nils-herrmann/clean_scirepeval huggingface dataset:
Effects of aerobic and resistance training on hemoglobin A1c levels in patients with type 2 diabetes: a randomized controlled trial.

Exercise guidelines for individuals with diabetes include both aerobic and resistance training although few studies have directly examined this exercise combination.



To examine the benefits of aerobic training alone, resistance training alone, and a combination of both on hemoglobin A(1c) (HbA(1c)) in individuals with type 2 diabetes.



A randomized controlled trial in which 262 sedentary men and women in Louisiana with type 2 diabetes and HbA(1c) levels of 6.5% or higher were enrolled in the 9-month exercise program between April 2007 and August 2009.



Forty-one participants were assigned to the nonexercise control group, 73 to resistance training 3 days a week, 72 to aerobic exercise in which they expended 12 kcal/kg per week; and 76 to combined aerobic and resistance training in which they expended 10 kcal/kg per week and engaged in resistance training twice a week.  Change in HbA(1c) level. Secondary outcomes included measures of anthropometry and fitness.



The study included 63.0% women and 47.3% nonwhite participants who were a mean (SD) age of 55.8 years (8.7 years) with a baseline HbA(1c) level of 7.7% (1.0%). Compared with the control group, the absolute mean change in HbA(1c) in the combination training exercise group was -0.34% (95% confidence interval [CI], -0.64% to -0.03%; P = .03). The mean changes in HbA(1c) were not statistically significant in either the resistance training (-0.16%; 95% CI, -0.46% to 0.15%; P = .32) or the aerobic (-0.24%; 95% CI, -0.55% to 0.07%; P = .14) groups compared with the control group. Only the combination exercise group improved maximum oxygen consumption (mean, 1.0 mL/kg per min; 95% CI, 0.5-1.5, P < .05) compared with the control group. All exercise groups reduced waist circumference from -1.9 to -2.8 cm compared with the control group. The resistance training group lost a mean of -1.4 kg fat mass (95% CI, -2.0 to -0.7 kg; P < .05) and combination training group lost a mean of -1.7 (-2.3 to -1.1 kg; P < .05) compared with the control group.



Among patients with type 2 diabetes mellitus, a combination of aerobic and resistance training compared with the nonexercise control group improved HbA(1c) levels. This was not achieved by aerobic or resistance training alone.
A randomized, double-blind, placebo-controlled, delayed start study to assess rasagiline as a disease modifying therapy in Parkinson's disease (the ADAGIO study): rationale, design, and baseline characteristics.

A neuroprotective therapy is the single most important unmet medical need in Parkinson's disease. Several promising agents in the laboratory have been tested in the clinic, but none has been established in clinical trials to have a disease modifying effect despite positive results because of potential confounding symptomatic or pharmacologic effects. The delayed start design was developed to try to avoid a symptomatic confound when testing a putative neuroprotective therapy. In this study design, patients are randomly assigned to study drug or placebo in the first phase of the study, and both groups receive the active drug in the second phase. If benefits seen at the end of phase I persist through the end of phase II, they cannot be readily explained by a symptomatic effect (as patients in both groups are receiving the same medication) and benefits in the early start group must relate to the early initiation of the treatment. Although the precise mechanism responsible for such an effect can be debated, positive results in a delayed start study indicate that patients who receive early treatment have a better outcome than those where the treatment is delayed. We are using the delayed start design to assess the potential disease modifying effects of rasagiline in a prospective double blind controlled trial (the ADAGIO study). We here describe the rationale for the study and baseline characteristics of the 1,176 patients who have been enrolled into the trial.
Trajectories of target reaching arm movements in individuals with spinal cord injury: Effect of external trunk support

Deficits in trunk control due to spinal cord injury (SCI) lead to slower target-reaching movements of the hand. We investigated whether the movement path is also affected, and whether providing external support for the trunk can abolish the kinematic differences. To compare movement trajectories between individuals with SCI and neurologically normal individuals, with and without external trunk support. Neural Control/Biomechanics Laboratory, University of Illinois, Chicago, USA.Methods: Five subjects with levels of injury between C7 and T4 were tested 3–8 years post-injury, and compared with five control subjects. Two targets were employed. Trajectories were recorded by a motion-capture system using infrared emitting markers. Peak speed and path curvature were calculated for the fingertip and for the acromion. Compared with control subjects, the subjects with SCI exhibited lower peak speed of the fingertip but not of the acromion, and less straight paths for both. When the trunk was supported externally, the difference in fingertip speed persisted. The support abolished the difference in path curvature for the fingertip but accentuated that for the acromion. The slower hand movements of individuals with SCI are not simply time-scaled versions of those of normal subjects, and the provision of trunk support does not erase the kinematic differences between the reaching movements of the two groups.
Aripiprazole, Ziprasidone and Quetiapine in the treatment of first-episode nonaffective psychosis: A 12-week randomized, flexible-dose, open-label trial

Differences among antipsychotics in terms of effectiveness have turned out to be a topic of increasing research interest, although comparisons between the different second generation antipsychotics (SGAs) are scarce. We aimed to compare the clinical effectiveness in the short-term of Aripiprazole, Ziprasidone and Quetiapine in the treatment of first-episode schizophrenia-spectrum disorders.



From October 2005 to January 2011, a prospective, randomized, open-label study was undertaken. 202 first-episode drug-naïve patients were randomly assigned to Aripiprazole (N = 78), Ziprasidone (N = 62), or Quetiapine (N = 62) and followed-up for 3 months. The primary effectiveness measure was all-cause of treatment discontinuation. In addition, an analysis based on intention-to-treat populations was conducted in the analysis for clinical efficacy.



The overall dropout rate at 3 months was small (13.86%). The treatment discontinuation rate differed significantly between treatment groups (Aripiprazole = 23.1%, Ziprasidone = 37.1% and Quetiapine = 61.3%) (χ(2) = 21.334; p < 0.001). Insufficient efficacy in the group of Quetiapine is the main reason for discontinuation rate differences (χ(2) = 20.223; p < 0.001). The mean time to all-cause discontinuation was significantly different between groups (LogRank = 23.467 p < 0.001). Aripiprazole and Quetiapine were associated with a greater depressive symptoms improvement (p = 0.043). The profile of side-effects varies between treatments. Patients on Quetiapine were less likely to be prescribed hypnotics.



Patients treated with Quetiapine had a higher risk of treatment discontinuation in the short-term after a first episode due to insufficient efficacy. Establishing differences between SGAs may help clinicians in prescribing decisions for the treatment of individuals presenting with first-episode schizophrenia.
Ambulatory monitoring derived blood pressure variability and cardiovascular risk factors in elderly hypertensive patients.

Hypertension in the elderly is characterized by isolated systolic hypertension and high variability, but its clinical significance is not yet fully understood. The goal of this paper was to assess circadian blood pressure variability (BPV) in elderly hypertensives, and to determine its relationship to cardiovascular risk factors. To achieve this goal, a number of 75 inefficiently treated hypertensive patients were studied, 45 elderly, aged over 60 years, 30 middle-aged, younger than 60 years. After 24-hour ambulatory blood pressure monitoring (ABPM), blood pressure (BP) values, pulse pressure (PP), morning surge were compared between the groups. BPV was calculated using average real variability (ARV). The relationships between BPV, pulse pressure, left ventricular mass index (LVMI), and cardiovascular risk factors were assessed in both groups. As a result, it was found that left ventricular mass (p=0.01), PP, morning surge, 24-hour systolic ARV were significantly higher in the elderly group (p<0.05). In both groups, higher 24-hour BPV was associated with an increase in LVMI. In the elderly population 24-hour BPV was positively correlated to increased PP, total cholesterol and triglyceride levels (p<0.05). Moreover, it was concluded that ABPM-derived BP variability index could be an early predictive marker of end-organ damage in hypertension. Its reduction might be an important objective of hypertension management in elderly.
Bevacizumab and irinotecan in children with recurrent or refractory brain tumors: toxicity and efficacy trends.

Bevacizumab, a monoclonal antibody targeting the vascular endothelial growth factor, has proven efficacy in some adult tumors; it is now proposed as a new therapeutic strategy for refractory or recurrent brain tumors in some children, either alone or combinated.


PROCEDURE
We retrospectively analyzed 28 children who received bevacizumab on a compassionate basis for refractory or recurrent brain tumors between June 2007 and August 2010 in 7 French centers. Among them, 12 had high-grade gliomas, 7 low-grade gliomas, 4 ependymomas, 2 primitive neurectodermal tumors, 3 neuroglial tumors. The median age at start of bevacizumab was 11.0 years. Bevacizumab was administered at 5-10 mg/kg every 2 weeks, with concomitant chemotherapy for 27 patients.



Bevacizumab was used in combination with irinotecan in 27 patients. Bevacizumab-related toxicity was mild. Toxicities reported were grade I-II hypertension (n = 4), proteinuria (n = 1), lymphopenia (n = 2), wound healing delay (n = 2). Whereas tumor reduction could be observed in 6:7 patients with low-grade gliomas, no efficacy could be documented in patients with high-grade glioma, nor PNET nor ependymoma.



Bevacizumab-related acute toxicity appears to be low in children, even in combination with irinotecan. Further prospective trials are required to confirm the hypothetical efficacy of bevacizumab and to assess the risk of long-term toxicity especially in the youngest children.
A randomized controlled trial of rivastigmine for chronic sequels of traumatic brain injury-what it showed and taught?

To evaluate the effectiveness of rivastigmine for chronic sequels of traumatic brain injury (TBI).



Randomized, placebo-controlled, double-blind crossover trial.



Of 772 outpatients with TBI treated during 1993-2002, all eligible patients were contacted and 102 patients volunteered. They were randomized to receive either rivastigmine (Exelon) or placebo. The study included two periods with titration to the highest tolerated or maximum dose (12 mg rivastigmine daily) and a maintenance period of 8 weeks, separated by a 4-week washout. Computerized neuropsychological testing and standardized clinical interviews were used to assess the outcome.



Sixty-nine patients completed the study and 17 withdrew because of adverse effects. In two measures of computerized testing (subtraction test, p = 0.034 and correct answers in the 10-15 minute vigilance test, p = 0.048) rivastigmine was better than placebo. The clinical interviews did not yield significant results. After the study, 45% of patients considered rivastigmine beneficial compared to 20% with placebo.



A weak trend favouring rivastigmine for chronic symptoms of TBI was observed. The clinical significance of the results and the problems in conducting drug trials for chronic TBI symptoms are discussed.
Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases.

To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases.



In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents).



One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases).



Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.
Comparative Study of Core Needle Biopsy and Fine Needle Aspiration Cytology in Palpable Breast Lumps: Scenario in Developing Nations.

The purpose of this study was to evaluate the utility of core needle biopsy as a diagnostic tool for palpable breast lumps in developing countries as compared to fine needle aspiration cytology.



All patients attending the surgery outpatient department with palpable breast lumps were subjected to fine needle aspiration cytology and core needle biopsy by the same operator in a single session. Fine needle aspiration cytology was performed by the standard technique. Core needle biopsy was done freehand using a 14G manual core biopsy needle. Reporting categories of the two techniques were taken from the standard National Health Service Breast Screening Programme criteria and were compared with the final histopathology results.



A total of 107 patients underwent fine needle aspiration cytology and core needle biopsy simultaneously. Histopathology was available for 85 cases. Statistical analysis of fine needle aspiration cytology and core needle biopsy showed no significant difference between the diagnoses offered by core needle biopsy and histopathology while there was a significant difference between fine needle aspiration cytology and histopathology diagnoses.



Core needle biopsy detected more breast carcinomas as compared to fine needle aspiration cytology with a sensitivity 95.83% as opposed to 64.58%. Though both the techniques were equally specific (100%), Core needle biopsy was able to correctly categorize borderline / inadequate lesions into definitely benign and malignant categories. We suggest that core needle biopsy should be preferred over fine needle aspiration cytology for the diagnosis of palpable breast lumps with fine needle aspiration cytology being reserved for definitely benign lesions.
Down-regulation of interferon signature in systemic lupus erythematosus patients by active immunization with interferon α-kinoid.

We developed interferon-α-kinoid (IFN-K), a drug composed of inactivated IFNα coupled to a carrier protein, keyhole limpet hemocyanin. In human IFNα-transgenic mice, IFN-K induces polyclonal antibodies that neutralize all 13 subtypes of human IFNα. We also previously demonstrated that IFN-K slows disease progression in a mouse model of systemic lupus erythematosus (SLE). This study was undertaken to examine the safety, immunogenicity, and biologic effects of active immunization with IFN-K in patients with SLE.



We performed a randomized, double-blind, placebo-controlled, phase I/II dose-escalation study comparing 3 or 4 doses of 30 μg, 60 μg, 120 μg, or 240 μg of IFN-K or placebo in 28 women with mild to moderate SLE.



IFN-K was well tolerated. Two SLE flares were reported as serious adverse events, one in the placebo group and the other in a patient who concomitantly stopped corticosteroids 2 days after the first IFN-K dose, due to mild fever not related to infection. Transcriptome analysis was used to separate patients at baseline into IFN signature-positive and -negative groups, based on the spontaneous expression of IFN-induced genes. IFN-K induced anti-IFNα antibodies in all immunized patients. Notably, significantly higher anti-IFNα titers were found in signature-positive patients than in signature-negative patients. In IFN signature-positive patients, IFN-K significantly reduced the expression of IFN-induced genes. The decrease in IFN score correlated with the anti-IFNα antibody titer. Serum complement C3 levels were significantly increased in patients with high anti-IFNα antibody titers.



These results show that IFN-K is well tolerated, immunogenic, and significantly improves disease biomarkers in SLE patients, indicating that further studies of its clinical efficacy are warranted.
A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness.

This article compares the effects of initiating three contemporary antiretroviral therapy (ART) regimens on progression of carotid artery intima-media thickness (IMT) over 3 years.



Randomized clinical trial.



Multicenter (26 institutions).



ART-naive HIV-infected individuals (n = 328) without known cardiovascular disease or diabetes mellitus.



Random assignment to tenofovir/emtricitabine along with atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r), or raltegravir (RAL).



Right-sided carotid IMT was evaluated by B-mode ultrasonography before ART initiation, and then after 48, 96, and 144 weeks. Comparisons of yearly rates of change in carotid IMT used mixed-effects linear regression models that permitted not only evaluation of the effects of ART on carotid IMT progression but also how ART-associated changes in traditional risk factors, bilirubin, and markers of HIV infection were associated carotid IMT progression.



HIV-1 RNA suppression rates were high in all arms (>85%) over 144 weeks. Modest increases in triglycerides and non-high-density lipoprotein cholesterol levels were observed in the protease inhibitor-containing arms compared with decreases with RAL. In contrast, carotid IMT progressed more slowly on ATV/r [8.2, 95% confidence interval (5.6, 10.8) μm/year] than DRV/r [12.9 (10.3, 15.5) μm/year, P = 0.013]; changes with RAL were intermediate [10.7 (9.2, 12.2) μm/year, P = 0.15 vs. ATV/r; P = 0.31 vs. DRV/r]. Bilirubin and non-high-density lipoprotein cholesterol levels appeared to influence carotid IMT progression rates.



In ART-naive HIV-infected individuals at low cardiovascular disease risk, carotid IMT progressed more slowly in participants initiating ATV/r than those initiating DRV/r, with intermediate changes associated with RAL. This effect may be due, in part, to hyperbilirubinemia.
Predictors of large esophageal varices in patients with cirrhosis

Recent guidelines recommend that all cirrhotics undergo screening upper endoscopy to identify those patients at risk for bleeding from varices. However, this practice may not be cost effective as large esophageal varices are seen only in 9–36% of these patients. The aim of this study was to determine whether clinical variables were predictive of the presence of large esophageal varices.This is a retrospective analysis of cirrhotics who had a screening upper endoscopy during an evaluation for liver transplantation at three different centers and who had not previously bled from varices. A multivariate model was derived on the combined cohort using logistic regression. Three hundred forty-six patients were eligible for the study.The prevalence of large esophageal varices was 20%. On multivariate analysis, splenomegaly detected by computed tomographic scan (odds ratio: 4.3; 95% confidence interval: 1.6–11.5) or by physical examination (odds ratio: 2.0; 95% confidence interval: 1.1–3.8), and low platelet count were independent predictors of large esophageal varices. On the basis of these variables, cirrhotics were stratified into high- and low-risk groups for the presence of large esophageal varices. Patients with a platelet count of ≥88,000/mm3 (median value) and no splenomegaly by physical examination had a risk of large esophageal varices of 7.2%. Those with splenomegaly or platelet count <88,000/mm3 had a risk of large esophageal varices of 28% (p < 0.0001).Conclusions:Our data show that clinical predictors could be used to stratify cirrhotic patients for the risk of large esophageal varices and such stratification could be used to improve the cost effectiveness of screening endoscopy.
The effect of leucocyte-depleting arterial line filters on cerebral microemboli and neuropsychological outcome following coronary artery bypass surgery.

A randomised clinical trial sought evidence as to whether leucocyte-depleting (LD) arterial line filters added a further degree of neuroprotection in patients undergoing elective coronary artery bypass graft (CABG) surgery.



One hundred and ninety-two patients were randomised to the use of a Pall Leukoguard-6 LD filter or either an Avecor Affinity or Pall Autovent-6 control filter. Cerebral microemboli during surgery were recorded by transcranial Doppler (TCD) monitor over the right middle cerebral artery. Evidence of cerebral impairment was obtained by comparing patients' performance in a neuropsychological (NP) test battery (nine tests) administered 6-8 weeks post-operatively with their pre-operative scores.



The groups proved well balanced in pre-operative variables. During cardiopulmonary bypass (CPB) the median number and range of microemboli was 15 (3-180) in the LD group compared to 67 (5-846) and 55 (2-773) for the Avecor and AV6 groups, respectively (P<0.0001). One hundred and sixty-two patients completed all the NP tests. The LD group showed better post-operative performance in all but one of the nine tests although the difference in a total change score just failed to reach significance (P=0.07 one-tailed t-test).



LD filtration during CABG reduced the number of cerebral microemboli recorded by TCD and showed a strong trend towards improving NP performance post-operatively. These findings suggest that the use of such filters in CABG surgery may offer increased neuroprotection.