nils-herrmann/clean_scirepeval huggingface dataset:
In answer to the question: "As compared to what?" A progress report on the EC/IC bypass study.

THE DEVASTATION of a major stroke for an individual and his family needs no elaboration for the readers of this journal. To reduce the incidence of this common catastrophe is the goal and preoccupation of many physicians and surgeons. Into the scientific appraisal of therapeutic measures a new element has entered — modern methodology. There is a growing demand by critical members of our profession for convincing accreditation of measures purported to be effective in stroke prevention. As a result medical, and also surgical, means of stroke prophylaxis have been submitted to this type of enquiry by clinical trials. Pitfalls in design, execution and analysis have been encountered in most studies to date, resulting in criticism and cynicism directed at these trials. Both are welcome as they will lead to improvement in methods for further studies. Critics and cynics can hamper, very seriously, the success of an attempt to validate a therapy because if their voices are authoritative they may persuade practitioners and the public that clinical judgement based on experience, well-remembered anecdotes of happy or unfortunate outcomes, or long series of uncontrolled studies with apparently reduced morbidity and mortality are adequate evidence of effective treatment and preferable to "experimenting on people." Trie development of microsurgery followed the pioneering studies of Donaghey and Yasargil who demonstrated that the blood supply of the scalp could be successfully grafted onto that of the brain with safety and patency in humans as well as in the laboratory. 1-* Subsequently, such surgery has been done frequently enough to convince the most critical that it is a procedure of low morbidity and mortality and a large number of neurosurgeons now can perform EC/IC anastomosis with skill and operative success. Patency rates are high and cerebral blood flow studies often demonstrate quantitative improvement in regional cerebral blood flow. Proposed Indications for EC/IC Anastomosis As a sequel to this technical advance there are several potential clinical applications. The first is the prevention of stroke resulting from deliberate surgical occlusion of cerebral arteries. A number of instances are known where a preliminary bypass has permitted deliberate ligation of middle cerebral or internal carotid arteries in dealing with giant aneurysms or tumors at the base of the brain. These observations have demonstrated that despite the small size of the anastomosis between branches of the superficial temporal artery and the middle cerebral artery sufficient blood can be supplied to prevent …
The Munich Barrett follow up study: suspicion of Barrett's oesophagus based on either endoscopy or histology only--what is the clinical significance?

The incidence of distal oesophageal adenocarcinoma is rising, with chronic reflux and Barrett's oesophagus being considered risk factors. Reliable detection of Barrett's oesophagus during upper endoscopy is therefore mandatory but requires both endoscopy and histology for confirmation. Appropriate management of patients with endoscopic suspicion but negative on histology, or vice versa, or of patients with no endoscopic suspicion but with a biopsy diagnosis of intestinal metaplasia at the gastro-oesophageal junction, has not yet been studied prospectively.



In a prospective multicentre study, 929 patients (51% male, mean age 50 years) referred for upper gastrointestinal endoscopy were included; 59% had reflux symptoms. The endoscopic aspect of the Z line and any suspicion of Barrett's oesophagus were noted, and biopsies were taken in all patients from the Z line (n = 4), gastric cardia (n = 2), and body and antrum (n = 2 each). Biopsies positive for specialised intestinal metaplasia (SIM) were reviewed by a reference pathologist for a final Barrett's oesophagus diagnosis. All patients with endoscopic and/or histological suspicion of Barrett's oesophagus were invited for a follow up endoscopy; the remaining cases (no endoscopic or histological suspicion of Barrett's oesophagus) were followed clinically.



Of 235 patients positive for Barrett's oesophagus on endoscopy and/or histology, 63% agreed to undergo repeat endoscopy (mean follow up period 30.5 months). 46% of patients with an endoscopic Barrett's oesophagus diagnosis but no histological confirmation (group A) showed the same distribution, a further 42% did not have Barrett's oesophagus, and 11% had confirmed Barrett's oesophagus on both endoscopy and biopsy on follow up. In the group with a histological Barrett's oesophagus diagnosis but negative on initial endoscopy (group B), follow up showed the same in 26% whereas 46% had no Barrett's oesophagus, and confirmed Barrett's oesophagus (endoscopy plus histology) was diagnosed in 17%. Of the study population, 16 patients had Barrett's oesophagus on initial endoscopy confirmed by histology which remained constant in 70% at follow up (group C). Of the remaining patients without an initial Barrett's oesophagus diagnosis on either endoscopy or histology (group D) and only clinical follow up (mean follow up period 38 months), one confirmed Barrett's oesophagus case was found among 100 patients re-endoscoped outside of the study protocol. However, no single case of dysplasia or cancer of the distal oesophagus was detected in any patient during the study period.



Even in a specialised gastroenterology setting, reproducibility of presumptive endoscopic or histological diagnoses of Barrett's oesophagus at follow up were poor. Only 10-20% of cases with either endoscopic or histological suspicion of Barrett's oesophagus had established Barrett's oesophagus after 2.5 years of follow up. The risk of dysplasia in this population was very low and hence meticulous follow up may not be required.
Effects of homeopathic medicines on polysomnographic sleep of young adults with histories of coffee-related insomnia.

Homeopathy, a common form of alternative medicine worldwide, relies on subjective patient reports for diagnosis and treatment. Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians claim exert effects on sleep quality in susceptible individuals. Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies.



Young adults of both sexes (ages 18-31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity (but not both) and a history of coffee-induced insomnia participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N=54) received placebo pellets on night 8 (single-blind) and verum pellets on night 22 (double-blind) in 30c doses of one of two homeopathic remedies, Nux Vomica or Coffea Cruda. Subjects completed daily morning sleep diaries and weekly Pittsburgh sleep quality index scales, as well as profile of mood states scales at bedtime on polysomnography nights.



Verum remedies significantly increased PSG total sleep time and NREM, as well as awakenings and stage changes. Changes in actigraphic and self-rated scale effects were not significant.



The study demonstrated the feasibility of using in-home, all-night sleep recordings to study homeopathic remedy effects. Findings are similar though not identical to those reported in animals with the same remedies. Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies.
Visualization of Variability in Complex Development Structures

Mass customization in modern industries leads to an increased complexity in product line engineering due to the high level of variability. Real-world industry-sized product lines can easily end up with thousands of features and constraints. Using sophisticated information visualization techniques is one important component in handling this complexity successfully as they provide a higher level of cognitive support and make the comprehension of the underlying structures easier and faster. However, it is still an unresolved problem to handle the occurring variability in a satisfactory way. This means that we need visualization mechanisms able to cope with the requirements of engineers as well as with the needs of the responsible managers. This paper addresses the issue of visualizing large product lines and discusses different techniques which can be used towards an efficient visualization of variability. Furthermore, it presents alternative methods to visualize complex constraints and group cardinalities. These techniques will then be illustrated with the help of a prototypical implementation.
Vasomotor symptoms decrease in women with breast cancer randomized to treatment with applied relaxation or electro-acupuncture: a preliminary study.

To evaluate the effect of applied relaxation and electro-acupuncture on vasomotor symptoms in women treated for breast cancer.



Thirty-eight postmenopausal women with breast cancer and vasomotor symptoms were randomized to treatment with electro-acupuncture (n = 19) or applied relaxation (n = 19) during 12 weeks. The number of hot flushes was registered daily in a logbook before and during treatment and after 3 and 6 months of follow-up.



Thirty-one women completed 12 weeks of treatment and 6 months of follow-up. After 12 weeks of applied relaxation, the number of flushes/24 h had decreased from 9.2 (95% confidence interval (CI) 6.6-11.9) at baseline to 4.5 (95% CI 3.2-5.8) and to 3.9 (95% CI 1.8-6.0) at 6 months follow-up (n = 14). The flushes/24 h were reduced from 8.4 (95% CI 6.6-10.2) to 4.1 (95% CI 3.0-5.2) after 12 weeks of treatment with electro-acupuncture and to 3.5 (95% CI 1.7-5.3) after 6 months follow-up (n = 17). In both groups, the mean Kupperman Index score was significantly reduced after treatment and remained unchanged 6 months after end of treatment.



We suggest that applied relaxation and electro-acupuncture should be further evaluated as possible treatments for vasomotor symptoms in postmenopausal women with breast cancer.
Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3.

The primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer.  After curatively intentioned surgery, patients with stage II and III colon cancer were randomly allocated surgery to receive LV5FU2 (LV 200 mg/m(2) as a 2-hour infusion, followed by FU; as a 400 mg/m(2) bolus and then a 600 mg/m(2) continuous infusion over 22 hours, days 1 and 2, every 2 weeks for 12 cycles: de Gramont regimen) with or without irinotecan (180 mg/m(2) as a 30- to 90-minute infusion, day 1, every 2 weeks). In total, 260 (7.9%) of 3,278 patients received an alternative high-dose infusional FU/LV regimen (Arbeitsgemeinschaft Internische Onkologie regimen) with or without irinotecan.  The principal efficacy analysis was based on 2,094 treated patients with stage III disease, randomly allocated in the LV5FU2 strata. After a median follow-up of 66.3 months, the 5-year DFS rate was 56.7% with irinotecan/LV5FU2 and 54.3% with LV5FU2 alone (primary end point: log-rank P = .106). Combining irinotecan with LV5FU2 did not significantly improve overall survival in this patient group compared with LV5FU2 alone (5-year rate 73.6% v 71.3%, respectively; log-rank P = .094). The addition of irinotecan to LV5FU2 was associated with an increased incidence of grade 3 to 4 GI events and neutropenia.  Irinotecan added to LV5FU2 as adjuvant therapy did not confer a statistically significant improvement in DFS or overall survival in patients with stage III colon cancer compared with LV5FU2 alone.
Two doses of NGR-hTNF in combination with capecitabine plus oxaliplatin in colorectal cancer patients failing standard therapies

asparagine-glycine-arginine-human tumour necrosis factor (NGR-hTNF), an agent selectively damaging the tumour vasculature, showed a biphasic dose-response curve in preclinical models. Previous phase I trials of NGR-hTNF indicated 0.8 and 45 μg/m(2) as optimal biological and maximum-tolerated dose, respectively.



Two sequential cohorts of 12 colorectal cancer (CRC) patients who had failed standard therapies received NGR-hTNF 0.8 or 45 μg/m(2) in combination with capecitabine-oxaliplatin (XELOX).



Median number of prior treatment lines was 3 in the low-dose and 2 in the high-dose cohort. Overall, 21 patients had been pretreated with oxaliplatin-based regimens. No grade 3-4 NGR-hTNF-related toxicities were observed. Grade 1-2 chills were reported in 43% and 40% of cycles in the low-dose and high-dose cohorts, respectively. In the low-dose cohort, one patient achieved a partial response and five had stable disease for a median of 4.6 months. In the high-dose cohort, six patients had stable disease for a median of 3.6 months. Three-month progression-free survival (PFS) rates were 50% and 33% in the low-dose and high-dose cohort, respectively. Three patients in low-dose cohort experienced PFS longer than PFS on last prior therapy.



Both NGR-hTNF doses were safely combined with XELOX in pretreated CRC patients. Hint of activity was apparent only with low-dose NGR-hTNF.
Clinical outcome of HCV-positive patients with diffuse large B-cell lymphoma treated with rituximab-based chemotherapy

The influence of rituximab therapy on prognosis and hepatic toxicity (HT) in patients with hepatitis C virus (HCV)-positive diffuse large B-cell lymphoma (DLBCL) is unclear. Thus, we assessed HT and clinical outcome in patients with DLBCL and HCV infection who received rituximab-containing immunochemotherapy. We carried out a prospective analysis on a total of 280 HCV-positive patients with DLBCL, 200 of whom received chemotherapy plus rituximab (R-CHT), 80 received chemotherapy (CHT)-only. Survival outcomes and HT were compared according to rituximab administration. The median follow-up was 41 months. Addition of rituximab did not significantly affect prognosis (median progression-free survival, 40 vs 35 months, P = 0.26; median overall survival, 51 vs 43 months P = 0.09). Of 200 patients who received rituximab, 53 (26.5 %) had severe HT (grade 3–4), compared with 11 of 80 (13.75 %) patients who received rituximab-free regimens (P = 0.033). Among patients treated with rituximab, 50 patients (25 %) did not complete planned course of therapy, 14 patients because of hepatic toxicity and 36 patients because of progressive disease. Pretreatment liver function impairment was predictive of severe HT. These results raise concerns regarding the routine use of rituximab with chemotherapy in individuals with HCV-positive DLBCL. However, more studies are warranted before a definitive conclusion can be made.
Subthalamic nucleus stimulation-induced regional blood flow responses correlate with improvement of motor signs in Parkinson disease.

Deep brain stimulation of the subthalamic nucleus (STN DBS) improves motor symptoms in idiopathic Parkinson's disease, yet the mechanism of action remains unclear. Previous studies indicate that STN DBS increases regional cerebral blood flow (rCBF) in immediate downstream targets but does not reveal which brain regions may have functional changes associated with improved motor manifestations. We studied 48 patients with STN DBS who withheld medication overnight and underwent PET scans to measure rCBF responses to bilateral STN DBS. PET scans were performed with bilateral DBS OFF and ON in a counterbalanced order followed by clinical ratings of motor manifestations using Unified Parkinson Disease Rating Scale 3 (UPDRS 3). We investigated whether improvement in UPDRS 3 scores in rigidity, bradykinesia, postural stability and gait correlate with rCBF responses in a priori determined regions. These regions were selected based on a previous study showing significant STN DBS-induced rCBF change in the thalamus, midbrain and supplementary motor area (SMA). We also chose the pedunculopontine nucleus region (PPN) due to mounting evidence of its involvement in locomotion. In the current study, bilateral STN DBS improved rigidity (62%), bradykinesia (44%), gait (49%) and postural stability (56%) (paired t-tests: P < 0.001). As expected, bilateral STN DBS also increased rCBF in the bilateral thalami, right midbrain, and decreased rCBF in the right premotor cortex (P < 0.05, corrected). There were significant correlations between improvement of rigidity and decreased rCBF in the SMA (r(s) = -0.4, P < 0.02) and between improvement in bradykinesia and increased rCBF in the thalamus (r(s) = 0.31, P < 0.05). In addition, improved postural reflexes correlated with decreased rCBF in the PPN (r(s) = -0.38, P < 0.03). These modest correlations between selective motor manifestations and rCBF in specific regions suggest possible regional selectivity for improvement of different motor signs of Parkinson's disease.
Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis

We conducted a randomized, double-blind trial to assess the effect of 28.2 μg teriparatide versus placebo (1.4 μg teriparatide) on reduction of the incidence of vertebral fractures. Individuals enrolled in this study included patients with primary osteoporosis with one to five vertebral fractures and capable of self-supported walking. Attention was focused on incident vertebral fractures, change in bone mineral density (BMD) of the lumbar spine, and safety. A total of 316 subjects participated in the study, which lasted up to 131 weeks. Incident vertebral fractures occurred in 3.3 % of subjects in the 28.2 μg teriparatide-treated group and 12.6 % of subjects in the placebo group during the 78-weeks study period. Kaplan–Meier estimates of risk after 78 weeks were 7.5 and 22.2 % in the teriparatide and placebo groups, respectively, with a relative risk reduction of 66.4 % by teriparatide (P = 0.008). Lumbar BMD in the 28.2 μg teriparatide group increased significantly by 4.4 ± 4.7 % at 78 weeks, which was significantly higher than the corresponding data in the placebo group (P = 0.001). Adverse events were observed in 86.7 % of individuals in the teriparatide group and 86.1 % of those in the placebo group. In conclusion, weekly injection of a low-dose of teriparatide (28.2 μg) reduced the risk of incident vertebral fractures and increased lumbar BMD.
Objectively Measured Sedentary Time Is Related to Quality of Life among Cancer Survivors

While exercise has been shown to be beneficial in improving health-related quality of life (HRQOL) among cancer survivors, evidence is limited on the independent role of sedentary behavior. We examined how objectively measured sedentary time was associated with HRQOL among long-term cancer survivors.



This cross-sectional study included 54 cancer survivors, on average 3.4 years postdiagnosis, who were enrolled into an exercise trial designed to improve cognitive function. At baseline, we measured sedentary time and moderate-vigorous intensity physical activity with the ActivPal, cardiorespiratory fitness with treadmill testing, and self-reported HRQOL with an established scale (SF-36). In multivariate models, we regressed HRQOL on sedentary time (percent of waking time spent sitting and lying).



Survivors with higher sedentary time had significantly poorer physical functioning (β = -0.50, p = 0.028), general health (β = -0.75, ptrend = 0.004), and physical summary scores (β = -0.34, p = 0.003). We did not observe associations between sedentary time and role-physical (p = 0.342), bodily-pain (p = 0.117), vitality (p = 0.095), social functioning (p = 0.407), role-emotional (p = 0.509), mental health (p = 0.494), or mental summary scores (p = 0.527).



In this cross-sectional study of cancer survivors, we observed deleterious associations between sedentary time and aspects of physical HRQOL. Future prospective studies of sedentary time and HRQOL are needed to establish temporality and to facilitate the design of effective health promotion interventions for cancer survivors.
Cross-cultural adaptation and validation of the Michigan Hand Outcomes Questionnaire (MHQ) for Brazil: validation study.

Rheumatoid arthritis is a chronic systemic disease that causes joint damage. A variety of methods have been used to evaluate the general health status of these patients but few have specifically evaluated the hands. The objective of this study was to translate, perform cultural adaptation and assess the validity of the Michigan Hand Outcomes Questionnaire for Brazil.



Validation study conducted at a university hospital in Curitiba, Brazil.



Firstly, the questionnaire was translated into Brazilian Portuguese and back-translated into English. The Portuguese version was tested on 30 patients with rheumatoid arthritis and proved to be understandable and culturally adapted. After that, 30 patients with rheumatoid arthritis were evaluated three times. On the first occasion, two evaluators applied the questionnaire to check inter-rater reproducibility. After 15 days, one of the evaluators reassessed the patients to verify intra rater reproducibility. To check the construct validity at the first assessment, one of the evaluators also applied other similar instruments.



There were strong inter and intra rater correlations in all the domains of the Michigan Hand Outcomes Questionnaire. Cronbach's alpha was higher than 0.90 for all the domains of the questionnaire, thus indicating excellent internal validity. Almost all domains of the questionnaire presented moderate or strong correlation with other instruments, thereby showing good construct validity.



The Brazilian Portuguese version of the Michigan Hand Outcomes Questionnaire was translated and culturally adapted successfully, and it showed excellent internal consistency, reproducibility and construct validity.