nils-herrmann/clean_scirepeval huggingface dataset:
Self-management of fatigue in rheumatoid arthritis: a randomised controlled trial of group cognitive-behavioural therapy

To investigate the effect of group cognitive behavioural therapy (CBT) for fatigue self-management, compared with groups receiving fatigue information alone, on fatigue impact among people with rheumatoid arthritis (RA).



Two-arm, parallel randomised controlled trial in adults with RA, fatigue ≥ 6/10 (Visual Analogue Scale (VAS) 0-10, high bad) and no recent change in RA medication. Group CBT for fatigue self-management comprised six (weekly) 2 h sessions, and consolidation session (week 14). Control participants received fatigue self-management information in a 1 h didactic group session. Primary outcome at 18 weeks was the impact of fatigue measured using two methods (Multi-dimensional Assessment of Fatigue (MAF) 0-50; VAS 0-10), analysed using intention-to-treat analysis of covariance with multivariable regression models.



Of 168 participants randomised, 41 withdrew before entry and 127 participated. There were no major baseline differences between the 65 CBT and 62 control participants. At 18 weeks CBT participants reported better scores than control participants for fatigue impact: MAF 28.99 versus 23.99 (adjusted difference -5.48, 95% CI -9.50 to -1.46, p=0.008); VAS 5.99 versus 4.26 (adjusted difference -1.95, 95% CI -2.99 to -0.90, p<0.001). Standardised effect sizes for fatigue impact were MAF 0.59 (95% CI 0.15 to 1.03) and VAS 0.77 (95% CI 0.33 to 1.21), both in favour of CBT. Secondary outcomes of perceived fatigue severity, coping, disability, depression, helplessness, self-efficacy and sleep were also better in CBT participants.



Group CBT for fatigue self-management in RA improves fatigue impact, coping and perceived severity, and well-being.
Evaluation of a new online hemodiafiltration mode with automated pressure control of convection.

Postdilution hemodiafiltration (HDF) still remains the gold standard for solute removal, but with high hemoglobin levels transmembrane pressure (TMP) may reach high levels, reducing filter performance. We compared three online postdilution HDF treatments without TMP alarms for convective volume and plasma changes following treatment.



Twelve patients were enrolled in a trial with three online postdilution HDF treatments. In the volume-controlled mode (VOLc), we set the exchanged volume to obtain a filtration fraction close to 25% without TMP alarms. In the pressure-controlled mode (TMPc), we set the TMP at 100 mm Hg. In the ULTRAc mode (TMP scan combined with TMPc), the dialysis machine automatically selects the TMP with a scan. All treatments were performed with an AK200 ULTRA-S system.



Even with hemoglobin levels >12 g/dl, we found a 57% rise in ultrafiltration rate in TMPc versus VOLc and a 92% rise in ULTRAc versus VOLc. Phosphates and myoglobin levels were significantly affected by treatment type.



ULTRAc may be a useful tool to achieve an excellent purification performance without the constraints associated with the risk of hemoconcentration.
Which patients improve the most after arthritis rehabilitation? A study of predictors in patients with inflammatory arthritis in Northern Europe, the STAR-ETIC collaboration.

To study health-related quality of life (HRQoL) in arthritis rehabilitation performed by multidisciplinary teams in patients with chronic inflammatory arthritis. Predictors of change in health-related quality of life and the proportion of patients with clinical improvement were investigated.



Multicentre prospective observational study in 4 European countries.



HRQoL was measured with the European Quality 5 Dimensions (EQ-5D) and the Short Form 36 Health Survey (SF-36) in 731 patients who underwent multidisciplinary rehabilitation. Potential predictors were physical functioning (Health Assessment Questionnaire (HAQ)), self-efficacy (Arthritis Self Efficacy Scale (ASES)), psychological health (Hopkins Symptom Check List (HSCL-25)), pain/fatigue (numeric rating scales (NRS)), age, sex, diagnosis, comorbidity, education, clinical setting and change of medication during rehabilitation. Analysis of covariance (ANCOVA) was used to assess for potential predictors and interactions. The minimal important differences for HRQoL were analysed.



Reporting worse function (b 0.05, p = 0.01), less psychological well-being (b 0.09, p = 0.000), and experiencing more pain (b 0.03, p = 0.000) or fatigue (b 0.02, p = 0.000) at admission predicted improved HRQoL. Change in medication during rehabilitation (b 0.08, p = 0.013) was associated with greater improvement in HRQoL. These EQ-5D findings were supported by SF-36 findings. Positive minimal important differences were noted in 46% (EQ-5D) and 23-47% (SF-36 subscales) of the patients.



Patients with more severe symptoms experienced the largest gain in HRQoL post-intervention. The results of this study are of value for selecting the right patients for rheumatological team rehabilitation.
Nonoxidized, biologically active parathyroid hormone determines mortality in hemodialysis patients.

It was shown that nonoxidized PTH (n-oxPTH) is bioactive, whereas the oxidation of PTH results in a loss of biological activity.



In this study we analyzed the association of n-oxPTH on mortality in hemodialysis patients using a recently developed assay system.



Hemodialysis patients (224 men, 116 women) had a median age of 66 years. One hundred seventy patients (50%) died during the follow-up period of 5 years. Median n-oxPTH levels were higher in survivors (7.2 ng/L) compared with deceased patients (5.0 ng/L; P = .002). Survival analysis showed an increased survival in the highest n-oxPTH tertile compared with the lowest n-oxPTH tertile (χ², 14.3; P = .0008). Median survival was 1702 days in the highest n-oxPTH tertile, whereas it was only 453 days in the lowest n-oxPTH tertile. Multivariable-adjusted Cox regression showed that higher age increased odds for death, whereas higher n-oxPTH reduced the odds for death. Another model analyzing a subgroup of patients with intact PTH (iPTH) concentrations at baseline above the upper normal range of the iPTH assay (70 ng/L) revealed that mortality in this subgroup was associated with oxidized PTH but not with n-oxPTH levels.



The predictive power of n-oxPTH and iPTH on the mortality of hemodialysis patients differs substantially. Measurements of n-oxPTH may reflect the hormone status more precisely. The iPTH-associated mortality is most likely describing oxidative stress-related mortality.
Therapy of Established Postmenopausal Osteoporosis with Monofluorophosphate plus Calcium: Dose-Related Effects on Bone Density and Fracture Rate

Recent experience from different groups suggests that low fluoride doses resulting in moderate increases in bone mineral density (BMD) may be advantageous in terms of fracture-reducing potency. In a randomized prospective 3-year study we examined the therapeutic efficacy of different dosages of monofluorophosphate (MFP) plus calcium in comparison with calcium alone in 134 women with established postmenopausal osteoporosis (mean age 64.0 years, average vertebral fractures per patient 3.6). Group A received 1000 mg calcium/day and a low-dose intermittent MFP regimen (3 months on, 1 month off) corresponding to an average daily fluoride ion dose of 11.2 mg. Group B received 1000 mg calcium/day plus continuous MFP corresponding to 20 mg fluoride ions per day. Group C was treated with 1000 mg calcium alone throughout the study period. Bone density was measured with dual-energy X-ray absorptiometry at L2–4 and three proximal femur areas and with single photon absorptiometry at two radius sites. New vertebral fractures were identified from annual lateral radiographs of the spine. A significant reduction in subjective complaints as measured by a combined pain–mobility score (CPMS) was found in both fluoride groups in comparison with the calcium monotherapy group. Group A showed increases in BMD at all six measuring sites, reaching +12.6% at the spine after 3 years. In group B we found significant increases at the spine, Ward’s triangle and distal radius, but slight decreases at the femoral neck and radius shaft. For the spine the average change amounted to +19.5% after 3 years. In group C losses of BMD were observed at all six sites, with an average loss of 1.6% for the spine at the end of the study. The incidence of new vertebral fractures per 100 patient-years was 8.6, 17.0 and 31.6 in groups A, B and C, respectively. In conclusion, both calcium–MFP regimens resulted in significantly lower vertebral fracture rates than calcium monotherapy. However, the low intermittent MFP regimen, leading to a mean annual increase in spinal BMD of only 4.2%, showed a clear trend to greater effectiveness in reducing vertebral fracture than the higher fluoride dosage that was followed by an average spinal BMD increase of 6.5% per year. Furthermore the rate of fluoride-specific side effects (lower-extremity pain syndrome) was 50% lower in patients receiving the lower fluoride dosage.
Early post-operative endoscopic recurrence in Crohn's disease patients: data from an Italian Group for the study of inflammatory bowel disease (IG-IBD) study on a large prospective multicenter cohort.

The incidence of endoscopic recurrence (ER) in Crohn's disease following curative resection is up to 75% at 1 year. Endoscopy is the most sensitive method to detect the earliest mucosal changes and the severe ER at 1 year seems to predict a clinical relapse.



The aim of this prospective study was to evaluate the incidence of early ER 6 months after curative resection. Secondary outcome was to evaluate the role of 5-aminosalicylic acid (5-ASA) in the prevention of ER at 6 months. A total of 170 patients were included in the study. They were carried-out from the evaluation of the appearance of ER during a trial performed to assess the role of azathioprine vs. 5-ASA as early treatment of severe ER. All the patients started 5-ASA treatment 2 weeks after surgery.



Six months after surgery ER was observed in 105 patients (62%). The endoscopic score was reported as severe in 78.1% of them (82 out of 105). At univariable analysis only ileo-colonic disease influenced the final outcome associating to a lower risk of severe ER (p=0.04; OR 0.52, 95% CI 0.277-0.974).



In this prospective Italian multicenter IG-IBD study a great proportion of ER occur within 6 months from ileo-colonic resection, with a significant rate of severe ER. Furthermore this study confirms the marginal role of 5-ASA in the prevention of ER. This suggests that post-surgical endoscopic evaluation should be performed at 6 months instead of 1 year to allow an adequate early treatment.
Time of day for exercise on blood pressure reduction in dipping and nondipping hypertension

Time of day (TOD) for exercise may influence blood pressure (BP) reduction in hypertension because of the diurnal variation of BP and the duration of BP reduction following a single bout of exercise. The purpose of this study was to observe the effects of TOD for exercise on ambulatory blood pressure reduction in dipping (n=5) and nondipping (n=9) hypertension (<10% drop in nighttime BP (BPnight)).  (1) evening exercise (PMex) would exhibit a greater BPnight reduction in Non-Dippers than Dippers, (2) morning exercise (AMex) would exhibit similar daytime BP (BPday) reduction in Dippers and Non-Dippers, (3) AMex would exhibit greater 24 h BP (BP24 h) reduction than PMex in Dippers, and (4) AMex and PMex would exhibit similar BP24 h reduction in Non-Dippers. BP responses to AMex (0600–0800 h; 30 min at 50% VO2peak) and PMex (1700–1900 h) were compared to each control day in a randomized design. Systolic (S) and diastolic (D) BP were averaged for BP24 h, BPday, and BPnight. A two-way ANOVA (dipping X time of exercise) using BP reduction with repeated measures were performed at P<0.05.  (1) Non-Dippers respond to exercise despite of TOD for exercise, (2) PMex exhibited a greater SBPnight reduction in Non-Dippers than Dippers, (3) AMex exhibited similar SBPday reductions in Dippers and Non-Dippers, and (4) AMex and PMex exhibited similar SBP24 h reduction in Dippers and Non-Dippers. Dippers and Non-Dippers respond differently to TOD for exercise. The duration of the BP reduction persists up to 24 h after exercise.
Effect of Depot Medoxyprogesterone Acetate on Immune Functions and Inflammatory Markers of HIV-Infected Women.

Depot medroxyprogesterone acetate (DMPA) was associated with increased HIV transmission and accelerated disease progression in untreated women. The potential underlying mechanisms include immune modulation. We evaluated the effect of a single DMPA injection on cell-mediated immunity (CMI), T-cell activation, T-cell regulation (Treg), and inflammation in HIV-infected women on combination antiretroviral regimen (cART).



Women with HIV plasma RNA ≤ 400 copies per milliliter on stable cART received DMPA and had immunologic and medroxyprogesterone acetate (MPA) measurements at baseline, 4 weeks [peak MPA concentration (Cmax)], and 12 weeks [highest MPA area under the concentration curve].



At baseline, among 24 women with median age of 32 years and 622 CD4(+) cells per microliter, ≥ 68% had HIV, varicella-zoster virus, phytohemagglutinin A and CD3/CD28 CMI measured by lymphocyte proliferation, and/or IFNγ/IL2 dual-color fluorospot. CMI did not significantly change after DMPA administration except for a 1.4-fold increase in IL2/IFNγ varicella-zoster virus fluorospot at week 12. T-cell activation decreased after DMPA administration, reaching statistical significance at week 12 for CD4(+)CD25+%. Treg behaved heterogeneously with an increase in CD8+FOXP3+% at week 4 and a decrease in CD4+IL35+% at week 12. There was a decrease in TGFβ at week 12 and no other changes in plasma biomarkers. Correlation analyses showed that high MPA Cmax and/or area under the concentration curve were significantly associated with increases of IFNγ HIV enzyme-linked ImmunoSpot, CD4+IL35+%, and CD4+TGFβ+% Treg and decreases of plasma IL10 from baseline to weeks 4 and/or 12.



A single dose of DMPA did not have immune-suppressive or pro-inflammatory effects in HIV-infected women on cART. Additional studies need to assess the effect of multiple doses.
Adoption of workplaces and reach of employees for a multi-faceted intervention targeting low back pain among nurses’ aides

Workplace adoption and reach of health promotion are important, but generally poorly reported. The aim of this study is therefore to evaluate the adoption of workplaces (organizational level) and reach of employees (individual level) of a multi-faceted workplace health promotion and work environment intervention targeting low back pain among nurses' aides in elderly care.



Percentage of adopters was calculated among eligible workplaces and differences between adopters and non-adopters were evaluated through workplace registrations and manager questionnaires from all eligible workplaces. From the adopted workplaces reach was calculated among eligible employees as the percentage who responded on a questionnaire. Responders were compared with non-responders using data from company registrations. Among responders, comparisons based on questionnaire data were performed between those consenting to participate in the intervention (consenters) and those not consenting to participate in the intervention (non-consenters). Comparisons were done using Student's t-test for the continuous variables, Fisher's exact test for dichotomous variables and the Pearson's chi(2) for categorical variables. Moreover odds ratios for non-responding and non-consenting were investigated with binary logistic regression analyses.



The project was adopted by 44% of the offered workplaces. The main differences between adopters and non-adopters were that workplaces adopting the intervention had a more stable organization as well as a management with positive beliefs of the intervention's potential benefits. Of eligible employees, 71% responded on the questionnaire and 57% consented to participate. Non-responders and non-consenters did not differ from the responders and consenters on demographic factors and health. However, more non-responders and non-consenters were low skilled, worked less than 30 hours pr. week, and worked evening and nightshift compared to responders and consenters, respectively. Consenters had more musculoskeletal pain and reduced self-rated health, as well as higher physical exertion during work compared to non-consenters.



Our recruitment effort yielded a population of consenters that was representative of the target population of nurses' aides with respect to demographic factors, and health. Moreover more consenters had problems like pain and high physical exertion during work, which fitted the scope of the intervention.
Microdevices for dielectrophoretic flow - through cell separation

A novel dielectrophoretic cell-separation technique has been developed for the separation of white blood cells. A microdevice was constructed from two consecutive arrays of microelectrodes, one to focus the particles into a sheet and the second to separate them using a combination of positive and negative dielectrophoresis. At a flow rate of 1 ml/hour, experiments showed that THP-1 cells were captured on the electrode array. The experimental results were compared with a 2-D numerical simulation of the particle dynamics. The device is shown to be effective at fractionating subpopulations of cells into different bands along the array.
Restricted-Expressed Proliferation–Associated Protein (Repp86) Expression in Squamous Cell Carcinoma of the Oral Cavity

To determine the expression of repp86 (restricted–expressed protein of 86 kDa theoretical molecular mass), a proliferation– associated protein expressed in S–, G2– and M–phases of the cell cycle, in samples of normal mucosa as well as squamous cell carcinoma of the oral cavity (OSCC). The repp86 labeling index (LI) was determined imunohistochemically in ten samples of normal oral mucosa and 59 samples of OSCC. Repp86 LI was correlated with tumor stage, histopathologic grading, and the expression of Ki–67 and topoisomerase IIα. Repp86 was detectable in all tissues analyzed. The mean LI was 4.7% for normal mucosa and 18.4% for squamous cell carcinoma (p < 0.0001). Repp86 expression was not related to tumor size, lymph node invasion, or histopathologic grading but was positively correlated with Ki–67 index (r = 0.48; p < 0.01) as well as with topoisomerase IIα (r = 0.39; p < 0.01). Ki–67 and topoisomerase IIα levels were also significantly correlated with each other (r = 0.34; p < 0.05). These results indicate that repp86 expression can be an additional proliferation marker among Ki–67 and topoisomerase IIα in OSCC. Further research will be directed at the evaluation of the prognostic value of repp86 expression in OSCC as well as in leukoplakia and early–stage OSCC. Erfassung der Expression von Repp86 ("restricted–expressed proliferation–associated protein"), eines in den Zyklusphasen S, G2 und M exprimierten, proliferationsassoziierten Proteins, bei Normalschleimhaut und Plattenepithelkarzinomen der Mundhöhle. Im Rahmen dieser retrospektiven Untersuchung wurde formalinfixiertes histopathologisches Routinematerial von 59 Patienten mit Plattenepithelkarzinomen der Mundhöhle sowie zehn Proben unveränderter normaler Mundschleimhaut untersucht. Die Markierungsindizes von Repp86, Ki–67 und Topoisomerase IIα wurden immunhistochemisch ermittelt und mit klinischen Parametern korreliert. Repp86 konnte in allen untersuchten Gewebeproben nachgewiesen werden. Der mittlere Markierungsindex betrug 4,7% in normaler Mundschleimhaut sowie 18,4% in Proben von Plattenepithelkarzinomen der Mundhöhle (p < 0,0001). Ein signifikanter Zusammenhang zwischen Repp86–Expression und TNM–Stadium bzw. histopathologischem Differenzierungsgrad zeigte sich nicht. Dagegen korrelierten die Markierungsindizes von Repp86 und Ki–67 bzw. Topoisomerase IIα (r = 0,48; p < 0,01 bzw. r = 0,39; p < 0,01) sowie die Markierungsindizes von Ki–67 und Topoisomerase IIα (r = 0,34; p < 0,05). Die Ergebnisse dieser Studie zeigen, dass die Repp86–Expression zur Beurteilung der Proliferationsaktivität beim Plattenepithelkarzinom der Mundhöhle herangezogen werden kann. Im Rahmen weiterer Studien wird die prognostische Bedeutung der Repp86–Expression beim Plattenepithelkarzinom der Mundhöhle untersucht werden.
Effects of intravenous zoledronate on bone turnover and BMD persist for at least 24 months.

The duration of the antiresorptive effects of the intravenous bisphosphonate, zoledronate, is not known. Recently, we reported that two annual 4-mg doses of zoledronate suppressed bone turnover and increased BMD in HIV-infected men over 24 mo. We set out to determine the persistence of these effects after two doses of zoledronate. Thirty-three HIV-infected men who completed a randomized trial of 4 mg annual zoledronate (n = 17) or placebo (n = 16) were studied for a further 12 mo, during which time no skeletal therapy was administered. Participants received calcium (400 mg/d) and vitamin D supplements (50,000 IU/mo) for the first 24 mo of the study only. Biochemical markers of bone turnover and BMD were measured every 6 mo. Bone turnover markers were stably suppressed at 24 and 36 mo (12 and 24 mo after the second annual dose of zoledronate, respectively). There were no significant within-group changes in urine N-telopeptide, serum C-telopeptide, and osteocalcin between 24 and 36 mo (p > 0.07), and at each time point, each of the turnover markers was significantly lower in the zoledronate group. There were also no significant between-group differences in the changes in BMD at each site between 24 and 36 mo (p > 0.5), and at each time point, BMD at each site was significantly higher in the zoledronate group. These results suggest that the antiresorptive effects of zoledronate last >12 mo and raise the possibility that zoledronate could be administered less frequently than annually. Randomized trials that address this issue should be performed.