nils-herrmann/clean_scirepeval huggingface dataset:
Acetazolamide for Prevention of Contrast-Induced Nephropathy: A New Use for an Old Drug

Reactive oxygen species play a major role in the pathogenesis of contrast-induced nephropathy (CN). Hydration with sodium bicarbonate (HCO 3 − ) can reduce the incidence of CN in high-risk patients, suggesting a direct causal relationship between low pH of tubular fluid and enhanced activity of generated reactive oxygen species to damage renal tubular cells. Whether acetazolamide (AZ), a carbonic anhydrase inhibitor, is more effective than HCO 3 − unknown. Ninety-six children with stable chronic renal insufficiency were randomly assigned to receive either a 154 mEq/L infusion of sodium bicarbonate (HCO 3 − ) (n = 46) or 0.9% sodium chloride plus oral AZ (n = 50) at a rate of 3 ml/kg/hr for 1 hour before and 1 ml/kg/hr for 6 hours after the radiographic procedure. Serum creatinine concentration (Scr) was measured before and 48 hours after the procedure. The primary endpoint was an increase in the Scr concentration of ≥25% 48 hours after the contrast administration. The baseline clinical and biochemical characteristics of the two groups were similar. The mean Scr concentration after contrast administration was significantly lower in the AZ group (p = 0.02) than in the HCO 3 − group (p = 0.27). The mean absolute decrease in Scr concentration at 48 hours was significantly greater in the AZ group (p < 0.01). Four of the 46 patients (8.7%) in the HCO 3 − group had an increase in the Scr concentration of ≥25% compared with none of the 50 patients (0%) in the AZ group (p = 0.049). Thus, compared to HCO 3 − , AZ plus saline hydration was more effective for the prevention CN after radiographic procedure.
Validation of a specific health-related quality of life instrument in a large cohort of patients with psoriasis: the QualiPso Questionnaire.

The aim of this study was to develop and validate a standardized tool designed to assess health-related quality of life (HRQoL) in a large cohort of French patients with psoriasis, the QualiPso Questionnaire. A draft questionnaire was developed based on a literature review, followed by one-to-one interviews of 50 patients with psoriasis conducted by trained psychologists. The interview transcripts were analysed, after which 56 items were retained and validated in a cohort of 569 patients. Four QualiPso subscales were derived from factor analysis. The first factor encompasses disturbances of social life, a key factor in HRQoL among psoriasis patients (Cronbach's alpha coefficient: α=0.948). The second factor assesses the impact of psoriasis on mental health (α=0.932). The third factor reflects concerns related to treatment outcomes (α=0.873), and the fourth factor is related to skin symptoms (α=0.772). The subscales are related but distinct, accounting for 60% of the common variance. In conclusion, the QualiPso questionnaire provides a reliable and valid measure of a patient's psychosocial well-being in relation to psoriasis. It also measures the impact of concerns related to treatment outcomes and skin symptoms, which have not been addressed previously by HRQoL research on psoriasis.
Radiological validation of a fluoroscopic guided technique for femoral implant positioning during hip resurfacing

The positioning of the femoral cup in hip resurfacing is essential for the survival of the implant. We described a technique in 2005 to position the femoral cup guided by fluoroscopy independent of the approach performed. The main objectives were to study the positioning of the femoral components of the implant and the accuracy of the technique. Between 2003 and 2011 we conducted a prospective study of 160 consecutive hip resurfacings all operated with this fluoroscopic-guided technique. Three independent observers performed a radiographic analysis at the pre-operative planning stage and on postoperative radiographs using OsiriX software. The statistical analysis was based on comparison of two groups by Student’s t test. The entire implant was positioned in valgus, with an average of 7.816° valgus (p <0.001). All implants were positioned in neutral or anteverted with a mean of 1.98° (p <0.001). The risk of malpositioning on the antero-posterior plane was less than 1.41° with p <0.019. The risk of profile positioning error was lower than 0.80° with p <0.047. This study validates a technique of femoral implant positioning for resurfacing. It is simple, precise and independent of the approach performed.
The effect of breathing exercises on the fatigue levels of patients with chronic obstructive pulmonary disease.

to assess the effect of breathing exercises on fatigue level of the patients with COPD.



this quasi-experimental research was conducted on 60 COPD patients hospitalized at hospitals affiliated to Tehran University of Medical Sciences. The subjects were randomized into "experience" and "control" groups. Data were gathered by interview and data registration from the files. The data gathering tools were questionnaires, fatigue severity scale (FSS) and respiratory exercise usage checklist. The data were analyzed using SPSS software with the descriptive and deductive statistical methods (Paired-T, Chi-Square and Pearson correlation tests).



the average fatigue severity before (55.766) and after (40.166) using the respiratory exercises in the experience group (p=0%) was significantly different. While in the control group (p=0.002) before (54.166) and after (52.200) the study has a slight difference. There was a significant inverse correlation between using respiratory exercises and fatigue severity (r=-0.593, p=0.001). Mean fatigue intensity for the experience and control groups decreased to 40.916 ± 14.4 and 52.20 ± 8.539 after the study, respectively (p=0.001). There was a significant difference in fatigue severity between experience and control groups after the study.



respiratory exercise is effective in reducing the fatigue in the patients with COPD.
Quality improvement in heart failure: a randomized educational intervention to change provider behavior.

Whether provider education changes practice for HF has not been reported. (NHeFT)™ uses didactic and experiential training of primary care providers (PCP) to optimize treatment of HF. We randomized PCP's in the Cleveland VA clinics to training (T) vs control (C).



Primary - the number of patients with EF < 40% treated with ACEI/ARB and Beta Blocker, +/- diuretic post T vs pre T; Secondary - the number of patients with increase in ACEI/ARB or a decrease in diuretic post T vs. pre T. Of 641 patients, 216 (85 C,131 T) had EF < 40%; 188 (85%) did not meet the primary endpoint at baseline. After T, a similar proportion (64.2% C, 74.4%,T) met the endpoint at end of study (P = 0.14). The odds of a patient meeting the primary endpoint by care of a T provider, was not significantly higher than C (OR 1.496, 95% CI (0.751, 2.982)). Patients seen by T were more likely to have the diuretic dose decreased vs patients under C, without increases in ACEI or ARB (P < 0.03). Thus, a didactic program of HF plus a preceptorship changed practice modestly. Studies should address provider readiness of change and self efficacy to adhere to evidenced-based care.
DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL

As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation.



One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation.



There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period.



This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.
Weight loss, nutritional status and physical activity in patients with Alzheimer’s Disease

The etiology of weight loss in Alzheimer’s disease (AD) patients is still uncertain. This study was designed to investigate the possible factors that might contribute to weight change of AD patients. From July 1999 to June 2001, we recruited 51 AD patients and 27 non-demented controls. Demographic data, neuropsychological tests, Geriatric Depression Scale-Short Form, eating behavior questionnaire, dietary and physical activity diaries, anthropometric and laboratory measures of nutritional status were assessed. More than half of our AD patients developed body weight loss, and overall, the AD patients were significantly thinner than the non-demented subjects. Anthropometric and laboratory measures suggested a poorer nutritional status in the AD patients. The AD patients had fewer daily physical activities. More AD patients had the problem of poor appetite. However, daily calorie intake was not significantly different between the two groups. The AD patients, especially those who presented with body weight loss, even consumed more calories per body weight kilogram (kg) per day. In the food composition analysis, AD patients took more carbohydrate than controls. Multivariate regression analysis showed the existence of AD and poor appetite were the main risk factors of weight loss. We suggest that the pathophysiological process in AD gives rise to the changes of appetite and metabolic state in AD patients, and that these changes contribute to the weight loss.
Carbohydrate-restricted diets high in either monounsaturated fat or protein are equally effective at promoting fat loss and improving blood lipids.

When substituted for carbohydrate in an energy-reduced diet, dietary protein enhances fat loss in women. It is unknown whether the effect is due to increased protein or reduced carbohydrate.



We compared the effects of 2 isocaloric diets that differed in protein and fat content on weight loss, lipids, appetite regulation, and energy expenditure after test meals.



This was a parallel, randomized study in which subjects received either a low-fat, high-protein (LF-HP) diet (29 +/- 1% fat, 34 +/- 0.8% protein) or a high-fat, standard-protein (HF-SP) diet (45 +/- 0.6% fat, 18 +/- 0.3% protein) during 12 wk of energy restriction (6 +/- 0.1 MJ/d) and 4 wk of energy balance (7.4 +/- 0.3 MJ/d). Fifty-seven overweight and obese [mean body mass index (in kg/m(2)): 33.8 +/- 0.9] volunteers with insulin concentrations >12 mU/L completed the study.



Weight loss (LF-HP group, 9.7 +/- 1.1 kg; HF-SP group, 10.2 +/- 1.4 kg; P = 0.78) and fat loss were not significantly different between diet groups even though the subjects desired less to eat after the LF-HP meal (P = 0.02). The decrease in resting energy expenditure was not significantly different between diet groups (LF-HP, -342 +/- 185 kJ/d; HF-SP, -349 +/- 220 kJ/d). The decrease in the thermic effect of feeding with weight loss was smaller in the LF-HP group than in the HF-SP group (-0.3 +/- 1.0% compared with -3.6 +/- 0.7%; P = 0.014). Glucose and insulin responses to test meals improved after weight loss (P < 0.001) with no significant diet effect. Bone turnover, inflammation, and calcium excretion did not change significantly.



The magnitude of weight loss and the improvements in insulin resistance and cardiovascular disease risk factors did not differ significantly between the 2 diets, and neither diet had any detrimental effects on bone turnover or renal function.
Long-term prognostic role of functional limitations among women with breast cancer.

The long-term prognostic role of functional limitations among women with breast cancer is poorly understood.



We studied a cohort of 2202 women with breast cancer at two sites in the United States, who provided complete information on body functions involving endurance, strength, muscular range of motion, and small muscle dexterity following initial adjuvant treatment. Associations of baseline functional limitations with survival were evaluated in delayed entry Cox proportional hazards models, with adjustment for baseline sociodemographic factors, body mass index, smoking, physical activity, comorbidity, tumor characteristics, and treatment. Difference in covariates between women with and without limitations was assessed with Pearson χ(2) and Student t tests. All statistical tests were two-sided.



During the median follow-up of 9 years, 112 deaths were attributable to competing causes (5% of the cohort) and 157 were attributable to breast cancer causes (7% of the cohort). At least one functional limitation was present in 39% of study participants. Proportionately, more breast cancer patients with functional limitations after initial adjuvant treatment were older, less educated, and obese (P < .001). In multivariable models, functional limitations were associated with a statistically significantly increased risk of death from all causes (hazard ratio [HR] = 1.40, 95% confidence interval [CI] = 1.03 to 1.92) and from competing causes (HR = 2.60, 95% CI = 1.69 to 3.98) but not from breast cancer (HR = 0.90, 95% CI = 0.64 to 1.26). The relationship between functional limitations and overall survival differed by tumor stage (among women with stage I and stage III breast cancer, HR = 2.02, 95% CI = 1.23 to 3.32 and HR = 0.74, 95% CI = 0.42 to 1.30, respectively).



In this prospective cohort study, functional limitations following initial breast cancer treatment were associated with an important reduction in all-cause and competing-cause survival, irrespective of clinical, lifestyle, and sociodemographic factors.
Phase I trial of three-weekly Docetaxel, Carboplatin and oral lenalidomide (Revlimid®) in patients with advanced solid tumors

Lenalidomide is an immunomodulatory derivative of thalidomide with significantly greater in vitro activity and a different toxicity profile. In preclinical trials it has shown synergy with chemotherapy.  Primary objective of this study was to determine the maximum tolerated doses of docetaxel and carboplatin when combined with oral lenalidomide in a standard phase I study design. Between September 2004 and May 2005, 14 patients with pathologically proven solid tumors, ≤2 prior chemotherapy regimens, performance status ECOG 0/1, and adequate organ function were enrolled. Dose limiting toxicities (DLT) were defined as ≥ grade 3 non-hematological, or grade 4 hematological toxicity. No growth factors were used during cycle 1.  Three of four patients treated at dose level 1, docetaxel 60 mg/m2 and carboplatin AUC 6 on Day 1, and lenalidomide 10 mg orally daily on Days 1–14 of a 21 day cycle experienced DLT (grade 3 electrolyte changes in two patients, and grade 4 neutropenia in one patient). Ten patients were treated at dose level −1, docetaxel 60 mg/m2 and carboplatin AUC 6 on Day 1, and lenalidomide 5 mg orally daily on Days 1–14 of a 21 day cycle with one DLT (Grade 4 neutropenia). There were no treatment-related deaths or irreversible toxicities. Of the 14 response-evaluable patients, five achieved a partial response (5 out of 9 patients with non-small cell lung cancer.  Docetaxel 60 mg/m2 and carboplatin AUC 6 on Day 1, with lenalidomide 5 mg orally daily on Days 1–14 days of a 21 day cycle is the maximum tolerated dose without the use of prophylactic growth factors. This combination is active and further evaluation in a phase II trial is warranted.
Income in Multiple Sclerosis Patients with Different Disease Phenotypes

Multiple sclerosis (MS) is a disease with profound heterogeneity in clinical course.



To analyze sources and levels of income among MS patients in relation to disease phenotype with a special focus on identifying differences/similarities between primary progressive MS (PPMS) and secondary progressive MS (SPMS).



A total of 6890 MS patients aged 21-64 years and living in Sweden in 2010 were identified for this cross-sectional study. Descriptive statistics, logistic, truncated linear, and zero-inflated negative binomial regression models were used to estimate differences in income between SPMS, PPMS and relapsing-remitting MS (RRMS) patients.



RRMS patients earned almost twice as much as PPMS and SPMS patients (on average SEK 204,500, SEK 114,500, and SEK 79,800 in 2010, respectively). The difference in earnings between PPMS and SPMS was not statistically significant when analyzed with multivariable regression. The estimated odds ratio for PPMS patients to have income from earnings was not significantly different from SPMS patients (95% CI 0.98 to 1.59). PPMS and RRMS patients were less likely to receive benefits when compared to SPMS patients (by 6% and 27% lower, respectively).



Our findings argue for similarities between PPMS and SPMS and highlight the socioeconomic importance of preventing RRMS patients convert to SPMS.
Peritoneal colorectal carcinomatosis treated with surgery and perioperative intraperitoneal chemotherapy: retrospective analysis of 523 patients from a multicentric French study.

Peritoneal carcinomatosis (PC) from colorectal cancer traditionally is considered a terminal condition. Approaches that combine cytoreductive surgery (CRS) and perioperative intraperitoneal chemotherapy (PIC) have been developed recently. The purpose of this study was to assess early and long-term survival in patients treated with that strategy.  A retrospective-cohort, multicentric study from French-speaking countries was performed. All consecutive patients with PC from colorectal cancer who were treated with CRS and PIC (with or without hyperthermia) were included. Patients with PC of appendiceal origin were excluded.  The study included 523 patients from 23 centers in four French-speaking countries who underwent operation between 1990 and 2007. The median follow-up was 45 months. Mortality and grades 3 to 4 morbidity at 30 days were 3% and 31%, respectively. Overall median survival was 30.1 months. Five-year overall survival was 27%, and five-year disease-free survival was 10%. Complete CRS was performed in 84% of the patients, and median survival was 33 months. Positive independent prognostic factors identified in the multivariate analysis were complete CRS, PC that was limited in extent, no invaded lymph nodes, and the use of adjuvant chemotherapy. Neither the grade of disease nor the presence of liver metastases had a significant prognostic impact.  This combined treatment approach against PC achieved low postoperative morbidity and mortality, and it provided good long-term survival in patients with peritoneal scores lower than 20. These results should improve in the future, because the different teams involved will gain experience. This approach, when feasible, is now considered the gold standard in the French guidelines.
The use of onabotulinum toxin A (Botox®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study

Chronic migraine is a debilitating headache, whose treatment is often complicated by the concomitant overuse of symptomatic medication and by the poor efficacy of standard prophylactic treatments. The PREEMPT studies have demonstrated the efficacy and tolerability of onabotulinum toxin A (Botox®) in the treatment of this headache type. Data about its use in clinical practice are still scarce. Our study evaluated all subjects with chronic migraine who were treated with onabotulinum toxin A between February 2014 and November 2015 at the Parma Headache Centre. Botox was injected according to the PREEMPT paradigm every 3 months. The data about variations in the number of headache days and in symptomatic medication intake before and after the Botox injections were collected from the patients’ headache diaries. The study also evaluated tolerability to treatment, disability, and depressive symptoms. Of the 52 treated subjects, 14 received Botox treatment for at least 9 months and showed a significant decrease in the median number of headache days (from 19 to 14.5, p = 0.011) and in the median number of days of symptomatic medications intake and symptomatic drugs. Overall, the treatment was well tolerated. The average MIDAS and BDI-II scores after 9 months were reduced, though not significantly. The treatment with Botox proved effective and well tolerated in our clinical practice. Further studies on larger patient samples will help shed light on the persistence of the drug’s effect at long term and identify the predictive factors of response to treatment.
Comparison of closing-wedge and opening-wedge high tibial osteotomy for medial compartment osteoarthritis of the knee: a randomized controlled trial with a six-year follow-up.

Varus deformity increases the risk of progression of medial compartment knee osteoarthritis. The aim of this study was to investigate the clinical and radiographic mid-term results of closing-wedge and opening-wedge high tibial osteotomy when used to treat this condition.



From January 2001 to April 2004, ninety-two patients were randomized to receive either a closing-wedge or an opening-wedge high tibial osteotomy. The clinical outcome and radiographic results were examined preoperatively; at one year; and, for the present study, at six years postoperatively. The outcomes that we reviewed included maintenance of the achieved correction, progression of osteoarthritis (based on the Kellgren and Lawrence classification), severity of pain (as assessed on a visual analog scale [VAS]), knee function (as measured with the Hospital for Special Surgery [HSS] score and Knee injury and Osteoarthritis Outcome Score [KOOS]), walking distance, complications, and survival with conversion to a total knee arthroplasty as the end point. The results were analyzed on the basis of the intention-to-treat principle.



Six years postoperatively, the mean hip-knee-ankle (HKA) angle (and standard deviation) was 3.2° ± 4.1° of valgus after a closing-wedge high tibial osteotomy and 1.3° ± 5.0° of valgus after an opening-wedge high tibial osteotomy (p = 0.343). In both groups, the six-year postoperative HKA angles did not differ from the respective one-year postoperative angles. No difference in the severity of pain or in knee function was found between the two groups. Four complications (9%) occurred in the closing-wedge group and seventeen (38%), in the opening-wedge group. Ten (22%) of the patients in the closing-wedge group and three (8%) in the opening-wedge group needed conversion to a total knee arthroplasty within the six-year period (p = 0.05). The difference in the percentage of cases with conversion to total knee arthroplasty was 14% (95% confidence interval [CI] = 21.7 to 0.2).



In the group of patients without conversion to a total knee arthroplasty, there was no difference between the high tibial closing-wedge and opening-wedge osteotomies in terms of clinical outcomes or radiographic alignment at six years postoperatively. Opening-wedge osteotomy was associated with more complications, but closing-wedge osteotomy was associated with more early conversions to total knee arthroplasty.