nils-herrmann/clean_scirepeval huggingface dataset:
Radiotherapy for parotid cancer

Parotid malignancies represent a heterogeneous group of tumors primarily managed by surgical extirpation. Moderately high recurrence rates are seen after surgery alone, and postoperative radiotherapy has been used for patients with higher risks for local failure.  To assess the role of radiotherapy in the management of patients with malignant tumors of the parotid gland, the records of 68 patients receiving megavoltage therapy at our institution from 1966 to 1989 were reviewed. Patients were placed into three groups for analyses. Group I was composed of 41 patients receiving radiotherapy following total gross removal of parotid cancer by surgical procedures, varying from excisional biopsy through total parotidectomy. Radiation dose for this group ranged from 4,995 to 6,500 cGy. Group II was composed of 10 patients treated with radiotherapy after incisional biopsy or excision with positive margins. These patients received radiation doses of 4,000–9,470 cGy. Group III was composed of 17 patients receiving radiotherapy for a postsurgical local recurrence. Their radiation dose ranged from 4,300 to 8,400 cGy.  Two of the 41 patients from group I developed a local recurrence. Two of these patients also developed distant metastases, one concurrent. Two of 10 group II patients failed locally, whereas three developed distant metastases. Only nine of the 17 patients in group III were controlled locally, and four patients developed distant dissemination.  Total gross excision of parotid cancer, sparing facial nerve if possible and followed by regional radiotherapy, provides excellent rates of local control and survival with modest toxicity. Patients presenting postoperatively with gross residual tumor or recurrence after surgery should be considered for trials of more aggressive treatment with combined chemotherapy or altered fractionation schemes of irradiation.
Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study.

Doubling the dose of antihypertensive drugs is necessary to manage hypertension in patients whose disease is uncontrolled. However, this strategy can result in safety issues. This study compared the safety and efficacy of up-titration of the nifedipine gastrointestinal therapeutic system (GITS) with up-titration of valsartan monotherapy; these were also compared with low-dose combinations of the two therapies.



This prospective, open-label, randomized, active-controlled, multicenter study lasted 8 weeks. If patients did not meet the target blood pressure (BP) after 4 weeks of treatment with low-dose monotherapy, they were randomized to up-titration of the nifedipine GITS dose from 30 mg (N30) to 60 mg or valsartan from 80 mg to 160 mg or they were randomized to receive a low-dose combination of N30 and valsartan 80 mg for another 4 weeks. BP variability was assessed by using the SD or the %CV of the short-term BP measured at clinic.



Of the 391 patients (20~70 years with stage II or higher hypertension) screened for study inclusion, 362 patients who had 3 BP measurements were enrolled. The reduction in the mean systolic/diastolic BP from baseline to week 4 was similar in both low-dose monotherapy groups with either N30 or valsartan 80 mg. BP variability (SD) was unchanged with either therapy, but the %CV was slightly increased in the N30 group. There was no significant difference in BP variability either in SD or %CV between responders and nonresponders to each monotherapy despite the significant difference in the mean BP changes. The up-titration effect of nifedipine GTS from 30 to 60 mg exhibited an additional BP reduction, but this effect was not shown in the up-titration of valsartan from 80 to 160 mg. Although the difference in BP was obvious between high-dose nifedipine GTS and valsartan, the BP variability was unchanged between the 2 drugs and was similar to the low-dose combinations. There was a low rate of adverse events in all treatment groups. In addition, escalating the dose of either nifedipine GITS or valsartan revealed a similar occurrence of adverse effects with low-dose monotherapy or the low-dose combination.



Compared with up-titration of the angiotensin receptor blocker valsartan, up-titration of the calcium channel blocker nifedipine GITS provided no additional increased safety concerns and revealed better mean reductions in BP without affecting short-term BP variability.
Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

Evidence is lacking to inform providers' and patients' decisions about many common treatment strategies for patients with end stage renal disease (ESRD).



The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003-2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006-2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community.



The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies' impact on clinical care and patients' outcomes.
Usefulness of psyllium in rehabilitation of obstructed defecation

Rehabilitation is the first therapeutic step of obstructed defecation, after failure of conservative therapy with high-fiber diet and laxatives. This study evaluates the usefulness of psyllium, a bulk-forming agent, when used during rehabilitation of obstructed defecation. Between January 2008 and December 2010, 45 patients affected by obstructed defecation were included in the study. Two randomized groups were selected. Group 1 (21 women; age range 25–67 (mean, 51.8) years) continued to consume a high-fiber diet (approximately 30 g fiber per day) during rehabilitation. Group 2 (24 women; age range 46–71 (mean, 59.8) years) consumed only psyllium (3.6 g × 2/day; Psyllogel® Fibra, Nathura, Montecchio Emilia, Italy) during the rehabilitative cycle. After a preliminary clinical evaluation, including the obstructed defecation syndrome (ODS) score, patients underwent defecography and anorectal manometry as well as rehabilitative treatment according to the “multimodal rehabilitative program” for obstructive defecation. At the end of the program, patients were reassessed by clinical evaluation and anorectal manometry. Post-rehabilitative ODS scores were used for an arbitrary schedule of patients divided into three classes: Class I, good (score ≤ 4); Class II, fair (score > 4 to ≤ 8); Class III, poor (score > 8). The number of bowel movements per week did not increase significantly after rehabilitation. Both groups had a significantly better Bristol stool form scale score (Group 1: P < 0.034; Group 2: P < 0.02). The overall mean ODS score from Groups 1 and 2 showed significant improvement after treatment (P < 0.001). Twenty-eight patients (82.3%) were Class I (good results) without significant differences between groups. Nine women were symptom-free. Significant differences were found between pre-rehabilitative and post-rehabilitative manometric data from the straining test (P < 0.001) and duration of maximal voluntary contraction (Group 1: P < 0.004; Group 2: P < 0.02). A significant difference was found between the pre-rehabilitative and post-rehabilitative conscious rectal sensitivity threshold (CRST) in Group 2 women (P < 0.02). The Group 2 women who underwent volumetric rehabilitation (11 patients) had significantly lower post-rehabilitative CRST values than pre-rehabilitative values (P < 0.002); the length of volumetric rehabilitation was also significantly shorter in Group 2 patients (P < 0.04) than in Group 1 patients. After rehabilitation of obstructed defecation, some patients became symptom-free and many had an improved ODS score. Psyllium is helpful for volumetric rehabilitation: patients who consumed psyllium had lower post-rehabilitative CRST values than subjects were on high-fiber diet.
Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial

Antipsychotic drugs are usually the first line of treatment for schizophrenia; however, many patients refuse or discontinue their pharmacological treatment. We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs.



We did a single-blind randomised controlled trial at two UK centres between Feb 15, 2010, and May 30, 2013. Participants aged 16-65 years with schizophrenia spectrum disorders, who had chosen not to take antipsychotic drugs for psychosis, were randomly assigned (1:1), by a computerised system with permuted block sizes of four or six, to receive cognitive therapy plus treatment as usual, or treatment as usual alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. Our primary outcome was total score on the positive and negative syndrome scale (PANSS), which we assessed at baseline, and at months 3, 6, 9, 12, 15, and 18. Analysis was by intention to treat, with an ANCOVA model adjusted for site, age, sex, and baseline symptoms. 
74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual (n=37), or treatment as usual alone (n=37). Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group, with an estimated between-group effect size of -6.52 (95% CI -10.79 to -2.25; p=0.003). We recorded eight serious adverse events: two in patients in the cognitive therapy group (one attempted overdose and one patient presenting risk to others, both after therapy), and six in those in the treatment as usual group (two deaths, both of which were deemed unrelated to trial participation or mental health; three compulsory admissions to hospital for treatment under the mental health act; and one attempted overdose).



Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs. Evidence-based treatments should be available to these individuals. A larger, definitive trial is needed.



National Institute for Health Research.
Effect of an intervention to improve the cardiovascular health of family members of patients with coronary artery disease: a randomized trial.

Family members of patients with coronary artery disease (CAD) have higher risk of vascular events. We conducted a trial to determine if a family heart-health intervention could reduce their risk of CAD.



We assessed coronary risk factors and randomized 426 family members of patients with CAD to a family heart-health intervention (n = 211) or control (n = 215). The intervention included feedback about risk factors, assistance with goal setting and counselling from health educators for 12 months. Reports were sent to the primary care physicians of patients whose lipid levels and blood pressure exceeded threshold values. All participants received printed materials about smoking cessation, healthy eating, weight management and physical activity; the control group received only these materials. The main outcomes (ratio of total cholesterol to high-density lipoprotein [HDL] cholesterol; physical activity; fruit and vegetable consumption) were assessed at 3 and 12 months. We examined group and time effects using mixed models analyses with the baseline values as covariates. The secondary outcomes were plasma lipid levels (total cholesterol, low-density lipoprotein cholesterol, HDL cholesterol and triglycerides); glucose level; blood pressure; smoking status; waist circumference; body mass index; and the use of blood pressure, lipid-lowering and smoking cessation medications.



We found no effect of the intervention on the ratio of total cholesterol to HDL cholesterol. However, participants in the intervention group reported consuming more fruit and vegetables (1.2 servings per day more after 3 mo and 0.8 servings at 12 mo; p < 0.001). There was a significant group by time interaction for physical activity (p = 0.03). At 3 months, those in the intervention group reported 65.8 more minutes of physical activity per week (95% confidence interval [CI] 47.0-84.7 min). At 12 months, participants in the intervention group reported 23.9 more minutes each week (95% CI 3.9-44.0 min).



A health educator-led heart-health intervention did not improve the ratio of total cholesterol to HDL cholesterol but did increase reported physical activity and fruit and vegetable consumption among family members of patients with CAD. Hospitalization of a spouse, sibling or parent is an opportunity to improve cardiovascular health among other family members.
Transarterial chemoembolization is ineffective for neuroendocrine tumors metastatic to the caudate lobe: a single institution review

Caudate lobe liver metastases occur commonly in patients with neuroendocrine tumors. It is unknown, however, how these lesions respond to regional therapy and how their presence impacts outcomes. We reviewed our experience treating these lesions using transarterial chemoembolization (TACE).



We reviewed radiographic response to TACE in 86 patients with metastatic neuroendocrine tumors to the liver. We determined the impact of caudate lesions on outcomes in comparison to the cohort of patients without caudate lesions, as well as response of caudate lesions to TACE versus lesions elsewhere in the liver.



Caudate lesions were identified in 45 (52%) patients. All patients had disease in other liver segments. Only seven caudate lesions (12.3%) had a radiographic response to TACE, whereas 82% of lesions elsewhere in the liver demonstrated a response. The presence or absence of a caudate lesion did not impact the overall radiographic (82.2% vs. 82.9%), symptomatic (64.4% vs. 56.1%), or biochemical (97.6% vs. 88.9%) response to TACE (P > 0.1 for all). However, median overall survival was reduced in those presenting with caudate lesions (87.1 vs. 45.6 months, P = 0.031).



Metastatic neuroendocrine tumors to the caudate lobe respond poorly to TACE. Symptomatic or threatening caudate lobe lesions should be considered for palliative resection in spite of additional inoperable liver metastases.
Niacin Therapy Increases High-Density Lipoprotein Particles and Total Cholesterol Efflux Capacity But Not ABCA1-Specific Cholesterol Efflux in Statin-Treated Subjects.

We investigated relationships between statin and niacin/statin combination therapy and the concentration of high-density lipoprotein particles (HDL-P) and cholesterol efflux capacity, 2 HDL metrics that might better assess cardiovascular disease risk than HDL-cholesterol (HDL-C) levels.



In the Carotid Plaque Composition Study, 126 subjects with a history of cardiovascular disease were randomized to atorvastatin or combination therapy (atorvastatin/niacin). At baseline and after 1 year of treatment, the concentration of HDL and its 3 subclasses (small, medium, and large) were quantified by calibrated ion mobility analysis (HDL-PIMA). We also measured total cholesterol efflux from macrophages and ATP-binding cassette transporter A1 (ABCA1)-specific cholesterol efflux capacity.



Atorvastatin decreased low-density lipoprotein cholesterol by 39% and raised HDL-C by 11% (P=0.0001) but did not increase HDL-PIMA or macrophage cholesterol efflux. Combination therapy raised HDL-C by 39% (P<0.0001) but increased HDL-PIMA by only 14%. Triglyceride levels did not correlate with HDL-PIMA (P=0.39), in contrast to their strongly negative correlation with HDL-C (P<0.0001). Combination therapy increased macrophage cholesterol efflux capacity (16%, P<0.0001) but not ABCA1-specific efflux. ABCA1-specific cholesterol efflux capacity decreased significantly (P=0.013) in statin-treated subjects, with or without niacin therapy.



Statin therapy increased HDL-C levels but failed to increase HDL-PIMA. It also reduced ABCA1-specific cholesterol efflux capacity. Adding niacin to statin therapy increased HDL-C and macrophage efflux, but had much less effect on HDL-PIMA. It also failed to improve ABCA1-specific efflux, a key cholesterol exporter in macrophages. Our observations raise the possibility that niacin might not target the relevant atheroprotective population of HDL.
Determining the optimal level of smoothing in cortical thickness analysis: A hierarchical approach based on sequential statistical thresholding

The extent of smoothing applied to cortical thickness maps critically influences sensitivity, anatomical precision and resolution of statistical change detection. Theoretically, it could be optimized by increasing the trade-off between vertex-wise sensitivity and specificity across several levels of smoothing. But to date neither parametric nor nonparametric methods are able to control the error at the vertex level if the null hypothesis is rejected after smoothing of cortical thickness maps. To overcome these drawbacks, we applied sequential statistical thresholding based on a simple hierarchical model. This methodology aims at controlling erroneous detections; firstly at the level of clusters, over smoothed statistical maps; and secondly at the vertex level, over unsmoothed statistical maps, by applying an adaptive false discovery rate (FDR) procedure to clusters previously detected. The superior performance of the proposed methodology over other conventional procedures was demonstrated in simulation studies. As expected, only the hierarchical method yielded a predictable false discovery proportion near the predefined FDR q-value for any smoothing level at the same time as being as sensitive as the others at the optimal setting. It was therefore the only method able to approximate the optimal size of spatial smoothing when the true change was assumed unknown. The hierarchical method was further validated in a cross-sectional study comparing moderate Alzheimer's disease (AD) patients with healthy elderly subjects. Results suggest that the extent of cortical thinning reported in previous AD studies might be artificially inflated by the choice of inadequate smoothing. In these cases, interpretation should be based on the location of local maxima of suprathreshold regions rather than on the spatial extent of the detected signal in the statistical parametric map.
Transesophageal echocardiography to assess mitral valve movement and flow during long term cardiopulmonary resuscitation: How cardiac effects fade with time.

Although the cardiac pump and the thoracic pump are the two main theories, the actual mechanisms of blood flow during Cardiopulmonary Resuscitation (CPR) in humans are still unclear. The aim of this study was to explore the relationship between the pump mechanism and time after cardiac arrest.



20 patients with non-traumatic cardiac arrest were enrolled in this study. Transesophageal two-dimensional and pulse-doppler echocardiography were used during CPR. The duration of CPR was 60-80min if there was no return of spontaneous circulation (ROSC). We found: (1) The mechanisms of blood flow during CPR varied with time: the thoracic pump took the place of the cardiac pump after prolonged CPR in the same patient. (2) Peak transmitral flow (TMF) decreased (p<0.05) after prolonged CPR in patients with mitral valve closure during chest compressions. (3) Longer elapsed time from collapse to CPR and TEE was correlated to lower peak TMF in CPR (Both p<0.05). (4) Peak TMF(p<0.01), mitral valve time-velocity integrals(p<0.05), left ventricular stroke volume (p<0.05) and end-tidal carbon dioxide tension (p<0.05) is higher in the group of patients with mitral valve closure during chest compressions. This group of patients had a shorter time from collapse to CPR (p<0.01), shorter time from collapse to TEE (p<0.01) and had overall better outcomes.



The pump mechanism changes over the course of prolonged CPR. Cardiac effect is an essential part of the pump at the beginning of cardiac arrest, but it faded with time, making the thoracic pump the dominate mechanism after prolonged CPR.
Endovascular Therapy for Ruptured Cerebral Aneurysms in the Elderly: Poor Accessibility of the Guiding Catheter and Use of Local Anesthesia as the Predictors of Procedure-Related Rupture.

Endovascular therapy is favored for ruptured intracranial aneurysms in the elderly. However, poor accessibility to the aneurysm through the parent artery and use of local anesthesia in this age group may predispose to intraprocedural complications.



To evaluate whether age-related poor access to the ruptured target aneurysm and use of local anesthesia are associated with increased incidence of procedure-related rupture during endovascular embolization.



A total of 117 patients with 117 ruptured aneurysms underwent endovascular embolization at a single institution. Correlation of increasing age with poor accessibility of the guiding catheter was analyzed. In addition, the distance from the aneurysm to the guiding catheter was investigated to identify an association with incidence of procedure-related rupture. Correlation of local anesthesia with procedure-related rupture was also evaluated in the multivariable analysis.



Increasing age was significantly associated with poor accessibility of the guiding catheter (P = .001, Mann-Whitney U test). Procedure-related rupture occurred in 9 of 117 aneurysms (7.7%). Longer distance between distal aneurysms and low-positioned guiding catheters carried a higher risk of procedure-related rupture than a shorter distance between proximal aneurysms and high-positioned guiding catheters (odds ratio, 19.3; 95% confidence interval, 1.84-201; P = .01, multivariable analysis). Use of local anesthesia was also a significant risk factor of procedure-related rupture by multivariable analysis.



Increasing age was correlated with poor accessibility of the guiding catheter in endovascular embolization of ruptured intracranial aneurysms. Distally located aneurysms treated through a low-positioned guiding catheter and use of local anesthesia increased the risk of procedure-related rupture.