nils-herrmann/clean_scirepeval huggingface dataset:
Predicting erythropoietin resistance in hemodialysis patients with type 2 diabetes

Resistance to ESAs (erythropoietin stimulating agents) is highly prevalent in hemodialysis patients with diabetes and associated with an increased mortality. The aim of this study was to identify predictors for ESA resistance and to develop a prediction model for the risk stratification in these patients.



A post-hoc analysis was conducted of the 4D study, including 1015 patients with type 2 diabetes undergoing hemodialysis. Determinants of ESA resistance were identified by univariate logistic regression analyses. Subsequently, multivariate models were performed with stepwise inclusion of significant predictors from clinical parameters, routine laboratory and specific biomarkers.



In the model restricted to clinical parameters, male sex, shorter dialysis vintage, lower BMI, history of CHF, use of ACE-inhibitors and a higher heart rate were identified as independent predictors of ESA resistance. In regard to routine laboratory markers, lower albumin, lower iron saturation, higher creatinine and higher potassium levels were independently associated with ESA resistance. With respect to specific biomarkers, higher ADMA and CRP levels as well as lower Osteocalcin levels were predictors of ESA resistance.



Easily obtainable clinical parameters and routine laboratory parameters can predict ESA resistance in diabetic hemodialysis patients with good discrimination. Specific biomarkers did not meaningfully further improve the risk prediction of ESA resistance. Routinely assessed data can be used in clinical practice to stratify patients according to the risk of ESA resistance, which may help to assign appropriate treatment strategies.


 The sponsor protocol ID and clinical trial unique identified number was CT-981-423-239. The results of the study are published and available at http://www.ncbi.nlm.nih.gov/pubmed/16034009.
Clinical and Immunological Impact of Early Postoperative Enteral Immunonutrition After Total Gastrectomy in Gastric Cancer Patients: A Prospective Randomized Study

Enteral immunodiet has been gaining increasing attention, but experimental data of its clinical effects in patients with gastric cancer are inconsistent, contradictory, and poorly investigated. The aim of this study was to assess the impact of early postoperative enteral immunonutrition on clinical and immunological outcomes in a homogeneous group of gastric cancer patients submitted to total gastrectomy. A total of 109 patients with gastric cancer were randomized to receive early postoperative enteral immunonutrition (formula supplemented with arginine, omega-3 fatty acids and ribonucleic acid [RNA]), or an isocaloric–isonitrogenous control. The postoperative outcome was evaluated based on clinical variables, including postoperative infectious complications, anastomotic leak rate, and length of hospitalization. In addition, state of cellular immunity was evaluated and compared between the 2 groups. The incidence of postoperative infectious complications in the immunodiet group (7.4 %) was significantly (p < .05) lower than that of the control group (20 %), as well as the anastomotic leak rate (3.7 % in immunodiet group vs 7.3 % in standard nutrition group, p < .05). Mortality rate did not show any significant differences; patients of the immunodiet group were found to have a significantly reduced length of hospitalization (12.7 ± 2.3 days) when compared with standard diet group (15.9 ± 3.4 days, p = .029). The data on cellular immunity showed that the postoperative CD4+ T-cell counts decreased in both groups, but the reduction in the IED group was significantly higher (p = .032) compared with the SND group. Early postoperative enteral immunonutrition significantly improves clinical and immunological outcomes in patients undergoing gastrectomy for gastric cancer.
Time-released garlic powder tablets lower systolic and diastolic blood pressure in men with mild and moderate arterial hypertension

Numerous clinical investigations that have focused on the hypotensive effects of garlic-based preparations have led to controversial results that may be partially because of differences in the composition of the preparations and in the biological responses they induce. It is possible that garlic powder tablets with a prolonged mode of action could induce more potent biological effects. In this double-blind, placebo-controlled trial with an active control arm, the hypotensive action of time-released garlic powder tablets (Allicor) was compared with that of regular garlic pills (Kwai) in 84 men with mild or moderate arterial hypertension. After an 8-week placebo treatment run-in phase, patients were randomized either to 600 mg Allicor (n=30) or to placebo (n=20) daily for 8 weeks. In addition, in the open-label branch, patients received either 2400 mg Allicor daily (n=18) or 900 mg Kwai daily (n=16). Allicor treatment (600 mg daily) resulted in a reduction of both systolic and diastolic blood pressures by 7.0 mm Hg (95% confidence interval (95% CI): 5.3–8.7) and 3.8 mm Hg (95% CI: 2.7–4.8), respectively. Increasing the Allicor dosage to 2400 mg daily did not provide any additional benefit. Treatment with Kwai resulted in the same decrease in systolic blood pressure (5.4 mm Hg, 95% CI: 1.9–8.8) as that seen with Allicor, but no decrease in diastolic blood pressure was observed with Kwai. Different effects of Allicor and Kwai on diastolic blood pressure may be because of the prolonged action of Allicor, which allows better bioavailability of the vasoactive constituents of garlic powder. The results of this study show that time-released garlic powder tablets are more effective for the treatment of mild and moderate arterial hypertension than are regular garlic supplements.
The relationship between schizotypal ideation and subjective cognition reflects more than just cognitive disorganisation: introducing the Brief Cognitive Schizotypy Index.

Internet surveys of psychometric schizotypy can usefully explore the relationship between the schizophrenia spectrum and cognition, but significant participant drop-out can be a difficulty. We aimed to identify the aspects of schizotypal thinking associated with self-reported cognitive difficulties with a view to developing a brief index of schizotypy that is maximally sensitive to subjective cognitive complaints.



Two online surveys were launched over two years. One explored schizotypal personality and subjective cognition. The other provided data for principal components analyses. The OLIFE was used in both surveys alongside other more specific measures of schizotypal features and a measure of affect.



Fifteen OLIFE cognitive disorganisation items, seven OLIFE unusual experiences items and three OLIFE introvertive anhedonia items were reliably associated with a range of self-reported cognitive difficulties as measured by the Cognitive Failures Questionnaire. The 25 items of the new Brief Cognitive Schizotypy Index (BCSI) loaded on three factors, labelled Unusual experiences, Affect and Cognition. The BCSI correlated strongly with a propensity to hallucinations scale, a persecutory ideation scale and two other measures of everyday cognition. These correlations survived correction for the role of prevailing negative affect.



Particular aspects of schizotypal ideation, reflecting the full range of such experiences, are related to reports of day-to-day cognitive difficulties. Future work should replicate these findings in a wider sample and explore relationships with objective cognitive measures.
The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle

Physical activity (PA)/exercise have become an integral part of the management of type 2 diabetes mellitus (T2DM). However, current guidelines are difficult to put into action in this population due to a number of barriers, especially the lack of acceptable, feasible, and validated behavioral intervention strategies. The present manuscript reports the rationale, study design and methods, and design considerations of the Italian Diabetes and Exercise Study (IDES)-2, a randomized controlled trial testing the efficacy of a behavior change strategy in increasing total daily PA and reducing sedentary time (SED-time) in patients with T2DM.



Starting 7 January 2014, the IDES_2 began enrolling 300 patients with known T2DM of at least 1-year duration in three tertiary referral outpatient Diabetes Clinics in Rome. Additional requirements are age 40 to 80 years, body mass index 27 to 40 kg/m(2), sedentary lifestyle, and physically inactive for at least 6 months, ability to walk 1.6 km without assistance, and eligibility after cardiovascular evaluation. Patients are randomized by center and within each center, by age and type of diabetes treatment to either the intervention or the control group. Patients in the intervention (INT) group (n = 150) receive theoretical and practical exercise counseling consisting of aggregated behavior change techniques (one individual theoretical counseling session plus eight twice-a-week individual theoretical and practical exercise counseling sessions) once a year for 3 years. Patients in the control (CON) group (n = 150), receive standard care, including general physician recommendations for daily PA. The primary outcomes are total daily PA and SED-time, as measured objectively by the use of an accelerometer. Secondary outcomes include physical fitness, modifiable cardiovascular risk factors, musculoskeletal disturbances, well-being/depression, and health-related quality of life.



The behavioral intervention strategy tested in the IDES_2 is based on solid theoretical grounds and uses several behavioral change techniques, two factors which were found to improve effectiveness of behavioral intervention. In addition, physicians and exercise specialists have been specifically trained for counselling/prescribing and supervising PA/exercise, respectively, in subjects suffering from metabolic disorders. Finally, the large sample size, the long study duration, and the objective measurement of PA allow statistically significant and scientifically robust conclusions to be drawn on the feasibility and efficacy of this intervention in T2DM patients.
Slow-Absorbing Modified Starch before and during Prolonged Cycling Increases Fat Oxidation and Gastrointestinal Distress without Changing Performance

While prior research reported altered fuel utilization stemming from pre-exercise modified starch ingestion, the practical value of this starch for endurance athletes who consume carbohydrates both before and during exercise is yet to be examined. The purpose of this study was to determine the effects of ingesting a hydrothermally-modified starch supplement (HMS) before and during cycling on performance, metabolism, and gastrointestinal comfort. In a crossover design, 10 male cyclists underwent three nutritional interventions: (1) a commercially available sucrose/glucose supplement (G) 30 min before (60 g carbohydrate) and every 15 min during exercise (60 g∙h(-1)); (2) HMS consumed at the same time points before and during exercise in isocaloric amounts to G (Iso HMS); and (3) HMS 30 min before (60 g carbohydrate) and every 60 min during exercise (30 g·h(-1); Low HMS). The exercise protocol (~3 h) consisted of 1 h at 50% Wmax, 8 × 2-min intervals at 80% Wmax, and 10 maximal sprints. There were no differences in sprint performance with Iso HMS vs. G, while both G and Iso HMS likely resulted in small performance enhancements (5.0%; 90% confidence interval = ±5.3% and 4.4%; ±3.2%, respectively) relative to Low HMS. Iso HMS and Low HMS enhanced fat oxidation (31.6%; ±20.1%; very likely (Iso); 20.9%; ±16.1%; likely (Low), and reduced carbohydrate oxidation (-19.2%; ±7.6%; most likely; -22.1%; ±12.9%; very likely) during exercise relative to G. However, nausea was increased during repeated sprints with ingestion of Iso HMS (17 scale units; ±18; likely) and Low HMS (18; ±14; likely) vs. G. Covariate analysis revealed that gastrointestinal distress was associated with reductions in performance with Low HMS vs. G (likely), but this relationship was unclear with Iso HMS vs. G. In conclusion, pre- and during-exercise ingestion of HMS increases fat oxidation relative to G. However, changes do not translate to performance improvements, possibly owing to HMS-associated increases in gastrointestinal distress, which is not attenuated by reducing the intake rate of HMS during exercise.
Acceptability of a novel vaginal microbicide during a safety trial among low-risk women.

The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users.



A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews.



Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection.



Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.
Differential response to antidepressants in women with premenstrual syndrome/premenstrual dysphoric disorder: a randomized controlled trial.

Studies show that selective serotonin reuptake inhibitors are effective for severe premenstrual syndrome and premenstrual dysphoric disorder. This study compares the efficacy of a selective serotonin reuptake inhibitor with that of a tricyclic antidepressant to determine whether efficacy for premenstrual syndrome/premenstrual dysphoric disorder is a general or more serotonergic effect of antidepressants.



After 3 screening months, 189 subjects were randomized to sertraline hydrochloride, desipramine hydrochloride, or placebo for 3 months of double-blind treatment. The flexible dosage range was 50 to 150 mg/d. The outcome measures included the Penn Daily Symptom Report (DSR), the Hamilton Depression Rating Scale, the Clinical Global Impressions-Severity Scale, the Quality of Life Scale, and Patient Global Ratings of Functioning and Improvement. Analyses included all subjects with treatment data, with the last observation carried forward.



Sertraline was significantly more effective than placebo or desipramine; desipramine was not better than placebo (F2,163 = 12.47, P<.001). All DSR factors were more improved with sertraline compared with desipramine and placebo; the factors for mood (P<.001) and pain (P = .05) were significant, and the results of all outcome measures were consistent. A history of depression, postmenstrual symptom levels, and other diagnostic variables added individually as covariates did not alter the treatment results. At end point analysis, DSR symptoms had decreased by more than 50% in 40 subjects (65%) in the sertraline group, 18 subjects (36%) in the desipramine group, and 16 subjects (29%) in the placebo group (P<.001).



The comparison of 2 classes of antidepressants strongly favored the serotonergic drug, which effectively reduced symptoms and improved functioning and was well tolerated by women with severe premenstrual syndrome. A history of depression did not alter the treatment results.
Higher dose imatinib for children with de novo chronic phase chronic myelogenous leukemia: a report from the Children's Oncology Group.

To determine the efficacy of imatinib in children with newly diagnosed chronic phase (CP) chronic myelogenous leukemia (CML).



This was an open label, multi-center phase II clinical trial. Courses were defined as consecutive 28-day intervals. Oral imatinib was administered daily at 340 mg/m² without interruption in the absence of toxicity.



Fifty-one children received 978 28-day courses of imatinib. The most common toxicities encountered were hematologic. Forty-one patients (80%) achieved a complete hematologic response by the end of course 2. Nineteen children (38%) obtained a complete cytogenetic response (CCyR) at the end of course 3. Overall, 72% achieved CCyR at a median time of 5.6 months. The rate of complete molecular response (>3 log reduction) was 27%. Progression-free and overall survival at 3 years were 72%  ± 6.4% and 92%  ± 3.9%, respectively.



Daily oral imatinib at a dose of 340 mg/m² is well tolerated in children. In addition, imatinib therapy is effective in inducing a high percent of hematologic, cytogenetic and molecular responses, comparable to adults with CML.
Intermittent levosimendan treatment in patients with severe congestive heart failure

Levosimendan (LS) is a novel inodilator for the treatment of severe congestive heart failure (CHF). In this study, we investigated the potential long-term effects of intermittent LS treatment on the pathophysiology of heart failure. Thirteen patients with modest to severe CHF received three 24-h intravenous infusions of LS at 3-week intervals. Exercise capacity was determined by bicycle ergospirometry, well-being assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ) and laboratory parameters of interest measured before and after each treatment. One patient experienced non-sustained periods of ventricular tachycardia (VT) during the first infusion and had to discontinue the study. Otherwise the LS infusions were well tolerated. Exercise capacity (VO2max) did not improve significantly during the study although symptoms decreased (P < 0.0001). Levels of plasma NT-proANP, NT-proBNP and NT-proXNP decreased 30–50 % during each infusion (P < 0.001 for all), but the changes disappeared within 3 weeks. Although norepinephrine (NE) appeared to increase during the first treatment (P = 0.019), no long-term changes were observed. Intermittent LS treatments decreased effectively and repetitively plasma vasoactive peptide levels, but no carryover effects were observed. Patients’ symptoms decreased for the whole study period although there was no objective improvement of their exercise capacity. The prognostic significance of these effects needs to be further studied.
The harmless acute pancreatitis score: a clinical algorithm for rapid initial stratification of nonsevere disease.

Only severe acute pancreatitis requires treatment, according to the principles of intensive care medicine in an intensive care or intermediate care unit. The aim of the study was to define and evaluate a simple clinical algorithm for rapid initial identification of patients with a first attack of acute pancreatitis who do not require intensive care.



This prospective study included 394 patients who were admitted to the Municipal Clinic of Lüneburg, Germany, between 1987 and 2003. From a number of parameters of disease severity on admission, 3 parameters that showed the strongest prediction of a nonsevere course (no rebound tenderness and/or guarding, normal hematocrit level, and normal serum creatinine level) were combined to form the harmless acute pancreatitis score (HAPS). The score then was validated in a German multicenter study including 452 patients between 2004 and 2006.



In both the initial and the validation set, the HAPS correlated with a nonsevere course of the disease (P < .0001). The score correctly identified a harmless course in 200 (98%) of 204 patients.



The HAPS enables identification, within approximately 30 minutes after admission, of patients with acute pancreatitis whose disease will run a mild course. The high level of accuracy of this test (98%) will allow physicians to identify patients quickly who do not require intensive care, and potentially those who will not require inpatient treatment at all. Thus, the HAPS may save substantial hospital costs.
A communication strategy and brochure for relatives of patients dying in the ICU.

There is a need for close communication with relatives of patients dying in the intensive care unit (ICU). We evaluated a format that included a proactive end-of-life conference and a brochure to see whether it could lessen the effects of bereavement.



Family members of 126 patients dying in 22 ICUs in France were randomly assigned to the intervention format or to the customary end-of-life conference. Participants were interviewed by telephone 90 days after the death with the use of the Impact of Event Scale (IES; scores range from 0, indicating no symptoms, to 75, indicating severe symptoms related to post-traumatic stress disorder [PTSD]) and the Hospital Anxiety and Depression Scale (HADS; subscale scores range from 0, indicating no distress, to 21, indicating maximum distress).



Participants in the intervention group had longer conferences than those in the control group (median, 30 minutes [interquartile range, 19 to 45] vs. 20 minutes [interquartile range, 15 to 30]; P<0.001) and spent more of the time talking (median, 14 minutes [interquartile range, 8 to 20] vs. 5 minutes [interquartile range, 5 to 10]). On day 90, the 56 participants in the intervention group who responded to the telephone interview had a significantly lower median IES score than the 52 participants in the control group (27 vs. 39, P=0.02) and a lower prevalence of PTSD-related symptoms (45% vs. 69%, P=0.01). The median HADS score was also lower in the intervention group (11, vs. 17 in the control group; P=0.004), and symptoms of both anxiety and depression were less prevalent (anxiety, 45% vs. 67%; P=0.02; depression, 29% vs. 56%; P=0.003).



Providing relatives of patients who are dying in the ICU with a brochure on bereavement and using a proactive communication strategy that includes longer conferences and more time for family members to talk may lessen the burden of bereavement.