric Migraine Disability Assessment Score ( PedMIDAS ) greater than @ points were assigned to the CBT plus amitriptyline group ( n = @ ) or the headache education plus amitriptyline group ( n = @ ) .


The study was conducted in the Headache Center at Cincinnati Children 's Hospital between October @ and September @ ; @ completed @-week follow-up and @ completed @-month follow-up .


Ten CBT vs @ headache education sessions involving equivalent time and therapist attention .


Each group received @ mg/kg/d of amitriptyline and a @-week end point visit .


In addition , follow-up visits were conducted at @ , @ , @ , and @ months .


The primary end point was days with headache and the secondary end point was PedMIDAS ( disability score range : @-@ points ; @-@ for little to none , @-@ for mild , @-@ for moderate , > @ for severe ) ; both end points were determined at @ weeks .


Durability was examined over the @-month follow-up period .


Clinical significance was measured by a @ % or greater reduction in days with headache and a disability score in the mild to none range ( < @ points ) .


At baseline , there were a mean ( SD ) of @ ( @ ) days with headache per @ days and the mean ( SD ) PedMIDAS was @ ( @ ) points .


At the @-week end point , days with headache were reduced by @ for the CBT plus amitriptyline group vs @ for the headache education plus amitriptyline group ( difference , @ -LSB- @ % CI , @-@ @ -RSB- days ; P = @ ) .


The PedMIDAS decreased by @ points for the CBT group vs @ points for the headache education group ( difference , @ -LSB- @ % CI , @-@ @ -RSB- points ; P = @ ) .


In the CBT group , @ % had a @ % or greater reduction in headache days vs @ % in the headache education group ( odds ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) .


At @-month follow-up , @ % of the CBT group had a @ % or greater reduction in headache days vs @ % of the headache education group ; @ % of the CBT group had a PedMIDAS of less than @ points vs @ % of the headache education group .


Measured treatment credibility and integrity was high for both groups .


Among young persons with chronic migraine , the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline .


These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents .


Interventions targeting sedentary time are needed .


We used detailed EMG recordings to study the short-term effectiveness of simple sedentary time-targeted tailored counseling on the total physical activity spectrum .


This cluster randomized controlled trial was conducted between @ and @ ( InPact , ISRCTN@ ) , and short-term effectiveness of counseling is reported in the present study .


A total of @ office workers volunteered to participate , from which muscle activity data were analyzed from @ ( intervention , n = @ ; control , n = @ ) .


After a lecture , face-to-face tailored counseling was used to set contractually binding goals regarding breaking up sitting periods and increasing family based physical activity .


Primary outcome measures were assessed @ @ h before and a maximum of @ wk after counseling including quadriceps and hamstring muscle inactivity time , sum of the five longest muscle inactivity periods , and light muscle activity time during work , commute , and leisure time .


Compared with those in the controls , counseling decreased the intervention group 's muscle inactivity time by @ @ min from @ % @ % to @ % @ % ( whole day , P < @ ; work , P < @ ; leisure , P < @ ) and the sum of the five longest inactivity periods from @ @ to @ @ min ( whole day , P < @ ; leisure , P < @ ) .


Concomitantly , light muscle activity time increased by @ @ min , from @ % @ % to @ % @ % ( whole day , P < @ ; work , P < @ ; leisure , P < @ ) , and during work time , average EMG amplitude ( percentage of EMG during maximal voluntary isometric contraction ( MVC ) ( % EMG MVC ) ) increased from @ % @ % to @ % @ % ( P < @ ) in the intervention group compared with that in the controls .


A simple tailored counseling was able to reduce muscle inactivity time by @ min , which was reallocated to @ min of light muscle activity .


During work time , average EMG amplitude increased by @ % , reaching an average of @ % of EMG MVC .


If maintained , this observed short-term effect may have health-benefiting consequences .


To compare the diagnostic performance of adaptive statistical iterative reconstruction applied low-dose computed tomography ( CT ) ( LDCT ) with that of the standard-dose CT ( SDCT ) for local recurrence in patients with stomach cancer .


Seventy-nine consecutive patients who had undergone surgical resection for stomach cancer were enrolled .


To monitor recurrence , SDCT ( @ kilovolt peak -LSB- kVp -RSB- , @mAs ) had been performed .


The LDCT ( @ kVp , @ mA s ) was taken , and images were reconstructed with @ levels of adaptive statistical iterative reconstruction ( ASIR ) blending ( @ % , @ % , @ % , and @ % ) .


Two blinded radiologists recorded the diagnostic confidence scores for local recurrence in each data set using a @-point scale .


Endoscopic biopsy results served as the reference standard .


Receiver operating characteristic ( ROC ) curve analysis was used to calculate the diagnostic performance .


The diagnostic performance of LDCT with variable ASIR blending ratios was comparable to that of SDCT ( area under ROC curve , @-@ @ , @ , respectively , P > @ ) .


The diagnostic performance of ASIR applied LDCT is comparable to that of SDCT .


To evaluate and compare the shear bond strength ( SBS ) of stainless steel and gold-plated attachments to impacted lower third molars in vivo and in vitro with a light-cured orthodontic resin .


Sixteen patients with bilaterally full soft tissue impaction of lower third molars were recruited on a voluntary basis from an oral and maxillofacial surgery department .


A split-arch technique was used .


Following surgical exposure of the crown , the tooth was luxated but not extracted .


Then , two attachments ( one stainless steel button and one gold-plated eyelet ) were bonded to the labial enamel surface of the loosened tooth .


Five minutes later , the luxated tooth was removed from its socket .


In each patient , the impacted tooth on the other side was extracted , and attachments were bonded in vitro .


The SBSs of the attachments were evaluated .


For comparison , analysis of variance and multiple range tests were used ( = @ ) .


Statistically significant differences were evident in attachment adhesion to the impacted tooth surfaces among the four groups ( p < @ ) .


Superior SBS values were obtained for stainless steel button groups bonded in vitro .


The mean bond strengths of the groups bonded in vitro were better than those of the same groups bonded in vivo .


Although the in vitro-bonded groups showed higher SBS values , adequate bond strength is possible with stainless steel buttons bonded in vivo .


The current study evaluated the costs and benefits of a simple aerobic walking program for patients with chronic obstructive pulmonary disease ( COPD ) .


This was a blinded randomized controlled clinical trial that recruited @ patients diagnosed with COPD , @ of whom were included in the study and divided into two groups -LSB- control group ( CG ) and pulmonary rehabilitation group ( GPR ) -RSB- .


We assessed pulmonary function , distance covered during the @-minute walk test ( @MWT ) , respiratory and peripheral muscle strength , health-related quality of life ( HRQOL ) , body composition , and level of activities of daily living ( ADLs ) before and after an @-week walking program .


The financial costs were calculated according to the pricing table of the Brazilian Unified Health System ( SUS ) .


Only @ of the @ patients remained in the final sample ; @ in the CG and @ in the GPR ( FEV@ : @ @ % predicted and FEV@ : @ @ % predicted , respectively ) .


The intervention group exhibited improvements in the @MWT , sensation of dyspnea and fatigue , work performed , BODE index ( p < @ ) , HRQOL , ADL level ( p < @ ) , and lower limb strength ( p < @ ) .


The final mean cost per patient for the GPR was R$ @ ( ~ US$ @ ) and no patient significantly exceeded this value .


However , @ patients in the CG did exceed this value , incurring a cost of R$ @ ( ~ US$ @ ) .


Aerobic walking demonstrated significant clinical benefits in a cost-efficient manner in patients with COPD .


The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections .


Between March @ and April @ , @ patients with plantar fasciitis were randomized to receive radiation therapy ( total dose of @ Gy applied in @ fractions of @ Gy three times a week ) or local corticosteroid injections a @ ml injection of @ mg methylprednisolone and @ ml @ % lidocaine under the guidance of palpation .


The results were measured using a visual analog scale , a modified von Pannewitz scale , and a @-level function score .


The fundamental phase of the study was @ months , with a follow-up period of up to @ months .


The median follow-up period for all patients was @ months ( range , @-@ @ months ) .


For the radiation therapy patients , the median follow-up period was @ months ( range , @-@ @ months ) , whereas in the palpation-guided ( PG ) steroid injection arm , it was @ months ( range , @-@ @ months ) .


After @ months , results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm ( visual analog scale , P < @ ; modified von Pannewitz scale , P < @ ; @-level function score , P < @ ) .


Requirements for a second treatment did not significantly differ between the @ groups , but the time interval for the second treatment was significantly shorter in the PG steroid injection group ( P = @ ) .


This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least @ months after treatment .


Dispatcher-assisted CPR ( DA-CPR ) can increase rates of bystander CPR , survival , and quality of life following cardiac arrest .


Dispatcher protocols designed to improve rapid recognition of arrest and coach CPR may increase survival by ( @ ) reducing preventable time delays to start of chest compressions and ( @ ) improving the quality of bystander CPR .


We conducted a randomized controlled trial comparing a simplified DA CPR script to a conventional DA CPR script in a manikin cardiac arrest simulation with lay participants .


The primary outcomes measured were the time interval from call receipt to the first chest compression and the core metrics of chest compression ( depth , rate , release , and compression fraction ) .


CPR was measured using a recording manikin for the first @ min of participant CPR .


Of the @ participants , @ were randomized to the simplified instructions and @ were randomized to the conventional instructions .


The interval from call receipt to first compression was @ s using the simplified script and @ s using the conventional script for a difference of @s ( p < @ ) .


Although hand position was judged to be correct more often in the conventional instruction group ( @ % versus @ % , p < @ ) , compression depth was an average @ mm deeper among those receiving the simplified CPR script ( @ mm versus @ mm , p < @ ) .


No statistically significant differences were detected between the two instruction groups for compression rate , complete release , number of hands-off periods , or compression fraction .


Simplified DA-CPR instructions to lay callers in simulated cardiac arrest settings resulted in significant reductions in time to first compression and improvements in compression depth .


These results suggest an important opportunity to improve DA CPR instructions to reduce delays and improve CPR quality .


Calcium intake during growth is essential for future bone health but varies widely between individuals and populations .


The impact on bone of increasing calcium intake is unknown in a population where low calcium intake , stunting , and delayed puberty are common .


To determine the effect of prepubertal calcium supplementation on mean age at peak velocity for bone growth and mineral accrual .


Prospective follow-up of boys in rural Gambia , West Africa , who had participated in a double-blind , randomized , placebo-controlled trial of calcium supplementation .


Eighty boys , initially aged @-@ @ years , were followed up for @ years .


Subjects received @ year of calcium carbonate supplementation ( @ mg daily , @ d/wk ) .


Dual-energy x-ray absorptiometry measurements were carried out for whole body ( WB ) , lumbar spine , and total hip bone mineral content , bone area ( BA ) , and WB lean mass .


Super imposition by translation and rotation models was made to assess bone growth .


Age at peak velocity was consistently earlier in the calcium group compared to the placebo group , for WB bone mineral content ( mean , -@ -LSB- SE , @ -RSB- ; P = @ ) , WB BA ( mean , -@ -LSB- SE , @ -RSB- mo ; P = @ ) , lumbar spine and total hip BA .


By young adulthood , supplementation did not change the amount of bone accrued ( mineral or size ) or the rate of bone growth .


Twelve months of prepubertal calcium carbonate supplementation in boys with a low calcium diet advanced the adolescent growth spurt but had no lasting effect on bone mineral or bone size .


There is a need for caution when applying international recommendations to different populations .


To evaluate the long-term clinical outcomes of fractional flow reserve ( FFR ) - guided versus intravascular ultrasound ( IVUS ) - guided percutaneous coronary intervention ( PCI ) for intermediate coronary lesions .


A total of @ patients with @ intermediate coronary artery lesions ( stenosis of @ % -@ % ) confirmed by coronary angiography were randomized into @ groups to undergo PCI for a minimal lumen cross sectional area ( MLA ) < @ mm ( @ ) ( IVUS group , @ lesions ) or for a FFR < @ ( FFR group , @ lesions ) , or to receive standard medical treatment ( medication group , @ lesions ) .


The primary outcome was major adverse cardiac events including death , myocardial infarction , and ischemia-driven target vessel revascularization at @ year after the index procedure .


The baseline percent diameter stenosis and lesion length were similar between the @ groups , but more patients in IVUS group than in FFR group received PCI ( P < @ ) .


No significant difference was found in the incidence of major adverse cardiac events between the @ groups ( P = @ ) .


Both FFR - and IVUS-guided PCI strategy for intermediate coronary artery disease are associated with favorable outcomes , but IVUS-guided PCI based on the single index of MLA can increase the rate of revascularization therapy .


Thalassemia major is the most common genetic disorder in Pakistan .


The study was done to compare the efficacy and safety of the deferiprone with deferrioxamine for the treatment of iron overload in children with thalassemia major .


This randomized controlled trail was conducted at thalassemia blood transfusion unit of Allied Hospital , Faisalabad ( AHF ) / District Headquarter Hospital ( DHQ ) , Faisalabad .


Thalassemia-Unit Hilal-e-Ahmar , Alizeb Foundation and Blood Bank Services Faisalabad from November @ to December @ .


Children with beta thalassemia major of age more than @ years and less than @ years with transfusion iron over load were randomly allocated to one of the two groups each comprising of @ patients .


One group received deferiprone given at a daily dose of @mg/kg in three divided doses orally while the other group received deferrioxamine at dose @ mg/kg/@hrs for @ days/week as parental infusion .


Changes in the serum ferritin level were assessed .


Cardiac function and toxicity were also examined .


Serum ferritin was significantly reduced after @ year in both treatment arms ( p = @ ) .


Neutropenia observed in @ ( @ % ) non-splenectomized patients taking deferiprone .


Transient elevations in ALT were observed in @ ( @ % ) children taking deferiprone .


Left ventricular ejection fraction ( LVEF ) remained in normal range in both treatment arm but has decreased significantly in Deferrioxamine group compliance .


Compliance was better in deferiprone as compared to deferrioxamine .


Discontinuing percentage @ ( @ % ) vs @ ( @ % ) .


Deferiprone is a highly efficacious and safe chelation therapy for patients with thalassemia major who are non-compliant to Deferrioxamine .


Deferiprone have an efficacy profile comparable to standard Deferrioxamine .


The objective of the present study was to develop population pharmacokinetic models for olmesartan medoxomil and hydrochlorothiazide and to investigate the influence of demographic factors on these population pharmacokinetics .


Plasma concentrations of olmesartan medoxomil and hydrochlorothiazide were measured in @ healthy volunteers enrolled in our bioequivalence study by LC-MS/MS following oral administration of an olmesartan medoxomil/hydrochlorothiazide ( @/@ @ mg ) fixed-dose combination tablet .


This data and covariates were subjected to nonlinear mixed-effect modeling analysis using the NONMEM software .


Evaluation featured a visual predicted check and bootstrapping .


The distributions of olmesartan medoxomil and hydrochlorothiazide were best fitted using a two-compartment model with no lag time and first-order elimination .


When analyzing hydrochlorothiazide kinetics , we found that TCHO and CL/F were correlated , while .


HB and Ka influenced olmesartan medoxomil modeling .


All evaluations indicated that the pharmacokinetic profiles of olmesartan medoxomil and hydrochlorothiazide were adequately described using our PPK model .


This study indicates that demographic factors influence the inter-individual variability in the disposition of the combination drug , and it might be more useful to apply it to the PK of olmesartan medoxomil/hydrochlorothiazide ( @/@ @ mg ) FDC tablets administered to patients with hypertension .


* These two authors contributed equally to this work .


Physician-coded verbal autopsy ( PCVA ) is the most widely used method to determine causes of death ( CODs ) in countries where medical certification of death is uncommon .


Computer-coded verbal autopsy ( CCVA ) methods have been proposed as a faster and cheaper alternative to PCVA , though they have not been widely compared to PCVA or to each other .


We compared the performance of open-source random forest , open-source tariff method , InterVA-@ , and the King-Lu method to PCVA on five datasets comprising over @,@ verbal autopsies from low - and middle-income countries .


Metrics to assess performance were positive predictive value and partial chance-corrected concordance at the individual level , and cause-specific mortality fraction accuracy and cause-specific mortality fraction error at the population level .


The positive predictive value for the most probable COD predicted by the four CCVA methods averaged about @ % to @ % across the datasets .


The average positive predictive value improved for the top three most probable CODs , with greater improvements for open-source random forest ( @ % ) and open-source tariff method ( @ % ) than for InterVA-@ ( @ % ) .


The average partial chance-corrected concordance for the most probable COD predicted by the open-source random forest , open-source tariff method and InterVA-@ were @ % , @ % and @ % , respectively , with better results for the top three most probable CODs .


Performance generally improved with larger datasets .


At the population level , the King-Lu method had the highest average cause-specific mortality fraction accuracy across all five datasets ( @ % ) , followed by InterVA-@ ( @ % across three datasets ) , open-source random forest ( @ % ) and open-source tariff method ( @ % ) .


On an individual level , no single method was able to replicate the physician assignment of COD more than about half the time .


At the population level , the King-Lu method was the best method to estimate cause-specific mortality fractions , though it does not assign individual CODs .


Future testing should focus on combining different computer-coded verbal autopsy tools , paired with PCVA strengths .


This includes using open-source tools applied to larger and varied datasets ( especially those including a random sample of deaths drawn from the population ) , so as to establish the performance for age - and sex-specific CODs .


The cause of infertility is unexplained or poorly explained in @-@ % of couples undergoing standard investigations , and treatment ranges from expectant management to IUI and IVF .


The aim of this study was to compare the clinical pregnancy rates and costs of intra-uterine insemination ( IUI ) and in vitro fertilisation ( IVF ) in women where the same ovarian stimulation led to the development of two or three mature follicles .


A randomised controlled clinical trial compared the efficacy of IUI and IVF in a tertiary fertility centre ( ISRCTN@ ) .


Primary outcome measures were fetal heart positive pregnancy rate and cost per live birth .


The selection criteria were age : females @-@years and males @-@years , infertility for one year or more , no IVF or IUI for @months prior to the trial , and no coital , tubal or ovulatory disorders , oligospermia , untreated endometriosis or contraindication for multiple pregnancy .


All women ( n = @ ) had the same dose FSH stimulation protocol .


Those who developed two or three preovulatory follicles were randomised @:@ to IUI ( n = @ ) or IVF ( n = @ ) .


IUI or IVF was performed @h after hCG administration with single or double embryo transfer on day two .


Clinical pregnancy rates ( @ % vs @ % , P = @ ) and live birth rate ( @ % vs @ % , P = @ ) were higher for IVF than IUI .


The cost per live birth was AU$ @ for IVF compared with $ @,@ for IUI .


This study provides evidence that IVF is more successful and cost-effective than IUI using the same doses of FSH .


Further confirmatory studies are required .


Given verapamil 's property as a glycoprotein inhibitor , this drug could increase the effective concentration of antiepileptic drugs ( AEDs ) in the epileptic foci , reducing the number of seizures .


This pilot study was designed to evaluate the safety and efficacy of verapamil as adjunct therapy in pharmacoresistant patients with focal onset seizures .


This was a single-centered , randomized , double-blind and placebo-controlled trial evaluating verapamil as an add-on therapy for adult patients with refractory epilepsy .


Twenty-two patients were randomized , but five of them withdrew and one patient passed away after consent , having no exposure to either verapamil or placebo ; four patients withdrew during or after the double-blind phase due to side effects .


From these four patients , only one patient was in the verapamil group .


Twelve patients ( @ % ) finished the study .


Some patients experienced lower seizure frequencies , but none of them reached @ % reduction .


In addition , there was no statistically significant decrease in the seizure frequency of patients receiving verapamil .


When comparing the verapamil with the placebo at the double-blind or the open label study phases , the average difference in seizure range also failed to show significance ( p = @ and p = @ , respectively ) .


No significant cardiovascular effects were observed , and side effects unique to verapamil were skin rashes and feet edema .


Throughout the study , carbamazepine , valproic acid and clobazam levels increased following verapamil intake ; minor dosage adjustment was required in one patient on carbamazepine .


This pilot study has shown mild benefits of verapamil use in comparison to placebo as an add-on therapy for a group of non-selected patients with refractory epilepsy .


A partial response in a subset of patients was seen .


No significant safety problems happened , but adjustments on AEDs may be required during verapamil use .


Depression has been widely studied in primary care settings , yet studies of medically uninsured populations are lacking .


We sought to determine whether depression screening and treatment improved depression scores of a medically uninsured , mostly African American primary care population .


The study was a prospective repeated-measures design that recruited uninsured patients .


Patients were screened for depression , and the rate of depression diagnosis was compared with baseline .


Patients who were diagnosed and accepted treatment were randomized to @ of @ treatment arms : ( @ ) usual care ; ( @ ) usual care and psychotherapy ; ( @ ) usual care and education and psychotherapy ; and ( @ ) usual care and education .


Patients were then reevaluated at @ , @ , and @ weeks .


A total of @ patients participated .


Depression prevalence was significantly higher among those screened ( @ % ) than at baseline ( @ % ) .


All treatment groups showed a significant reduction in depression scores over a @-month period , from a mean score of @ at baseline to @ at @ weeks ( P < @ ) .


All treatment interventions were equally effective .


Screening improves the rate of diagnosis of depression in an uninsured , primarily African American population , and subsequent treatment significantly reduces the burden of depression .


In patients with resistant hypertension ( RH ) and obstructive sleep apnea ( OSA ) , the blood pressure response to continuous positive airway pressure ( CPAP ) treatment is highly variable and could be associated with differential micro-ribonucleic acid ( miRNA ) profiles .


Currently , no available methods exist to identify patients who will respond favorably to CPAP treatment .


The aim of this study was to identify plasma miRNA profiles that predict blood pressure responses to CPAP treatment .


Cardiovascular system-focused circulating miRNA expression was evaluated in plasma samples using an @-miRNA array among patients with RH and OSA at baseline and after @ months of adherent CPAP use .


Pathway analysis and miRNA target gene enrichment were performed in silico .


Plasma levels of peptides and hormones related to cardiovascular function were also measured .


The OSA responder group exhibited blood pressure decreases exceeding the observed median ( > @ mm Hg ) after CPAP , which were not present in the nonresponder group ( @ mm Hg ) ( p < @ ) .


Three miRNAs provided a discriminatory predictive model for such a favorable blood pressure response to CPAP ( area under the curve : @ ; p = @ ) .


Additionally , CPAP treatment significantly altered a total of @ plasma miRNAs and decreased aldosterone-to-renin ratios in the responder group ( p = @ ) but not in the nonresponder group .


A singular pre-CPAP treatment cluster of @ plasma miRNAs predicts blood pressure responses to CPAP treatment in patients with RH and OSA .


CPAP treatment is accompanied by changes in cardiovascular system-related miRNAs that may potentially influence the risk for cardiovascular disease among patients with OSA and RH .


( Effect of Continuous Positive Airway Pressure -LSB- CPAP -RSB- Treatment in the Control of Refractory Hypertension ; NCT@ ) .


To evaluate and compare the effects of single intravitreal injection of ranibizumab and bevacizumab on central retinal and choroidal thickness in patients with neovascular age-related macular degeneration ( AMD ) .


Forty eyes of @ patients with neovascular AMD that underwent intravitreal injection of vascular endothelial growth factor inhibitors ( anti-VEGFs ) were included .


Patients were randomized into @ groups : @ eyes received ranibizumab and @ eyes received bevacizumab injection .


Central retinal and choroidal thicknesses of all eyes at baseline and @ month postinjection scans were measured with Fourier-domain optical coherence tomography ( OCT ) .


Student t test and Mann-Whitney U test were used to compare the data .


The mean central retinal thickness ( CRT ) showed significant decrease after single injection of ranibizumab ( from @ m to @ m , p < @ ) and bevacizumab ( from @ m to @ m , p < @ ) at the first month , respectively .


There was no significant difference regarding the CRT change between groups ( p = @ ) .


The mean choroidal thickness decreased from @ m ( @-@ ) to @ m ( @-@ ) in the ranibizumab group and from @ m ( @-@ ) to @ m ( @-@ ) in bevacizumab group .


The decrease was not significant between groups ( p = @ ) .


Intravitreal injection of both ranibizumab and bevacizumab provided a significant decrease in CRT ; however , the agents caused no significant change in choroidal thickness .


Additionally , no difference between ranibizumab versus bevacizumab was observed related to macular edema inhibition .


To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery .


A randomized , double-blind comparative study .


Ankara Numune Training and Research Hospital , Turkey , from January and June @ .


Sixty adults undergoing total knee arthroplasty were enrolled in this study .


The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion ( @ g/kg/minute ) or the same volume of saline .


A visual analogue scale ( VAS ) was used to measure each patient 's level of pain at @ , @ , @ , @ , and @ hours after surgery .


Time to first analgesic request , postoperative morphine consumption and the incidence of side effects were also recorded .


Low-dose ketamine infusion prolonged the time to first analgesic request .


It also reduced postoperative cumulative morphine consumption at @ , @ , @ , @ , and @ hours postsurgery ( p < @ ) .


Postoperative VAS scores were also significantly lower in the ketamine group than placebo , at all observation times .


Incidences of side effects were similar in both study groups .


Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects .


AZD@ has demonstrated potential as an inhaled , long-acting , muscarinic antagonist ( LAMA ) bronchodilator .


However , in patients with COPD , but not in healthy subjects , a transient initial drop in FEV@ was observed following inhalation of nebulised doses of AZD@ in citrate buffer.Two additional studies were conducted to further assess the safety and tolerability of multiple ascending doses of AZD@ in @ white and @ Japanese healthy subjects and in @ patients with COPD .


In these studies , AZD@ was inhaled via Turbuhaler .


These were Phase I , randomised , double-blind , placebo-controlled , multiple ascending dose ( MAD ) studies conducted in Sweden and UK .


Healthy subjects ( mean age @ yrs ) and patients with COPD ( mean age @ yrs , mean post-bronchodilator FEV@ @ % predicted normal value ) were randomised @:@ to active treatment ( @ , @ or @ g delivered doses of AZD@ ) or placebo .


No safety or tolerability concerns were identified in the healthy subjects at doses up to and including @ g and both studies confirmed the bronchodilator effect of AZD@ .


However , the first @ patients in the COPD cohort who received AZD@ ( @ g ) experienced a transient fall in FEV@ @ to @ minutes after inhalation of AZD@ while the patient receiving placebo did not .


The study safety review process then resulted in cessation of further activities on AZD@ .


Retrospective analysis showed that two healthy subjects had also had transient falls in FEV@ shortly after inhalation of AZD@ @ and @ g respectively , although neither reported any related respiratory symptoms or other AEs .


These results show that transient paradoxical bronchoconstriction can occur in some healthy subjects , in addition to patients with COPD , following inhalation of AZD@ and that the citrate buffer used in the nebulised formulation can not have been the only cause of the drop in FEV@ in previous studies .


As preclinical data do not provide an explanation , the reasons for this brief post-dose drop in FEV@ remain unclear .


However , these results highlight the importance of monitoring lung function immediately post-dose when investigating novel inhaled treatments , even when a rapid onset of effect is not expected .


Testosterone ( T ) administration to men increases T , estradiol ( E@ ) , dihydrotestosterone ( DHT ) , and fat-free mass ( FFM ) , and decreases fat mass ( FM ) but does not consistently improve insulin sensitivity ( IS ) .


The aim of this study was to examine the effects of T administration in obese , nondiabetic men on body composition and IS , and to determine if inhibition ( i ) of metabolism of T to E@ with anastrazole or to DHT with dutasteride alters these effects .


This was a @-day randomized , double-blind , parallel group , placebo-controlled trial of @ men , @-@ year , free T in the lower @ % of normal range ( < @ nmol/L ) , body mass index @ kg/m ( @ ) .


Subjects were randomized to one of four groups : ( i ) placebo : gel , pills , and injection ; ( ii ) T/DHT/iE@ : T gel , anastrazole , and acyline ( gonadotropin releasing-hormone antagonist to suppress endogenous T ) ; ( iii ) T/iDHT/E@ : T gel , dutasteride , and acyline ; ( iv ) T/DHT/E@ : T gel , placebo pills , and acyline .


Main outcome measures are insulin sensitivity as percent change ( % ) in glucose disposal rates ( GDR ) from a two-step euglycemic clamp ( GDR@ and @ ) , and % FM and % FFM by dual X-ray absorptiometry scan .


Insulin Sensitivity : % GDR@ differed across groups ( P = @ , anova ) and was significantly higher in the dutasteride ( T/iDHT/E@ ) compared with the placebo and T gel ( T/DHT/E@ ) groups .


% GDR@ was higher in the dutasteride ( T/iDHT/E@ ) compared with the anastrazole ( T/DHT/iE@ ) group .


Body Composition : T gel alone ( T/DHT/E@ ) or with dutasteride ( T/iDHT/E@ ) significantly increased % FFM ( P < @ ) and decreased % FM ( P < @ ) .


There was no change in % FFM or % FM after placebo or anastrazole ( T/DHT/iE@ ) .


The combination of T plus dutasteride improved body composition and IS while T alone improved body composition but not IS , suggesting that when T is administered to men , reduction to DHT attenuates the beneficial effects of aromatization to E@ on IS but not body composition .


High-dose oestrogen treatment has been used to reduce growth in tall adolescent girls .


The long-term safety with regard to cancer has not been clarified .


Our aim was to study if this growth reduction therapy affects cancer risk later in life .


A cohort study of @ ( @ treated , @ untreated ) Swedish women who in @-@ were assessed for tall adolescent stature was designed .


Data were collected from university hospital records , patient questionnaires , and the Swedish Cancer Register .


Risks are presented as odds ratios ( ORs ) with @ % confidence intervals comparing treated to untreated subjects .


In treated subjects , the overall OR for having a tumour ( malignant or non-malignant ) was @ ( @-@ @ ) .


The ORs were @ ( @-@ @ ) for breast tumours , @ ( @-@ @ ) for gynaecological tumours , and @ ( @ - ) for melanoma .


When limiting to malignant tumours , the crude ORs were of similar magnitude .


The OR for any melanoma was higher in treated than in untreated women , suggesting an increased risk of melanoma associated with high-dose oestrogen treatment during adolescence .


Although the risk estimates were increased for overall tumours , breast tumours , malignant gynaecological tumours , and malignant melanoma , these associations were not statistically significant .


Our results need to be verified in a larger cohort .


To locate sites of genital tenderness in breast cancer survivors not using estrogen who experience dyspareunia and to test the hypothesis that tenderness is limited to the vulvar vestibule rather than the vagina and is reversed by topical anesthetic .


Postmenopausal survivors of breast cancer with moderate and severe dyspareunia were recruited for an examination including randomization to a double-blind intervention using topical aqueous @ % lidocaine or normal saline for @ minutes to the areas found to be tender .


Comparisons of changes in patients ' reported numerical rating scale values were made with the Wilcoxon rank-sum test with significance set at P < @ .


Forty-nine patients aged @-@ years ( mean @ years ) had a median coital pain score of @ ( interquartile range @-@ , scale @-@ ) .


On examination , all women had tenderness in the vulvar vestibule ( worst site @ o'clock median @ , @-@ ) .


In addition , one had significant vaginal mucosal tenderness and two had pelvic floor myalgia .


All had vulvovaginal atrophy with @ % having no intravaginal discharge .


Aqueous lidocaine @ % reduced the vestibular tenderness of all painful sites .


For example , pain at the worst site changed from a median of @ ( @-@ ) to @ ( @-@ ) as compared with saline placebo , which changed the worst site score from @ ( @-@ ) to @ ( @-@ ) ( P < @ ) .


After lidocaine application , speculum placement was nontender in the @ without either myalgia or vaginal mucosal tenderness .


In breast cancer survivors with dyspareunia , exquisite sensitivity was vestibular and reversible with aqueous lidocaine .


Vaginal tenderness was rare despite severe atrophy .


Panax ginseng and Gingko biloba are commonly used herbal supplements in the United States that have been reported to increase alertness and cognitive function .


The objective of this study was to investigate the effects of these specific herbals on driving performance .


@ volunteers were tested using the STISIM@ Driving Simulator ( Systems Technology Inc. , Hawthorne , CA , USA ) in this double-blind , placebo-controlled study .


The subjects were randomized into @ groups of @ subjects per group .


After @-min of simulated driving , subjects received either ginseng ( @ mg ) , Gingko ( @ mg ) , or placebo administered orally .


The test herbals and placebo were randomized and administered by a research assistant outside of the study to maintain blinding .


One hour following administration of the herbals or placebo , the subjects completed an additional @-min of simulated driving .


Standard driving parameters were studied including reaction time , standard deviation of lateral positioning , and divided attention .


Data collected for the divided attention parameter included time to response and number of correct responses .


The data was analyzed with repeated-measures analysis of variance ( ANOVA ) and Kruskal-Wallis test using SPSS @ ( IBM , Armonk , NY , USA ) .


There was no difference in reaction time or standard deviation of lateral positioning for both the ginseng and Ginkgo arms .


For the divided attention parameter , the response time in the Ginkgo arm decreased from @ to @ s.


The ginseng arm also decreased from @ to @ s. None of these values were statistically significant when between group differences were analyzed .


The data suggests there was no statistically significant difference between ginseng , Ginkgo or placebo on driving performance .


We postulate this is due to the relatively small numbers in our study .


Further study with a larger sample size may be needed in order to elucidate more fully the effects of Ginkgo and ginseng on driving ability .


Patient-specific femoral and tibial cutting blocks produced with use of data from preoperative computed tomography ( CT ) or magnetic resonance imaging ( MRI ) scans have been employed recently to optimize component alignment in total knee arthroplasty .


We report the results of a randomized controlled trial in which CT scans were used to compare postoperative component alignment between patients treated with custom instruments and those managed with traditional instruments .


The in-hospital data and early clinical outcomes , including Knee Society scores , were determined in a randomized clinical trial of forty-seven patients who had undergone a total of forty-eight primary total knee arthroplasties with patient-specific instruments ( twenty-two knees ) or standard instruments ( twenty-six knees ) .


Orientation of the implants was compared by using three-dimensional CT data .


No significant differences were found between the study and control groups with respect to any clinical outcome after a minimum of six months of follow-up .


The patient-specific tibial cutting block was abandoned in favor of a standard external alignment jig in seven of the twenty-two study knees because of possible malalignment .


A detailed analysis of intent-to-treat and per-protocol groups of study and control knees did not show any significant improvement in component alignment , including femoral component rotation in the axial plane , in the patients treated with the custom instruments .


The percentage of outliers -- defined as less than -@ or more than @ from the correct orientation of the tibial slope -- was significantly higher in the group treated with use of patient-specific blocks than it was in the control group , in both the intent-to-treat ( @ % versus @ % , p = @ ) and the per-protocol ( @ % versus @ % , p = @ ) analysis .


There were no significant improvements in clinical outcomes or knee component alignment in patients treated with patient-specific cutting blocks as compared with those treated with standard instruments .


The group treated with patient-specific cutting blocks had a significantly higher prevalence of malalignment in terms of tibial component slope than the knees treated with standard instruments .


The quantity of subarachnoid ( SAH ) and intraventricular hemorrhage ( IVH ) occurring in the setting of a ruptured cerebral aneurysm is strongly associated with subsequent complications and poor outcomes .


We randomly allocated aneurysmal SAH patients with a modified Fisher score of @ , who had been treated with endovascular coil embolization and ventricular drainage , to receive either @ mg intraventricular tissue plasminogen activator ( TPA ) every @ h ( maximum @ mg ) or placebo .


Computed tomography scans were performed @ , @ , and @ h after administration .


Primary outcomes included feasibility ( enrollment and consent rates ) , safety ( assessed by prospectively screening for complications ) , and rate of intracranial blood clearance ( measured using sequential IVH , modified Graeb , and SAH sum scores ) .


Secondary outcomes included angiographic vasospasm , delayed cerebral ischemia , need for ventriculoperitoneal shunting , and @-month neurological outcomes .


Seventy-seven patients were screened , @ were eligible , and @ were randomized .


The consent rate was @ % .


There were no cases of new intracranial hemorrhage complicating use of TPA .


Models fit using generalized estimating equations demonstrated more rapid reduction in IVH volume ( p = @ ) , modified Graeb score ( p < @ ) , and SAH sum score ( p < @ ) among patients treated with TPA .


SAH clearance at @ h was enhanced by earlier drug administration ( p = @ ) .


There were no differences in secondary outcomes .


Intraventricular TPA accelerates clearance of SAH and IVH , especially when administered early .


A larger-scale clinical trial of intraventricular TPA is feasible , will need to be conducted at multiple centers , and is required to determine whether this practice reduces complications and improves outcomes .


To compare a sulphonylurea with the glucagon like peptide-@ ( GLP-@ ) receptor agonist liraglutide in combination with metformin in patients on mono/dual oral therapy with established type @ diabetes fasting during Ramadan .


Ninety-nine adults intending to fast during Ramadan -LSB- @ % male , mean age @years , body mass index ( BMI ) @kg/m ( @ ) -RSB- were randomized from two UK sites .


Baseline data were collected @days prior to Ramadan and at @ and @weeks after Ramadan .


At @weeks , more patients in the liraglutide compared with the sulphonylurea group achieved a composite endpoint of haemoglobin A@c ( HbA@c ) < @ % , no weight gain and no severe hypoglycaemia but this did not reach statistical significance -LSB- odds ratio ( OR ) @ , @ % confidence interval ( CI ) @ , @ , p = @ -RSB- .


From a baseline of @ % there was no change in HbA@c at @weeks in the sulphonylurea ( +@ % ) compared with a @ % reduction in the liraglutide group ( adjusted coefficient -@ , @ % CI -@ , @ , p = @ ) .


Significant reductions were also observed in weight and diastolic blood pressure ( BP ) in the liraglutide compared with the sulphonylurea group .


Treatment satisfaction was comparable across the treatment groups .


There were no episodes of severe hypoglycaemia in either group , however , self-recorded episodes of blood glucose @ mmol/l were significantly lower with liraglutide ( incidence rate ratio @ , @ % CI @ , @ , p < @ ) .


Liraglutide compared with sulphonylurea is well tolerated and maybe an effective therapy in combination with metformin during Ramadan with more patients able to achieve target HbA@c , lose or maintain weight with no severe hypoglycaemia .


This was achieved with a high level of treatment satisfaction .


Vulval intraepithelial neoplasia is a skin disorder affecting the vulva that , if left untreated , can become cancerous .


Currently , the standard treatment for patients with vulval intraepithelial neoplasia is surgery , but this approach does not guarantee cure and can be disfiguring , causing physical and psychological problems , particularly in women of reproductive age .


We aimed to assess the activity , safety , and feasibility of two topical treatments -- cidofovir and imiquimod -- as an alternative to surgery in female patients with vulval intraepithelial neoplasia .


We recruited female patients ( age @ years or older ) from @ centres to an open-label , randomised , phase @ trial .


Eligibility criteria were biopsy-proven vulval intraepithelial neoplasia grade @ and at least one lesion that could be measured accurately .


We randomly allocated patients to topical treatment with either @ % cidofovir ( supplied as a gel in a @ g tube , to last @ weeks ) or @ % imiquimod ( one @ mg sachet for every application ) , to be self-applied three times a week for a maximum of @ weeks .


Randomisation ( @:@ ) was done by stratified minimisation via a central computerised system , with stratification by hospital , disease focality , and presentation stage .


The primary endpoint was a histologically confirmed complete response at the post-treatment assessment visit @ weeks after the end of treatment ( a maximum of @ weeks after treatment started ) .


Analysis of the primary endpoint was by intention to treat .


Secondary outcomes were toxic effects ( to assess safety ) and adherence to treatment ( to assess feasibility ) .


We present results after all patients had reached the primary endpoint assessment point at @ weeks ; @-year follow-up of complete responders continues .


This trial is registered with Current Controlled Trials , ISRCTN @ .


Between Oct @ , @ , and Jan @ , @ , @ participants were enrolled to the study ; @ patients were randomly allocated cidofovir and @ were assigned imiquimod .


At the post-treatment assessment visit , a complete response had been achieved by @ ( @ % ; @ % CI @-@ ) patients allocated cidofovir and by @ ( @ % ; @-@ ) patients assigned imiquimod .


After @ weeks of treatment , @ ( @ % ) patients ( @ in each group ) had adhered to the treatment regimen .


Five patients in the cidofovir group and seven in the imiquimod group either withdrew or were lost to follow-up before the first @-week safety assessment .


Adverse events of grade @ or higher were reported in @ ( @ % ) of @ patients allocated cidofovir and @ ( @ % ) of @ patients assigned imiquimod ; the most frequent grade @ and @ events were pain in the vulva , pruritus , fatigue , and headache .


Cidofovir and imiquimod were active , safe , and feasible for treatment of vulval intraepithelial neoplasia and warrant further investigation in a phase @ setting .


Both drugs are effective alternatives to surgery for female patients with vulval intraepithelial neoplasia after exclusion of occult invasive disease .


The aim of this study was to determine the relative utility of anatomic and ischemic burden of coronary artery disease for predicting outcomes .


Both anatomic burden and ischemic burden of coronary artery disease determine patient prognosis and influence myocardial revascularization decisions .


When both measures are available , their relative utility for prognostication and management choice is controversial .


A total of @ patients enrolled in the COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation ) trial with baseline quantitative nuclear single-photon emission computed tomography ( SPECT ) and quantitative coronary angiography were studied .