nils-herrmann/clean_scirepeval huggingface dataset:
Dietary total antioxidant capacity and mortality in the PREDIMED study.

The aim of the present study was to assess the association between the dietary total antioxidant capacity, the dietary intake of different antioxidants and mortality in a Mediterranean population at high cardiovascular disease risk.



A total of 7,447 subjects from the PREDIMED study (multicenter, parallel group, randomized controlled clinical trial), were analyzed treating data as an observational cohort. Different antioxidant vitamin intake and total dietary antioxidant capacity were calculated from a validated 137-item food frequency questionnaire at baseline and updated yearly. Deaths were ascertained through contact with families and general practitioners, review of medical records and consultation of the National Death Index. Cox regression models were fitted to assess the relationship between dietary total antioxidant capacity and mortality. Dietary total antioxidant capacity was estimated using ferric-reducing antioxidant power assays.



A total of 319 deaths were recorded after a median follow-up of 4.3 years. Subjects belonging to the upper quintile of antioxidant capacity were younger, ex-smokers, with high educational level, and more active and had higher alcohol intake. Multivariable-adjusted models revealed no statistically significant difference between total dietary antioxidant capacity and mortality (Q5 vs. Q1 ref HR 0.85; 95% CI 0.60-1.20) neither for the intake of all the vitamins studied.



No statistically significant association was found between antioxidant capacity and total mortality in elderly subjects at high cardiovascular risk.
Clinical evaluation of BCR-ABL peptide immunisation in chronic myeloid leukaemia: results of the EPIC study

Peptides from the e14a2 BCR-ABL junction will elicit T-cell responses in vitro. Here, 19 imatinib treated CML patients in first chronic phase were vaccinated with BCR-ABL peptides spanning the e14a2 fusion junction, some of which were linked to the pan DR epitope PADRE to augment CD4+ T cell help. Six vaccinations were given over 9 weeks, together with sargramostim. All patients developed mild local reactions. T cell responses to PADRE were seen in all patients. Fourteen of 19 patients developed T cell responses to BCR-ABL peptides. The development of an anti-BCR-ABL T cell response correlated with a subsequent fall in BCR-ABL transcripts. No molecular benefit was seen in the 5 patients not in major cytogenetic response (MCR) at baseline. However, of the 14 patients in MCR at baseline, 13 developed at least 1 log fall in BCR-ABL transcripts, though this occurred several months after completing vaccination, consistent with an effect at a primitive CML stem cell level. Vaccination may improve the fall in BCR-ABL transcripts in patients who have received imatinib for more than 12 months. BCR-ABL peptide vaccination may improve control of CML, especially in patients responding well to imatinib. Randomised trials are required to address this further.
Does adherence monitoring reduce controlled substance abuse in chronic pain patients?

Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Given that controlled substance abuse and illicit drug use are prevalent phenomena, adherence monitoring of patients that are prescribed opioids is becoming common. Adherence monitoring is carried out by an appropriate history, periodic evaluation of appropriate intake of drugs, random drug testing, and pill counts. Crucial to adherence monitoring is an initial controlled substance agreement and repeated review of the terms of this agreement with on-going education. However, the effect of adherence monitoring on drug abuse is unclear.



To identify controlled substance abuse through implementation of the terms of a controlled substance agreement, including periodic review and monitoring outside the organization.



Prospective evaluation with historical controls.



Five hundred consecutive patients receiving prescription controlled substances were followed in a prospective manner. The evaluation consisted of a chart review to monitor controlled substance intake, with special attention to drugs obtained from outside the organization. Data collection for this purpose included information from records, pharmacies, referring physicians, and all the physicians involved in the treatment of the patient.



Results from 500 consecutive patients were evaluated. Controlled substance abuse was seen in 9% of patients; overall, 5% of patients were obtaining controlled substances from other physicians, and 4% from illegal sources.



Adherence monitoring, including controlled substance agreements and various periodic measures of compliance was associated with a 50% reduction in opioid abuse.
“Add-On”-therapy with an individualized preparation consisting of free amino acids for patients with a major depression

The efficacy of a deficit oriented add-on therapy with free amino acids in depressive patients treated with the antidepressant Remeron® was evaluated. About 40 in-patients were investigated by a randomised double-blind placebo-controlled study during 4 weeks. Plasma levels of 20 amino acids and measures of depression, suicidal behaviour and aggression were surveyed on admission and after a 4 weeks’ therapy with Remeron® plus an individualized amino acid mixture or placebo. The preparation of the amino acid mixture was based on an aminogram and consisted of essential amino acids plus vitamins and trace elements as co-factors for the amino acid metabolism. Patients of the experimental group showed a significantly better improvement of depression and a higher responder rate than those of the placebo group. The results suggest that oral application of a deficit oriented amino acid mixture can improve the therapeutic outcome of an antidepressant. Furthermore, lacking side effects of the amino acids resulting also in a better patient compliance may improve the benefit/risk ratio.
Psychosocial Well-Being of Young People Who Participated in a Support Group Following the Loss of a Parent to Cancer.

Despite the evidence of unmet support needs among young people who have lost a parent to cancer, only a few support group initiatives have been reported. This observational prospective study explored the psychosocial well-being of young people who participated in support groups at a Swedish specialist palliative care setting. On three occasions, 29 participants, aged 16-28 years, answered questionnaires covering characteristics of the participants, circumstances of the losses, psychosocial well-being of the young people, and their own assessment of the support groups. The support groups attracted mostly young women who were often unprepared for the loss. The living arrangements differed between younger and older participants; however, the loss-related variables did not differ. Significant positive changes were found regarding a sense of meaning in their future life and life satisfaction. The helpfulness of the group was assessed as high/very high and the group brought a valuable fellowship with others in a similar situation. Universality and beneficial interactions were reported and strengthened psychosocial well-being developed over time. This change, according to the young people themselves, may be attributed to the group support. The findings are useful for planning interventions to support young people in bereavement in order to enhance their psychosocial well-being.
High-dose Chemotherapy with Stem Cell Rescue as Initial Therapy for Anaplastic Oligodendroglioma

Anaplastic oligodendroglioma is a chemosensitive glial neoplasm. To improve disease control and postpone cranial radiotherapy, we designed a phase II study of intensive procarbazine, lomunstine and vincristine followed by high-dose thiotepa with autologous stem cell rescue for patients with newly diagnosed anaplastic or aggressive oligodendroglioma.  Sixty-nine patients with a median age of 42 (range: 18–67) and a median Karnofsky Performance Score of 90 (range: 70–100) were enrolled. Sixteen patients had a prior diagnosis of low-grade oligodendroglioma and 16 had mixed oligoastrocytoma pathology. Only patients with demonstrably chemosensitive enhancing tumors or those free of enhancing tumor after surgery and induction therapy were eligible to receive high-dose thiotepa.  Thirty-nine patients (57%) completed the transplant regimen; their estimated median progression-free survival is 69 months and median overall survival has not been reached. Twelve transplanted patients (31%) relapsed. Neither histology nor prior low-grade oligodendroglioma correlated with relapse; however, persistent non-enhancing tumor at transplant conferred an increased risk of relapse (p = 0.028). The transplant regimen was well-tolerated; median hospital stay was 20 days (range: 7–43) with a median time to ANC and platelet engraftment of 10 days. Thirty patients (43%) did not receive high-dose thiotepa because of stable or progressive disease (n = 21), excessive toxicity (n = 4), refusal of further therapy (n = 2), failure to obtain insurance coverage (n = 2), or other (n = 1). No treatment-related or long-term neurotoxicity was seen in the transplanted patients.  High-dose chemotherapy with stem cell rescue as initial treatment for anaplastic oligodendroglioma is feasible and associated with prolonged tumor control in some patients.
Lack of circadian variation and reduction of heart rate variability in women with breast cancer undergoing lumpectomy: a descriptive study

Changes in the autonomic nervous system with increased sympathetic tone may be a cause of postoperative short-, and long-term cardiovascular complications. Heart rate variability (HRV) is assessed by Holter monitoring as a measure of autonomic tone and has not been investigated in patients with breast cancer undergoing surgery. We aimed to investigate evening- and night-time HRV after lumpectomy. Twelve patients were included in this descriptive study. HRV was measured the night before surgery (PREOP), the night after surgery (PO1) and 14 days after surgery (PO14) from 1900 to 0700 h. For calculation of HRV, time domain parameters (SDNN-standard deviation of all normal-to-normal (NN) intervals around the mean NN for the period of measurement, pNN50-percentage of beats where the change from one beat to the next is more than 50 ms, rMSSD-root mean square of successive differences) were used. We analyzed the variation of the overall time period and the circadian variation between evening and night (sympathetic vs. parasympathetic tonus). Mean heart rate increased from PREOP to PO1 (p < 0.001) and also increased between PREOP and PO14 (p < 0.05). SDNN (p < 0.001) and PNN50 (p < 0.001) decreased from PREOP to PO1. There was also a significant decrease between PREOP and PO14 for both parameters (p < 0.005 and p = 0.05 respectively). SDNN increased from PO1 to PO14 (p < 0.005). rMSSD decreased from PREOP to PO1 (p < 0.001). A circadian variation was found in the mean heart rate for all three monitoring periods (p < 0.005). Circadian variation was also present on PREOP for pNN50 (p ≤ 0.05) and rMSSD (p < 0.05). This variation was missing for both PO1 and PO14. Patients had a shift of autonomic tone with reduced parasympathetic activity and lack of circadian variation 14 days after lumpectomy.
Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study.

Current classification of traumatic brain injury (TBI) is suboptimal, and management is based on weak evidence, with little attempt to personalize treatment. A need exists for new precision medicine and stratified management approaches that incorporate emerging technologies.



To improve characterization and classification of TBI and to identify best clinical care, using comparative effectiveness research approaches.



This multicenter, longitudinal, prospective, observational study in 22 countries across Europe and Israel will collect detailed data from 5400 consenting patients, presenting within 24 hours of injury, with a clinical diagnosis of TBI and an indication for computed tomography. Broader registry-level data collection in approximately 20,000 patients will assess generalizability. Cross sectional comprehensive outcome assessments, including quality of life and neuropsychological testing, will be performed at 6 months. Longitudinal assessments will continue up to 24 months post TBI in patient subsets. Advanced neuroimaging and genomic and biomarker data will be used to improve characterization, and analyses will include neuroinformatics approaches to address variations in process and clinical care. Results will be integrated with living systematic reviews in a process of knowledge transfer. The study initiation was from October to December 2014, and the recruitment period was for 18 to 24 months.



Collaborative European NeuroTrauma Effectiveness Research in TBI should provide novel multidimensional approaches to TBI characterization and classification, evidence to support treatment recommendations, and benchmarks for quality of care. Data and sample repositories will ensure opportunities for legacy research.



Comparative effectiveness research provides an alternative to reductionistic clinical trials in restricted patient populations by exploiting differences in biology, care, and outcome to support optimal personalized patient management.
Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise

Canagliflozin is a sodium glucose co-transporter 2 inhibitor in development for type 2 diabetes mellitus (T2DM). The efficacy and safety of canagliflozin were evaluated in subjects with T2DM inadequately controlled with diet and exercise.



In this 26-week, randomized, double-blind, placebo-controlled, phase 3 trial, subjects (N = 584) received canagliflozin 100 or 300 mg or placebo once daily. Primary endpoint was the change from baseline in haemoglobin A1c (HbA1c) at week 26. Secondary endpoints included the proportion of subjects achieving HbA1c < 7.0%; change from baseline in fasting plasma glucose (FPG), 2-h postprandial glucose (PPG) and systolic blood pressure (BP); and percent change in body weight, high-density lipoprotein cholesterol (HDL-C) and triglycerides. Adverse events (AEs) were recorded throughout the study.



At week 26, HbA1c was significantly reduced from baseline with canagliflozin 100 and 300 mg compared with placebo (-0.77, -1.03 and 0.14%, respectively; p < 0.001 for both). Both canagliflozin doses significantly decreased FPG, 2-h PPG, body weight and systolic BP (p < 0.001 for all), and increased HDL-C compared with placebo (p < 0.01 for both). Overall incidences of AEs were modestly higher with canagliflozin versus placebo; rates of serious AEs and AE-related discontinuations were low and similar across groups. Incidences of genital mycotic infections, urinary tract infections and osmotic diuresis-related AEs were higher with canagliflozin; these led to few discontinuations. The incidence of hypoglycaemia was low across groups.



Canagliflozin treatment improved glycaemic control, reduced body weight and was generally well tolerated in subjects with T2DM inadequately controlled with diet and exercise.
EDV-gestützter Behandlungspfad für Schizophrenie

Standardisierung in der Psychiatrie ist eine Entwicklung, die nach der Psychopathologie und Nosologie zunehmend nun auch den Bereich der Behandlung erfasst hat. Die Entwicklung von Leitlinien für die Behandlung psychiatrischer Krankheitsbilder ist mittlerweile selbstverständlich geworden, jedoch ist ihre Verbindlichkeit im Alltag limitiert. Behandlungspfade bringen die Leitlinienempfehlungen in einen klaren und praxisrelevanten Algorithmus. Voraussetzung hierfür ist jedoch die Einbeziehung aller Behandlungselemente und Berufsgruppen sowie eine tragfähige EDV-Grundlage. Ein solcher Ansatz wird hier am Beispiel der Entwicklung und Implementierung eines Behandlungspfades für stationäre Patienten mit einer schizophrenen Störung dargestellt. Erste Ergebnisse zeigen, dass Patienten, die gemäß dem EDV-gestützten Behandlungspfad multimodal behandelt wurden, klinisch deutlich besser, gemessen mit CGI, PANSS und PSP, abschnitten als die Vergleichspatienten. Dies zeigt, dass durch Einführung von Behandlungspfaden die Behandlungsqualität bei Patienten mit Schizophrenie angehoben werden konnte. Standardisierung und Evaluation psychiatrischer Behandlungsprozesse könnten vor dem Hintergrund des neuen Entgeltsystems bedeutsam sein. Standardization in psychiatry is a developmental process which, following on from psychopathology and nosology is now increasingly affecting the field of treatment. The development of guidelines for the treatment of psychiatric diseases has now become well accepted, although the impact on routine practice is still limited. Treatment pathways bring recommendations from guidelines into a clear and practice-oriented algorithm. The prerequisite for this is the inclusion of all aspects and elements of the treatment as well as all professions involved in the treatment and a valid electronic data processing foundation. Such an approach is presented here with the example of the development and implementation of a clinical pathway for inpatients with schizophrenia. Initial results revealed that patients who received multi-professional treatment within such a clinical pathway, improved better than patients of the control group, as measured by CGI, PANSS and PSP. This shows that introduction of a clinical pathway leads to an improvement of treatment quality. Standardization of psychiatric treatment processes could be highly relevant in respect to the new remuneration system for psychiatry in Germany.
Clinical outcomes of severe malnutrition in a high tuberculosis and HIV setting.

Case death rates for severe childhood malnutrition remain stubbornly elevated in high HIV prevalence settings, despite the implementation of WHO guidelines. This study examined case death and other clinical outcomes in malnourished children with and without HIV infection.



A prospective, observational study was undertaken at three tertiary hospitals in Johannesburg, South Africa. All severely malnourished children had their HIV status established, and anthropometric, clinical and diagnostic findings and admission outcomes were analysed.



Just over half (51%) of the 113 severely malnourished children were HIV infected, but 31/58 (54%) of these children had their positive status diagnosed only after admission. Marasmic children were significantly more likely to be HIV infected (OR 9.7, 95% CI 3.5 to 29.1). Tuberculosis (TB) was strongly suspected and treated in 27 children (24%) although confirmed in only five (4%). The overall case death rate was 11.5%. HIV infection, pallor and shock were significant predictors of death. HIV-infected children were six times more likely to die compared with HIV-negative children (19% vs 3.6%, OR 6.2, 95% CI 1.2 to 59). HIV-'affected' children (HIV negative but exposed) and HIV-negative children had similar outcomes.



HIV infection significantly increases severe malnutrition case death. WHO guidelines for the management of severe malnutrition in high HIV prevalence settings need to be modified to include routine HIV and TB testing and offer guidance on the criteria and timing of TB treatment and highly active antiretroviral therapy initiation.
The "delay effect" of donning a gown during cardiopulmonary resuscitation in a simulation model.

We sought to determine whether the use of currently issued gowns delays initiation of chest compressions and ventilations during cardiopulmonary resuscitation and whether simple gown modifications can reduce this delay.



Firefighter defibrillation instructors were allocated into pairs and videotaped while performing standardized cardiac arrest scenarios. Three scenarios were compared: "no gown," "standard gown" and "modified gown." Key time intervals were extracted from videotaped data.



Ninety-five scenarios were analyzed. Mean time interval to chest compression was 39 seconds (95% confidence interval [CI] 34-43) for "no gown" scenarios, 71 seconds (95% CI 66-77) for "standard gown" scenarios and 59 seconds (95% CI 54-63) for "modified gown" scenarios (p < 0.001). Time to first ventilation was 146 seconds (95% CI 134-158), 238 seconds (95% CI 224-253) and 210 seconds (95% CI 198-223) in the 3 groups, respectively (p < 0.001). Post hoc testing showed that the time differences between all groups were statistically significant.



Standard gowns protect front-line care providers but cause significant delays to chest compressions and ventilations, potentially increasing patient morbidity and mortality. Minor gown modifications, including pre-tied neck straps and longer waist ties that tie in front, allow for easier use and shorter delays to time-critical interventions. Future research is required to reduce care delays while maintaining adequate protection of emergency medical service providers from infectious disease.
Dyspnea-12-Arabic: testing of an instrument to measure breathlessness in Arabic patients with chronic obstructive pulmonary disease.

The aim of this study was to develop the Dyspnoea-12-Arabic (D-12-A) questionnaire and test its reliability and validity for the assessment of breathlessness in Arabic speaking patients with chronic obstructive pulmonary disease (COPD) in Jordan.



Breathlessness is a complex multidimensional symptom which incorporates physiology and psychology.



The D-12-A, Hospital Anxiety and Depression Scale (HADS), and Quality of Life Index pulmonary version (QLI-P) were completed by 67 Jordanian patients with COPD. Cronbach alpha was used to assess internal consistency, and Pearson product-moment correlation calculated for construct validity.



The D-12-A and its sub-components ('physical' and 'affective') demonstrated excellent internal reliability (Cronbach alpha range from 0.88 to 0.91). D-12-A scores correlated significantly with other relevant outcome measures and demonstrated good construct validity.



The D-12-A should provide clinicians and researchers with a useful tool for the assessment of breathlessness in Arabic speaking patients with COPD.
Cost effectiveness of peginterferon alpha-2b plus ribavirin versus interferon alpha-2b plus ribavirin for initial treatment of chronic hepatitis C.

Peginterferon alpha-2b plus ribavirin therapy in previously untreated patients with chronic hepatitis C yields the highest sustained virological response rates of any treatment strategy but is expensive.



To estimate the cost effectiveness of treatment with peginterferon alpha-2b plus ribavirin compared with interferon alpha-2b plus ribavirin for initial treatment of patients with chronic hepatitis C.



Individual patient level data from a randomised clinical trial with peginterferon plus ribavirin were applied to a previously published and validated Markov model to project lifelong clinical outcomes. Quality of life and economic estimates were based on German patient data. We used a societal perspective and applied a 3% annual discount rate.



Compared with no antiviral therapy, peginterferon plus fixed or weight based dosing of ribavirin increased life expectancy by 4.2 and 4.7 years, respectively. Compared with standard interferon alpha-2b plus ribavirin, peginterferon plus fixed or weight based dosing of ribavirin increased life expectancy by 0.5 and by 1.0 years with incremental cost effectiveness ratios of 11,800 euros and 6600 euros per quality adjusted life year (QALY), respectively. Subgroup analyses by genotype, viral load, sex, and histology showed that peginterferon plus weight based ribavirin remained cost effective compared with other well accepted medical treatments.



Peginterferon alpha-2b plus ribavirin should reduce the incidence of liver complications, prolong life, improve quality of life, and be cost effective for the initial treatment of chronic hepatitis C.