nils-herrmann/clean_scirepeval huggingface dataset:
Value of a complete or partial remission in severe lupus nephritis.

The value of a complete remission in severe lupus nephritis is well known but little is known about the impact of a partial remission in this patient population. The purpose of this study was to evaluate the long-term prognosis of achieving a complete or partial remission in a well-defined group of patients with severe lupus nephritis.



In this study, 86 patients with diffuse lupus glomerulonephritis were reviewed for assessment of the value of a partial remission (50% reduction in baseline proteinuria to < or =1.5 g/d and < or =25% increase in baseline creatinine) and complete remission (proteinuria < or =0.33 g/d and serum creatinine < or =1.4 mg/dl) on outcomes compared with patients who did not attain a remission. These well-characterized patients were entered into a prospective therapeutic trial conducted by the Collaborative Study Group and were followed for more than 10 yr.



All biopsies showed diffuse lupus nephritis. A complete remission was attained in 37 (43%) patients, a partial remission in 21 (24%) patients, and no remission in 28 (32%) patients. Baseline clinical and serologic features were similar among the groups, but patients with a complete remission had a lower serum creatinine and chronicity index compared with patients with partial or no remission. The patient survival at 10 yr was 95% for complete remission, 76% for partial remission, and 46% for no remission. The renal survival at 10 yr was 94% for complete remission, 45% for partial remission, and 19% for no remission, and the patient survival without end-stage renal disease at 10 yr was 92% for complete remission, 43% for partial remission, and 13% for no remission.



Even a partial remission in lupus nephritis is associated with a significantly better patient and renal survival compared with no remission.
Hemodynamic effects of mannitol infusion in patients with acute intracerebral hemorrhage.

To evaluate hemodynamic effects of mannitol infusion in patients with acute intracerebral hemorrhage.



Thirty patients with acute intracerebral hemorrhage were enrolled. Transcranial doppler was used to detect variables of bilateral middle cerebral arteria (MCA) including mean velocity (Vm) and pulsitility index (PI) before and after 125 ml and 250 ml mannitol infusion (0, 30, 60, 90, 120, 180, 240 min).



When 125 ml or 250 ml mannitol was infused in patients with acute intracerebral hemorrhage, Vm of bilateral MCA elevated, and reached the top at 30 min, and then decreased. PI decreased in the affected MCA (250 ml) and in the unaffected MCA (125 ml and 250 ml).



Mannitol infusion in patients with acute intracerebral hemorrhage can improve cerebral blood flow in bilateral hemispheres and decrease intracranial pressure in the hemorrhagic hemisphere (250 ml) and in the nonhemorrhagic hemisphere (125 ml and 250 ml).
Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial.

Weight loss of 5% to 10% can improve type 2 diabetes and related comorbidities. Few safe, effective weight-management drugs are currently available.



To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes.



Fifty-six-week randomized (2:1:1), double-blind, placebo-controlled, parallel-group trial with 12-week observational off-drug follow-up period. The study was conducted at 126 sites in 9 countries between June 2011 and January 2013. Of 1361 participants assessed for eligibility, 846 were randomized. Inclusion criteria were body mass index of 27.0 or greater, age 18 years or older, taking 0 to 3 oral hypoglycemic agents (metformin, thiazolidinedione, sulfonylurea) with stable body weight, and glycated hemoglobin level 7.0% to 10.0%.



Once-daily, subcutaneous liraglutide (3.0 mg) (n = 423), liraglutide (1.8 mg) (n = 211), or placebo (n = 212), all as adjunct to 500 kcal/d dietary deficit and increased physical activity (≥150 min/wk).



Three coprimary end points: relative change in weight, proportion of participants losing 5% or more, or more than 10%, of baseline weight at week 56.



Baseline weight was 105.7 kg with liraglutide (3.0-mg dose), 105.8 kg with liraglutide (1.8-mg dose), and 106.5 kg with placebo. Weight loss was 6.0% (6.4 kg) with liraglutide (3.0-mg dose), 4.7% (5.0 kg) with liraglutide (1.8-mg dose), and 2.0% (2.2 kg) with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, -4.00% [95% CI, -5.10% to -2.90%]; liraglutide [1.8 mg] vs placebo, -2.71% [95% CI, -4.00% to -1.42%]; P < .001 for both). Weight loss of 5% or greater occurred in 54.3% with liraglutide (3.0 mg) and 40.4% with liraglutide (1.8 mg) vs 21.4% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8 mg] vs placebo, 19.0% [95% CI, 9.1% to 28.8%]; P < .001 for both). Weight loss greater than 10% occurred in 25.2% with liraglutide (3.0 mg) and 15.9% with liraglutide (1.8 mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 18.5% [95% CI, 12.7% to 24.4%], P < .001; for liraglutide [1.8 mg] vs placebo, 9.3% [95% CI, 2.7% to 15.8%], P = .006). More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and placebo. No pancreatitis was reported.



Among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide (3.0 mg) daily, compared with placebo, resulted in weight loss over 56 weeks. Further studies are needed to evaluate longer-term efficacy and safety.
Weekly docetaxel and gemcitabine as first-line treatment for metastatic breast cancer: results of a multicenter phase II study.

We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients.



We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days.



All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53-28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71-16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3%) but grade 3-4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experienced grade 3 alopecia.



The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study.
One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial.

Adjuvant imatinib administered for 12 months after surgery has improved recurrence-free survival (RFS) of patients with operable gastrointestinal stromal tumor (GIST) compared with placebo.



To investigate the role of imatinib administration duration as adjuvant treatment of patients who have a high estimated risk for GIST recurrence after surgery.



Patients with KIT-positive GIST removed at surgery were entered between February 2004 and September 2008 to this randomized, open-label phase 3 study conducted in 24 hospitals in Finland, Germany, Norway, and Sweden. The risk of GIST recurrence was estimated using the modified National Institutes of Health Consensus Criteria.



Imatinib, 400 mg per day, orally for either 12 months or 36 months, started within 12 weeks of surgery.



The primary end point was RFS; the secondary end points included overall survival and treatment safety.



Two hundred patients were allocated to each group. The median follow-up time after randomization was 54 months in December 2010. Diagnosis of GIST was confirmed in 382 of 397 patients (96%) in the intention-to-treat population at a central pathology review. KIT or PDGFRA mutation was detected in 333 of 366 tumors (91%) available for testing. Patients assigned for 36 months of imatinib had longer RFS compared with those assigned for 12 months (hazard ratio [HR], 0.46; 95% CI, 0.32-0.65; P < .001; 5-year RFS, 65.6% vs 47.9%, respectively) and longer overall survival (HR, 0.45; 95% CI, 0.22-0.89; P = .02; 5-year survival, 92.0% vs 81.7%). Imatinib was generally well tolerated, but 12.6% and 25.8% of patients assigned to the 12- and 36-month groups, respectively, discontinued imatinib for a reason other than GIST recurrence.



Compared with 12 months of adjuvant imatinib, 36 months of imatinib improved RFS and overall survival of GIST patients with a high risk of GIST recurrence.
Randomized comparison of volar locking plates and intramedullary nails for unstable distal radius fractures.

To compare minimally invasive intramedullary nails (IMN) and volar locking plates (VLP) for the treatment of unstable distal radius fractures by evaluating postoperative subjective, radiographic, and functional outcomes. The hypothesis was that IMN patients would have less pain and required less pain medication in the early postoperative period and returned to work earlier than VLP patients.



Sixty patients with closed, displaced, unstable, extra-articular, metaphyseal fractures of the distal radius were randomized to receive a VLP or an IMN for internal fixation. Functional outcomes (Quick Disabilities of the Arm, Shoulder, and Hand, Michigan Hand Questionnaire), radiographic measurements (ulnar variance, radial height, inclination, and volar tilt), and range of motion were assessed until final follow-up at 2 years after surgery. Narcotic pain medication use was documented for 5 weeks following surgery.



There were 2 groups of 30 patients with IMN (mean age, 55 ± 14 y) or VLP (mean age, 55 ± 16 y) with similar demographics and comorbidities. Patients with IMN regained extension earlier but had similar range of motion to patients with VLP at final follow-up. There was similar improvement in Michigan Hand Questionnaire, Quick Disabilities of the Arm, Shoulder, and Hand, and strength between groups. Five weeks after surgery, fewer IMN patients required narcotic pain medication (13%) than VLP patients (33%). Radiographic outcomes were similar at final follow-up. There were 3 failures with IMN versus 1 failure with VLP. All 10 employed patients with IMN returned to previous work compared with 10 of the 12 employed patients with VLP. Time to return to work was similar for both groups.



In a cohort of similar patients, IMN and VLP provided comparable improvement in functional and radiographic outcomes. Patients with IMN required less narcotic pain medication after surgery than VLP patients.



Therapeutic II.
Effects of 6-Month Folic Acid Supplementation on Cognitive Function and Blood Biomarkers in Mild Cognitive Impairment: A Randomized Controlled Trial in China.

This study is to examine the effects of folic acid supplementation on cognitive function in Chinese older adults with mild cognitive impairment who are unexposed to folic acid fortification and assess cognitive functioning in relation to folate, homocysteine, and vitamin B12 values at baseline.



This was a single-center, randomized, controlled trial in Tianjin, China; 180 individuals aged 65 years and older who had mild cognitive impairment were assigned randomly to one of two groups: (a) those treated with oral folic acid (400 µg/day) and (b) those treated via conventional treatment. Tests of cognitive performance and biomarkers were measured at baseline, 3 months, and 6 months. Analysis was by intention-to-treat. Changes in cognitive or clinical function were analyzed by repeated-measure analysis of variance or mixed-effects models. This trial has been registered with the trial number ChiCTR-TRC-13003227.



Total of 159 participants (intervention group: 80; control group: 79) completed the trial. Repeated-measure analysis of variance showed significant improvements in serum folate (ηp (2) = 0.712, p = .009), homocysteine (ηp (2) = 0.119, p = .017), serum vitamin B12 (ηp (2) = 0.144, p = .022), and S-adenosylmethionine (ηp (2) = 0.117, p = .033) in the intervention group over the control group. Folic acid supplementation improved Full Scale IQ (p = .031; effect size d = 0.168), Digit Span (p = .009; d = 0.176), and Block Design (p = .036; effect size d = 0.146) scores at 6 months in comparison to the control. There were no significant findings for all other cognitive measures.



There was a beneficial effect from relatively short-term folate supplementation on cognitive functioning in later life. Larger-scale, randomized, controlled trials of longer duration in selected age groups are needed.
Moderators of Varenicline Treatment Effects in a Double-Blind, Placebo-Controlled Trial for Alcohol Dependence: An Exploratory Analysis.

To explore whether varenicline (Chantix) showed more efficacy in treating certain subgroups of patients. In a recent multisite trial, varenicline was shown to be effective in reducing drinking in alcohol-dependent patients, both smokers and nonsmokers. Given the heterogeneity among alcohol-dependent patients, secondary analyses were conducted to determine whether certain subgroups responded more favorably than others to treatment with varenicline.



Data were drawn from a phase 2 randomized, double-blind, placebo-controlled multisite 13-week trial of varenicline in alcohol-dependent patients (Litten et al., 2013). Seventeen moderator variables were selected for exploratory testing on the basis of theoretical and scientific interest.



Of the 17 moderator variables assessed, 4 were statistically significant, including cigarettes per day reduction, treatment drinking goal, years drinking regularly, and age of the patient. Two other variables—the type of adverse events experienced by patients and the severity of alcohol-related consequences—seemed to moderate the varenicline treatment effect at borderline statistical significance. Individuals who reduced the number of cigarettes per day experienced a significant effect from varenicline in reducing drinking, whereas those who did not change or who increased their number of cigarettes observed no beneficial effect. Reviewing the moderators related to severity, varenicline seemed to have greater efficacy than placebo among less severely dependent patients.



Varenicline seems to be more efficacious in certain subgroups, particularly in those who reduced their smoking and in the "less severe" patient. Additional studies are warranted to confirm the results of these exploratory analyses.
Effect of kinesio taping on standing balance in subjects with multiple sclerosis: A pilot study\m{1}.

The aim of this study was to assess the effect of Kinesio Taping on body stability in subjects with MS.



Non controlled intervention study in a Rehabilitation Unit.



A consecutive convenience sample of 15 individuals with multiple sclerosis was assessed. Kinesio Tex Tape was applied directly to the skin of both calves and kept for the next two days.



Clinical and stabilometric assessments were performed at baseline, immediately after application of the tape and the day after its removal. To control for learning effect 10 subject with multiple sclerosis were tested repeatedly under the same conditions without tape.



No statistically or clinically relevant differences were observed among conditions in the mediolateral plane. In the AP plane Friedman's ANOVA showed statistically significant differences between baseline and taping condition with respect to length of sway. A trend towards statistically relevant differences were found also with respect to mean sway and velocity of sway. No learning effect was found for repeated testing within the no treated group.



These preliminary results suggest that the use of ankle taping may be useful in immediately stabilising body posture.
Association between long travel and venous thromboembolic disease: a systematic review and meta-analysis of case-control studies

The term “economy-class syndrome” defines an infrequent episode of venous thromboembolism (VTED) related to a long travel, namely by plane. However, this relation has not clearly been demonstrated by investigators. We carried out a systematic review and a meta-analysis of cases-control studies that had studied this topic. We realised a systematic review of the literature and selected all the case-control studies published. Two authors carried out a methodological evaluation according to the Scottish Intercollegiate Guidelines Network items (concordance was analysed by weighted kappa index), and a systematic analysis of the potential biases of each study was assessed. We carried out the meta-analysis with the data extracted from the studies. We recovered eight cases-control studies. The relation between the antecedent of a long travel and subsequent VTED varied from OR = 1.1 to OR = 4.0 and was found to be significant in four studies. The studies were highly heterogeneous in methodology and so the results obtained about the relation between the long travel and the VTED and the score at SIGN50. Two meta-analysis were carried out: only with travels by plane in which the relation was not significant (OR = 1.21; CI 95%, 0.95–1.55) and with all types of transport, with a slightly significant relation (OR = 1.46; CI95%, 1.24–1.72). We may deduce from this systematic review that there does exist a weak association between episodes of VTED and a long travel, but not by plane specifically. The heterogeneity and the methodological quality of the studies published preclude of more robust conclusions.
Cross-cultural adaptation of the Malay version of the parent-proxy Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL-25) in Malaysia

We aimed to cross-culturally adapt the parent-proxy Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL-25) into Malay and to determine its validity and reliability among parents of children with epilepsy in Malaysia.



The English version of the parent-proxy CHEQOL-25 was translated according to international guidelines to Malay. Content validity was verified by an expert panel and piloted in five parents of children with epilepsy (CWE). The Malay parent-proxy CHEQOL-25 was then administered to 40 parents of CWE, aged 8-18years from two tertiary hospitals, at baseline and 2weeks later. Parents were also required to complete the Malay PedsQL™ 4.0 so that convergent validity could be assessed. Hypothesis testing was assessed by correlating the individual subscales in the parent-proxy CHEQOL-25 with epilepsy severity, the number of anticonvulsants, and the number of close friends.



Participants from the pilot study did not encounter any problems in answering the final translated Malay parent-proxy CHEQOL-25. Hence, no further modifications were made. Cronbach's α for each subscale of the Malay parent-proxy CHEQOL-25 ranged from 0.67 to 0.83. The intraclass correlation coefficient for all items at test-retest ranged from 0.70 to 0.94. Both the CHEQOL-25 and the PedsQL™ 4.0 showed good correlation in the social and emotional subscales (r=0.598, p=0.002 and r=0.342, p=0.031, respectively). The severity of epilepsy, higher number of antiepileptic drug(s), poorer cognitive ability of the child, lower number of close friends, and lesser amount of time spent with friends were significantly associated with poorer health-related quality of life.



The Malay parent-proxy CHEQOL-25 was found to be a valid and reliable instrument to assess parents' perceived HRQOL of their CWE in Malaysia.
No effect of n-3 long-chain polyunsaturated fatty acid (EPA and DHA) supplementation on depressed mood and cognitive function: a randomised controlled trial.

Low dietary intakes of the n-3 long-chain PUFA (LCPUFA) EPA and DHA are thought to be associated with increased risk for a variety of adverse outcomes, including some psychiatric disorders. Evidence from observational and intervention studies for a role of n-3 LCPUFA in depression is mixed, with some support for a benefit of EPA and/or DHA in major depressive illness. The present study was a double-blind randomised controlled trial that evaluated the effects of EPA+DHA supplementation (1.5 g/d) on mood and cognitive function in mild to moderately depressed individuals. Of 218 participants who entered the trial, 190 completed the planned 12 weeks intervention. Compliance, confirmed by plasma fatty acid concentrations, was good, but there was no evidence of a difference between supplemented and placebo groups in the primary outcome - namely, the depression subscale of the Depression Anxiety and Stress Scales at 12 weeks. Mean depression score was 8.4 for the EPA+DHA group and 9.6 for the placebo group, with an adjusted difference of - 1.0 (95 % CI - 2.8, 0.8; P = 0.27). Other measures of mood, mental health and cognitive function, including Beck Depression Inventory score and attentional bias toward threat words, were similarly little affected by the intervention. In conclusion, substantially increasing EPA+DHA intake for 3 months was found not to have beneficial or harmful effects on mood in mild to moderate depression. Adding the present result to a meta-analysis of previous relevant randomised controlled trial results confirmed an overall negligible benefit of n-3 LCPUFA supplementation for depressed mood.
Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study.

Bilateral subthalamic nucleus (STN) stimulation is used to alleviate Parkinson's disease (PD) motor symptoms. Recently, it has been shown that this therapeutic also increased gut cholinergic contractions. We therefore investigated the effect of STN stimulation on esophageal motility in an interventional randomized study.



Sixteen humans PD patients (4 women, 12 men; age: 62.4 ± 9.3-years old) who underwent STN stimulation for at least 6 months were randomly evaluated with either stimulator turned OFF then ON, or inversely. Esophageal high resolution manometry was performed at the end of each ON and OFF period, with a 5 min resting period followed by ten swallows of 5 mL.



During the ON, an increase in the distal contractility index was found (OFF: 1750 ± 629 vs ON: 2171 ± 755 mmHg/cm/s; p = 0.03), with no difference in the distal front velocity. A decrease in the integrative relaxation pressure of the lower esophageal sphincter (LES) was noted (OFF: 11.1 ± 1.8 mmHg vs ON: 7.2 ± 1.8 mmHg; p < 0.05) in ON. The LES resting pressure remained unchanged during the two periods. This resulted in a decrease in the intrabolus pressure (p = 0.03). No difference was observed for the upper esophageal sphincter, nor the pharyngeal contraction amplitude and velocity.


In conclusion, STN stimulation in PD patients increased esophageal body contractions and enhanced the LES opening. This suggests that the nigrostriatal-striatonigral loop is involved in the control of esophageal motility.