nils-herrmann/clean_scirepeval huggingface dataset:
Potent men undergoing radical prostatectomy: a prospective study measuring sexual health outcomes and the impact of erectile dysfunction treatments.

Radical prostatectomy (RP) can have a significant impact on sexual health. The purpose of this study was to measure changes in sexual health after RP, assess the impact of various treatments for erectile dysfunction, and define an appropriate endpoint for maintaining sexual health after surgery.



One hundred sixteen men with good preoperative sexual health undergoing RP completed a validated anonymous survey preop and annually thereafter. Subgroup analysis was performed based on the use of erectile dysfunction (ED) treatments. Endpoints for evaluation included an erection adequate for intercourse and a return to baseline in sexual domain scores.



Overall there was a significant reduction in scores after surgery for each of the sexual health questions and the function and bother domains. ED treatments providing an erection adequate for intercourse resulted in domain scores significantly higher than those in men unable to achieve such an endpoint, and comparable to those of men returning to good native erectile function, but still lower than preop. Even in men with good preoperative sexual health, with erections adequate for intercourse postop, the return to baseline rate was only 26% in sexual function and 40% in sexual bother.



RP appears to have a significant impact on sexual health. Overall, ED treatments, when providing a functional erection, improve sexual health scores, even comparable to men returning to spontaneous erectile function. Although, men functioning well prior to surgery infrequently returned to their preoperative level of sexual health, even with return of native erectile function or the successful use of an ED treatment.
The effect of dried plum on serum levels of receptor activator of NF-κB ligand, osteoprotegerin and sclerostin in osteopenic postmenopausal women: a randomised controlled trial.

Although several studies have confirmed the bone-protective properties of dried plum, its exact mechanisms of action remain unclear. Recent research has shown that osteocytes may control bone formation via the production of sclerostin and bone resorption via the receptor activator of NF-κB ligand (RANKL) and its inhibitor osteoprotegerin (OPG). To investigate the mechanism of action of dried plum in reversing bone loss, we measured serum levels of RANKL, OPG and sclerostin in osteopenic postmenopausal women (n 160). Participants were randomly assigned to the treatment group of either 100 g dried plum/d or 75 g dried apple/d (comparative control) for 1 year. All participants received 500 mg Ca plus 400 IU (10 μg) vitamin D daily. Bone mineral densities (BMD) of the lumbar spine, forearm, hip and whole body were assessed at baseline and at the end of the study using dual-energy X-ray absorptiometry. Blood samples were collected at baseline and after 12 months to assess bone biomarkers. Dried plum significantly increased the BMD of the ulna and spine in comparison with the control group. In comparison with corresponding baseline values, dried plum increased the RANKL levels by only +1·99 v. +18·33% and increased the OPG levels by +4·87 v. - 2·15% in the control group. Serum sclerostin levels were reduced by - 1·12% in the dried plum group v. +3·78% in the control group. Although percentage changes did not reach statistical significance (P≤ 0·05), these preliminary data may indicate that the positive effects of dried plum on bone are in part due to the suppression of RANKL production, the promotion of OPG and the inhibition of sclerostin.
Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial.

The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.



We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.



At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.



Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.
A Scoring System to Determine Risk of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Lesions.

After endoscopic mucosal resection (EMR) of colorectal lesions, delayed bleeding is the most common serious complication, but there are no guidelines for its prevention. We aimed to identify risk factors associated with delayed bleeding that required medical attention after discharge until day 15 and develop a scoring system to identify patients at risk.



We performed a prospective study of 1214 consecutive patients with nonpedunculated colorectal lesions 20 mm or larger treated by EMR (n = 1255) at 23 hospitals in Spain, from February 2013 through February 2015. Patients were examined 15 days after the procedure, and medical data were collected. We used the data to create a delayed bleeding scoring system, and assigned a weight to each risk factor based on the β parameter from multivariate logistic regression analysis. Patients were classified as being at low, average, or high risk for delayed bleeding.



Delayed bleeding occurred in 46 cases (3.7%, 95% confidence interval, 2.7%-4.9%). In multivariate analysis, factors associated with delayed bleeding included age ≥75 years (odds ratio [OR], 2.36; P < .01), American Society of Anesthesiologist classification scores of III or IV (OR, 1.90; P ≤ .05), aspirin use during EMR (OR, 3.16; P < .05), right-sided lesions (OR, 4.86; P < .01), lesion size ≥40 mm (OR, 1.91; P ≤ .05), and a mucosal gap not closed by hemoclips (OR, 3.63; P ≤ .01). We developed a risk scoring system based on these 6 variables that assigned patients to the low-risk (score, 0-3), average-risk (score, 4-7), or high-risk (score, 8-10) categories with a receiver operating characteristic curve of 0.77 (95% confidence interval, 0.70-0.83). In these groups, the probabilities of delayed bleeding were 0.6%, 5.5%, and 40%, respectively.



The risk of delayed bleeding after EMR of large colorectal lesions is 3.7%. We developed a risk scoring system based on 6 factors that determined the risk for delayed bleeding (receiver operating characteristic curve, 0.77). The factors most strongly associated with delayed bleeding were right-sided lesions, aspirin use, and mucosal defects not closed by hemoclips. Patients considered to be high risk (score, 8-10) had a 40% probability of delayed bleeding.
Multicentre observational study evaluating immediate and progressive switching from carbamazepine to oxcarbazepine in patients with epilepsy.

This observational study was performed to identify the clinical reasons leading physicians to opt for immediate or progressive procedures when switching patients from carbamazepine to oxcarbazepine, and to evaluate the clinical feasibility of the two procedures in a general unselected patient population. Five hundred and twenty-seven patients (aged 14 years or older, treated with carbamazepine as monotherapy or in combination therapy) were recruited at 50 Italian centres and freely assigned to immediate (n=361) or progressive (n=166) switch procedures. Vital and clinical data (including seizure frequency) were comparable in the two groups at baseline. The proportion of patients with simple partial seizures only was significantly higher in the immediate group (immediate: 33.0% vs progressive: 23.5%, p=0.0275), whereas the proportion of patients on combination therapy was slightly higher in the progressive group (immediate: 47.1 vs progressive: 55.4%, p=0.0756). At the end of the switch period, overall treatment satisfaction was greater in the immediate switch group, both in patients (p<0.002) and physicians (p<0.0005). Physicians preferred the immediate over the progressive switch procedure. The only clinical features of patients found to relate to the physician?s choice of switch procedure were simple partial seizures only (favouring the immediate switch) and, possibly, combination therapy with other anti-epileptic drugs (favouring the progressive switch). "Overnight" switching from carbamazepine to oxcarbazepine also appears feasible in most patients on polytherapy.
Self-reported financial burden and satisfaction with care among patients with cancer.

Health care-related costs and satisfaction are compelling targets for quality improvement in cancer care delivery; however, little is known about how financial burden affects patient satisfaction.



This was an observational, cross-sectional, survey-based study assessing patient-reported financial burden (FB). Eligible patients were ≥ 21 years with solid tumor malignancy and were receiving chemotherapy or hormonal therapy for ≥ 1 month. The Patient Satisfaction Questionnaire Short-Form assessed patient satisfaction with health care. Subjective FB related to cancer treatment was measured on a 5-point Likert scale.



Of 174 participants (32% response rate), 47% reported significant/catastrophic FB. Participants reported highest satisfaction with interpersonal manner and lowest satisfaction with financial aspects of care. In adjusted analysis, high FB was negatively associated with general satisfaction (coefficient: -.29), satisfaction with technical quality (coefficient: -.26), and satisfaction with financial aspects of care (coefficient: -.62). Older age was associated with higher scores in all satisfaction subscales except patient-physician communication and financial aspects. Annual household income of <$20,000 was associated with lower satisfaction scores in all subscales except time spent with doctor. High FB was not associated with patient satisfaction scores for accessibility and convenience, communication, interpersonal manner, or time spent with doctor.



FB is a potentially modifiable correlate of poor satisfaction with cancer care including general satisfaction and satisfaction with the technical quality of care. Addressing cancer-associated FB may lead to improved satisfaction, which in turn can influence adherence, outcomes, and quality of life.
Resistance training alters skeletal muscle structure and function in human heart failure: effects at the tissue, cellular and molecular levels.

Reduced skeletal muscle function in heart failure (HF) patients may be partially explained by altered myofilament protein content and function. Resistance training increases muscle function, although whether these improvements are achieved by correction of myofilament deficits is not known. To address this question, we examined 10 HF patients and 14 controls prior to and following an 18 week high-intensity resistance training programme. Evaluations of whole muscle size and strength, single muscle fibre size, ultrastructure and tension and myosin-actin cross-bridge mechanics and kinetics were performed. Training improved whole muscle isometric torque in both groups, although there were no alterations in whole muscle size or single fibre cross-sectional area or isometric tension.Unexpectedly, training reduced the myofibril fractional area of muscle fibres in both groups. This structural change manifested functionally as a reduction in the number of strongly bound myosin-actin cross-bridges during Ca²⁺ activation. When post-training single fibre tension data were corrected for the loss of myofibril fractional area, we observed an increase in tension with resistance training. Additionally, training corrected alterations in cross-bridge kinetics (e.g. myosin attachment time) in HF patients back to levels observed in untrained controls. Collectively, our results indicate that improvements in myofilament function in sedentary elderly with and without HF may contribute to increased whole muscle function with resistance training. More broadly, these data highlight novel cellular and molecular adaptations in muscle structure and function that contribute to the resistance-trained phenotype.
Nateglinide versus repaglinide for type 2 diabetes mellitus in China

The purpose of this study is to evaluate efficacy and safety of nateglinide tablet administration in comparison with those of repaglinide tablet as control on treating type 2 diabetes mellitus in China. Pooled-analysis with analysis of covariance (ANCOVA) method was applied to assess the efficacy and safety based on original data collected from four independent randomized clinical trials with similar research protocols. However meta-analysis was applied based on the outcomes of the four studies. The results by meta-analysis were comparable to those obtained by pooled-analysis. The means of HbA1c, and fasting blood glucose in both the nateglinide and repaglinide groups were reduced significantly after 12 weeks duration but no statistical differences in reduction between the two groups. The adverse reaction rates were 9.89 and 6.51% in the nateglinide and repaglinide groups respectively, with the rate difference showing no statistical significance, and the Odds Ratio of adverse reaction rate (95% confidence interval) was 1.59 (0.99, 2.55). Both nateglinide and repaglinide administration have similarly significant effects on reducing HbA1c and FBG. However, the adverse reaction rate in the nateglinide group is higher than that in the latter using repaglinide but no statistical significance difference as revealed in the four clinical trials detailed below.
RNA-based gene therapy for HIV with lentiviral vector-modified CD34(+) cells in patients undergoing transplantation for AIDS-related lymphoma.

AIDS patients who develop lymphoma are often treated with transplanted hematopoietic progenitor cells. As a first step in developing a hematopoietic cell-based gene therapy treatment, four patients undergoing treatment with these transplanted cells were also given gene-modified peripheral blood-derived (CD34(+)) hematopoietic progenitor cells expressing three RNA-based anti-HIV moieties (tat/rev short hairpin RNA, TAR decoy, and CCR5 ribozyme). In vitro analysis of these gene-modified cells showed no differences in their hematopoietic potential compared with nontransduced cells. In vitro estimates of successful expression of the anti-HIV moieties were initially as high as 22% but declined to approximately 1% over 4 weeks of culture. Ethical study design required that patients be transplanted with both gene-modified and unmanipulated hematopoietic progenitor cells obtained from the patient by apheresis. Transfected cells were successfully engrafted in all four infused patients by day 11, and there were no unexpected infusion-related toxicities. Persistent vector expression in multiple cell lineages was observed at low levels for up to 24 months, as was expression of the introduced small interfering RNA and ribozyme. Therefore, we have demonstrated stable vector expression in human blood cells after transplantation of autologous gene-modified hematopoietic progenitor cells. These results support the development of an RNA-based cell therapy platform for HIV.
Neuromodulation of emotion using functional electrical stimulation applied to facial muscles.

Major depressive disorder (MDD) is a common condition for which available pharmaceutical treatments are not always effective and can have side-effects. Therefore, alternative and/or complementary MDD treatments are needed. Research on facial expressions has shown that facial movements can induce the corresponding emotions, particularly when specific attention is paid to voluntarily activating muscles that are typically only activated involuntarily while expressing emotions. We hypothesized that functional electrical stimulation (FES) applied to facial muscles may enhance this effect due to its ability to modulate central nervous system plasticity. Thus, applying FES to the facial muscles associated with smiling (including the "Duchenne marker") may increase the activity of subcortical nuclei related to positive emotions and counteract symptoms of depression.



Twelve able-bodied subjects received FES and were compared with a group of 12 control subjects. Both groups underwent the same experimental procedures involving a cognitive task, and a deception was used such that subjects were unaware that the objective was to modulate mood. Assessments with the Positive and Negative Affect Schedule-Expanded Form (PANAS-X) were administered before and after the experiment.



No significant between-group differences were found in the change scores for our primary outcomes, the PANAS-X item "happy," and aggregate scores "Joviality" and "Positive Affect." Significant differences were, however, detected for secondary outcomes "determined," "daring," "scared," and "concentrating."



These results suggest that modulating emotion using FES may be possible, but is difficult to target accurately. Further work is warranted to explore FES applications to MDD.
Etoposide-cisplatin alternating with vinorelbine-cisplatin versus etoposide-cisplatin alone in patients with extensive disease combined with small cell lung cancer.

The aim of this study was to evaluate the efficacy of alternating etoposide-cisplatin and vinorelbine-cisplatin (EP-NP) compared with an etoposide-cisplatin (EP) regimen for advanced combined small cell carcinomas.



Histologically confirmed combined small cell carcinoma patients who met the inclusion criteria were randomly assigned (1:1) into either the EP-NP setting (group A) or the EP setting (group B). The primary endpoint was progression-free survival in patients who received at least one dose of treatment.



Eighty-two patients entered into this trial, 42 in group A and 40 in group B. The objective response rates in group A and group B were 42.9% and 32.5%, respectively (p=0.334). Survival analysis showed that median progression-free survival was 6.1 months in group A, which was significantly longer than the 4.1 months in group B (p=0.041). However, as to overall survival, no significant difference was found between the two groups (11.0 vs 10.1 months in groups A and B, respectively, p=0.545). No unexpected side effects were observed in either group.



The EP-NP regimen for combined small cell carcinomas prolonged progression- free survival compared with the EP regimen. Further clinical investigations are warranted.
Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients

A randomized, blinded, crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction (ED) in male spinal cord-injured (SCI) patients. To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of tadalafil 10 mg versus sildenafil 50 mg. Neurourology Section, Careggi Hospital, Florence, Italy. During a screening (visit 1), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects made at least four attempts at intercourse. At visit 2, 15 patients (group 1) were assigned sildenafil and 15 (group 2) started with tadalafil. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13–14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 h of taking the first tablet, within 12 h for the second tablet, 24 h for the third, and the fourth from 24 to 36 h. At visit 3, the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given tadalafil, and Group 2 was given sildenafil. Patients were required to observe the same criteria in taking the four tablets as in visit 2. After 4 weeks (visit 5), we evaluated the patients as we did in visit 3.Results: Overall, 28 patients completed the study. No subjects discontinued the drugs due to drawbacks.Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil (P<0.01) and improved overall sex life satisfaction as well as sexual relations with partner. Based on these data, tadalafil may have the potential to become an important treatment option for ED in SCI patients. This study was not sponsored.
The VEINES-QOL/Sym questionnaire is a reliable and valid disease-specific quality of life measure for deep vein thrombosis in elderly patients

To prospectively evaluate the psychometric properties of the Venous Insufficiency Epidemiological and Economic Study (VEINES-QOL/Sym) questionnaire, an instrument to measure disease-specific quality of life and symptoms in elderly patients with deep vein thrombosis (DVT), and to validate a German version of the questionnaire. In a prospective multicenter cohort study of patients aged ≥65 years with acute venous thromboembolism, we used standard psychometric tests and criteria to evaluate the reliability, validity, and responsiveness of the VEINES-QOL/Sym in patients with acute symptomatic DVT. We also performed an exploratory factor analysis. Overall, 352 French- and German-speaking patients were enrolled (response rate of 87 %). Both language versions of the VEINES-QOL/Sym showed good acceptability (missing data, floor and ceiling effects), reliability (internal consistency, item-total and inter-item correlations), validity (convergent, discriminant, known-groups differences), and responsiveness to clinical change over time in elderly patients with DVT. The exploratory factor analysis of the VEINES-QOL/Sym suggested three underlying dimensions: limitations in daily activities, DVT-related symptoms, and psychological impact. The VEINES-QOL/Sym questionnaire is a practical, reliable, valid, and responsive instrument to measure quality of life and symptoms in elderly patients with DVT and can be used with confidence in prospective studies to measure outcomes in such patients.