nils-herrmann/clean_scirepeval huggingface dataset:
Effects of massage therapy on sleep quality after coronary artery bypass graft surgery

Having poor sleep quality is common among patients following cardiopulmonary artery bypass graft surgery. Pain, stress, anxiety and poor sleep quality may be improved by massage therapy.



This study evaluated whether massage therapy is an effective technique for improving sleep quality in patients following cardiopulmonary artery bypass graft surgery.



Participants included cardiopulmonary artery bypass graft surgery patients who were randomized into a control group and a massage therapy group following discharge from the intensive care unit (Day 0), during the postoperative period. The control group and the massage therapy group comprised participants who were subjected to three nights without massage and three nights with massage therapy, respectively. The patients were evaluated on the following mornings (i.e., Day 1 to Day 3) using a visual analogue scale for pain in the chest, back and shoulders, in addition to fatigue and sleep. Participants kept a sleep diary during the study period.



Fifty-seven cardiopulmonary artery bypass graft surgery patients were enrolled in the study during the preoperative period, 17 of whom were excluded due to postoperative complications. The remaining 40 participants (male: 67.5%, age: 61.9 years ± 8.9 years, body mass index: 27.2 kg/m² ± 3.7 kg/m²) were randomized into control (n = 20) and massage therapy (n = 20) groups. Pain in the chest, shoulders, and back decreased significantly in both groups from Day 1 to Day 3. The participants in the massage therapy group had fewer complaints of fatigue on Day 1 (p=0.006) and Day 2 (p=0.028) in addition, they reported a more effective sleep during all three days (p=0.019) when compared with the participants in the control group.



Massage therapy is an effective technique for improving patient recovery from cardiopulmonary artery bypass graft surgery because it reduces fatigue and improves sleep.
Influence of hormonal and reproductive factors on the risk of vertebral deformity in European women

The aim of this study was to determine whether variation in the level of selected hormonal and reproductive variables might explain variation in the occurrence of vertebral deformity across Europe. A population-based cross-sectional survey method was used. A total of 7530 women aged 50–79 years and over were recruited from 30 European centres. Subjects were invited to attend for an interviewer-administered questionnaire and lateral spinal radiographs which were taken according to a standard protocol. After adjusting for age, centre, body mass index and smoking, those in the highest quintile of menarche (age 2=16 years) had an increased risk of vertebral deformity (odds ratio [OR]=1.48; 95% confidence interval [CI] 1.16, 1.88). Increased menopausal age (>52.5 years) was associated with a reduced risk of deformity (OR=0.78; 95% CI 0.60, 1.00), while use of the oral contraceptive pill was also protective (OR=0.76; 95% CI 0.58, 0.99). There was a smaller protective effect associated with one or more years use of hormone replacement therapy, though the confidence limits clearly embraced unity. There was no apparent effect of parity or breast-feeding on the risk of deformity. We conclude that oestrogen status is an important determinant of vertebral deformity. Ever use of the oral contraceptive pill was associated with a 25% reduction in risk of deformity though the effect may be a result of the higher-dosage oestrogen pills used in the past. Parity and breast-feeding do not appear to be important and would appear to have little potential for identification of women at high risk of vertebral deformity.
Dementia in residential care: education intervention trial (DIRECT); protocol for a randomised controlled trial

There is scope to improve the quality of life (QOL) of people with dementia living in residential care facilities (RCF). The DIRECT study will determine if delivery of education to General Practitioners (GPs) and care staff improves the quality of life of residential care recipients with cognitive impairment.



A prospective randomised controlled trial conducted in residential aged care facilities in the metropolitan area of Perth, Western Australia. Participants are care facility residents, aged 65 years and older and with mini-mental state examination scores less than 25. GPs and care facility staff have been independently randomised to intervention or control groups. An education programme, designed to meet the perceived needs of learners, will be delivered to GPs and care staff in the intervention groups. The primary outcome of the study will be quality of life of the people with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD) and Alzheimer Disease Related QOL Scale (ADRQL), 4 weeks and 6 months after the conclusion of the education intervention.



Recruitment of 351 people with dementia, cared for by staff in 39 residential facilities and 55 GPs, was undertaken between May 2007 and July 2008. Collection of baseline data is complete. Education has been delivered to GPs and Care staff between September 2008 and July 2009. Follow-up data collection is underway.



The study results will have tangible implications for proprietors, managers and staff from the residential care sector and policy makers. The results have potential to directly benefit the quality of life of both patients and carers.
Total elbow arthroplasty for acute distal humeral fractures in patients over 65 years old - results of a multicenter study in 87 patients.

Fractures of the distal humerus represent 5% of osteoporosis fragility fractures in subjects over the age of 60. Osteoporosis, comorbidities and intra-articular comminution make management of this entity difficult.



The hypothesis was that total elbow arthroplasty could be a reliable treatment option in subjects over the age of 65 presenting with a fracture of the distal humerus.



Eight-seven patients (80 women and 7 men) mean age 79 years old (65-93) underwent total elbow arthroplasty for the treatment of an AO type A fracture in 9 cases, type B in 8 and type C in 70.



After a mean follow-up of 37.5 months (6-106) the Mayo Elbow Performance Score MEPS was 86±14, the quick-DASH score was 24±19 and the Katz score was 5±1.5 points. The MEPS was better in patients with a high preoperative Katz score and a history of inflammatory arthritis who were living at home. Fifty-five patients (63%) presented with a pain-free elbow, and 20 (24%) with slight pain. The flexion-extension range of motion was 97±22° and 48% presented with a flexion-extension arc of at least 100°. Function was normal in 69 patients. Complications were identified in 20 cases (23%) and revision surgery was necessary in 8 (9%). Two arthroplasties had to be changed, one for a fracture of the humeral stem component and the other for loosening. Only one infection occurred in this series.



Total elbow arthroplasties provide fractured patients with immediate satisfactory results and a stable, painless and functional elbow. These results seem to be reliable and durable. The rate of complications is low with revision surgery in approximately 10%.
[Etiology and clinical management of anemia in heart failure. GESAIC Study].

Studies about anemia in heart failure (HF) tend to link the anemia to a cardio-renal dysfunction, and its syndromic value is seldom evaluated. Our objective was to assess the etiology and clinical management of anemia in HF patients in a hospital setting.



Initial cross-sectional analysis of a multi-center and prospective cohort of patients with HF and anemia. Anemia was defined according to the WHO criteria; the Modification of Diet in Renal Disease equation was used to assess glomerular filtration and the etiology of anemia was defined according to common criteria.



We evaluated 228 patients, with a median age of 79.1 years and 59.65% women. Iron deficiency anemia was present in 36,8% of patients and anemia of chronic disease in 30.3%. Of note, 12.7% cases did not meet any etiological criteria. The main factor associated with iron deficiency was anti-platelet therapy (OR=1.99; 95% CI, 1.16-1.68) and the main factors associated with anemia of chronic disease were the use of angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor antagonists (ARA-II) (OR=3.29; 95% CI, 1.36-7.94). The main factor associated with undefined anemia was initial heart failure (OR=5.41; 95% CI, 1.65-17.65). On the other hand, 8.1% of patients required transfusion, 6% were treated with erythropoietin and 25.3% were treated with iron. Both age (OR=1.04; 95% CI, 1-1.08) and hemoglobin level at admission (OR=1.81; 95% CI, 1.46-2.25) were associated with active treatment for anemia.



A clinical study of anemia in patients with HF can establish an etiological diagnosis in 70% of cases, resulting in a more effective treatment.
Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin.

Tesamorelin, a growth hormone-releasing hormone analogue, decreases visceral adipose tissue (VAT) by 15%-20% over 6-12 months in individuals with human immunodeficiency virus (HIV)-associated abdominal adiposity, but it is unknown whether VAT reduction is directly associated with endocrine and metabolic changes.



In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks. At week 26, patients initially receiving tesamorelin were randomly assigned to continue receiving tesamorelin or to receive placebo for an additional 26 weeks. In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with ≥8% reduction in VAT were defined a priori as responders per the statistical analysis plan. Post hoc analyses were performed to assess differences between responders and nonresponders.



Compared with tesamorelin nonresponders, responders experienced greater mean (±SD) reduction in triglyceride levels (26 weeks: -0.6 ± 1.7 mmol/L vs -0.1 ± 1.2 mmol/L [P = .005]; 52 weeks: -0.8 ± 1.8 mmol/L vs 0.0 ± 1.1 mmol/L [P = .003]) and attenuated changes in fasting glucose levels (26 weeks: 1 ± 16 mg/dL vs 5 ± 14 mg/dL [P = .01]; 52 weeks: -1 ± 14 mg/dL vs 8 ± 17 mg/dL [P < .001]), hemoglobin A1c levels (26 weeks: 0.1 ± 0.3% vs 0.3 ± 0.4% [P < .001]; 52 weeks: 0.0 ± 0.3% vs 0.2 ± 0.5% [P = .003]), and other parameters of glucose homeostasis. Similar patterns were seen for adiponectin levels, with significant improvement in responders vs nonresponders. Changes in lipid levels and glucose homeostasis were significantly associated with percentage change in VAT.



In contrast to nonresponders, HIV-infected patients receiving tesamorelin with ≥8% reduction in VAT have significantly improved triglyceride levels, adiponectin levels, and preservation of glucose homeostasis over 52 weeks of treatment.
Simultaneous integrated boost of biopsy proven, MRI defined dominant intra-prostatic lesions to 95 Gray with IMRT: early results of a phase I NCI study

To assess the feasibility and early toxicity of selective, IMRT-based dose escalation (simultaneous integrated boost) to biopsy proven dominant intra-prostatic lesions visible on MRI.



Patients with localized prostate cancer and an abnormality within the prostate on endorectal coil MRI were eligible. All patients underwent a MRI-guided transrectal biopsy at the location of the MRI abnormality. Gold fiducial markers were also placed. Several days later patients underwent another MRI scan for fusion with the treatment planning CT scan. This fused MRI scan was used to delineate the region of the biopsy proven intra-prostatic lesion. A 3 mm expansion was performed on the intra-prostatic lesions, defined as a separate volume within the prostate. The lesion + 3 mm and the remainder of the prostate + 7 mm received 94.5/75.6 Gray (Gy) respectively in 42 fractions. Daily seed position was verified to be within 3 mm.



Three patients were treated. Follow-up was 18, 6, and 3 months respectively. Two patients had a single intra-prostatic lesion. One patient had 2 intra-prostatic lesions. All four intra-prostatic lesions, with margin, were successfully targeted and treated to 94.5 Gy. Two patients experienced acute RTOG grade 2 genitourinary (GU) toxicity. One had grade 1 gastrointestinal (GI) toxicity. All symptoms completely resolved by 3 months. One patient had no acute toxicity.



These early results demonstrate the feasibility of using IMRT for simultaneous integrated boost to biopsy proven dominant intra-prostatic lesions visible on MRI. The treatment was well tolerated.
Mild intraoperative hypothermia reduces production of reactive oxygen intermediates by polymorphonuclear leukocytes.

Mild hypothermia directly impairs numerous immune functions in vitro. However, the in vivo effects of mild hypothermia on neutrophil phagocytosis and oxidative killing remain unknown. We tested the hypothesis that mild intraoperative hypothermia decreases neutrophil phagocytic capacity and generation of reactive oxygen intermediates (a measure of oxidative killing). Additionally, we evaluated the effects of in vitro temperature manipulations on each function. Thermal management was randomly assigned in 10 surgical patients, causing intraoperative core temperatures to range from 33 to 37 degrees C. Production of reactive oxygen intermediates and neutrophil phagocytosis were evaluated using flow cytometry at ambient temperature. Phagocytic capacity was assessed by uptake of fluorescein isothiocyanate-labeled Escherichia coli. Reactive oxygen production was estimated by the intracellular conversion of dihydrorhodamine 123 to rhodamine 123. Blood samples were obtained preoperatively, 1 h after surgery started, and 2 h postoperatively. Blood was also obtained from 10 matched control subjects and tested at 32, 37, and 40 degrees C. Neutrophil oxidative and phagocytic capacities were significantly reduced intraoperatively, compared with preoperative and postoperative values. Intraoperative production of reactive oxygen species was linearly related to core temperature. In contrast, there was no correlation between core temperature and phagocytic activity. In vitro production of reactive oxygen intermediates increased sixfold from 32 to 40 degrees C. In vitro phagocytic capacity increased fourfold in this temperature range. Production of oxidative intermediates was most closely related to intraoperative core temperature, decreasing nearly fourfold over a 4 degree C range. This in vitro temperature dependence was matched in vitro. Impaired neutrophil oxidative killing may contribute to the observed hypothermia-induced reduction in resistance to infection.
Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial

Low back pain (LBP) is a common health problem and a substantial part of LBP is presumed to be attributable to degeneration of the intervertebral disc. For patients suffering from intractable discogenic LBP, there are few evidence-based effective interventional treatment options available. In 2010, the results of a randomized controlled trial (RCT) were published concerning "intradiscal methylene blue injection" (IMBI), in which this intervention appeared to be very successful in relieving discogenic pain. Therefore, we decided to repeat this study to investigate whether we could replicate the published results. The results of our preliminary feasibility study gave reason to set up an RCT. The aim of this RCT is to evaluate if IMBI is a more effective treatment of discogenic low back pain as an intradiscal placebo intervention, and furthermore, to assess the cost-effectiveness of this intervention.



Consecutive discogenic low back pain patients referred to four specialized pain treatment facilities are being screened for eligibility. After a positive standardized provocation discography and informed consent, patients are randomized into two groups. The treatment group receives an intradiscal injection with methylene blue, lidocaine, and contrast, and the control group receives intradiscal isotonic saline with lidocaine and contrast. Main outcome measures are pain at the 6-month follow-up, patient's global impression of change, cost-effectiveness, quality of life, disability, and analgesic intake.



The importance of this study is emphasized by the fact that for intractable discogenic low back pain patients, evidence-based effective pain treatments are rare. If this study establishes clinical success and cost-effectiveness, IMBI could become the "pain treatment of choice" for a selected group of patients with chronic discogenic low back pain for whom noninvasive treatment options have failed.
Oral administration of RAC-alpha-lipoic acid modulates insulin sensitivity in patients with type-2 diabetes mellitus: a placebo-controlled pilot trial.

Alpha-lipoic acid (ALA), a naturally occuring compound and a radical scavenger was shown to enhance glucose transport and utilization in different experimental and animal models. Clinical studies described an increase of insulin sensitivity after acute and short-term (10 d) parenteral administration of ALA. The effects of a 4-week oral treatment with alpha-lipoic acid were evaluated in a placebo-controlled, multicenter pilot study to determine see whether oral treatment also improves insulin sensitivity. Seventy-four patients with type-2 diabetes were randomized to either placebo (n = 19); or active treatment in various doses of 600 mg once daily (n = 19), twice daily (1200 mg; n = 18), or thrice daily (1800 mg; n = 18) alpha-lipoic acid. An isoglycemic glucose-clamp was done on days 0 (pre) and 29 (post). In this explorative study, analysis was done according to the number of subjects showing an improvement of insulin sensitivity after treatment. Furthermore, the effects of active vs. placebo treatment on insulin sensitivity was compared. All four groups were comparable and had a similar degree of hyperglycemia and insulin sensitivity at baseline. When compared to placebo, significantly more subjects had an increase in insulin-stimulated glucose disposal (MCR) after ALA treatment in each group. As there was no dose effect seen in the three different alpha-lipoic acid groups, all subjects receiving ALA were combined in the "active" group and then compared to placebo. This revealed significantly different changes in MCR after treatment (+27% vs. placebo; p < .01). This placebo-controlled explorative study confirms previous observations of an increase of insulin sensitivity in type-2 diabetes after acute and chronic intravenous administration of ALA. The results suggest that oral administration of alpha-lipoic acid can improve insulin sensitivity in patients with type-2 diabetes. The encouraging findings of this pilot trial need to be substantiated by further investigations.
Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study

Deterioration of health related quality of life (HRQoL) is common in brain tumor patients. This study evaluated validity and reliability of the Medical Outcomes Study 36-Item Short Form (SF-36) in patients with brain tumors.



Two hundred and seventy-seven patients admitted for brain tumor surgery were evaluated for HRQoL (SF-36 questionnaire); depressive symptoms (Beck Depression Inventory-II or BDI-II); and functional status (Barthel index or BI). Final histological diagnosis was obtained from pathology reports.



Two-hundred and twenty-seven (completion rate of 82%) patients (69% women; mean age 55.8 ± 14.4 years) completed the SF-36 questionnaire. The most common brain tumor diagnosis was meningioma (40%), followed high-grade glioma (19%). Missing data rates were ≤4%. Internal consistency was adequate for all (Cronbach α ≥ .728) but Social Functioning (Cronbach α = .527) and General Health (Cronbach α = .693) subscales. Ceiling (≥36%) and floor (≥22%) effect rates were the greatest for the Role Limitations subscales. The SF-36 subscales pertaining physical health correlated the strongest with the BI score, while the SF-36 subscales pertaining emotional health correlated the strongest with the BDI-II score. Patients with mild-moderate depressive symptoms (BDI-II score ≥20) scored lower across all SF-36 subscales, and handicap patients (BI score <90) scored the lower across all, but Mental Health, subscales.



The SF-36 is a valid and reliable instrument in brain tumor patients and therefore can be reliably applied for evaluation of HRQoL in neuro-oncology setting. Further studies exploring other psychometric properties of the SF-36 in brain tumor patients across disease progression stages are warranted.
HIV-1 DNA concentrations and evolution among African HIV-1-infected children under antiretroviral treatment (ANRS 1244/1278).

The objectives of this study were to describe the pretreatment HIV-1 DNA concentrations in children infected with HIV and to evaluate the impact of antiretroviral therapy (ART) on HIV-DNA concentrations.



This was a retrospective analysis of all children followed up in the 'Programme Enfant Yopougon' cohort, Abidjan, Côte d'Ivoire, from 2000 to 2004, who had cryopreserved peripheral blood mononuclear cells (PBMCs) and plasma samples. HIV-DNA was measured using a real-time PCR assay. Mixed-model analysis was used to analyse the factors associated with change in HIV-DNA concentration.



The study included 121 children infected with HIV-1. The median age at inclusion was 6 years (IQR: 3.5-9) and children were at an advanced stage of HIV disease (46.6% and 20.3% presenting CDC stage B and CDC stage C, respectively). At baseline, the median HIV-DNA concentration was 3.4 log₁₀ copies/10(6) PBMCs (IQR: 3.1-3.6). Fifty-four children were initiated on ART during follow-up. After 24 months of ART, HIV-DNA load decreased by 0.32 (IQR: 0.08-0.57) log₁₀ copies/10(6) PBMCs. The only factor associated with the HIV-DNA decrease was a concomitant low HIV-RNA viral load result. Children with efficient ART had a 0.51 log₁₀ copies (IQR: 0.40-0.86) HIV-DNA decrease per million PBMCs.



HIV-DNA concentrations decreased following ART initiation in a large African paediatric cohort. This decline was exclusively associated with the decrease in ongoing replication level achieved. Our study points out that a strong adherence is needed for ART to be efficient on the viral reservoirs, and further reinforces that adherence support is also essential to diminish the reservoir.