nils-herrmann/clean_scirepeval huggingface dataset:
Adipocytokines attenuate the association between visceral adiposity and diabetes in older adults.

To examine whether adiponectin is independently associated with diabetes and whether adiponectin and other adipocytokines account for the relationship between fat and diabetes.



A nested case-control study from the Health, Aging, and Body Composition (Health ABC) study. We measured four adipocytokines: adiponectin, interleukin (IL)-6, tumor necrosis factor-alpha, and plasminogen activator inhibitor 1 (PAI-1). Regional fat area was determined by computed tomography scan. The 519 case subjects had diabetes defined by fasting plasma glucose level > or =126 mg/dl or by use of diabetes medications. The 519 control subjects had normal glucose tolerance and were matched by sex, race, and study site. Sex-specific logistic models were adjusted for age, race, site, total adiposity, smoking, and physical activity.



Higher adiponectin levels were associated with lower risk of diabetes (P < 0.001). Visceral fat was the only adiposity measure associated with diabetes after adjusting for BMI (odds ratio 3.0 [2.1-4.3] in women and 1.3 [1.0-1.6] in men, P < 0.001 between-sex comparison). Adipocytokines attenuated the association between visceral fat and diabetes for both sexes but more strongly in men (women 2.3 [1.5-3.3], men 1.1 [0.9-1.4]). In men, adiponectin, IL-6, and PAI-1 remained independently associated with diabetes after adjusting for fat depots; in women, adiponectin was the only independently associated adipocytokine. Controlling for insulin, HDL, triglycerides, and blood pressure did not change these results.



Adiponectin is associated with lower odds of diabetes in older men and women. Whereas several adipocytokines explained the relationship between visceral adiposity and diabetes in men, only adiponectin partially mediated this association among women.
Effect of "motivational interviewing" on quality of care measures in screen detected type 2 diabetes patients: a one-year follow-up of an RCT, ADDITION Denmark.

"Motivational interviewing" (MI) has shown to be broadly applicable in the management of behavioural problems and diseases. Only a few studies have evaluated the effect of MI on type 2 diabetes treatment and none has explored the effect of MI on target-driven intensive treatment.  Patients were cluster-randomized by GPs, who were randomized to training in MI or not. Both groups received training in target-driven intensive treatment of type 2 diabetes. The intervention consisted of a 1½-day residential course in MI with half-day follow-up twice during the first year. Blood samples, case record forms, national registry files, and validated questionnaires from patients were obtained.  After one year significantly improved metabolic status measured by HbA1c (p < 0.01) was achieved in both groups. There was no difference between groups. Medication adherence was close to 100% within both treatment groups. GPs in the intervention group did not use more than an average of 1.7 out of three possible MI consultations.  The study found no effect of MI on metabolic status or on adherence of medication in people with screen detected type 2 diabetes. However, there was a significantly improved metabolic status and excellent medication adherence after one year within both study groups. An explanation may be that GPs in the control group may have taken up core elements of MI, and that GPs trained in MI used less than two out of three planned MI consultations. The five-year follow-up of this study will reveal whether MI has an effect over a longer period.
Ki-67 and PCNA expression in prostate cancer and benign prostatic hyperplasia.

Ki-67 is a proliferation-associated nuclear antigen and is expressed in all cycling cells except for resting cells in the G0-phase. PCNA is an acidic nuclear protein and has been recognized as a histologic marker for the G1/S phase in the cell cycle. Ki-67and PCNA labeling indices are considered to reflect cell proliferation, particularly, growth fraction. The purpose of this study is to investigate the expression levels of Ki-67 and PCNA in prostate cancer (PCa) and benign prostatic hyperplasia (BPH) and their potential on the early diagnosis of PCa.



Human prostate cancer cell lines LNCaP and PC-3, human normal prostate epithelial cell line HuPEC, tissues from patients with PCa (121 cases) and BPH (45) and 36 normal cases were examined for the expression of Ki-67 and PCNA by Reverse Transcription-Polymerase Chain Reaction (RT-PCR). Then, the association of Ki-67 and PCNA expression with clinical grading of PCa was analyzed by immunohistochemistry staining.



The ratios of PCNA and Ki-67 expression levels in LNCaP and PC-3 were higher (P < 0.05, P < 0.001) than that in HuPEC. The two markers were differentially expressed in three tissues and showed increased expression in PCa (P < 0.05) and BPH (P < 0.05), relative to human normal prostate tissues. Compared with BPH, the ratio of Ki-67 and PCNA expressed in tumour tissue was increased (P < 0.05). The increase of Ki-67 was greater than that of PCNA. Expression of the two markers increased after different grading of PCa cases. The values of Ki-67/PCNA were: 0.073 in grade I PCa tissues, 0.119 in grade IIa PCa tissues, 0.141 in grade IIa PCa tissues, 0.234 in grade III PCa tissues.



The combination of Ki-67 and PCNA, specific proliferative markers of PCa, may improve the accuracy of early diagnosis of prostatic cancer.
Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial

Conventional anticoagulant treatment for acute deep vein thrombosis (DVT) effectively prevents thrombus extension and recurrence, but does not dissolve the clot, and many patients develop post-thrombotic syndrome (PTS). We aimed to examine whether additional treatment with catheter-directed thrombolysis (CDT) using alteplase reduced development of PTS.



Participants in this open-label, randomised controlled trial were recruited from 20 hospitals in the Norwegian southeastern health region. Patients aged 18-75 years with a first-time iliofemoral DVT were included within 21 days from symptom onset. Patients were randomly assigned (1:1) by picking lowest number of sealed envelopes to conventional treatment alone or additional CDT. Randomisation was stratified for involvement of the pelvic veins with blocks of six. We assessed two co-primary outcomes: frequency of PTS as assessed by Villalta score at 24 months, and iliofemoral patency after 6 months. Analyses were by intention to treat. 
209 patients were randomly assigned to treatment groups (108 control, 101 CDT). At completion of 24 months' follow-up, data for clinical status were available for 189 patients (90%; 99 control, 90 CDT). At 24 months, 37 (41·1%, 95% CI 31·5-51·4) patients allocated additional CDT presented with PTS compared with 55 (55·6%, 95% CI 45·7-65·0) in the control group (p=0·047). The difference in PTS corresponds to an absolute risk reduction of 14·4% (95% CI 0·2-27·9), and the number needed to treat was 7 (95% CI 4-502). Iliofemoral patency after 6 months was reported in 58 patients (65·9%, 95% CI 55·5-75·0) on CDT versus 45 (47·4%, 37·6-57·3) on control (p=0·012). 20 bleeding complications related to CDT included three major and five clinically relevant bleeds.



Additional CDT should be considered in patients with a high proximal DVT and low risk of bleeding.



South-Eastern Norway Regional Health Authority; Research Council of Norway; University of Oslo; Oslo University Hospital.
The efficacy of a condensed Seeking Safety intervention for women in residential chemical dependence treatment at 30 days posttreatment.

This study examined the efficacy of a condensed version of the Seeking Safety intervention in the reduction of trauma-related symptoms and improved drug abstinence rates among women in residential chemical dependence treatment. One hundred and four women were randomly assigned to treatment including a condensed (six session) Seeking Safety intervention or the standard chemical dependence intervention. The Seeking Safety participants reported lower sexual-abuse-related trauma symptoms at 30 days posttreatment as compared to participants who received only standard treatment. However, the condensed Seeking Safety intervention was not more advantageous in reducing overall trauma symptoms or relapse 30 days after treatment ended.
Prevalence of ocular motor cranial nerve palsy and associations following stroke

AimOccurrence of ocular motor cranial nerve palsies (OMCNP), following stroke, has not been reported in relation to the type of OMCNP seen and in relation to brain area affected by stroke. The aim of this study was to identify all patients referred with suspected visual impairment to establish the presence and type of OMCNP.MethodsProspective, observation study with standardised referral and assessment forms across 20 sites. Visual assessment included visual acuity measurement, visual field assessment, ocular alignment, and movement and visual inattention assessment. Multicentre ethics approval and informed patient consent was obtained.ResultsIn total, 915 patients were recruited with mean age of 69.18 years (SD 14.19). Altogether, 498 patients (54%) were diagnosed with ocular motility abnormalities. Of these, 89 patients (18%) had OMCNP. Unilateral third nerve palsy was present in 23 patients (26%), fourth nerve palsy in 14 patients (16%), and sixth nerve palsy in 52 patients (58%). Out of these, 44 patients had isolated OMCNP and 45 had OMCNP combined with other ocular motility abnormalities. Location of stroke was reported mainly in cerebellum, brain stem, thalamus, and internal and external capsules. Treatment was provided for each case including prisms, occlusion, typoscope, scanning exercises, and refraction.ConclusionsOMCNP account for 18% of eye movement abnormalities in this stroke sub-population. Sixth CNP was most common, followed by third and fourth CNP. Half were isolated and half combined with other eye movement abnormality. Most were treated with prisms or occlusion. The reported brain area affected by stroke was typically the cerebellum, brain stem, and diencephalic structures.
Changing illness perceptions after myocardial infarction: an early intervention randomized controlled trial.

This study was designed to examine whether a brief hospital intervention designed to alter patients' perceptions about their myocardial infarction (MI) would result in a better recovery and reduced disability.



In a prospective randomized study, 65 consecutive patients with their first MI aged were assigned to receive an intervention designed to alter their perceptions about their MI or usual care from rehabilitation nurses. Patients were assessed in hospital before and after the intervention and at 3 months after discharge from hospital.



The intervention caused significant positive changes in patients' views of their MI. Patients in the intervention group also reported they were better prepared for leaving hospital (p<.05) and subsequently returned to work at a significantly faster rate than the control group (p<.05). At the 3-month follow-up, patients in the intervention group reported a significantly lower rate of angina symptoms than control subjects (14.3 vs. 39.3, p<.03). There was no significant differences in rehabilitation attendance between the two groups.



An in-hospital intervention designed to change patients' illness perceptions can result in improved functional outcome after MI.
Hydroxyethyl starch versus Ringer solution in cardiopulmonary bypass prime solutions (a randomized controlled trial)

In our study we compared the Ringer solution, which is the standard prime solution of our department, with the HES (Hydroxyethyl starch) 130-0.4 solution, which can be a potential alternative prime solution with an indispensable material for the cardio-pulmonary bypass applications.



140 patients undergoing to CABG (Coronary Artery Bypass Graft surgery) were electively enrolled to the study. 1500 ml Ringer solution + 200 ml mannitol + 60 ml sodium bicarbonate + 150 U/kg heparin was used as a prime solution to start cardiopulmonary by-pass in 70 patients which was defined as group 1. On the other hand, 1500 ml HES 130 - 0.4 + 200 ml mannitol + 60 ml sodium bicarbonate + 150 U/kg heparin was used as a prime solution in 70 patients in group 2.



INR (International Normalized Ratio), urea levels and blood platelet counts were significantly different between the groups. INR level was higher in group 1, while blood urea and creatinine levels and platelet count were higher in group 2 at the end of the 12th and 24nd hours postoperatively (p = 0.001).In this study, it was shown that the usage of HES 130-0.4 as a prime solution did not have negative effect on postoperative INR level, platelet count, the need for transfusion and the amount of drainage, despite the negative opinions that similar solutions caused coagulation disorders. Another interesting result of the study was that blood platelet count at 24th hour was statistically significantly higher in group 2 (p = 0.001).



HES 130-0.4 solution is an alternative colloidal solution which can be used as the prime solution or as a mixture with the crystalloids in cardio-pulmonary bypass applications.
Improved equations estimating GFR in children with chronic kidney disease using an immunonephelometric determination of cystatin C

The Chronic Kidney Disease in Children study is a cohort of about 600 children with chronic kidney disease (CKD) in the United States and Canada. The independent variable for our observations was a measurement of glomerular filtration rate(GFR) by iohexol disappearance (iGFR) at the first two visits 1 year apart and during alternate years thereafter. In a previous report, we had developed GFR estimating equations utilizing serum creatinine, blood urea nitrogen, height, gender, and cystatin C measured by an immunoturbidimetric method; however, the correlation coefficient of cystatin C and GFR(0.69) was less robust than expected. Therefore, 495 samples were re-assayed using immunonephelometry. The reciprocal of immunonephelometric cystatin C was as well correlated with iGFR as was height/serum creatinine (both 0.88). We developed a new GFR estimating equation using a random 2/3 of 965 person-visits and applied it to the remaining 1/3 as a validation data set. In the validation dataset, the correlation of the estimated GFR with iGFR was 0.92 with high precision and no bias; 91 and 45% of eGFR values were within 30 and 10% of iGFR, respectively. This equation works well in children with CKD in a range of GFR from 15 to 75 ml/min per 1.73 m2. Further studies are needed to establish the applicability to children of normal stature and muscle mass, and higher GFR.
Immediate effect of Masai Barefoot Technology shoes on knee joint moments in women with knee osteoarthritis.

Footwear modification can beneficially alter knee loading in patients with knee osteoarthritis. This study evaluated the effect of Masai Barefoot Technology shoes on reductions in external knee moments in patients with knee osteoarthritis. Three-dimensional motion analysis was used to examine the effect of Masai Barefoot Technology versus control shoes on the knee adduction and flexion moments in 17 women (mean age, 63.6 years) with radiographically confirmed knee osteoarthritis. The lateral and anterior trunk lean values, knee flexion and adduction angles, and ground reaction force were also evaluated. The influence of the original walking pattern on the changes in knee moments with Masai Barefoot Technology shoes was evaluated. The knee flexion moment in early stance was significantly reduced while walking with the Masai Barefoot Technology shoes (0.25±0.14Nm/kgm) as compared with walking with control shoes (0.30±0.19 Nm/kgm); whereas the knee adduction moment showed no changes. Masai Barefoot Technology shoes did not increase compensatory lateral and anterior trunk lean. The degree of knee flexion moment in the original walking pattern with control shoes was correlated directly with its reduction when wearing Masai Barefoot Technology shoes by multiple linear regression analysis (adjusted R2=0.44, P<0.01). Masai Barefoot Technology shoes reduced the knee flexion moment during walking without increasing the compensatory trunk lean and may therefore reduce external knee loading in women with knee osteoarthritis.
Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study.

The immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) administered according to its licensed vaccination schedule (3-dose, 3D) and formulation (20 μg of each HPV antigen; 20/20F) has previously been demonstrated. This partially-blind, controlled, randomized trial (NCT00541970) evaluated 2-dose (2D) schedules using the licensed 20/20F or an alternative formulation containing 40 μg of each antigen (40/40F), compared with the licensed 3D schedule. Healthy females stratified by age (9-14, 15-19, 20-25 y) were randomized to receive 2 doses of 20/20F at Months (M) 0,6 (n=240), 40/40F at M0,6 (n=241) or 40/40F at M0,2 (n=240), or 3 doses of 20/20F at M0,1,6 (licensed schedule/formulation, n=239). One month after the last dose, the 3D schedule was not immunologically superior to 2D schedules except in the 40/40F M0,2 group for HPV-16 (lower limit of 95% CI geometric mean antibody titer (GMT) ratio [2D/3D] < 0.5). For both HPV-16 and HPV-18, the 2D schedules in girls 9-14 y were immunologically non-inferior to the 3D schedule in women 15-25 y (the age group in which efficacy has been demonstrated) (upper limit of 95% CI for GMT ratio [3D/2D] < 2) one month after the last dose. At Month 24, non-inferiority was maintained for the 2D M0,6 schedules in girls 9-14 y versus the 3D schedule in women 15-25 y. All formulations had acceptable reactogenicity and safety profiles. These results indicate that the HPV-16/18 vaccine on a 2D M0,6 schedule is immunogenic and generally well tolerated in girls 9-14 y and that the 2D schedule is likely adequate for younger females.
Phase II clinical and exploratory biomarker study of dacomitinib in recurrent and/or metastatic esophageal squamous cell carcinoma

The purpose of this study was to investigate the clinical activity, safety and predictive biomarkers of dacomitinib, an irreversible pan-HER inhibitor, in patients with recurrent or metastatic esophageal squamous cell carcinoma (R/M-ESCC). Patients, whose diseases were not amenable to curative treatment and had progressed on platinum-based chemotherapy, were treated with dacomitinib 45 mg/day. The primary endpoint was objective response rate by RECISTv 1.1. Predictive biomarker analyses included the characterization of somatic mutations and gene expression using the Ion Torrent AmpliSeq Cancer Hotspot Panel and Nanostring nCounter, and investigation of their relationship with clinical outcomes. Of the 48 evaluable patients, 6 (12.5%) achieved partial responses and 29 (60.4%) had stable disease. The median response duration was 7.1 months. The median progression free survival (PFS) and overall survival (OS) was 3.3 months (95% CI, 2.4-4.3 months) and 6.4 months (95% CI, 4.4-8.4 months). Adverse events were mostly grade 1-2. Gene set enrichment analysis revealed that ERBB signaling pathway is significantly enriched in patients with PFS ≥ 4 months (n = 12) than PFS < 4 months (n = 21) (p < 0.001). Upregulation of ERBB signaling pathway was significantly associated with longer PFS (5.0 vs. 2.9 months, P = 0.016) and OS (10.0 vs. 4.8 months, P = 0.022). The most frequent mutations were TP53 (61%) followed by CDKN2A (8%), MLH1 (8%), FLT3 (8%) and EGFR (8%). Dacomitinib demonstrated clinical efficacy with manageable toxicity in platinum-failed R/M-ESCC. Screening of ERBB pathway-related gene expression profiles may help identify patients who are most likely benefit from dacomitinib.
Intermittent versus maintenance iron therapy in children on hemodialysis: a randomized study

In patients with renal anemia, iron therapy can be administered intermittently or regularly at a low dose. We performed a randomized clinical trial in pediatric patients with end-stage renal failure on hemodialysis and absolute or functional iron deficiency. The study group received maintenance iron therapy according to the ferritin serum levels and the control group received intermittent 10-weekly doses. Success was defined as stabilization of ferritin levels between 100 and 800 μg/l and transferrin saturation (TSAT) between 20% and 50%, in addition to an increase in the hemoglobin level. The major reason for exclusion was iron overload. The study group received 6 mg/kg per month of parenteral iron [95% confidence interval (CI) 3.3–8.8] and the control group 14.4 mg/kg per month (95% CI 12–16.8) (P<0.001). After 4 months of treatment, ferritin levels increased to 66 μg/l (95% CI 69–200) in the study group and to 334 μg/l (95% CI 145–522) in the control group (P=0.009). Maintenance therapy and intermittent weekly doses were successful in 73% and 38%, respectively. After 3 months of treatment, hemoglobin levels increased to 10 g/dl, with no difference between the groups. However, in the control group the increase in hemoglobin levels was unsustained, and 3 patients needed transfusion. Patients in the control group had a higher risk of iron overload than patients in the study group (70% vs. 19%). Thus, the regimen based on assessment of serum ferritin levels was more efficient than the intermittent regimen because it increased and maintained the hemoglobin levels with lower iron doses and a lower risk of iron overload.
Under-treatment of elderly patients with ovarian cancer: a population based study

Ovarian cancer is the fourth most common cancer among women in France, and mainly affects the elderly. The primary objective of this study was to compare treatment of ovarian cancer according to age. All patients with invasive cancer (n = 1151) diagnosed between 1997 and 2011 in the Herault Department of southern France were included. Demographic data (age, area of residence), cancer characteristics (stage, histology, grade) and treatment modality (type, period and location of treatment) were analysed. Univariate and multivariate logistic regression was used to compare treatment by age. Ovarian cancer was less treated in elderly compared to younger patients, regardless of the type of treatment. This difference was more pronounced for chemotherapy, and was maximal for surgery followed by chemotherapy (odds ratio (OR) for surgery for patients aged >70 vs those aged <70 years = 0.47 [0.24–0.91], OR for chemotherapy, age >70 vs <70 = 0.30 [0.16–0.55] and OR for surgery plus chemotherapy, age >70 vs <70 = 0.14 [0.08–0.28]). This effect of age was independent of other variables, including stage and grade. The probability of receiving standard treatment, in accordance with recommendations, was reduced by 50 % in elderly patients compared to their younger counterparts. Overall and net survival of elderly patients with standard treatment was similar to those of younger patients treated outside standard treatment. Elderly women with ovarian cancer were therapeutically disadvantaged compared to younger women. Further studies including co morbidities are necessary to refine these results and to improve therapeutic management of elderly patients with ovarian cancer.