nils-herrmann/clean_scirepeval huggingface dataset:
Unilateral leptomeningeal enhancement after carotid stent insertion detected by magnetic resonance imaging.

Percutaneous transluminal angioplasty combined with vascular stenting is currently being assessed in the treatment of patients with symptomatic, severe carotid stenosis. The immediate cerebral hemodynamic effects resulting from stenting are not fully understood. This article describes a novel finding: abnormal leptomeningeal enhancement after stenting shown by MRI.



Fourteen patients with symptomatic severe carotid bifurcation stenosis underwent MRI within 4 hours before and within 3 hours after attempted carotid stenting. Twelve patients were successfully stented. Part of the MR investigation consisted of the acquisition of T1-weighted images before and after administration of the contrast agent Gd-DTPA, both before and after the procedure.



All 12 patients who underwent successful stenting did not have abnormal enhancement of the leptomeninges before stenting but developed unilateral enhancement following intervention but before the second injection of contrast agent. No contrast enhancement was detected in the 2 patients who had the angiographic procedure but were not stented.



These findings suggest that abnormal changes to the leptomeningeal vasculature occur during carotid stenting which are not associated with sudden development of neurological symptoms. The anatomic distribution of the enhancement suggests that it is a consequence of the sudden change in brain hemodynamics secondary to the improvement in carotid flow after stenting.
Urinary albumin excretion and 24-hour blood pressure as predictors of pre-eclampsia in Type I diabetes

To evaluate the value of 24-h blood pressure monitoring compared to office blood pressure and urinary albumin excretion in predicting pre-eclampsia in Type I (insulin-dependent) diabetes mellitus.¶Methods. The study included 136 consecutive pregnancies in Caucasian women with Type I diabetes before gestation without diabetic nephropathy, anamnestic hypertension or early abortion. Values of urinary albumin excretion and office blood pressure before pregnancy and the HbA1C value at the time of conception were obtained. Microalbuminuria was defined as urinary albumin excretion of 30–300 mg/24 h in two out of three consecutive urine samples. Single measurements of 24-h urinary albumin excretion, office blood pressure and HbA1C were done five 5 times during pregnancy. In a subgroup of 74 women 24-h blood pressure measurements were done at 10 and 28 weeks of gestation. Pre-eclampsia was defined as office blood pressure higher than 140/90 mm Hg accompanied by proteinuria above 0.3 g/24 h later than 20 weeks of gestation.¶Results. Urinary albumin excretion and systolic blood pressure were higher before and throughout pregnancy in 14 women developing pre-eclampsia compared with women remaining normotensive (p < 0.001; p < 0.05, respectively). By logistic regression analysis the best predictor for pre-eclampsia was microalbuminuria before pregnancy (p < 0.05) with no additive predictive effect of 24-h blood pressure or office blood pressure measurement. The night:day ratio of blood pressure was similar in the two groups.¶Conclusion/interpretation. Microalbuminuria before pregnancy is the strongest predictor of pre-eclampsia in Type I diabetes. Measuring 24-h blood pressure early in pregnancy did not improve the ability to identify women at risk.
Use of complementary medicine amongst diabetic patients in a public primary care clinic in Ipoh.

The use of Complementary Medicine (CM) amongst diabetic patients attending the Diabetes/Hypertension, Clinic. Out Patient Department, Ipoh Hospital was studied: Forty-three patients were selected by systematic random sampling (1:5) over a one-week period starting 5/12/01. Data were collected by patient interview, from medical records and through a questionnaire. 56% were using CM together with conventional therapy. Most commonly used were herbal therapy, homeopathy and reflexology. The majority took CM daily with a mean duration of 7 years. Over half had subjective relief of pain with increased energy. Patients on CM or conventional therapy both showed poorly controlled FBS levels. There is a need to assess the effect of these therapies on diabetic outcome.
A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes)

Type 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time.



Adults aged 18-40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables.



187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures.



A structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus on environmental change. Moreover, some participants reported a focus on physical activity rather than reductions in sitting per se. The habitual nature of sedentary behaviour means that behaviour change is challenging.
Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial.

The randomized Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial (NCT00543881) was performed during 2008 and 2010 to determine whether physician-led remote patient management (RPM) compared with usual care would result in reduced mortality and morbidity in stable out-patient heart failure (HF) patients. However, besides results of clinical benefit, the acceptance by patients and primary physicians is necessary for the implementation of RPM as part of the upcoming out-patient HF-care programs.



Two months after finishing of the trial, a survey based analysis of the perception of telemedical care with patients (n=288) and primary physicians (n=102) was carried out. The survey included questions regarding self-management, usability and physician-patient communication.



The concept of RPM was perceived positively by patients and physicians. The devices were assessed as easy to use (98.6%, n=224) and robust (88.8%, n=202). Through trial participation and daily measurements most of the patients (85.5%, n=195) felt more confident in dealing with their disease than before. The perception of the nurses and physicians of the telemedical centers was professional (92.1%, n=210 and 89.9%, n=205) and committed (94.3%, n=215 and 91.7%, n=209). Also more than half of the patients noticed an improvement in the contact with their primary physician (52.6%, n=120); and for 46.1% (n=105) the contact has not been changed.



RPM will be a medical care concept for recently hospitalized HF- patients in the near future but the optimal telemedical setting of RPM and the duration of this intervention have to be defined in further clinical trials.
Insulin Secretion and Its Determinants in the Progression of Impaired Glucose Tolerance to Type 2 Diabetes in Impaired Glucose-Tolerant Individuals

We investigated the effect of early-phase insulin secretion on the incidence of type 2 diabetes in individuals with impaired glucose tolerance (IGT) participating in the Finnish Diabetes Prevention Study (DPS). We examined how a lifestyle intervention affected early-phase insulin secretion (ratio of total insulin area under the curve [AUC] and total glucose AUC [AIGR] from 0 to 30 min) during a 4-year follow-up intervention trial and whether AIGR(0-30) response was modified by insulin sensitivity (IS) and obesity.



A total of 443 participants with IGT originally randomized to a lifestyle intervention or control group were studied. IS and AIGR(0-30) were estimated from an oral tolerance glucose test administered annually during the 4-year follow-up trial and were related to the risk of diabetes onset over a 6-year follow-up.



Lifestyle intervention resulted in higher IS (P = 0.02) and lower unadjusted AIGR(0-30) (P = 0.08) during the 4-year follow-up. A higher IS and a lower BMI during the follow-up were associated with a lower unadjusted AIGR(0-30) during the follow-up, independently of study group (P < 0.001). A greater increase in IS on the median cutoff point of a 0.69 increase was associated with higher IS-adjusted AIGR(0-30) during the follow-up (P = 0.002). In multivariate models, IS and IS-adjusted AIGR(0-30) were both inversely associated with diabetes incidence (P < 0.001). Participants who progressed to type 2 diabetes were more obese and had lower IS and Matsuda IS index-AIGR(0-30) than nonprogressors.



Our results indicate that the reduction in the risk of developing type 2 diabetes after lifestyle intervention is related to the improvement of IS along with weight loss. Improved IS may also have beneficial effects on preservation of β-cell function.
Association between dietary acid-base load and cardiometabolic risk factors in young Japanese women.

Mild metabolic acidosis, which can be caused by diet, may adversely affect cardiometabolic risk factors, possibly by increasing cortisol production. Methodologies for estimating diet-induced acid-base load using dietary-intake information have been established. To our knowledge, however, the possible association between dietary acid-base load and cardiometabolic risk factors has not been investigated. We cross-sectionally examined associations between dietary acid-base load and cardiometabolic risk factors in a free-living population. The subjects were 1136 female Japanese dietetic students aged 18-22 years. Dietary acid-base load was characterized as the potential renal acid load (PRAL), which was determined using an algorithm including dietary protein, P, K, Ca and Mg, as well as the ratio of dietary protein to K (Pro:K). Estimates of each nutrient were obtained from a validated comprehensive self-administered diet history questionnaire. Body height and weight, waist circumference and blood pressure were measured. Fasting blood samples were collected. After adjustment for potential confounding factors, higher PRAL and Pro:K (more acidic dietary acid-base loads) were associated with higher systolic and diastolic blood pressure (P for trend = 0.028 and 0.035 for PRAL and 0.012 and 0.009 for Pro:K, respectively). PRAL was also independently positively associated with total and LDL-cholesterol (n 1121; P for trend = 0.042 and 0.021, respectively). Additionally, Pro:K showed an independent positive association with BMI and waist circumference (P for trend = 0.024 and 0.012, respectively). In conclusion, more acidic dietary acid-base load was independently associated with adverse profile of several cardiometabolic risk factors in free-living young Japanese women.
Determinants of progressive vascular calcification in haemodialysis patients.

We determined recently that targeted treatment with calcium-based phosphate binders (calcium acetate and carbonate) led to progressive coronary artery and aortic calcification by electron beam tomography (EBT), while treatment with the non-calcium-containing phosphate binder, sevelamer, did not. Aside from the provision of calcium, we hypothesized that other factors might be related to the likelihood of progressive calcification in both or either treatment groups.



We explored potential determinants of progressive vascular calcification in 150 randomized study subjects who underwent EBT at baseline and at least once during follow-up (week 26 or 52).



Among calcium-treated subjects, higher time-averaged concentrations of calcium, phosphorus and the calcium-phosphorus product were associated with more pronounced increases in EBT scores; no such associations were demonstrated in sevelamer-treated subjects. The relation between parathyroid hormone (PTH) and the progression of calcification was more complex. Lower PTH was associated with more extensive calcification in calcium-treated subjects, whereas higher PTH was associated with calcification in sevelamer-treated subjects. Serum albumin was inversely correlated with progression in aortic calcification. Sevelamer was associated with favourable effects on lipids, although the link between these effects and the observed attenuation in vascular calcification remains to be elucidated.



Calcium-based phosphate binders are associated with progressive coronary artery and aortic calcification, especially when mineral metabolism is not well controlled. Calcium may directly or indirectly (via PTH) adversely influence the balance of skeletal and extraskeletal calcification in haemodialysis patients.
Hip disability and osteoarthritis outcome score (HOOS) – validity and responsiveness in total hip replacement

The aim of the study was to evaluate if physical functions usually associated with a younger population were of importance for an older population, and to construct an outcome measure for hip osteoarthritis with improved responsiveness compared to the Western Ontario McMaster osteoarthritis score (WOMAC LK 3.0).



A 40 item questionnaire (hip disability and osteoarthritis outcome score, HOOS) was constructed to assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life). The HOOS contains all WOMAC LK 3.0 questions in unchanged form. The HOOS was distributed to 90 patients with primary hip osteoarthritis (mean age 71.5, range 49-85, 41 females) assigned for total hip replacement for osteoarthritis preoperatively and at six months follow-up.



The HOOS met set criteria of validity and responsiveness. It was more responsive than WOMAC regarding the subscales pain (SRM 2.11 vs. 1.83) and other symptoms (SRM 1.83 vs. 1.28). The responsiveness (SRM) for the two added subscales sport and recreation and quality of life were 1.29 and 1.65, respectively. Patients <or= 66 years of age (range 49-66) reported higher responsiveness in all five subscales than patients >66 years of age (range 67-85) (Pain SRM 2.60 vs. 1.97, other symptoms SRM 3.0 vs. 1.60, activity of daily living SRM 2.51 vs. 1.52, sport and recreation function SRM 1.53 vs. 1.21 and hip related quality of life SRM 1.95 vs. 1.57).



The HOOS 2.0 appears to be useful for the evaluation of patient-relevant outcome after THR and is more responsive than the WOMAC LK 3.0. The added subscales sport and recreation function and hip related quality of life were highly responsive for this group of patients, with the responsiveness being highest for those younger than 66.
The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors

Gallbladder toxicity, including cholecystitis, has been reported with motesanib, an orally administered small-molecule antagonist of VEGFRs 1, 2 and 3; PDGFR; and Kit. We assessed effects of motesanib on gallbladder size and function. Patients with advanced metastatic solid tumors ineligible for or progressing on standard-of-care therapies with no history of cholecystitis or biliary disease were randomized 2:1:1 to receive motesanib 125 mg once daily (Arm A); 75 mg twice daily (BID), 14-days-on/7-days-off (Arm B); or 75 mg BID, 5-days-on/2-days-off (Arm C). Primary endpoints were mean change from baseline in gallbladder size (volume by ultrasound; independent review) and function (ejection fraction by CCK-HIDA; investigator assessment). Forty-nine patients received ≥1 dose of motesanib (Arms A/B/C, n = 25/12/12). Across all patients, gallbladder volume increased by a mean 22.2 cc (from 38.6 cc at baseline) and ejection fraction decreased by a mean 19.2% (from 61.3% at baseline) during treatment. Changes were similar across arms and appeared reversible after treatment discontinuation. Three patients had cholecystitis (grades 1, 2, 3, n = 1 each) that resolved after treatment discontinuation, one patient developed grade 3 acute cholecystitis requiring cholecystectomy, and two patients had other notable grade 1 gallbladder disorders (gallbladder wall thickening, gallbladder dysfunction) (all in Arm A). Two patients developed de novo gallstones during treatment. Twelve patients had right upper quadrant pain (Arms A/B/C, n = 8/1/3). The incidence of biliary “sludge” in Arms A/B/C was 39%/36%/27%. Motesanib treatment was associated with increased gallbladder volume, decreased ejection fraction, biliary sludge, gallstone formation, and infrequent cholecystitis.
Five-times-sit-to-stand test in children with cerebral palsy: reliability and concurrent validity.

Five-times-sit-to-stand test (FTSST) is a reliable tool for measuring lower limb functional strength and balance ability. However, reports of the reliability of FTSST in children with cerebral palsy have been scarce. The purposes of this study were (1) to investigate the test-retest and inter-rater reliability of the FTSST and (2) to investigate the correlation between the FTSST and standard functional balance tests in children with cerebral palsy.



Cross-sectional study.



Thirty-three school children aged from 6 to 18 years with Gross motor functional classification system expanded and revised version (GMFCS-E&R) level I to III were recruited. Reliability of the FTSST and concurrent validity between FTSST and Timed up and go test (TUG) and Berg balance scale (BBS) were determined using the Pearson product moment correlation.



The intra-class correlation coefficient (ICC) for test-retest and inter-rater reliability of FTSST were 0.91 and 0.88 respectively. FTSST showed moderate correlation with TUG (r = 0.552, P < 0.01) and with BBS (r = -0.561, P < 0.01).



FTSST is a reliable assessment tool and correlates with functional balance ability tests in children with mild to moderate cerebral palsy.
Interleukin-6 as a potential positive modulator of human beta-cell function: an exploratory analysis—the Verona Newly Diagnosed Type 2 Diabetes Study (VNDS) 6

Recent studies in mouse models of T2D showed that interleukin-6 (IL-6), released from skeletal muscle, is associated with increased glucose-dependent insulin secretion. Few data currently exist exploring the relationship between IL-6 and beta-cell function in humans. We investigated whether IL-6 is positively associated with beta-cell function in newly diagnosed T2D. We extended the same analyses to IL-10, because it regulated similarly to IL-6 in skeletal muscle, and TNF-α and C-reactive protein (CRP), as general biomarkers of inflammation. In 330 VNDS participants, we assessed (1) basal plasma concentrations of IL-6, IL-10, TNF-α, and CRP; (2) beta-cell function, estimated by OGTT minimal modeling and expressed as derivative (DC) and proportional control (PC); (3) insulin sensitivity, by euglycemic insulin clamp. IL-6 was positively associated with PC in both univariate analysis (p = 0.04) and after adjustment for age, sex, BMI, HbA1c, and M-clamp (p = 0.01). HbA1c was the major independent contributor to the overall variance of PC (16 %), followed by BMI and IL-6 (~2 % each). Similar results were obtained for IL-10 (p = 0.048, univariate; p = 0.04, fully adjusted). TNF-α and CRP were not significantly associated with any component of beta-cell function. Our data are the first evidence in human subjects that an endocrine loop involving IL-6 may act as positive modulator of glucose-dependent insulin secretion. Further functional studies are needed to corroborate IL-6 system as a potential druggable target in diabetes. NCT01526720 ( http://www.clinicaltrial.gov ).
Genetic variants of CYP 3 A 5 , CYP 2 D 6 , SULT 1 A 1 , UGT 2 B 15 and tamoxifen response in postmenopausal patients with breast cancer

Tamoxifen therapy reduces the risk of recurrence and prolongs the survival of oestrogen-receptor-positive patients with breast cancer. Even if most patients benefit from tamoxifen, many breast tumours either fail to respond or become resistant. Because tamoxifen is extensively metabolised by polymorphic enzymes, one proposed mechanism underlying the resistance is altered metabolism. In the present study we investigated the prognostic and/or predictive value of functional polymorphisms in cytochrome P450 3A5 CYP3A5 (*3), CYP2D6 (*4), sulphotransferase 1A1 (SULT1A1; *2) and UDPglucuronosyltransferase 2B15 (UGT2B15; *2) in tamoxifentreated patients with breast cancer.  In all, 677 tamoxifen-treated postmenopausal patients with breast cancer, of whom 238 were randomised to either 2 or 5 years of tamoxifen, were genotyped by using PCR with restriction fragment length polymorphism or PCR with denaturing high-performance liquid chromatography.  The prognostic evaluation performed in the total population revealed a significantly better disease-free survival in patients homozygous for CYP2D6*4. For CYP3A5, SULT1A1 and UGT2B15 no prognostic significance was observed. In the randomised group we found that for CYP3A5, homozygous carriers of the *3 allele tended to have an increased risk of recurrence when treated for 2 years with tamoxifen, although this was not statistically significant (hazard ratio (HR) = 2.84, 95% confidence interval (CI) = 0.68 to 11.99, P = 0.15). In the group randomised to 5 years' tamoxifen the survival pattern shifted towards a significantly improved recurrence-free survival (RFS) among CYP3A5*3-homozygous patients (HR = 0.20, 95% CI = 0.07 to 0.55, P = 0.002). No reliable differences could be seen between treatment duration and the genotypes of CYP2D6, SULT1A1 or UGT2B15. The significantly improved RFS with prolonged tamoxifen treatment in CYP3A5*3 homozygotes was also seen in a multivariate Cox model (HR = 0.13, CI = 0.02 to 0.86, P = 0.03), whereas no differences could be seen for CYP2D6, SULT1A1 and UGT2B15.  The metabolism of tamoxifen is complex and the mechanisms responsible for the resistance are unlikely to be explained by a single polymorphism; instead it is a combination of several mechanisms. However, the present data suggest that genetic variation in CYP3A5 may predict response to tamoxifen therapy.  Tamoxifen is widely used as an endocrine treatment for patients with oestrogen-receptor (ER)-positive breast cancer. Five years of adjuvant tamoxifen therapy reduces the risk of recurrence and prolongs the survival of women with ER-positive tumours . Nevertheless, in a proportion of patients, tumours are resistant to tamoxifen, or become so, with a subsequent relapse in the disease. The mechanisms underlying