Oral and topical hydrogen intervention was found to augment plasma viscosity decrease as compared with the control group ( P = 0.04 ) .


Differences were found for range-of-motion recovery between the 3 groups ; oral and topical hydrogen intervention resulted in a faster return to normal joint range of motion for both flexion and extension of the injured limb as compared with the control intervention ( P < 0.05 ) .


These preliminary results support the hypothesis that the addition of hydrogen to traditional treatment protocols is potentially effective in the treatment of soft tissue injuries in male professional athletes .


Trial identification : Clinicaltrials.gov number NCT01759498 .


The p53 : miR-34a : E2F positive feed-forward loop and the p53 : miR-605 : Mdm2 positive feed-back loop have been identified to be crucial oncogenesis/tumor suppressor-regulating signaling pathways .


In this study , we sought to examine the hypothesis that neoadjuvant chemotherapy ( NAC ) is a better approach with improved prognosis and outcomes after laparoscopical radical hysterectomy ( LRH ) on patients with cervical cancer and to elucidate the potential roles of the p53 : miR-34a : E2F1 and the p53 : miR-605 : Mdm2 signaling pathways in this therapy .


Twenty-one patients with stage IIB cervical cancer were recruited to this study and they were randomly divided into two groups : LRH ( n = 10 ) and NAC+LRH ( n = 11 ) groups .


The NAC+LRH group consisted of 4 cycles of cisplatin , paclitaxel and carboplatin .


Complication rates and NAC outcomes ( tumor size changes , 2-year disease-free survival rate , and 2-year overall survival rate ) were compared between the two groups .


Expression of p53 , Mdm2 , E2F1 , miR-34a , and miR-605 at mRNA and protein levels from the tumor tissues was analyzed .


We observed that the diameter of tumors following chemotherapy was substantially smaller in the NAC+LRH patients than in LRH patients .


No recurrence or metastasis after surgery was observed in the NAC+LRH patients , whereas 2 out of 10 LRH patients had recurrences and 1 had metastasis .


The 2-year disease-free and overall survival rates were apparently higher in the NAC+LRH group than in the LRH group .


Furthermore , molecular biology analyses revealed that the protein and mRNA levels of p53 were both markedly increased in patients who received NAC than those who did not , and oppositely , the levels of E2F1 and Mdm2 were significantly lower in the NAC+LRH patients than in the LRH patients .


The levels of miR-34a and miR-605 were considerably higher with NAC relative to without NAC .


Among the three anti-cancer drugs included in NAC , cisplatin was found to be the main component that caused increases in p53 protein levels , miR-34a and miR-605 miRNA levels , and decreases in Mdm2 and E2F1 protein levels .


Furthermore , ERK1/2 inhibitor U0126 or TAB1 siRNA mitigated these changes induced by cisplatin .


These findings not only indicate NAC as a rational approach for better treatment of cervical cancer with improved therapeutic outcomes , due partly to the ability of cisplatin to promote the p53 : miR-34a : E2F1 positive feed-forward loop and the p53 : miR-605 : Mdm2 positive feedback loop .


Infliximab ( IFX ) , a monoclonal chimeric antibody against tumour necrosis factor ( TNF ) , is effective for induction and maintenance of remission in moderate to severe Crohn 's disease .


Discontinuation of IFX maintenance therapy in patients in remission should be considered in order to reduce the potential long-term side effects and lower costs .


This is a prospective , double-blind , randomised , placebo-controlled , multicentre study of patients with luminal Crohn 's disease who have been treated with IFX for at least 1year and are in sustained complete clinical , biochemical and endoscopic remission ( ie , Crohn 's Disease Activity Index ( CDAI ) score < 150 , complete mucosal healing and biochemical markers of inflammation within the normal range ) .


These patients are randomised to receive placebo infusions or continue IFX maintenance therapy .


The primary end point is the proportion of patients in maintained remission after 48weeks ( def .


CDAI < 150 ) .


It is estimated that the knowledge gained about how to optimally handle patients with Crohn 's disease in complete long-term sustained remission on IFX is proportionate to the risks and inconveniences related to participation in this study .


Prolonged exposure to IFX may cause severe side effects and increased risk of malignancies .


Conversely , IFX discontinuation should not unnecessarily create a high risk of relapse .


Thus , empirical evidence is needed concerning the safety of discontinuing IFX once a patient exhibits sustained remission .


Study results will be published in an English language scientific medical journal .


The study is approved by the Danish Medicines Agency ( EudraCT-number : 2012-002702-51 ) and the Regional Ethics Committee of Region Hovedstaden Denmark ( Approval-number : H-4-2012-099 ) .


The project is reported to the Danish Data Protection Agency ( ID-number : 2007-58-0015 / HEH.750.89-27 ) , registered at Clinicaltrials.gov , and monitored by independent GCP units for the University of Copenhagen , Odense and Aarhus .


The current approved protocol is V. 3.2 , dated 1 June 2014 .


http://clinicaltrials.gov/show/NCT01817426 .


MK-5442 is an orally bioavailable calcium-sensing receptor antagonist that is hypothesized to stimulate bone formation by stimulating endogenous secretion of a pulse of PTH .


Earlier clinical and preclinical studies demonstrated increased bone mineral density ( BMD ) after treatment .


Our objective was to identify a dose of MK-5442 that produces osteoanabolic effects without excessive hypercalcemia .


This was a randomized , double-blind , placebo-controlled , parallel-group trial of private or institutional practice .


In total , 383 postmenopausal women with osteoporosis were administered daily oral MK-5442 ( 2.5 , 5 , 7.5 , 10 , or 15 mg ) or placebo .


Serum PTH and calcium , bone turnover markers , areal BMD , and safety were evaluated .


A dose-dependent transient increase in PTH occurred after an MK-5442 dose and lasted more than 3.5 hours .


Compared with placebo , significant increases in bone formation markers ( serum procollagen 1 N-terminal peptide and bone-specific alkaline phosphatase ) were observed by 6 months , whereas bone resorption markers ( serum C-telopeptide of type 1 collagen , urine N-telopeptides of type 1 collagen ) initially decreased but were also significantly increased by 6 months .


Despite the biochemical marker changes suggestive of an anabolic response , there were no statistically significant differences between any dose of MK-5442 and placebo in percent change from baseline at month 6 in any of the BMD endpoints .


The frequency of hypercalcemia ( trough serum calcium 10.8 mg/dL ) was greater with higher MK-5442 doses .


In postmenopausal women with low bone mass , treatment with MK-5442 resulted in transient pulses of PTH .


Bone formation markers increased quickly and bone resorption markers decreased temporarily , suggestive of an anabolic window .


However , there were no increases in BMD versus placebo .


The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial .


In a randomized , double-blind trial , we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism .


Eligible patients had right ventricular dysfunction on echocardiography or computed tomography , as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T.


The primary outcome was death or hemodynamic decompensation ( or collapse ) within 7 days after randomization .


The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization .


Of 1006 patients who underwent randomization , 1005 were included in the intention-to-treat analysis .


Death or hemodynamic decompensation occurred in 13 of 506 patients ( 2.6 % ) in the tenecteplase group as compared with 28 of 499 ( 5.6 % ) in the placebo group ( odds ratio , 0.44 ; 95 % confidence interval , 0.23 to 0.87 ; P = 0.02 ) .


Between randomization and day 7 , a total of 6 patients ( 1.2 % ) in the tenecteplase group and 9 ( 1.8 % ) in the placebo group died ( P = 0.42 ) .


Extracranial bleeding occurred in 32 patients ( 6.3 % ) in the tenecteplase group and 6 patients ( 1.2 % ) in the placebo group ( P < 0.001 ) .


Stroke occurred in 12 patients ( 2.4 % ) in the tenecteplase group and was hemorrhagic in 10 patients ; 1 patient ( 0.2 % ) in the placebo group had a stroke , which was hemorrhagic ( P = 0.003 ) .


By day 30 , a total of 12 patients ( 2.4 % ) in the tenecteplase group and 16 patients ( 3.2 % ) in the placebo group had died ( P = 0.42 ) .


In patients with intermediate-risk pulmonary embolism , fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke .


( Funded by the Programme Hospitalier de Recherche Clinique in France and others ; PEITHO EudraCT number , 2006-005328-18 ; ClinicalTrials.gov number , NCT00639743 . )


To investigate the effect of lung recruitment maneuver ( LRM ) with positive end-expiratory pressure ( PEEP ) on oxygenation and outcomes in preterm infants ventilated by proportional assist ventilation ( PAV ) for respiratory distress syndrome ( RDS ) .


Preterm infants on PAV for RDS after surfactant randomly received an LRM ( group A , n = 12 ) or did not ( group B , n = 12 ) .


LRM entailed increments of 0.2 cm H2O PEEP every 5 min , until fraction of inspired oxygen ( FiO2 ) = 0.25 .


Then PEEP was reduced and the lung volume was set on the deflation limb of the pressure/volume curve .


When saturation of peripheral oxygen fell and FiO2 rose , we reincremented PEEP until SpO2 became stable .


Group A and B infants were similar : gestational age 29.5 1.0 vs 29.4 0.9 weeks ; body weight 1314 96 vs 1296 88 g ; Silverman Anderson score for babies at start of ventilation 8.6 0.8 vs 8.2 0.7 ; initial FiO2 0.56 0.16 vs 0.51 0.14 , respectively .


The less doses of surfactant administered in group A than that in group B ( P < 0.05 ) .


Groups A and B showed different max PEEP during the first 12 h of life ( 8.4 0.5 vs 6.7 0.6 cm H2O , P = 0.00 ) , time to lowest FiO2 ( 101 18 versus 342 128 min ; P = 0.000 ) and O2 dependency ( 7.83 2.04 vs 9.92 2.78 days ; P = 0.04 ) .


FiO2 levels progressively decreased ( F = 43.240 , P = 0.000 ) and a/AO2 ratio gradually increased ( F = 30.594 , P = 0.000 ) .


No adverse events and no differences in the outcomes were observed .


LRM led to the earlier lowest FiO2 of the first 12 h of life and a shorter O2 dependency .


The purpose of this study was to evaluate the efficacy and safety of ( 177 ) Lu-EDTMP for pain palliation in patients with bone metastases from castration-resistant prostate and breast cancer .


The secondary objective was to compare low-dose and high-dose ( 177 ) Lu-EDTMP in bone pain palliation .


Included in the study were 44 patients with documented breast carcinoma ( 12 patients ; age 4713 years ) or castration-resistant prostate carcinoma ( 32 patients ; age 669 years ) and skeletal metastases .


Patients were randomized into two equal groups treated with ( 177 ) Lu-EDTMP intravenously at a dose of 1,295 MBq ( group A ) or 2,590 MBq ( group B ) .


Pain palliation was evaluated using a visual analogue score ( VAS ) , analgesic score ( AS ) and Karnofsky performance score ( KPS ) up to 16 weeks .


Toxicity was assessed in terms of haematological and renal parameters .


The overall response rate ( in all 44 patients ) was 86 % .


Complete , partial and minimal responses were seen in 6 patients ( 13 % ) , 21 patients ( 48 % ) and 11 patients ( 25 % ) , respectively .


A favourable response was seen in 27 patients ( 84 % ) with prostate cancer and in 11 patients ( 92 % ) with breast cancer .


There was a progressive decrease in the VAS from baseline up to 4 weeks ( p < 0.05 ) .


Also , AS decreased significantly from 1.80.7 to 1.20.9 ( p < 0.0001 ) .


There was an improvement in quality of life of the patients as reflected by an increase in mean KPS from 565 to 757 ( p < 0.0001 ) .


The overall response rate in group A was 77 % compared to 95 % in group B ( p = 0.188 ) .


There was a significant decrease in VAS and AS accompanied by an increase in KPS in both groups .


Nonserious haematological toxicity ( grade I/II ) was observed in 15 patients ( 34 % ) and serious toxicity ( grade III/IV ) occurred in 10 patients ( 23 % ) .


There was no statistically significant difference in haematological toxicity between the groups .


( 177 ) Lu-EDTMP was found to be a safe and effective radiopharmaceutical for bone pain palliation in patients with metastatic prostate and breast carcinoma .


There were no differences in efficacy or toxicity between patients receiving low-dose and high-dose ( 177 ) Lu-EDTMP .


To determine whether human patient simulation ( HPS ) is superior to case-based learning ( CBL ) in teaching diabetic ketoacidosis ( DKA ) and thyroid storm ( TS ) to pharmacy students .


In this cross-over , open-label , single center , randomized control trial , final-year undergraduate pharmacy students enrolled in an applied therapeutics course were randomized to HPS or CBL groups .


Pretest , posttest , knowledge retention tests , and satisfaction survey were administered to students .


One hundred seventy-four students participated in this study .


The effect sizes attributable to HPS were larger than CBL in both cases .


HPS groups performed significantly better in posttest and knowledge retention test compared to CBL groups pertaining to TS case ( p < 0.05 ) .


Students expressed high levels of satisfaction with HPS sessions .


HPS was superior to CBL in teaching DKA and TS to final-year undergraduate pharmacy students .


Platinum chemotherapy has a role in the treatment of metastatic triple-negative breast cancer but its full potential has probably not yet been reached .


We assessed whether a cisplatin plus gemcitabine regimen was non-inferior to or superior to paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer .


For this open-label , randomised , phase 3 , hybrid-designed trial undertaken at 12 institutions or hospitals in China , we included Chinese patients aged 18-70 years with previously untreated , histologically confirmed metastatic triple-negative breast cancer , and an ECOG performance status of 0-1 .


These patients were randomly assigned ( 1:1 ) to receive either cisplatin plus gemcitabine ( cisplatin 75 mg/m ( 2 ) on day 1 and gemcitabine 1250 mg/m ( 2 ) on days 1 and 8 ) or paclitaxel plus gemcitabine ( paclitaxel 175 mg/m ( 2 ) on day 1 and gemcitabine 1250 mg/m ( 2 ) on days 1 and 8 ) given intravenously every 3 weeks for a maximum of eight cycles .


Randomisation was done centrally via an interactive web response system using block randomisation with a size of eight , with no stratification factors .


Patients and investigator were aware of group assignments .


The primary endpoint was progression-free survival and analyses were based on all patients who received at least one dose of assigned treatment .


The margin used to establish non-inferiority was 12 .


If non-inferiority of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine was achieved , we would then test for superiority .


The trial is registered with ClinicalTrials.gov , number NCT01287624 .


From Jan 14 , 2011 , to Nov 14 , 2013 , 240 patients were assessed for eligibility and randomly assigned to treatment ( 120 in the cisplatin plus gemcitabine group and 120 in the paclitaxel plus gemcitabine group ) .


236 patients received at least one dose of assigned chemotherapy and were included in the modified intention-to-treat analysis ( 118 per group ) .


After a median follow-up of 163 months ( IQR 144-268 ) in the cisplatin plus gemcitabine group and 159 months ( 107-254 ) in the paclitaxel plus gemcitabine group , the hazard ratio for progression-free survival was 0692 ( 95 % CI 0523-0915 ; pnon-inferiority < 00001 , psuperiority = 0009 , thus cisplatin plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine .


Median progression-free survival was 773 months ( 95 % CI 616-930 ) in the cisplatin plus gemcitabine group and 647 months ( 576-718 ) in the paclitaxel plus gemcitabine group .


Grade 3 or 4 adverse events that differed significantly between the two groups included nausea ( eight [ 7 % ] vs one [ < 1 % ] ) , vomiting ( 13 [ 11 % ] vs one [ < 1 % ] ) , musculoskeletal pain ( none vs ten [ 8 % ] ) , anaemia ( 39 [ 33 % ] vs six [ 5 % ] ) , and thrombocytopenia ( 38 [ 32 % ] vs three [ 3 % ] ) , for the cisplatin plus gemcitabine compared with the paclitaxel plus gemcitabine groups , respectively .


In addition , patients in the cisplatin plus gemcitabine group had significantly fewer events of grade 1-4 alopecia ( 12 [ 10 % ] vs 42 [ 36 % ] ) and peripheral neuropathy ( 27 [ 23 % ] vs 60 [ 51 % ] ) , but more grade 1-4 anorexia ( 33 [ 28 % ] vs 10 [ 8 % ] ) , constipation ( 29 [ 25 % ] vs 11 [ 9 % ] ) , hypomagnesaemia ( 27 [ 23 % ] vs five [ 4 % ] ) , and hypokalaemia ( 10 [ 8 % ] vs two [ 2 % ] ) .


Serious drug-related adverse events were seen in three patients in the paclitaxel plus gemcitabine group ( interstitial pneumonia , anaphylaxis , and severe neutropenia ) and four in the cisplatin plus gemcitabine group ( pathological bone fracture , thrombocytopenia with subcutaneous haemorrhage , severe anaemia , and cardiogenic syncope ) .


There were no treatment-related deaths .


Cisplatin plus gemcitabine could be an alternative or even the preferred first-line chemotherapy strategy for patients with metastatic triple-negative breast cancer .


Shanghai Natural Science Foundation .


To compare the efficacy differences on delayed encephalopathy after carbon monoxide poisoning ( DEACMP ) between acupuncture to restore consciousness combined with hyperbaric oxygen treatment and simple hyperbaric oxygen treatment .


Forty-one patients with DEACMP were randomly divided into an observation group ( 21 cases ) and a control group ( 20 cases ) .


In the observation group , acupuncture was applied at Neiguan ( PC 6 ) , Shuigou ( GV 26 ) , Baihui ( GV 20 ) , Sishencong ( EX-HN 1 ) , Fengchi ( GB 20 ) , Hegu ( LI 4 ) , Sanyinjiao ( SP 6 ) and Taichong ( LR 3 ) , and hyperbaric oxygen treatment was given as well .


In the control group , simple hyperbaric oxygen treatment was used .


The treatment was adopted once every day , and continuous 5 days ' treatment made one session in the two groups .


There were two days at the interval between two sessions and 6 sessions in the two groups .


The changes of scores of mini mental state examination ( MMSE ) and Barthel index ( BI ) for activity of daily life and routine electroencephalogram ( EEG ) before and after treatment were compared .


After treatment , the scores of MMSE and BI and EEG were all improved compared with those before treatment ( all P < 0.01 ) .


The raise of the scores of MMSE and BI in the observation group was more obvious than that in the control group ( both P < 0.05 ) and the improvement of EEG abnormal condition in the observation group was also superior to that in the control group after treatment ( P < 0.05 ) .


Acupuncture to restore consciousness combined with hyperbaric oxygen could obviously improve the cognitive function , activity of daily life and changes of EEG , and it is better than simple hyperbaric oxygen treatment .


Because the blood circulation system of retina and brain are closely related to each other , we examined whether stroke is associated with localized retinal nerve fiber layer defects ( RNFLDs ) .


Patients with acute ischemic stroke as part of a hospital-based study group were compared with the participants of the population-based group Beijing Eye Study .


The retina was imaged by spectral-domain optical coherence tomography for the detection of localized RNFLDs .


The study included 154 patients with acute ischemic stroke and 2890 subjects from the Beijing Eye Study for whom optical coherence tomographic images of the retinal nerve fiber layer and data on a previous cerebral stroke were available .


In logistic regression analysis , acute stroke was significantly associated with localized RNFLDs ( P < 0.001 ; odds ratio , 6.23 ; 95 % confidence interval , 4.17-9 .30 ) after adjusting for age , male sex , arterial hypertension , diabetes mellitus , and higher concentration of the C-reactive protein .


In a similar manner , previous stroke was associated with localized RNFLDs ( P = 0.04 ; odds ratio , 1.48 ; 95 % confidence interval , 1.02-2 .16 ) in multivariate analysis .


In a reverse manner , presence of localized RNFLDs was associated with cerebral stroke ( P < 0.001 ; odds ratio , 3.54 ; 95 % confidence interval , 2.68-4 .67 ) after adjusting for age , sex , and prevalence of diabetes mellitus .


Localized RNFLDs showed a strong association with previous or acute cerebrovascular stroke and vice versa after adjustment for other systemic and ocular factors .


Localized RNFLDs that can be assessed by noninvasive optical coherence tomographic imaging may be added to the panoply of retinal morphological features of stroke .


Few data are published on the long-term follow-up of ipilimumab-induced hypophysitis , a cytotoxic T-lymphocyte antigen 4 antibody .


We characterized hypophysitis in terms of clinical signs , endocrinological profile , and imaging at diagnosis and during a long-term follow-up .


Fifteen patients , treated for malignant melanoma and who presented ipilimumab-induced hypophysitis , were observed between June 2006 and August 2012 in Timone Hospital , Marseille .


Symptoms , pituitary function , and pituitary imaging at diagnosis of hypophysitis and during the follow-up were recorded .


Of 131 patients treated with ipilimumab or a placebo , 15 patients ( 10mg/kg in 11/15 ) presented with hypophysitis ( 11.5 % ) at 9.55.9 weeks ( means.d . )


after treatment start , occurring in 66 % after the third infusion .


The main initial symptoms were headache ( n = 13 ) and asthenia ( n = 11 ) .


All patients but one had at least one hormonal defect : thyrotroph ( n = 13 ) , gonadotroph ( n = 12 ) , or corticotroph ( n = 11 ) deficiencies .


None had diabetes insipidus .


Pituitary imaging showed a moderately enlarged gland in 12 patients .


Clinical symptoms improved rapidly on high-dose glucocorticoids ( n = 11 ) or physiological replacement doses ( n = 4 ) .


At the end of follow-up ( median 33.6 months , range 7-53 .5 ) , corticotroph deficiency remained in 13 patients , 11 recovered thyrotroph and ten gonadotroph functions .


Pituitary imaging remained abnormal in 11 patients .


Ipilimumab-induced hypophysitis is a common side-effect with frequent hormonal deficiencies at diagnosis .


Usually , hormonal deficiencies improved , except for corticotroph function .


Patients receiving these immunomodulatory therapies should be closely monitored especially by systematic baseline hormone measurements after the third infusion and remain at a risk of adrenal insufficiency in the long-term .


The growing number of web-based psychological treatments , based on textual communication , generates a wealth of data that can contribute to knowledge of online and face-to-face treatments .


We investigated whether clients ' language use predicted treatment outcomes and adherence in Master Your Mood ( MYM ) , an online group course for young adults with depressive symptoms .


Among 234 participants from a randomised controlled trial of MYM , we tested whether their word use on course application forms predicted baseline levels of depression , anxiety and mastery , or subsequent treatment adherence .


We then analysed chat session transcripts of course completers ( n = 67 ) to investigate whether word use changes predicted changes in treatment outcomes .


Depression improvement was predicted by increasing use of ` discrepancy words ' during treatment ( e.g. should ) .


At baseline , more discrepancy words predicted higher mastery level .


Adherence was predicted by more words used at application , more social words and fewer discrepancy words .


Many variables were included , increasing the chance of coincidental results .


This risk was constrained by examining only those word categories that have been investigated in relation to depression or adherence .


This is the first study to link word use during treatment to outcomes of treatment that has proven to be effective in an RCT .


The results suggest that paying attention to the length of problem articulation at application and to ` discrepancy words ' may be wise , as these seem to be psychological markers .


To expand knowledge of word use as psychological marker , research on web-based treatment should include text analysis .


To investigate the safety and efficiency of the disposable circumcision suture device ( DCSD ) in the surgical treatment of phimosis and redundant prepuce .


We randomly assigned 249 outpatients with phimosis or redundant prepuce to be treated with DCSD ( n = 129 ) and by conventional circumcision ( CC , n = 120 ) , respectively .


Then we compared the safety and efficiency of the two strategies .


Comparisons between DCSD and CC showed that the operation time was ( 4.02 + / - 0.69 ) vs ( 30.8 + / - 4.05 ) min , blood loss was ( 1.07 + / - 1.29 ) vs ( 8.72 + / - 2.15 ) ml , intraoperative pain score was 0.81 + / - 0.81 vs 2.42 + / - 1.15 , 24-hour postoperative pain score was 1.84 + / - 1.02 vs 4.99 + / - 1.36 , postoperative complication rate was 13.95 % ( 18/129 ) vs 9.17 % ( 11/120 ) , wound healing time was ( 13.99 + / - 9.06 ) vs ( 17.48 + / - 3.49 ) d , satisfaction with the penile appearance was 98.4 % ( 127/129 ) vs 95 % ( 109/120 ) , and treatment cost was ( 2215.62 + / - 17.67 ) vs ( 576.47 + 15.58 ) Y RMB .


DCSD exhibited obvious superiority over CC for shorter operation time , less blood loss , milder intraoperative pain , sooner wound healing , and better penile appearance , but it also had a higher rate of postoperative complications ( P > 0.05 ) and involved more treatment cost than the latter ( P < 0.05 ) .


The disposable circumcision suture device affords ideal clinical effects and therefore deserves clinical popularization .


To report tolerability findings and maintenance of seizure control from a pooled analysis of phase I open-label trial OV-1015 ( NCT01079351 ) and phase III study 13181A ( NCT01128959 ) .


Patients receiving a stable oral dosage of carbamazepine were switched to an intravenous ( IV ) carbamazepine formulation solubilized in a cyclodextrin matrix ( at a 70 % dosage conversion ) for either a 15 - or a 30-min infusion every 6 h for up to 7 days and then switched back .


A subset of patients who tolerated 15-min infusions also received 2 - to 5-min ( rapid ) infusions .


Assessments included physical and laboratory evaluations , electrocardiography ( ECG ) studies , as well as adverse event ( AE ) monitoring for tolerability .


Convulsion/seizure AE terms and data from seizure diaries were used as proxies for the assessment of consistency of seizure control between formulations .


Of the 203 patients exposed to IV carbamazepine ( 30 min , n = 43 ; 15 min , n = 160 ) , 113 received 149 rapid infusions .


During infusion , the most commonly reported AEs ( 5 % ) were dizziness ( 19 % ) , somnolence ( 6 % ) , headache ( 6 % ) , and blurred vision ( 5 % ) .


IV carbamazepine was not associated with clinically relevant cardiac AEs .


The tolerability profile appeared similar between patients who received < 1,600 mg/day ( n = 174 ) and 1,600 mg/day ( n = 29 ) carbamazepine .


Cyclodextrin exposure was not associated with clinically relevant changes in AEs or renal biomarkers .


Seizure control was maintained as patients transitioned between oral and IV carbamazepine .


IV carbamazepine administered as multiple 30 - or 15-min infusions every 6 h , and as a single rapid infusion , was well tolerated as a short-term replacement in adults with epilepsy receiving stable dosages of oral carbamazepine .


Infusion site reactions , which were generally mild , were the only unique AEs identified ; seizure control was generally unchanged when patients were switching between formulations .


postoperative sore throat is the commonest complication after endotracheal intubation .


The efficacy of intravenous non-steroidal anti-inflammatory drugs in alleviating postoperative sore throat has not been investigated .


To evaluate the effect of intravenous diclofenac sodium on the occurrence and severity of postoperative sore throat .


42 in-patients scheduled for laparoscopic surgery were randomized into two equal groups to receive either a single dose of 75mg intravenous diclofenac sodium in addition to standard treatment taken at our hospital for the prevention of postoperative sore throat or to receive standard treatment only .


All patients were interviewed postoperatively at 2 , 6 and 18 hours .


Data of the baseline characteristics , the incidence and severity of sore throat were collected .


If sore throat was present , a Visual Analogue Score was used to assess its severity .


the baseline characteristics of the participants were similar .


The majority of the patients undergoing laparoscopic surgery were women .


There was no statistically significant difference in the occurrence or severity of postoperative sore throat between the diclofenac and standard treatment groups at 2 , 6 and 18 hours postoperatively .


Intravenous diclofenac sodium does not reduce the occurrence or severity of postoperative sore throat .


Several studies have demonstrated subpar chest compression ( CC ) performance by trained health care professionals .


The objective of this study was to determine the immediate and sustained effect of instantaneous audiovisual feedback on CC quality .


A prospective , randomized , crossover study measuring the effect of audiovisual feedback training on the performance of CCs by health care providers and medical students in a simulated cardiopulmonary arrest scenario was performed .


Compression rate , hand placement , depth , and recoil were collected using 60-second epochs of CC on a simulation mannequin .


Data from 200 initial enrollments and 100 tested 1 year later were analyzed by evaluators using standard criterion .


At initial testing , feedback trainees demonstrated significantly improved depth compliance , recoil compliance , and accuracy of hand placement .


One year later , the previous year 's control group now receiving feedback demonstrated immediate improvement in depth , hand placement , and rate .


In the feedback group , the only statistically significant improvement from initial baseline to the baseline 1 year later was an 18 % improvement in depth compliance .


However , the same improvement rate was seen in the control group .


Improved depth compliance performance was correlated to the number of cardiopulmonary resuscitation training sessions received external to the study .


Instantaneous audiovisual feedback training on CC quality produces immediate improvements in compression rate , hand placement , as well as depth and recoil compliance .


These improvements , however , are not retained 1 year later .


Improved depth performance may be correlated to an increased training frequency .


To evaluate the pharmacokinetics , safety and survival of trabectedin , metabolized primarily by cytochrome P450 ( CYP ) 3A4 enzyme , when coadministered with rifampin ( CYP3A4 inducer ) or ketoconazole ( CYP3A4 inhibitor ) in adult patients with advanced solid tumors .


Two phase 1/2a , 2-way crossover studies were conducted .


For rifampin study , 12 patients were randomized ( 1:1 ) to sequence of a cycle of trabectedin ( 1.3 mg/m ( 2 ) , 3 h , i.v. ) coadministered with rifampin ( 600 mg/day , 6-days ) , and a cycle of trabectedin monotherapy ( 1.3 mg/m ( 2 ) , 3 h , i.v. ) .


In ketoconazole study , eight patients were randomized ( 1:1 ) to sequence of a cycle of trabectedin ( 0.58 mg/m ( 2 ) , 3 h , i.v. ) coadministered with ketoconazole ( 200 mg , twice-daily , 15-doses ) , and a cycle of trabectedin monotherapy ( 1.3 mg/m ( 2 ) , 3 h , i.v. ) .


The systemic exposure ( geometric means ) of trabectedin was decreased [ 22 % ( C max ) and 31 % ( AUClast ) ] with rifampin coadministration and increased [ 22 % ( C max ) and 66 % ( AUClast ) ] with ketoconazole coadministration .


This correlated with an increased clearance with rifampin ( 39.6-59 .8 L/h ) and a decreased clearance with ketoconazole ( 20.3-12 .0 L/h ) .


Consistent with earlier studies , the most common ( 40 % ) treatment-emergent adverse events in both studies were nausea , vomiting , diarrhea , hepatic function abnormal , anemia , neutropenia , thrombocytopenia and leukopenia .


Coadministration of rifampin or ketoconazole altered the pharmacokinetics of trabectedin , but no new safety signals were observed .


Coadministration of trabectedin with potent CYP3A4 inhibitors or inducers should be avoided if possible .


If coadministration of trabectedin with a strong CYP3A4 inhibitor is required , close monitoring for toxicities is recommended , so that appropriate dose reductions can be instituted as warranted .


Anaemia in pregnancy is a major public health problem especially in the low-income countries where it is highly prevalent .


There has been no recent study in Uganda about the factors associated with anaemia in pregnancy .


We aimed to assess the current haemoglobin ( Hb ) status and factors associated with anaemia ( Hb < 11.0 g/dl ) in pregnant women in Mpigi , Uganda .


We assessed Hb levels of 2436 pregnant women at 28 + weeks of gestation at six health facilities , who were approached to participate in a stepped-wedge cluster-randomised trial of antenatal distribution of misoprostol ( for self-administration after home birth or when oxytocin is not available ) .


Women were administered a questionnaire and their baseline blood haemoglobin was examined using portable HemoCueR Hb 301 system .


Predictors of anaemia were estimated using linear and logistic regression analysis .


The mean Hb was 11.5 ( 1.38 ) g/dl and prevalence of anaemia ( Hb < 11.0 g/dl ) was 32.5 % ( 95 % CI 30.6 % , 34.3 % ) .


After adjusting for measured confounders , factors associated with increased risk of anaemia in pregnancy were malaria infection ( OR : 1.32 , 95 % CI : 1.11 , 1.58 ) , Human Immuno-deficiency Virus infection ( OR : 2.13 , 95 % CI : 1.36 , 2.90 ) and lack of iron supplementation ( OR : 1.66 , 95 % CI : 1.36 , 2.03 ) .


Intermittent presumptive treatment of malaria , maternal age and parity showed a weak association with anaemia in pregnancy


The high prevalence of anaemia in pregnancy in our setting highlights the need to put more effort in the fight against malaria and HIV , and also ensure that pregnant women access iron supplements early in pregnancy .


Cannabis is widely abused , and efficacies of therapeutics for cannabis dependence remain suboptimal .


Magnetic resonance imaging ( MRI ) may aid in the identification of biological markers for successful treatment outcomes ( i.e. , abstinence ) .


Twenty men with cannabis dependence and twenty non-substance-using healthy comparison ( HC ) men underwent MRI scanning .


Cannabis-dependent individuals then participated in a 12-week randomized clinical trial of behavioral treatments ( contingency management ( CM ) , cognitive behavioral therapy ( CBT ) or both ) .


Pretreatment functional and structural data were compared between the cannabis-dependent and HC participants .


In addition , individuals with cannabis dependence were subdivided based on the successful achievement of 21 days of consecutive abstinence during treatment to assess whether abstinent versus non-abstinent cannabis-dependent participants displayed different pretreatment functional and structural characteristics when compared to HC participants .


In comparison to HC participants , cannabis-dependent participants demonstrated greater ventral striatal activation during the receipt of losing outcomes and smaller putamenal volumes .


Cannabis-dependent participants who did not subsequently achieve 21 days of consecutive abstinence had increased activity within the striatum during the receipt of losing outcomes , relative to HC participants .


Cannabis-dependent participants who did not achieve 21 days of abstinence had decreased bilateral putamen volumes prior to treatment , relative to HC participants .


Individual differences in pretreatment striatal function and structure may relate to individual differences in treatment responses for cannabis dependence .


While mechanisms underlying these associations require further exploration , the striatum might mediate treatment responses via its role in associative reward-learning ( e.g. , through skills training in CBT or reinforcement of abstinence in CM ) .


To assess LDL subfraction phenotype and lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) in naive HIV-infected patients starting atazanavir/ritonavir or darunavir/ritonavir plus tenofovir/emtricitabine .


This was a substudy of a multicentre randomized study .


Standard lipid parameters , LDL subfraction phenotype ( by gradient gel electrophoresis ) and Lp-PLA2 activity ( by 2-thio-PAF ) were measured at baseline and weeks 24 and 48 .


Multivariate regression analysis was performed .


Results are expressed as the median ( IQR ) .


Eighty-six ( atazanavir/ritonavir , n = 45 ; darunavir/ritonavir , n = 41 ) patients were included : age 36 ( 31-41 ) years ; 89 % men ; CD4 319 ( 183-425 ) cells/mm ( 3 ) ; and Framingham score 1 % ( 0 % -2 % ) .


No differences in demographics or lipid measurements were found at baseline .


At week 48 , a mild but significant increase in total cholesterol and HDL-cholesterol was observed in both arms , whereas LDL cholesterol increased only in the darunavir/ritonavir arm and triglycerides only in the atazanavir/ritonavir arm .


The apolipoprotein A-I/apolipoprotein B ratio increased only in the atazanavir/ritonavir arm .


At week 48 , the LDL subfraction phenotype improved in the darunavir/ritonavir arm ( increase in LDL particle size and in large LDL particles ) , whereas it worsened in the atazanavir/ritonavir arm ( increase in small and dense LDL particles , shift to a greater prevalence of phenotype B ) ; the worsening was related to the greater increase in triglycerides in the atazanavir/ritonavir arm .


No changes in total Lp-PLA2 activity or relative distribution in LDL or HDL particles were found at week 48 in either arm .


In contrast with what occurred in the atazanavir/ritonavir arm , the LDL subfraction phenotype improved with darunavir/ritonavir at week 48 .


This difference was associated with a lower impact on plasma triglycerides with darunavir/ritonavir .


To compare once - versus twice-daily insulin detemir added on OADS therapy in insulin-naive type 2 diabetes patients in terms of efficacy and safety .


An open-label study performed at a single center , comprised a randomized , crossover 24 week with insulin-naive type 2 diabetes patients .


Insulin detemir was initiated with mean 0.12 U/kg in all patients ( Group I once-daily , Group II twice-daily ) and titrated for 24 week .


A total of 50 patients completed the study ( Group I n :25 , Group II n :25 ) .


With use of once - and twice-daily insulin , HbA1c values were decreased by 1.8 % ( 2.0 ) and 1.5 % ( 1.4 ) within the first 12 weeks ( p < 0.01 ) , whereas increased by 0.21 % ( 0.7 ) and 0.14 % ( 0.8 ) in the second 12 weeks ( p > 0.05 ) .


The increases in the insulin doses were found as 0.22 U/kg and 0.35 U/kg with once - and twice-daily insulin use , respectively ( p :0.04 ) .


Although minor hypoglycemic events were similar in both groups in the first 12 weeks , 2-fold increase was found in the patients shifting from once - to twice-daily dose .


Within the first and second periods , the body weight of the patients was observed an increase of 0.4 and 1.6 kg with once-daily dose , whereas a decrease of 0.1 and 2.1 kg in the twice-daily dose , in the same period .


Once-daily use of insulin detemir up to 0.4 U/kg was found to have similar efficacy and safety as twice-daily use .


Twice dose use of insulin did not provide a prominent glycemic control advantage on 1.5-fold higher use of insulin .


We investigated whether mutations in the gene encoding the phosphatidylinositol 3-kinase ( PI3K ) catalytic subunit ( PIK3CA ) correlates with response to neoadjuvant human epidermal growth factor receptor 2 ( HER2 ) - targeted therapies in patients with breast cancer .


Baseline tissue biopsies were available from patients with HER2-positive early breast cancer who were enrolled onto the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization trial ( NeoALTTO ) .


Activating mutations in PIK3CA were identified using mass spectrometry-based genotyping .


PIK3CA mutations were identified in 23 % of HER2-positive breast tumors , and these mutations were associated with poorer outcome in all of the treatment arms .


Patients treated with a combination of trastuzumab and lapatinib who had wild-type PIK3CA obtained a total pathologic complete response ( pCR ) rate of 53.1 % , which decreased to 28.6 % in patients with tumors that carried PIK3CA activating mutations ( P = .012 ) .


Activating mutations in PIK3CA predicted poor pCR in patients with HER2-positive breast cancer treated with neoadjuvant therapies that target HER2 .


Consequently , the combination of anti-HER2 agents and PI3K inhibitors is being investigated .


Intravenous rituximab is a mainstay of treatment for follicular lymphoma .


A subcutaneous formulation that achieves equivalent rituximab serum concentrations might improve convenience and save health-care resources without sacrificing clinical activity .


We aimed to assess pharmacokinetic non-inferiority of 3 week cycles of fixed-dose subcutaneous rituximab versus standard intravenous rituximab .


In our two-stage , randomised , open-label , phase 3 trial , we enrolled patients with previously untreated grade 1-3a , CD20-positive follicular lymphoma at 67 centres in 23 countries .


In stage 1 , we randomly allocated patients 1:1 with the Pocock and Simon algorithm to intravenous rituximab ( 375 mg/m ( 2 ) ) or fixed-dose subcutaneous rituximab ( 1400 mg ) , stratified by induction chemotherapy regimen ( cyclophosphamide , doxorubicin , vincristine , prednisone or cyclophosphamide , vincristine , prednisone ) , Follicular Lymphoma International Prognostic Index score , and region .


After randomisation , patients received one induction dose of intravenous rituximab in cycle 1 and then allocated treatment for cycles 2-8 .


Patients with a complete or partial response following induction therapy continued intravenous or subcutaneous rituximab as maintenance every 8 weeks .


The primary endpoint was the ratio of observed rituximab serum trough concentrations ( Ctrough ) between groups at cycle 7 ( before cycle 8 dosing ) of induction treatment in a per-protocol population .


Patients were analysed as treated for safety endpoints .


Stage 2 follow-up is ongoing and is fully accrued .


This study is registered with ClinicalTrials.gov , number NCT01200758 .


Between Feb 4 , 2010 , and Oct 21 , 2011 , we enrolled 127 patients .


Pharmacokinetic data were available for 48 ( 75 % ) of 64 patients randomly allocated intravenous rituximab and 54 ( 86 % ) of 63 patients randomly allocated subcutaneous rituximab .


Geometric mean Ctrough was 8313 g/mL in the intravenous group and 13458 g/mL in the subcutaneous group ( ratio 162 , 90 % CI 136-194 ) , showing non-inferiority of subcutaneous rituximab .


57 ( 88 % ) of 65 patients in the intravenous rituximab safety population had adverse events ( 30 [ 46 % ] grade 3 ) , as did 57 ( 92 % ) of 62 patients in the subcutaneous rituximab safety population ( 29 [ 47 % ] grade 3 ) .


The most common grade 3 or worse adverse event in both groups was neutropenia ( 14 [ 22 % ] patients in the intravenous group and 16 [ 26 % ] patients in the subcutaneous group ) .


Adverse events related to administration were mostly grade 1-2 and occurred in 21 ( 32 % ) patients in the intravenous group and 31 ( 50 % ) patients in the subcutaneous group .


Stage 1 data show that the pharmacokinetic profile of subcutaneous rituximab was non-inferior to intravenous rituximab and was not associated with new safety concerns .


Stage 2 will provide data for efficacy and safety of the subcutaneous administration .


F Hoffmann-La Roche .


To evaluate mediators of resumption of menses ( ROM ) in adolescents with anorexia nervosa ( AN ) .


Anthropometrics , body composition by dual-energy X-ray absorptiometry , hormonal studies , and responses to mental health screens were obtained at 6-month intervals for 18 months in 37 adolescents with AN randomized to the placebo arm of a double-blind treatment trial .


Outcomes were compared between subjects with menstrual recovery and those without .


Twenty-four subjects ( 65 % ) had ROM .


Higher percentage body fat was associated with ROM ( odds ratio , 1.19 ; 95 % confidence interval , 1.06 , 1.33 ; p < .01 ) , as was body mass index and percent median body weight .


Estradiol 30 ng/mL alone did not predict menses ( p = .08 ) but was associated with ROM when coupled with percent mean body weight ( odds ratio , 2.49 ; 95 % confidence interval , 1.09 , 5.65 ; p = .03 ) .


Changes in leptin , cortisol , and mental health were not associated with return of menses .


Percentage body fat may be an additional , useful clinical assessment to follow in caring for adolescents with AN .


This study aimed to analyse data from two different studies ( phase II and phase III ) regarding the safety and efficacy of treatment with alum formulated glutamic acid decarboxylase GAD65 ( GAD-alum ) at 30 months after administration to children and adolescents with type 1 diabetes .


The phase II trial was a double-blind , randomised placebo-controlled study , including 70 children and adolescents who were followed for 30 months .


Participants received a subcutaneous injection of either 20g of GAD-alum or placebo at baseline and 1month later .


During a subsequent larger European phase III trial including three treatment arms , participants received two or four subcutaneous injections of either 20g of GAD-alum and/or placebo at baseline , 1 , 3 and 9 months .


The phase III trial was prematurely interrupted at 15months , but of the 148 Swedish patients , a majority completed the 21months follow-up , and 45 patients completed the trial at 30months .


Both studies included GAD65 auto-antibodies-positive patients with fasting C-peptide 0.10 nmol/l .


We have now combined the results of these two trials .


There were no treatment related adverse events .


In patients treated with 2 GAD-alum doses , stimulated C-peptide area under the curve had decreased significantly less ( 9 m : p < 0.037 ; 15m : p < 0.032 ; 21m : p < 0.003 and 30 m : p < 0.004 ) , and a larger proportion of these patients were also able to achieve a peak stimulated C-peptide > 0.2 nmol/L ( p < 0.05 ) , as compared with placebo .


Treatment with two doses of GAD-alum in children and adolescents with recent-onset type 1 diabetes shows no adverse events and preserves residual insulin secretion .


Studies have shown sodium restriction to have a beneficial effect on blood pressure ( BP ) of hypertensive patients .


To evaluate the impact of light salt substitution for regular salt on BP of hypertensive patients .


Uncontrolled hypertensive patients of both sexes , 20 to 65 years-old , on stable doses of antihypertensive drugs were randomized into Intervention Group ( IG - receiving light salt ) and Control Group ( CG - receiving regular salt ) .


Systolic BP ( SBP ) and diastolic BP ( DBP ) were analyzed by using casual BP measurements and Home Blood Pressure Monitoring ( HBPM ) , and sodium and potassium excretion was assessed on 24-hour urine samples .


The patients received 3 g of salt for daily consumption for 4 weeks .


The study evaluated 35 patients ( 65.7 % women ) , 19 allocated to the IG and 16 to the CG .


The mean age was 55.5 7.4 years .


Most participants had completed the Brazilian middle school ( up to the 8th grade ; n = 28 ; 80.0 % ) , had a family income of up to US$ 600 ( n = 17 ; 48.6 % ) and practiced regular physical activity ( n = 19 ; 54.3 % ) .


Two patients ( 5.7 % ) were smokers and 40.0 % consumed alcohol regularly ( n = 14 ) .


The IG showed a significant reduction in both SBP and DBP on the casual measurements and HBPM ( p < 0.05 ) and in sodium excretion ( p = 0.016 ) .


The CG showed a significant reduction only in casual SBP ( p = 0.032 ) .


The light salt substitution for regular salt significantly reduced BP of hypertensive patients .


Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world .


Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora , which can influence the gut-liver axis .


The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis , liver enzymes , and inflammatory markers in patients with NAFLD .


In a randomized , double-blind , placebo-controlled clinical trial conducted as a pilot study , 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule .


Both groups were advised to follow an energy-balanced diet and physical activity recommendations .


At the end of the study , the alanine aminotransferase ( ALT ) concentration decreased in both groups ; this reduction was significantly greater in the synbiotic group .


At the end of the study , the following significant differences [ means ( 95 % CIs ) ] were seen between the synbiotic and placebo groups , respectively : ALT [ -25.1 ( -26.2 , -24 ) compared with -7.29 ( -9.5 , -5.1 ) IU/L ; P < 0.001 ] , aspartate aminotransferase [ -31.33 ( -32.1 , -30.5 ) compared with -7.94 ( -11.1 , -4.8 ) IU/L ; P < 0.001 ] , - glutamyltransferase [ -15.08 ( -15.5 , -14.7 ) compared with -5.21 ( -6.6 , -3.9 ) IU/L ; P < 0.001 ] , high-sensitivity C-reactive protein [ -2.3 ( -3 , -1.5 ) compared with -1.04 ( -1.5 , -0.6 ) mmol/L ; P < 0.05 ] , tumor necrosis factor - [ -1.4 ( -1.7 , -1.1 ) compared with -0.59 ( -0.8 , -0.3 ) mmol/L ; P < 0.001 ] , total nuclear factor - B p65 [ -0.016 ( -0.022 , -0.011 ) compared with 0.001 ( -0.004 , -0.007 ) mmol/L ; P < 0.001 ] , and fibrosis score as determined by transient elastography [ - 2.98 ( -3.6 , -2.37 ) compared with -0.77 ( -1.32 , -0.22 ) kPa ; P < 0.001 ] .


Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD , at least partially through attenuation of inflammatory markers in the body .


Whether these effects will be sustained with longer treatment durations remains to be determined .


Recently , aflibercept was proposed with a protocol of a bimonthly fixed regimen .


Our purpose was to evaluate the results of this regimen in patients treated with ranibizumab .


We conducted a retrospective analysis of consecutive patients with nave neovascular age-related macular degeneration treated with a bimonthly fixed regimen of intravitreal injections of ranibizumab after 3 monthly injections .


Examination was performed every 4 weeks for 52 weeks , with the possibility of unscheduled rescue injections of ranibizumab .


A total of 27 patients , 24 women and 3 men , aged from 68 to 90 years ( mean : 81.2 ) were analyzed ; 25 eyes ( 92.5 % ) lost < 15 letters .


Mean BCVA rose from 58.3 ( range 12.9 ) to 66.7 ( range 14.3 ) letters .


The mean visual gain was 8.40 ( range 13.2 ) letters ; 11 patients ( 40.7 % ) gained 15 letters .


The mean number of injections of ranibizumab was 8.77 .


Bimonthly intravitreal ranibizumab achieved satisfactory visual results .


However , patients who required additional injections did not experience significant visual gain .


To assess the first-dose effectiveness and tolerability of metadoxine extended release ( MDX ) in adults with predominantly inattentive attention-deficit/hyperactivity disorder ( ADHD-PI ) .


In this double-blind , placebo-controlled , crossover study , adults with ADHD-PI were randomized 1:1:1 to receive a single dose of MDX 1400 mg , MDX 700 mg , and placebo ( ClinicalTrials.gov identifier : NCT01685281 ) .


The primary efficacy end point was the mean change in the Test of Variables of Attention ( TOVA ) ADHD score from baseline to 3 to 5 hours after drug administration .


Secondary assessments included TOVA subscores , TOVA response rates ( defined as an increase of 0.8 points in the TOVA ADHD score ) , and the Cambridge Neuropsychological Automated Test Battery .


Safety assessments included adverse events and vital signs .


The intention-to-treat population included 36 patients ( 52.8 % men ; mean age , 32 years ) .


The efficacy of MDX 1400 mg was demonstrated by a statistically significant difference in the mean ( SD ) change in the TOVA ADHD score at baseline to 3 to 5 hours after drug administration compared with placebo ( 2.0 [ 4.2 ] ; P = 0.009 ) .


The TOVA response time variability subscore was significantly different between MDX 1400 mg and placebo ( mean difference , 7.9 [ 19.2 ] points ; P = 0.022 ) .


Significantly more adults responded to single-dose MDX 1400 mg versus placebo ( 97.1 % vs 71.4 % , P = 0.006 ) .


There were no statistically significant differences between MDX 700 mg and placebo on any measures .


Exploratory analyses of the Cambridge Neuropsychological Automated Test Battery did not yield significant findings .


Fatigue and headache were the 2 most frequently reported adverse events .


There were no clinically significant abnormalities in laboratory values , vital signs measurements , Columbia-Suicide Severity Rating Scale scores , or electrocardiographic parameters .


Single-dose MDX 1400 mg significantly improved sustained and selective attention in adults with ADHD-PI as measured by the TOVA ADHD score 3 to 5 hours after drug administration .


Single doses of MDX 700 and 1400 mg were well tolerated .


The insertion of central venous access devices , such as totally implantable venous access ports ( TIVAPs ) , is routine in patients who need a safe and permanent venous access .


The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies .


Currently , two different strategies are being routinely used : surgical cut-down of the cephalic vein ( vena section ) and direct puncture of the subclavian vein .


The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax .


The PORTAS-3 trial is designed as a multicentre , randomised controlled trial to compare two implantation strategies .


A total of 1,154 patients will be randomised after giving written informed consent .


Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the designated side .


The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies .


The experimental intervention is as follows : open strategy , defined as surgical cut-down of the cephalic vein , supported by a rescue technique if necessary , and in the case of failure , direct puncture of the subclavian vein .


The control intervention is as follows : direct puncture of the subclavian vein using the Seldinger technique guided by sonography , fluoroscopy or landmark technique .


The trial duration is approximately 36 months , with a recruitment period of 18 months and a follow-up period of 30 days .


The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax .


Since TIVAP implantation is one of the most common procedures in general surgery , the results will be of interest for a large community of surgeons as well as oncologists and general practitioners .


The pragmatic trial design ensures that the results will be generalizable to a wide range of patients .


The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register ( DRKS00004900 ) .


The World Health Organization 's Universal Trial Number is U1111-1142-4420 .


We performed this randomized trial to compare the recovery profile of patients receiving single injection ( SISB ) and continuous interscalene brachial plexus block ( CISB ) or general anesthesia ( GA ) for arthroscopic rotator cuff repair surgery through the first postoperative week .


Our primary hypothesis was that the highest pain numeric rating scale ( NRS ) ( worst pain score ) at the end of the study week would be lower for patients in the CISB group than for patients in the SISB or GA groups .


Seventy-one patients scheduled for elective outpatient arthroscopic rotator cuff repair were enrolled .


CISB patients received 20 mL of 0.5 % ropivacaine as a bolus through a catheter , whereas SISB patients received the same injection volume through a needle .


CISB patients received an infusion of 0.2 % ropivacaine at 5 mL/h with a patient-controlled bolus of 5 mL hourly for 48 hours .


GA-only patients received a standardized general anesthetic .


Postoperative highest NRS pain scores through the first postoperative week , time-to-first pain , analgesic consumption , fast-tracked postoperative anesthesia care unit ( PACU ) bypass rate , length of PACU stay , time-to-discharge home , total hours of sleep , and related adverse effects were recorded in the PACU and at home on postoperative days 1 , 2 , 3 , and 7 .


No patient in the CISB or SISB groups reported a NRS 1 or required analgesics while in the PACU .


While most patients in the CISB and SISB groups were fast-tracked to PACU discharge , no patient in the GA group was fast-tracked ( P = 0.003 ) .


Length of stay in the PACU was significantly shorter for the CISB and SISB groups than for the GA group ( 20 31 , 30 42 , and 165 118 minutes , respectively ( CISB vs GA , P < 0.001 ; SISB vs GA , P < 0.001 ) , and time-to-discharge home was significantly shorter when compared with the GA group .


Time to first pain report was longer in the CISB group .


Mean NRS scores were lower for patients in the CISB group than in the SISB and GA groups on postoperative days 1 and 2 , and use of narcotics ( doses 1 ) was lower until postoperative day 3 .


Patients who received CISB slept significantly longer than patients who received SISB or GA ( P < 0.01 ) during the first 48 hours postoperatively .


By the end of the study week , 26 % of patients in the CISB group , 83 % in the SISB group , and 58 % of GA patients reported NRS 4 ( both P-values 0.05 ) .


The analgesic benefits of CISB found in the PACU and immediately after discharge extend through the intermediate recovery period ending on postoperative day 7 .


The present study was designed to understand the role of inflammatory cytokines secreted by corneal epithelial cells in keratoconus ( KC ) and the response to treatment with cyclosporine A ( CyA ) .


The study involved 129 Indian KC patients clinically graded according to Amsler-Krumeich classification and 20 healthy , nonectatic subjects as controls .


Tear levels of matrix metalloproteinase-9 ( MMP9 ) , interleukin-6 ( IL6 ) , and tumor necrosis factor - ( TNF ) were measured using ELISA kits .


Gene expression was measured by qPCR in corneal epithelial cells obtained by debridement from subjects undergoing ocular surface surgeries .


In addition , epithelial cells were stimulated with TNF and treated with CyA to study its role on MMP9 expression .


Finally , 20 KC patients ( 27 eyes ) with inflammatory symptoms were treated with topical CyA application .


We observed that MMP9 , TNF , and IL6 levels were strongly upregulated at the mRNA level in KC patient epithelia .


Similarly , tears collected from KC patients exhibited high levels of MMP9 and IL6 protein .


Cyclosporine A treatment significantly reduced the mRNA expression levels of IL6 and TNF in both short - and long-term treatments ; however , it reduced MMP9 levels only in long-term treatment in cultured corneal epithelial cells .


Subsequent treatment of KC patients with CyA for approximately 6 months reduced tear MMP9 levels and led to local reduction in corneal curvatures as determined by corneal topography maps .


The data indicate that corneal epithelium contributes to elevated MMP9 and inflammatory cytokine expression in tears of KC patients .


Cyclosporine A treatment reduced MMP9 and inflammatory cytokine levels in an in vitro inflammation model system .


In KC patients , CyA treatment reduced MMP9 levels measured in tears with concomitant arrest of disease progression .


Therefore , CyA might be a novel treatment strategy in KC patients but requires additional evaluation in larger cohorts .


( ClinicalTrials.gov number , NCT01746823 . )


To evaluate the effectiveness of the monotherapy of Cardura and the combination therapy of Cardura and Tolterodine L-Tartrate Tablets for II ?


benign prostate hyperplasia ( BPH ) with overactive bladder ( OAB ) .


This study included 87 cases of BPH with OAB , with a disease course > or = 3 months , daily urination > or = 8 times , nocturnal urination > or = 2 times , urine volume < 200 ml per time , International Prostate Symptom Score ( IPSS ) > or = 8 , OAB symptom score ( OABS ) > or = 3 , quality of life score ( QOL ) > or = 3 , post-void residual ( PVR ) < or = 100 ml , maximum urinary flow ( Qmax ) > or = 5 ml/s , prostate weight 25-50 g , and PSA < 4 microg/L .


We randomized the patients to a monotherapy group ( n = 44 ) and combination group ( n = 43 ) , the former treated with Cardura 4 mg qd , and the latter with Cardura 4 mg + Tolterodine L-Tartrate Tablets 4 mg qd , both for 8 weeks .


Then we recorded the IPSS , OABS , Qmax , PVR , PSA , and adverse events .


The baseline parameters showed no significant differences between the two groups ( P > 0.05 ) .


In comparison with the baseline , both the monotherapy group and the combination therapy group showed significant decreased in the IPSS ( 16.50 + / - 4.27 vs 13.68 + / - 3.69 and 15.51 + / - 3.80 vs 11.49 + / - 2.75 ) , urine storage symptom score ( 10.48 + / - 2.75 vs 7.98 + / - 2.34 and 9.47 + / - 2.31 vs 5.74 + / - 1.66 ) , OABS ( 8.55 + / - 2.69 vs 6.32 + / - 1.97 and 8.21 + / - 2.55 vs 4.44 + / - 1.62 ) , urgent micturition score ( 4.25 + / - 1.06 vs 3.23 + / - 0.99 and 4.07 + / - 0.83 vs 2.26 + / - 1.05 ) , QOL ( 5.36 + / - 0.72 vs 3.43 + / - 0.66 and 5.07 + / - 0.86 vs 2.37 + / - 0.76 ) and PVR ( [ 44.55 + / - 22.39 ] vs [ 38.30 + / - 20.20 ] ml and [ 36.19 + / - 21.21 ] vs [ 24.98 + / - 17.60 ] ml ) ( P < 0.01 ) .


All the six parameters were significantly more improved in the combination therapy group than in the monotherapy group ( P < 0.01 ) , but there were no remarkable differences between the groups in Qmax and voiding symptom score ( P > 0.05 ) .


Neither group exhibited significant changes in the PSA level and prostate weight after treatment as compared with the baseline ( P > 0.05 ) .


No acute urinary retention and other severe adverse reactions were observed during the medication .


Both Cardura monotherapy and the combination therapy of Cardura + Tolterodine L-Tartrate Tablets can improve II ?


BPH with OAB , and the latter has an even better efficacy than the former .


This study was conducted to assess the impact of left ventricular ( LV ) lead position on longer-term survival after cardiac resynchronization therapy ( CRT ) .


An optimal LV lead position in CRT is associated with improved clinical outcome .


A strategy of speckle-tracking echocardiography can be used to guide the implanter to the site of latest activation and away from segments of low strain amplitude ( scar ) .


Long-term , prospective survival data according to LV lead position in CRT are limited .


Data from a follow-up registry of 250 consecutive patients receiving CRT between June 2008 and July 2010 were studied .


The study population comprised patients recruited to the derivation group and the subsequent TARGET ( Targeted Left Ventricular Lead Placement to guide Cardiac Resynchronization Therapy ) randomized , controlled trial .


Final LV lead position was described , in relation to the pacing site determined by pre-procedure speckle-tracking echocardiography , as optimal ( concordant/adjacent ) or suboptimal ( remote ) .


All-cause mortality was recorded at follow-up .


An optimal LV lead position ( n = 202 ) conferred LV remodeling response superior to that of a suboptimal lead position ( change in LV end-systolic volume : -24 15 % vs. -12 17 % [ p < 0.001 ] ; change in ejection fraction : +7 8 % vs. +4 7 % [ p = 0.02 ] ) .


During long-term follow-up ( median : 39 months ; range : < 1 to 61 months ) , an optimal LV lead position was associated with improved survival ( log-rank p = 0.003 ) .


A suboptimal LV lead placement independently predicted all-cause mortality ( hazard ratio : 1.8 ; p = 0.024 ) .


An optimal LV lead position at the site of latest mechanical activation , avoiding low strain amplitude ( scar ) , was associated with superior CRT response and improved survival that persisted during follow-up .


To determine patient recall of specific risks associated with medication prescription and whether or not handouts are an effective tool to augment the informed consent process .


Double-blinded , randomized , controlled trial .


Informed consent for prednisone prescriptions was studied by comparing the effect of a verbal discussion ( describing 10 specific adverse drug reactions ) in conjunction with a handout going over same , to a verbal discussion alone .


Blinded assessments occurred by telephone interview 2 to 4 weeks following the intervention .


Outcomes assessed were the number of risks of prednisone that patients could list and the number of risks they recalled having discussed with their physician .


Other demographic details were also collected .


Twenty-five participants were randomly allocated to each group .


Without prompting , the median number of risks spontaneously recalled by the handout group was not significantly different than the control group , and both groups had very low recall ( two vs. one , P = .24 ) .


When provided a list of potential side effects , it was observed that the handout group recalled a higher median number of risks having been discussed with their physician compared to patients in the control group ( eight vs. five , P = .003 ) .


The groups ' demographics were otherwise identical .


Patients in general did not remember discussing adverse prednisone risks with their physician even a short time after the discussion took place .


Although the patient handout resulted in improved recall of risks following the prescription of prednisone , its importance in the informed medication consent process remains an open question .


1b .


Monosymptomatic nocturnal enuresis ( MNE ) is a common sociomedical problem affecting children that may persist until adulthood despite various lines of therapy .


The aim of this study was to assess the efficacy of combined laser acupuncture and desmopressin in managing patients with resistant MNE , compared with their efficacy when used as monotherapy .


The study included 186 patients with a mean age of 15.7 years ( range 10-21 years ) presenting with persistent MNE .


All patients were evaluated clinically and investigated with urine analysis , plain X-ray of the urinary tract and abdominal ultrasonography .


They were randomized into three equal groups based on the line of management : group A , managed with laser acupuncture alone ; group B , managed with desmopressin alone ; and group C , managed with a combination of laser acupuncture and desmopressin , with a treatment course of 3 months and follow-up period of 6 months to record the efficacy of therapy , side-effects and bladder capacity .


A statistically significant higher cure rate was reported in group C patients , being reported in 33 , 35 and 46 patients in groups A , B and C , respectively .


Improvement was reported in 18 , 17 and 13 cases in groups A , B and C , respectively , but the difference was not statistically significant .


Bladder capacity significantly increased only in patients receiving acupuncture ( groups A and C ) .


Combined laser acupuncture and desmopressin is a promising and valid option to manage resistant cases of MNE .


Obesity among Black women continues to exceed that of other women .


Most weight loss programs created without reference to specific cultural contexts are less effective for Black than White women .


Weight control approaches accessible to Black women and adapted to relevant cultural contexts are important for addressing this problem .


This paper reports the final results of SisterTalk , the randomized controlled trial of a cable TV weight control program oriented toward Black women .


A five group design included a comparison group and a 22 factorial comparison of a ) interactive vs. passive programming and b ) telephone social support vs no telephone support , with 12 weekly initial cable TV programs followed by 4 monthly booster videos .


At baseline , 3 , 8 , and 12months post randomization , telephone and in person surveys were administered on diet , physical activity , and physical measurements of height and weight were taken to calculate body mass index ( BMI ) .


Analysis of variance ( ANOVA ) was used to examine differences over time , and between treatment and comparison groups .


Dose variables reflecting use of the TV/video and written materials were also assessed .


At 3months , BMI , weight , and dietary fat were significantly lower and physical activity significantly higher among women exposed to the Cable TV intervention compared to the wait-list comparison group .


Significant dietary fat differences were still observed at 8 and 12month evaluations , but not BMI or physical activity differences .


Main effects were not observed for interactive programming or enhanced social support at any time point .


Within the intervention group , higher watching of the TV series and higher reading of educational materials were both ( separately ) associated with significantly lower dietary fat .


Cable TV was an effective delivery channel to assist Black women with weight control , increasing physical activity and decreasing dietary fat during an initial intervention period , but only dietary changes persisted Enhanced social support and the ability to interact with others during the show were not effective complementary intervention components as conducted in this trial .


Future research to strengthen the ability of this approach to achieve long term effects may offer even more promising outcomes .


There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus ( HIV ) infection and protection of their infants .


We conducted two double-blind , randomized , placebo-controlled trials of trivalent inactivated influenza vaccine ( IIV3 ) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected .


The immunogenicity , safety , and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth .


Immune responses were measured with a hemagglutination inhibition ( HAI ) assay , and influenza was diagnosed by means of reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assays of respiratory samples .


The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV .


At 1 month after vaccination , seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts .


Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients .


The attack rate for RT-PCR-confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6 % .


The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8 % and 1.9 % , respectively , and the respective vaccine-efficacy rates were 50.4 % ( 95 % confidence interval [ CI ] , 14.5 to 71.2 ) and 48.8 % ( 95 % CI , 11.6 to 70.4 ) .


Among HIV-infected women , the attack rate for placebo recipients was 17.0 % and the rate for IIV3 recipients was 7.0 % ; the vaccine-efficacy rate for these IIV3 recipients was 57.7 % ( 95 % CI , 0.2 to 82.1 ) .


Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV .


( Funded by the Bill and Melinda Gates Foundation and others ; ClinicalTrials.gov numbers , NCT01306669 and NCT01306682 . )


Individuals with a personal or family history of cancer , can opt for genetic counseling and DNA-testing .


Approximately 25 % of these individuals experience clinically relevant levels of psychosocial distress , depression and/or anxiety after counseling .


These problems are frequently left undetected by genetic counselors .


The aim of this study is to evaluate the efficacy of a cancer genetics-specific screening questionnaire for psychosocial problems , the ` Psychosocial Aspects of Hereditary Cancer ( PAHC ) questionnaire ' together with the Distress Thermometer , in : ( 1 ) facilitating personalized counselor-counselee communication ; ( 2 ) increasing counselors ' awareness of their counselees ' psychosocial problems ; and ( 3 ) facilitating the management of psychosocial problems during and after genetic counseling .


This multicenter , randomized controlled trial will include 264 individuals undergoing cancer genetic counseling in two family cancer clinics in the Netherlands .


Participants will be randomized to either : ( 1 ) an intervention group that completes the PAHC questionnaire , the results of which are made available to the genetic counselor prior to the counseling session ; or ( 2 ) a control group that completes the PAHC questionnaire , but without feedback being given to the genetic counselor .


The genetic counseling sessions will be audiotaped for content analysis .


Additionally , study participants will be asked to complete questionnaires at baseline , three weeks after the initial counseling session , and four months after a telephone follow-up counseling session .


The genetic counselors will be asked to complete questionnaires at the start of and at completion of the study , as well as a checklist directly after each counseling session .


The questionnaires/checklists of the study include items on communication during genetic counseling , counselor awareness of their clients ' psychosocial problems , the ( perceived ) need for professional psychosocial support , cancer worries , general distress , specific psychosocial problems , satisfaction with care received , and experience using the PAHC questionnaire .


This study will provide empirical evidence regarding the efficacy of a relatively brief psychosocial screening questionnaire in terms of facilitating personalized communication , increasing counselors ' awareness , and optimizing management of psychosocial problems in the cancer genetic counseling setting .


This study is registered at the Netherlands Trial Register ( NTR3205 ) and ClinicalTrials.gov ( NCT01562431 ) .


Advanced lung cancer ( LC ) patients and their families have reported low self-efficacy for self-care/caregiving and high rates of distress , yet few programs exist to address their supportive care needs during treatment .


This pilot study examined the feasibility , acceptability , and preliminary efficacy of a 6-session , telephone-based dyadic psychosocial intervention that was developed for advanced LC patients and their caregivers .


The program was grounded in self-determination theory ( SDT ) , which emphasizes the importance of competence ( self-efficacy ) , autonomy ( sense of choice/volition ) , and relatedness ( sense of belonging/connection ) for psychological functioning .


The primary outcomes were patient and caregiver psychological functioning ( depression/anxiety ) and caregiver burden .


The secondary outcomes were the SDT constructs of competence , autonomy , and relatedness .


Thirty-nine advanced LC patients who were within 1 month of treatment initiation ( baseline ) and their caregivers ( 51 % spouses/partners ) completed surveys and were randomized to the intervention or usual medical care .


Eight weeks after baseline , they completed follow-up surveys .


Solid recruitment ( 60 % ) and low attrition rates demonstrated feasibility .


Strong program evaluations ( mean , 8.6 / 10 ) and homework completion rates ( 88 % ) supported acceptability .


Participants receiving the intervention evidenced significant improvements ( P < .0001 ) in depression , anxiety , and caregiver burden in comparison with usual medical care .


Large effect sizes ( d1 .2 ) favoring the intervention were also found for patient and caregiver competence and relatedness and for caregiver autonomous motivation for providing care .


These findings support intervention feasibility , acceptability , and preliminary efficacy .


By empowering families with the skills to coordinate care and meet the challenges of LC together , this intervention holds great promise for improving palliative/supportive care services in cancer .


Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus .


To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass ( RYGB ) surgery compared with an intensive diabetes medical and weight management ( Weight Achievement and Intensive Treatment [ Why WAIT ] ) program for type 2 diabetes .


A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution .


Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study ; their body mass index was 30 to 42 ( calculated as weight in kilograms divided by height in meters squared ) and hemoglobin A1c ( HbA1c ) was greater than or equal to 6.5 % .


All participants were receiving antihyperglycemic medications .


RYGB ( n = 19 ) or Why WAIT ( n = 19 ) including 12 weekly multidisciplinary group lifestyle , medical , and educational sessions with monthly follow-up thereafter .


Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5 % , measures of cardiometabolic health , and patient-reported outcomes .


At 1 year , the proportion of patients achieving HbA1c below 6.5 % and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT ( 58 % vs 16 % , respectively ; P = .03 ) .


Other outcomes , including HbA1c , weight , waist circumference , fat mass , lean mass , blood pressure , and triglyceride levels , decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT .


Improvement in cardiovascular risk scores was greater in the surgical group .


At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total , physical health , and mental health , as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores .


At 1 year , improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups .


The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT .


In obese patients with type 2 diabetes , RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management , with emergent differences over 1 year .


Both treatments improve general quality-of-life measures , but RYGB provides greater improvement in the effect of weight on quality of life .


These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed .


clinicaltrials.gov Identifier : NCT01073020 .


Atrial fibrillation ( AF ) is the most common rhythm disorder seen in clinical practice .


Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF .


Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed ; however , its role as a first-line therapy needs further investigation .


To compare radiofrequency ablation with antiarrhythmic drugs ( standard therapy ) in treating patients with paroxysmal AF as a first-line therapy .


A randomized clinical trial involving 127 treatment-naive patients with paroxysmal AF were randomized at 16 centers in Europe and North America to received either antiarrhythmic therapy or ablation .


The first patient was enrolled July 27 , 2006 ; the last patient , January 29 , 2010 .


The last follow-up was February 16 , 2012 .


Sixty-one patients in the antiarrhythmic drug group and 66 in the radiofrequency ablation group were followed up for 24 months .


The time to the first documented atrial tachyarrhythmia of more than 30 seconds ( symptomatic or asymptomatic AF , atrial flutter , or atrial tachycardia ) , detected by either scheduled or unscheduled electrocardiogram , Holter , transtelephonic monitor , or rhythm strip , was the primary outcome .


Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias and quality of life measures assessed by the EQ-5D tool .


Forty-four patients ( 72.1 % ) in the antiarrhythmic group and in 36 patients ( 54.5 % ) in the ablation group experienced the primary efficacy outcome ( hazard ratio [ HR ] , 0.56 [ 95 % CI , 0.35-0 .90 ] ; P = .02 ) .


For the secondary outcomes , 59 % in the drug group and 47 % in the ablation group experienced the first recurrence of symptomatic AF , atrial flutter , atrial tachycardia ( HR , 0.56 [ 95 % CI , 0.33-0 .95 ] ; P = .03 ) .


No deaths or strokes were reported in either group ; 4 cases of cardiac tamponade were reported in the ablation group .


In the standard treatment group , 26 patients ( 43 % ) underwent ablation after 1-year .


Quality of life was moderately impaired at baseline in both groups and improved at the 1 year follow-up .


However , improvement was not significantly different among groups .


Among patients with paroxysmal AF without previous antiarrhythmic drug treatment , radiofrequency ablation compared with antiarrhythmic drugs resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years .


However , recurrence was frequent in both groups .


clinicaltrials.gov Identifier : NCT00392054 .


Few studies have compared simultaneously different antidepressants in long-term treatment of major depressive disorder ( MDD ) .


Long-term prevention of recurrences should be the main goal of MDD treatment .


The purpose of this study was to compare antidepressants of different pharmacological classes in terms of retention in treatment ( no discontinuation for recurrences , hospitalizations , side effects ) .


One hundred and fifty outpatients with an MDD diagnosis , treated with antidepressants in mono-therapy , were included .


Follow-up period was set at 24 months , and information have been obtained from charts , interviews with patients and their relatives , and from the Lombardy regional register .


A survival analysis ( Kaplan-Meier ) was performed , considering recurrences , hospitalizations , or discontinuation due to side effects as ` death ' events .


In our sample , 48.7 % of the patients presented a recurrence within the first 2 years of treatment .


Bupropion appears less effective in long-term treatment of MDD than the other compared antidepressants , with exception of fluoxetine ( p = 0.09 ) , amitriptyline ( p = 0.13 ) , fluvoxamine ( p = 0.83 ) , venlafaxine ( p = 0.5 ) , and trazodone ( p = 0.58 ) .


Fluvoxamine appears to be less effective than citalopram ( p = 0.036 ) , paroxetine ( p = 0.037 ) , clomipramine ( p = 0.05 ) , sertraline ( p = 0.011 ) , and duloxetine ( p = 0.024 ) .


Bupropion and fluvoxamine appear less effective in long-term treatment of MDD .


These results should be confirmed by randomized placebo-controlled prospective studies with larger samples .


Open haemorrhoidectomy has been associated with considerable postoperative pain and discomfort .


Perianal intradermal injection of methylene blue has been shown to ablate perianal nerve endings and may bring about temporary pain relief after haemorrhoidectomy .


We hypothesized that the administration of intradermal methylene blue would reduce postoperative pain during the initial period after surgery .


A randomized , prospective , single-blind placebo-controlled trial was conducted .


Patients were randomized to intradermal injection at haemorrhoidectomy of either 4ml 1 % methylene blue and 16ml 0.5 % marcaine or of 16ml 0.5 % marcaine and 4ml saline prior to surgical dissection .


Patients were asked to fill in a pain diary with a visual analogue scale .


The primary outcome measure was pain score and analgesic use .


Secondary outcomes were complications .


There were 37 patients in the methylene blue arm and 30 patients in the placebo arm .


There were no statistically significant differences in the sex , type of haemorrhoid , number of haemorrhoids excised , duration of surgery or hospital stay .


The mean pain scores were significantly lower and the use of paracetamol was also significantly less in the methylene blue group during the first three postoperative days .


The risk ratio of acute urinary retention occurring when methylene blue was not used was 2.320 ( 95 % CI 1.754-3 .067 ) .


Other complication rates were not significantly different .


Perianal intradermal injection of methylene blue was useful in reducing the initial postoperative pain of open haemorrhoidectomy .


To evaluate the efficacy of the combined drug furamag ( furasidine potassium and magnesium hydroxycarbonate ) in combination with the third-generation cephalosporin cefotaxime versus cephalosporin monotherapy for nosocomial urinary tract infections ( NUTI ) .


The randomized open-label comparative parallel group clinical trial enrolled 52 male and female patients aged over 18 years with a documented diagnosis of NUTI .


Group 1 ( a study group ) took oral furamag 300 mg/day in combination with intravenous cefotaxime 6 g/day ; Group 2 ( a control group ) received cefotaxime monotherapy .


The duration of therapy in both groups was 7 to 10 days until the efficiency levels were achieved .


A final efficiency analysis was made in 24 and 25 patients from Groups 1 and 2 who had different forms of NUTI ( catheter-associated NUTI , cystitis , pyelonephritis ) .


On day 3 of treatment , most patients were noted to have a decreased systemic inflammatory response ; lower C-reactive protein and procalcitonin levels being in the study group patients .


The clinical efficiency of antibacterial therapy , which had been evaluated both immediately after treatment termination and during further control , did not substantially differ in the furamag/cefotaxime combination and control groups although there was an obvious tendency towards the more marked effect of combined therapy 7-14 days after treatment ( 11.8 % efficiency differences ; p > 0.05 ) .


Analysis of bacteriological efficacy revealed its most pronounced and clinically significant differences between the groups : the cefotaxime/furamag combination led to higher pathogen eradication in all follow-up periods : after 3 days of treatment ( 82.6 % ) and following a complete therapy cycle ( 95.8 % ) versus the cefotaxime monotherapy group ( 43.5 and 70.8 % , respectively ; p < 0.01 ) .


Microbiological results showed that the major NUTI pathogens ( Escherichia coli , enterococci ) were more susceptible to potassium furasidine ( furamag ) versus cefotaxime .


The in vitro higher activity of furamag versus cefotaxime was attended by the significantly higher eradication of one of the two important NUTI pathogens - Enterococcus faecalis .


Furamag used in combination with the third-generation cephalosporin cefotaxime showed a higher bacteriological efficacy and a rapider reduction in the symptoms of a systemic inflammatory response in patients with NUTI .


On the basis of the findings , the above combination of furamag and cefotaxime may be recommended as first-line therapy for NUTI when multidrug - resistant nosocomial infection pathogens are widely distributed now .


To examine myopic progression and factors connected with myopic progression .


Myopic schoolchildren , with no previous spectacles , 119 boys and 121 girls , were recruited during 1983-1984 to a randomized 3-year clinical trial of bifocal treatment of myopia with a subsequent 20-year follow-up .


Participants ' mean age at Baseline was 10.9 , ranging from 8.7 to 12.8 years .


An ophthalmological examination was carried out annually for 3 years and twice thereafter at ca. 10-year intervals .


Additional refraction values were received from prescriptions issued by different ophthalmologists and opticians .


Altogether , 1915 refraction values were available .


Reading distance and accommodation were measured at each control visit .


Data on parents ' myopia , daily time spent on reading and close work , outdoor activities and watching television were gathered with a structured questionnaire .


Using bifocals ( +1.75 add ) or reading without glasses or accommodation stimulus during the 3-year period in childhood did not correlate with adulthood refraction .


Short reading distance in childhood predicted higher adulthood myopia among females .


The factors predicting faster myopic progression were parents ' myopia and less time spent on sports and outdoor activities at childhood .


Time spent on reading and close work in childhood was related to myopic progression during the first 3 years but did not predict adulthood myopia .


Myopia throughout follow-up was higher among those who watched television < 3 hr daily than those who spent more time watching television .


Mean myopic progression 8 years after age 20-24 was -0.45 D 0.71 ( SD ) , and in 45 % of cases , progression was 0.5 D.


In nearly half of the cases , myopia beginning at school continued to progress into adulthood .


Higher adulthood myopia was mainly related to parents ' myopia and less time spent on sports and outdoor activities in childhood .


Mobile phone-based psychological interventions enable real time self-monitoring and self-management , and large-scale dissemination .


However , few studies have focussed on mild-to-moderate symptoms where public health need is greatest , and none have targeted work and social functioning .


This study reports outcomes of a CONSORT-compliant randomised controlled trial ( RCT ) to evaluate the efficacy of myCompass , a self-guided psychological treatment delivered via mobile phone and computer , designed to reduce mild-to-moderate depression , anxiety and stress , and improve work and social functioning .


Community-based volunteers with mild-to-moderate depression , anxiety and/or stress ( N = 720 ) were randomly assigned to the myCompass program , an attention control intervention , or to a waitlist condition for seven weeks .


The interventions were fully automated , without any human input or guidance .


Participants ' symptoms and functioning were assessed at baseline , post-intervention and 3-month follow-up , using the Depression , Anxiety and Stress Scale and the Work and Social Adjustment Scale .


Retention rates at post-intervention and follow-up for the study sample were 72.1 % ( n = 449 ) and 48.6 % ( n = 350 ) respectively .


The myCompass group showed significantly greater improvement in symptoms of depression , anxiety and stress and in work and social functioning relative to both control conditions at the end of the 7-week intervention phase ( between-group effect sizes ranged from d = .22 to d = .55 based on the observed means ) .


Symptom scores remained at near normal levels at 3-month follow-up .


Participants in the attention control condition showed gradual symptom improvement during the post-intervention phase and their scores did not differ from the myCompass group at 3-month follow-up .


The myCompass program is an effective public health program , facilitating rapid improvements in symptoms and in work and social functioning for individuals with mild-to-moderate mental health problems .


Australian New Zealand Clinical Trials Registry ACTRN 12610000625077 .


The objective was to assess adverse outcomes in relation to the simplified Pulmonary Embolism Severity Index ( PESI ) score in patients treated with rivaroxaban or standard therapy in the phase III EINSTEIN PE study and to evaluate the utility of the simplified PESI score to identify low-risk pulmonary embolism ( PE ) patients .


A post hoc analysis of EINSTEIN PE data was performed to assess the efficacy and safety of rivaroxaban in patients with a range of simplified PESI scores .


Recurrent venous thromboembolism , fatal PE , all-cause mortality , and major bleeding were stratified by simplified PESI scores of 0 , 1 , or 2 and according to treatment period at 7 , 14 , 30 , and 90 days and at the end of the full intended treatment period .


Simplified PESI scores could be calculated in 4,831 of the 4,832 randomized patients ; of those , 53.6 , 36.7 , and 9.7 % had PESI scores of 0 , 1 , and 2 , respectively .


Among patients with simplified PESI scores of 0 or 1 , fatal PE , all-cause mortality , and other adverse outcomes were uncommon within the first 7 , 14 , and 30 days .


Patients with simplified PESI scores of 2 had more frequent adverse outcomes .


Major bleeding was lower in the rivaroxaban group , particularly in those with simplified PESI scores of 1 or 2 .


The findings support using risk stratification with the simplified PESI score to identify low-risk patients with PE .


This study compares moderators of initiation and maintenance of health behavior changes .


Data come from a cluster-randomized , 12-month telephone counseling intervention for physical activity and diet , targeting type 2 diabetes or hypertension patients ( n = 434 , Australia,2005-2007 ) .


Demographic and health-related characteristics , theoretical constructs , and baseline behavioral outcomes were considered as moderators .


Mixed models , adjusting for baseline values , assessed moderation of intervention effects for trial outcomes ( physical activity , intakes of fat , saturated fat , fiber , fruit , vegetables ) at end-of-intervention ( 12 months/initiation ) and maintenance follow-up ( 18 months ) , and compared moderation between these periods .


Social support for physical activity and baseline physical activity were significant ( p < 0.05 ) moderators of physical activity at 12 months .


Gender , marital status , social support for healthy eating , BMI , and number of chronic conditions were significant moderators of dietary changes at 12 - and/or 18 months .


Instances of moderation differing significantly between 12 - and 18 months were : baseline physical activity for physical activity ( initiation ) and marital status for fat intake ( maintenance ) .


This exploratory study showed that moderation of physical activity and diet effects sometimes differed between initiation and maintenance .


To identify unique moderators for initiation and/or maintenance of behavior changes , future studies need to report on and statistically test for such differences .


The role of a low glycemic index ( GI ) diet in the management of adolescent obesity remains controversial .


In this study , we aim to evaluate the impact of low GI diet versus a conventional Chinese diet on the body mass index ( BMI ) and other obesity indices of obese adolescents .


Obese adolescents aged 15-18years were identified from population-recruited , territory-wide surveys .


Obesity was defined as BMI 95th percentile of Hong Kong local age - and sex-specific references .


Eligible subjects were randomized to either an intervention with low GI diet ( consisting of 45-50 % carbohydrate , 30-35 % fat and 15-20 % protein ) or conventional Chinese diet as control ( consisting of 55-60 % carbohydrate , 25-30 % fat and 10-15 % protein ) .


We used random intercept mixed effects model to compare the differential changes across the time points from baseline to month 6 between the 2 groups .


104 obese adolescents were recruited ( 52 in low GI group and 52 in control group ; 43.3 % boys ) .


Mean age was 16.71.0 years and 16.8 1.0 years in low GI and control group respectively .


58.7 % subjects completed the study at 6months ( 65.4 % in low GI group and 51.9 % in control group ) .


After adjustment for age and sex , subjects in the low GI group had a significantly greater reduction in obesity indices including BMI , body weight and waist circumference ( WC ) compared to subjects in the control group ( all p < 0.05 ) .


After further adjustment for physical activity levels , WC was found to be significantly lower in the low GI group compared to the conventional group ( p = 0.018 ) .


Low GI diet in the context of a comprehensive lifestyle modification program may be an alternative to conventional diet in the management of obese adolescents .


ClinicalTrials.gov Ref .


No : NCT01278563 .


The ( C ) ce ( s ) haplotype , mainly found in black individuals , contains two altered genes : a hybrid RHD-CE-D ( s ) gene segregated with a ce ( s ) allele of RHCE with two single nucleotide polymorphisms , c. 733C > G ( p.Leu245Val ) in exon 5 and c. 1006G > T ( Gly336Cys ) in exon 7 .


This haplotype could be responsible for false positive genotyping results in RhD-negative individuals and at a homozygous level lead to the loss of a high incidence antigen RH34 .


The aim of this study was to screen for the ( C ) ce ( s ) haplotype in Tunisian blood donors , given its clinico-biological importance .