nils-herrmann/clean_scirepeval huggingface dataset:
6-tips diet: a simplified dietary approach in patients with chronic renal disease. A clinical randomized trial

The beneficial effects of dietary restriction of proteins in chronic kidney disease are widely recognized; however, poor compliance to prescribed low-protein diets (LPD) may limit their effectiveness. To help patients to adhere to the dietary prescriptions, interventions as education programmes and dietary counselling are critical, but it is also important to develop simple and attractive approaches to the LPD, especially when dietitians are not available. Therefore, we elaborated a simplified and easy to manage dietary approach consisting of 6 tips (6-tip diet, 6-TD) which could replace the standard, non-individualized LPD in Nephrology Units where dietary counselling is not available; hence, our working hypothesis was to evaluate the effects of such diet vs a standard moderately protein-restricted diet on metabolic parameters and patients’ adherence. In this randomized trial, 57 CKD patients stage 3b-5 were randomly assigned (1:1) to receive the 6-TD (Group 6-TD) or a LPD containing 0.8 g/kg/day of proteins (Group LPD) for 6 months. The primary endpoint was to evaluate the effects of the two different diets on the main “metabolic” parameters and on patients’ adherence (registration number NCT01865526). Both dietary regimens were associated with a progressive reduction in protein intake and urinary urea excretion compared to baseline, although the decrease was more pronounced in Group 6-TD. Effects on serum levels of urea nitrogen and urinary phosphate excretion were greater in Group 6-TD. Plasma levels of phosphate, bicarbonate and PTH, and urinary NaCl excretion remained stable in both groups throughout the study. 44 % of LPD patients were adherent to the dietary prescription vs 70 % of Group 6-TD. A simplified diet, consisting of 6 clear points easily managed by CKD patients, produced beneficial effects either on the metabolic profile of renal disease and on patients’ adherence to the dietary plan, when compared to a standard LPD.
Predictive gene signatures for bevacizumab and cetuximab as well as cytotoxic agents.

DOI 10.5414/CPP50070  2011 Correspondence to Prof. Dr. Heinz-Herbert Fiebig Oncotest GmbH, Institute for Experimental Oncology, Am Flughafen 12 – 14, 79108 Freiburg, Germany Fiebig@Oncotest.de
Elevation of whole-blood glutathione in peritoneal dialysis patients by L-2-oxothiazolidine-4-carboxylate, a cysteine prodrug (Procysteine).

Glutathione is a major cellular antioxidant that protects protein thiols and inhibits cellular damage due to oxygen free radicals. It has been reported previously that patients undergoing dialysis have low levels of blood glutathione, which may lead to increased susceptibility to oxidant stress. L-2-oxothiazolidine-4-carboxylic acid (OTZ) is a cysteine prodrug that raises cellular glutathione levels by increasing delivery of cysteine, the rate-limiting substrate for glutathione synthesis. This study investigates the effect of OTZ on blood glutathione in a blinded, placebo-controlled study of patients with chronic renal failure treated by peritoneal dialysis. Twenty patients were randomly selected to receive OTZ (0.5 g three times a day orally with meals) or placebo for 14 d. Patients visited the clinic for predose blood collection and safety evaluation at baseline (days 3, 7, and 14 and again at 14 d from the last dose [follow-up]). Glutathione concentrations were determined in whole blood by HPLC. OTZ resulted in a significant rise in whole-blood glutathione at days 7 (594 +/- 129 mumol/L) and 14 (620 +/- 108 mumol/L) compared with baseline (544 +/- 139 mumol/L) (P < 0.01 and P < 0.05, respectively). Glutathione was also significantly increased at days 7 and 14 when normalized by hematocrit (Hct) or hemoglobin to correct for anemic status (e.g., 20.7 +/- 5.7 mumol/L per % Hct [day 7] and 20.9 +/- 4.0 mumol/L per % Hct [day 14] versus 18.0 +/- 4.2 mumol/L per % Hct [baseline]; P < 0.05). Glutathione levels did not change in the placebo group at any patient visit, and levels in the OTZ-treated group returned to baseline at follow-up. There were no serious adverse events attributable to OTZ, and the drug appeared to be well tolerated by patients with renal failure treated by continuous ambulatory peritoneal dialysis. Our results show that OTZ increases blood glutathione levels, which may improve antioxidant status in dialysis patients.
Lovastatin effects on bone mineral density in postmenopausal women with type 2 diabetes mellitus

The objective of this study was to examine the effects of lovastatin on bone mineral density (BMD) of postmenopausal women with type 2 diabetes mellitus (DM). The study was an open-label clinical trial conducted from March 2002 to November 2003. Fifty-five postmenopausal women age 54–67 years with type 2 DM were allocated to lovastatin-treated and control (without lovastatin) groups based on low-density lipoprotein cholesterol (LDL-C) >130 or ≤130 mg/dl. The first group received lovastatin (20 mg daily titrated every 3 months to keep LDL-C less than 130 mg/dl) for a total of 18 months. The second group received their own diabetic regimen without statin. The BMD of the lumbar spine (L1-L4), femoral neck, Wards triangle, trochanter and total hip was measured by dual-energy X-ray absorptiometry at baseline and after 18 months. In the 28 women treated with lovastatin, the BMD increased in lumbar spine (from 0.946 (0.122) to 0.978 (0.135) g/cm2, p<0.01) and Ward’s triangle (from 0.685 (0.123) to 0.780 (0.186) g/cm2, p<0.01). In the 27 women not treated with statin, the changes in BMD at all bone sites were not statistically significant. BMD was higher in femoral neck (1.2% vs. −2.7%, p<0.05), Ward’s triangle (13.9% vs. 3.3%, p<0.05), trochanter (−0.1% vs. −2.9%, p<0.05), total hip (1.2% vs. −1.4%, p<0.05) and lumbar spine (3.4% vs. 1.2%, p>0.05) at the end of the study. Treatment with lovastatin may prevent bone loss in postmenopausal women with type 2 DM.
Results in 95 hemorrhagic stroke patients included in CLASS, a controlled trial of clomethiazole versus placebo in acute stroke patients.

Clomethiazole is a neuroprotective drug that enhances gamma-aminobutyrate type A (GABA(A)) receptor activity. Its efficacy and safety were tested in the CLomethiazole Acute Stroke Study (CLASS). The protocol allowed a CT scan to be done after randomization but within 7 days of stroke onset to minimize delays before start of treatment. Ninety-five of the 1360 patients randomized were diagnosed as having intracranial hemorrhage rather than ischemic stroke. Safety results for clomethiazole compared with placebo in this group are reported.



The study included patients with a clinical diagnosis of acute hemispheric cerebral infarction. Treatment was a 24-hour intravenous infusion of 75 mg/kg clomethiazole or placebo. Patients with intracranial hemorrhage discovered on a postrandomization CT were withdrawn from study treatment if treatment was ongoing, and all patients were followed up to 90 days.



Ninety-four patients received treatment, 47 in each group. The hemorrhage was classified as intracerebral in 89 patients (94%). Mortality at 90 days was 19.1% in the clomethiazole group and 23.4% in the placebo group. Sedation was the most common adverse event, occurring at a higher incidence in clomethiazole-treated patients (clomethiazole 53%, placebo 17%), followed by rhinitis and coughing. The incidence and pattern of serious adverse events was similar between the treatment groups. The percentage of patients reaching relative functional independence on the Barthel Index (score >/=60) at 90 days was 59.6% in the clomethiazole group and 53.2% in the placebo group.



Clomethiazole appears safe to administer to hemorrhagic stroke patients compared with placebo. These results would obviate the need for a CT scan before therapy is initiated in acute stroke. The safety of clomethiazole in hemorrhagic stroke patients will be further evaluated in a prospective study that is under way in North America.
Radioimmunoguided surgery for colorectal cancer

Operations for patients with colorectal cancer are based on traditions established by historical experience. Radioimmunoguided surgery (RIGS) provides new information that challenges these traditions.  Thirty-two patients with primary colorectal cancer underwent RIGS after being injected with anti-TAG-72 murine monoclonal antibody CC49 labeled with iodine-125. Sixteen of the patients had all gross tumor and RIGS-positive tissue removed (RIGS-negative group), and 16 had only traditional extirpation of the tumor because RIGS-positive tissue was too diffuse (RIGS-positive group).  In the 16 patients having all RIGS-positive tissue removed, five had traditional regional en bloc resections and 11 had additional extraregional tissues resected. Identification of extraregional disease added two liver resections and 25 lymphadenectomies: 10 of the gastrohepatic ligament, five celiac axis, six retroperitoneal, and four iliac. With a median follow-up of 37 months, survival in the RIGS-negative group is 100%. In 14 of 16 patients (87.5%) there is no evidence of disease. In the RIGS-positive group, follow-up shows 14 of 16 patients are dead and two are alive with disease (p<0.0001).  These results suggest that RIGS identifies patterns of disease dissemination different from those identified by traditional staging techniques. Removal of additional RIGS-positive tissues in nontraditional areas may improve survival.
CD47Low Status on CD4 Effectors Is Necessary for the Contraction/Resolution of the Immune Response in Humans and Mice

How do effector CD4 T cells escape cell death during the contraction of the immune response (IR) remain largely unknown. CD47, through interactions with thrombospondin-1 (TSP-1) and SIRP-α, is implicated in cell death and phagocytosis of malignant cells. Here, we reported a reduction in SIRP-α-Fc binding to effector memory T cells (T(EM)) and in vitro TCR-activated human CD4 T cells that was linked to TSP-1/CD47-induced cell death. The reduced SIRP-α-Fc binding (CD47(low) status) was not detected when CD4 T cells were stained with two anti-CD47 mAbs, which recognize distinct epitopes. In contrast, increased SIRP-α-Fc binding (CD47(high) status) marked central memory T cells (T(CM)) as well as activated CD4 T cells exposed to IL-2, and correlated with resistance to TSP-1/CD47-mediated killing. Auto-aggressive CD4 effectors, which accumulated in lymph nodes and at mucosal sites of patients with Crohn's disease, displayed a CD47(high) status despite a high level of TSP-1 release in colonic tissues. In mice, CD47 (CD47(low) status) was required on antigen (Ag)-specific CD4 effectors for the contraction of the IR in vivo, as significantly lower numbers of Ag-specific CD47(+/+)CD4 T cells were recovered when compared to Ag-specific CD47(-/-) CD4 T cells. In conclusion, we demonstrate that a transient change in the status of CD47, i.e. from CD47(high) to CD47(low), on CD4 effectors regulates the decision-making process that leads to CD47-mediated cell death and contraction of the IR while maintenance of a CD47(high) status on tissue-destructive CD4 effectors prevents the resolution of the inflammatory response.
Efficacy of sustained release theophylline given at three different evening intake times in addition to a baseline medication.

In this randomized crossover study of 26 outpatients with bronchial asthma the efficacy of a new once-daily theophylline formulation given in addition to a baseline medication was investigated; moreover, under steady state conditions, the effect of three evening intake times (6, 8 and 10 p.m.) on 24 h pharmacokinetics and peak-expiratory flow profiles was evaluated. The theophylline dose had been individually titrated. The pharmacodynamic results show a marked improvement of 24 h peak expiratory flow values after adding theophylline to a drug therapy including inhalative beta 2-agonists and corticosteroids in nearly all and inhalative anticholinergics in 50% of the treated outpatients. No significant differences between the pharmacokinetic characteristics and the 24 hr averages (mesors) of peak expiratory flow at the three different intake times 6, 8 and 10 p.m. were found; however, intake at 10 p.m. resulted in the highest nocturnal excess of serum theophylline concentrations and the highest peak expiratory flow during the early morning hours between 2 and 6
Acute and sustained effects of cognitive emotion regulation in major depression.

Dysfunctional regulation of mood and emotion is a key component of major depressive disorder and leads to sustained negative feelings. Using functional MRI (fMRI), we investigated the temporal dynamics of emotion regulation in patients with major depressive disorder and in healthy controls, testing for acute and sustained neural effects of active emotion regulation. Moderately depressed individuals (n = 17) and never-depressed healthy control subjects (n = 17) underwent fMRI during performance of an active cognitive emotion regulation task while viewing emotionally arousing pictures. In a second task, completed 15 min later, subjects were presented with the same stimuli in a passive viewing task. Whole-brain analyses and connectivity measures were used to determine acute and sustained effects of emotion regulation on brain activation and coupling between regions. On the group level, patients were able to downregulate negative emotions and corresponding amygdala activation, but this ability decreased with increasing symptom severity. Moreover, only healthy control subjects showed a sustained regulation effect in the amygdala after a 15 min delay, whereas depressed patients did not. Finally, patients exhibited diminished prefrontal activation and reduced prefrontolimbic coupling during active regulation. Although emotion regulation capacity in medicated depressive patients appears to be preserved depending on symptom severity, the effect is not sustained. Correlational analyses provide evidence that this diminished sustained-regulation effect might be related to reduced prefrontal activation during regulation.
The importance of catheter stability evaluated by VisitagTM during pulmonary vein isolation

The recurrence rates of atrial fibrillation (Af) after ablation are still high, and repeat procedures are required in these patients. The main reason for Af recurrence is the recovery of the conduction between the pulmonary veins and left atrium. The importance of catheter stability during the pulmonary vein isolation (PVI) is not well studied. The purpose of this study was to evaluate the contact force (CF), stable ablation time, and power during conduction blocking lesion formation for PVI. Thirty-two consecutive drug-refractory Af patients who underwent an initial PVI using CARTO 3 and Visitag were included. The CF, ablation time, force time integral (FTI), and ablation power were recorded by Visitag. Residual conduction gap points requiring touch-up ablation after an encircling linear ablation (R point), spontaneous reconnection points (S point), and dormant conduction points (D point) were considered as non-conduction blocking lesion points. Each ablation parameter for the non-conduction blocking lesion points was compared with the other lesion points. Twenty-one points in 16 patients were considered non-conduction blocking lesions. Ten were R, eight were S, and three were D points. The CF, ablation time, FTI, and power at the non-conduction blocking lesion points and other points were 12.0 g (7.0–21.5) and 12.0 g (9.0–16.0) (P = 0.9), 7.7 s (5.6–10.1) and 12.5 s (9.4–16.8) (P < 0.05), 103.0 g*s (62.0–174.5) and 149.0 g*s (104.0–213.0) (P < 0.05), and 30.0 W (22.5–30.0) and 30.0 W (30.0–30.0) (P = 0.06), respectively. Shorter ablation time recorded in Visitag lead to non-conduction blocking lesion.
A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial

Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial.



A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up.



This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs.
Demographics and correlates of five-year change in echocardiographic left ventricular mass in young black and white adult men and women: the Coronary Artery Risk Development in Young Adults (CARDIA) study.

The goal of this study was to determine the presence and correlates of change (Delta) in left ventricular (LV) mass by echocardiography in young adults.



Left ventricular mass is known to be a powerful independent predictor for cardiovascular disease events in adults. However, little is known about Delta in LV mass over time in young adults.



Coronary Artery Risk Development in Young Adults (CARDIA) is a multicenter, longitudinal, population-based study of black and white men and women who were ages 23 to 35 at the time of their initial two-dimensionally directed M-mode echocardiography exam (year 5); half the cohort had a repeat echocardiography exam five years later (year 10). Data were analyzed from 1,189 participants who had paired echocardiography studies. To minimize reader variability, blinded measurements on initial and repeat echocardiography were performed nearly contemporaneously by the same reader.



In multilinear regression analyses, significant (p < 0.05) predictors of year 10 two-dimensional guided M-mode LV mass included initial LV mass, initial body mass index (BMI) and change in BMI for all race/gender subgroups. Initial systolic blood pressure (SBP) was a significant predictor of year 10 LV mass in white men and black women; change in SBP was significant in black women with a trend towards significance in white women. Left ventricular mass remained constant in all race/gender subgroups, except black women, where it increased (by 5.9 g [mean]). Black women also had the largest increases in BMI and SBP. In black women, a five-year weight gain of 20 pounds and a 15-mm Hg increase in SBP would be expected to be associated with a 9% to 12% increase in LV mass.



Particularly in black women, weight and blood pressure control may be important community health and treatment goals to prevent LV hypertrophy.
Acute changes in endothelin after hemodialysis in children

The purpose of this study was to investigate the acute changes in endothelin (ET) levels immediately after hemodialysis and to determine whether these changes vary with the use of different membranes and hemodialysis solutions. Ten children were included in the study. Three different hemodialysis sessions were performed on all patients: session 1, acetate-based dialysate and polycarbonate membrane; session 2, bicarbonate-based dialysate and polycarbonate membrane; session 3, acetate-based dialysate and polysulfone membrane. In all cases blood samples were obtained before and after dialysis. Pre- and post-hemodialysis ET levels of the patients with acetate-based dialysate and polycarbonate membrane were 33.68±11.51 pg/ml and 28.27±12.85 pg/ml, respectively. The fall in ET levels after this session was statistically significant (P = 0.015). We did not observe a statistically significant change in ET levels in the other sessions. Post-dialysis mean arterial pressure values were significantly lower than the pre-dialysis values in all three dialysis sessions (P <0.01). A positive correlation was observed between plasma ET levels and blood urea nitrogen and serum potassium; a negative correlation was observed between plasma ET levels and hematocrit.
A Distributed and Optimal Motion Planning Approach for Multiple Mobile Robots

|We propose a distributed and optimal motion planning algorithm for multiple robots. The computationally expensive problem is decomposed into two modules { path planning and velocity planning. The D search method is applied in both modules, based on either geometric formulation or schedule formulation. Optimization is achieved at the individual robot level by de ning cost functions to minimize, and also at the team level by a global measurement function re ecting performance indices of interest as a team. Contrary to our knowledge of previous results on multirobot motion planning that either obtain optimal solutions through centralized and exhaustive computing, or achieve distributed implementations without considering any optimization issues, our approach combines these two features and explicitly optimizes performance functions through a distributed implementation. It is also one of the few that is capable of handling outdoor rough terrain environments and real time replanning. Simulations are shown on a Mars-like rough terrain using a 3D vehicle planner and control simulator. The algorithm was also implemented and successfully run on a group of Nomad 200 indoor robots. Keywords| Multi robots, motion planning, performance index, cost function, coordination diagram.