nils-herrmann/clean_scirepeval huggingface dataset:
Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial.

To test whether information about benefits and harms of screening for type 2 diabetes increases intentions to make lifestyle changes amongst attenders, predominantly among the socially advantaged and those with a strong future time orientation.



Planned subgroup analysis of attenders for screening participating in a randomized controlled trial of an informed choice invitation vs a standard invitation to attend for type 2 diabetes screening.



Potentially eligible participants were identified from practice registers using routine data which were used to calculate risk scores for diabetes for all aged 40-69 years without known type 2 diabetes and area deprivation based on post code. In total, 1272 individuals in the top 25% risk category were randomized to receive one of two invitations to attend their practices for screening: an informed choice invitation or a standard invitation. The subsequent attenders completed self-report measures of future time orientation and deprivation immediately before undergoing a screening test.



Individual-level deprivation demonstrated a significant moderator effect [F (4,635) = 4.32, P = 0.002]: individuals who were high in deprivation had lower intentions to engage in lifestyle change following receipt of the informed choice invitation. However, intentions were not patterned by deprivation when it was assessed at the area-level using the Index of Multiple Deprivation 2007. The hypothesized moderating effect of future time orientation on invitation type was also supported [F(14,613) = 2.46, P = 0.002): individuals low in future time orientation had markedly lower intentions to engage in lifestyle change following receipt of an informed choice invitation compared with a standard invitation for screening.



Efforts to enhance informed choice where the implications of diagnosis are a requirement for lifestyle change may require that the immediate benefits are communicated, and efforts to address the apparent barriers to diabetes self-care are made, if the potential for inequity is to be avoided.
Histological alterations in bone marrow in patients with late engraftment after autologous bone marrow transplantation

Bone marrow histology after bone marrow transplantation has rarely been studied. Here, we reviewed the pre- and post-transplant bone marrow biopsies (BMB) of 40 acute myelogenous leukemia (AML) patients autografted in our center, 28 with normal and 12 with delayed peripheral recovery. The two groups were comparable in terms of previous therapy, disease phase and the number of infused cells, and received the same conditioning regimen. In the former group, reduced bone marrow cellularity and mild reticulin abnormalities were usual histological findings; in the latter, five patients had the same pattern, but the other seven had an almost undetectable hematopoietic parenchyma and severe reticulin derangement. One of these seven patients died of reactivated hepatitis B virus infection; the others eventually achieved peripheral recovery, with none of them experiencing a relapse. Autografted AML patients are excellent subjects for histological investigations. They account for the majority of delayed engraftments, the contribution of extramedullary components to the timing of engraftment is minimal, and leukemia relapse cannot be ruled out. These results suggest that BMB is a useful investigation in the work-up of late engraftment. A high degree of reticulin derangement with an almost undetectable hematopoietic parenchyma appear to be the morphological hallmarks of late engraftment. Bone Marrow Transplantation (2000) 25, 837–841.
Predictors of drop-out in a multi-centre longitudinal study of participation and quality of life of children with cerebral palsy

SPARCLE is a study across nine European regions which examines the predictors of participation and quality of life of children with cerebral palsy. Children and their families were initially interviewed in 2004/2005 when the children were aged 8–12 years (SPARCLE1); they were approached again in 2009/2010 at age 13–17 years (SPARCLE2). The objective of this report is to assess potential for bias due to family non-response in SPARCLE2. Logistic regression was used to assess whether socio-demographic factors, parental stress and child impairment were related to non-response, both overall and by category (failure to trace families, death of child, traced families declining to participate). Of the 818 families who participated in SPARCLE1, 224/818 (27%) did not participate in SPARCLE2. 51/818 (6%) were not traced. Among the 767 traced families, 32/767 (4%) children with cerebral palsy had died, seven children had been incorrectly diagnosed as having cerebral palsy, thirteen families had moved out of the region and one family had language problems. Of the remaining 714 families, 120/714 (17%) declined to participate. Drop-out between SPARCLE1 and SPARCLE2 varied significantly between regions; families were more difficult to trace and more likely to decline to participate if the parents’ educational qualifications, as recorded in SPARCLE1, were lower; they were also more likely to decline to participate if SPARCLE1 recorded that they were more stressed or if they had not completed a SPARCLE1 stress questionnaire. To reduce the risk of bias, all SPARCLE2 analyses should allow for factors (region and walking ability) which determined the sampling strategy, either by adjusting for these factors or by using sampling weights. Further analyses should be performed, adjusting for additional factors that were associated with non-response: parents' educational qualifications, family structure and parental stress. To allow for differential non-response in studies which sample from population registers, such registers should routinely record socio-demographic information.
A phase I trial of ANG1/2-Tie2 inhibitor trebaninib (AMG386) and temsirolimus in advanced solid tumors (PJC008/NCI♯9041)

There is crosstalk between the ANG-Tie2 and the PI3K/Akt/mTOR pathways. Combined ANG1/2 and mTOR blockade may have additive anti-cancer activity. The combination of trebananib, an inhibitor of ANG1/2-Tie2 interaction, with temsirolimus was evaluated in patients with advanced solid tumors to determine tolerability, maximum tolerated dose (MTD), and preliminary antitumor activity.  Patients were enrolled using 3 + 3 design, and were given intravenous trebananib and temsirolimus on Day 1, 8, 15 and 22 of a 28-day cycle. Dose limiting toxicities (DLTs) were evaluated during cycle 1. Peripheral blood was collected for evaluation of Tie2-expressing monocytes (TEMs) and thymidine phosphorylase (TP). Sparse pharmacokinetic (PK) sampling for trebananib drug levels was performed on Day 1 and 8 of cycle 2.  Twenty-one patients were enrolled, 6 at dose level (DL) 1, 7 at DL −1, and 8 at DL −2. No effect of temsirolimus on trebananib PK was observed. The most common treatment-related adverse events (AEs) were: fatigue (81 %), edema (62 %), anorexia (57 %), nausea (52 %), rash (43 %) and mucositis (43 %). The most common grade ≥ 3 AEs included lymphopenia (28 %) and fatigue (28 %). The MTD was exceeded at DL-2. Of 18 response evaluable patients, 1 partial response was observed (ER+/HER2−/PIK3CA mutant breast cancer) and 4 patients had prolonged SD ≥ 24 weeks. No correlation with clinical benefit was observed with change in number TEMs or TP expression in TEMs with treatment.  The MTD was exceeded at trebananib 10 mg/kg weekly and temsirolimus 20 mg weekly, with frequent overlapping toxicities including fatigue, edema, and anorexia.
Obesity Is Associated With Low NAD(+)/SIRT Pathway Expression in Adipose Tissue of BMI-Discordant Monozygotic Twins.

Sirtuins (SIRTs) regulate cellular metabolism and mitochondrial function according to the energy state of the cell reflected by NAD(+) levels.



Our aim was to determine whether expressions of SIRTs and NAD(+) biosynthesis genes are affected by acquired obesity and how possible alterations are connected with metabolic dysfunction while controlling for genetic and familial factors.



We studied a cross-sectional sample of 40 healthy pairs of monozygotic twins, including 26 pairs who were discordant for body mass index (within-pair difference > 3 kg/m(2)), from the FinnTwin12 and FinnTwin16 cohorts.



Subcutaneous adipose tissue (SAT) transcriptomics was analyzed by using Affymetrix U133 Plus 2.0 chips, total SAT (poly-ADP) ribose polymerase (PARP) activity by an ELISA kit, body composition by dual-energy x-ray absorptiometry and magnetic resonance imaging/spectroscopy, and insulin sensitivity by an oral glucose tolerance test.



SIRT1, SIRT3, SIRT5, NAMPT, NMNAT2, NMNAT3, and NRK1 expressions were significantly down-regulated and the activity of main cellular NAD(+) consumers, PARPs, trended to be higher in the SAT of heavier co-twins of body mass index-discordant pairs. Controlling for twin-shared factors, SIRT1, SIRT3, NAMPT, NMNAT3, and NRK1 were significantly negatively correlated with adiposity, SIRT1, SIRT5, NMNAT2, NMNAT3, and NRK1 were negatively correlated with inflammation, and SIRT1 and SIRT5 were positively correlated with insulin sensitivity. Expressions of genes involved in mitochondrial unfolded protein response were also significantly down-regulated in the heavier co-twins.



Our data highlight a strong relationship of reduced NAD(+)/SIRT pathway expression with acquired obesity, inflammation, insulin resistance, and impaired mitochondrial protein homeostasis in SAT.
An effect of walking exercise applying the theory of planned behavior in people at risk of hypertension.

To investigate an effectiveness of walking exercise program applying the Theory of Planned Behavior in people at risk of hypertension in Samut Sakorn province.



The present study is a quasi-experimental research. The inclusion criteria were people aged 35-59 years old, systolic blood pressure 120-139 mmHg, and diastolic blood pressure 80-89 mmHg. Participants were randomly selected into the experimental group (n = 34) and the comparison group (n = 34). The experimental group received activities including health information, benefits of walking exercise, group discussion in exercise barriers, modeling and experience exchange, walking exercise practice, and practice on using walking monitoring booklet at the baseline and the 2nd week, whereas the comparison group received only health information and the booklet practice at the beginning of the intervention. Data were collected by self-administered questionnaires at the baseline, 2nd week, and 6th week. Statistical analysis was performed using Chi-square, Independent t-test, and repeated measures ANOVA.



The experimental group made significant improvements in attitude towards walking exercise, perceived behavior control, subjective norm, walking exercise intention, and walking exercise over time (p < 0.05). However, no statistically significant differences between the experimental and the comparison groups were found in subjective norm, systolic and diastolic blood pressure from baseline to the 6th week. The experimental group had a significant higher mean difference score of attitude towards walking exercise, perceived behavior control, walking exercise intention, walking exercise, weight, and BMI compared to those in the comparison group (p < 0.05). Subjective norm scores in the experimental group were more likely to increase from baseline to the 6th week, but not a significant difference.



Walking exercise programs applying the Theory of Planned Behavior should be recommended in people at risk of hypertension. Health professionals should also be motivated to practice with this program.
Modes, features, and state-based modeling for clarity and flexibility

The behavior of a complex system is frequently defined in terms of operational modes---mutually exclusive sets of the system behaviors. Within the operational modes, collections of features define the behavior of the system.
 Lucent and understandable modeling of operational modes and features using common state-based notations such as Statecharts or Stateflow can be challenging. In this paper we share some of our experiences from modeling modes and features in the medical device domain. We discuss the challenges and present a generic approach to structuring the modes and features of a generic Patient-Controlled Analgesia infusion pump.
Burden on the families of patients with schizophrenia: results of the BIOMED I study

The burden, the coping strategies and the social network of a sample of 236 relatives of patients with schizophrenia, living in five European countries, were explored by well-validated assessment instruments. In all centres, relatives experienced higher levels of burden when they had poor coping resources and reduced social support. Relatives in Mediterranean centres, who reported lower levels of social support, were more resigned, and more often used spiritual help as a coping strategy. These data indicate that family burden and coping strategies can be influenced by cultural factors, and suggest that family interventions should have also a social focus, aiming to increase the family social network and to reduce stigma.
Depression after cardiac hospitalisation--the Identifying Depression as a Comorbid Condition (IDACC) study.

The Identifying Depression as a Comorbid Condition (IDACC) study aimed to identify depressive symptoms in hospitalised cardiac patients and support management of depression in general practice.



This post hoc analysis of the IDACC trial examines the effectiveness and practicality of different forms of communication between hospital psychiatric services and general practitioners.



We randomised 669 cardiac inpatients with depressive symptoms, identified with the Center for Epidemiological Studies Depression Scale (CES-D), to an intervention or usual care control group. Individual depression scores and depression management guidelines were sent to GPs of all intervention patients. Where possible, psychiatric advice was provided to the GP either by multidisciplinary enhanced primary care case conference or one-to-one telephone advice.



Multidisciplinary case conferences were implemented for only 24% of intervention patients. General practitioners received individual telephone advice in 40% of cases, and 36% received written information only. The psychiatrist telephone advice resulted in a significant reduction in the proportion of patients with moderate to severe depression 12 months after cardiac hospitalisation (19% vs. 35%).



Screening, combined with psychiatrist telephone advice to GPs, was simple to organise and effective in reducing depression severity after cardiac admission.
Significance of serum magnesium as an independent correlative factor on the parathyroid hormone level in uremic patients.

PTH is a critical factor in mineral homeostasis, and chronic kidney disease mineral and bone metabolism disorder is a very important problem in patients with renal failure. Abnormal levels of PTH, serum phosphate, and calcium influence chronic kidney disease mineral and bone metabolism disorder, but there is little information about the influence of magnesium (Mg) on PTH.



The aim of this study was to elucidate the correlation between magnesium and PTH levels in uremic patients just prior to beginning hemodialysis (HD) for the first time.



We enrolled 1231 patients in nine Japanese facilities who had begun HD for end-stage renal disease. We investigated their serum Mg levels and the correlation between intact PTH (iPTH) and the serum Mg levels and other clinical parameters and medications.



The mean serum Mg was 2.2 ± 0.5 mg/dL, and hypermagnesemia was found in 663 patients (53.9%). Divided into two groups according to median iPTH level, the serum Mg levels were significantly higher in patients with low iPTH (2.3 ± 0.5 vs 2.1 ± 0.5, P < .01). Furthermore, divided into two groups according to the Mg level, iPTH levels were lower in patients with high Mg than in patients with normal serum Mg levels (277.9 ± 195.9 pg/mL vs 321.9 ± 203.7 pg/mL, P < .01). In the multiple regression analysis according to the effect of iPTH level, the serum Mg level was an independent variable after adjustment for other factors.



A high serum level of Mg is frequent in uremic patients with end-stage renal disease just prior to beginning HD. In the present set of patients, there was a significant correlation between the serum Mg and iPTH levels. Furthermore, the serum Mg level was an independent factor apart from the other factors regulating iPTH. These results suggest that serum Mg may be one of the factors regulating the serum PTH level in uremic patients.
Phase Ib study of Buparlisib plus Trastuzumab in patients with HER2-positive advanced or metastatic breast cancer that has progressed on Trastuzumab-based therapy.

Phosphoinositide 3-kinase (PI3K)/AKT/mTOR pathway activation in patients with HER2-positive (HER2(+)) breast cancer has been implicated in de novo and acquired trastuzumab resistance. The purpose of this study was to determine the clinical activity of the PI3K inhibitor buparlisib (BKM120) in patients with HER2(+) advanced/metastatic breast cancer resistant to trastuzumab-based therapy.



In the dose-escalation portion of this phase I/II study, patients with trastuzumab-resistant locally advanced or metastatic HER2(+) breast cancer were treated with daily oral doses of buparlisib and weekly intravenous trastuzumab (2 mg/kg). Dose escalation was guided by a Bayesian logistic regression model with overdose control.



Of 18 enrolled patients, 17 received buparlisib. One dose-limiting toxicity of grade 3 general weakness was reported at the 100-mg/day dose level (the single-agent maximum tolerated dose) and this dose level was declared the recommended phase II dose (RP2D) of buparlisib in combination with trastuzumab. Common (>25%) adverse events included rash (39%), hyperglycemia (33%), and diarrhea (28%). The pharmacokinetic profile of buparlisib was not affected by its combination with trastuzumab. At the RP2D, there were two (17%) partial responses, 7 (58%) patients had stable disease (≥6 weeks), and the disease control rate was 75%. Pharmacodynamic studies showed inhibition of the PI3K/AKT/mTOR and RAS/MEK/ERK pathways.



In this patient population, the combination of buparlisib and trastuzumab was well tolerated, and preliminary signs of clinical activity were observed. The phase II portion of this study will further explore the safety and efficacy of this combination at the RP2D. Clin Cancer Res; 20(7); 1935-45.
Effect of combined low-frequency repetitive transcranial magnetic stimulation and virtual reality training on upper limb function in subacute stroke: a double-blind randomized controlled trail

The effect of combined low-frequency repetitive transcranial magnetic stimulation (LF rTMS) and virtual reality (VR) training in patients after stroke was assessed. In a double-blind randomized controlled trial, 112 patients with hemiplegia after stroke were randomly divided into two groups: experimental and control. In experimental group, the patients received LF rTMS and VR training treatment, and those in control group received sham rTMS and VR training treatment. Participants in both groups received therapy of 6 days per week for 4 weeks. The primary endpoint including the upper limb motor function test of Fugl-meyer assessment (U-FMA) and wolf motor function test (WMFT), and the secondary endpoint including modified Barthel index (MBI) and 36-item Short Form Health Survey Questionnaire (SF-36) were assessed before and 4 weeks after treatment. Totally, 108 subjects completed the study (55 in experimental group and 53 in control group respectively). After 4-week treatment, the U-FMA scores [mean difference of 13.2, 95% confidence interval (CI) 3.6 to 22.7, P<0.01], WMFT scores (mean difference of 2.9, 95% CI 2.7 to 12.3, P<0.01), and MBI scores (mean difference 16.1, 95% CI 3.8 to 9.4, P<0.05) were significantly increased in the experimental group as compared with the control group. The results suggested the combined use of LF rTMS with VR training could effectively improve the upper limb function, the living activity, and the quality of life in patients with hemiplegia following subacute stroke, which may provide a better rehabilitation treatment for subacute stroke.
Intestinal Lesions Are Associated with Altered Intestinal Microbiome and Are More Frequent in Children and Young Adults with Cystic Fibrosis and Cirrhosis

Cirrhosis (CIR) occurs in 5-7% of cystic fibrosis (CF) patients. We hypothesized that alterations in intestinal function in CF contribute to the development of CIR.



Determine the frequency of macroscopic intestinal lesions, intestinal inflammation, intestinal permeability and characterize fecal microbiome in CF CIR subjects and CF subjects with no liver disease (CFnoLIV).



11 subjects with CFCIR (6 M, 12.8 yrs ± 3.8) and 19 matched with CFnoLIV (10 M, 12.6 yrs ± 3.4) underwent small bowel capsule endoscopy, intestinal permeability testing by urinary lactulose: mannitol excretion ratio, fecal calprotectin determination and fecal microbiome characterization.



CFCIR and CFnoLIV did not differ in key demographics or CF complications. CFCIR had higher GGT (59±51 U/L vs 17±4 p = 0.02) and lower platelet count (187±126 vs 283±60 p = 0.04) and weight (-0.86 ± 1.0 vs 0.30 ± 0.9 p = 0.002) z scores. CFCIR had more severe intestinal mucosal lesions on capsule endoscopy (score ≥4, 4/11 vs 0/19 p = 0.01). Fecal calprotectin was similar between CFCIR and CFnoLIV (166 μg/g ±175 vs 136 ± 193 p = 0.58, nl <120). mannitol ratio was elevated in 27/28 subjects and was slightly lower in CFCIR vs CFnoLIV (0.08±0.02 vs 0.11±0.05, p = 0.04, nl ≤0.03). Small bowel transit time was longer in CFCIR vs CFnoLIV (195±42 min vs 167±68 p<0.001, nl 274 ± 41). Bacteroides were decreased in relative abundance in CFCIR and were associated with lower capsule endoscopy score whereas Clostridium were more abundant in CFCIR and associated with higher capsule endoscopy score.



CFCIR is associated with increased intestinal mucosal lesions, slower small bowel transit time and alterations in fecal microbiome. Abnormal intestinal permeability and elevated fecal calprotectin are common in all CF subjects. Disturbances in intestinal function in CF combined with changes in the microbiome may contribute to the development of hepatic fibrosis and intestinal lesions.
EGFR expression is associated with decreased benefit from trastuzumab in the NCCTG N9831 (Alliance) trial

Epidermal growth factor receptor (EGFR) has been hypothesised to modulate the effectiveness of anti-HER2 therapy. We used a standardised, quantitative immunofluorescence assay and a novel EGFR antibody to evaluate the correlation between EGFR expression and clinical outcome in the North Central Cancer Treatment Group (NCCTG) N9831 trial.Tissue microarrays were constructed that allowed analysis of 1365 patients randomly assigned to receive chemotherapy alone (Arm A), sequential trastuzumab after chemotherapy (Arm B) and chemotherapy with concurrent trastuzumab (Arm C). Measurement of EGFR was performed using the EGFR antibody, D38B1, on the fluorescence-based AQUA platform. The result was validated using an independent retrospective metastatic breast cancer cohort (n=130).Results:Epidermal growth factor receptor assessed as a continuous (logarithmic transformed) variable shows an association with disease-free survival in Arm C (P=0.009) but not in Arm A or B. High EGFR expression was associated with worse outcome (Hazard ratio (HR)=2.15; 95% CI 1.28–3.60, P=0.004). Validation in a Greek metastatic breast cancer cohort showed an HR associated with high EGFR expression of 1.92 (High expression of EGFR appears to be associated with decreased benefit from adjuvant concurrent trastuzumab. Since other treatment options exist for HER2-driven tumours, further validation of these data may select patients for alternative or additive therapy.