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METHODS | Forty patients undergoing open hepatectomy were enrolled in this prospective , randomized , double-blinded , placebo-controlled trial . |
METHODS | Patients were divided into 2 groups : the 0.9 % saline continuous infusion group ( the control group ; n = 20 ) and the ropivacaine continuous infusion group ( the Ropi group ; n = 20 ) . |
METHODS | Outcomes measured postoperatively were pain score at rest and on movement , sufentanil consumption , incidence of nausea and vomiting , and sedation score across 48 postoperative hours . |
METHODS | Time to bowel recovery , liver function change , mean length of hospitalization , patient satisfaction , and other data after 48 postoperative hours were collected until hospital discharge . |
RESULTS | Pain scores at rest were lower for the ropivacaine group and reached significance after 8 and 16 hours ( P < 0.01 ) . |
RESULTS | Sufentanil consumption ( 41.5021.80 vs. 89.7035.22 g ; P < 0.01 ) after 48 hours , time to bowel recovery ( 1.800.70 vs. 3.151.04 d ; P < 0.01 ) , incidence of nausea and vomiting ( 1.750.72 vs. 2.400.68 ; P < 0.05 ) , and mean length of hospitalization ( 5.62.44 vs. 7.352.85 d ; P < 0.01 ) were significantly reduced , and the sedation score and liver function change were also comparable between the 2 groups . |
RESULTS | There was no difference with respect to pain scores on movement , nor with respect to patient satisfaction . |
CONCLUSIONS | Surgical wound infusion with ropivacaine after hepatectomy can improve pain relief at rest and accelerate recovery and discharge . |
###24911353 | null |
OBJECTIVE | Tuberculosis ( TB ) is highly prevalent among HIV-infected people , including those receiving combination antiretroviral therapy ( cART ) , necessitating a well tolerated and efficacious TB vaccine for these populations . |
OBJECTIVE | We evaluated the safety and immunogenicity of the candidate TB vaccine M72/AS01 in adults with well controlled HIV infection on cART . |
METHODS | A randomized , observer-blind , controlled trial ( NCT00707967 ) . |
METHODS | HIV-infected adults on cART in Switzerland were randomized 3:1:1 to receive two doses , 1 month apart , of M72/AS01 , AS01 or 0.9 % physiological saline ( N = 22 , N = 8 and N = 7 , respectively ) and were followed up to 6 months postdose 2 ( D210 ) . |
METHODS | Individuals with CD4 cell counts below 200 cells/l were excluded . |
METHODS | Adverse events ( AEs ) including HIV-specific and laboratory safety parameters were recorded . |
METHODS | Cell-mediated ( ICS ) and humoral ( ELISA ) responses were evaluated before vaccination , 1 month after each dose ( D30 , D60 ) and D210 . |
RESULTS | Thirty-seven individuals [ interquartile range ( IQR ) CD4 cell counts at screening : 438-872 cells/l ; undetectable HIV-1 viremia ] were enrolled ; 73 % of individuals reported previous BCG vaccination , 97.3 % tested negative for the QuantiFERON-TB assay . |
RESULTS | For M72/AS01 recipients , no vaccine-related serious AEs or cART-regimen adjustments were recorded , and there were no clinically relevant effects on laboratory safety parameters , HIV-1 viral loads or CD4 cell counts . |
RESULTS | M72/AS01 was immunogenic , inducing persistent and polyfunctional M72-specific CD4 T-cell responses [ medians 0.70 % ( IQR 0.37-1 .07 ) at D60 ] and 0.42 % ( 0.24-0 .61 ) at D210 , predominantly CD40LIL-2TNF - , CD40LIL-2 and CD40LIL-2TNF-IFN - ] . |
RESULTS | All M72/AS01 vaccines were seropositive for anti-M72 IgG after second vaccination until study end . |
CONCLUSIONS | M72/AS01 was clinically well tolerated and immunogenic in this population , supporting further clinical evaluation in HIV-infected individuals in TB-endemic settings . |
###25318787 | null |
OBJECTIVE | The aim of this study was to investigate whether remedial hydration ( RH ) reduces the incidence of contrast-induced nephropathy ( CIN ) and short-term adverse events in ST-elevation myocardial infarction ( STEMI ) patients undergoing primary percutaneous coronary intervention ( PCI ) . |
METHODS | A total of 216 consecutive STEMI patients were prospectively and randomly assigned into two groups : 108 patients in the RH group and 108 patients in the no RH ( control ) group . |
METHODS | The serum creatinine ( SCr ) and creatinine clearance ( CCr ) levels were measured on admission and at 24 , 48 and 72 hours after primary PCI . |
METHODS | The rates of CIN and short-term adverse events were analyzed for each group . |
METHODS | After surgery , the patients were categorized into four groups according to the Mehran risk score : low ( 5 , n = 98 ) , moderate ( 6-10 , n = 56 ) , high ( 11-15 , n = 40 ) or very high ( 16 , n = 22 ) . |
RESULTS | The incidence of CIN in the RH group was lower than that observed in the control group ( 22/108 ; 20.4 % vs. 38/108 ; 35.2 % , p < 0.05 ) . |
RESULTS | The subgroup analysis showed that the rate of CIN was lower in the moderate ( 6/29 ; 20.7 % vs. 13/30 ; 43.3 % , p < 0.10 ) and significantly lower in both the high ( 5/21 ; 23.8 % vs. 10/18 ; 55.6 % , p < 0.05 ) and very high score groups ( 3/12 ; 25.0 % vs. 8/12 ; 66.7 % , p < 0.05 ) among the RH patients compared to the controls . |
RESULTS | At 24 , 48 and 72 hours after PCI , the patients in the RH group exhibited lower SCr levels and higher CCr levels than the patients in the control group ( both p < 0.05 ) . |
RESULTS | A lower incidence of in-hospital clinical events was also observed in the RH group . |
CONCLUSIONS | Remedial hydration decreases the occurrence of CIN and improves the short-term prognosis of STEMI patients undergoing primary PCI . |
###24396280 | null |
BACKGROUND | An increased production of oxidizing species related to reactive oral diseases , such as chronic apical periodontitis , could have systemic implications such as an increase in cardiovascular morbidity . |
BACKGROUND | Based on this consideration , we conducted a prospective study to assess whether subjects affected by chronic periodontitis presented with higher values of oxidative stress than reference values before endodontic treatment , and whether endodontic treatment can reduce the oxidative imbalance and bring it back to normal in these subjects . |
METHODS | The authors recruited 2 groups of patients from private studies and dental clinics : these patients were recruited randomly . |
METHODS | The oxidative balance in both patients with chronic apical periodontitis ( CAP ) and healthy control patients was determined by measuring the oxidant status , using an identification of the reactive oxygen metabolites ( d-ROMs ) test , while the antioxidant status in these patients was determined using a biological antioxidant potential ( BAP ) test . |
METHODS | Both these tests were carried on plasma samples taken from enrolled patients . |
METHODS | Values were measured both before the endodontic treatment of the patients with chronic apical periodontitis , and 30 and 90 days after treatment , and compared to those obtained from healthy control patients . |
RESULTS | It was found that , on recruitment , the patients with chronic apical periodontitis exhibited significantly higher levels of oxidative stress than control patients , as determined by the d-ROMs and BAP tests . |
RESULTS | Furthermore , the d-ROMs test values were shown to decrease and the BAP test values to increase over time in patients with chronic apical periodontitis following endodontic therapy . |
RESULTS | As the levels of oxidative stress in these patients tended to reduce and return to normal by 90 days following treatment . |
CONCLUSIONS | This study has demonstrated a positive association between chronic apical periodontitis and oxidative stress . |
CONCLUSIONS | Subjects affected by chronic apical periodontitis are exposed to a condition of oxidative stress , which is extremely dangerous to general health . |
CONCLUSIONS | Moreover , one can infer from these findings that through proper endodontic therapy , a good oxidative balance can be restored , thereby avoiding the risk of contracting the abovementioned diseases . |
###24731889 | null |
BACKGROUND | Placebo effect has been largely studied and debated in medicine . |
BACKGROUND | Research focused mainly on children and adults but not on newborns . |
BACKGROUND | In osteopathy , few studies documented this effect and no research has been conducted in newborns . |
OBJECTIVE | To assess the presence of placebo effect in newborns using sham osteopathic manipulative treatment . |
METHODS | Randomized control trial . |
METHODS | Neonatal Intensive Care Unit in Italy . |
METHODS | Two groups ( 103 patients each ) of preterm infants aged 29-36 weeks without medical complications received routine pediatric care and osteopathic sham therapy was administrated to the study group only for the entire period of hospitalization . |
METHODS | Primary end point was the mean reduction of length of stay at discharge . |
METHODS | Secondary objective was the change in daily weight gain . |
RESULTS | 206 newborns entered the study . |
RESULTS | No difference between sham and control group was found for the primary outcome length of stay ( 30.020.3 ; 28.818.9 ; p = 0.70 ) . |
RESULTS | Multivariate analysis showed no difference between study and control group on length of stay . |
RESULTS | A negative association was found for gestational age ( -2.33 ; 95 % CI -3.81 to -0.85 ; p = 0.002 ) , birth weight ( -0.01 ; 95 % CI -0.02 to -0.01 ; p < 0.001 ) and milk volume at study enrollment ( -0.02 ; 95 % CI -0.05 to -0.01 ; p = 0.01 ) . |
CONCLUSIONS | To the best of our knowledge , this study is the first in the field showing no placebo effect on newborns . |
CONCLUSIONS | Further discussions are opened concerning the age when placebo effect starts . |
###25880933 | null |
BACKGROUND | Clostridium difficile infection ( CDI ) is a leading cause of diarrhoea in health care settings with symptoms ranging from mild and self-limiting to life threatening . |
BACKGROUND | SMT19969 is a novel , non-absorbable antibiotic currently under development for the treatment of CDI . |
BACKGROUND | Here we report the results from a Phase I study . |
METHODS | A double-blind , randomized , placebo-controlled study assessing safety and tolerability of single and multiple oral doses of SMT19969 in healthy volunteers . |
METHODS | Pharmacokinetic assessments included blood and faecal sampling . |
METHODS | The effect of food on systemic exposure and analysis of the gut microbiota were also included . |
RESULTS | Fifty-six healthy male subjects were enrolled . |
RESULTS | Following single oral doses of up to 2,000 mg in the fasted state , plasma concentrations of SMT19969 were generally below the lower limit of quantification . |
RESULTS | In the fed state levels ranged from 0.102 to 0.296 ng/mL after single dosing and after repeat dosing at Day 10 from 0.105 to 0.305 ng/mL . |
RESULTS | Following single and multiple oral doses of SMT19969 , mean daily faecal concentrations increased with increasing dose level and were significantly above the typical MIC range for C. difficile ( 0.06-0 .5 g/mL ) . |
RESULTS | At 200 mg BID , mean ( SD ) faecal concentrations of 1,466 ( 547 ) g/g and 1,364 ( 446 ) g/g were determined on days 5 and 10 of dosing respectively . |
RESULTS | No notable metabolites were detected in faeces . |
RESULTS | Overall , all doses of SMT19969 were well tolerated both as single oral doses or BID oral doses for 10 days . |
RESULTS | The majority ( 88 % ) of adverse events ( AEs ) were classified as gastrointestinal disorders and were mild in severity , resolving without treatment . |
RESULTS | The gut microbiota was analysed in the multiple dose groups with minimal changes observed in the bacterial groups analysed except for total clostridia which were reduced to below the limit of detection by day 4 of dosing . |
CONCLUSIONS | Oral administration of SMT19969 was considered safe and well tolerated and was associated with negligible plasma concentrations after single and multiple doses . |
CONCLUSIONS | In addition , minimal disruption of normal gut microbiota was noted , confirming the highly selective spectrum of the compound . |
CONCLUSIONS | These results support the further clinical development of SMT19969 as an oral therapy for CDI . |
BACKGROUND | Current Controlled Trials . |
BACKGROUND | ISRCTN10858225 . |
###25231496 | null |
BACKGROUND | While overall survival for most common cancers in Australia is improving , the rural-urban differential has been widening , with significant excess deaths due to lung , colorectal , breast and prostate cancer in regional Australia . |
BACKGROUND | Internationally a major focus on understanding variations in cancer outcomes has been later presentation to healthcare and later diagnosis . |
BACKGROUND | Approaches to reducing time to diagnosis of symptomatic cancer include public symptom awareness campaigns and interventions in primary care to improve early cancer detection . |
BACKGROUND | This paper reports the protocol of a factorial cluster-randomised trial of community and general practice ( GP ) level interventions to reduce the time to diagnosis of cancer in rural Western Australia ( WA ) . |
METHODS | The community intervention is a symptom awareness campaign tailored for rural Australians delivered through a community engagement model . |
METHODS | The GP intervention includes a resource card with symptom risk assessment charts and local referral pathways implemented through multiple academic detailing visits and case studies . |
METHODS | Participants are eligible if recently diagnosed with breast , colorectal , lung or prostate cancer who reside in specific regions of rural WA with a planned sample size of 1350 . |
METHODS | The primary outcome is the Total Diagnostic Interval , defined as the duration from first symptom ( or date of cancer screening test ) to cancer diagnosis . |
METHODS | Secondary outcomes include cancer stage , healthcare utilisation , disease-free status , survival at 2 and 5years and cost-effectiveness . |
BACKGROUND | Ethics approval has been granted by the University of Western Australia and from all relevant hospital recruitment sites in WA . |
RESULTS | Results of this trial will be reported in peer-reviewed publications and in conference presentations . |
BACKGROUND | Australian New Zealand Clinical Trials Registry ( ANZCTR ) . |
BACKGROUND | ACTRN12610000872033 . |
###26024687 | null |
BACKGROUND | This study aimed to evaluate whether incidental CT findings of emphysema , airway thickening and bronchiectasis , as seen on CT scans performed for other non-pulmonary clinical indications , are associated with future acute exacerbations of COPD resulting in hospitalisation or death . |
METHODS | This multicentre prospective case-cohort study comprised 6406 subjects who underwent routine diagnostic chest CT for non-pulmonary indications . |
METHODS | Using a case-cohort approach , we visually graded CT scans from cases and a random sample of 10 % of the baseline cohort ( n = 704 ) for emphysema severity ( range 0-20 ) , airway thickening ( range 0-5 ) and bronchiectasis ( range 0-5 ) . |