nils-herrmann/clean_scirepeval huggingface dataset:
Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy

Health-related quality of life (HRQOL) assessment is a key component of clinical oncology trials. However, few breast cancer trials comparing adjuvant conventional radiotherapy (CR) and hypofractionated tomotherapy (TT) have investigated HRQOL. We compared HRQOL in stage I-II breast cancer patients who were randomized to receive either CR or TT. Tomotherapy uses an integrated computed tomography scanner to improve treatment accuracy, aiming to reduce the adverse effects of radiotherapy. A total of 121 stage I–II breast cancer patients who had undergone breast conserving surgery (BCS) or mastectomy (MA) were randomly assigned to receive either CR or TT. CR patients received 25 × 2 Gy over 5 weeks, and BCS patients also received a sequential boost of 8 × 2 Gy over 2 weeks. TT patients received 15 × 2.8 Gy over 3 weeks, and BCS patients also received a simultaneous integrated boost of 15 × 0.6 Gy over 3 weeks. Patients completed the EORTC QLQ-C30 and BR23 questionnaires. The mean score (± standard error) was calculated at baseline, the end of radiotherapy, and at 3 months and 1, 2, and 3 years post-radiotherapy. Data were analyzed by the 'intention-to-treat' principle. On the last day of radiotherapy, patients in both treatment arms had decreased global health status and functioning scores; increased fatigue (clinically meaningful in both treatment arms), nausea and vomiting, and constipation; decreased arm symptoms; clinically meaningful increased breast symptoms in CR patients and systemic side effects in TT patients; and slightly decreased body image and future perspective. At 3 months post-radiotherapy, TT patients had a clinically significant increase in role- and social-functioning scores and a clinically significant decrease in fatigue. The post-radiotherapy physical-, cognitive- and emotional-functioning scores improved faster in TT patients than CR patients. TT patients also had a better long-term recovery from fatigue than CR patients. ANOVA with the Bonferroni correction did not show any significant differences between groups in HRQOL scores. TT patients had a better improvement in global health status and role- and cognitive-functioning, and a faster recovery from fatigue, than CR patients. These results suggest that a shorter fractionation schedule may reduce the adverse effects of treatment.
Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms.

Depressive symptoms are associated with poor smoking cessation outcomes, and there remains continued interest in behavioral interventions that simultaneously target smoking and depressive symptomatology. In this pilot study, we examined whether a behavioral activation treatment for smoking (BATS) can enhance cessation outcomes.



A sample of 68 adult smokers with mildly elevated depressive symptoms (M = 43.8 years of age; 48.5% were women; 72.7% were African American) seeking smoking cessation treatment were randomized to receive either BATS paired with standard treatment (ST) smoking cessation strategies including nicotine replacement therapy (n = 35) or ST alone including nicotine replacement therapy (n = 33). BATS and ST were matched for contact time and included 8 sessions of group-based treatment. Quit date was assigned to occur at Session 4 for each treatment condition. Participants completed a baseline assessment; furthermore, measures of smoking cessation outcomes (7-day verified point-prevalence abstinence), depressive symptoms (Beck Depression Inventory-II; Beck, Steer, & Brown, 1996), and enjoyment from daily activities (Environmental Reward Observation Scale; Armento & Hopko, 2007) were obtained at 1, 4, 16, and 26 weeks post assigned quit date.



Across the follow-ups over 26 weeks, participants in BATS reported greater smoking abstinence (adjusted odds ratio = 3.59, 95% CI [1.22, 10.53], p = .02) than did those in ST. Participants in BATS also reported a greater reduction in depressive symptoms (B = -1.99, SE = 0.86, p = .02) than did those in ST.



Results suggest BATS is a promising intervention that may promote smoking cessation and improve depressive symptoms among underserved smokers of diverse backgrounds.
Rheumatoid arthritis of the hand: monitoring with a simplified MR imaging scoring method--preliminary assessment.

To assess a simplified scoring method (Simplified Rheumatoid Arthritis Magnetic Resonance Imaging Score [SAMIS]) developed to shorten interpretation time, while retaining both correlation with Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) and same or better intra- and interreader reliability.



Ethics board approval and written patient consent were obtained. The study was HIPAA compliant. Thirty-eight patients with rheumatoid arthritis and 20 patients with no or early unclassified arthritis underwent magnetic resonance imaging of both wrists and hands. RAMRIS was used to evaluate erosions (scale, 0-10), edema (scale, 0-3), and synovitis (scale, 0-3). SAMIS assessed only one hand and was based on the radiographic Simple Erosion Narrowing Score, thus reducing the number of study areas from 116 to 36. Erosions were scored with a scale from 1 to 10. Edema and synovitis were, respectively, scored with scales from 0 to 1 and 0 to 2. SAMIS correlation with RAMRIS was tested by using the Spearman test. Last, the intra- and interobserver reproducibility of both scores were calculated.



SAMIS was closely correlated with RAMRIS for the entire series (r = 0.91, 0.79, and 0.94, respectively, for erosion, edema, and synovitis), as well as in patients with rheumatoid arthritis (r = 0.93, 0.81, and 0.92) and those with no or unclassified arthritis (r = 0.83, 0.73, and 0.94). The time needed to assess examination results with RAMRIS ranged from 5 to 20 minutes (13 minutes +/- 3.90 [standard deviation]), whereas it ranged from 2 to 7 minutes (5 minutes +/- 1.45) with SAMIS. For each of the three features (erosion, edema, and synovitis), intraobserver agreement (RAMRIS: kappa = 0.67, 0.94, 0.81, respectively; SAMIS: kappa = 0.66, 1.0, 0.91) and interobserver agreement (RAMRIS: kappa = 0.61, 0.58, 0.74, respectively; SAMIS: kappa = 0.59, 0.81, 0.81) were good to excellent.



This simplified reproducible scoring scheme could be used to monitor joint damage in rheumatoid arthritis. (c) RSNA, 2010.
Brain oxygen metabolism may relate to the temperature gradient between the jugular vein and pulmonary artery after cardiopulmonary resuscitation.

A gradient between the jugular vein temperature and core body temperature has been reported in animal and clinical studies; however, the pathophysiological meaning of this phenomenon remains unclear. This study was conducted to identify the temperature gradient between the jugular vein and pulmonary artery in comatose patients after cardiopulmonary resuscitation.



The temperatures of the jugular vein and pulmonary artery were measured in 19 patients at 6 and 24 hours after cardiopulmonary resuscitation. Jugular venous blood saturation (SjO2; %) was also measured concomitantly. The patients were divided into 2 groups: high SjO2 (SjO2 > 75%: H-group; n = 10) and normal SjO2 (SjO2 < or = 75%: N-group; n = 9). The temperature gradient was calculated by subtracting the temperature of the pulmonary artery from that of the jugular vein (jugular - pulmonary = dT degrees C). Statistical significance was defined as p < 0.05.



dT was significantly lower in the H-group than in the N-group at 6 hours (0.120 +/- 0.011: mean +/- SD vs. 0.389 +/- 0.036: p = 0.0012) and 24 hours (0.090 +/- 0.005 vs. 0.256 +/- 0.030: p = 0.0136) after cardiopulmonary resuscitation.



The temperature gradient between the jugular vein and pulmonary artery was significantly lower in patients with high SjO2 after cardiopulmonary resuscitation. This temperature gradient may be reflected in brain oxygen metabolism.
A controlled trial of itraconazole as primary prophylaxis for systemic fungal infections in patients with advanced human immunodeficiency virus infection in Thailand.

Cryptococcal meningitis and Penicillium marneffei infection are common serious fungal infections in patients infected with human immunodeficiency virus (HIV) in Southeast Asia. In a prospective, double-blind trial, 63 patients with HIV infection and CD4+ lymphocyte counts of <200 cells/microL were randomized to receive oral itraconazole (200 mg per day), and 66 similar patients received a matched placebo. Both groups were monitored for evidence of invasive fungal infections. Baseline characteristics and the CD4+ cell counts of the 2 groups were similar. In the intent-to-treat analysis, a systemic fungal infection developed in 1 patient (1.6%) assigned to receive itraconazole (P. marneffei) and in 11 patients (16.7%) given placebo (7 patients had cryptococcal meningitis, and 4 patients had P. marneffei infection; P=.003, by the log-rank test). The incidence of recurrent or refractory mucosal candidiasis was significantly reduced in the itraconazole group. The 2 groups did not differ with regard to adverse effects. Primary prophylaxis with oral itraconazole is well tolerated and prevents cryptococcosis and penicilliosis marneffei in patients with advanced HIV infection, especially those with CD4+ lymphocyte counts of <100 cells/microL. However, prophylaxis with itraconazole was not found to be associated with a survival advantage when it was given to patients with advanced HIV disease.
Diet quality and diet patterns in relation to circulating cardiometabolic biomarkers.

We examined the effects of diet quality and dietary patterns in relation to biomarkers of risk including leptin, soluble intracellular adhesion molecule 1 (sICAM-1), C-reactive protein (CRP), and irisin.



We analyzed data from 196 adults cross-sectionally. Dietary patterns were identified by factor analysis and diet quality scores were generated using a validated food-frequency questionnaire.



Both the alternate healthy eating index-2010 (AHEI-2010) and the Dietary Approaches to Stop Hypertension (DASH) scores were negatively related to CRP, even after controlling for body mass index and total energy intake. Similarly, the prudent diet pattern was negatively related to leptin, sICAM-1, and CRP, whereas the Western diet pattern showed positive associations with these markers; however, after adjusting for all confounders, the associations only remained significant for leptin and sICAM-1. Irisin was positively associated with DASH and the prudent diet after controlling for all confounders (standardized β = 0.23, P = 0.030; standardized β = 0.25, P = 0.021, respectively). Irisin showed positive associations with increasing fruit consumption, whereas the levels of irisin decreased as meat consumption increased.



Irisin was directly associated with healthy diet types and patterns. Further studies regarding these mechanisms are warranted.
Trends in acute myocardial infarction in 4 US states between 1992 and 2001: clinical characteristics, quality of care, and outcomes.

Because of the health impact of acute myocardial infarction (AMI), substantial resources have been dedicated to improving AMI care and outcomes. Long-term trends in the clinical characteristics, quality of care, and outcomes for AMI over time from the health system perspective in geographically diverse populations are not well known.



The present study included 20,550 Medicare patients aged > or = 65 years hospitalized in 4 US states (Alabama, Connecticut, Iowa, Wisconsin) with the confirmed primary discharge diagnosis of AMI in 4 periods: 1992-1993 (n=10,292), 1995 (n=5566), 1998-1999 (n=2413), and 2000-2001 (n=2279). With the use of standard quality indicator definitions, treatment of ideal candidates with aspirin and beta-blockers within 24 hours after presentation, beta-blockers, and angiotensin-converting enzyme inhibitors at discharge was assessed. Multivariable models were constructed to calculate adjusted 1-year mortality. The hospitalized Medicare population with AMI changed substantially during 1992-2001, with increasing age, more comorbidity, and fewer meeting ideal treatment criteria. Although treatment rates increased significantly for all medications, aspirin, beta-blockers, and angiotensin-converting enzyme inhibitors were not provided at discharge to 12.6%, 19.7%, and 25.2% of ideal candidates, respectively, in 2000-2001. Crude 1-year mortality increased (27.6%, 28.3%, 30.6%, and 31.0%; P=0.003 for trend, but adjusted mortality declined (compared with 1992-1993, relative risk in 1995=0.94 [95% CI, 0.88 to 1.01]; relative risk in 1998-1999=0.91 [95% CI, 0.85 to 0.98]; relative risk in 2000-2001=0.87 [95% CI, 0.81 to 0.94]).



The quality of care and adjusted 1-year mortality improved significantly for Medicare beneficiaries with AMI during 1992-2001. Nevertheless, fewer were ideal for guideline-based therapy, and absolute mortality remains high, suggesting the need for treatment strategies applicable to a broader range of older patients.
Children First Study: how an educational program in cardiovascular prevention at school can improve parents' cardiovascular risk.

To evaluate whether a multidisciplinary educational program (EP) in cardiovascular prevention (CVP) for children could improve the Framingham cardiovascular risk (FCR) of their parents after one year.



This was a prospective community-based study in Brazil during 2010 that randomized students aged 6 to 10 years old to two different approaches to receiving healthy lifestyle information. The control group received written educational material (EM) for their parents about healthy lifestyle. The intervention group received the same EM for parents, and children were exposed to a weekly EP in CVP with a multidisciplinary health team. At onset and end of the study, we collected data from parents and children (weight, height, arterial blood pressure, and laboratory tests). We studied 197 children and 323 parents. Analyzing the parents' FCR we found that 9.3% of the control group and 6.8% of the intervention group had more than a 10% year risk of cardiovascular heart disease (CHD) over the next 10 years. After the children's EP for the year, the intervention group had a reduction of 91% in the intermediate/high FCR group compared with a 13% reduction in the control group, p = 0.002). In the same way, analyzing the FCR of all parents, there was a reduction of the average risk in the intervention group (3.6% to 2.8% respectively, p < 0.001) compared with the control group (4.4% to 4.4%, p = 0.98).



An educational program in cardiovascular prevention directed at school-age children can reduce the FCR risk of their parents, especially in the intermediate/high risk categories.
Boceprevir in genotype 1 chronic hepatitis C: first experiences in Serbia.

The triple therapy which consists of one of the protease inhibitor plus pegylated interferon and ribavirin (P/R) is the standard of care for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection both in treatment-naïve and experienced patients.



The aim of this study was to analyze the efficacy and tolerability of this regime in hospital practice in Serbia.



From July 2012 to October 2012, 20 previously treated patients with advanced fibrosis and HCV G1 infection were included in the triple antiviral regimen in six referral centers in Serbia. All patients were treated with response guide therapy (RGT) regime according to the boceprevir treatment protocol. During the 4-week lead-in period all patients received peginterferon plus ribavirin. After the lead-in pe- riod boceprevir was added in the dosage of 800 mg three times a day orally.The subsequent treatment varied according to virologic response and fibrosis. During the therapy HCV RNA level was measured at week 4, 8, 12, 24 of the treatment for the assessment of virologic response profile. All patients who completed therapy were assessed at the end of the treatment and at the end of an additional 24-week treatment-free period for a sustained virologic response (SVR).



The total of 20 patients with advanced fibrosis was treated. Among patients with an undetectable HCV RNA level at week 8 the rate of SVR was 100%. No patient with decrease in the HCV RNA level < 1 log 10 IU/ml at treatment week 4 achieved SVR. The overall rate of SVR was 55%. The safety profile of the treatment regimen was good. Anemia was reported in 25% of patients. There was no life-threatening treatment adverse event.



Boceprevir in combination with P/R achieved fairly good SVR rates in patients that were"most difficult to treat"who failed on dual therapy and was effective among patients with cirrhosis.
Transcatheter closure of interatrial communications for secondary prevention of paradoxical embolism: single-center experience.

Patients with a patent foramen ovale (PFO) after cerebral, coronary, or systemic embolic events of presumed paradoxical origin are at risk for recurrent thromboembolism. We report our single-center experience of interventional closure of interatrial communications for secondary prevention of presumed paradoxical embolism. , percutaneous closure of interatrial communications was performed at our institution in 66 patients (mean age 47.8+/-12.7 years; 31 males) with a PFO or an atrial septal defect and at least 1 documented presumed paradoxical thromboembolic event. Fifty-eight patients had cerebral embolism, 10 had coronary embolism, and 3 had peripheral embolism. Several patients experienced multilocal arterial embolism. Fifty-four patients had a PFO, 33 of them with an atrial septal aneurysm, and 12 had an atrial septal defect. The implantation procedure was successful and without complication in all patients. After 3 months, only 2 patients showed a residual shunt, which disappeared in both cases after 12 months. In 112.2 patient-years of follow-up (range, 5 weeks to 3.5 years), we have not seen any recurrent thromboembolic event.



Interventional closure of interatrial communications is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. To further evaluate this strategy, randomized trials comparing interventional closure with anticoagulation have been initiated by us and others.
A phase I and pharmacokinetic study of didox administered by 36 hour infusion. The Cancer Research Campaign Phase I/II Clinical Trials Committee.

Twelve patients were treated with didox, a new ribonucleotide reductase inhibitor, by 36 h infusion. The maximum tolerated dose was 6 g m-2, above which dose-limiting hepatic toxicity was observed. Patient tolerance was significantly better using the 36 h infusion compared to patients receiving the drug by a 30 min infusion; in particular, there were no reports of nausea or vomiting. No responses were seen in these patients. Detailed pharmacokinetics were performed at 6 g m-2 comparing the 36 h and 30 min infusions in four patients. Parent drug AUC values were lower for the 36 h infusion, 67.8 micrograms ml-1 h-1 compared to 232 micrograms ml-1 h-1 for the 30 min infusion. AUC values for the 3-hydroxy metabolite were much higher following the 36 h infusion: 55.4 compared to 18.6 micrograms ml-1 h-1. In contrast, the amide metabolite was not detected following the 36 h infusion, but AUC values of 23 micrograms ml-1 h-1 were seen after the 30 min infusion. The mean peak plasma level was 72 micrograms ml-1 following 6 g m-2 given by a 30 min infusion compared to 2.8 micrograms ml-1 following the prolonged infusion. Clearance was higher following the 36 h infusion: 97.6 versus 24.4 l h-1.
Indicators of pretreatment suicidal ideation in adults with major depressive disorder.

In order to evaluate the presence of treatment emergent suicidal ideation (SI), it becomes necessary to identify those patients with SI at the onset of treatment. The purpose of this report is to identify sociodemographic and clinical features that are associated with SI in major depressive disorder (MDD) patients prior to treatment with a selective serotonin reuptake inhibitor.



This multisite study enrolled 265 out-patients with non-psychotic MDD. Sociodemographic and clinical features of participants with and without SI were compared post hoc.



Social phobia, bulimia nervosa, number of past depressive episodes, and race were independently associated with SI by one or more SI measure.



Concurrent social phobia and bulimia nervosa may be potential risk factors for SI in patients with non-psychotic MDD. Additionally, patients with more than one past depressive episode may also be at increased risk of SI.
Exploring sensory integrative dysfunction in process schizophrenia.

During a 6-week period, the effects of sensory integrative activities on a group of seven chronic nonparanoid schizophrenic adults were compared to the effects of sedentary activities in a control group of seven similar subjects. The effects of each therapeutic approach were evaluated by measuring the patients' performance in several areas using the Nurses Observation Scale of Inpatient Evaluation-30 (NOSIE-30), The Object Manipulation Speed Test, a gait analysis, and grip strength. The results indicated general improvement in the experimental group. Behaviors measured by the NOSIE-30 showed the most significant improvements. The control group showed isolated improvements in grooming (measured by the NOSIE-30) and in right-hand use (measured by The Object Manipulation Speed Test). These findings suggest that 6 weeks of sensory integrative activities can improve the overall functioning of chronic nonparanoid schizophrenic patients, facilitate their adaptive responses, and enable them to participate more fully in other areas of therapeutic intervention.
Effect of seasonal variation on hospital admission due to cardiovascular disease - findings from an observational study in a divisional hospital in Bangladesh

Seasonal variation in the hospital admission due to cardiovascular disease (CVDs) has been widely reported. However, very limited data on Bangladesh is available regarding this matter. The aim of the current study was to investigate the effect of seasonal variation on hospital admission due to CVDs in a leading hospital of Bangladesh.



Over a period of two years (from May 2010 to April 2012), the number of patients hospitalized due to various CVDs and number of death among these hospitalized patients were recorded on a day-to-day basis. The data were recorded according to the chief reason of hospital admission such as myocardial infarction or MI (acute, old and non-ST elevation), unstable angina (UA), exaggeration of stable angina, acute left ventricular failure (LVF), cardiomyopathy (ischemic and dilated) or heart failure, syncope and arrhythmia. The data were cumulated and analyzed on month-wise and season-wise manner.



A total of 8371 patients were admitted over the study period (5909 male and 2462 female; M/F ratio - 2.4:1). The highest number of patients were admitted during winter (n = 2839, 33.9%) and lowest during summer (n = 1648, 19.7%). The hospital admission was also significantly higher in winter compared to other seasons (p-value versus summer, autumn and spring was 0.018, 0.020 and 0.023 respectively). Acute MI (n = 2374), Acute LVF (n = 1582) and UA (n = 1277) were the top three reasons for hospitalization. Number of death also significantly higher in winter compared to other seasons (p-value versus summer, winter and spring was 0.044, 0.050 and 0.014 respectively).



A seasonal variation in the hospital admission due to CVDs with a peak in winter was clearly demonstrated in the study. These data could be useful to improve causative prevention measures, therapeutic management, and educational strategies.