Physician follow-up visits will be conducted at @ , @ , and @ months for assessment of adherence to therapy and ET , functional status , quality of life , and clinical events .


Secondary end points will include quality-of-life questionnaire , economic end points , blood pressure , and hemoglobin A@C levels .


Cardiac rehabilitation and ET are relatively inexpensive and accessible and can be beneficial in HFpEF patients .


Our trial is designed to evaluate the impact of early posthospitalization comprehensive rehabilitation program on clinical end points of mortality , hospitalization , and quality of life in HFpEF patients .


There is growing evidence that cognitive training ( CT ) can improve the cognitive functioning of the elderly .


CT may be influenced by cultural and linguistic factors , but research examining CT programs has mostly been conducted on Western populations .


We have developed an innovative electroencephalography ( EEG ) - based brain-computer interface ( BCI ) CT program that has shown preliminary efficacy in improving cognition in @ healthy English-speaking elderly adults in Singapore .


In this second pilot trial , we examine the acceptability , safety , and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly .


Thirty-nine elderly participants were randomized into intervention ( n = @ ) and wait-list control ( n = @ ) arms .


Intervention consisted of @ half-hour sessions with our BCI-based CT training system to be completed in @ weeks ; the control arm received the same intervention after an initial @-week waiting period .


At the end of the training , a usability and acceptability questionnaire was administered .


Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS ) , which was translated and culturally adapted for the Chinese-speaking local population .


Users were asked about any adverse events experienced after each session as a safety measure .


The training was deemed easily usable and acceptable by senior users .


The median difference in the change scores pre - and post-training of the modified RBANS total score was @ ( @ % confidence interval -LSB- CI -RSB- : @-@ @ , P = @ ) higher in the intervention arm than waitlist control , while the mean difference was @ ( @ % CI : @-@ @ , P = @ ) .


Ten ( @ % ) participants reported a total of @ adverse events - all of which were graded `` mild '' except for one graded `` moderate '' .


Our BCI training system shows potential in improving cognition in both English - and Chinese-speaking elderly , and deserves further evaluation in a Phase III trial .


Overall , participants responded positively on the usability and acceptability questionnaire .


To investigate short - and long-term benefits and safety of acupoint injection of kakkonein for early - or mid-stage Parkinson 's disease ( PD ) .


A total of @ patients with early - or mid-stage PD were enlisted and @ cases completed the observation , including @ cases in the acupoint-injection group , @ cases in the acupuncture group and @ cases in the medication group .


Patients of the acupoint-injection group were treated by injection of kakkonein ( @ mL ) into bilateral Fengchi ( GB @ ) , once very other day for @ weeks .


For acupuncture intervention , bilateral GB @ acupoints were punctured with filiform needles , once every other day for @ weeks .


Patients of the medication group were treated by oral administration of compound levodopa ( @ mg/time , twice a day ) for @ weeks .


The disease severity was assessed by using Unified Parkinson 's Disease Rating Scale ( UPDRS , version @ ) before and after treatment , and one month after the treatment .


After the treatment , scores of psychosis , behavior and emotion , daily life activity and motor function were all significantly decreased in the three groups in comparison with pre-treatment in each group ( P < @ ) , suggesting an improvement of the PD patients ' conditions .


The therapeutic effect of acupoint-injection and acupuncture groups was markedly superior to that of the medication group ( P < @ ) .


One-month 's follow-up showed that the scores of behavior-emotion and daily life activity were obviously lower in the acupoint-injection group than in the acupuncture and medication groups ( P < @ ) .


No significant differences were found between the acupuncture and medication groups in down-regulating scores of behavior-emotion , daily life activity and motor function ( P > @ ) .


Acupoint injection of kakkonein can improve patients ' behavior , emotion , and daily life activity in early - or mid-stage PD patients and has both short - and longer-term benefits .


Because hydrogen therapy has been found beneficial for the treatment of inflammation , ischemia-reperfusion injury , and oxidative stress in humans , it seems useful to evaluate the effects of exogenously administered hydrogen as an element in the immediate management of sports-related soft tissue injuries .


The main aim of this pilot study was to examine the effects of @-week administration of hydrogen on the biochemical markers of inflammation and functional recovery in male professional athletes after acute soft tissue injury .


During the @ season ( from March to May ) , @ professional athletes were recruited as participants and examined by a certified sports medicine specialist in the first @ hours after an injury was sustained .


Subjects were allocated to @ randomly assigned trials in a single-blind design .


Those in the control group received a traditional treatment protocol for soft tissue injury .


Subjects in the first experimental group followed the same procedures as the control group but with additional administration throughout the study of oral hydrogen-rich tablets ( @ g per day ) .


Subjects in the second experimental group also followed the procedures of the control group , with additional administration throughout the study of both oral hydrogen-rich tablets ( @ g per day ) and topical hydrogen-rich packs ( @ times per day for @ minutes ) .


Participants were evaluated at the time of the injury report and at @ and @ days after baseline testing .


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


Differences were found for range-of-motion recovery between the @ 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 < @ ) .


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 NCT@ .


The p@ : miR-@a : E@F positive feed-forward loop and the p@ : miR-@ : Mdm@ 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 p@ : miR-@a : E@F@ and the p@ : miR-@ : Mdm@ 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 = @ ) and NAC+LRH ( n = @ ) groups .


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


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


Expression of p@ , Mdm@ , E@F@ , miR-@a , and miR-@ 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 @ out of @ LRH patients had recurrences and @ had metastasis .


The @-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 p@ were both markedly increased in patients who received NAC than those who did not , and oppositely , the levels of E@F@ and Mdm@ were significantly lower in the NAC+LRH patients than in the LRH patients .


The levels of miR-@a and miR-@ 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 p@ protein levels , miR-@a and miR-@ miRNA levels , and decreases in Mdm@ and E@F@ protein levels .


Furthermore , ERK@/@ inhibitor U@ or TAB@ 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 p@ : miR-@a : E@F@ positive feed-forward loop and the p@ : miR-@ : Mdm@ 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 @year and are in sustained complete clinical , biochemical and endoscopic remission ( ie , Crohn 's Disease Activity Index ( CDAI ) score < @ , 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 @weeks ( def .


CDAI < @ ) .


MK-@ 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-@ 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 , @ postmenopausal women with osteoporosis were administered daily oral MK-@ ( @ , @ , @ , @ , or @ 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-@ dose and lasted more than @ hours .


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


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


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


In postmenopausal women with low bone mass , treatment with MK-@ 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 @ days after randomization .


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


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


Death or hemodynamic decompensation occurred in @ of @ patients ( @ % ) in the tenecteplase group as compared with @ of @ ( @ % ) in the placebo group ( odds ratio , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Between randomization and day @ , a total of @ patients ( @ % ) in the tenecteplase group and @ ( @ % ) in the placebo group died ( P = @ ) .


Extracranial bleeding occurred in @ patients ( @ % ) in the tenecteplase group and @ patients ( @ % ) in the placebo group ( P < @ ) .


Stroke occurred in @ patients ( @ % ) in the tenecteplase group and was hemorrhagic in @ patients ; @ patient ( @ % ) in the placebo group had a stroke , which was hemorrhagic ( P = @ ) .


By day @ , a total of @ patients ( @ % ) in the tenecteplase group and @ patients ( @ % ) in the placebo group had died ( P = @ ) .


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 , @-@-@ ; ClinicalTrials.gov number , NCT@ . )


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 = @ ) or did not ( group B , n = @ ) .


LRM entailed increments of @ cm H@O PEEP every @ min , until fraction of inspired oxygen ( FiO@ ) = @ .


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 FiO@ rose , we reincremented PEEP until SpO@ became stable .


Group A and B infants were similar : gestational age @ @ vs @ @ weeks ; body weight @ @ vs @ @ g ; Silverman Anderson score for babies at start of ventilation @ @ vs @ @ ; initial FiO@ @ @ vs @ @ , respectively .


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


Groups A and B showed different max PEEP during the first @ h of life ( @ @ vs @ @ cm H@O , P = @ ) , time to lowest FiO@ ( @ @ versus @ @ min ; P = @ ) and O@ dependency ( @ @ vs @ @ days ; P = @ ) .


FiO@ levels progressively decreased ( F = @ , P = @ ) and a/AO@ ratio gradually increased ( F = @ , P = @ ) .


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


LRM led to the earlier lowest FiO@ of the first @ h of life and a shorter O@ dependency .


The purpose of this study was to evaluate the efficacy and safety of ( @ ) 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 ( @ ) Lu-EDTMP in bone pain palliation .


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


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


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


Toxicity was assessed in terms of haematological and renal parameters .


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


Complete , partial and minimal responses were seen in @ patients ( @ % ) , @ patients ( @ % ) and @ patients ( @ % ) , respectively .


A favourable response was seen in @ patients ( @ % ) with prostate cancer and in @ patients ( @ % ) with breast cancer .


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


Also , AS decreased significantly from @ to @ ( p < @ ) .


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


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


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 @ patients ( @ % ) and serious toxicity ( grade III/IV ) occurred in @ patients ( @ % ) .


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


( @ ) 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 ( @ ) 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 < @ ) .


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 @ , hybrid-designed trial undertaken at @ institutions or hospitals in China , we included Chinese patients aged @-@ years with previously untreated , histologically confirmed metastatic triple-negative breast cancer , and an ECOG performance status of @-@ .


These patients were randomly assigned ( @:@ ) to receive either cisplatin plus gemcitabine ( cisplatin @ mg/m ( @ ) on day @ and gemcitabine @ mg/m ( @ ) on days @ and @ ) or paclitaxel plus gemcitabine ( paclitaxel @ mg/m ( @ ) on day @ and gemcitabine @ mg/m ( @ ) on days @ and @ ) given intravenously every @ 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 @ .


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 NCT@ .


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


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


After a median follow-up of @ months ( IQR @-@ ) in the cisplatin plus gemcitabine group and @ months ( @-@ ) in the paclitaxel plus gemcitabine group , the hazard ratio for progression-free survival was @ ( @ % CI @-@ ; pnon-inferiority < @ , psuperiority = @ , thus cisplatin plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine .


Median progression-free survival was @ months ( @ % CI @-@ ) in the cisplatin plus gemcitabine group and @ months ( @-@ ) in the paclitaxel plus gemcitabine group .


Grade @ or @ adverse events that differed significantly between the two groups included nausea ( eight -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) , vomiting ( @ -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) , musculoskeletal pain ( none vs ten -LSB- @ % -RSB- ) , anaemia ( @ -LSB- @ % -RSB- vs six -LSB- @ % -RSB- ) , and thrombocytopenia ( @ -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) , 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 @-@ alopecia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) and peripheral neuropathy ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , but more grade @-@ anorexia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , constipation ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , hypomagnesaemia ( @ -LSB- @ % -RSB- vs five -LSB- @ % -RSB- ) , and hypokalaemia ( @ -LSB- @ % -RSB- vs two -LSB- @ % -RSB- ) .


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 .


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 ( @ cases ) and a control group ( @ cases ) .


In the observation group , acupuncture was applied at Neiguan ( PC @ ) , Shuigou ( GV @ ) , Baihui ( GV @ ) , Sishencong ( EX-HN @ ) , Fengchi ( GB @ ) , Hegu ( LI @ ) , Sanyinjiao ( SP @ ) and Taichong ( LR @ ) , 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 @ days ' treatment made one session in the two groups .


There were two days at the interval between two sessions and @ 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 < @ ) .


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


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 @ patients with acute ischemic stroke and @ 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 < @ ; odds ratio , @ ; @ % confidence interval , @-@ @ ) 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 = @ ; odds ratio , @ ; @ % confidence interval , @-@ @ ) in multivariate analysis .


In a reverse manner , presence of localized RNFLDs was associated with cerebral stroke ( P < @ ; odds ratio , @ ; @ % confidence interval , @-@ @ ) 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 @ 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 @ and August @ in Timone Hospital , Marseille .


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


Of @ patients treated with ipilimumab or a placebo , @ patients ( @mg/kg in @/@ ) presented with hypophysitis ( @ % ) at @ weeks ( means.d . )


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


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


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


None had diabetes insipidus .


Pituitary imaging showed a moderately enlarged gland in @ patients .


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


At the end of follow-up ( median @ months , range @-@ @ ) , corticotroph deficiency remained in @ patients , @ recovered thyrotroph and ten gonadotroph functions .


Pituitary imaging remained abnormal in @ 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 @ 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 = @ ) 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 @ outpatients with phimosis or redundant prepuce to be treated with DCSD ( n = @ ) and by conventional circumcision ( CC , n = @ ) , respectively .


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


Comparisons between DCSD and CC showed that the operation time was ( @ + / - @ ) vs ( @ + / - @ ) min , blood loss was ( @ + / - @ ) vs ( @ + / - @ ) ml , intraoperative pain score was @ + / - @ vs @ + / - @ , @-hour postoperative pain score was @ + / - @ vs @ + / - @ , postoperative complication rate was @ % ( @/@ ) vs @ % ( @/@ ) , wound healing time was ( @ + / - @ ) vs ( @ + / - @ ) d , satisfaction with the penile appearance was @ % ( @/@ ) vs @ % ( @/@ ) , and treatment cost was ( @ + / - @ ) vs ( @ + @ ) 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 > @ ) and involved more treatment cost than the latter ( P < @ ) .


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-@ ( NCT@ ) and phase III study @A ( NCT@ ) .


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


A subset of patients who tolerated @-min infusions also received @ - to @-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 @ patients exposed to IV carbamazepine ( @ min , n = @ ; @ min , n = @ ) , @ received @ rapid infusions .


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


IV carbamazepine was not associated with clinically relevant cardiac AEs .


The tolerability profile appeared similar between patients who received < @,@ mg/day ( n = @ ) and @,@ mg/day ( n = @ ) 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 @ - or @-min infusions every @ 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 .


@ in-patients scheduled for laparoscopic surgery were randomized into two equal groups to receive either a single dose of @mg 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 @ , @ and @ 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 @ , @ and @ 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 @-second epochs of CC on a simulation mannequin .


Data from @ initial enrollments and @ tested @ 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 @ year later was an @ % 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 @ 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 P@ ( CYP ) @A@ enzyme , when coadministered with rifampin ( CYP@A@ inducer ) or ketoconazole ( CYP@A@ inhibitor ) in adult patients with advanced solid tumors .


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


For rifampin study , @ patients were randomized ( @:@ ) to sequence of a cycle of trabectedin ( @ mg/m ( @ ) , @ h , i.v. ) coadministered with rifampin ( @ mg/day , @-days ) , and a cycle of trabectedin monotherapy ( @ mg/m ( @ ) , @ h , i.v. ) .


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


The systemic exposure ( geometric means ) of trabectedin was decreased -LSB- @ % ( C max ) and @ % ( AUClast ) -RSB- with rifampin coadministration and increased -LSB- @ % ( C max ) and @ % ( AUClast ) -RSB- with ketoconazole coadministration .


This correlated with an increased clearance with rifampin ( @-@ @ L/h ) and a decreased clearance with ketoconazole ( @-@ @ L/h ) .


Consistent with earlier studies , the most common ( @ % ) 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 CYP@A@ inhibitors or inducers should be avoided if possible .


If coadministration of trabectedin with a strong CYP@A@ 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 < @ g/dl ) in pregnant women in Mpigi , Uganda .


We assessed Hb levels of @ pregnant women at @ + 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 @ system .


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


The mean Hb was @ ( @ ) g/dl and prevalence of anaemia ( Hb < @ g/dl ) was @ % ( @ % CI @ % , @ % ) .


After adjusting for measured confounders , factors associated with increased risk of anaemia in pregnancy were malaria infection ( OR : @ , @ % CI : @ , @ ) , Human Immuno-deficiency Virus infection ( OR : @ , @ % CI : @ , @ ) and lack of iron supplementation ( OR : @ , @ % CI : @ , @ ) .


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 @-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 @ 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 @ 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 @ 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 A@ ( Lp-PLA@ ) 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-PLA@ activity ( by @-thio-PAF ) were measured at baseline and weeks @ and @ .


Multivariate regression analysis was performed .


Results are expressed as the median ( IQR ) .


Eighty-six ( atazanavir/ritonavir , n = @ ; darunavir/ritonavir , n = @ ) patients were included : age @ ( @-@ ) years ; @ % men ; CD@ @ ( @-@ ) cells/mm ( @ ) ; and Framingham score @ % ( @ % -@ % ) .


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


At week @ , 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 @ , 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-PLA@ activity or relative distribution in LDL or HDL particles were found at week @ in either arm .


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


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 @ diabetes patients in terms of efficacy and safety .


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


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


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


With use of once - and twice-daily insulin , HbA@c values were decreased by @ % ( @ ) and @ % ( @ ) within the first @ weeks ( p < @ ) , whereas increased by @ % ( @ ) and @ % ( @ ) in the second @ weeks ( p > @ ) .


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


Although minor hypoglycemic events were similar in both groups in the first @ weeks , @-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 @ and @ kg with once-daily dose , whereas a decrease of @ and @ kg in the twice-daily dose , in the same period .


Once-daily use of insulin detemir up to @ 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 @-fold higher use of insulin .


We investigated whether mutations in the gene encoding the phosphatidylinositol @-kinase ( PI@K ) catalytic subunit ( PIK@CA ) correlates with response to neoadjuvant human epidermal growth factor receptor @ ( HER@ ) - targeted therapies in patients with breast cancer .


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


Activating mutations in PIK@CA were identified using mass spectrometry-based genotyping .


PIK@CA mutations were identified in @ % of HER@-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 PIK@CA obtained a total pathologic complete response ( pCR ) rate of @ % , which decreased to @ % in patients with tumors that carried PIK@CA activating mutations ( P = @ ) .


Activating mutations in PIK@CA predicted poor pCR in patients with HER@-positive breast cancer treated with neoadjuvant therapies that target HER@ .


Consequently , the combination of anti-HER@ agents and PI@K 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 @ week cycles of fixed-dose subcutaneous rituximab versus standard intravenous rituximab .


In our two-stage , randomised , open-label , phase @ trial , we enrolled patients with previously untreated grade @-@a , CD@-positive follicular lymphoma at @ centres in @ countries .


In stage @ , we randomly allocated patients @:@ with the Pocock and Simon algorithm to intravenous rituximab ( @ mg/m ( @ ) ) or fixed-dose subcutaneous rituximab ( @ 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 @ and then allocated treatment for cycles @-@ .


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


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


Patients were analysed as treated for safety endpoints .


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


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


Between Feb @ , @ , and Oct @ , @ , we enrolled @ patients .


Pharmacokinetic data were available for @ ( @ % ) of @ patients randomly allocated intravenous rituximab and @ ( @ % ) of @ patients randomly allocated subcutaneous rituximab .


Geometric mean Ctrough was @ g/mL in the intravenous group and @ g/mL in the subcutaneous group ( ratio @ , @ % CI @-@ ) , showing non-inferiority of subcutaneous rituximab .


@ ( @ % ) of @ patients in the intravenous rituximab safety population had adverse events ( @ -LSB- @ % -RSB- grade @ ) , as did @ ( @ % ) of @ patients in the subcutaneous rituximab safety population ( @ -LSB- @ % -RSB- grade @ ) .


The most common grade @ or worse adverse event in both groups was neutropenia ( @ -LSB- @ % -RSB- patients in the intravenous group and @ -LSB- @ % -RSB- patients in the subcutaneous group ) .


Adverse events related to administration were mostly grade @-@ and occurred in @ ( @ % ) patients in the intravenous group and @ ( @ % ) patients in the subcutaneous group .


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


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


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 @-month intervals for @ months in @ 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 ( @ % ) had ROM .


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


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


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 GAD@ ( GAD-alum ) at @ months after administration to children and adolescents with type @ diabetes .


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


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


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


The phase III trial was prematurely interrupted at @months , but of the @ Swedish patients , a majority completed the @months follow-up , and @ patients completed the trial at @months .


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


We have now combined the results of these two trials .


There were no treatment related adverse events .


In patients treated with @ GAD-alum doses , stimulated C-peptide area under the curve had decreased significantly less ( @ m : p < @ ; @m : p < @ ; @m : p < @ and @ m : p < @ ) , and a larger proportion of these patients were also able to achieve a peak stimulated C-peptide > @ nmol/L ( p < @ ) , as compared with placebo .


Treatment with two doses of GAD-alum in children and adolescents with recent-onset type @ 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 , @ to @ 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 @-hour urine samples .


The patients received @ g of salt for daily consumption for @ weeks .


The study evaluated @ patients ( @ % women ) , @ allocated to the IG and @ to the CG .


The mean age was @ @ years .


Most participants had completed the Brazilian middle school ( up to the @th grade ; n = @ ; @ % ) , had a family income of up to US$ @ ( n = @ ; @ % ) and practiced regular physical activity ( n = @ ; @ % ) .


Two patients ( @ % ) were smokers and @ % consumed alcohol regularly ( n = @ ) .


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


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


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 , @ patients with NAFLD were supplemented twice daily for @ 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 -LSB- means ( @ % CIs ) -RSB- were seen between the synbiotic and placebo groups , respectively : ALT -LSB- -@ ( -@ , -@ ) compared with -@ ( -@ , -@ ) IU/L ; P < @ -RSB- , aspartate aminotransferase -LSB- -@ ( -@ , -@ ) compared with -@ ( -@ , -@ ) IU/L ; P < @ -RSB- , - glutamyltransferase -LSB- -@ ( -@ , -@ ) compared with -@ ( -@ , -@ ) IU/L ; P < @ -RSB- , high-sensitivity C-reactive protein -LSB- -@ ( -@ , -@ ) compared with -@ ( -@ , -@ ) mmol/L ; P < @ -RSB- , tumor necrosis factor - -LSB- -@ ( -@ , -@ ) compared with -@ ( -@ , -@ ) mmol/L ; P < @ -RSB- , total nuclear factor - B p@ -LSB- -@ ( -@ , -@ ) compared with @ ( -@ , -@ ) mmol/L ; P < @ -RSB- , and fibrosis score as determined by transient elastography -LSB- - @ ( -@ , -@ ) compared with -@ ( -@ , -@ ) kPa ; P < @ -RSB- .


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 @ monthly injections .


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


A total of @ patients , @ women and @ men , aged from @ to @ years ( mean : @ ) were analyzed ; @ eyes ( @ % ) lost < @ letters .


Mean BCVA rose from @ ( range @ ) to @ ( range @ ) letters .


The mean visual gain was @ ( range @ ) letters ; @ patients ( @ % ) gained @ letters .


The mean number of injections of ranibizumab was @ .


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 @:@:@ to receive a single dose of MDX @ mg , MDX @ mg , and placebo ( ClinicalTrials.gov identifier : NCT@ ) .


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


Secondary assessments included TOVA subscores , TOVA response rates ( defined as an increase of @ 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 @ patients ( @ % men ; mean age , @ years ) .


The efficacy of MDX @ mg was demonstrated by a statistically significant difference in the mean ( SD ) change in the TOVA ADHD score at baseline to @ to @ hours after drug administration compared with placebo ( @ -LSB- @ -RSB- ; P = @ ) .


The TOVA response time variability subscore was significantly different between MDX @ mg and placebo ( mean difference , @ -LSB- @ -RSB- points ; P = @ ) .


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


There were no statistically significant differences between MDX @ 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 @ 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 @ mg significantly improved sustained and selective attention in adults with ADHD-PI as measured by the TOVA ADHD score @ to @ hours after drug administration .


Single doses of MDX @ and @ 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-@ trial is designed as a multicentre , randomised controlled trial to compare two implantation strategies .


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


Patients must be over @ 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 @ months , with a recruitment period of @ months and a follow-up period of @ days .


The PORTAS-@ 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 .


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


CISB patients received an infusion of @ % ropivacaine at @ mL/h with a patient-controlled bolus of @ mL hourly for @ 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 @ , @ , @ , and @ .


No patient in the CISB or SISB groups reported a NRS @ 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 = @ ) .


Length of stay in the PACU was significantly shorter for the CISB and SISB groups than for the GA group ( @ @ , @ @ , and @ @ minutes , respectively ( CISB vs GA , P < @ ; SISB vs GA , P < @ ) , 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 @ and @ , and use of narcotics ( doses @ ) was lower until postoperative day @ .


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


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


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


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 @ Indian KC patients clinically graded according to Amsler-Krumeich classification and @ healthy , nonectatic subjects as controls .


Tear levels of matrix metalloproteinase-@ ( MMP@ ) , interleukin-@ ( IL@ ) , 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 MMP@ expression .


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


We observed that MMP@ , TNF , and IL@ levels were strongly upregulated at the mRNA level in KC patient epithelia .


Similarly , tears collected from KC patients exhibited high levels of MMP@ and IL@ protein .


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


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


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


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


In KC patients , CyA treatment reduced MMP@ 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 , NCT@ . )


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 @ cases of BPH with OAB , with a disease course > or = @ months , daily urination > or = @ times , nocturnal urination > or = @ times , urine volume < @ ml per time , International Prostate Symptom Score ( IPSS ) > or = @ , OAB symptom score ( OABS ) > or = @ , quality of life score ( QOL ) > or = @ , post-void residual ( PVR ) < or = @ ml , maximum urinary flow ( Qmax ) > or = @ ml/s , prostate weight @-@ g , and PSA < @ microg/L .


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


In comparison with the baseline , both the monotherapy group and the combination therapy group showed significant decreased in the IPSS ( @ + / - @ vs @ + / - @ and @ + / - @ vs @ + / - @ ) , urine storage symptom score ( @ + / - @ vs @ + / - @ and @ + / - @ vs @ + / - @ ) , OABS ( @ + / - @ vs @ + / - @ and @ + / - @ vs @ + / - @ ) , urgent micturition score ( @ + / - @ vs @ + / - @ and @ + / - @ vs @ + / - @ ) , QOL ( @ + / - @ vs @ + / - @ and @ + / - @ vs @ + / - @ ) and PVR ( -LSB- @ + / - @ -RSB- vs -LSB- @ + / - @ -RSB- ml and -LSB- @ + / - @ -RSB- vs -LSB- @ + / - @ -RSB- ml ) ( P < @ ) .


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


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


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 @ consecutive patients receiving CRT between June @ and July @ 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 = @ ) conferred LV remodeling response superior to that of a suboptimal lead position ( change in LV end-systolic volume : -@ @ % vs. -@ @ % -LSB- p < @ -RSB- ; change in ejection fraction : +@ @ % vs. +@ @ % -LSB- p = @ -RSB- ) .


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


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


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 @ specific adverse drug reactions ) in conjunction with a handout going over same , to a verbal discussion alone .


Blinded assessments occurred by telephone interview @ to @ 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 = @ ) .


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 = @ ) .


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 .


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 @ patients with a mean age of @ years ( range @-@ 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 @ months and follow-up period of @ 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 @ , @ and @ patients in groups A , B and C , respectively .


Improvement was reported in @ , @ and @ 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 @ factorial comparison of a ) interactive vs. passive programming and b ) telephone social support vs no telephone support , with @ weekly initial cable TV programs followed by @ monthly booster videos .


At baseline , @ , @ , and @months 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 @months , 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 @ and @month 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 ( IIV@ ) in South Africa during @ in pregnant women infected with HIV and during @ and @ in pregnant women who were not infected .


The immunogenicity , safety , and efficacy of IIV@ in pregnant women and their infants were evaluated until @ 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 @ pregnant women who were not infected with HIV and @ pregnant women who were infected with HIV .


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


Newborns of IIV@ 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 @ % .


The attack rates among HIV-uninfected IIV@ recipients and their infants were @ % and @ % , respectively , and the respective vaccine-efficacy rates were @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) and @ % ( @ % CI , @ to @ ) .


Among HIV-infected women , the attack rate for placebo recipients was @ % and the rate for IIV@ recipients was @ % ; the vaccine-efficacy rate for these IIV@ recipients was @ % ( @ % CI , @ to @ ) .


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 , NCT@ and NCT@ . )


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


Approximately @ % 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 : ( @ ) facilitating personalized counselor-counselee communication ; ( @ ) increasing counselors ' awareness of their counselees ' psychosocial problems ; and ( @ ) facilitating the management of psychosocial problems during and after genetic counseling .


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


Participants will be randomized to either : ( @ ) 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 ( @ ) 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 .


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 @-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 @ month of treatment initiation ( baseline ) and their caregivers ( @ % 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 ( @ % ) and low attrition rates demonstrated feasibility .


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


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


Large effect sizes ( d@ @ ) 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 @ 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 -LSB- Why WAIT -RSB- ) program for type @ diabetes .


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


Participants included persons aged @ to @ years with type @ diabetes diagnosed more than @ year before the study ; their body mass index was @ to @ ( calculated as weight in kilograms divided by height in meters squared ) and hemoglobin A@c ( HbA@c ) was greater than or equal to @ % .


All participants were receiving antihyperglycemic medications .


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


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


At @ year , the proportion of patients achieving HbA@c below @ % and fasting glucose below @ mg/dL was higher following RYGB than Why WAIT ( @ % vs @ % , respectively ; P = @ ) .


Other outcomes , including HbA@c , 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-@ 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 @ year , improvements in Short Form-@ 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 @ diabetes , RYGB produces greater weight loss and sustained improvements in HbA@c and cardiometabolic risk factors compared with medical management , with emergent differences over @ 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 @ diabetes until larger randomized trials are performed .


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 @ treatment-naive patients with paroxysmal AF were randomized at @ centers in Europe and North America to received either antiarrhythmic therapy or ablation .


The first patient was enrolled July @ , @ ; the last patient , January @ , @ .


The last follow-up was February @ , @ .


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


The time to the first documented atrial tachyarrhythmia of more than @ 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-@D tool .


Forty-four patients ( @ % ) in the antiarrhythmic group and in @ patients ( @ % ) in the ablation group experienced the primary efficacy outcome ( hazard ratio -LSB- HR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


For the secondary outcomes , @ % in the drug group and @ % in the ablation group experienced the first recurrence of symptomatic AF , atrial flutter , atrial tachycardia ( HR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


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


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


Quality of life was moderately impaired at baseline in both groups and improved at the @ 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 @ years .


However , recurrence was frequent in both groups .


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 @ 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 , @ % of the patients presented a recurrence within the first @ years of treatment .


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


Fluvoxamine appears to be less effective than citalopram ( p = @ ) , paroxetine ( p = @ ) , clomipramine ( p = @ ) , sertraline ( p = @ ) , and duloxetine ( p = @ ) .


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 @ml @ % methylene blue and @ml @ % marcaine or of @ml @ % marcaine and @ml 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 @ patients in the methylene blue arm and @ 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 @ ( @ % CI @-@ @ ) .


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 @ male and female patients aged over @ years with a documented diagnosis of NUTI .


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


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


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


On day @ 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 @-@ days after treatment ( @ % efficiency differences ; p > @ ) .


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 @ days of treatment ( @ % ) and following a complete therapy cycle ( @ % ) versus the cefotaxime monotherapy group ( @ and @ % , respectively ; p < @ ) .


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 , @ boys and @ girls , were recruited during @-@ to a randomized @-year clinical trial of bifocal treatment of myopia with a subsequent @-year follow-up .


Participants ' mean age at Baseline was @ , ranging from @ to @ years .


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


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


Altogether , @ 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 ( +@ add ) or reading without glasses or accommodation stimulus during the @-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 @ years but did not predict adulthood myopia .


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


Mean myopic progression @ years after age @-@ was -@ D @ ( SD ) , and in @ % of cases , progression was @ 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 = @ ) 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 @-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 @ % ( n = @ ) and @ % ( n = @ ) 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 @-week intervention phase ( between-group effect sizes ranged from d = @ to d = @ based on the observed means ) .


Symptom scores remained at near normal levels at @-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 @-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 .


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 @ , @ , or @ and according to treatment period at @ , @ , @ , and @ days and at the end of the full intended treatment period .


Simplified PESI scores could be calculated in @,@ of the @,@ randomized patients ; of those , @ , @ , and @ % had PESI scores of @ , @ , and @ , respectively .


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


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


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


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 , @-month telephone counseling intervention for physical activity and diet , targeting type @ diabetes or hypertension patients ( n = @ , Australia,@-@ ) .


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 ( @ months/initiation ) and maintenance follow-up ( @ months ) , and compared moderation between these periods .


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


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