High efficacy and safety of cortexin in the complex treatment of patients with II has been shown .


The best therapeutic effect was seen in group 1 ( two 10-day courses of cortexin ) .


The results were confirmed by the pharmacoeconomic analysis of treatment tactics based on the estimation of `` net monetary benefit '' .


Cortexin is recommended for treatment and rehabilitation of patients with II .


To compare postoperative blood loss under different negative pressures of drainage after total hip arthroplasty for the treatment of femoral neck fractures .


From January 1st to December 30th 2013 , 74 patients with femoral neck fractures treated with total hip arthroplasty were randomly divided into two groups : high negative pressure drainage group and low negative pressure drainage group .


In high negative pressure drainage group , there were 34 cases including 10 males and 24 females , with a mean age of ( 75.94 9.02 ) years old , and the patients were treated with 60 kPa negative pressure of drainage .


In the low negative pressure drainage group , there were 40 cases including 13 males and 27 females , with an average age of ( 74.93 8.90 ) years old , and the patients were treated with 30 kPa negative pressure of drainage .


The amount of total drainage , total blood loss , and hemoglobin change were compared between these two groups .


All the patients got primary healing without infections .


In high negative pressure drainage group , the change of hemoglobin was ( 41.74 15.69 ) g/L , total blood loss was ( 1,217.73 459.50 ) ml and the drainage volume was ( 312.94 103.44 ) ml ; while in low negative pressure drainage group , the results were ( 34.90 12.90 ) g/L , ( 904.01 381.58 ) ml and ( 129.25 44.25 ) ml separately .


All the results in high negative pressure drainage group were higher than those in the other group .


Three days after operation , the change of hemoglobin was ( 46.00 13.29 ) g/L and total blood loss was ( 1,304.72 421.75 ) ml ; while in low negative pressure drainage group , the changes of hemoglobin was ( 43.87 11.39 ) g/L and total blood loss was ( 1,196.78 344.20 ) ml ; there were no statistically significant differences between two groups .


When placing drainage devices after total hip arthroplasty for the treatment of femoral neck fractures , the level of negative pressure should be chosen according to preoperative level of hemoglobin and HCT in patients .


For old patients with femoral neck fracture , low negative pressure is more suitable .


One objective of this study was to assess the effects of laughter on the psychological , immunological and physiological systems of the body .


Another objective was to introduce the Laughing Qigong Program ( LQP ) , as a method of standardization for simulated laughter interventions .


A randomized , prospective , experimental study of the LQP was conducted in a group of adolescents ( n = 67 ) in Taiwan .


During study-hall sessions , experimental subjects ( n = 34 ) attended the LQP for eight-weeks .


Simultaneously , control subjects ( n = 33 ) read or did their homework .


All subjects were tested before and after the intervention on the following : Rosenberg Self-Esteem scale ( RSE ) , Chinese Humor Scale ( CHS ) and Face Scale ( FS ) as psychological markers ; saliva cortisol ( CS ) as an immunological marker ; blood pressure ( BP ) , heart rate ( HR ) , and heart rate variability ( HRV ) as physiological markers of the body 's response to stress .


Mood states ( FS ) were measured before/after each LQP session .


Mood states ( p = .00 ) and humor ( p = .004 ; p = .003 ) improved in the experimental group ; no significant changes were found in the controls ( p = 69 ; p = 60 ) .


The immunological marker of stress , cortisol levels , decreased significantly for those who participated in the LQP ( p = .001 ) , suggesting lower levels of stress after completion of the program .


The LQP is a non-pharmacological and cost-effective means to help adolescents mitigate stresses in their everyday life .


Neisseria meningitidis serogroup B ( MnB ) is a major cause of invasive meningococcal disease in infants .


A conserved , surface-exposed lipoprotein , LP2086 ( a factor H-binding protein [ fHBP ] ) , is a promising MnB vaccine target .


A bivalent , recombinant vaccine targeting the fHBP ( rLP2086 ) of MnB was developed .


This phase 1/2 clinical study was designed to assess the immunogenicity , safety , and tolerability of a 4-dose series of the rLP2086 vaccine at 20 - , 60 - , 120 - , or 200-g dose levels in vaccine-naive infants when given with routine childhood vaccines .


The study was to consist of two phases : a single-blind sentinel phase and an open-label full enrollment phase .


During the sentinel phase , randomization of subjects to the next higher dose was delayed pending a 14-day safety review of dose 1 of the preceding dose cohort .


The full enrollment phase was to occur after completion of the sentinel phase .


Local reactions were generally mild and adverse events infrequent ; however , after only 46 infants were randomized into the study , fever rates were 64 % and 90 % in subjects receiving one 20 - or 60-g rLP2086 dose , respectively .


Most fevers were < 39.0 C. Only 2 subjects in the 20-g group and 1 subject in the 60-g group experienced fevers > 39.0 C ; no fevers were > 40.0 C. Due to these high fever rates , the study was terminated early .


No immunogenicity data were collected .


This report discusses the safety and acceptability of rLP2086 in infants after one 20 - or 60-g dose .


Due to the high fever rate experienced in the 20 - and 60-g groups , rLP2086 in the current formulation may not be acceptable for infants .


To compare effects of integrated treatment traditional Chinese medicine and Western medicine ( TCM-WM ) and simple western medicine on TCM clincal symptoms in the patient of AIDS with pulmonary inflammation .


A multicenter randomized controlled trials of 164 subjects evaluated the effects of clinical symptoms of AIDS with pulmonary inflammation of TWO regimens : the TCM-WM group ( n = 111 ) and western medicine treatment group ( n = 53 ) , while incidence of TCM symptoms in different time points in two groups were analyzed .


Twenty eight days after treatment , the cured and markedly effective rate of TCM symptoms in the TCM-WM group significantly exceeding that in the western medicine treatment group ( cured and markedly effective rate significant efficiency 44.55 % vs 20.00 % ) , while the incidence rate for the TCM symptoms of fever and headache in the TCM-WM group was significantly lower than that in western medicine group .


The integrated treatment of traditional Chinese medicine and Western medicine helps to alleviate the TCM clinical symptoms of AIDS with pulmonary inflammation .


We evaluated the effects of cognitive speed of processing training ( SOPT ) on the development of additional Instrumental Activities of Daily Living ( IADL ) difficulties and the reduction of depressive symptoms in the Iowa Healthy and Active Minds Study ( IHAMS ) .


Six hundred eighty-one patients were randomized to 4 groups : 10 hr of on-site SOPT , 10 hr of on-site SOPT plus 4 hr of boosters , 10 hr of at-home SOPT , or 10 hr of on-site attention-control ( crossword puzzles ) .


Developing additional difficulties with IADLs and reductions in depressive symptoms 1 year later were evaluated using multiple logistic regression .


The on-site SOPT with boosters group had reduced odds of developing additional difficulties with IADLs ( adjusted odds ratio [ AOR ] = 0.45 , p = .044 ) compared with attention-controls .


The on-site SOPT with boosters group also had increased odds of reduced depressive symptom levels ( AOR = 2.93 , p = .003 ) compared with attention-controls .


These findings provide evidence that SOPT transfers beyond the cognitive skills trained to meaningful downstream improvements in the lives of middle-aged and older adults .


The success of damage-control surgery ( DCS ) for the treatment of trauma has led to its use in other surgical problems such as abdominal sepsis .


Previous studies using direct peritoneal resuscitation ( DPR ) for the treatment of trauma have yielded promising results .


We present the results of the application of this technique to patients experiencing abdominal sepsis .


We enrolled 88 DCS patients during a 5 year-period ( January 2008 to December 2012 ) into a propensity-matched study to evaluate the utility of using DPR in addition to standard resuscitation .


DPR consisted of peritoneal lavage with 2.5 % DELFLEX , and abdominal closure was standardized across both groups .


Patients were matched using Acute Physiology and Chronic Health Evaluation II ( APACHE II ) variables .


Univariate and multivariate analyses were performed .


There were no differences between the control and experimental groups with regard to age , sex , ethnicity , or APACHE II at 24 hours .


Indications for damage control included pancreatitis , perforated hollow viscous , bowel obstruction , and ischemic enterocolitis .


Patients undergoing DPR had both a higher rate of ( 68 % vs. 43 % , p < 0.03 ) and a shorter time to definitive fascial closure ( 5.9 [ 3.2 ] days vs. 7.7 [ 4.1 ] days , p < 0.02 ) .


DPR patients had a decreased APACHE II and Sequential Organ Failure Assessment ( SOFA ) score compared with the controls at 48 hours .


In addition , DPR patients had fewer abdominal complications compared with the controls ( RR , 0.57 ; 95 % confidence interval , 0.32-1 .01 ; p = 0.038 ) .


Ventilator days and intensive care unit length of stay were both significantly reduced in the DPR group .


The DPR group showed a lower overall mortality at 30 days ( 16 % vs. 27 % , p = 0.15 ) .


DPR reduces time to definitive abdominal closure , increases primary fascial closure , and reduces intra-abdominal complications following DCS .


DPR may also attenuate progressive physiologic injury as demonstrated by a reduction in 48-hour intensive care unit severity scores .


As a result , DPR following DCS may afford better outcomes to patients experiencing shock .


Therapeutic study , level III .


The importance of vitamin D on bone health and osteoporosis was studied by many researchers .


The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization .


Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D.


The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term ( 2 weeks ) low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers .


A three-month , single-blinded , randomized , placebo-controlled clinical trial was conducted at the University hospital in Daegu , Republic of Korea .


Fifty-two postmenopausal Korean women ( older than 65 years ) with osteoporosis were randomly allocated to have either low energy UVB or placebo for 30 minutes a day for two weeks of treatment during winter .


Laboratory analysis and physical examination before and 4 , 8 and 12 weeks after treatment were carried out and BMD was measured before and 8 and 12 weeks after treatment .


The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis , and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group [ serum 25 ( OH ) D3 concentration < 30 ng/mL ] .


In vitamin D insufficient group , the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed .


The vitamin D insufficient group showed statistically significant increment in serum 25 ( OH ) D3 compared with the normal group ( p < 0.05 ) .


However , there was no significant difference between two groups in the other bone turnover markers , such as serum calcium , PTH-C , serum osteocalcin , serum CTX and BMD .


Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D synthesis .


There was a modest benefit in change of bone ALP especially in women with the insufficient vitamin D.


This phase II study evaluated the synthetic DNA-based immunomodulator and Toll-like receptor 9 agonist MGN1703 as maintenance treatment in metastatic colorectal carcinoma ( mCRC ) .


Fifty-nine patients with mCRC and disease control after standard first-line chemotherapy were randomised to MGN1703 60mg ( N = 43 ) or placebo ( N = 16 ) .


The hazard ratio ( HR ) for the primary endpoint [ progression-free survival ( PFS ) from the start of maintenance ] was 0.56 ( 95 % CI 0.29-1 .08 ; P = 0.07 ) and 0.55 ( 95 % CI 0.3-1 .0 ; P = 0.04 ) by independent and investigator review , respectively .


MGN1703 significantly improved PFS measured from the start of induction therapy versus placebo on independent ( HR 0.49 ; 95 % CI 0.26-0 .94 ; P = 0.03 ) and investigator review ( HR 0.50 ; 95 % CI 0.31-1 .02 ; P = 0.02 ) .


Overall survival ( OS ) data remain immature ( HR 95 % ; 95 % CI 0.3-1 .5 ; P = 0.29 ) with 28/43 patients alive after a medium follow-up of > 17months .


Retrospective subgroup analysis showed a significant effect of MGN1703 on PFS versus placebo in patients with greater than median tumour size reduction and normalised carcinoembryonic antigen concentrations following induction therapy , and in patients with elevated activated NKT cells3 .08 % .


Adverse events were mild to moderate and limited to injection-site reactions or linked to general immune system activation .


MGN1703 maintenance treatment was well tolerated and appears to induce durable and prolonged PFS and disease control in a subgroup of patients with mCRC following induction therapy .


Activated NKT cells may be a predictive biomarker for selecting patients likely to benefit more from MGN1703 .


Rheumatoid Arthritis ( RA ) is one of the most common autoimmune diseases , affecting approximately 1 % of the UK adult population .


Patients suffer considerable pain , stiffness and swelling and can sustain various degrees of joint destruction , deformity , and significant functional decline .


In addition , the economic burden due to hospitalisation and loss of employment is considerable , with over 50 % of patients being work-disabled within 10years of diagnosis .


Despite several biologic disease modifying anti-rheumatic drugs ( bDMARD ) now available , there is a lack of data to guide biologic sequencing .


In the UK , second-line biologic treatment is restricted to a single option , rituximab .


The aim of the SWITCH trial is to establish whether an alternative-mechanism-TNF-inhibitor ( TNFi ) or abatacept are as effective as rituximab in patients with RA who have failed an initial TNFi drug .


SWITCH is a pragmatic , phase IV , multi-centre , parallel-group design , open-label , randomised , controlled trial ( RCT ) comparing alternative-mechanism-TNFi and abatacept with rituximab in patients with RA who have failed an initial TNFi drug .


Participants are randomised in a 1:1:1 ratio to receive alternative mechanism TNFi , ( monoclonal antibodies : infliximab , adalimumab , certolizumab or golimumab or the receptor fusion protein , etanercept ) , abatacept or rituximab during the interventional phase ( from randomisation up to week 48 ) .


Participants are subsequently followed up to a maximum of 96weeks , which constitutes the observational phase .


The primary objective is to establish whether an alternative-mechanism-TNFi or abatacept are non-inferior to rituximab in terms of disease response at 24weeks post randomisation .


The secondary objectives include the comparison of alternative-mechanism-TNFi and abatacept to rituximab in terms of disease response , quality of life , toxicity , safety and structural and bone density outcomes over a 12-month period ( 48weeks ) and to evaluate the cost-effectiveness of switching patients to alternative active therapies compared to current practice .


SWITCH is a well-designed trial in this therapeutic area that aims to develop a rational treatment algorithm to potentially inform personalised treatment regimens ( as opposed to switching all patients to only one available ( and possibly unsuccessful ) therapy ) , which may lead to long-term improved patient outcomes and gains in population health .


UKCRN Portfolio ID : 12343 ; ISRCTN89222125 ; NCT01295151 .


There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer , but randomized controlled trials in surgery are often difficult to conduct .


The ROMIO ( Randomized Open or Minimally Invasive Oesophagectomy ) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer .


A pilot randomized controlled trial ( RCT ) , in two centers ( University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust ) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study .


Interventions will include esophagectomy by : ( 1 ) open gastric mobilization and right thoracotomy , ( 2 ) laparoscopic gastric mobilization and right thoracotomy , and ( 3 ) totally minimally invasive surgery ( in the Bristol center only ) .


The primary outcomes of the feasibility study will be measures of recruitment , successful development of methods to monitor quality of surgery and fidelity to a surgical protocol , and development of a core outcome set to evaluate esophageal cancer surgery .


The study will test patient-reported outcomes measures to assess recovery , methods to blind participants , assessments of surgical morbidity , and methods to capture cost and resource use .


ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons , nurses , and patients to provide feedback for recruiting staff .


The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer .


The pilot trial has Current Controlled Trials registration number ISRCTN59036820 ( 25/02/2013 ) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol .


Posttransplant anemia is associated with an increased risk of congestive heart failure , left ventricular hypertrophy , and death .


The purpose of this study was to evaluate the effect of long-acting erythropoietin-stimulating agents on anemia after kidney transplant .


In 2306 kidney transplant recipients , 250 anemic patients ( 11 % ) with stable graft function were followed at the Hamed Al-Essa Organ Transplant Centre ( Kuwait ) and were assessed for anemia .


We enrolled 120 patients into this open-label study in 2 groups : group 1 had treatment with darbepoetin alfa ( 86 patients ) and group 2 had continuous erythropoietin receptor activator ( 34 patients ) .


Patient age correlated negatively with serum iron level .


Serum ferritin correlated negatively with hemoglobin level 6 months after transplant but not at time of transplant .


Most patients were women who received their grafts from male donors .


The 2 groups were comparable in frequency of rejection and mean hemoglobin and serum albumin levels at 3 , 6 , 9 , and 12 months after transplant .


There was no difference between the 2 groups in renal function ( estimated glomerular filtration rate ) ; posttransplant complications such as new-onset diabetes after transplant , hypertension , serious bacterial infections , or patient and graft outcomes .


Anemia is an important problem after kidney transplant , and iron use is suboptimal in kidney transplant recipients .


Darbepoetin alfa and continuous erythropoietin receptor activator had comparable positive results .


This study evaluates persistence and severity of docetaxel-induced neuropathy ( peripheral neuropathy ( PN ) ) and impact on health related quality of life in survivors from early-stage breast cancer .


One thousand and thirty-one patients with early-stage breast cancer , who received at least one cycle of docetaxel and provided information on PN during treatment , completed questionnaires on PN as an outcome ( Common Toxicity Criteria ( CTC ) scores , European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 ( EORTC CIPN20 ) and EORTC Quality of Life Questionnaire ( QLQ ) - C30 ) after 1-3years .


Upon completion of docetaxel treatment , 241 patients ( 23 % ) reported PN , grades 2-4 .


PN persisted for 1-3years among 81 ( 34 % ) while PN regressed to grades 0-1 among 160 ( 66 % ) .


Among 790 patients ( 77 % ) without PN , 76 ( 10 % ) developed PN 1-3years later while 714 ( 90 % ) stayed free from PN .


Significant risk factors for persistent PN were age 55 ( p = 0.001 ) , maximum grade of PN during docetaxel treatment ( p < 0.0001 ) , persistent muscle and joint pain ( p < 0.0001 ) , stomatitis ( p = 0.047 ) and fatigue ( p = 0.001 ) .


Persistent PN had a significant negative correlation with health-related quality of life ( HRQOL ) , functional scales and symptom scales .


Overall , 15 % of breast cancer survivors treated with docetaxel report PN 1-3years after treatment with a significant negative impact on HRQOL .


A multivariable training has a positive impact on balance skills and risk of injury .


To date the effect of this training using the Nintendo Wii balance board in sportive people has not yet been investigated .


The aim of this study was to investigate whether training with the Nintendo Wii balance board can improve balance skills .


20 people were randomized into a control and an intervention group each with 10 people who performed a unilateral stance test with eyes open and closed as well as the star excursion balance test before and after the intervention .


The control group completed their usual sports and the intervention group an adjunct training with the Nintendo Wii balance board for 4 weeks .


Adjunct Training using the Nintendo Wii Balance Board did not improve sportive people 's balance skills significantly .


The intervention group , however , attained better results in the star excursion balance test , whereas the control group did not show any changes .


The unilateral stance tests did not provide significant differences before and after training within both groups .


The use of the Nintendo Wii balance board should be further investigated by employing individual difficulty levels .


Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia , a recent large trial of group art therapy found no clinical advantage over standard care , but the study population was heterogeneous and uptake of the intervention was poor .


This study aimed to investigate whether art therapy was more effective for specific subgroups of patients .


Secondary analysis of data from a randomised controlled trial of group art therapy as an adjunctive treatment for schizophrenia ( n = 140 ) versus standard care alone ( n = 137 ) .


Positive and Negative Syndrome Scale scores at 12 months were compared between trial arms .


Interaction between intervention effect and different subgroups , including those with more severe negative symptoms of schizophrenia , and those who expressed a preference for art therapy prior to randomisation , was tested using a linear mixed model .


The clinical effectiveness of group art therapy did not significantly differ between participants with more or less severe negative symptoms [ interaction for difference in PANSS = 1.7 , 95 % CI ( -8.6 to 12.1 ) , P = 0.741 ] , or between those who did and did not express a preference for art therapy [ interaction = 3.9 , 95 % CI ( -6.7 to 14.5 ) , P = 0.473 ] .


None of the other exploratory subgroups suggested differences in intervention effect .


There was no evidence of greater improvement in clinical symptoms of schizophrenia for those with more severe negative symptoms or those with a preference for art therapy .


Identification of patients with schizophrenia who may benefit most from group art therapy remains elusive .


To investigate the feasibility and potential efficacy of the Nintendo Wii for balance rehabilitation after stroke .


Phase II , single-blind , randomized controlled trial .


Inpatient rehabilitation facility .


Thirty adults ( mean age 63.6 ( 14.7 ) years ) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported .


Participants were allocated to a Balance Group , using the ` Wii Fit Plus ' in standing , or Upper Limb Group , using the ` Wii Sports/Sports Resort ' in sitting .


Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care .


The primary focus was feasibility , addressed by recruitment , retention , adherence , acceptability and safety .


Efficacy was evaluated by balance , mobility and upper limb outcomes .


Twenty-one percent of individuals screened were recruited and 86 % ( n = 30 ) of eligible people agreed to participate .


Study retention and session adherence was 90 % and > 99 % , respectively , at two weeks ; dropping to 70 % and 87 % at four weeks due to early discharge .


All participants reported enjoying the sessions and most felt they were beneficial .


No major adverse events occurred .


Wii use by the Balance Group was associated with trends for improved balance , with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores .


The Upper Limb Group had larger , non-significant changes in arm function .


A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation .


A larger randomized controlled trial is recommended to further investigate efficacy .


Poor prognosis patients with bulky stage III locally advanced non-small-cell lung cancer may not be offered concurrent chemoradiotherapy ( CRT ) .


Following a phase III trial concerning the effect of palliative CRT in inoperable poor prognosis patients , this analysis was performed to explore how tumor size influenced survival and health-related quality of life ( HRQOL ) .


A total of 188 poor prognosis patients recruited in a randomized clinical trial received four courses intravenous carboplatin day 1 and oral vinorelbine day 1 and 8 , at 3-week intervals .


The experimental arm ( N = 94 ) received radiotherapy with fractionation 42 Gy/15 , starting at the second chemotherapy course .


This subset study compares outcomes in patients with tumors larger than 7 cm ( N = 108 ) versus tumors 7 cm or smaller ( N = 76 ) .


Among those with tumors larger than 7 cm , the median overall survival in the chemotherapy versus CRT arm was 9.7 and 13.4 months , respectively ( p = 0.001 ) .


The 1-year survival was 33 % and 56 % , respectively ( p = 0.01 ) .


Except for a temporary decline during treatment , HRQOL was maintained in the CRT arm , regardless of tumor size .


Among those who did not receive CRT , patients with tumors larger than 7 cm experienced a gradual decline in the HRQOL .


The CRT group had significantly more esophagitis and hospitalizations because of side effects regardless of tumor size .


In patients with poor prognosis and inoperable locally advanced non-small-cell lung cancer , large tumor size should not be considered a negative predictive factor .


Except for performance status 2 , patients with tumors larger than 7 cm apparently benefit from CRT .


To evaluate the role of intravitreal aflibercept injection as a treatment for eyes with chronic central serous chorioretinopathy ( CSCR ) .


This prospective pilot study enrolled 12 patients with chronic CSCR who received a 6-month treatment regimen of intravitreal aflibercept .


Patients were followed with monthly Early Treatment of Diabetic Retinopathy Study ( ETDRS ) best-corrected visual acuity ( BCVA ) and spectral domain optical coherence tomography ( SD-OCT ) with enhanced depth imaging .


All patients were men between 29 and 64years ( median 55 ) .


Subfoveal fluid was present on OCT for a median duration of 6months ( range 4-29months ) prior to treatment .


Baseline BCVA ranged from 20/25 to 20/160 ( median 20/50 ) with a mean of 62 ( SD = 13 ) ETDRS letters .


No patients experienced serious ocular or systemic adverse events over the course of the study .


Post-treatment BCVA ranged from 20/20 to 20/200 ( median 20/40 ) , with a mean of 64 ( SD = 16 ) ETDRS letters ( p = 0.56 ) .


At baseline , three patients ( 25 % ) had BCVA of 20/40 versus seven patients ( 58 % ) at the conclusion of the study .


Two patients gained at least 15 ETDRS letters and no patients lost more than 15 ETDRS letters .


Six of 12 patients ( 50 % ) had complete resolution of subfoveal fluid .


Mean central macular thickness decreased from 400m ( SD = 104m ) to 306m ( SD = 94m ) ( p = 0.03 ) , and mean subfoveal fluid decreased from 159m ( SD = 93m ) to 49m ( SD = 68m ) ( p = 0.02 ) .


Mean choroidal thickness decreased from 307m ( SD = 72m ) to 263m ( SD = 63m ) ( p = 0.0003 ) .


Intravitreal aflibercept was well tolerated over a 6-month treatment course for chronic CSCR .


No change was observed in visual acuity metrics .


Anatomic trends may suggest some morphological activity , but larger controlled trials are needed .


NCT01710332 .


Serum infliximab trough levels correlate with efficacy ; dose escalation is often beneficial in patients with Crohn 's disease who stop responding to infliximab treatment .


To carry out a post hoc analysis of A Crohn 's Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen I ( ACCENT I ) to evaluate the association between serum infliximab trough levels and C-reactive protein ( CRP ) after 14weeks of induction treatment with durable sustained long-term response ( Crohn 's Disease Activity Index decrease 70 points and reduction 25 % from baseline ) .


ACCENT I was a multicentre , randomised , placebo-controlled study .


Week 14 trough levels and CRP percentage decrease from baseline to week 14 were compared between patients with and without durable sustained response through week 54 .


Sensitivity and specificity were determined to predict durable sustained response .


Receiver operating characteristic ( ROC ) curves identified optimal cut-off points ; logistic regression determined ORs .


After induction with 5mg/kg infliximab , 25 % ( 37/147 ) and 33 % ( 47/144 ) of patients sustained week 14 response to infliximab 5 or 10mg/kg , respectively , administered every 8weeks without dose escalation , through week 54 .


Median week 14 trough levels of patients with and without durable sustained response to infliximab 5mg/kg were 4.0 and 1.9 g/mL , respectively ( p = 0.0331 ) .


Optimal predictors of durable sustained response to maintenance infliximab 5mg/kg were week 14 trough level 3.5 g/mL and 60 % CRP decrease ( ORs ( 95 % CI ) , 3.5 ( 1.1 to 11.4 ) and 7.3 ( 1.4 to 36.7 ) ) , respectively , in patients with raised baseline CRP ( > 8.0 mg/L ) ; area under the ROC curve was 0.75 for both predictors .


A 3.5 g/mL week 14 infliximab serum level did not predict durable sustained response to 10mg/kg maintenance infliximab .


Patients with durable sustained response to maintenance infliximab 5mg/kg had higher postinduction trough levels than patients without durable sustained response .


Serum infliximab trough levels 3.5 g/mL and 60 % CRP decrease were significantly associated with durable sustained response .


Intimate partner violence ( IPV ) and HIV are important and interconnected public health concerns .


While it is recognized that they share common social drivers , there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level .


The SASA !


study assessed the community-level impact of SASA !


, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors .


From 2007 to 2012 a pair-matched cluster randomized controlled trial ( CRT ) was conducted in eight communities ( four intervention and four control ) in Kampala , Uganda .


Cross-sectional surveys of a random sample of community members , 18 - to 49-years old , were undertaken at baseline ( n = 1,583 ) and four years post intervention implementation ( n = 2,532 ) .


Six violence and HIV-related primary outcomes were defined a priori .


An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up .


The intervention was associated with significantly lower social acceptance of IPV among women ( adjusted risk ratio 0.54 , 95 % confidence interval ( CI ) 0.38 to 0.79 ) and lower acceptance among men ( 0.13 , 95 % CI 0.01 to 1.15 ) ; significantly greater acceptance that a woman can refuse sex among women ( 1.28 , 95 % CI 1.07 to 1.52 ) and men ( 1.31 , 95 % CI 1.00 to 1.70 ) ; 52 % lower past year experience of physical IPV among women ( 0.48 , 95 % CI 0.16 to 1.39 ) ; and lower levels of past year experience of sexual IPV ( 0.76 , 95 % CI 0.33 to 1.72 ) .


Women experiencing violence in intervention communities were more likely to receive supportive community responses .


Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities ( 0.57 , 95 % CI 0.36 to 0.91 ) .


This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV , the past year prevalence of IPV and levels of sexual concurrency .


SASA !


achieved important community impacts , and is now being delivered in control communities and replicated in 15 countries .


ClinicalTrials.gov #NCT 00790959 .


It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure .


We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding .


We performed a randomized , double-blind , placebo-controlled trial in which , after perioperative interruption of warfarin therapy , patients were randomly assigned to receive bridging anticoagulation therapy with low-molecular-weight heparin ( 100 IU of dalteparin per kilogram of body weight ) or matching placebo administered subcutaneously twice daily , from 3 days before the procedure until 24 hours before the procedure and then for 5 to 10 days after the procedure .


Warfarin treatment was stopped 5 days before the procedure and was resumed within 24 hours after the procedure .


Follow-up of patients continued for 30 days after the procedure .


The primary outcomes were arterial thromboembolism ( stroke , systemic embolism , or transient ischemic attack ) and major bleeding .


In total , 1884 patients were enrolled , with 950 assigned to receive no bridging therapy and 934 assigned to receive bridging therapy .


The incidence of arterial thromboembolism was 0.4 % in the no-bridging group and 0.3 % in the bridging group ( risk difference , 0.1 percentage points ; 95 % confidence interval [ CI ] , -0.6 to 0.8 ; P = 0.01 for noninferiority ) .


The incidence of major bleeding was 1.3 % in the no-bridging group and 3.2 % in the bridging group ( relative risk , 0.41 ; 95 % CI , 0.20 to 0.78 ; P = 0.005 for superiority ) .


In patients with atrial fibrillation who had warfarin treatment interrupted for an elective operation or other elective invasive procedure , forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreased the risk of major bleeding .


( Funded by the National Heart , Lung , and Blood Institute of the National Institutes of Health ; BRIDGE ClinicalTrials.gov number , NCT00786474 . )


The Strategic Timing of AntiRetroviral Treatment ( START ) trial has recruited antiretroviral-nave individuals with high CD4 cell counts from all regions of the world .


We describe the distribution of cardiovascular disease ( CVD ) risk factors , overall and by geographical region , at study baseline .


The distribution of CVD risk factors was assessed and compared by geographical region among START participants who had a baseline electrocardiogram ( n = 4019 ; North America , 11 % ; Europe/Australia/Israel , 36 % ; South America , 26 % ; Asia , 4 % ; Africa , 23 % ; median age 36 years ; 26 % female ) .


About 58.3 % ( n = 2344 ) of the participants had at least one CVD risk factor and 18.9 % ( n = 761 ) had two or more .


The most common CVD risk factors were current smoking ( 32 % ) , hypertension ( 19.3 % ) and obesity ( 16.5 % ) .


There were significant differences in the prevalence of CVD risk factors among geographical regions .


The prevalence of at least one risk factor across regions was as follows : North America , 70.0 % ; Europe/Australia/Israel , 65.1 % ; South America , 49.4 % ; Asia , 37.0 % ; Africa , 55.8 % ( P-value < 0.001 ) .


Significant regional differences were also observed when risk factors were used as part of the Framingham and Data Collection on Adverse events of Anti-HIV Drugs ( D : A :D ) risk scores or used to define a favourable risk profile .


CVD risk factors are common among START participants , and their distribution varies by geographical region .


Better understanding of how and why CVD risk factors develop in people with HIV infection and their geographical distributions could shed light on appropriate strategies for CVD prevention and may inform the interpretation of the results of START , as CVD is expected to be a major fraction of the primary endpoints observed .


This randomized controlled trial aimed to evaluate whether the serum procalcitonin ( PCT ) level can be utilized to guide the use of antibiotics in the treatment of acute exacerbations of asthma .


A total of 293 consecutive patients with suspected asthma attacks from February 2005 to July 2010 participated in this study .


225 patients completed the study .


Serum PCT levels , and other inflammatory biomarkers of all patients were measured .


In addition to the standard treatment , the control group received antibiotics according to the attending physicians ' discretions , while the patients in the PCT group were treated with antibiotics according to serum PCT concentrations .


Antibiotics usage was strongly discouraged when the PCT concentration was below 0.1 g/L ; discouraged when the PCT concentration was between 0.1 g/L and 0.25 g/L ; or encouraged when the PCT concentration was above 0.25 g/L .


The primary endpoint was the determination of antibiotics usage .


The second endpoints included the diagnostic accuracy of PCT and other laboratory biomarkers the effectiveness of asthma control , secondary ED visits , hospital re-admissions , repeated needs for steroids or dosage increase , needs for antibiotics , WBC count , PCT levels and FEV1 % .


At baseline , two groups were identical regarding clinical , laboratory and symptom score .


Probability of the antibiotics usage in the PCT group ( 46.1 % ) was lower than that in the control group ( 74.8 % ) ( 2 = 21.97 , p < 0.001 .


RR = 0.561 , 95 % CI 0.441-0 .713 ) .


PCT and IL-6 showed good diagnostic significance for bacterial asthma ( r = 0.705 , p = 0.003 ) .


The degrees of asthma control in patients were categorized to three levels and were comparable between the two groups at the six weeks follow-up period ( 2 = 1.62 , p = 0.45 ) .


There were no significant difference regarding other secondary outcomes ( p > 0.05 ) .


The serum PCT concentration can be used to effectively determine whether the acute asthma patients have bacterial infections in the respiratory tract , and to guide the use of antibiotics in the treatment of acute asthma exacerbations , which may substantially reduce unnecessary antibiotic use without compromising the therapeutic outcomes .


ICTRP ChiCTR-TRC-12002534 .


The SYMPLICITY HTN-3 randomized , blinded , sham-controlled trial confirmed the safety of renal denervation ( RDN ) , but did not meet its primary efficacy endpoint .


Prior RDN studies have demonstrated significant and durable reductions in blood pressure .


This analysis investigated factors that may help explain these disparate results .


Patients with resistant hypertension were randomized 2 : 1 to RDN ( n = 364 ) or sham ( n = 171 ) .


The primary endpoint was the difference in office systolic blood pressure ( SBP ) change at 6 months .


A multivariable analysis identified predictors of SBP change .


Additional analyses examined the influence of medication changes , results in selected subgroups and procedural factors .


Between randomization and the 6-month endpoint , 39 % of patients underwent medication changes .


Predictors of office SBP reduction at 6 months were baseline office SBP 180 mmHg , aldosterone antagonist use , and non-use of vasodilators ; number of ablations was a predictor in the RDN group .


Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham ; -15.2 23.5 vs. -8.6 24.8 mmHg , respectively ( P = 0.012 ) .


Greater reductions in office and ambulatory SBP , and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern .


Post hoc analyses , although derived from limited patient cohorts , reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups .


These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension .


CLINICALTRIALS.GOV IDENTIFIER : NCT01418261 .


To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency ( SVI ) have greater benefits from treatment than those with only symptomatic varicose veins .


A commonly held view is that SVI is only a minor ailment , yet randomized clinical trials ( RCTs ) show that treatment improves quality of life ( QoL ) and is cost-effective .


In an effort to curb the treatment costs of this common disorder , rationing is applied in many health care systems , often limiting the reimbursement of treatment to those with soft tissue changes .


This cohort study draws its data from an interventional RCT .


After informed consent , consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation .


This analysis differentially studies the outcomes of patients with simple varicose veins ( C2 : n = 191 ) and soft tissue complications ( C3-4 : n = 76 ) .


Effectiveness outcomes measured up to 1 year included the following : Qol [ short form 36 ( SF36 ) , EuroQol , and the Aberdeen Varicose Veins Questionnaire ] , clinical recurrence , and the need for secondary procedures .


Multivariable regression analysis was used to control for potential confounding factors .


Both groups saw significant improvements in QoL .


All improvements were equal between groups apart from the SF36 domain of Bodily Pain , where C2 saw an improvement of 12.8 [ 95 % confidence interval ( CI ) : 4.8-20 .8 ] points over C3-4 participants ( P = 0.002 ) , who also suffered more recurrence [ odds ratio ( OR ) = 2.7 , 95 % CI : 1.2-6 .1 , P = 0.022 ] and required more secondary procedures ( OR = 4.4 , 95 % CI : 1.2-16 .3 , P = 0.028 ) .


This study suggests that rationing by clinical severity contradicts the evidence .


Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence .


NCT00759434 Clinicaltrials.gov .


To determine whether addition of an electronic sepsis evaluation and management tool to electronic sepsis alerting improves compliance with treatment guidelines and clinical outcomes in septic ICU patients .


A pragmatic randomized trial .


Medical and surgical ICUs of an academic , tertiary care medical center .


Four hundred and seven patients admitted during a 4-month period to the medical or surgical ICU with a diagnosis of sepsis established at the time of admission or in response to an electronic sepsis alert .


Patients were randomized to usual care or the availability of an electronic tool capable of importing , synthesizing , and displaying sepsis-related data from the medical record , using logic rules to offer individualized evaluations of sepsis severity and response to therapy , informing users about evidence-based guidelines , and facilitating rapid order entry .


There was no difference between the electronic tool ( 218 patients ) and usual care ( 189 patients ) with regard to the primary outcome of time to completion of all indicated Surviving Sepsis Campaign 6-hour Sepsis Resuscitation Bundle elements ( hazard ratio , 1.98 ; 95 % CI , 0.75-5 .20 ; p = 0.159 ) or time to completion of each element individually .


ICU mortality , ICU-free days , and ventilator-free days did not differ between intervention and control .


Providers used the tool to enter orders in only 28 % of available cases .


A comprehensive electronic sepsis evaluation and management tool is feasible and safe but did not influence guideline compliance or clinical outcomes , perhaps due to low utilization .


Colorectal cancer is a major public health problem .


There is growing support for colorectal cancer survivors who are experiencing problems after cancer treatment to engage in self-management programs to reduce symptom distress .


However , there is inconclusive evidence as to the effectiveness of such program especially in Asian region .


This study tested the effects of a six-month nurse-led self-efficacy-enhancing intervention for patients with colorectal cancer , compared with routine care over a six-month follow up .


A randomized controlled trial with repeated measures , two-group design .


Three teaching hospitals in Guangzhou , China .


One hundred and fifty-two Chinese adult patients with a diagnosis of colorectal cancer were recruited .


The intervention group ( n = 76 ) received self-efficacy-enhancing intervention and the control group ( n = 76 ) received standard care .


The participants were randomized into either intervention or control group after baseline measures .


The outcomes of the study ( self-efficacy , symptom distress , anxiety , depression and quality of life ) were compared at baseline , three and six months after the intervention .


Sixty-eight participants in the intervention group and 53 in the control group completed the study .


Their mean age was 53 ( SD = 11.3 ) .


Repeated measure MANOVA found that the patients in the intervention group had significant improvement in their self-efficacy ( F = 7.26 , p = 0.003 ) and a reduction of symptom severity ( F = 5.30 , p = 0.01 ) , symptom interference ( F = 4.06 , p = 0.025 ) , anxiety ( F = 6.04 , p = 0.006 ) and depression ( F = 6.96 , p = 0.003 ) at three and six months , compared with the control group .


However , no statistically significant main effect was observed in quality of life perception between the two groups .


The nurse-led self-efficacy enhancing intervention was effective in promoting self-efficacy and psychological well-being in patients with colorectal cancer , compared with standard care .


The intervention can be incorporated into routine care .


Future empirical work is required to determine the longer term effects of the intervention .


Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results .


The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren .


Cluster randomized trial study of 712 schoolchildren , 8-10 years , from 20 public schools in the Province of Cuenca , Spain .


The intervention ( MOVI-2 ) consisted of play-based and non-competitive activities .


MOVI-2 was conducted during two 90-minute sessions on weekdays and one 150-minute session on Saturday mornings every week between September 2010 and May 2011 .


We measured changes in adiposity ( overweight/obesity prevalence , body mass index [ BMI ] , triceps skinfold thickness [ TST ] , body fat % , fat-free mass , waist circumference ) and other cardiometabolic risk factors ( LDL-cholesterol , triglycerides/HDL-cholesterol ratio , insulin , C-reactive protein and blood pressure ) .


The analyses used mixed regression models to adjust for baseline covariates under cluster randomization .


Among girls , we found a reduction of adiposity in intervention versus control schools , with a decrease in TST ( -1.1 mm ; 95 % confidence interval [ CI ] -2.3 to -0.7 ) , body fat % ( -0.9 % ; 95 % CI -1.3 to -0.4 ) , waist circumference ( -2.7 cm ; 95 % CI -4.5 to -0.9 ) , and an increase in fat-free mass ( 0.3 kg ; 95 % CI 0.01 to 0.6 ) .


The intervention also led to lower serum LDL-cholesterol and insulin levels .


Among boys , a reduction in waist circumference ( -1.4 cm ; 95 % CI -2.6 to -0.1 ; P = 0.03 ) , and an increase in fat-free mass ( 0.5 kg ; 95 % CI 0.2 to 0.9 ; P = 0.003 ) was associated with the intervention versus control schools .


The prevalence of overweight/obesity or underweight , BMI , and other cardiometabolic risk factors was not modified by the intervention .


No important adverse events were registered .


An extracurricular intervention of non-competitive physical activity during an academic year , targeting all schoolchildren regardless of body weight , is a safe and effective measure to reduce adiposity in both genders and to improve cardiometabolic risk profile in girls .


Clinical trials NCT01277224 .


We investigated potential biomarkers of efficacy in a phase III trial of sunitinib versus interferon-alpha ( IFN - ) , first-line in metastatic renal cell carcinoma ( mRCC ) , by analyzing plasma levels of vascular endothelial growth factor ( VEGF ) - A , VEGF-C , soluble VEGF receptor-3 ( sVEGFR-3 ) and interleukin ( IL ) -8 .


Seven hundred and fifty mRCC patients were randomized to oral sunitinib 50 mg/day in repeated cycles of a 4-week on/2-week off schedule or IFN - 9 million units subcutaneously thrice weekly .


Plasma samples collected from a subset of 63 patients on days 1 and 28 of cycles 1-4 and at end of treatment were analyzed by ELISA .


Baseline characteristics of biomarker-evaluated patients in sunitinib ( N = 33 ) and IFN - ( N = 30 ) arms were comparable to their respective intent-to-treat populations .


By univariate Cox regression analysis , low baseline soluble protein levels were associated with lower risk of progression/death ( all P < 0.05 ) : in both treatment arms , baseline VEGF-A and IL-8 were associated with overall survival ( OS ) and baseline VEGF-C with progression-free survival ( PFS ) ; in the sunitinib arm , baseline VEGF-A was associated with PFS and baseline sVEGFR-3 with PFS and OS ; in the IFN - arm , baseline IL-8 was associated with PFS .


In multivariate analysis , baseline sVEGFR-3 and IL-8 remained independent predictors of OS in the sunitinib arm , while no independent predictors of outcome remained in the IFN - arm .


Pharmacodynamic changes were not associated with PFS or OS for any plasma protein investigated .


Our findings suggest that , in mRCC , baseline VEGF-A and IL-8 may have prognostic value , while baseline sVEGFR-3 may predict sunitinib efficacy .


The aim of the study was to evaluate the relation between nutritional intake ( kilocalories , protein ) and weight and length growth in preterm infants , and to describe their metabolic tolerance with a focus on those with high protein intake ( 4.6 g kg ( -1 ) day ( -1 ) ) .


Secondary analysis of data from appropriate-for-gestational age preterm infants in a 28-day randomized clinical trial that evaluated growth , tolerance , and safety of a new ultraconcentrated liquid human milk fortifier ( original study n = 150 ) .


This subset of 56 infants had complete growth and nutrition data and met criteria for the original study 's `` efficacy analysis '' ( eg , > 80 % of kilocalorie intake from study diet ) .


Nutritional intake was estimated , not actual .


Regressions were used to test cumulative kilocalories and protein as the predictors of 28-day change in weight and length z scores ( growth status ) , and to evaluate protein tolerance .


Average intake was 118 8 kcal kg ( -1 ) day ( -1 ) and 4.3 0.4 g protein kg ( -1 ) day ( -1 ) , with 16 3 g kg ( -1 ) day ( -1 ) and 1.1 0.2 cm/week growth for 28 days .


Cumulative total kilocalories and protein were significant predictors of improved length z score ( P = 0.0054 , 0.0005 ) but not weight z score change .


Regression models indicated that protein not kilocalories explained the improvement in length z score , with protein explaining 19 % of the variability .


The high protein group averaged 4.6 to 5.5 g kg ( -1 ) day ( -1 ) ( n = 16 ) .


Protein tolerance was adequate for all of the study infants based on metabolic measures ( blood urea nitrogen , serum carbon dioxide , pH ) .


Higher cumulative protein intake was tolerated and overall lessened the commonly occurring decline in the length but not weight growth status in a 28-day study of preterm infants .


The objective of this study was to investigate whether ingestion of fructose and fructans ( such as inulin ) can exacerbate irritable bowel syndrome ( IBS ) symptoms .


The aim was to better understand the origin of these symptoms by magnetic resonance imaging ( MRI ) of the gut .


A total of 16 healthy volunteers participated in a four-way , randomized , single-blind , crossover study in which they consumed 500ml of water containing 40g of either glucose , fructose , inulin , or a 1:1 mixture of 40g glucose and 40g fructose .


MRI scans were performed hourly for 5h , assessing the volume of gastric contents , small bowel water content ( SBWC ) , and colonic gas .


Breath hydrogen ( H2 ) was measured and symptoms recorded after each scan .


Data are reported as mean ( s.d. ) ( 95 % CI ) when normally distributed and median ( range ) when not .


Fructose increased area under the curve ( AUC ) from 0-5h of SBWC to 71 ( 23 ) l/min , significantly greater than for glucose at 36 ( 11-132 ) l/min ( P < 0.001 ) , whereas AUC SBWC after inulin , 33 ( 17-106 ) l/min , was no different from that after glucose .


Adding glucose to fructose decreased AUC SBWC to 55 ( 28 ) l/min ( P = 0.08 ) vs. fructose .


Inulin substantially increased AUC colonic gas to 33 ( 20 ) l/min , significantly greater than glucose and glucose + fructose ( both P < 0.05 ) .


Breath H2 rose more with inulin than with fructose .


Glucose when combined with fructose significantly reduced breath H2 by 7,700 ( 3,121-12 ,300 ) p.p.m. / min relative to fructose alone ( P < 0.01 , n = 13 ) .


Fructose but not inulin distends the small bowel with water .


Adding glucose to fructose reduces the effect of fructose on SBWC and breath hydrogen .


Inulin distends the colon with gas more than fructose , but causes few symptoms in healthy volunteers .


This open-label phase III trial evaluated efficacy and tolerability of linifanib versus sorafenib in patients with advanced hepatocellular carcinoma ( HCC ) without prior systemic therapy .


Patients were randomly assigned in a 1:1 ratio to linifanib 17.5 mg once daily or sorafenib 400 mg twice daily .


Patients were stratified by region ( Outside Asia , Japan , and rest of Asia ) , Eastern Cooperative Oncology Group performance score ( ECOG PS ; 0 or 1 ) , vascular invasion or extrahepatic spread ( yes or no ) , and hepatitis B virus ( HBV ) infection ( yes or no ) .


The primary end point of the study was overall survival ( OS ) .


Secondary end points were time to progression ( TTP ) and objective response rate ( ORR ) per RECIST v1 .1 .


We randomly assigned 1,035 patients ( median age , 60 years ; Asian , 66.6 % ; ECOG PS 0 , 65.2 % ; HBV , 49.1 % ; vascular invasion or extrahepatic spread , 70.1 % ) .


Median OS was 9.1 months on the linifanib arm ( 95 % CI , 8.1 to 10.2 ) and 9.8 months on the sorafenib arm ( 95 % CI , 8.3 to 11.0 ; hazard ratio [ HR ] , 1.046 ; 95 % CI , 0.896 to 1.221 ) .


For prespecified stratification subgroups , OS HRs ranged from 0.793 to 1.119 and the 95 % CI contained 1.0 .


Median TTP was 5.4 months on the linifanib arm ( 95 % CI , 4.2 to 5.6 ) and 4.0 months on the sorafenib arm ( 95 % CI , 2.8 to 4.2 ; HR , 0.759 ; 95 % CI , 0.643 to 0.895 ; P = .001 ) .


Best response rate was 13.0 % on the linifanib arm versus 6.9 % on the sorafenib arm .


Grade 3/4 adverse events ( AEs ) ; serious AEs ; and AEs leading to discontinuation , dose interruption , and reduction were more frequent with linifanib ( all P < .001 ) .


Linifanib and sorafenib had similar OS in advanced HCC .


Predefined superiority and noninferiority OS boundaries were not met for linifanib and the study failed to meet the primary end point .


TTP and ORR favored linifanib ; safety results favored sorafenib .


While many of the commonly used conservative treatments for knee osteoarthritis ( OA ) have been recognized to be effective , there is still insufficient evidence available .


Among the pharmacological treatments for knee OA , oral non-steroidal anti-inflammatory drugs ( NSAIDs ) act rapidly and are recommended for the management of OA .


However , frequent and serious adverse effects of NSAIDs have been recognized .


Intra-articular injections of hyaluronic acid ( IA-HA ) for the treatment of knee OA have been shown to reduce pain and improve joint function .


However , there has been no qualified direct comparison study of the efficacy and safety between IA-HA and NSAIDs for patients with knee OA .


The aim of this study was to clarify the efficacy and safety of early-phase IA-HA in comparison to those of NSAIDs for patients with knee OA .


This multicenter , randomized , open-label , parallel-group , non-inferiority comparison study with an oral NSAID involved a total of 200 patients with knee OA .


An independent , computer-generated randomization sequence was used to randomly assign patients in a 1:1 ratio to NSAIDs three times per day for five weeks ( n = 100 ) or IA-HA once a week for five weeks ( n = 100 ) .


The primary endpoint was the percentage change in the patient-oriented outcome measure for knee OA , the Japanese Knee Osteoarthritis Measure ( JKOM ) score .


All patients were questioned regarding any adverse events during treatment .


The full analysis set ( FAS ) was used for analysis .


The margin of non-inferiority was 10 % .


The analyses of primary endpoint included 98 patients in the IA-HA group and 86 patients in the NSAID group .


The difference in the percentage changes of the JKOM score between the two intervention arms ( IA-HA ; -34.7 % ( P < 0.001 ) , NSAID ; -32.2 % ( P < 0.001 ) ) was -2.5 % ( 95 % confidence interval ( CI ) : -14.0 to 9.1 ) , indicating IA-HA was not inferior to NSAID .


The frequency of both withdrawal and adverse events in the IA-HA group were significantly lower than those in the NSAID group ( P = 0.026 and 0.004 , respectively ) .


The early efficacy of IA-HA is suggested to be not inferior to that of NSAIDs , and that the safety of the early phase of IA-HA is superior to that of NSAIDs for patients with knee OA .


UMIN Clinical Trials Registry ( UMIN-CTR ) , UMIN000001026 .


Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published .


The ELIOT Trial used electrons ( IOERT ) , and the TARGIT-A Trial Update used 50-kV X-rays ( IORT ) .


These studies were compared for similarities and differences .


The results were analyzed and used to determine which patients might be suitable for single-dose treatment .


The primary sources of data were the ELIOT Trial and TARGIT-A Trial , as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation ( APBI ) using 50-kV X-rays or electrons .


Studies published or presented prior to March 2014 were analyzed for efficacy , patient restrictions , complications , and outcome .


With a median follow-up of 5.8 years , the 5-year recurrence rates for ELIOT versus external beam radiation therapy ( EBRT ) patients were 4.4 % and 0.4 % , respectively , p = .0001 .


A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 % .


With a median follow-up of 29months , the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 % and 1.3 % , respectively , p = .042 .


With 5.8 years of median follow-up , IOERT appears to have a subset of low-risk women for whom IOERT is acceptable .


With 29months of median follow-up the results of IORT with 50-kV devices are promising , but longer follow-up data are required .


At the current time , single-fraction IOERT or IORT patients should be treated under strict institutional protocols .


To examine whether baseline obesity severity modifies the effects of two different , primary care-based , technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome .


We compared mean differences in changes from baseline to 15 months in clinical measures of general and central obesity among participants randomized to usual care alone ( n = 81 ) or usual care plus a coach-led group ( n = 79 ) or self-directed individual ( n = 81 ) intervention , stratified by baseline body mass index ( BMI ) category .


Participants with baseline BMI 35 + had greater reductions in mean BMI , body weight ( as percentage change ) , and waist circumference in the coach-led group intervention , compared to usual care and the self-directed individual intervention ( P < 0.05 for all ) .


In contrast , the self-directed intervention was more effective than usual care only among participants with baseline BMIs between 25 35 .


Mean weight loss exceeded 5 % in the coach-led intervention regardless of baseline BMI category , but this was achieved only among self-directed intervention participants with baseline BMIs < 35 .


Baseline BMI may influence behavioral weight-loss treatment effectiveness .


Researchers and clinicians should take an individual 's baseline BMI into account when developing or recommending lifestyle focused treatment strategy .


This trial is registered with ClinicalTrials.gov NCT00842426 .


Patients ' reported opinions of the health system need to be understood in order to provide patient-centered care .


We investigated determinants of women 's ratings of the quality of care during their most recent facility delivery .


We conducted a census of all deliveries in the 6 weeks to 12 months preceding the survey , in villages served by 24 primary care clinics in rural Pwani Region , Tanzania .


Women who had delivered children in a study facility were included in this analysis ( n = 855 ) .


We interviewed women about demographic and obstetric factors and the quality of their obstetric care using a structured questionnaire .


We created a composite index of perceived quality from six quality questions .


We also assessed the functioning of the local health clinic using structured surveys .


We used a multi-level model to analyze factors associated with women 's rating of the quality of care during delivery .


14 % of respondents rated the overall quality of care received during delivery as excellent .


Women who listened to the radio daily reported lower quality composite scores ( : -0.99 , p < 0.001 ) .


Women who reported receiving more services in ANC had higher quality scores ( : 0.46 , p = 0.001 ) , as did women receiving more delivery services ( : 0.55 , p < 0.001 ) .


Women who reported disrespect and abuse during delivery had significantly lower quality scores ( : -4.13 , p < 0.001 ) .


A woman 's expectations and prior and current experiences influence her perception of the quality of care she received .


Health facility characteristics did not influence ratings of overall quality .


Focusing on improving the process rather than inputs of service delivery during ANC visits and delivery may increase perceived quality of delivery care in low-resource settings .


ISRCTN17107760 .


There is a lack of knowledge about antidementia drug treatment in community dwelling people with dementia in Germany .


To determine the frequency of treatment with antidementia drugs in patients in primary care , and the socio-demographic and clinical variables associated with antidementia drug treatment .


Present analyses are based on preliminary data from the DelpHi-trial , an ongoing GP-based , cluster-randomized , controlled intervention trial to implement and evaluate an innovative concept of collaborative dementia care management in Germany .


Our sample consists of n = 243 subjects who screened positive for dementia .


29.6 % ( n = 72 ) of participants received antidementia drugs : memantine 44.5 % ( n = 32 ) ; donepezil 30.5 % ( n = 22 ) ; rivastigmine 13.9 % ( n = 10 ) ; galantamine 11.1 % ( n = 8 ) .


A total of 46.4 % ( n = 45 ) of the subgroup of participants with a formal dementia diagnosis received antidementia drug treatment .


Approximately 37.5 % ( n = 27 ) of our sample received treatment with antidementia drugs without having a formal diagnosis .


Treatment with antidementia drugs was significantly associated with more severe cognitive impairment and having a formal dementia diagnosis .


One in three people who screened positive for dementia in primary care received antidementia drug treatment , indicating the frequent use of this class of drugs .


For those with a formal dementia diagnosis , these drug treatment rates are more than triple , compared to those in nursing homes .


Internet-delivered trauma-focused cognitive behavioural therapy is efficacious for PTSD ; however , no studies have investigated the roles of individual treatment components or the safety of online treatments .


To compare the efficacy and safety of an online treatment for PTSD comprised of psychoeducation , stress management , cognitive restructuring and exposure components with the equivalent protocol without the exposure components , using a randomised controlled trial design .


Sixty-six individuals were randomised to a non-exposure condition and 59 to the full protocol with exposure components .


Treatment duration was 8 weeks and pre - , post-treatment and three-month follow-up outcomes were analysed using a mixed linear modelling approach .


Both groups achieved improvements in symptoms with no differences between groups on any primary or secondary outcome measures , diagnostic remission rates or adverse events .


The study included several secondary measures that have not been previously validated and treatments were not time matched in terms of number of lessons .


These findings indicate that trauma-focused cognitive behavioural therapy for PTSD with or without exposure components can be safe and efficacious .


Patients with genotype 3 hepatitis C virus ( HCV ) infection and cirrhosis have poor response rates after 24 weeks treatment with pegylated interferon and ribavirin .


Treatment for 48 weeks is therefore recommended , although the benefits of this are untested .


We examined extended therapy in patients with genotype 3 HCV and advanced fibrosis .


Multicentre , open labelled randomized trial comparing therapy with 24 weeks pegylated interferon and ribavirin to 48 weeks of the same therapy .


136 patients completed the study .


67 received 24 weeks therapy and the SVR rate ( 48 % ) did not differ from that seen in the 69 patients who received 48 weeks therapy ( 42 % ) .


The response rates in patients with biopsy proven cirrhosis ( 13 patients treated for 24 weeks , 18 patients treated for 48 weeks ) or cirrhosis proven on imaging ( 28 patients treated for 24 weeks and 25 patients treated for 48 weeks ) were 46 % in those treated for 24 weeks and 40 % in those treated for 48 weeks .


The differences were not significantly different .


Treatment failure was due to relapse in the majority of patients .


Patients with genotype 3 HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin .


Epidemiological research links aggression to low serum concentrations of omega-3 fatty acids , such as those found in fish oil .


However , no studies have specifically examined whether fish oil supplementation can reduce the frequency and severity of impulsive aggression in children with disruptive behavior disorders .


Children presenting with impulsive aggression and meeting research criteria for diagnosis of disruptive behavior disorders were randomized to receive either : 1 ) Fish oil capsules ( 4g daily ) for 6 weeks followed by placebo ( identical-looking capsules ) for 6 weeks ; or 2 ) placebo for 6 weeks , followed by fish oil for 6 weeks , in a double-blind , crossover design .


Primary outcomes were the Children 's Aggression Scale and the Modified Overt Aggression Scale .


Secondary outcomes included emotional and behavioral functioning ( Strengths and Difficulties Questionnaire [ SDQ ] ) , hyperactivity symptoms ( Attention-Deficit/Hyperactivity Disorder [ ADHD ] Rating Scale ) , family functioning ( Family Assessment Device ) , and cognitive functioning ( Stop Signal Task , Trail-Making Task , and Eriksen Flanker Task ) .


Serum concentrations of omega-3 and omega-6 fatty acids were measured at baseline , and at 6 and 12 weeks .


Twenty-one children participated ( 81 % male ; mean age 10.32.2 years ; range 7-14 ) .


Fish oil treatment increased serum concentrations of eicosapentanoic acid ( F = 14.76 , p < 0.05 ) and total omega-3s ( F = 20.56 , p < 0.05 ) , but did not influence primary ratings of aggression .


In fact , a trend suggested that fish oil worsened a secondary measure of aggression ( SDQ Conduct Subscale , F = 4.34 , p = 0.06 ) .


Fish oil treatment was associated with an improvement in one rating of hyperactivity ( SDQ Hyperactivity Subscale , F = 2.22 , p < 0.05 ) , but did not influence any other outcome measures .


These findings suggest that fish oil treatment does not improve aggression in children with disruptive behavior disorders .


To compare outcomes of illuminated microcatheter-assisted circumferential trabeculotomy vs combined mitomycin C-augmented trabeculotomy-trabeculectomy for primary congenital glaucoma .


Prospective , randomized trial .


Of the 30 patients ( 60 eyes ) analyzed with bilateral primary congenital glaucoma aged 2 years , 1 eye of each patient was randomized to : illuminated microcatheter-assisted trabeculotomy ( Group I ) or combined trabeculotomy with trabeculectomy augmented with mitomycin C ( Group II ) .


Primary outcome measure was intraocular pressure ( IOP ) reduction .


Categorization into absolute success ( IOP 15mm Hg without medication ) and qualified success ( IOP 15mm Hg with medication ) was done .


Secondary outcomes included change in corneal diameter and clarity , optic disc status , refraction , need for anti-glaucoma therapy , and occurrence of complications .


Mean age of patients was 6.63 5.74 months .


IOP fell by 49.3 % ( 22.25 10.88 to 11.56 3.33 mm Hg ) in Group I and 46.6 % in Group II ( 21.73 8.89 to 11.60 3.03 mm Hg ) ( P < .001 in both ) .


At 1 year , absolute success was achieved in 86.7 % ( 26/30 ) and 90.0 % ( 27/30 ) in Groups I and II , respectively ( P > .99 ) and qualified success in 93.3 % ( 28/30 ) in both groups ( P = 1 ) .


There was significant improvement in corneal clarity ( P < .001 ) and cup-to-disc ratio ( P .01 ) in both groups at 1 year .


Though incidence of hyphema was significantly more in Group I ( P = .0001 ) , no vision-threatening complications occurred in either group .


Illuminated microcatheter-assisted circumferential trabeculotomy achieved comparable surgical outcomes to mitomycin C-augmented combined trabeculotomy-trabeculectomy and may be recommended as the initial surgical procedure for primary congenital glaucoma .


Non-attenders for cervical screening are at increased risk of cervical cancer .


Studies offering self-sampling for high-risk Human Papillomavirus ( HrHPV ) testing have shown greater uptake than sending another invitation for cytology .


To explore whether uptake would increase in a less diverse , more stable population than the previous English study , which demonstrated a lower response rate than other studies .


The primary objective was whether non-attenders were more likely to respond to a postal invitation , including kit , to collect a self-sample compared with a further invitation for cytology screening .


The secondary objective was whether women with an abnormal result would attend for follow-up .


6000 non-attenders for screening in this pragmatic , randomized ( 1:1 ) controlled trial in Newcastle-upon-Tyne were sent an HPV self-sample kit ( intervention ) or a further invitation for cytology screening ( comparator ) .


411 ( 13 % ) responded to the intervention , returning a self-sample ( 247 ( 8 % ) ) or attending for cytology ( 164 ( 5 % ) ) , compared with 183 ( 6 % ) attending for cytology , relative risk 2.25 ( 95 % CI 1.90-2 .65 ) ( comparator arm ) .


Of those testing hrHPV positive ( 32 ( 13 % ) ) , 19 ( 59 % ) subsequently attended cytology screening .


Of those in the intervention group who attended for cytology screening without returning an hrHPV self-sample ( n = 164 ) , 5 % ( n = 8 ) were referred for colposcopy-all attended .


In the comparator group eight of the nine referred for colposcopy attended .


Persistent non-responders to invitations for cervical screening are significantly more likely to respond to a postal invitation to return a self-collected sample for HPV testing than a further invitation for cytology screening .


However , just over half followed up on this positive HPV result .


To examine how the location where reading takes place and the availability of prior images can affect performance in breast test-set reading .


Under optimized viewing conditions , 10 expert screen readers each interpreted a reader-specific set of images containing 200 mammographic cases .


Readers , randomly divided into two groups read images under one of two pairs of conditions : clinical read with prior images and laboratory read with prior images ; laboratory read with prior images and laboratory read without prior images .


Region-of-interest ( ROI ) figure-of-merit ( FOM ) was analysed using JAFROC software .


Breast side-specific sensitivity and specificity were tested using Wilcoxon matched-pairs signed rank tests .


Agreement between pairs of readings was measured using Kendall 's coefficient of concordance .


Group performances between test-set readings demonstrated similar ROI FOMs , sensitivity and specificity median values , and acceptable levels of agreement between pairs of readings were shown ( W = 0.75-0 .79 , p < 0.001 ) for both pairs of reading conditions .


On an individual reader level , two readers demonstrated significant decreases ( p < 0.05 ) in ROI FOMs when prior images were unavailable .


Reading location had an inconsistent impact on individual performance .


Reading location and availability of prior images did not significantly alter group performance .


Effective strategies for contacting and recruiting study participants are critical in conducting clinical research .


In this study , we conducted two sequential randomized controlled trials of mail - and telephone-based strategies for contacting and recruiting participants , and evaluated participant-related variables ' association with time to survey completion and survey completion rates .


Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical , cognitive and mental health outcomes , with their last study visit completed at a median of 34 months previously .


Eligible subjects were contacted to complete a new research survey as part of two randomized trials , initially using a randomized mail-based contact strategy , followed by a randomized telephone-based contact strategy for non-responders to the mail strategy .


Both strategies focused on using either a personalized versus a generic approach .


In addition , 18 potentially relevant subject-related variables ( e.g. , demographics , last known physical and mental health status ) were evaluated for association with time to survey completion .


Of 308 eligible subjects , 67 % completed the survey with a median ( IQR ) of 3 ( 2 , 5 ) contact attempts required .


There was no significant difference in the time to survey completion for either randomized trial of mail - or phone-based contact strategy .


Among all subject-related variables , age 40 years and minority race were independently associated with a longer time to survey completion .


We found that age 40 years and minority race were associated with a longer time to survey completion , but personalized versus generic approaches to mail - and telephone-based contact strategies had no significant effect .


Repeating both mail and telephone contact attempts was important for increasing survey completion rate .


NCT00719446 .


The purpose of this study was to compare the pain rating scale measurements from an exposure group ( injections with the aid of DentalVibe Injection Comfort System ) and control group ( traditional injection without the aid of the DentalVibe ) in adolescent patients using self-reported pain during administration of local anesthetic injections .


This was a randomized , controlled study .


Subjects consisted of 36 10 - to 17-year-old patients who required local anesthesia for dental treatment on both sides of the maxilla or mandible .


All subjects received a conventional injection ( control ) and an injection using DentalVibe ( experimental ) .


A pain rating for each injection was obtained from subjects using the Wong-Baker FACES Pain Rating Scale .


Statistical analysis using a Wilcoxon signed rank test found a significant reduction in pain ratings for injections with the DentalVibe when compared to control injections .


There was a positive correlation between the pain rating for control injection and the difference between the two types of injection , indicating that subjects who reported a higher pain score with the control injection had a greater reduction when DentalVibe was used .


When compared to a conventional approach , DentalVibe significantly lowered self-reported pain during local anesthesia injection for adolescent subjects in this study .


Recent recommendations for lung protective mechanical ventilation include a tidal volume target of 6 mL/kg predicted body weight ( PBW ) .


Different PBW equations might introduce important differences in tidal volumes delivered to research subjects and patients .


PBW equations use height , age , and sex as input variables .


We compared National Institutes of Health ( NIH ) ARDS Network ( ARDSNet ) , actuarial table ( ACTUARIAL ) , and Stewart ( STEWART ) PBW equations used in clinical trials , across physiologic ranges for age and height .


We used three-dimensional and two-dimensional surface analysis to compare these PBW equations .


We then used age and height from actual clinical trial subjects to quantify PBW equation differences .


Significant potential differences existed between these PBW predictions .


The ACTUARIAL and ARDSNet surfaces for women were the only surfaces that intersected and produced both positive and negative differences .


Mathematical differences between PBW equations at limits of height and age exceeded 30 % in women and 24 % in men for ACTUARIAL vs ARDSNet and about 25 % for women and 15 % for men for STEWART vs ARDSNet .


The largest mathematical differences were present in older , shorter subjects , especially women .


Actual differences for clinical trial subjects were as high as 15 % for men and 24 % for women .


Significant differences between PBW equations for both men and women could be important sources of interstudy variation .


Studies should adopt a standard PBW equation .


We recommend using the NIH National Heart , Lung , and Blood Institute ARDS Network PBW equation because it is associated with the clinical trial that identified 6 mL/kg PBW as an appropriate target .


The authors examined the impacts of whole-body vibration ( WBV ) applications on balance control in postmenopausal women using clinical balance tests and computerized static posturography .


Patients were randomly divided into two groups and treated with WBV and/or home-based balance coordination exercises ( BCEs ) .


Patients in the WBV-BCE group were asked to stand on the platform in standing , squat , and deep squat positions .


During each position , 30-sec vibration ( 30-35 Hz ) and 60-sec rest periods were applied twice ( 20 sessions in total ) .


The BCE program was performed by subjects twice per day .


All subjects were evaluated before and after treatment using the Timed Up and Go test and the Berg Balance Scale ( BBS ) .


The fall index and the Fourier index were assessed via computerized static posturography .


Sixty patients were recruited for the study , but only 42 patients ( 21 in each group ) completed it .


Fall index and the total values of the Fourier index 2-4 and Fourier index 5-6 frequencies indicated a significant improvement in the WBV-BCE group ( P < 0.05 ) .


Both groups showed significant improvements in the Berg Balance Scale and Timed Up and Go test ( P < 0.05 ) .


The ease of applying WBV furthermore supports its inclusion in daily treatment protocols for age-related decline in balance performance in women and improved balance and mobility measures associated with increased fall risk .


There is controversy in medical literature regarding the use of electromagnetic fields to promote bone healing .


After designing and building devices capable of generating an electromagnetic field for this study , their safety was confirmed and the electromagnetic therapy was randomly allocated and compared to placebo in patients with fracture of the femoral diaphysis .


Treatment began six weeks after the fracture and it was administered once a day , during 1 h , for eight consecutive weeks .


Twenty device were built , 10 of which were placebo-devices .


Between June 2008 and October 2009 , 64 patients were randomized in two different hospitals and were followed for 24 weeks .


The mean age was 30 years ( 18-59 ) and 81 % were males .


Healing observed at week 12 was 75 % vs. 58 % ( p = 0.1 ) ; at week 18 it was 94 % vs. 80 % ( p = 0.15 ) ; and at week 24 it was 94 % vs. 87 % ( p = 0.43 ) for the device group and the placebo group , respectively .


This study suggests that an electromagnetic field stimulus can promote earlier bone healing compared to placebo in femoral diaphyseal fractures .


Faster bone healing translates into sooner weight bearing , which -- in turn -- permits quicker return to normal daily activities .


The aim of this study was to assess in healthy subjects the safety , tolerability , pharmacokinetics , and pharmacodynamics of ponesimod , an oral selective sphingosine-1-phosphate receptor 1 ( S1P1 ) modulator in development for multiple sclerosis , by using an uptitration scheme up to supratherapeutic doses .


This was a double-blind , placebo-controlled , randomised , parallel group , uptitration study .


Male and female subjects received ascending oral doses of ponesimod ( n = 12 ) or placebo ( n = 4 ) once daily for 3 days at each dose level ( 10-20-40-60-80-100mg ) .


The most frequent adverse events were chest discomfort , headache , dizziness , dyspnoea , abdominal pain , and night sweats .


Chest discomfort and dyspnoea were considered dose-limiting .


A transient decrease in heart rate was observed following the first 10-mg ponesimod dose ( maximum mean decrease of 9 beats per minute ( bpm ) ( placebo : 2 bpm ) ) .


After uptitration , effects on heart rate were indistinguishable from placebo .


A dose-dependent effect on pulmonary function tests was observed and reached a plateau with 60-80 mg ponesimod ( maximum mean decrease from baseline of 1.24 l ( -30.5 % ) in forced expiratory volume in 1s ) .


A plateau in mean lymphocyte count reduction of approximately 70 % from baseline was reached at the 40 mg dose level .


Observed effects were fully reversible within 10days after treatment discontinuation .


No relevant sex differences were observed .


At supratherapeutic doses , symptoms of chest discomfort and dyspnoea were dose-limiting .


An uptitration dosing scheme is to be preferred in clinical studies in patients in order to limit effects of ponesimod on heart rate and atrioventricular ( AV ) conduction .


A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness .


One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects .


We examined the impact of non-assigned treatment use on cessation outcomes in The iQUITT Study , a randomized trial of Internet and telephone treatment for smoking cessation .


Participants were randomized to a basic Internet ( BI ) comparison condition ( N = 675 ) , enhanced Internet ( EI : N = 651 ) , or EI plus telephone counseling ( EI+P : N = 679 ) .


The primary outcome was 30-day point prevalence abstinence ( ppa ) at 3 and 6 months .


Assigned intervention use was assessed with automated tracking data .


Assessment of non-assigned treatments included pharmacotherapy , behavioral , alternative , and non-study Internet treatments .


Univariate and multivariate logistic regression models examined whether non-assigned treatment use was associated with 30-day ppa .


About 70 % of participants used at least one non-assigned treatment .


A higher rate of non-study Internet treatment among BI participants was the only treatment group difference at both 3 and 6 months .


Multivariate models controlling for condition and baseline predictors of non-assigned treatment use showed that high-intensity non-study Internet treatment was positively associated with 30-day ppa at 3 and 6 months , and pharmacotherapy and behavioral treatment use was negatively associated with 30-day ppa at 6 months .


Non-assigned treatment use is an important factor to consider when evaluating Internet cessation interventions .


Results highlight methodological issues in selecting a comparison condition .


Researchers should report non-assigned treatment use alongside main trial outcomes .


To explore the effects of nutritional liquid supplement designed for diabetes mellitus on postprandial glucose state and pregnancy outcomes in patients with gestational diabetes mellitus ( GDM ) .


A total of 69 cases of pregnant GDM women at Department of Obstetrics & Gynecology , First Affiliated Hospital , Chongqing Medical University from October 2011 to January 2012 were randomized into the intervention and control groups .


But only 31 cases in intervention group finished the study versus 29 cases in control group .


The inter-group differences were analyzed for general clinical profiles before intervention , 2-hour postprandial blood glucose levels and pregnancy outcomes , etc. .


The General Linear Model Repeated Measures process was used to analyze the variance of 2-hour postprandial blood glucose data .


And the Mauchy 's test of sphericity was employed to determine the correlation .


( 1 ) No significant difference in general clinical profiles before intervention between intervention and control groups ( P > 0.05 ) .


( 2 ) The mean values of 2-hour postprandial blood glucose were as follows : intervention group ( mmol/L ) : 6.2 0.7 ( 1w ) , 5.9 0.5 ( 2w ) , 5.7 0.5 ( 3w ) , 5.8 0.6 ( 4w ) , 5.7 0.5 ( 5w ) , 5.7 0.4 ( 6w ) , 5.9 0.3 ( 7w ) , 6.0 0.4 ( 8w ) , 6.0 0.5 ( 9w ) ; control group : 6.7 0.3 ( 1w ) , 6.2 0.4 ( 2w ) , 6.2 0.5 ( 3w ) , 6.2 0.4 ( 4w ) , 6.1 0.4 ( 5w ) , 6.0 0.3 ( 6w ) , 5.8 0.4 ( 7w ) , 6.1 0.4 ( 8w ) , 6.1 0.4 ( 9w ) .


The results of Mauchy 's test of sphericity indicated that the blood glucose level of the intervention group was significantly lower than that of the control group ( P < 0.01 ) .


( 3 ) The incidence of premature rupture of membranes and polyhydramnios , rate of neonatal pneumonia , weight of newborn and pregnancy women and level of glycosylated hemoglobin in intervention group were significantly lower than those in control group ( P < 0.05 ) .


Compared with common diet , after using nutritional supplement , the postprandial blood glucose level is significantly reduced and the pregnancy outcomes also improved in GDM patients .


This prospective randomized study evaluated the efficacy of a 2.0 mm locking plate/screw system compared with a 2.0-mm nonlocking plate/screw system in fixation of 60 isolated non-comminuted mandibular angle fractures .


Sixty patients were randomly assigned to receive a 2.0 mm locking plate ( group A , n = 30 ) or 2.0 mm non-locking plate ( group B , n = 30 ) .


All patients were followed up to 6 months postoperatively and evaluated for complications , occlusal stability and overall results of fixation .


Five complications occurred in the locking group and fourteen in the non-locking group with complication rates equalling 17 % and 47 % respectively .


When comparing the overall results according to plates used , the test showed a statistically significant difference between the locking and non-locking plates ( p < 0.01 ) .


Fewer patients required IMF in group A.


Mandibular angle fractures treated with 2.0 mm locking plates show greater stability and were associated with fewer complications than with 2.0 mm non-locking plates .


To conduct a follow-up association mapping to independent genome-wide linkage and admixture mapping studies of uterine leiomyoma .


Case-control , cross-sectional study .


Not applicable .


A total of 1,045 premenopausal North American participants in the National Institute of Environmental Health Sciences Uterine Fibroid Study .


None .


We genotyped 2,772 single-nucleotide polymorphisms from candidate genes located in peaks of linkage ( 2q37 , 3p21 , 5p13 , 10p11 , 11p15 , 12q14 , and 17q25 ) or admixture linkage disequilibrium ( 2q37 , 4p16 .1 , and 10q26 ) mapping and reported to have regulated expression in uterine fibroids .


We report significant associations of variant members of the collagen gene family with risk and tumor size , including missense variants in COL6A3 and COL13A , with replications in African American and European American study groups .


Furthermore , the cell-matrix Rho GTPase-encoding ARHGAP26 gene , and MAN1C1 , a gene encoding a Golgi mannosidase involved in the maturation of procollagens , emerged as new candidate uterine leiomyoma genes affecting both risk and tumor size .


Our data converge onto a possible model of uterine leiomyoma pathogenesis resulting from altered regulation , maintenance , and/or renewal of the extracellular matrix .


Ureaplasma urealyticum biovar 2 ( UU-2 ) , but not Ureaplasma parvum ( UP ) , has been associated with non-gonococcal urethritis ( NGU ) , but little is known about species-specific responses to standard therapies .


We examined species-specific treatment outcomes and followed men with treatment failure for 9weeks .


From May 2007 to July 2011 , men aged 16 attending a sexually transmitted disease ( STD ) clinic in Seattle , Washington , with NGU ( urethral discharge or urethral symptoms plus 5 polymorphonuclear leucocytes / high-powered field ) enrolled in a double-blind , randomised trial .


Participants received active azithromycin ( 1g ) + placebo doxycycline or active doxycycline ( 100mg twice a day 7days ) + placebo azithromycin .


Ureaplasma were detected in culture followed by species-specific PCR .


Outcomes were assessed at 3 , 6 and 9weeks .


At 3weeks , men with persistent Ureaplasma detection received ` reverse therapy ' ( e.g. , active doxycycline if they first received active azithromycin ) .


At 6weeks , persistently positive men received moxifloxacin ( 400mg7days ) .


Of 490 men , 107 ( 22 % ) and 60 ( 12 % ) were infected with UU-2 and UP , respectively , and returned at 3weeks .


Persistent detection was similar for UU-2-infected men initially treated with azithromycin or doxycycline ( 25 % vs. 31 % ; p = 0.53 ) , but differed somewhat for men with UP ( 45 % vs. 24 % ; p = 0.11 ) .


At 6weeks , 57 % of UU-2-infected and 63 % of UP-infected men who received both drugs had persistent detection .


Failure after moxifloxacin occurred in 30 % and 36 % , respectively .


Persistent detection of UU-2 or UP was not associated with signs/symptoms of NGU .


Persistent detection after treatment with doxycycline , azithromycin and moxifloxacin was common for UU and UP , but not associated with persistent urethritis .


NCT00358462 .


To explore effects of whole-head/body tilt in the roll plane on ocular-vestibular evoked myogenic potentials ( oVEMP ) .


Twenty healthy subjects were randomly tilted in an Eply Omniax rotator across a series of eight angles from 0 to 360 ( at 45 separations ) in the roll plane .


At each position , oVEMPs to air-conducted ( AC ) and bone-conducted ( BC ) stimulation were recorded from unrectified infra-orbital surface electromyography during upward gaze .


oVEMP amplitudes , latencies and amplitude asymmetry were compared across each angle of orientation .


Head orientation had a significant effect on oVEMP reflex amplitudes for both AC and BC stimulation ( p < 0.001 ) .


For both stimuli there was a trend for lower amplitudes with increasing angular departure from the upright position .


Mean amplitudes decreased by 42.6-56 .8 % ( AC ) and 23.2-25 .5 % ( BC ) when tilted 180 .


Roll-plane tilt had a significant effect on amplitude asymmetry ratios recorded in response to AC stimuli ( p < 0.001 ) , indicating a trend for lower amplitudes from the dependent ( down ) ear .


Amplitude asymmetry ratios for BC stimuli were unaffected by head and body orientation .


The results confirm an effect of head and body orientation on oVEMP reflexes recorded in response to air - and bone-conducted stimuli .


The upright position yields an optimal oVEMP response .


To evaluate the efficacy and safety of nebulized pentoxifylline for reducing the duration of oxygen supplementation in extremely preterm neonates at high risk of bronchopulmonary dysplasia ( BPD ) .


Single-center , randomized , double-blind , placebo-controlled trial was conducted .


Infants of 23 ( 0 ) to 27 ( 6 ) weeks ' gestational age requiring mechanical ventilation or 30 % supplemental oxygen on continuous positive airway pressure at 72-168 hours were randomized to receive 20 mg/kg ( 1 mL/kg ) nebulized pentoxifylline or an equal volume of normal saline placebo every 6 hours for 10 consecutive days via a vibrating mesh nebulizer .


The primary outcome was the duration of oxygen supplementation at 40 weeks ' postmenstrual age .


We used Cox proportional hazards regression modeling to analyze outcomes .


All infants had adequate data for analysis of the primary outcome .


Intention-to-treat analysis revealed no differences in duration of oxygen supplementation at 40 weeks ' postmenstrual age between pentoxifylline ( n = 41 ) and placebo ( n = 40 ) groups ( median 2262 vs 2160 hours , adjusted hazard ratio : 1.14 , 95 % CI 0.72-1 .80 , P = .63 ) .


There was no difference in mortality and further secondary outcomes .


No adverse effects were noted .


Nebulized pentoxifylline is safe but did not reduce the duration of oxygen supplementation in extremely preterm infants at high risk of BPD .


Dose-ranging studies and large , well-designed clinical trials are required to determine whether the use of nebulized or systemic pentoxifylline as a prophylactic therapy offers small but relevant benefits for prevention of BPD .


Australian New Zealand Clinical Trials Registry : ACTRN12611000145909 .


Secondhand smoke exposure ( SHSe ) is a significant modifiable risk for respiratory health in children .


Although SHSe is declining overall , it has increased for low-income and minority populations .


Implementation of effective SHSe interventions within community organizations has the potential for significant public health impact .


To evaluate the effectiveness of motivational interviewing ( MI ) delivered in the context of a SHS education reduction initiative within Head Start to reduce preschool children 's SHSe .


A total of 350 children enrolled in Baltimore City Head Start whose caregivers reported a smoker living in the home were recruited .


Caregivers were randomized to MI + education or education alone .


Assessments were conducted at baseline , 3 , 6 , and 12 months .


The primary outcome measure was household air nicotine levels measured by passive dosimeters .


Secondary outcomes included child salivary cotinine , self-report of home smoking ban ( HSB ) , and smoking status .


Participants in the MI + education group had significantly lower air nicotine levels ( 0.29 vs. 0.40 mg ) , 17 % increase in prevalence of caregiver-reported HSBs , and a 13 % decrease in caregiver smokers compared with education-alone group ( all P values < 0.05 ) .


Although group differences in salivary cotinine were not significant , among all families who reported having an HSB , salivary cotinine and air nicotine levels declined in both groups ( P < 0.05 ) .


MI may be effective in community settings to reduce child SHSe .


More research is needed to identify ways to tailor interventions to directly impact child SHSe and to engage more families to make behavioral change .


Clinical trial registered with www.clinicaltrials.gov ( NCT 00927264 ) .


Conspicuous differences in participation rates for breast self-examination ( BSE ) , clinical breast examination ( CBE ) , and referral for further investigations have been observed indicating involvement of a number of different factors .


This study analysed determinants for participation in different levels of the breast cancer screening process in Indian females .


An intervention group of 52,011 women was interviewed in a breast cancer screening trial in Trivandrum district , India .