nils-herrmann/clean_scirepeval huggingface dataset:
Head-of-bed elevation and early outcomes of gastric reflux, aspiration and pressure ulcers: a feasibility study.

Guidelines recommending head of bed (HOB) elevation greater than 30º to prevent ventilator-associated pneumonia conflict with guidelines to prevent pressure ulcers, which recommend HOB elevation less than 30º.



To examine the feasibility of 45º HOB elevation and describe and compare the occurrence of reflux, aspiration, and pressure ulcer development at 30º and 45º HOB elevation.



A randomized 2-day crossover trial was conducted. HOB angle was measured every 30 seconds. Oral and tracheal secretions were analyzed for pepsin presence. Skin was assessed for pressure ulcers. Wilcoxon signed rank tests and Kendall τ correlations were conducted.



Fifteen patients were enrolled; 11 completed both days. Patients were maintained at 30º (mean, 30º) for 96% of minutes and at 45º (mean, 39º) for 77% of minutes. No patients showed signs of pressure ulcers. A total of 188 oral secretions were obtained, 82 (44%) were pepsin-positive; 174 tracheal secretions were obtained, 108 (62%) were pepsin-positive. The median percentage of pepsin-positive oral secretions was not significantly higher (P = .11) at 30º elevation (54%) than at 45º elevation (20%). The median percentage of pepsin-positive tracheal secretions was not significantly higher (P = .37) at 30º elevation (71%) than 45º elevation (67%). Deeper sedation correlated with increased reflux (P = .03).



HOB elevation greater than 30º is feasible and preferred to 30º for reducing oral secretion volume, reflux, and aspiration without pressure ulcer development in gastric-fed patients receiving mechanical ventilation. More deeply sedated patients may benefit from higher HOB elevations.
Benefits of physical exercise on executive functions in older people with Parkinson’s disease

The benefits of physical exercise on cognitive functioning have been reported in the literature, but the potential benefits to slow the eventual decline in executive functioning (EF) caused by neurodegeneration from Parkinson's Disease (PD) have rarely been studied. Thus the objective of this study was to analyze the effects of a multimodal physical exercise program on EF in older people with Parkinson's disease. The EF of the older people was evaluated by neuropsychological testing, and for confounding variables such as attention, depressive symptoms and anxiety, before and after intervention. The 20 participants were assigned into Control (CG) and Trained (TG) Groups. The TG participated in generalized physical training for 6 months. The ANOVA showed a significant interaction (p<.05) that indicated a beneficial contribution of training on EF. No significant interactions were found in the results for confounding variables between groups and pre- and post-intervention, which supports the beneficial findings of physical exercise training on EF.
Difference in patient's acceptance of early versus late initiation of psychosocial support in breast cancer

The present study was performed to assess the difference in acceptance of psychosocial counseling and resulting benefits between patients with breast cancer with early or late onset. In a prospective randomized controlled study conducted over 6 months, 41 women with a new diagnosis of early breast cancer (group 1) and 43 patients with advanced breast cancer (group 2) received individually tailored psychosocial support and were compared against controls. This therapy was free of charge, and the duration of support was determined by the patients' wishes and needs. Among the patients with new onset of disease acceptance of the psychosocial counseling was high, and these patients experienced significant improvements in their quality of life. In contrast, acceptance of psychosocial counseling was low in the advanced breast cancer group and the therapy did not improve quality of life over the observation period of 6 months. Early psychosocial support in patients with breast cancer meets with a high acceptance rate and improves quality of life.
Risk-adapted approach for fever and neutropenia in paediatric cancer patients--a national multicentre study.

In this national multicentre study, we examined the safety of reducing antibiotics in selected paediatric cancer patients with febrile neutropenia.



Patients with signs of a bacterial infection and/or abnormal vital signs indicating sepsis were considered high risk and received antibiotic therapy. Remaining patients were allocated to low- or medium risk, depending on their interleukin-8 level. Low-risk patients did not receive any antibiotics and were discharged from the hospital after having been afebrile for 12 h. Medium-risk patients were re-evaluated after 72 h of antibiotic treatment and, in selected patients, antibiotics were stopped.



Two hundred thirty-three febrile neutropenic episodes in 141 paediatric cancer patients were included in the study. Sixty-four episodes were classified high risk (28%), 122 medium risk (52%), and 47 (20%) low risk. In the medium-risk group, antibiotics were stopped after 72 h in 50 in 122 episodes (41%). Median duration of antibiotic treatment and hospital admission was significantly lower in low- and medium-risk episodes with early discharge. No failures were observed in the medium-risk group with early discharge. In the low-risk group, six failures were observed (12.8%), due to coagulase-negative staphylococci-positive blood cultures and recurrent fever.



We showed that it is safe to shorten antibiotic treatment to 72 h in selected medium-risk patients with febrile neutropenia, regardless of the neutrophil count. The safety of withholding antibiotics in selected low-risk paediatric cancer patients with febrile neutropenia requires further investigation, using more suitable definitions for safety. Reduction in hospital admissions allows children with cancer more time at home and consequently improves their quality of life.
Influence of complete spinal cord injury on skeletal muscle cross-sectional area within the first 6 months of injury

In this study we examined the influence of complete spinal cord injury (SCI) on affected skeletal muscle morphology within 6 months of SCI. Magnetic resonance (MR) images of the leg and thigh were taken as soon as patients were clinically stable, on average 6 weeks post injury, and 11 and 24 weeks after SCI to assess average muscle cross-sectional area (CSA). MR images were also taken from nine able-bodied controls at two time points separated from one another by 18 weeks. The controls showed no change in any variable over time. The patients showed differential atrophy (P = 0.0001) of the ankle plantar or dorsi flexor muscles. The average CSA of m. gastrocnemius and m. soleus decreased by 24% and 12%, respectively (P = 0.0001). The m. tibialis anterior CSA showed no change (P = 0.3644). As a result of this muscle-specific atrophy, the ratio of average CSA of m. gastrocnemius to m. soleus, m. gastrocnemius to m. tibialis anterior and m. soleus to m. tibialis anterior declined (P = 0.0001). The average CSA of m, quadriceps femoris, the hamstring muscle group and the adductor muscle group decreased by 16%, 14% and 16%, respectively (P ≤ 0.0045). No differential atrophy was observed among these thigh muscle groups, thus the ratio of their CSAs did not change (P = 0.6210). The average CSA of atrophied skeletal muscle in the patients was 45–80% of that of age- and weight-matched able-bodied controls 24 weeks after injury. In conclusion, the results of this study suggest that there is marked loss of contractile protein early after SCI which differs among affected skeletal muscles. While the mechanism(s) responsible for loss of muscle size are not clear, it is suggested that the development of muscular imbalance as well as diminution of muscle mass would compromise force potential early after SCI.
Adjuvant leuprolide with or without docetaxel in patients with high-risk prostate cancer after radical prostatectomy (TAX-3501): important lessons for future trials.

The current trial evaluated 2 common therapies for patients with advanced prostate cancer, docetaxel and hormonal therapy (HT), in the surgical adjuvant setting.



TAX-3501 was a randomized, phase 3, adjuvant study post-radical prostatectomy (RP) in high-risk patients with prostate cancer (n=228) comparing 18 months of HT with (CHT) without docetaxel chemotherapy either immediately (I) or deferred (D). High-risk disease was defined as a 5-year freedom-from-disease-progression rate of ≤ 60% as predicted by a post-RP nomogram. Progression-free survival (PFS), including prostate-specific antigen disease recurrence, was the primary endpoint. The authors also assessed the accuracy of the nomogram and analyzed testosterone recovery in 108 patients treated with HT who had at least 1 posttreatment testosterone value.



Between December 2005 and September 2007, 228 patients were randomized between the treatment cohorts. TAX-3501 was terminated prematurely because of enrollment challenges, leaving it underpowered to detect differences in PFS. After a median follow-up of 3.4 years (interquartile range, 2.3-3.8 years), 39 of 228 patients (17%) demonstrated PSA disease progression, and metastatic disease progression occurred in 1 patient. The median time to baseline testosterone recovery after the completion of treatment was prolonged at 487 days (95% confidence interval, 457-546 days). The nomogram's predicted versus observed freedom from disease progression was significantly different for the combination D(HT) and D(CHT) group (P<.00001).



TAX-3501 illustrated several difficulties involved in conducting postoperative adjuvant systemic trials in men with high-risk prostate cancer: the lack of consensus regarding patient selection and treatment, the need for long follow-up time, nonvalidated intermediate endpoints, evolving standard approaches, and the need for long-term research support. Except for selected patients at very high-risk of disease recurrence and death, surgical adjuvant trials in patients with prostate cancer may not be feasible.
Sequential combination of robot-assisted therapy and constraint-induced therapy in stroke rehabilitation: a randomized controlled trial

Robot-assisted therapy (RT) and constraint-induced therapy (CIT) both show great promise to improve stroke rehabilitation outcomes. Although the respective treatment efficacy of RT and CIT has been validated, the additive effects of RT combined with CIT remain unknown. This study investigated the treatment effects of RT in sequential combination with a distributed form of CIT (RT + dCIT) compared with RT and conventional rehabilitation (CR). Forty-eight patients with stroke were enrolled and randomized to receive one of the three interventions for 4 weeks. Primary outcomes assessed the changes of motor impairment and motor function on the Fugl-Meyer Assessment (FMA) and Wolf Motor Function Test (WMFT). Secondary outcomes, including the Motor Activity Log (MAL) and accelerometers, examined functional performance during daily activities. The three treatment groups improved significantly on most primary and secondary outcomes over time. The combined RT + dCIT group exhibited significantly greater improvement on the FMA and functional ability subscale of the WMFT than the RT and CR groups. The improvements on the MAL and accelerometers were not significantly different among the three groups. RT in sequential combination with CIT led to additive effects on participants’ motor ability and functional ability to perform motor tasks after stroke, which support that combined therapy can be an effective means to intensify outcomes. Further research investigating the potential long-term effects of combination therapy, especially on real-life performance, would be valuable.
Exemplary care as a mediator of the effects of caregiver subjective appraisal and emotional outcomes.

Exemplary care (EC) is a new construct encompassing care behaviors that warrants further study within stress process models of dementia caregiving. Previous research has examined EC within the context of cognitively intact older adult care recipients (CRs) and their caregivers (CGs). This study sought to expand our knowledge of quality of care by investigating EC within a diverse sample of dementia CGs.



We examined the relation between CG subjective appraisal (daily care bother, burden, and behavioral bother), EC, and CG emotional outcomes (depression and positive aspects of caregiving [PAC]). Specifically, EC was examined as a possible mediator of the effects of CG subjective appraisals on emotional outcomes. Using a bootstrapping method and an SPSS macro developed by Preacher and Hayes (2008 Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models), we tested the indirect effect of EC on the relation between CG subjective appraisals and CG emotional outcomes.



Overall, EC partially mediates the relation between the subjective appraisal variables (daily care bother, burden, and behavioral bother) and PAC. Results for depression were similar except that EC did not mediate the relation between burden and depression. This pattern of results varied by race/ethnicity.



Overall, CGs' perception of providing EC to individuals with dementia partially explains the relation between subjective appraisal and symptoms of depression and PAC. Results of this study suggest that interventions may benefit from training CGs to engage in EC to improve their emotional outcomes and quality of care.
Effect of raloxifene on insulin-like growth factor-I, insulin-like growth factor binding protein-3, and leptin in premenopausal women at high risk for developing breast cancer.

Elevated insulin-like growth factor I (IGF-I) is associated with an increased risk for developing breast cancer in premenopausal women, whereas lower leptin levels have been documented in premenopausal breast cancer cases. We determined the effect of raloxifene on IGF-I, insulin-like growth factor binding protein 3 (IGFBP-3), and leptin in premenopausal women at high risk for developing invasive breast cancer. Twenty-eight premenopausal women (median age 43 years) participating in a pilot breast cancer prevention trial provided 56 matched serum samples. Specimens were collected at baseline and after treatment with 60 mg of raloxifene daily. Median treatment duration was 3 months (range: 6 weeks to 12 months). Samples were frozen at -70 degrees C until analysis. IGF-I, IGFBP-3, and leptin were measured by ELISA. Significance was evaluated by the Wilcoxon signed rank test. Raloxifene administration increased serum IGFBP-3 [mean change 245 ng/ml; P = 0.017; 95% confidence interval (CI), 76-415] and leptin (mean change 2.1 ng/ml; P = 0.005; 95% CI, 0.6-3.7). No significant change in serum IGF-I was detected (mean change 2.6 ng/ml; P = 0.84; 95% CI, -15.4 to 20.6). IGF-I:IGFBP-3 molar ratio was stable (mean change -0.014; P = 0.30; 95% CI, -0.041 to 0.012). Raloxifene administration is associated with an increase in IGFBP-3 and leptin in premenopausal high risk women. Increases in IGFBP-3 may potentially decrease the activity of circulating IGF-I. The effect of modulating the IGF pathway and leptin on breast cancer risk needs additional evaluation.
Medication errors in the home: a multisite study of children with cancer.

As home medication use increases, medications previously managed by nurses are now managed by patients and their families. Our objective was to describe the types of errors occurring in the home medication management of children with cancer.



In a prospective observational study at 3 pediatric oncology clinics in the northeastern and southeastern United States, patients undergoing chemotherapy and their parents were recruited from November 2007 through April 2011. We reviewed medical records and checked prescription doses. A trained nurse visited the home, reviewed medication bottles, and observed administration. Two physicians independently made judgments regarding whether an error occurred and its severity. Overall rates of errors were weighted to account for clustering within sites.



We reviewed 963 medications and observed 242 medication administrations in the homes of 92 patients. We found 72 medication errors. Four errors led to significant patient injury. An additional 40 errors had potential for injury: 2 were life-threatening, 13 were serious, and 25 were significant. Error rates varied between study sites (40-121 errors per 100 patients); the weighted overall rate was 70.2 errors per 100 patients (95% confidence interval [CI]: 58.9-81.6). The weighted rate of errors with injury was 3.6 (95% CI: 1.7-5.5) per 100 patients and with potential to injure the patient was 36.3 (95% CI: 29.3-43.3) per 100 patients. Nonchemotherapy medications were more often involved in an error than chemotherapy.



Medication errors were common in this multisite study of outpatient pediatric cancer care. Rates of preventable medication-related injuries in this outpatient population were comparable or higher than those found in studies of hospitalized patients.
Molecular response to treatment redefines all prognostic factors in children and adolescents with B-cell precursor acute lymphoblastic leukemia: results in 3184 patients of the AIEOP-BFM ALL 2000 study.

The Associazione Italiana di Ematologia Oncologia Pediatrica and the Berlin-Frankfurt-Münster Acute Lymphoblastic Leukemia (AIEOP-BFM ALL 2000) study has for the first time introduced standardized quantitative assessment of minimal residual disease (MRD) based on immunoglobulin and T-cell receptor gene rearrangements as polymerase chain reaction targets (PCR-MRD), at 2 time points (TPs), to stratify patients in a large prospective study. Patients with precursor B (pB) ALL (n = 3184) were considered MRD standard risk (MRD-SR) if MRD was already negative at day 33 (analyzed by 2 markers, with a sensitivity of at least 10(-4)); MRD high risk (MRD-HR) if 10(-3) or more at day 78 and MRD intermediate risk (MRD-IR): others. MRD-SR patients were 42% (1348): 5-year event-free survival (EFS, standard error) is 92.3% (0.9). Fifty-two percent (1647) were MRD-IR: EFS 77.6% (1.3). Six percent of patients (189) were MRD-HR: EFS 50.1% (4.1; P < .001). PCR-MRD discriminated prognosis even on top of white blood cell count, age, early response to prednisone, and genotype. MRD response detected by sensitive quantitative PCR at 2 predefined TPs is highly predictive for relapse in childhood pB-ALL. The study is registered at http://clinicaltrials.gov: NCT00430118 for BFM and NCT00613457 for AIEOP.
Multiple cycles of dose-intensive chemotherapy with repeated stem cell support as induction treatment in metastatic breast cancer: a feasibility study

The purpose of this trial was to study feasibility and tolerance of a dose-intensive multicyclic alternating induction chemotherapy with repeated stem cell support in a series of 43 metastatic breast cancer patients. Anthracycline-naive patients (n = 21) received cyclophosphamide 2.5 g/m2 plus doxorubicin 80 mg/m2 alternating every 14 days with paclitaxel 200–350 mg/m2 plus cisplatin 120 mg/m2. Patients who had previously received anthracyclines (n = 22) received cisplatin 120 mg/m2 plus etoposide 600 mg/m2 alternating with paclitaxel 200–350 mg/m2 plus ifosfamide 8 g/m2. Peripheral blood stem cells were infused after every course except the first, with a median CD34+ dose of 2.1 × 106/kg per cycle. Positive selection of CD34+ cells was performed in good mobilizers. The median number of cycles administered was six (4–8), and the time interval between them was 17 days. Median summation dose intensities (SDI) actually administered for the CA-TP and PE-TI protocol were 4.95 and 4.69, respectively (87% of scheduled SDI). There were 15 complete (35%) and 21 partial responses (49%), for an overall response rate of 84% (95% CI, 73%–95%). Infection or neutropenic fever occurred in 50% of the cycles. There was one treatment-related death. After a median follow-up of 26 months, the median event-free-survival was 12 months (95% CI: 10–14) and overall survival was 31 months. These high dose-intensity induction treatments seem to be feasible with sequential stem cell support. Bone Marrow Transplantation (2001) 28, 235–242.
Vestibulo-ocular and optokinetic impairments in left unilateral neglect

Right brain damaged patients affected by left unilateral neglect (N+) typically fail to explore the contralesional space. For the first time, this study investigates the dynamic and spatial features of the horizontal vestibular-ocular response (VOR), the optokinetic response (OKR) and the VOR-OKR interaction in six N+ and in five right brain damaged patients without neglect (N-). No lateral asymmetry of the gain (i.e. eye velocity to head velocity ratio) of VOR slow phases was found in either group. In the VOR, N+ had higher frequency of slow-rightward/fast-leftward phases and higher contralesional shift of the beating field (i.e. orbital position of fast phases). In the VOR-OKR, there was an increase of gain in both lateral directions and in both groups even though in N-, there was a lower phase shift between eye and head velocity. In contrast to the VOR, in the VOR-OKR, N+ had higher frequency of slow-leftward/fast-rightward phases. The VOR-OKR interaction also introduced an ipsilesional shift of the beating field in both N+ and N-. In the OKR, N+ showed a drop in the velocity, amplitude and frequency of slow-rightward/fast-leftward phases. These findings potentially suggest that each hemisphere modulates VOR with contralaterally directed slow phases and OKR with ipsilaterally directed slow phases. This organisation could facilitate maintenance or fast recovery of combined VOR + OKR after unilateral brain damage. The same findings suggest that by inducing slow-leftward phases, vestibular and optokinetic stimulation improve left side neglect through the activation of different hemispheric pathways. No ipsilesional deviation of the subjective "straight ahead" was found in N+. These results show that chronic unilateral neglect can be dissociated both from deficits of ipsilesionally directed VOR and from ipsilesional deviation of the subjective midsagittal plane of the body.
Initiating insulin treatment in insulin-requiring type 2 diabetic patients: comparative efficiency and cost of outpatient and inpatient management. INNOV Study Group.

The main objective of this randomised study was to compare glycaemic control (as determined by HbA1c levels) in two groups of insulin-requiring Type 2 diabetic patients three months after initiation of insulin therapy either on an inpatient (group A, n = 58) or outpatient (group B, n = 56) basis. Evaluation of the safety and cost of both methods was a secondary objective. Although HbA1c level at inclusion was slightly but significantly lower in group A than group B (10.17 +/- 0.19% vs. 10.87 +/- 0.22% respectively, P = 0.019), covariance analysis showed equivalent glycaemic control at 3 months in both groups (adjusted means with respect to inclusion values: 9.00 +/- 1.14% vs. 9.37 +/- 1.14% respectively; equivalence hypothesis: P = 0.01). A low and similar incidence of episodes of hypoglycaemia and hyperglycaemia with ketonuria was observed. Clinical tests, paramedical care and the cost of hospitalisation itself resulted in a direct cost of initiating treatment that was more than four times higher in group A than in group B (mean total cost per patient: FF 15,231 and FF 3,296 respectively). Insulin-requiring Type 2 diabetic patients can be efficiently and safely started on insulin as outpatients, and this approach to initiating insulin therapy is cost-effective.