nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study.

Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients.



Japanese T2DM patients aged 20-74 years with hemoglobin A1c (HbA1c) of 6.9-10.5%, fasting plasma glucose (FPG) ≥126 mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin (0.5, 2.5, or 5 mg) or placebo once daily for 12 weeks (n = 61, 61, 61, and 56, respectively). The primary endpoint was the change in HbA1c from baseline to end of treatment. Other endpoints included FPG, 2 h postprandial plasma glucose (PPG) in a meal tolerance test (MTT), and body weight. Drug safety was also assessed.



Changes in HbA1c from baseline to end of treatment were -0.36, -0.62, and -0.75% in the 0.5, 2.5, and 5 mg luseogliflozin groups, respectively, versus +0.06% in the placebo group (all P < 0.001). The reductions in FPG and 2 h-PPG in the MTT were also significantly greater in the luseogliflozin groups (all P < 0.01) without increases in insulin levels from baseline. Luseogliflozin reduced body weight at all doses. There were no significant differences in the incidences of adverse events among groups. Most adverse events were mild in severity. There were no serious adverse events.



Although this was a small-scale study with a short duration, all tested doses of luseogliflozin significantly improved glycemic control, reduced body weight, and were well tolerated in Japanese T2DM patients over the 12-week treatment period.
BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus.

To devise a more discriminating version of the British Isles Lupus Assessment Group (BILAG) disease activity index and to show that it is reliable.



A nominal consensus approach was undertaken by members of BILAG to update and improve the BILAG lupus disease activity index. The index has been revised following intense consultations over a 1-yr period. It has been assessed in two real-patient exercises. These involved patients with diverse clinical features of SLE, including gastrointestinal, hepatic and ophthalmic problems, which the earlier versions of the index did not fully take into account. Reliability in terms of the ability to differentiate patients was assessed by calculating intraclass correlation coefficients. The level of agreement between physicians was determined by calculating the ratio of estimates of the standard error (SE) attributable to the physicians to the SE attributable to the patients.



Good reliability and high levels of physician agreement were observed in one or both exercises in the constitutional, mucocutaneous, neurological, cardiorespiratory, renal, ophthalmic and haematological systems. In contrast, the musculoskeletal system did not score as well, although providing more clear-cut glossary definitions should greatly improve the situation.



Some significant changes in the BILAG disease activity index to assess patients with SLE are proposed. The process of demonstrating validity and reliability has started with these two exercises assessing real patients. Further validation studies are under way. BILAG 2004 is likely to be valuable in clinical trials assessing new therapies for the treatment of SLE, as it provides a more comprehensive system-based disease activity measure than has been available previously.
The effect of HIV infection on time off work in a large cohort of gold miners with known dates of seroconversion

To estimate the effect of HIV infection on time off work. To provide baseline estimates for economic and actuarial models, and for evaluations of ART and other workplace interventions.



A retrospective cohort study of gold miners with known dates of seroconversion to HIV, and an HIV-negative comparison group, used routinely collected data to estimate the proportion of time off work by calendar period (1992-2002, prior to the introduction of ART), age, time since seroconversion and period before death. The authors calculated ORs for overall time off work and RR ratios (RRR, using multinomial logistic regression) for reasons off work relative to being at work.



1703 HIV-positive and 4859 HIV-negative men were followed for 34 424 person-years. HIV-positive miners spent a higher proportion of time off work than negative miners (20.7% vs 16.1%) due to greater medical and unauthorised absence. Compared with HIV-negative miners, overall time off work increased in the first 2years after seroconversion (adjusted OR 1.40 (95% CI 1.36 to 1.45)) and then remained broadly stable for a number years, reaching 38.8% in the final year before death (adjusted OR 3.27, 95% CI 2.95 to 3.63). Absence for medical reasons showed the strongest link to HIV infection, increasing from an adjusted RRR of 2.66 (95% CI 2.45 to 2.90) for the first 2years since seroconversion to 13.6 (95% CI 11.8 to 15.6) in the year prior to death.



Time off work provides a quantifiable measure of the effect of HIV on overall morbidity. HIV/AIDS affects both labour supply (increased time off work) and demand for health services (increased medical absence). The effects occur soon after seroconversion and stabilise before reaching very high levels in the period prior to death. Occupational health services are an important setting to identify HIV-infected men early.
Sustaining and broadening intervention impact: a longitudinal randomized trial of 3 adolescent risk reduction approaches.

To determine whether the addition of a parental monitoring intervention (Informed Parents and Children Together [ImPACT]) alone or with "boosters" could enhance (either broaden or sustain or both) the effect of a small group, face-to-face adolescent risk reduction intervention Focus on Kids (FOK).



A longitudinal, randomized, community-based cohort study was conducted of 35 low-income, community-based, in-town settings. A total of 817 black youths aged 12 to 16 years at baseline were studied. After completion of baseline measures, youths were randomized to receive a face-to-face intervention alone (FOK only), a face-to-face intervention and a parental monitoring intervention (FOK plus ImPACT), or both of the above plus boosters (FOK plus ImPACT plus boosters). Risk and protective behaviors were assessed at 6 and 12 months after intervention.



At 6 months' follow-up, youths in families that were assigned to FOK plus ImPACT reported significantly lower rates of sexual intercourse, sex without a condom, alcohol use, and cigarette use and marginally lower rates of "risky sexual behavior" compared with youths in families that were assigned to FOK only. At 12 months after intervention, rates of alcohol and marijuana use were significantly lower and cigarette use and overall risk intention were marginally lower among FOK plus ImPACT youths compared with FOK only youths. With regard to the boosters delivered at 7 and 10 months, 2 risk behaviors--use of crack/cocaine and drug selling--were significantly lower among the youths who were assigned to receive the additional boosters compared with youths without the boosters. The rates of the other risk behaviors and intentions did not differ significantly.



The results of this randomized, controlled trial indicate that the inclusion of a parental monitoring intervention affords additional protection from involvement in adolescent risk behaviors 6 and 12 months later compared with the provision of an intervention that targets adolescents only. At the same time, the results of the present study do not provide sufficient evidence that booster sessions further improve targeted behaviors enough to include them in a combined parent and youth intervention.
MPI-aware compiler optimizations for improving communication-computation overlap

Several existing compiler transformations can help improve communication-computation overlap in MPI applications. However, traditional compilers treat calls to the MPI library as a black box with unknown side effects and thus miss potential optimizations. This paper's contributions enable the development of an MPI-aware optimizing compiler that can perform transformations exploiting knowledge of MPI call effects to increase communication-computa-tion overlap. We formulate a set of data flow equations and rules to describe the side effects of key MPI functions so an MPI-aware compiler can automatically assess the safety of transformations. After categorizing existing compiler transformations based on their effect on the application code, we present an optimization algorithm that specifies when and how to apply these optimizing transformations to achieve improved communication-computation overlap. By manually applying the optimization algorithm to kernels extracted from HYCOM and the NAS benchmarks, we show that even when transforming these highly optimized codes, execution time can be decreased by an average of over 30%.
Health-Related Quality of Life, Treatment Satisfaction, and Costs Associated With Intraperitoneal Versus Subcutaneous Insulin Administration in Type 1 Diabetes

To investigate the effects of continuous intraperitoneal insulin infusion (CIPII) compared with subcutaneous insulin on health-related quality of life (HRQOL) and treatment satisfaction, and to perform a cost analysis in type 1 diabetes.



We used an open-label, prospective, crossover, randomized, 16-month study (N = 24). HRQOL and patient satisfaction were assessed with questionnaires (the 36-item short-form health survey [SF-36], the World Health Organization-Five Well-Being Index [WHO-5], and the Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Direct costs of CIPII and continuous subcutaneous insulin infusion (CSII) were compared.



Questionnaire scores were higher with CIPII than with subcutaneous therapy. Yearly direct pump- and procedure-associated costs for CIPII were estimated at 10,910 euroscompared with 4,810 euros for CSII.



Apart from improving glycemic control, CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin. Direct pump- and procedure-associated costs are considerably higher for CIPII, however.
Self-regulation strategies support children with ADHD to overcome symptom-related behavior in the classroom.

Children with attention deficit hyperactivity disorder (ADHD) suffer from self-regulation deficits that cause inattention, impulsivity, and hyperactivity. Self-regulation interventions may address these deficits, but to date, only few empirical studies have examined their benefits for children with ADHD in everyday life. The present study investigated three classroom interventions to promote self-regulation and tested their benefit on self-regulatory competencies (assessed with an ADHD questionnaire) in children with ADHD. Students of a special education school for children with ADHD participated in the intervention study that included three sessions (Session 1: Goal Intention or Goal Intention + If-Then Plan; Session 2: Goal Intention + If-Then Plan;  Goal Intention + If-Then Plan + Self-Monitoring). Teacher-rated self-regulatory competencies were assessed both before and after the intervention sessions. Children with ADHD had better self-regulatory competencies after their first Goal Intention + If-Then Plan Session, but lasting intervention effects were found only when children started with a mere goal intention session.
Improving health-related quality of life of patients with chronic heart failure: effects of relaxation therapy.

This paper is a report of a study conducted to examine the effects of a relaxation training programme on the health-related quality of life of Chinese patients with chronic heart failure.



Despite the substantial evidence indicating the beneficial effects of relaxation therapy on the health-related quality of life of various cardiac populations, the value of this intervention in patients with chronic heart failure remains uncertain. Even less is known about its therapeutic effects in Chinese culture.



A total of 121 Chinese patients with chronic heart failure and over 60 years of age were recruited in 2002-2003 and randomly allocated to a relaxation training programme (n = 59) or an attention-control intervention (n = 62). The training included two relaxation training sessions, one skill revision workshop, twice daily relaxation self-practice and biweekly telephone follow-up. The World Health Organization Quality of Life questionnaire was completed at hospital discharge and at the 8th and 14th weeks after discharge.



Repeated measures analysis of covariance indicated that those who attended the relaxation training programme reported statistically significantly greater improvement in psychological (P = 0.007, eta(2) = 0.043) and social (P = 0.016, eta(2) = 0.035) health-related quality of life than those who received the attention-control intervention over the evaluative period. Comparing outcomes at timepoints showed that the statistically significant group differences in the improvement of psychological and social health-related quality of life occurred mainly during the first evaluative endpoints.



Relaxation techniques are beneficial to the emotional and social health-related quality of life of Chinese patients with chronic heart failure. Combining this intervention with other treatment modalities may produce a more substantial improvement in their health-related quality of life.
Research Validity Scales for the NEO-PI-R: additional evidence for reliability and validity.

We examined the reliability and validity of the research validity scales (Schinka, Kinder, & Kremer, 1997) for the NEO-Personality Inventory-Revised (NEO-PI-R) in a clinical sample. The Negative Presentation Management (NPM) and Positive Presentation Management (PPM) scales were found to have satisfactory internal consistency reliability. Support for the validity of these scales was provided by the pattern of convergent and discriminant correlations with respective Personality Assessment Inventory (PAI) validity scales. Finally, PAI profiles of individuals with invalid NPM scores were found to differ significantly from those with valid NPM scores. Comparisons of the invalid profiles with profiles from other clinical samples provided additional support for the use of the NPM scale as a measure of negative impression management.
Facilitating exercise adherence for patients with multiple myeloma.

Physical exercise is becoming an accepted part of therapy for many patients with cancer. Exercise may alleviate patients' fatigue and improve physical performance and psychological outlook. Much of the research is limited to women with breast cancer and excludes patients with bone metastases. This article reports on the authors' work in facilitating exercise adherence for patients with multiple myeloma (MM) and bone lesions while they were enrolled in a feasibility/pilot exercise study as they were receiving treatment for their disease in an outpatient treatment program. The exercise program for these patients receiving high-dose chemotherapy and stem cell transplantation consisted of aerobic and strength-building components. The program was home based, and patients performed exercises without direct supervision. On average, the patients completed the six-month exercise prescription 75% of the time. Overall trends showed that all 14 patients in the exercise group improved in several areas of testing, and the test results of all 10 patients in the usual-care group declined. Flexibility and simplicity are essential when designing exercise programs for patients, and encouragement and support also are needed to help patients adhere to prescribed exercise.
Comparison of graft-versus-host-disease and survival after HLA-identical sibling bone marrow transplantation in ethnic populations.

The association of ethnicity with the incidence of graft-versus-host disease (GVHD) and other clinical outcomes after transplantation is controversial. We compared the results of HLA-identical sibling bone marrow transplantations for leukemia, performed between 1990 and 1999, among different ethnic populations, including 562 Japanese, 829 white Americans, 71 African Americans, 195 Scandinavians, and 95 Irish. Results for adults and children were analyzed separately. Multivariate analyses of adult patients showed that white Americans, African Americans, and Irish cohorts were at significantly higher risk for acute GVHD than Japanese or Scandinavian cohorts (relative risk [RR] = 1.77, P < .001; RR = 1.84, P < .006; RR = 2.22, P < .001, respectively). White Americans, African Americans, and Irish, but not Scandinavians, were at significantly higher risk for early (within 3 months of transplantation) transplant-related mortality (TRM) compared with Japanese (RR = 2.99, P < .001; RR = 5.88, P < .001; RR = 2.66, P < .009, respectively). No differences in the risk for chronic GVHD, relapse, and overall survival were noted. In the pediatric cohort (limited to Japanese and white Americans), white Americans were at significantly higher risk for acute (RR = 1.93; P = .04) and chronic (RR = 3.16; P = .002) GVHD. No differences in other clinical outcomes were noted. Our findings suggest that ethnicity may influence the risk for GVHD, though overall survival rates after transplantation remain similar.
Retest reliability of measuring hip extensor muscle strength in different testing positions in young people with cerebral palsy

In young people with spastic diplegic cerebral palsy weakness of the hip extensor muscles are associated with limitations in activity. It is important that clinicians can reliably measure hip extensor muscle strength to monitor changes over time and the effects of any interventions. Previous research has demonstrated high reliability for measuring strength of all muscles of the lower limb, with the exception of the hip extensors. Therefore the aim of this study was to examine the retest reliability of measuring hip extensor strength in young people with cerebral palsy.



Using a test-retest reliability research design, 19 participants with spastic diplegic cerebral palsy (Gross Motor Function Classification System Levels II and III) (mean 19 y 2 mo [S D 2 y 5 mo]) attended two testing sessions held 12 weeks apart. Three trials with a hand-held dynamometer were taken at each testing session in supine, prone and standing. Retest reliability was calculated with Intraclass Correlation Coefficients (ICC(2,1)) and with units of measurement (kilograms) converted to a percentage strength change.



ICC values ranged from .74 to .78 in supine, .75 to .80 in prone, and .73 to .75 in standing. To be 95% confident that real change had occurred, an individual's strength would need to increase 55 to 60% in supine, 86 to 102% in prone, and 102 to 105% in standing. To be 95% confident that real change had occurred across groups, strength would need to increase 4 to 8% in supine, 22 to 31% in prone, and 32% to 34% in standing. Higher ICC values were observed when three trials were used for testing.



The supine testing position was more reliable than the prone or standing testing positions. It is possible to measure hip extensor strength with sufficient reliability to be able monitor change within groups using the supine position provided three trials are used during testing. However, there is insufficient reliability to monitor changes in hip extensor strength in individuals with cerebral palsy unless they exhibit very large strength increases.
Vitamin D metabolism-related genetic variants, dietary protein intake and improvement of insulin resistance in a 2 year weight-loss trial: POUNDS Lost

Vitamin D and related genetic variants are associated with obesity and insulin resistance. We aimed to examine whether vitamin D metabolism-related variants affect changes in body weight and insulin resistance in response to weight-loss diets varying in macronutrient content. Three vitamin D metabolism-related variants, DHCR7 rs12785878, CYP2R1 rs10741657 and GC rs2282679, were genotyped in 732 overweight/obese participants from a 2 year weight-loss trial (POUNDS Lost). We assessed genotype effects on changes in body weight, fasting levels of glucose and insulin, and HOMA-IR at 6 months (up to 656 participants) and 2 years (up to 596 participants) in response to low-protein vs high-protein diets, and low-fat vs high-fat diets. We found significant interactions between DHCR7 rs12785878 and diets varying in protein, but not in fat, on changes in insulin and HOMA-IR at both 6 months (p for interaction <0.001) and 2 years (p for interaction ≤0.03). The T allele (vitamin-D-increasing allele) of DHCR7 rs12785878 was associated with greater decreases in insulin and HOMA-IR (p < 0.002) in response to high-protein diets, while there was no significant genotype effect on changes in these traits in the low-protein diet group. Generalised estimating equation analyses indicated significant genotype effects on trajectory of changes in insulin resistance over the 2 year intervention in response to high-protein diets (p < 0.001). We did not observe significant interaction between the other two variants and dietary protein or fat on changes in these traits. Our data suggest that individuals carrying the T allele of DHCR7 rs12785878 might benefit more in improvement of insulin resistance than noncarriers by consuming high-protein weight-loss diets.
Predictors of fluoxetine remission for hospitalized patients with major depressive disorder.

The goal of treating major depressive disorder is to achieve remission. This prospective study aimed to identify predictors of remission in a cohort of depressive inpatients who received fluoxetine.



A total of 131 newly hospitalized patients with major depressive disorder received a fixed dose of 20 mg/day (the recommended dose from the literature) of fluoxetine for 6 weeks. Symptom severity was assessed using the 17-item Hamilton Depression Rating Scale at weeks 0, 1, 2, 3, 4 and 6. Remission was defined as a score of ≤7 on the 17-item Hamilton Depression Rating Scale after 6 weeks of treatment. We compared the remitters and non-remitters in terms of baseline variables. The Short-Form-36 pain interference item was used to assess pain. It was classified as high (score ≥ 3) or low (score < 3).



A total of 31 (27.7%) of 112 completers remitted after 6 weeks of treatment. The remitters and non-remitters did not differ in baseline variables, except pain interference, baseline depression severity, and depression improvement at week 1.



These findings obtained from newly hospitalized major depression patients support the previous notion that pain interference, depression severity, and early improvement can be the predictors for remission. Patients with high pain interference, a greater depression severity or a less early improvement are likely to require aggressive treatment early. These data require confirmation and extension to outpatients and other antidepressants.