nils-herrmann/clean_scirepeval huggingface dataset:
Do Comprehensive, Coordinated, Recovery-Oriented Services Alter the Pattern of Use of Treatment Services? Mental Health Treatment Study Impacts on SSDI Beneficiaries’ Use of Inpatient, Emergency, and Crisis Services

Current arrangements for financing and delivering behavioral health services to U.S. working-age adults with severe and persistent mental disorders (SPMD) have major inadequacies in funding for and access to critical elements of a recovery-oriented, comprehensive, and coordinated package of community-based treatment and rehabilitation services. This study presents results from a nation-wide 2-year randomized trial, involving 2,238 SSDI beneficiaries with SPMD, of a comprehensive intervention including evidence-based treatment and employment services. Estimates of impacts of the MHTS service intervention package, from a variety of regression specifications, showed clearly significant treatment group reductions in four outcomes (hospital stays and days, ER visits for mental health problems, and psychiatric crisis visits); these estimates suggest annual inpatient hospital treatment cost savings in excess of approximately $900 to 1,400. Negative estimated MHTS effects on three other utilization outcomes (hospital stays and days for mental health problems, overall ER visits) generally did not achieve statistical significance. Possible study implications for cost offsets from further expansions/replications of the MHTS intervention model are considered within the context of health reform.
Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial

New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.



This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. 
Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.



The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.



Medtronic Cardiovascular and Biosensors Interventional Technologies.
Low-dose methotrexate for the treatment of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation

Methotrexate (MTX) is commonly used in the prophylaxis of graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). In order to evaluate the efficacy and safety of low-dose MTX treatment in patients with GVHD after allo-HSCT, 38 patients with acute GVHD (aGVHD), chronic GVHD (cGVHD) or GVHD post-donor lymphocyte infusion (post-DLI GVHD) after allo-HSCT received intravenous MTX at a dose of 5 or 10 mg every 5–7 days until a complete or partial response was seen, or there was treatment failure or intolerable side effects. The overall response rate was 94.7% (18/19 patients) in patients with aGVHD, 76.2% (16/21 patients) in patients with cGVHD and 2/2 in patients with post-DLI GVHD. The response rate for GVHD involving various organs was 100% in skin, 75% in gut, 55.6% in liver, 75% in mouth and 100% in the eye, among all enrolled patients. Side effects were minor. Short-term, low-dose MTX is a tolerable and an effective regimen for patients with aGVHD, cGVHD or post-DLI GVHD after allo-HSCT.
Is serum leptin related to physical function and is it modifiable through weight loss and exercise in older adults with knee osteoarthritis?

To determine the effect of weight loss and exercise interventions on serum leptin and to investigate the relationship of physical function and osteoarthritis (OA) severity with serum leptin in older overweight and obese adults with knee OA. In addition, the study examined if serum leptin predicts weight loss. Longitudinal, controlled clinical trial of weight loss and exercise interventions. Community dwelling, older, overweight and obese adults (n=316; >60 years of age; body mass index ≥28.0 kg m−2) with symptomatic knee OA and self-reported difficulty in performing selected physical activities were recruited. Participants were randomized into one of four groups for the 18-month study duration: Healthy Lifestyle Controls, Dietary Weight Loss (Diet), Exercise Training (Exercise), and a combination of Dietary Weight Loss and Exercise Training (Diet+Exercise). The weight loss goal for the two Diet groups was 5% from baseline at 18 months. Participants in the Exercise groups were trained for 3 days week−1, 60 min day−1.MEASUREMENTS: Body weight, body mass index, serum leptin, physical function, and OA severity were measured at baseline, 6 months, and 18 months. Diet and Diet+Exercise groups lost 5.3 and 6.1% of their weight, respectively, at 18 months with the Exercise group losing 2.9%. There was a significant main effect of weight loss on serum leptin with a decrease in serum leptin averaged across the 6- and 18-month time points for the Diet and Diet+Exercise groups compared to the other two groups (β=0.245; P<0.01). No main effect for exercise training was observed. Serum leptin was related to self-reported physical function. In all participants, a mixed model analysis demonstrated that lower levels of baseline serum leptin predict larger weight loss ( Decreases in serum leptin may be one mechanism by which weight loss improves physical function and symptoms in OA patients.
Biochemical markers of bone turnover to monitor the bone response to postmenopausal hormone replacement therapy

Hormone replacement therapy (HRT) prevents postmenopausal bone loss, and is therefore increasingly prescribed to prevent the development of postmenopausal osteoporosis. Because of individual differences in the response to HRT as well as problems with compliance, it has been debated how the skeletal response to HRT should be monitored. When estrogen production decreases at the menopause, a number of biochemical markers of bone turnover increase considerably in the order of 50%–100% from baseline. When HRT is instituted, the markers decrease again within the following 3–6 months. In the present prospective study we investigated whether the determination of biochemical markers of bone turnover may be useful for monitoring the skeletal effect of HRT. Seventy-six early postmenopausal women received HRT and 43 received placebo. The treatment period was 24 months and the women were followed with repeated bone mass measurements (every 3 months) which allowed calculation of the bone loss. Serum and urine samples were collected at 3, 6, 12 and 24 months. The placebo group lost a significant amount of bone mineral density in both the forearm and the spine (p<0.001), whereas the HRT group did not. There was, however, a relatively large overlap of values between the HRT and placebo groups, especially in the spine. After 3 months' treatment the correlation between the changes in the markers and the bone loss wasr=0.59, and this value increased tor=0.66 at 6 months andr=0.76 andr=0.77 at 12 and 24 months, respectively. The present study thus indicates that biochemical markers of bone turnover may be of value for monitoring the bone response to HRT.
Validation of the Consumption Screen for Problem Gambling (CSPG)

A 3 item screen for problem gambling was developed based on a conceptual analogue of the Alcohol Use Disorders Identification Test—Consumption (Bush et al.  1998); a brief screen that measures consumption rather than harm. Data were collected from an email panel survey of 588 men and 810 women (n = 1,398) across all states in Australia. Respondents indicated their consumption of gambling products using the 3 items of the new Consumption Screen for Problem Gambling (CSPG). Receiver Operating Characteristics curve analysis was used to analyze the performance of the new items relative to the Problem Gambling Severity Index (Ferris and Wynne in The Canadian problem gambling index: Final report, 2001). Results show a 98% probability that the CSPG score for a randomly chosen positive case of problem gambling will exceed the score for a randomly chosen negative case. In addition, a score of 4+ on the CSPG identified all 14 cases of Problem Gambling correctly, while only 7.3% of non-problem gamblers had scores of 4+ (sensitivity = 100%; specificity = 92.7%). Lastly, only 3.0% of respondents without any gambling problems had CSPG scores of 4+. The current study suggests that the CSPG, a brief consumption-based measure for gambling products, can quickly and accurately identify people who are likely to be experiencing gambling problems.
Clinical outcomes of a novel combination of lenalidomide and rituximab followed by stem cell transplantation for relapsed/refractory aggressive B-cell non-hodgkin lymphoma

We retrospectively compared outcomes of patients with relapsed/refractory non-Hodgkin lymphoma (NHL) who underwent stem cell transplantation (SCT) with stable disease or better following a novel combination of lenalidomide and rituximab (LR) treatment and did not undergo SCT in a phase I/II clinical trial. We retrospectively compared outcomes of patients who underwent SCT with that of patients who had stable disease or better following LR treatment and did not undergo SCT. Twenty-two patients enrolled in LR clinical trial and undergone SCT were identified, 13 with mantle cell lymphoma (MCL) and nine with large B-cell lymphoma (LBCL). All patients who underwent SCT achieved complete response. In the MCL subset, there were no significant differences between SCT and non-SCT groups except that non-SCT patients were older and had a higher mantle-cell international prognostic index score. There was no difference between SCT-group and non-SCT-group in response duration (P=0.3), progression-free survival (PFS) (P=0.304) and overall survival (OS) (P=0.87). In LBCL subgroup, there were no significant differences between two groups except that non-SCT group had a higher international prognostic index score. Patients with LBCL who underwent SCT had significantly longer response duration (P=0.001), PFS (P=0.000), and OS (P=0.003) than the non-SCT group. The novel therapeutic combination offers a bridge to SCT in patients with relapsed/refractory aggressive B-cell NHL.
Treating Opioid Dependence With Injectable Extended-Release Naltrexone (XR-NTX)

Once-monthly intramuscular extended-release naltrexone (XR-NTX) has demonstrated efficacy for the prevention of relapse in opioid dependence, providing an alternative to agonist or partial agonist maintenance (ie, methadone and buprenorphine). The question remains, for whom is this unique treatment most efficacious and can patient-treatment matching factors be identified?



A moderator analysis was conducted on a previously reported 24-week, placebo-controlled, multisite, randomized controlled trial of XR-NTX (n = 126) versus placebo (n = 124) among recently detoxified opioid-dependent adults in Russia, which showed XR-NTX superior to placebo in proportion of opioid abstinent weeks. The moderator analysis examined a dichotomous indicator of good clinical response-achieving at least 90% of weeks abstinent over the 24-week trial. A series of logistic regression models were fit for this outcome as functions of treatment (XR-NTX vs placebo), each baseline moderator variable, and their interactions. The 25 baseline variables included demographics, clinical severity (Addiction Severity Index, SF-36, and Clinical Global Impression-Severity), functioning (EQ-5D), craving, and HIV serostatus (HIV+).



More XR-NTX patients achieved 90% abstinence (64/126, 51%) versus placebo (39/124, 31%; P = 0.002). There were no significant interactions between baseline variables and treatment. There was a significant main effect of Clinical Global Impression-Severity score (P = 0.02), such that higher severity score was associated with a lower rate of Good Clinical Response.



The absence of significant baseline by treatment interactions indicates that no patient-treatment matching variables could be identified. This suggests that XR-NTX was effective in promoting abstinence from opioids across a range of demographic and severity characteristics.
Parathyroidectomy eliminates arrhythmic risk in primary hyperparathyroidism, as evaluated by exercise test.

To investigate whether parathyroidectomy (PTx) reverses risk factors for arrhythmias related to the QT dynamic changes evaluated during bicycle ergometry exercise test (ET).



Twenty-four postmenopausal women with primary hyperparathyroidism (PHPT) (mean age 60.08.4 years) and 30 sex- and age-matched controls underwent ET, echocardiography, and biochemical evaluation. The following stages were considered during ET: rest, peak exercise, and recovery. The patients were randomized to two groups: 12 underwent PTx (group A) and 12 were followed-up conservatively (group B). After 6 months, the patients were studied again.



Groups A and B showed no differences in mean baseline biochemical values, echocardiographic parameters, and QTC interval. PHPT patients showed an increased occurrence of ventricular premature beats (VPBS) during ET compared with controls (37.0 vs 6.6%, P=0.03). Serum calcium level was a predictor of VPBS (P=0.05). Mean value of QTC was in the normal range at baseline (Group A: 401±16.9; group B: 402.25±13.5 ms) but significantly lower than controls (417.8±25.1 ms, P<0.01). A negative correlation was found between QTc and calcium values (P=0.03). Physiological reduction of QTc interval from rest to peak exercise was not observed in PHPT patients before surgery. After PTx, group A had a significant reduction in VPBs compared with baseline (at baseline, 5 of 12 vs none of 12 patients after PTx, P=0.03) and a restored normal QT adaptation during ET. Group B showed no significant changes after a 6-month period.



PTx reduces the occurrence of VPBs and restored the QTc adaptation during ET.
The relationship between mandated community treatment and perceived barriers to care in persons with severe mental illness.

In recent decades debate has intensified over both the ethics and effectiveness of mandated mental health treatment for persons residing in the community. Perceived barriers to care among persons subjected to mandated community treatment, and the possibility that fear of involuntary treatment may actually create or strengthen such barriers rather than dissolve them, are key issues relevant to this debate but have been little studied. This article explores the link between receipt of mandated (or "leveraged") community treatment and reasons for avoiding or delaying treatment reported by persons with severe mental illness. It also examines the potential moderating effect of social support on the association between mandated treatment experiences and barriers attributable to fear of involuntary commitment or forced treatment.



Data are presented from a survey of 1011 persons with psychiatric disorders being treated in public-sector mental health service systems in five U.S. cities. Logistic and negative binomial regression analyses were used to examine the association between mandated community treatment and perceptions of barriers to care, controlling for demographic and clinical characteristics.



Across sites, 32.4% to 46.3% of respondents reported barriers attributed to fear of forced treatment. Whereas 63.7% to 76.1% reported at least one non-mandate-related barrier to care; the mean number of non-mandated barriers to care ranged from 1.6 to 2.3 (range 0-7). Between 44.1% and 59.0% of participants had experienced at least one type of leveraged treatment. Persons experiencing multiple forms of mandated treatment were more likely to report barriers to care in comparison to those not reporting mandated treatment. Findings also indicated that social support moderates the relationship between multiple leverages (three or four forms) and mandate-related barriers to care.



Perceived barriers to care associated with mandated treatment experience have the potential to adversely affect both treatment adherence and therapeutic alliance. Awareness of potential barriers to care and how they interact with patients' perceived social support may lead to improved outcomes associated with mandated treatment.
Change of white blood cell count more prognostic important than baseline values after primary percutaneous coronary intervention for ST elevation myocardial infarction.

Elevated baseline white blood cell (WBC) counts in patients with ST segment elevation myocardial infarction (STEMI) have been associated with increased infarct size and higher in-hospital and long-term mortality [1–6]. Persistent WBC count elevation may be an even more important predictor of a poor prognosis than a single baseline WBC count. However, the relationship between serial WBC measurements and clinical outcome in patients with STEMI is unknown. Therefore, we measured serial WBC counts, before and after
Health-Related Quality of Life and Participation in Osteoporosis Clinical Trials

Although osteoporosis affects millions of elderly women, the quality of their lives is extremely complex and is only recently being appreciated. We recently used a disease-specific Osteoporosis Quality of Life questionnaire (OQLQ) to measure quality of life for 105 elderly osteoporotic women, and reported that by path analysis, spinal fractures, health perception, and several sociodemographic factors accounted for 63% of the variance in quality of life. On the other hand, bone density, Colles fracture, hip fractures, pharmacologic agents, exercise, and several sociodemographic variables were not significant factors. Of particular note was the positive, indirect effect (via health perception and spinal fractures) that participation in a clinical trial (17.5% of the patients) had on life quality. In order to determine how involvement in a research study might affect health perception in this same cohort we examined OQLQ scores in the five domains of the OQLQ for the 18 postmenopausal osteoporotic women enrolled in two different phase III clinical trials with oral bisphosphonates and 87 osteoporotic women treated conventionally (estrogen, bisphosphonate, calcitonin, calcium/vitamin D) in our metabolic bone clinic. Research and clinical patients did not differ in age, femoral BMD, or number of spinal fractures. However, women in research trials had significantly greater aggregate OQLQ scores (5.67 versus 4.23, P < 0.0001) and perceived health (7.28 versus 5.85, P= 0.001) than clinical patients. These differences were highly significant (P < 0.001) for domains of quality of life including physical function, activities of daily living, symptoms, and leisure/social activity and marginally significant for the emotional function domain (P= 0.05). Hence, by regression-based path analysis and subgroup analysis of cross-sectional data, participation in a clinical trial had a significant and positive impact on health-related quality of life. If these findings are confirmed by other studies, identifying those factors inherent in clinical studies that positively impact the lives of osteoporotic patients should become as important a priority as development of new therapies for this chronic disease.
Temperature rise after peginterferon alfa-2a injection in patients with chronic hepatitis C is associated with virological response and is modulated by IL28B genotype.

Interferon treatment for chronic hepatitis C is associated with non-specific symptoms including fever. We aimed to determine the association of temperature changes with interferon antiviral activity.



60 treatment-naïve patients with chronic hepatitis C (67% genotype 1/4/6, 33% genotype 2/3) were admitted to start peginterferon alfa-2a and ribavirin in a clinical trial. Temperature was measured at baseline and 3 times daily for the first 24h and the maximal increase from baseline during that time (ΔTmax) was determined. Serum HCV-RNA, interferon-gamma-inducible protein-10 (IP-10) and expression of interferon-stimulated genes (ISGs - CD274, ISG15, RSAD2, IRF7, CXCL10) in peripheral blood mononuclear cells (PBMCs) were measured at very early time points, and response kinetics calculated. The IL28B single nucleotide polymorphism, rs12979860, was genotyped.



Temperatures rose by 1.2±0.8°C, peaking after 12.5h. ΔTmax was strongly associated with 1st phase virological decline (r=0.59, p<0.0001) and was independent of gender, cirrhosis, viral genotype or baseline HCV-RNA. The association with 1st phase decline was seen in patients with rs12979860CC genotype (r = 0.65, p <0.0001) but not in CT/TT (r = 0.13, p = 0.53) and patients with CC genotype had a higher DTmax (1.4 ± 0.8 C vs. 0.8 ± 0.6 +C, p = 0.001). DTmax was associated with 6- and 24-h induction of serum IP-10 and of PBMC ISG expression, but only in patients with rs12979860CC [corrected].ΔTmax weakly predicted early virological response (AUC=0.68, CI 0.49-0.88).



Temperature rise following peginterferon injection is closely associated with virological response and is modulated by IL28B polymorphism, reflecting host interferon-responsiveness.
Comprehensive evaluation of community-based diabetic patients: effect of feedback to patients and their physicians: a randomized controlled trial.

To demonstrate improvements in diabetes care stimulated by comprehensive evaluation of community-based diabetic patients with feedback to the patients and their physicians.



A comprehensive evaluation of community-based diabetic patients with annotated reporting of results to both patients and their physicians (universal intervention) was followed by random assignment of 50% of patients to individual counseling (randomized intervention). In four communities, two large and two small, 55 type 1 and 376 type 2 diabetic patients were recruited, evaluated, and reassessed at 1 year. Outcome measures were HbA1c, serum cholesterol, and systolic and diastolic blood pressure.



There were significant improvements in all outcome measures for type 2 diabetic patients randomized to individual counseling (P = 0.03; follow-up rate 84%) and significant improvements in all outcome measures for all high-risk type 2 patients (highest P value = 0.004; follow-up rate 85%).



Comprehensive evaluation of diabetic patients at the community level with annotated reporting of results to the patients and their physicians was associated with improvement of mean HbA1c, cholesterol, and systolic and diastolic blood pressure, particularly in patients in high-risk status for these outcome variables. Individual counseling of 50% of patients, randomly selected, enhanced these results.