nils-herrmann/clean_scirepeval huggingface dataset:
A pilot study on using acupuncture and transcutaneous electrical nerve stimulation to treat chronic non-specific low back pain.

The present study tests whether a combined treatment of acupuncture and transcutaneous electrical nerve stimulation (TENS) is more effective than acupuncture or TENS alone for treating chronic low back pain (LBP).



Thirty-two patients with chronic LBP were randomly allocated to four groups. The acupuncture group (ACP) received only acupuncture treatment at selected acupoints for low back pain; the TENS group (TENS) received only TENS treatment at pain areas; the acupuncture and TENS group (A&T) received both acupuncture and TENS treatments; the control group (CT) received topical poultice (only when necessary). Each group received specific weekly treatment five times during the study. Outcome measures were pain intensity in terms of visual analogue scale (VAS) and QOL of low back in terms of Roland-Morris Disability Questionnaire (RDQ).



The ACP, TENS and A&T groups all reported lower VAS and RDQ scores. Significant reduction in pain intensity (P<0.008) and significant improvement in QOL (P<0.008) were shown in the A&T group.



Combined acupuncture and TENS treatment is effective in pain relief and QOL of low back improvement for the sampled patients suffering from chronic LBP.
Triple combination therapy with amlodipine, valsartan, and hydrochlorothiazide vs dual combination therapy with amlodipine and hydrochlorothiazide for stage 2 hypertensive patients

This post hoc analysis evaluated the efficacy and safety of triple therapy with amlodipine/valsartan+hydrochlorothiazide (Aml/Val+HCTZ) vs dual therapy with Aml+HCTZ in stage 2 hypertensive patients.



The analysis included patients from an eight-week, multicenter, double-blind study, randomized to Aml/Val 10/160 mg or Aml 10 mg groups, who received add-on HCTZ 12.5 mg at week 4 if mean sitting systolic blood pressure (msSBP) was >130 mmHg.



Of the patients receiving Aml/Val+HCTZ and Aml+HCTZ, 98% (N = 133/136) and 96% (N = 200/208) completed the study, respectively. Baseline characteristics were similar across groups (Caucasians, 80.2%; diabetics, 14.8%; age, 58.6 years [28.2% ≥ 65 years]; body mass index, 31 kg/m(2); mean sitting blood pressure (msBP), 171.5/95.5 mmHg [18% msSBP ≥ 180 mmHg]). Aml/Val+HCTZ provided significantly greater msBP reductions from baseline to week 8 than Aml+HCTZ (30.5/13.8 vs 24.3/8.3 mmHg, P < 0.0001). The incremental msBP reduction (week 4 to 8) with HCTZ added to Aml/Val was greater than when added to Aml (6.9/3.5 vs 3.1/1.0 mmHg, P < 0.01). Treatments were well tolerated with similar overall incidence of adverse events (Aml/Val+HCTZ: 33.8%, Aml+HCTZ: 33.2%).



Aml/Val+HCTZ provided significantly greater BP reductions than Aml+HCTZ in patients with stage 2 hypertension. Aml/Val+HCTZ triple therapy may be a suitable option for patients requiring more than two agents to reach target BP.
Design and evaluation of Mina: A robotic orthosis for paraplegics

Mobility options for persons suffering from paraplegia or paraparesis are limited to mainly wheeled devices. There are significant health, psychological, and social consequences related to being confined to a wheelchair. We present the Mina, a robotic orthosis for assisting mobility, which offers a legged mobility option for these persons. Mina is an overground robotic device that is worn on the back and around the legs to provide mobility assistance for people suffering from paraplegia or paraparesis. Mina uses compliant actuation to power the hip and knee joints. For paralyzed users, balance is provided with the assistance of forearm crutches. This paper presents the evaluation of Mina with two paraplegics (SCI ASIA-A). We confirmed that with a few hours of training and practice, Mina is currently able to provide paraplegics walking mobility at speeds of up to 0.20 m/s. We further confirmed that using Mina is not physically taxing and requires little cognitive effort, allowing the user to converse and maintain eye contact while
Docetaxel in combination with mitoxantrone and granulocyte colony-stimulating factor as front-line chemotherapy in metastatic breast cancer: a multicenter phase II study.

To evaluate the activity and tolerance of docetaxel in combination with mitoxantrone and granulocyte colony-stimulating factor (G-CSF) as front-line treatment in patients with metastatic breast cancer (MBC).



Fifty-four previously untreated patients with MBC who had bidimensionally measurable disease were enrolled onto the study. Forty-eight (89%) patients had visceral metastases and nineteen (36%) had relapsed within twelve months following adjuvant chemotherapy. Docetaxel (100 mg/m2) was given on day 1 after appropriate premedication and mitoxantrone (20 mg/m2) on day 8. G-CSF (150 mcg/m2/d s.c.) was administered from day 2 to day 6 and from day 9 to day 15. The regimen was repeated every three weeks, on an outpatient basis.



In an intention-to-treat analysis, 9 (17%) CRs, 24 (44%) PRs, (overall response rate 61%; 95% confidence interval (CI): 48.1%-74.1%), 12 (22%) SD and 9 (17%) PD were observed. The median duration of response and the median time to tumor progression was 12.5 and 14 months, respectively. The overall median survival was 16.5 months, whilst the probability for one- and three-year survival was 61% and 35%, respectively. Grade 3-4 neutropenia occurred in 37 (69%) patients, and febrile neutropenia in 16 (30%); there was one death due to sepsis. Grade 3-4 thrombocytopenia occurred in four (8%) patients. Grade 2-3 neurosensory toxicity was observed in 8 (15%) patients and grade 2-3 asthenia in 24 (45%).



Docetaxel in combination with mitoxantrone and G-CSF support is an intensified and active front-line regimen for patients with MBC; despite its hematological toxicity, this regimen merits further comparison with other standard anthracycline- and/or taxane-based combinations.
Magnetic resonance brain imaging in people with dizziness: a comparison with non-dizzy people.

Dizziness is a common symptom affecting about 30% of people over the age of 65.



To investigate the hypothesis that structural abnormalities of the brain and cervical cord are more common in dizzy than in non-dizzy subjects.



A case-control study of subjects over the age of 65 with and without dizziness: 125 dizzy subjects and 86 non-dizzy subjects were recruited from the community through articles in the local press. Magnetic resonance imaging (MRI) of the brain and neck was performed, and was read by a consultant neuroradiologist blind to the clinical details.



All dizzy subjects and all controls had at least one structural abnormality. Cerebral atrophy was found in 86% of dizzy subjects and 85% controls (p = 1.0) At least one white matter lesion was found in 69% of dizzy subjects and 78% controls (p = 0.21). White matter lesions in the midbrain were more common in dizzy than in non-dizzy subjects (22% v 4%, p < 0.001). There were no significant differences in the prevalence of cord compression, cervical subluxation, facet joint degeneration, vertebral artery compression, or vertebral artery occlusion between dizzy and non-dizzy subjects.



Structural abnormalities of the brain and neck are common in both dizzy and non-dizzy subjects. "Routine" MRI is unlikely to reveal a specific cause for dizziness. The observation of more frequent white matter lesions in the midbrain in dizzy subjects requires further study to determine whether small vessel changes could cause dizziness in older people.
Economic analysis of a transesophageal echocardiography-guided approach to cardioversion of patients with atrial fibrillation: the ACUTE economic data at eight weeks.

The aim of this study was to compare the relative cost of a transesophageal echocardiography (TEE)-guided strategy versus conventional strategy for patients with atrial fibrillation (AF) >2 days duration undergoing electrical cardioversion over an eight-week period.



The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) trial found no difference in embolic rates between the two approaches. However, the TEE-guided strategy had a shorter time to cardioversion and a lower rate of composite bleeding. While similar clinical efficacy was concluded, the relative cost of these two strategies has not been explored.



Two economic approaches were employed in the ACUTE trial. The first approach was based on hospital charge data from complete hospital Universal Billing Code of 1992 forms, a detailed hospital charge questionnaire, or imputation. Regression analysis was used to investigate the added cost of adverse events. The second economic approach involved the development of an independent analytic model simulating treatment and actual ACUTE outcome costs as a validation of clinically derived data. Sensitivity analysis was performed on the analytic model to investigate the potential range in cost differences between the strategies.



A total of 833 of the 1,222 patients were enrolled from 53 U.S. sites; TEE-guided (n = 420) and conventional (n = 413). At eight-week follow-up, total mean costs did not significantly differ between the two groups, respectively (6,508 dollars vs. 6,239 dollars; difference of 269 dollars; p = 0.50). Cumulative costs were 24% higher in the conventional group, primarily due to increased incidence of bleeding and hospital costs associated with bleeding. A separate analytic model showed that treatment costs were higher for the TEE-guided strategy, but outcome costs were higher for the conventional strategy. Sensitivity analysis of the analytic model illustrated that varying the incidence and cost of major bleeding and the cost of TEE had the greatest impact on cost differences between the two groups.



In patients with AF >2 days duration undergoing electrical cardioversion, the TEE-guided group showed little difference in patient costs compared with the conventional group. The TEE strategy had higher initial treatment costs but lower outcome-associated costs. Cumulative costs were 24% higher in the conventional group, primarily due to bleeding. The TEE-guided strategy is an economically feasible approach compared with the conventional strategy.
Long-term outcome of chronic myeloid leukemia patients treated frontline with imatinib

For almost 10 years imatinib has been the therapeutic standard of chronic myeloid leukemia. The introduction of other tyrosine kinase inhibitors (TKIs) raised a debate on treatment optimization. The debate is still heated: some studies have protocol restrictions or limited follow-up; in other studies, some relevant data are missing. The aim of this report is to provide a comprehensive, long-term, intention-to-treat, analysis of 559 newly diagnosed, chronic-phase, patients treated frontline with imatinib. With a minimum follow-up of 66 months, 65% of patients were still on imatinib, 19% were on alternative treatment, 12% died and 4% were lost to follow-up. The prognostic value of BCR-ABL1 ratio at 3 months (⩽10% in 81% of patients) was confirmed. The prognostic value of complete cytogenetic response and major molecular response at 1 year was confirmed. The 6-year overall survival was 89%, but as 50% of deaths occurred in remission, the 6-year cumulative incidence of leukemia-related death was 5%. The long-term outcome of first-line imatinib was excellent, also because of second-line treatment with other TKIs, but all responses and outcomes were inferior in high-risk patients, suggesting that to optimize treatment results, a specific risk-adapted treatment is needed for such patients.
Early changes in serum IL-6 and VEGF levels predict clinical outcome following first-line therapy in aggressive non-Hodgkin’s lymphoma

Inflammatory cytokines play important roles in the pathogenesis of lymphomas and may reflect underlying biological processes including tumour–host interactions with prognostic information that is not afforded by conventional clinical parameters. Several lines of evidence suggest that serum levels of interleukin (IL)-6 and vascular endothelial growth factor (VEGF) are independent indicators of long-term outcome in non-Hodgkin’s lymphoma (NHL), but the clinical impact of early serial monitoring of these cytokines has not been reported. Serum samples from 64 newly diagnosed patients with aggressive NHL were obtained before the first cycle of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) and then weekly until the second cycle was given. Serum IL-6 and VEGF were measured by commercial enzyme-linked immunosorbent assays (ELISA). Pre-treatment serum IL-6 and VEGF levels were significantly correlated to response rate and overall survival. A significant decrease of IL-6 and VEGF levels was observed in the first weeks after CHOP therapy in patients achieving a complete remission after treatment. Multivariate analysis indicated that early changes of IL-6 and VEGF serum levels within the first 3 weeks after initiation of chemotherapy were independent predictors of clinical response even when corrected for the influence of clinical prognostic factors. Only changes in serum IL-6 level had borderline significance for the prediction of overall survival. The data indicate that serial measurements of serum IL-6 and VEGF may be early prognostic indicators and support the hypothesis of a clinical impact by early recognition of poor-risk patients and candidates for new treatment options.
Genetic Heterogeneity of Benign Thyroid Lesions

The present series includes 75 thyroid lesions (38 goiters, 30 adenomas, 3 follicullo-papillary encapsulated carcinomas and 4 normal thyroid) that were studied by static and flow cytometry. Four cases were also analyzed by in situ hybridization (centromeric probes for chromosomes 1 and 17) and 10 cases by G-banding cytogenetics. Results demonstrate a polymorphysm and genetic instability in the thyroid tissue that may be related to the spontaneous polyploidization of their cells. The most consistent finding in cytometry was the presence of two clones associated with clinical or histological hyperactivity (46% versus 23% in non-functioning cases; χ distribution with a p < 0.05). Chromosomal anomalies were detected in two out of 10 cases: 46, XX, t(5,19) in 87% of cells of a diffuse hyperplastic goiter and 49, XX, +7, +17, +22 in 19% of cells of thyroiditis case. Finally, the in situ hybridization technique showed hidden trisomies of clonal origin in all of the cases studied. Evaluation of clonal trisomies by the in situ hybridization technique using the confidence interval of a binomial distribution is discussed.
HIV Shedding from Male Circumcision Wounds in HIV-Infected Men: A Prospective Cohort Study

A randomized trial of voluntary medical male circumcision (MC) of HIV-infected men reported increased HIV transmission to female partners among men who resumed sexual intercourse prior to wound healing. We conducted a prospective observational study to assess penile HIV shedding after MC.



HIV shedding was evaluated among 223 HIV-infected men (183 self-reported not receiving antiretroviral therapy [ART], 11 self-reported receiving ART and had a detectable plasma viral load [VL], and 29 self-reported receiving ART and had an undetectable plasma VL [<400 copies/ml]) in Rakai, Uganda, between June 2009 and April 2012. Preoperative and weekly penile lavages collected for 6 wk and then at 12 wk were tested for HIV shedding and VL using a real-time quantitative PCR assay. Unadjusted prevalence risk ratios (PRRs) and adjusted PRRs (adjPRRs) of HIV shedding were estimated using modified Poisson regression with robust variance. HIV shedding was detected in 9.3% (17/183) of men not on ART prior to surgery and 39.3% (72/183) of these men during the entire study. Relative to baseline, the proportion shedding was significantly increased after MC at 1 wk (PRR = 1.87, 95% CI = 1.12-3.14, p = 0.012), 2 wk (PRR = 3.16, 95% CI = 1.94-5.13, p < 0.001), and 3 wk (PRR = 1.98, 95% CI = 1.19-3.28, p = 0.008) after MC. However, compared to baseline, HIV shedding was decreased by 6 wk after MC (PRR = 0.27, 95% CI = 0.09-0.83, p = 0.023) and remained suppressed at 12 wk after MC (PRR = 0.19, 95% CI = 0.06-0.64, p = 0.008). Detectable HIV shedding from MC wounds occurred in more study visits among men with an HIV plasma VL > 50,000 copies/ml than among those with an HIV plasma VL < 400 copies/ml (adjPRR = 10.3, 95% CI = 4.25-24.90, p < 0.001). Detectable HIV shedding was less common in visits from men with healed MC wounds compared to visits from men without healed wounds (adjPRR = 0.12, 95% CI = 0.07-0.23, p < 0.001) and in visits from men on ART with undetectable plasma VL compared to men not on ART (PRR = 0.15, 95% CI = 0.05-0.43, p = 0.001). Among men with detectable penile HIV shedding, the median log10 HIV copies/milliliter of lavage fluid was significantly lower in men with ART-induced undetectable plasma VL (1.93, interquartile range [IQR] = 1.83-2.14) than in men not on ART (2.63, IQR = 2.28-3.22, p < 0.001). Limitations of this observational study include significant differences in baseline covariates, lack of confirmed receipt of ART for individuals who reported ART use, and lack of information on potential ART initiation during follow-up for those who were not on ART at enrollment.



Penile HIV shedding is significantly reduced after healing of MC wounds. Lower plasma VL is associated with decreased frequency and quantity of HIV shedding from MC wounds. Starting ART prior to MC should be considered to reduce male-to-female HIV transmission risk. Research is needed to assess the time on ART required to decrease shedding, and the acceptability and feasibility of initiating ART at the time of MC.
Subthalamic stimulation and neuronal activity in the substantia nigra in Parkinson's disease.

High-frequency stimulation of the subthalamic nucleus (STN) is an effective treatment for severe forms of Parkinson's disease (PD). To study the effects of high-frequency STN stimulation on one of the main output pathways of the basal ganglia, single-unit recordings of the neuronal activity of the substantia nigra pars reticulata (SNr) were performed before, during, and after the application of STN electrical stimulation in eight PD patients. During STN stimulation at 14 Hz, no change in either the mean firing rate or the discharge pattern of SNr neurons was observed. STN stimulation at 140 Hz decreased the mean firing rate by 64% and the mean duration of bursting mode activity of SNr neurons by 70%. The SNr residual neuronal activity during 140-Hz STN stimulation was driven by the STN stimulation. How the decrease in rate and modification of firing pattern of SNr-evoked neural activity, during high-frequency STN stimulation, contribute to the improvement of parkinsonian motor disability remains to be elucidated.
The influence of antihypertensive drugs on mineral status in hypertensive patients.

Long-term therapy of hypertension may influence mineral status in patients. However, drug-micronutrient interactions are largely unexplored in practice. This study intended to evaluate the effect of hypotensive monotherapy on iron, zinc, and copper levels, as well as on selected biochemical parameters, in newly diagnosed patients with hypertension, and to assess the influence of diet with optimal mineral levels on the mineral balance in these subjects.



Forty-five patients, aged 18-65 years with diagnosed essential hypertension, beginning monotherapy treatment with diuretics, calcium antagonists, angiotensin-converting enzyme inhibitors, and β-blockers, were employed. Over three months, the patients underwent monotherapy (stage II). Next, patients were randomly divided into a diet group (of 27 subjects) and a control group (of 18 subjects). In this stage, which lasted one month, patients were given the same drug but also followed an optimal mineral-content diet (for the diet group), or else continued drug use without any change in diet (for control group) (stage III). Lipids, glucose, ceruloplasmin, and ferritin--along with superoxide dismutase and catalase activities--were assayed in serum. Iron, zinc, and copper concentrations in serum, erythrocytes, and urine were determined using flame atomic absorption spectrometry. Blood pressure was measured. Diet intake was monitored at each stage.



It was found that the zinc level in serum significantly decreased following treatment, and that the use of the optimal-mineral diet during antihypertensive treatment markedly increased zinc serum concentration. After treatment, a significant increase in zinc excretion in the urine was observed. Glucose levels in the serum of patients in stage II were significantly higher than in the baseline. In patients in the diet group, glucose levels markedly decreased. Moreover, a negative correlation was found between serum glucose and zinc levels in patients.



Antihypertensive treatments should include monitoring of mineral status. It seems that the zinc balance of patients on long-term therapy with hypotensive drugs may benefit from an optimal-mineral diet.
Rheumatoid factor and anti-CCP do not predict progressive joint damage in patients with early rheumatoid arthritis treated with prednisolone: a randomised study

To analyse if predictors of radiographic progression differ between patients treated with or without prednisolone in early rheumatoid arthritis (RA). Radiographs of hands and feet were assessed using the modified Sharp/van der Heijde score and radiographic progression was defined as an increase in the total Sharp score above 5.8 (the smallest detectable change).



Prospective, randomised study of patients with early RA.



Secondary level of care; six participating centres from southern Sweden; both urban and rural populations.



In all, 225 patients, 64% women, with a diagnosis of RA according to the American College of Rheumatology criteria, were included if they were between 18 and 80 years of age and had a disease duration of less than 1 year.



The patients were randomised to 7.5 mg prednisolone daily for 2 years (P-group; n=108) or no prednisolone (NoP-group; n=117) when they started with their first disease-modifying anti-rheumatic drug and were prospectively followed for 2 years.



The frequency of patients with radiographic progression after 2 years was 26% in the P-group and 39% in the NoP-group (p=0.033). Relevant interactions between treatment and rheumatoid factor (RF) (p=0.061) and between treatment and anti-cyclic citrullinated peptide 2 (anti-CCP) (p=0.096) were found. RF and anti-CCP independently predicted radiographic progression only in the NoP-group, OR (95% CI) 9.4 (2.5 to 35.2), p=0.001 and OR (95% CI) 8.7 (2.5 to 31.3), p=0.001, respectively.



The presence of RF and anti-CCP predicted radiographic progression in patients not treated with prednisolone but failed to predict progression in patients treated with this drug. The data suggest that early treatment with prednisolone may modulate not only inflammation but also autoimmunity-associated pathogenetic mechanisms.