nils-herrmann/clean_scirepeval huggingface dataset:
Solitaire AB stent-assisted coiling of wide-necked intracranial aneurysms: short-term results from a prospective, consecutive, European multicentric study

Solitaire AB stent-assisted coiling facilitates the endovascular treatment of wide-necked intracranial aneurysms. Solitaire Aneurysm Remodeling is the first prospective, consecutive, European multicentric study whose main objective was to evaluate the safety, short-, and long-term efficacy of the Solitaire AB stent. This first analysis is focused on the short-term results. After exclusion of one patient, 66 Solitaire AB stents were used to treat via endovascular approach 64 aneurysms (63 patients) in seven European centers. Technical and clinical complications were recorded. A core laboratory evaluated the angiographic efficacy by using the Raymond classification scale. The mean width of aneurysm sac was 7.5 mm, and the mean diameter of aneurysm neck was 4.7 mm. Complete occlusion was achieved in 27 aneurysms (42.2 %); neck remnant was seen in 25 aneurysms (39.1 %) and aneurysm remnant in 12 aneurysms (18.7 %). Technical and clinical complications related to the procedure were encountered in eight patients (12.7 %). Postprocedural modification of the clinical status was observed in one patient (1.6 %). No patients died (0 %); one had a permanent deficit (1.6 %), and one had a transient deficit (1.6 %). Treatment-related mortality was 0 %, and permanent morbidity was 1.6 %. The Solitaire AB stent has an excellent rate of technical success navigation with the absence of dislodgement. The safety and short-term efficacy are comparable to those previously reported with coiling alone. Mid- and long-term follow-up will be required to elucidate the impact of the Solitaire AB stent on recanalization rate.
The effect of amlodipine on endothelial function in young adults with a strong family history of premature coronary artery disease: a randomised double blind study.

Endothelial dysfunction, an early event in atherogenesis, has been demonstrated in young asymptomatic subjects with a strong family history of premature coronary artery disease (CAD). In these subjects, preventive measures involving risk factor modification are not appropriate, and strategies employing novel antiatherogenic agents, such as the dihydropyridine calcium channel blocker, amlodipine, may be useful. Ninety-one subjects (mean age, 28.6 years; range, 18-40) with a strong family history of premature CAD and no other identified vascular risk factors were randomised to either 5 mg amlodipine (49 subjects) or placebo (42 subjects). Brachial artery flow mediated dilatation (FMD) (endothelium-dependent response) and response to glyceryltrinitrate (GTN) (direct smooth muscle dilator) were assessed non-invasively at baseline, and after 12 and 24 weeks using high-resolution vascular ultrasound. In those treated with amlodipine, mean FMD increased from 2.32+/-2.23% at baseline to 3.52+/-3.1% at 24 weeks (P<0.005). However, FMD also increased in the placebo group from 1.64+/-2.12 to 3.37+/-2.68% (P<0.002), and the difference between the FMD response in the amlodipine and placebo groups was not significant. Dilatation to GTN did not change in either group. Therefore, impaired endothelial function improved in family history subjects taking both amlodipine and placebo, but there is no difference between the groups.
The Effects of Game-Based Breathing Exercise on Pulmonary Function in Stroke Patients: A Preliminary Study

Reduction of respiratory function along with hemiparesis leads to decreased endurance, dyspnea, and increased sedentary behavior, as well as to an increased risk of stroke. The main purpose of this study was to investigate the preliminary effects of game-based breathing exercise (GBE) on pulmonary function in stroke patients.



Thirty-eight in-patients with stroke (22 men, 16 women) were recruited for the study. Participants were randomly allocated into 2 groups: patients assigned to the GBE group (n=19), and the control group (n=19). The GBE group participated in a GBE program for 25 minutes a day, 3 days a week, during a 5 week period. For the same period, both groups participated in a conventional stroke rehabilitation program. Forced vital capacity (FVC), forced expiratory volume at 1 second (FEV1), FEV1/FVC, and maximum voluntary ventilation (MVV) were measured by a spirometer in pre- and post-testing.



The GBE group had significantly improved FVC, FEV1, and MVV values compared with the control group (p<0.05), although there was no significant difference in FEV1/FVC value between groups. Significant short-term effects of the GBE program on pulmonary function in stroke patients were recorded in this study.



These findings gave some indications that it may be feasible to include GBE in rehabilitation interventions with this population.
Hyponatremia as predictor of worse outcome in real world patients admitted with acute heart failure.

Our aim was to determine if hyponatremia, defined as serum sodium level < 135 mmol/L, is a predictor of worse outcome in a cohort of real-world patients with heartfailure (HF).



We used data of the National registry of HF (RICA) from Spain, an ongoing multicenter, prospective cohort study. The patients were assigned to two groups regarding sodium levels. Primary end-point was first all-cause readmission, or death by any cause. Secondary end-points were the number of days hospitalized, and the presence of complications.



We identified 973 patients, 147 (15.11%) with hyponatremia. The median age of patients enrolled was 77.25 ± 8.79 years-old, the global comorbidity measured by Charlson comorbidity index (CCI) was upper 3 points and preserved ejection fraction was present in67.1% of them. Clinical complications during admission were significantly higher in the patients with hyponatremia (35.41%, p < 0.001) and this remained as significant predictor after logistic regression adjustment (OR 1.08, p < 0.01). Also mortality and readmissions were more frequent in patients with hyponatremia (20.69% and 22.41%, respectively) but after Cox regression adjustment hyponatremia in our cohort was not associated with increase in 90-day all-cause mortality and readmissions, and only CCI remained significant for primaryend-point (HR 1.08, p < 0.001).



Hyponatremia is an independent predictor of complications during hospitalization in our real-world cohort, but was not associated with 90 days mortality or readmissions. Global comorbidity, however, played an important role, and could influence the mortality and readmissions of our patients.
Recovery of the blood pressure – cerebral flow relation after carotid stenting in elderly patients

As a sensitive and convenient means for the cerebral hemodynamic monitoring, dynamic cerebral autoregulation testing could be especially useful in medical conditions where less invasive diagnostics and therapies are preferred. This study analysed the effect of carotid stenting on dynamic autoregulation in elderly patients focussing on the relation between blood pressure and cerebral blood flow velocity.  We examined 20 patients age 69 ± 8 years with coexisting cerebrovascular and medical risk factors before and at least six month after stenting of severe carotid stenoses. Data were compared to 24 age-matched healthy controls. Slow spontaneous oscillations were studied in continuous recordings of Transcranial Doppler and beat-to-beat blood pressure. Analysis was based on the “high-pass filter model”, which predicts a positive phase relationship between these oscillations.  Whereas phase shift angles were diminished (20.4 ± 14.1°) before stenting, after stenting these values were significantly increased to normal (48.1 ± 16.6°), to the level of controls (46.7 ± 15.9°). Medical conditions such as coronary artery disease, arterial hypertension, and dyslipidemia did not diminish this recovery. The level of increase was inversely correlated with the initial autoregulatory deficit (r = −0.68) which was largest with insufficient collateral blood supply and symptomatic carotid stenoses.  The study showed that an impaired cerebral autoregulation may recover after stent-guided carotid angioplasty even in the elderly with co-existing medical conditions. In this respect to regain vasomotor capability, patients with cerebrovascular risk factors seemed to benefit particularly.
Day versus inpatient treatment for cocaine dependence: An experimental comparison

This study was designed to explore the question of whether day treatment is a viable alternative to inpatient treatment for cocaine-dependent patients. Inpatient subjects were compared with day-treatment subjects in a randomized, prospective study design. Treatment outcome was evaluated at three and six months posttreatment. At three months posttreatment, the inpatient group had a statistically significant higher rate of total abstinence than the day-treatment group, but the difference at six months was not statistically significant. The two groups also were statistically comparable at six months posttreatment in terms of “current” abstinence and in terms of other measures. Average costs for day-treatment subjects was 48–61% of the cost for inpatient subjects. The results of this study support the use of day treatment as a clinically and economically effective alternative to inpatient treatment for many cocaine-dependent patients, especially when steps are taken to minimize drop out.
Multiprocessor enhancements of the SimpleScalar tool set

This paper describes multiprocessor enhancements of the SimpleScalar tool set. The core simulation code has been modified to support multiprocessing, and a run-time library has been introduced for thread creation and synchronization. Measurements using the SPLASH-2 parallel benchmark suite [13] indicate that the multiprocessor enhancements introduce simulation overhead of 30%-50% relative to the original uniprocessor simulator. An idealized multiprocessor cache simulator has also been developed, and a dynamic visualization tool for cache coherence has also been developed. These multiprocessor enhancements are available at the WWW site for the SimpleScalar tool set.
Nilotinib for the frontline treatment of Ph(+) chronic myeloid leukemia.

Nilotinib has a higher binding affinity and selectivity for BCR-ABL with respect to imatinib and is an effective treatment of chronic myeloid leukemia (CML) after imatinib failure. In a phase 2 study, 73 early chronic-phase, untreated, Ph(+) CML patients, received nilotinib at a dose of 400 mg twice daily. The primary endpoint was the complete cytogenetic response (CCgR) rate at 1 year. With a median follow-up of 15 months, the CCgR rate at 1 year was 96%, and the major molecular response rate 85%. Responses were rapid, with 78% CCgR and 52% major molecular response at 3 months. During the first year, the treatment was interrupted at least once in 38 patients (52%). The mean daily dose ranged between 600 and 800 mg in 74% of patients, 400 and 599 mg in 18% of patients, and was less than 400 mg in 8% of patients. Dose interruptions were mainly due to nonhematologic and biochemical side effects. Myelosuppression was irrelevant. One patient progressed to blastic crisis after 6 months; one went off-treatment for lipase increase grade 4 (no pancreatitis). Nilotinib is safe and very active in early chronic-phase CML. These data support a role for nilotinib for the frontline treatment of CML.
Half-Dose Rabeprazole Has an Equal Efficacy to Standard-Dose Rabeprazole on Endoscopic Submucosal Dissection-Induced Ulcer

Although endoscopic submucosal dissection (ESD)-induced ulcers heal faster and recur less often than non-iatrogenic gastric ulcers, the optimal dosage and duration of proton pump inhibitor treatment for ESD-induced ulcers remain unclear. To evaluate the efficacy of half-dose rabeprazole on endoscopic submucosal dissection-induced ulcer compared with standard dose rabeprazole. The study was a prospective randomized controlled double-blind trial at a single tertiary hospital. A total of 80 patients who underwent ESD for gastric neoplasia were enrolled. Of these patients, 10 were not followed to completion. Final analysis included the remaining 70 patients. Rabeprazole 20 or 10 mg, depending on randomization, was given orally for 4 weeks after ESD. Of the 70 patients, 45 (64 %) were men, and the median age was 65.2 ± 9.7 years. The mean ESD-induced ulcer area was 673 mm2. No significant differences in ulcer area reduction ratio (p = 0.49) or ulcer-related symptoms (p = 0.91) were observed between the two groups at 4 weeks after ESD. For ESD-induced ulcers, treatment with 10 mg of rabeprazole daily produces a similar outcome as 20 mg of rabeprazole with regard to healing efficacy and symptom resolution.
Uncooked, lactobacilli-rich, vegan food and rheumatoid arthritis.

We tested the effects of an uncooked vegan diet, rich in lactobacilli, in rheumatoid patients randomized into diet and control groups. The intervention group experienced subjective relief of rheumatic symptoms during intervention. A return to an omnivorous diet aggravated symptoms. Half of the patients experienced adverse effects (nausea, diarrhoea) during the diet and stopped the experiment prematurely. Indicators of rheumatic disease activity did not differ statistically between groups. The positive subjective effect experienced by the patients was not discernible in the more objective measures of disease activity (Health Assessment Questionnaire, duration of morning stiffness, pain at rest and pain on movement). However, a composite index showed a higher number of patients with 3-5 improved disease activity measures in the intervention group. Stepwise regression analysis associated a decrease in the disease activity (measured as change in the Disease Activity Score, DAS) with lactobacilli-rich and chlorophyll-rich drinks, increase in fibre intake, and no need for gold, methotrexate or steroid medication (R2=0.48, P=0.02). The results showed that an uncooked vegan diet, rich in lactobacilli, decreased subjective symptoms of rheumatoid arthritis. Large amounts of living lactobacilli consumed daily may also have positive effects on objective measures of rheumatoid arthritis.
The challenge of validating SF-12 for its use with community-dwelling elderly in Israel

To evaluate the psychometric properties and feasibility of using a Hebrew version of the SF-12 for community-dwelling elderly. Four hundred and twenty-one people aged 70+ were interviewed in a longitudinal study, using the Barthel Index, GDS and SF-12. Score distribution was satisfactory, with minimal missing data and item-to-item correlations were satisfactory. There were no floor and ceiling effects. Factor analysis yields the two-dimensional factors of physical and mental health and a third factor of physical role. Reliability of domain and the complete scores using the internal consistency method point to good internal consistency. Regarding construct validity of the scale, the mental health domain scores had a significant, negative relation with scores on the GDS and the physical health domain scores had a significant, positive relation with scores on the ADL scale and a significant, negative relation with scores on the IADL scale. The Hebrew version of the SF-12 appears to be a practical instrument for use among the elderly population and the resulting health domains correlate highly with other measures of functional, physical, and mental health used for the elderly.
The effect of sulphasalazine on neutrophil superoxide generation in rheumatoid arthritis.

The production of superoxide by the peripheral blood neutrophils of 19 patients with active rheumatoid arthritis was measured during treatment with sulphasalazine (SASP). The response to drug treatment was determined by change in plasma viscosity, CRP, early morning stiffness and articular index over a 10-point scale. Of the 19 patients studied, eight were considered to have responded well to SASP and seven to have responded poorly or not at all. Over the treatment period, plateau levels of superoxide production fell in seven of the eight responders (P = 0.028) compared with a non-significant fall in 3/7 of the non-responder groups. The initial rate of superoxide production also fell in the responder group, but this was not statistically significant. Initial values in both the responder and non-responder groups were comparable with those seen for normal controls. Analysis of drug levels showed all patients to be compliant with drug treatment; however, drug levels and neutrophil activity were not correlated. Studies of the effect of SASP and sulphapyridine on superoxide production in vitro showed no difference between good and poor responders. These results suggest that there is no inherent difference between good and poor responders regarding the susceptibility of their neutrophils to SASP. SASP's action on neutrophils, therefore, appears not to be its main mechanism of disease-modifying activity in RA.
Safety and Efficacy of a Saquinavir-Containing Antiretroviral Regimen in Previously ART-Naïve or Pretreated but Protease Inhibitor-Naïve HIV-Positive Patients

The RAINBOW survey is a multinational observational study assessing the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r), using the 500-mg filmcoated SQV formulation, in routine clinical practice. This analysis presents data from the German subgroup of antiretroviral therapy (ART)-naïve and pretreated but protease inhibitor (PI)-naïve patients. This was a multicenter, prospective, open-label, 48-week observational cohort study. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 48. Efficacy assessments included changes in the proportion of patients with HIV-1 RNA <50 and <400 copies/ml, and changes in CD4 cell count from baseline to week 48. The analysis included 275 ART-naïve and 179 pretreated but PI-naïve patients. The proportion of ART-naïve patients achieving <50 copies/ml by 48 weeks was 53.1% by intent-to-treat (ITT) analysis and 67.3% using last observation carried forward (LOCF) analysis. In pretreated but PInaïve patients, the proportions achieving <50 copies/ml by 48 weeks were 53.1% (ITT) and 70.4% (LOCF). The median increase in CD4 count at week 48 was +174 cells/mm3 (interquartile range [IQR] 86, 265) in the ART-naïve group and +100 cells/mm3 (IQR 0, 209) in the pretreated but PInaïve group (p < 0.01 for both; LOCF). Drug-related adverse events were reported in 7.6% of ART-naïve and 2.8% of pretreated but PI-naïve patients. Treatment with SQV/r was stopped in 21.5% of ART-naïve and 17.9% of pretreated but PI-naïve patients (due to side effects in 3.3% and 2.8%, respectively). There were no clinically relevant changes in liver enzyme levels. Overall, the total cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein levels increased to week 48, although the levels remained within normal ranges in the majority of patients. The results of this observational cohort study of treatment with the 500-mg tablet formulation of SQV are consistent with high efficacy and tolerability results seen in controlled studies of SQV/r. This analysis confirms that SQV/r is effective and well tolerated in ART-naïve and pretreated but PI-naïve patients in ‘real-world’ clinical settings.
Vinorelbine and prednisone in frail elderly patients with intermediate-high grade non-Hodgkin's lymphomas.

Frail patients with non-Hodgkin's lymphoma (NHL) are generally excluded from clinical trials and not even treated. The aim of this study was to evaluate the efficacy and tolerability of vinorelbine and prednisone in frail elderly patients with NHL.



Thirty consecutive frail elderly patients were entered in a phase II study with vinorelbine 25 mg/m2 i.v. on days 1 and 8 and oral prednisone 30 mg total dose on days 1-8 for six cycles. Criteria of frailty were age > or =80 years, or age > or =70 years and three or more comorbidities of grade 3 or at least one comorbidity of grade 4 according to the Cumulative Illness Rating Scale (CIRS), or not self-sufficient or the presence of one or more geriatric syndromes.



Of 30 evaluable patients, three (10.0%) achieved a complete response (CR), nine (30.0%) showed a partial response (PR), while 10 presented with stable disease and eight with progressive disease. The median duration of CR was 29 months (range 5-36 months), and the median duration of PR was 1 month (range 1-22 months). Three patients had grade 3 neutropenia and one had grade 4. One grade 4 neurotoxicity was observed. Three patients died because of heart failure within 28 days of therapy, and one patient died after 4 days because of rapid progression. The median overall survival was only 10 months.



Vinorelbine and prednisone is a relatively non-toxic combination with modest activity in frail patients with NHL. If initial aggressive chemotherapy has been excluded, this combination could be tried to obtain a temporary palliation.
Renal function in long-term survivors of stem cell transplantation in childhood. A prospective trial

The aim of this prospective study was to assess glomerular and tubular renal function before, and 1 and 2 years after hematological stem cell therapy (HSCT) in children and adolescents. 137 consecutive patients undergoing HSCT, for malignant diseases, were included in a prospective trial. Forty-four patients were followed for up to 1 year after HSCT and 36 for up to 2 years, without relapse. Ninety healthy school children were used as a control group. The following parameters were investigated: inulin clearance (GFR), urinary excretion of albumin, α1-microglobulin (α1-MG), calcium, β-N-acetylglucosaminidase (β-NAG) and Tamm–Horsfall protein (THP), tubular phosphate reabsorption (TP/Clcr) and percent reabsorption of amino acids (TAA). Significantly lower GFR was found 1 and 2 years after HSCT but within the normal range in the period before HSCT. There was no correlation between GFR within the first month after HSCT and long-term outcome of GFR. Tubular dysfunction was found in 14–45% of patients 1 and 2 years after HSCT depending on the parameter investigated. Pathological values 1 and 2 years after HSCT were found for α1-MG excretion in 40% and 39%, respectively, for TP/Clcr in 44% and 45%, for β-NAG in 26% and 19%. Median TP/Clcr was significantly lower 2 years after HSCT than before. TAA was mildly impaired in 7/14 patients before, in 5/29 one and in 9/29 2 years after HSCT, but median TAA was within normal range at all times. The median excretion of albumin, THP and calcium was within the normal range at all investigations. No influence of ifosfamide pre-treatment on the severity of tubulopathy was found. The investigation of tubular renal function should be part of a long-term follow-up in children after HSCT. Bone Marrow Transplantation (2001) 27, 319–327.