nils-herrmann/clean_scirepeval huggingface dataset:
Non-HDL-C is a Better Predictor for the Severity of Coronary Atherosclerosis Compared with LDL-C.

Recent guidelines recommended both low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) are the primary target of lipid modulating therapy. However, which lipid measure is most closely related to the severity of coronary atherosclerosis has not yet been assessed.



We studied 1757 consecutive subjects undergoing coronary angiography who were not receiving any lipid-lowering therapy. Low-density lipoprotein cholesterol was measured directly, and non-HDL-C was calculated. The severity of coronary stenosis was determined using the Gensini Score (GS) system.



In the overall population, LDL-C and non-HDL-C were all dramatically increased according to the quartiles of GS (p<0.001, both). In patients with coronary atherosclerosis (n=1097), non-HDL-C (r=0.138, p<0.001) was more closely related to GS than LDL-C (r=0.113, p<0.001) tested by Spearman correlation analysis. Multivariate logistic regression analysis suggested that non-HDL-C (OR=1.326, 95% CI 1.165-1.508, p<0.001) was slightly superior to LDL-C (OR=1.286, 95% CI 1.130-1.463, p<0.001) in predicting high GS after adjusting for potential confounders. Among patients with LDL-C less than the median, discordant non-HDL-C could not provide extra value in predicting high GS (OR=0.759, 95% CI 0.480-1.201). However, among patients with LDL-C greater than or equal to the median, the cardiovascular risk was overestimated for patients with discordant non-HDL-C (OR=0.458, 95% CI 0.285-0.736).



Our data support the use of non-HDL-C ahead of LDL-C in predicting the severity of coronary atherosclerosis, especially among patients with LDL-C greater than or equal to the median.
[Treatment duration of extra-pulmonary tuberculosis: 6 months or more? TB-INFO database analysis].

The recommended duration of pulmonary tuberculosis therapy is 6 months. For extrapulmonary tuberculosis, treatment duration depends on tuberculosis involvement and HIV status. The objective of this study was to describe the main characteristics of a cohort of extrapulmonary tuberculosis patients, to compare patients with a 6-month treatment to those with more than a 6-month treatment, and to analyze the compliance of medical centres with recommended duration of treatment.



A retrospective cohort study of 210 patients with extrapulmonary tuberculosis was carried from January 1999 to December 2006 in two hospitals in the north-east of Paris. These patients were treated with quadruple therapy during two months, followed by dual therapy during 4 months (n=77) or more (n=66). The characteristics of each group were compared by uni- and multivariate analysis. The primary endpoint was the rate of relapse or treatment failure at 24-month follow-up after treatment completion.



No relapse was observed after 24 months of follow-up after the end of treatment in the two groups. In univariate analysis, patients with lymph node tuberculosis were more often treated for 6 months than at other sites of tuberculosis (respectively 61% versus 40.9%; P=0.02); the decision of treatment duration was related to medical practices (79.2% treated 6 months in one hospital versus 20.7% in the other, P<0.001); patients living in private residence were more often treated during 6 months than patients living in residence (24.2% versus 10.3%, P=0.042). In multivariate analysis, only hospital (P=0.046), sex (P=0.007) and private residence were significantly different in each group.



A period of 6 months seems to be sufficient to treat extrapulmonary tuberculosis (except for neuromeningeal localization).
An investigation of gait in children with Attention Deficit Hyperactivity Disorder: A case controlled study

This study aimed to compare the gait of children with ADHD - Combined Type (ADHD-CT) to typically developing (TD) children. Children with ADHD-CT (n=14; mean age 10 years 4 months) and a TD group (n=13; mean age 10 years 9 months) walked at self-selected slow, preferred and fast speed on an electronic walkway system. Participants completed a total of 15 walking trials; 5 trials per walking condition. Groups were matched on age, intellectual functioning, height and weight. In the preferred walking condition, there was no difference in spatio-temporal gait variables between the ADHD-CT and TD control groups. At self-selected fast speed, children with ADHD-CT were faster and walked with a higher cadence. The subtle alterations in gait pattern that may reflect a timing deficit is consistent with previous ADHD motor studies. In addition, this study extends previous studies in characterising the unique gait profile of non-medicated children with ADHD-CT where a diagnosis of autism spectrum disorder has been ruled out.
A prospective multicenter registry of patients with chronic gastroesophageal reflux disease receiving transoral incisionless fundoplication.

This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings.



Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up.



One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02).



Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up.
Korean translation and validation of the functional assessment of cancer therapy-breast (FACT-B) scale version 4

We undertook to translate and cross-culturally adapt the Functional Assessment of Cancer Therapy-Breast (FACT-B) scale into Korean and to evaluate its reliability and validity. The translation procedure followed the standard Functional Assessment of Chronic Illness Therapy translation methodology. A total of 201 breast cancer patients (mean age, 43.87 years) were studied for psychometric properties of the FACT-B scale. A pre-test of 20 Korean breast cancer patients indicated that the Korean FACT-B scale provided good content coverage and overall comprehensibility. Our results indicated high internal consistency of the FACT-B scale, with Cronbach’s α coefficients ranging from 0.79 to 0.90. The only exception was the Breast Cancer Scale (BCS), which had a Cronbach’s α coefficient of 0.67. We can consider that most of the patients in this study had not resumed sexual activity after surgery and found it difficult to comment on this aspect. We also considered that contents of the BCS may have been somewhat heterogeneous. After performing a factor analysis of the BCS data from this study, we identified three factors, accounting 58.8%: psychological distress (5 items, with explained variances of 27.5%), feminine satisfaction (2 items, with explained variances of 17.1%), and physical complaints (2 items, with explained variances of 14.2%). The FACT-B scale also demonstrated good convergent and divergent validity when correlated with the shortened forms of the Profile of Mood States and the Functional Living Index-Cancer (FLIC). We can now evaluate the Quality of Life (QoL) of Korean breast cancer patients using this reliable and valid instrument. Nevertheless our study has the limitation that it did not evaluate the sensitivity to the changes of the patients’ QoL in the long term follow-up, and we will supplement it in our further study.
Pharmacokinetics of high-dose simvastatin in refractory and relapsed chronic lymphocytic leukemia patients

To evaluate the pharmacokinetics of simvastatin at the maximum tolerated dose (MTD) of 7.5 mg/kg, twice daily, in the context of a pilot trial enrolling patients with recurrent and refractory chronic lymphocytic leukemia. Patients received simvastatin orally at MTD for 7 days during a 21-day cycle for 6 cycles. Blood samples were collected during cycle 1. Simvastatin lactone and carboxylate concentrations were measured in plasma and peripheral blood mononuclear cells (PBMCs) using a validated HPLC–MS/MS assay. Patients accrued to this study showed high variability in their exposure to simvastatin. Exposure was dose proportional (AUC and C max) as compared to those receiving standard hyperlipidemia therapy. Peak plasma concentrations ranged from 0.08 to 2.2 and from 0.03 to 0.6 μM for simvastatin lactone and carboxylate, respectively. Our study shows that when simvastatin is administered at its MTD, only low micro-molar concentrations are achieved in plasma and PBMCs, which is consistent with the results observed in previous studies with lovastatin, but far lower than the concentrations required for anticancer effects in vitro. However, whether simvastatin at its MTD can confer therapeutic benefits to patients still remains to be determined.
Interaction design of 2D/3D map navigation on wall and tabletop displays

We propose interaction design of a map navigation system that displays Google Maps on a tabletop display, and Google Earth and Google Street View on the wall display. In Google Maps on the table, we introduce the use of hand gestures to pan, rotate, and zoom for providing basic interaction. We also introduce a function that enables comparison of maps of different scales and locations. In Google Earth on the wall, the user can see the 3D world from a bird's-eye view by linking Google Maps and the proposed hang glider device, creating the sense of flying on Google Maps. Google Street View can be displayed on the wall and the user can move around it by using the finger gesture of walking on the table.
Methodological overview of an African American couple-based HIV/STD prevention trial.

To provide an overview of the National Institute of Mental Health Multisite HIV/sexually transmitted disease (STD) Prevention Trial for African American Couples conducted in 4 urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described.



This is a 2-arm randomized trial, implementing a modified randomized block design, to evaluate the efficacy of a couples-based intervention designed for HIV-serodiscordant African American couples.



The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV-serodiscordant heterosexual African American couples. There are 2 theoretically derived behavioral interventions with 8 group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction whereas the control was individual based and focused on health promotion. The 2 study conditions were structurally similar in length and types of activities. At baseline, participants completed an audio computer-assisted self-interview and interviewer-administered questionnaire and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months.



The trial results will be analyzed across the 4 sites by randomization assignment. Generalized estimating equations and mixed-effects modeling are planned to test: (1) the effects of the intervention on STD incidence and condom use and on mediator variables of these outcomes and (2) whether the effects of the intervention differ depending on key moderator variables (eg, gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history).



The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples-based clinical trials in HIV/STD risk reduction and can be generalized to other couples-based behavioral interventions.
Mediators of depressive symptoms in children with type 1 diabetes and their mothers.

To examine the relationships among maternal and child depressive symptoms and child and family psychosocial factors.



Secondary analysis of baseline data for a coping skills intervention for school-age children (ages 8-12) with type 1 diabetes (T1D) and their mothers. Children and mothers completed measures of depressive symptoms, coping, quality of life, and family functioning.



There was a strong relationship between maternal and child depressive symptoms (r = .44, p < .001). Maternal depressive symptoms were negatively related to child quality of life, perceptions of coping, and family functioning. Impact of diabetes on quality of life, finding coping with diabetes upsetting, and family warmth mediated the relationship between maternal and child depressive symptoms.



Maternal depression may negatively affect child adjustment through its influence on quality of life, coping, and family functioning. Implications for interventions to improve psychosocial adjustment in children with T1D are discussed.
Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.
Combination of Alpha Lipoic Acid and Superoxide Dismutase Leads to Physiological and Symptomatic Improvements in Diabetic Neuropathy

The management of diabetic neuropathy is still a challenge for physicians. The aim of this study was to assess the efficacy of a new combination of alpha lipoic acid and superoxide dismutase for the treatment of diabetic neuropathy.



The setting of this study was ambulatory (outpatient) care. A prospective, non-randomized, open-label study was conducted in 50 patients with diabetes mellitus and with a deficit in both motor and sensory nerve conduction. Treatment was with a new combination of alpha lipoic acid and superoxide dismutase (ALA600SOD®) for 4 months. Electroneurographic parameters and perceived pain were assessed at baseline and after treatment.



After 4 months of treatment, patients significantly (p < 0.001) improved their electroneurographic parameters and their perception of pain. Best improvements were observed in sensory nerve conduction.



The combination of two powerful antioxidant agents leads to improvement in both subjective and objective parameters in patients with diabetic neuropathy. New profitable directions for investigations are opened for a non-invasive treatment of diabetic neuropathy in the future.
Clinical efficacy and safety of arbekacin for high-risk infections in patients with hematological malignancies.

We performed a clinical trial to investigate the efficacy and safety of arbekacin (ABK), a unique aminoglycoside with activity against methicillin-resistant Staphylococcus aureus (MRSA), in patients with hematological malignancies complicated by high-risk infections. ABK was administered intravenously at a dose of approximately 5 mg/kg with various broad-spectrum β-lactams, followed by therapeutic drug monitoring (TDM). A total of 54 febrile or infectious episodes were registered, and TDM was performed in 44 (81%) cases. The absolute neutrophil count was below 500/μl in 49 (91%) cases, and cytotoxic chemotherapy was being administered in 47 (87%) cases. Before initiation of ABK, 52 (96%) patients had received fluoroquinolones (n = 37) and/or broad-spectrum β-lactams (n = 34). There were 10 cases of documented infections including one of MRSA pneumonia, and 44 cases of febrile neutropenia. The efficacy at the end of treatment was 80% for all patients, and efficacy was significantly higher in patients attaining maximum concentrations ≥ 16 µg/ml or receiving TDM-guided dose-adjustment of ABK (n = 19, 95 vs. 71%, P = 0.039). Renal toxicity was observed in six cases (11%) but was generally acceptable. This study demonstrated that TDM-guided ABK administration may be applicable under limited conditions for patients with hematological malignancies.
Discrepancies between patients' assessments of outcome: qualitative study nested within a randomised controlled trial.

tal groups in the primary outcome measures (table): change of diabetes treatment (36% v 42%), lipid lowering drugs (9% v 12%), or blood pressure drugs (10% v 16%) and referral to dietician (13% v 10%). There were no differences in other interventions between the control and experimental groups. Among high risk patients, however, those in the experimental group were more likely to be prescribed blood pressure and lipid lowering drugs than those in the control group (P < 0.02, Mantel-Haenszel test). Despite this difference, the time until the next hospital outpatient appointment was the same in the two groups, with 24% in each group (39 in the experimental group and 38 in the control group) receiving an appointment in less than six months.
Rapid A 1 c Availability Improves Clinical Decision-Making in an Urban Primary Care Clinic

We recruited 597 subjects. Patients were 79% female and 96% African American, with average age of 61 years, duration of diabetes 10 years, BMI 33 kg/m, and A1c 8.5%. The rapid and routine groups had similar clinical demographics. Rapid A1c availability resulted in more frequent intensification of therapy when A1c was 7.0% at the baseline visit (51 vs. 32% of patients, P 0.01), particularly when A1c was 8.0% and/or random glucose was in the 8.4–14.4 mmol/l range (151–250 mg/dl). In 275 patients with two follow-up visits, A1c fell significantly in the rapid group (from 8.4 to 8.1%, P 0.04) but not in the routine group (from 8.1 to 8.0%, P 0.31).
Plasma homocysteine predicts mortality independently of traditional risk factors and C-reactive protein in patients with angiographically defined coronary artery disease.

Plasma homocysteine (tHCY) has been associated with coronary artery disease (CAD). We tested whether tHCY also increases secondary risk, after initial CAD diagnosis, and whether it is independent of traditional risk factors, C-reactive protein (CRP), and methylenetetrahydrofolate reductase (MTHFR) genotype.



Blood samples were collected from 1412 patients with severe angiographically defined CAD (stenosis >/=70%). Plasma tHCY was measured by fluorescence polarization immunoassay. The study cohort was evaluated for survival after a mean of 3.0+/-1.0 years of follow-up (minimum 1.5 years, maximum 5.0 years). The average age of the patients was 65+/-11 years, 77% were males, and 166 died during follow-up. Mortality was greater in patients with tHCY in tertile 3 than in tertiles 1 and 2 (mortality 15.7% versus 9.6%, P:=0.001 [log-rank test], hazard ratio [HR] 1.63). The relative hazard increased 16% for each 5-micromol/L increase in tHCY (P:<0.001). In multivariate Cox regression analysis, controlling for univariate clinical and laboratory predictors, elevated tHCY remained predictive of mortality (HR 1.64, P:=0.009), together with age (HR 1. 72 per 10-year increment, P:<0.0001), ejection fraction (HR 0.84 per 10% increment, P:=0.0001), diabetes (HR 1.98, P:=0.001), CRP (HR 1. 42 per tertile, P:=0.004), and hyperlipidemia. Homozygosity for the MTHFR variant was weakly predictive of tHCY levels but not mortality.



In patients with angiographically defined CAD, tHCY is a significant predictor of mortality, independent of traditional risk factors, CRP, and MTHFR genotype. These findings increase interest in tHCY as a secondary risk marker and in secondary prevention trials (ie, with folate/B vitamins) to determine whether reduction in tHCY will reduce risk.
The efficacy of a blended motivational interviewing and problem solving therapy intervention to reduce substance use among patients presenting for emergency services in South Africa: A randomized controlled trial

The treatment of substance use disorders is a public health priority, particularly in South Africa where the prevalence of these disorders is high. We tested two peer-counsellor delivered brief interventions (BIs) for risky substance use among adults presenting to emergency departments (EDs) in South Africa.



In this randomised controlled trial, we enrolled patients presenting to one of three 24-hour EDs who screened at risk for substance use according to the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Eligible patients were randomly allocated to one of three conditions: Motivational Interviewing (MI), blended MI and Problem Solving Therapy (MI-PST) or a Psycho-educational Control Group (CG). The primary outcome was reduction in ASSIST scores at three months follow-up.



Of the 2736 patients screened, 335 met inclusion criteria, were willing to participate in the intervention and were randomised to one of three conditions: 113 to MI, 112 to MI-PST and 110 to CG. ASSIST scores at three months were lower in the MI-PST group than they were in the MI and CG groups (adjusted mean difference of -1.72, 95 % CI -3.36 - -0.08). We recorded no significant difference in ASSIST scores between the CG and MI group (adjusted mean difference of -0.02, 95 % CI -2.01 - 1.96).



With the addition of minimal resources, BIs are feasible to conduct in EDs in a low resourced country. These preliminary findings report that MI-PST appears to be an effective BI for reducing substance use among at risk participants. Further research is required to replicate these findings with effort to limit attrition, to determine whether reductions in substance use are persistent at 6 and 12 month follow-up and whether parallel changes occur in other indications of treatment outcomes, such as injury rates and ED presentations.