nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: methodological insights from a pneumonia prevention trial.

This report discusses how methodological aspects of study efficacy and effectiveness combine in cluster randomized trials in nursing homes. Discussion focuses on the relationships between these study aspects in the Pneumonia Reduction in Institutionalized Disabled Elders (PRIDE) trial, an ongoing cluster randomized clinical trial of pneumonia prevention among nursing home residents launched in October 2009 in Greater New Haven,  This clinical trial has enrolled long-term care nursing home residents, over 65years in age, who have either inadequate oral care or swallowing difficulty, previously identified risk factors for pneumonia. It has used a multicomponent intervention consisting of manual tooth/gum brushing, 0.12% chlorhexidine oral rinse administered twice daily by nurses, and upright feeding positioning at meals to reduce rates of radiographically documented pneumonia. Cluster randomization is attractive for nursing home intervention studies because physical proximity and administrative arrangements make it difficult to deliver different interventions to residents of the same nursing home. Implementing an intervention in an entire home requires integration into the daily life of residents and into the administrative procedures of the nursing home. This characteristic of nursing home cluster randomized trials makes them approximate "real-world" research contexts, but implementation can be challenging. The PRIDE trial of pneumonia prevention utilized specific methodological choices that include both efficacy and effectiveness elements. Cluster randomized trials in nursing homes having elements of both efficacy and effectiveness (i.e., hybrid designs) can address some of the methodological challenges of conducting clinical research in nursing homes; they have distinctive advantages and some limitations.
Ischemic preconditioning prior to intermittent Pringle maneuver in liver resections.

Continuous inflow vascular occlusion during liver resections causes less severe ischemia and reperfusion injury (IRI) if it is preceded by ischemic preconditioning (IP) or if intermittent inflow occlusion is used during the resection. No previous clinical trial has studied the effects of adding IP to intermittent inflow occlusion.



Consecutive patients (n = 32) with suspicion of malignant liver disease had liver resections (minimum 2 segments) performed with inflow occlusion (intermittent clamping in a manner of 15 min of ischemia and 5 min of reperfusion repetitively; 15/5). Half of the patients were randomized to receive IP (10 min of ischemia and 10 min of reperfusion before parenchymal transection; 10/10). The patients were stratified according to volume of resection and none had chronic liver disease. The patients were followed for 5 days with microdialysis (μD).



All patients completed the study and there were no deaths. No differences were seen between the groups regarding demographics or perioperative parameters (bleeding, duration of ischemia, resection volume, complications, and serum laboratory tests). There were no differences in alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or prothrombin time (PT)-INR levels, but μD revealed lower levels of lactate, pyruvate, and glucose in the IP group having major liver resections (analysis of variance; ANOVA). Nitrite and nitrate levels in μD decreased postoperatively, but no differences were seen between the groups. In one patient an elevated μD-glycerol curve was seen before the diagnosis of a stroke was made.



IP before intermittent vascular occlusion does not reduce the serum parameters used to assess IRI. IP seems to improve aerobic glucose metabolism, as the levels of glucose, pyruvate, and lactate locally in the liver were reduced, compared to controls, in patients having >3 segments resected. μD may be used to monitor metabolism locally.
Effect of etanercept on insulin secretion and insulin sensitivity in a randomized trial with psoriatic patients at risk for developing type 2 diabetes mellitus

Tumor necrosis factor-alpha (TNF-alpha) inhibitors have been used in the treatment of psoriasis, which is associated with the insulin resistance syndrome. The purpose of this study was to determine the effect of etanercept, a TNF-alpha inhibitor, on insulin secretion and insulin sensitivity in psoriatic patients with high risk factors to develop type 2 diabetes mellitus. Randomized double blind clinical trial with 2 weeks of follow-up. The allocation was done by simple randomization. The investigation was performed in 12 psoriatic patients with indication of systemic treatment and 2 or more risk factors for type 2 diabetes mellitus. Patients with infections, topical corticosteroids or salicylic acid ointments for 6 weeks before the study, diabetes, acromegaly, cancer and other systemic diseases were excluded. All subjects gave written informed consent to participate in the study and the protocol was approved by the hospital-based Ethical Committee. Etanercept was injected in a subcutaneous dose of 25 mg in 1 ml twice by week for 2 weeks or 1 ml of saline solution as placebo. Insulin secretion was estimated with the formula for the homeostasis model analysis β-cell function index and insulin sensitivity was assessed using the euglycemic-hyperinsulinemic clamp technique. There was no significant difference in insulin secretion and insulin sensitivity with etanercept. Fasting serum insulin levels were decreased in the etanercept group (146 ± 117–111 ± 87 pmol/l, P = 0.04). Etanercept did not modify insulin secretion and insulin sensitivity in psoriatic patients with risk factors for type 2 diabetes mellitus.
Sulphonylurea and insulin: combined treatment in Type 1 (insulin-dependent) diabetes

Dear Sir, In contrast to the recent observations of Ratzmann et al.  that tolbutamide is not a useful adjunct to insulin treatment in Type 1 diabetes, I would like to refer to our recent work on a similar theme [2]. We demonstrated that when a combination of insulin and glibenclamide treatment was given to patients with Type i diabetes in a randomized and double-blind cross-over trial for periods of 3 months, measurements of diabetic control improved significantly in those patients who retained residual endogenous insulin secretion. During an oral glucose tolerance test 3 months after combined treatment, C-peptide secretion increased by 47%, the mean + SD daily blood glucose level fell from 8.4+ 1.7 to 7.4+ 1.5 mmol/1 (p < 0.02) and the mean glycosylated haemoglobin decreased from 8.1_+0.5% to 7.5_+0.9% (p <0.05). These results substantiate a previous study  which showed that glibenclamide, when added to the insulin regimen of Type 1 diabetic patients with residual insulin secretion, increased their C-peptide secretion by 60% over a 1-month period. Less than half of the seven subjects in Ratzmann et al.'s study could be described as having retained residual endogenous insulin secretion according to the criteria of Madsbad [4] of a plasma C-peptide concentration > 0.07 mmol/1. Although limited insulin and glibenclamide treatment may be only of limited value, I believe that further research is needed to follow up our observations and determine how long increased insulin secretion and improved metabolic control persist. Yours sincerely,
[(11)C]methionine positron emission tomography and survival in patients with bone and soft tissue sarcomas treated by carbon ion radiotherapy.

The development of the novel carbon ion radiotherapy (CIRT) in the treatment of refractory cancers has resulted in the need for a way to accurately evaluate patient prognosis. We evaluated whether L-[methyl-(11)C]-methionine (MET) uptake and its change after CIRT were the early survival predictors in patients with unresectable bone and soft tissue sarcomas.



MET positron emission tomography was prospectively performed in 62 patients with unresectable bone and soft tissue sarcomas before and within 1 month after CIRT. Tumor MET uptake was measured with the semiquantitative tumor:nontumor ratio (T/N ratio). The MET uptake in the tumor and relevant clinical parameters were entered into univariate and multivariate survival analysis.



The overall median survival time was 20 months. Patients with a baseline T/N ratio of <or=6 had a significant better survival than patients with a baseline T/N ratio >6 (2-year survival rate: 69.4% versus 32.3%; P = 0.01). Patients with a post-CIRT ratio of <or=4.4 had a better survival than that with a post-CIRT ratio >4.4 (2-year survival rate: 63.7% versus 41.3%; P = 0.01). A significant higher survival rate was observed in patients with post-therapeutic MET uptake change of >30% than patients in lower change group (2-year survival rate: 74.6% versus 41.6%; P = 0.049). The multivariate analysis showed that both baseline and post-CIRT T/N ratio were statistically significant independent predictors of patient survival. Tumors with larger T/N ratio had a significantly poorer prognosis.



MET uptake as measured by either baseline or post-CIRT T/N ratio was an independent predictor of survival in patients with bone and soft tissue sarcomas treated by carbon ion radiotherapy, whereas post-therapeutic MET uptake change might have potential value for the same purpose.
Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia.

The objectives of this pilot study were to determine the feasibility and effect on glycaemic control of a low-glycaemic-index (GI) diet in women with gestational diabetes or impaired glucose tolerance of pregnancy.



participants, recruited from the Diabetes-in-Pregnancy Clinic of an inner-city teaching hospital serving a predominantly non-Caucasian population, were randomized to a low-GI (n=23) or control (n=24) diet and followed from 28 weeks gestation until delivery. Self-monitored-blood-glucose (SMBG), maternal and infant weight were collected from medical charts. Dietary intakes were assessed using diet records and questionnaires.



diet GI on control (58, 95% CI: 56,60) was significantly higher than on low-GI (49, 95% CI: 47,51; p=0.001). Glycaemic control improved on both diets, but more postprandial glucose values were within target on low-GI (58.4% of n=1891) than control (48.7% of n=1834; p<0.001). SMBG post-breakfast was directly related to pre-pregnancy BMI in the control, but not the low-GI group (BMI*diet interaction; p=0.021). Participants accepted the study foods and were willing to consume them post-intervention.



a low-GI diet was feasible and acceptable in this sample and facilitated control of postprandial glucose. A larger study is needed to determine the effect of a low-GI diet on maternal and infant outcomes.
Evaluation of retinal nerve fiber layer thickness in Alzheimer disease using spectral-domain optical coherence tomography.

To evaluate the retinal nerve fiber layer (RNFL) thickness in patients with Alzheimer disease (AD) and to compare the results with those of healthy controls.



Forty patients (mean age: 75.02 ± 6.34 years; 23 women) with untreated AD and 40 age-, sex-, and education-matched healthy patients were examined in this case-control prospective study. All patients underwent detailed ophthalmic and neurological examination. The Mini Mental State Examination (MMSE) was performed and RNFL thickness was measured using spectral-domain optical coherence tomography. The association between RNFL and MMSE score was also assessed.



The average RNFL thickness was 84 ± 7.0 µm in AD patients and 107 ± 6.3 µm in healthy subjects (P < 0.001). The mean MMSE score was 21.9 ± 2.13 in AD patients. There was no significant correlation between the RNFL thickness and MMSE score.



Patients with AD had reduced RNFL thickness in all quadrants compared with the control group. This finding suggests that RNFL thickness analysis may be useful in the early diagnosis of AD.
Treatment of early RA in clinical practice: a comparative study of two different DMARD/corticosteroid options.

To study the outcome in clinical practice of first DMARD and/or corticosteroid (CS) treatment in patients with recent onset rheumatoid arthritis (RA).



245 patients with active RA, not previously treated with DMARDs or CS, were randomised to one of two treatment groups, T1 = 7.5-15 mg of prednisolone (PRE) daily for one to three months followed, if needed, by methotrexate (MTX) in a weekly dose of 5-15 mg in addition to the lowest possible dose of PRE or T2 = sulfasalazine (SAL), supplemented with lowest possible CS dose if needed.



The EULAR individual response criteria were applied and remission was defined as a final DAS28 < 2.6. Function was assessed by the HAQ and radiographic progression by Larsen scores. A patient who managed to remain on the allocated treatment for two years was described as a "completer".



After 2 years of treatment, 70% of the patients in T1 and 63% in T2 were responders (30% and 33% "good responders", respectively). In T1 29% and in T2 19% were in remission. There was a significant functional improvement in both groups but radiographic progression occurred. The mean decrease in HAQ and increase in the Larsen score were similar in the two groups. One-third of the patients were non-completers, 19% from T1 and 47% from T2. Non-completers had, compared with completers, a significantly lower rate of individual response and remission. Completers and non-completers had similar functional improvement and similar radiological progression.



Individual response and remission was reduced in patients who did not complete their first DMARD/CS treatment option. Treatment failures were significantly more frequent in the sulfasalazine plus optional CS than in the CS plus optional methotrexate treatment group.
One month treatment with the once daily oral beta 2-agonist bambuterol in asthmatic patients.

Bambuterol is a new long-acting oral bronchodilator for once daily use in patients with asthma. It is a prodrug of terbutaline, designed to be slowly metabolized to terbutaline. Results from comparative studies have shown that it has similar clinical efficacy to other oral bronchodilators, but less side-effects. The present study was aimed at verifying the 24 h effect duration of bambuterol, 10 and 20 mg in comparison with placebo during a one month treatment period. The study was conducted as a double-blind, randomized, parallel group placebo-controlled, multicentre trial. It started with a one week run-in period with placebo, when oral bronchodilators were withdrawn. At the end of this reference period, the patients were randomized to one of three treatments: placebo, bambuterol 10 mg, or bambuterol 20 mg, once daily in the evening. The treatment period lasted for 4 weeks. Four hundred and eighty seven patients with a mean age of 45 yrs were included. Mean baseline forced expiratory volume in one second (FEV1) and FEV1% of predicted were 2.05 l and 62%, respectively. Administration of 10 mg bambuterol resulted in a significant 24 h effect duration, expressed as an increase in mean daily morning and evening peak expiratory flow (PEF) (+11 l.min-1, adjusted means) throughout the study, as compared with placebo. Bambuterol, 20 mg, gave a significant 24 h effect duration in both FEV1 and morning and evening PEF as compared with placebo. Furthermore, the adverse events observed during the study were relatively few and mild.(ABSTRACT TRUNCATED AT 250 WORDS)
Multiple Beneficial Effects of Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension.

Pulmonary arterial hypertension with systemic dysfunctions, including metabolic disorders and renal dysfunction, has a poor prognosis. However, it remains to be elucidated whether chronic thromboembolic pulmonary hypertension (CTEPH) is also associated with systemic dysfunctions, and if so, whether balloon pulmonary angioplasty (BPA) improves them.



Fifty-five consecutive patients who underwent BPA from March 2012 to December 2014 for systemic dysfunctions, including glycemic control, lipid profiles, renal and vascular function, and nutritional status were examined. The analyses were performed before and after BPA (mean, 3.5 sessions/patient) and changes in hemodynamic parameters were compared. The average follow-up period was 474±245 days. Baseline prevalence of hypertension, diabetes mellitus, dyslipidemia and advanced chronic kidney disease was 58, 7, 33 and 36%, respectively. BPA caused marked hemodynamic improvements in the CTEPH patients. Importantly, BPA also significantly improved dysglycemia (fasting blood sugar, hemoglobin A1c and homeostatic assessment model of insulin resistance), renal (creatinine and estimated glomerular filtration rate) and vascular (cardio-ankle vascular index) functions and nutritional status (albumin, cholesterols, and body mass index). Importantly, there were positive correlations between the degrees of the hemodynamic improvements and those of other improvements.



These results indicate that BPA may exert multiple beneficial effects in CTEPH patients, not only in terms of hemodynamics but also in other systemic functions, with positive correlations among them.
Onset of effect of aclidinium, a novel, long-acting muscarinic antagonist, in patients with COPD.

Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV(1)) ≥30% and <60% predicted. On study days, patients received single doses of aclidinium 200 μg, tiotropium 18 μg, or placebo. Serial spirometry was conducted from 10 minutes to 3 hours post-dose. The primary variable was the percentage of patients with an increase in FEV(1) of ≥10% above baseline at 30 minutes post-dose. Other assessments included change from baseline in FEV(1) and dyspnea over 3 hours post-dose. A total of 115 patients entered the study. Significantly more patients had an increase in FEV(1) of ≥10% above baseline at 30 minutes with aclidinium and tiotropium versus placebo (49.5% and 51.8% versus 13.8%; p < 0.0001). At 30 minutes, the relative increase from baseline in FEV(1) was significantly higher for aclidinium and tiotropium versus placebo (12% and 11% versus 3%; p < 0.0001). Aclidinium and tiotropium also significantly increased FEV(1) (p < 0.01) and improved the perception of dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.
Endoscopic fluorescence detection of high-grade dysplasia in Barrett's esophagus.

Early detection and treatment of esophageal cancer in Barrett's esophagus may improve patient survival if dysplasia is effectively detected at endoscopy. Typically, four-quadrant pinch biopsy specimens are taken at 2-cm intervals. This study was conducted to determine whether laser-induced fluorescence spectroscopy could be used to detect high-grade dysplasia in patients with Barrett's esophagus.



Four hundred ten-naonometer laser light was used to induce autofluorescence of Barrett's mucosa in 36 patients. The spectra were analyzed using the differential normalized fluorescence (DNF) index technique to differentiate high-grade dysplasia from either low-grade or nondysplastic mucosa. Each spectrum was classified as either premalignant or benign using two different DNF indices.



Analysis of the fluorescence spectra from all patients collectively using the DNF intensity at 480 nm (DNF480) index showed that 96% of nondysplastic Barrett's esophagus samples were classified as benign, all low-grade dysplasia samples as benign, 90% of high-grade dysplasia samples as premalignant, and 28% of low-grade with focal high-grade dysplasia samples as premalignant. Using the two DNF indices concurrently, all patients with any high-grade dysplasia were classified correctly.



Laser-induced fluorescence spectroscopy has great potential to detect high-grade dysplasia in Barrett's esophagus when using the DNF technique.
Improving Care of Patients At-Risk for Osteoporosis: A Randomized Controlled Trial

Despite accurate diagnostic tests and effective therapies, the management of osteoporosis has been observed to be suboptimal in many settings. We tested the effectiveness of an intervention to improve care in patients at-risk of osteoporosis. Randomized controlled trial. Primary care physicians and their patients at-risk of osteoporosis, including women 65 years and over, men and women 45 and over with a prior fracture, and men and women 45 and over who recently used ≥90 days of oral glucocorticoids. A multifaceted program of education and reminders delivered to primary care physicians as well as mailings and automated telephone calls to patients.  Either undergoing a bone mineral density (BMD) testing or filling a prescription for a bone-active medication during the 10 months of follow-up. After the intervention, 144 (14%) patients in the intervention group and 97 (10%) patients in the control group received either a BMD test or filled a prescription for an osteoporosis medication. This represents a 4% absolute increase and a 45% relative increase (95% confidence interval 9–93%, p = 0.01) in osteoporosis management between the intervention and control groups. No differences between groups were observed in the incidence of fracture. An intervention targeting primary care physicians and their at-risk patients increased the frequency of BMD testing and/or filling prescriptions for osteoporosis medications. However, the absolute percentage of at-risk patients receiving osteoporosis management remained low.
Red Blood Cell Distribution Width is Independently Correlated With Diurnal QTc Variation in Patients With Coronary Heart Disease

To investigate the relationship between red blood cell distribution width (RDW) and diurnal corrected QT (QTc) variation in patients with coronary heart disease. This retrospective study included 203 patients who underwent coronary angiography between February 2013 and June 2014. RDW values and dynamic electrocardiography (Holter) results were collected to investigate the relationship between RDW and diurnal QTc variation. Patients were separated into three groups (A, B, and C) by binning their RDW values in an ascending order. RDW values, coronary artery scores and diurnal QTc variations were significantly different among these groups (P < 0.05). While coronary artery scores gradually rose with increased RDW, diurnal QTc variation decreased. Pearson's correlation analysis was applied to control for confounding factors, and multiple correlation analysis showed that coronary artery score was positively correlated with RDW (r = 0.130, P = 0.020), while it was not correlated with the diurnal QTc variation (r = -0.226, P = 0.681). RDW was negatively correlated with diurnal QTc variation (r = -0.197, P = 0.035). RDW is independently associated with diurnal QTc variation in patients with coronary heart disease.