nils-herrmann/clean_scirepeval huggingface dataset:
Effect of B-vitamin therapy on progression of diabetic nephropathy: a randomized controlled trial.

Hyperhomocysteinemia is frequently observed in patients with diabetic nephropathy. B-vitamin therapy (folic acid, vitamin B(6), and vitamin B(12)) has been shown to lower the plasma concentration of homocysteine.



To determine whether B-vitamin therapy can slow progression of diabetic nephropathy and prevent vascular complications.



A multicenter, randomized, double-blind, placebo-controlled trial (Diabetic Intervention with Vitamins to Improve Nephropathy [DIVINe]) at 5 university medical centers in Canada conducted between May 2001 and July 2007 of 238 participants who had type 1 or 2 diabetes and a clinical diagnosis of diabetic nephropathy.



Single tablet of B vitamins containing folic acid (2.5 mg/d), vitamin B(6) (25 mg/d), and vitamin B(12) (1 mg/d), or matching placebo.



Change in radionuclide glomerular filtration rate (GFR) between baseline and 36 months. Secondary outcomes were dialysis and a composite of myocardial infarction, stroke, revascularization, and all-cause mortality. Plasma total homocysteine was also measured.



The mean (SD) follow-up during the trial was 31.9 (14.4) months. At 36 months, radionuclide GFR decreased by a mean (SE) of 16.5 (1.7) mL/min/1.73 m(2) in the B-vitamin group compared with 10.7 (1.7) mL/min/1.73 m(2) in the placebo group (mean difference, -5.8; 95% confidence interval [CI], -10.6 to -1.1; P = .02). There was no difference in requirement of dialysis (hazard ratio [HR], 1.1; 95% CI, 0.4-2.6; P = .88). The composite outcome occurred more often in the B-vitamin group (HR, 2.0; 95% CI, 1.0-4.0; P = .04). Plasma total homocysteine decreased by a mean (SE) of 2.2 (0.4) micromol/L at 36 months in the B-vitamin group compared with a mean (SE) increase of 2.6 (0.4) micromol/L in the placebo group (mean difference, -4.8; 95% CI, -6.1 to -3.7; P < .001, in favor of B vitamins).



Among patients with diabetic nephropathy, high doses of B vitamins compared with placebo resulted in a greater decrease in GFR and an increase in vascular events.
An interim analysis of the Quality of Life, Effectiveness, Safety, and Tolerability (QU.E.S.T.) evaluation of mixed amphetamine salts extended release in adults with ADHD.

Evaluate safety and efficacy of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD).



10-week interim analysis of the Quality of life, Effectiveness, Safety, and Tolerability (QU.E.S.T.) trial, an ongoing, 30-week, open-label, multicenter investigation of once-daily MAS XR (10-60 mg/day) in adults (>or=18 years of age) with ADHD in community practice settings.



With up to 10 weeks of open-label MAS XR 10 to 60 mg/day (final visit mean dose: 37.2 mg/day), 725 adults exhibited rapid, sustained improvement in ADHD symptoms. At end point, significant decreases from baseline were seen in ADHD Rating Scale IV total scores (-19.8+/-11.6; P<.0001), hyperactivity/impulsivity subscale (-8.1+/-6.1; P<.0001), and inattentive subscale (-11.6+/-6.7; P<.0001). Most subjects (74.4%) were rated as very much/much improved. Based on the 36-item Short Form Health Survey (version 2), significant improvements in quality of life were seen in the domains of general health, physical and mental health, vitality, and social, emotional and physical role functioning (P<.0001). Few subjects (6.9%) withdrew due to adverse events; the most common MAS XR-related adverse events were decreased appetite and dry mouth (19.2% each), insomnia (17.8%), and headache (16.8%).



In adults with ADHD, MAS XR treatment is generally safe and demonstrates significant improvement in ADHD symptoms and related quality of life.
Patient engagement with a diabetes self-management intervention.

To explore how people living with type 2 diabetes self-manage their condition in everyday life and the impact of the Diabetes Manual programme, a one-to-one structured educational intervention aiming to increase skills and confidence for self-management.



Semi-structured interviews with 12 participants on the Diabetes Manual trial, sampled purposively according to baseline self-efficacy and educational attainment.



When describing their experience of living with diabetes, there was little difference between intervention and control participants, although those who had received the programme talked more about the use of blood glucose self-assessment. Programme users were grouped into three categories, Programme Engagers (n = 2), Programme Browsers (n = 4) and Information Seekers (n = 6). Of the two participants engaging with the programme, one described a very positive experience, the other felt unsupported by their practice. None noticed a difference in the approach used by their health professional. Participants' approach to the Diabetes Manual programme suggests they will continue to use it as a resource in the future.



Participants used the Diabetes Manual programme in different ways, choosing the timing and depth of engagement. Their experience suggests that the programme requires close communication and openness towards collaborative approaches to improve skills and confidence for self-management.
Peginterferon alpha-2b and ribavirin for the treatment of chronic hepatitis C in Japanese pediatric and young adult patients: a survey of the Japan Society of Pediatric Hepatology.

Only a few studies on the treatment with peginterferon-2b and ribavirin are available in children with chronic hepatitis C virus (HCV). The aim of this study was to evaluate both the efficacy and the safety of the treatment in Japanese children and young adults.



Twenty-two of 41 members of the Japan Society of Pediatric Hepatology reported on 37 cases who were treated with peginterferon and ribavirin.



Of the 37 patients, 29 have completed the treatment and all of them cleared the HCV virus. Three patients are still being treated, whereas the remaining five failed to complete the treatment. Cessation of the treatment was because of the nonresponsiveness (n=3), the expense of the treatment (n = 1), or lethargy (n=1). After excluding the three patients, who were continuing the treatment and one who has not completed the 24-week follow-up period, from the 37 patients, 33 were available for sustained virologic response (SVR) analysis. After 4 weeks of follow-up, one of the 33 relapsed. An intention-to-treat analysis showed that 27 of the 33 (81.8%) achieved a SVR. The only factor significantly associated with SVR was their virologic response status at week 4.



The results showed that the present patients infected with HCV and treated with peginterferon-2b and ribavirin achieved a remarkably high SVR rate. In addition, most of the patients achieved a SVR once they showed a virologic response at week 4. The combination of peginterferon-alpha with ribavirin may be considered as a standard therapy for children and young adults.
Cooling via one hand improves physical performance in heat-sensitive individuals with Multiple Sclerosis: A preliminary study

Many individuals afflicted with multiple sclerosis (MS) experience a transient worsening of symptoms when body temperature increases due to ambient conditions or physical activity. Resulting symptom exacerbations can limit performance. We hypothesized that extraction of heat from the body through the subcutaneous retia venosa that underlie the palmar surfaces of the hands would reduce exercise-related heat stress and thereby increase the physical performance capacity of heat-sensitive individuals with MS.



Ten ambulatory MS patients completed one or more randomized paired trials of walking on a treadmill in a temperate environment with and without cooling. Stop criteria were symptom exacerbation and subjective fatigue. The cooling treatment entailed inserting one hand into a rigid chamber through an elastic sleeve that formed an airtight seal around the wrist. A small vacuum pump created a -40 mm Hg subatmospheric pressure enviinside the chamber where the palmar surface of the hand rested on a metal surface maintained at 18-22 degrees C. During the treatment trials, the device was suspended from above the treadmill on a bungee cord so the subjects could comfortably keep a hand in the device without having to bear its weight while walking on the treadmill.



When the trials were grouped by treatment only, cooling treatment increased exercise durations by 33% (43.6 +/- 17.1 min with treatment vs. 32.8 +/- 10.9 min. without treatment, mean +/- SD, p < 5.0.10-6, paired t-test, n = 26). When the average values were calculated for the subjects who performed multiple trials before the treatment group results were compared, cooling treatment increased exercise duration by 35% (42.8 +/- 16.4 min with treatment vs. 31.7 +/- 9.8 min. without treatment, mean +/- SD, p < 0.003, paired t-test, n = 10).



These preliminary results suggest that utilization of the heat transfer capacity of the non-hairy skin surfaces can enable temperature-sensitive individuals with MS to extend participation in day-to-day physical activities despite thermally stressful conditions. However, systematic longitudinal studies in larger cohorts of MS patients with specific deficits and levels of disability conducted under a variety of test conditions are needed to confirm these preliminary findings.
Outcomes of home visits for pregnant mothers and their infants: a cluster randomized controlled trial.

To evaluate the effect of home visits by community health workers (CHWs) on maternal and infant well being from pregnancy through the first 6 months of life for women living with HIV (WLH) and all neighborhood mothers.



In a cluster randomized controlled trial in Cape Town townships, neighborhoods were randomized within matched pairs to either standard care, comprehensive healthcare at clinics (n=12 neighborhoods; n=169 WLH; n=594 total mothers); or Philani Intervention Program, home visits by CHWs in addition to standard care (PIP; n=12 neighborhoods; n=185 WLH; n=644 total mothers). Participants were assessed during pregnancy (2% refusal) and reassessed at 1 week (92%) and 6 months (88%) postbirth. We analyzed PIP's effect on 28 measures of maternal and infant well being among WLH and among all mothers using random effects regression models. For each group, PIP's overall effectiveness was evaluated using a binomial test for correlated outcomes.



Significant overall benefits were found in PIP compared to standard care among WLH and among all participants. Secondarily, compared to standard care, PIP WLH were more likely to complete tasks to prevent vertical transmission, use one feeding method for 6 months, avoid birth-related medical complications, and have infants with healthy height-for-age measurements. Among all mothers, compared to standard care, PIP mothers were more likely to use condoms consistently, breastfeed exclusively for 6 months, and have infants with healthy height-for-age measurements.



PIP is a model for countries facing significant reductions in HIV funding whose families face multiple health risks.
Antinuclear antibodies in children with epilepsy treated by carbamazepine

An increased prevalence of antinuclear antibodies (ANAs) has been reported among patients with epilepsy. The aim of this study was to determine the prevalence of ANAs in children with epilepsy who were taking carbamazepine as monotherapy.



This was an observational, descriptive study at Motahary outpatient Clinic, Shiraz, Iran. All patients with epilepsy between the ages 3-18 years, taking carbamazepine as monotherapy, were studied and blood samples were obtained for ANA and other tests.



Totally, 58 patients (38 boys and 20 girls) were studied. The mean age of the patients was 11.5+/-2.6 years. The mean duration of carbamazepine therapy before ANA measurement was 14+/-6 months. ANA was positive in only one patient. ANA had a speckled pattern and titer of 1:80 dilution in that patient. It was negative in the remaining patients.



The prevalence of ANA is not considerable among children with epilepsy treated by carbamazepine. Moreover, this inconsiderable rate of positive ANA seems to have no clinical implications. Therefore, it seems that there is no need to be concerned of this side-effect of carbamazepine in children, unless clinically indicated.
Health-Related Quality of Life Dynamics of HIV-positive South African Women up to ART Initiation: Evidence from the CAPRISA 002 Acute Infection Cohort Study

Few studies have investigated the long-term dynamics in health-related quality of life (HRQoL) among HIV-positive persons from acute infection. From 2004, 160 women were enrolled into the CAPRISA 002 Acute Infection study at two sites in the province of KwaZulu-Natal and underwent 3–6 monthly HRQoL assessments using the functional assessment of HIV infection (FAHI) instrument. Overall and 5 sub-scale FAHI scores [physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB) and cognitive functioning (CF)] were calculated up to antiretroviral therapy (ART) initiation and scores at enrollment were compared to the acute, early and established infection phases. Mixed-effects regression models adjusting for behavioral and clinical factors were applied to assess HRQoL trends and the proportion of women meeting minimally important differences was calculated. Our analyses revealed that overall/sub-scale scores improved over time, except from PWB and CF. A higher educational status, contraceptive use and a higher BMI were the strongest predictors of higher overall/sub-scale FAHI scores. CD4 count and HIV viral load were strongly associated with PWB and CF, but not overall FAHI and other sub-scales. Women newly diagnosed with acute HIV infection face profound HRQoL challenges. While early ART delivery may be important for PWB and CF, factors such as education, contraception provision and good nutritional status should be promoted to maximize HRQoL in HIV positive individuals.
Sympathetic skin response and heart rate variability in predicting autonomic disorders in patients with Parkinson disease

The purpose of this study was to evaluate sympathetic skin response (SSR) and heart rate variability (HRV) in determining autonomic nervous system (ANS) involvement in patients with Parkinson disease (PD). Forty-eight idiopathic PD patients and 30 healthy controls participated in this study. SSR, HRV, Unified Parkinson's Disease Rating Scale (UPDRS) III, the Scales for outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), Hoehn and Yahr (H&Y) scale were evaluated. Absent lower limb SSR was determined unilaterally in 2, bilaterally in 1 of 3 advanced PD patients; there was significant difference between PD and control groups in terms of the SSR (P < 0.01), significant prolonged SSR latencies and decreased SSR amplitudes from bilateral hands and feet. Significant difference was noted in HRV between PD and control groups except for root mean square of successive differences (rMSSD) and high-frequency (HF) power (P < 0.05). There was a significant different correlation between the parameters of SSR and the SCOPA-AUT, and between the parameters (except HF power) of HRV and the SCOPA-AUT. Some parameters of SSR were relevantly associated with HRV. The right hand SSR amplitude correlated positively with the (SD) of all R-R interval, total spectral power, very low frequency. The right foot amplitude correlated positively with total spectral power. Both SSR and HRV parameters are sensitive in determining ANS dysfunction not only in late but also in the early stage of PD, which can be used for early detection of autonomic dysfunction in patients with PD and have the potential to serve as electrophysiological markers of dysautonomia of PD.
Plerixafor is effective given either preemptively or as a rescue strategy in poor stem cell mobilizing patients with multiple myeloma.

Harvest of more than one CD34+ stem cell transplant has become the standard, to ensure the option for a second autologous transplantation in patients with relapsed or progressive multiple myeloma (MM). Additional administration of the CXCR-4 inhibitor plerixafor has been shown to increase the efficiency of CD34+ stem cell harvest. However, the algorithm when to apply plerixafor is still under debate.



In this retrospective study, 46 MM patients were categorized into four groups according to their CD34+ stem cell count in peripheral blood (PB) and mobilization with or without plerixafor: Group A comprised poor mobilizers with CD34+ cell counts of fewer than 20 × 10(6) /L in PB. Group B included inadequate mobilizers with CD34+ cell counts of 20 × 10(6) /L or more in PB and a low CD34+ stem cell yield in the first leukapheresis session. Patients receiving plerixafor preemptively (Group A1) and as a rescue strategy (Group B1) were compared to patients continuing stem cell collection with granulocyte-colony-stimulating factor alone (Groups A2 and B2).



In both, the preemptive and the rescue settings, plerixafor enhanced the CD34+ stem cell yield significantly. Poor mobilization and administration of plerixafor was not associated with delayed engraftment.



Our data demonstrate that administration of plerixafor is safe and effective and facilitates a significantly higher CD34+ stem cell harvest. Based on the presented data, we propose an algorithm for the use of plerixafor for CD34+ stem cell mobilization and harvesting in poor mobilizing myeloma patients.
Wearable sensor based multimodal human activity recognition exploiting the diversity of classifier ensemble

Effectively utilizing multimodal information (e.g., heart rate and acceleration) is a promising way to achieve wearable sensor based human activity recognition (HAR). In this paper, an activity recognition approach MARCEL (<u>M</u>ultimodal <u>A</u>ctivity <u>R</u>ecognition with <u>C</u>lassifier <u>E</u>nsemble) is proposed, which exploits the diversity of base classifiers to construct a good ensemble for multimodal HAR, and the diversity measure is obtained from both labeled and unlabeled data. MARCEL uses neural network (NN) as base classifiers to construct the HAR model, and the diversity of classifier ensemble is embedded in the error function of the model. In each iteration, the error of the model is decomposed and back-propagated to base classifiers. To ensure the overall accuracy of the model, the weights of base classifiers are learnt in the classifier fusion process with sparse group lasso. Extensive experiments show that MARCEL is able to yield a competitive HAR performance, and has its superiority on exploiting multimodal signals.
Increased oxidative stress in women with pregnancy-induced hypertension.

To investigate whether pregnancy-induced hypertension (PIH) may increase oxidative stress in women with PIH, and to explore the mechanisms by which PIH may increase oxidative stress and potential free radical damage.



Seventy women with PIH and seventy women with uncomplicated normotensive pregnancy (UNP) whose age, nutritional conditions, levels of hemoglobin and albumin were all matched, were enrolled in a randomized controlled trial. Their plasma concentrations of nitric oxide (NO), vitamin C (VC), vitamin E (VE), and beta-carotene (beta-CAR) as well as their erythrocyte malondialdehyde (MDA), and activities of superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GPX) were determined by spectrophotometry.



Compared with average values of the above experimental parameters in the women with UNP, the average value of erythrocyte MDA in the women with PIH significantly increased (P<0.0001), while the average values of plasma NO, VC, VE, and beta-CAR as well as those of erythrocyte SOD, CAT, and GPX in the women with PIH significantly decreased (P<0.0005-0.0001). The findings from partial correlation analysis (controlling for age) for 70 women with PIH showed that with elevated systolic blood pressure (SBP) and diastolic blood pressure (DBP), MDA value gradually increased (P<0.001), and NO, VC, VE, beta-CAR, SOD, CAT, and GPX values gradually decreased (P<0.02-0.001). The findings from reliability analysis for NO, VC, VE, beta-CAR, SOD, CAT, GPX, and MDA values used to reflect increased oxidative stress and potential free radical damage in women with PIH showed that the reliability coefficients (alpha, 8 items) = 0.7062, P<0.0001, and the standardized item alpha = 0.9116, P<0.0001.



The findings in the present research suggest that pregnancy-induced hypertension can increase oxidative stress and potential free radical damage in women with pregnancy-induced hypertension.
Walking stabilizes cognitive functioning in Alzheimer's disease (AD) across one year.

AD is a public health epidemic, which seriously impacts cognition, mood and daily activities; however, one type of activity, exercise, has been shown to alter these states. Accordingly, we sought to investigate the relationship between exercise and mood, in early-stage AD patients (N=104) from California, over a 1-year period. Patients completed the Mini-Mental State Examination (MMSE), Geriatric Depression Scale (GDS), and Blessed-Roth Dementia Rating Scale (BRDRS), while their caregivers completed the Yale Physical Activity Survey (YALE), Profile of Mood States (POMS), the Neuropsychiatric Inventory (NPI) and Functional Abilities Questionnaire (FAQ). Approximately half of the participants were female, from a variety of ethnic groups (Caucasian=69.8%; Latino/Hispanic Americans=20.1%). Our results demonstrated that the patients spent little time engaged in physical activity in general, their overall activity levels decreased over time, and this was paired with a change in global cognition (e.g., MMSE total score) and affect/mood (e.g., POMS score). Patients were parsed into Active and Sedentary groups based on their Yale profiles, with Active participants engaged in walking activities, weekly, over 1 year. Here, Sedentary patients had a significant decline in MMSE scores, while the Active patients had an attenuation in global cognitive decline. Importantly, among the Active AD patients, those individuals who engaged in walking for more than 2 h/week had a significant improvement in MMSE scores. Structured clinical trials which seek to increase the amount of time AD patients were engaged in walking activities and evaluate the nature and scope of beneficial effects in the brain are warranted.
Measurement properties of the short version of the Van Lieshout test for arm/hand function of persons with tetraplegia after spinal cord injury

Two validation studies.To assess the measurement properties of the short version of the Van Lieshout test (VLT-SV), a new test for arm/hand function of persons with tetraplegia after spinal cord injury (Two specialized rehabilitation centres in The Netherlands.Study 1 (N=12) – assessment of inter-rater reliability (intraclass correlations (ICC); weighted kappa; Bland–Altman plots). Study 2 (N=55) – assessment of convergent validity by computing Spearman's correlations with the Grasp-Release test (GRT; criterion standard) and with motor level of injury, ASIA impairment scale, international classification for surgery of the hand, and the self-care and transfer scales of the functional independence measure. All statistics were computed separately for the right- and the left-hand scores.Inter-rater reliability was excellent (ICC 0.98 and 0.99). Agreement was independent of the height of the scores and the limits of agreement were ±0.5 points on a 0–5 scale. Convergent validity was very good with a Spearman correlation of 0.87and 0.90 between the VLT-SV and the GRT and correlations between 0.35 and 0.85 with the other indicators of arm/hand function.The VLT-SV seems a reliable and valid test to assess arm/hand function of persons with tetraplegia after SCI.