nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy of amantadine on quality of life in patients with chronic hepatitis C treated with interferon-alpha and ribavirin: results from a randomized, placebo-controlled, double-blind trial.

The aim of this study was to investigate whether amantadine reduces deterioration of quality of life in patients with chronic hepatitis C during and after treatment with interferon-alpha (IFN-alpha) and ribavirin.



In this randomized, prospective, placebo-controlled, multicenter trial, previously untreated patients with chronic hepatitis C were treated with IFN-alpha plus ribavirin [17] and randomized for treatment with amantadine (200 mg/day, orally, n=136) or placebo (n=131). Quality of life was assessed with the 'Profile of Mood States' scale and the 'Everyday Life' questionnaire at baseline, treatment week (TW) 8, TW24, TW48, and at follow-up.



Early during treatment at TW8, quality of life was not different between patients in the control and the amantadine group. At TW24, the control group but not the amantadine group, however, showed significant deterioration of the modalities depression, fatigue, and vigor compared with baseline. Especially, nonresponders in the amantadine group showed significantly lower deterioration of depression, anger, mind function, everyday life, and zest for life than those in the placebo group. After treatment, the beneficial effects of amantadine disappeared.



The addition of amantadine to IFN-alpha plus ribavirin combination therapy may reduce deterioration of depression, fatigue, and vigor during treatment but does not affect quality of life after treatment.
Long-term cognitive and functional effects of potentially inappropriate medications in older women.

The use of potentially inappropriate medications in older adults can lead to known adverse drug events, but long-term effects are less clear. We therefore conducted a prospective cohort study of older women to determine whether PIM use is associated with risk of functional impairment or low cognitive performance.



We followed up 1,429 community-dwelling women (≥ 75 years) for a period of 5 years at four clinical sites in the United States. The primary predictor at baseline was PIM use based on 2003 Beers Criteria. We also assessed anticholinergic load using the Anticholinergic Cognitive Burden scale. Outcomes included scores on a battery of six cognitive tests at follow-up and having one or more incident impairments in instrumental activities of daily living. Regression models were adjusted for baseline age, race, education, smoking, physical activity, a modified Charlson Comorbidity Index, and cognitive score.



The mean ± SD age of women at baseline was 83.2 ± 3.3. In multivariate models, baseline PIM use and higher ACB scores were significantly associated with poorer performance in category fluency (PIM: p = .01; ACB: p = .02) and immediate (PIM: p = .04; ACB: p = .03) and delayed recall (PIM: p = .04). Both PIM use (odds ratio [OR]: 1.36 [1.05-1.75]) and higher ACB scores (OR: 1.11 [1.04-1.19]) were also strongly associated with incident functional impairment.



The results provide suggestive evidence that PIM use and increased anticholinergic load may be associated with risk of functional impairment and low cognitive performance. More cautious selection of medications in older adults may reduce these potential risks.
Melatonin improves the oocyte and the embryo in IVF patients with sleep disturbances, but does not improve the sleeping problems

We aimed to analyse the in vitro fertilization-embryo transfer (IVF-ET) outcomes of the patients with sleep disturbances who were administered melatonin. A total of 60 patients with sleep disturbances were divided into two groups. The study group (group A, n = 30) had underwent the IVF-ET with melatonin administration and the control group (group B, n = 30) without melatonin. Sleeping status after melatonin administration and the IVF outcomes were compared between the two groups. Sleeping status change was not significant (p > 0.05). The mean number of the retrieved oocytes, the mean MII oocyte counts, the G1 embryo ratio were significantly higher in the melatonin administered group (group A) than that the non-administered group (group B); p = 0.0001; p = 0.0001; p < 0.05 respectively. IVF patients with sleep disorders may benefit from melatonin administration in improving the oocyte and the embryo quality, but the sleeping problem itself may not be fixed.
Circulating Plasma MiR-141 Is a Novel Biomarker for Metastatic Colon
                    Cancer and Predicts Poor Prognosis

Colorectal cancer (CRC) remains one of the major cancer types and cancer related death worldwide. Sensitive, non-invasive biomarkers that can facilitate disease detection, staging and prediction of therapeutic outcome are highly desirable to improve survival rate and help to determine optimized treatment for CRC. The small non-coding RNAs, microRNAs (miRNAs), have recently been identified as critical regulators for various diseases including cancer and may represent a novel class of cancer biomarkers. The purpose of this study was to identify and validate circulating microRNAs in human plasma for use as such biomarkers in colon cancer.



By using quantitative reverse transcription-polymerase chain reaction, we found that circulating miR-141 was significantly associated with stage IV colon cancer in a cohort of 102 plasma samples. Receiver operating characteristic (ROC) analysis was used to evaluate the sensitivity and specificity of candidate plasma microRNA markers. We observed that combination of miR-141 and carcinoembryonic antigen (CEA), a widely used marker for CRC, further improved the accuracy of detection. These findings were validated in an independent cohort of 156 plasma samples collected at Tianjin, China. Furthermore, our analysis showed that high levels of plasma miR-141 predicted poor survival in both cohorts and that miR-141 was an independent prognostic factor for advanced colon cancer.



We propose that plasma miR-141 may represent a novel biomarker that complements CEA in detecting colon cancer with distant metastasis and that high levels of miR-141 in plasma were associated with poor prognosis.
Trichuris suis therapy in Crohn's disease.

Crohn's disease is common in highly industrialised Western countries where helminths are rare and uncommon in less developed areas of the world where most people carry worms. Helminths diminish immune responsiveness in naturally colonised humans and reduce inflammation in experimental colitis. Thus exposure to helminths may help prevent or even ameliorate Crohn's disease.



The aim of the study was to determine the safety and possible efficacy of the intestinal helminth Trichuris suis in the treatment of patients with active Crohn's disease.



Twenty nine patients with active Crohn's disease, defined by a Crohn's disease activity index (CDAI) > or =220 were enrolled in this open label study.



All patients ingested 2500 live T suis ova every three weeks for 24 weeks, and disease activity was monitored by CDAI. Remission was defined as a decrease in CDAI to less than 150 while a response was defined as a decrease in CDAI of greater than 100.



At week 24, 23 patients (79.3%) responded (decrease in CDAI >100 points or CDAI <150) and 21/29 (72.4%) remitted (CDAI <150). Mean CDAI of responders decreased 177.1 points below baseline. Analysis at week 12 yielded similar results. There were no adverse events.



This new therapy may offer a unique, safe, and efficacious alternative for Crohn's disease management. These findings also support the premise that natural exposure to helminths such as T suis affords protection from immunological diseases like Crohn's disease.
A randomized controlled trial of salmon calcitonin to prevent bone loss in corticosteroid-treated temporal arteritis and polymyalgia rheumatica

Patients treated with high-dose or long-term corticosteroids are at risk of accelerated osteoporosis and spontaneous vertebral and traumatic fractures. To assess the efficacy of salmon calcitonin in preventing corticosteroid-induced osteoporosis, 48 patients with newly diagnosed polymyalgia rheumatica, temporal arteritis, and other vasculitides were enrolled in a 2-year, double-blind, randomized, controlled trial. Patients were randomized to receive subcutaneous injections t.i.w. of either 100 IU of salmon calcitonin (25 patients) or placebo (23 patients). After 2 years, 19 and 21 patients, respectively, were evaluable. All patients also received supplemental calcium carbonate (1500 mg daily in divided doses) and vitamin D3 (400 IU daily). Baseline and serial radiologic assessments included dual-energy X-ray absorptiometry (DXA) of the lumbar spine and hip, and spine radiographs to detect vertebral fractures. There were no significant baseline differences between the two study groups. The mean within-subject percentage change in DXA lumbar spine density in the two groups over the 2-year period of the study was only −0.1% (calcitonin plus calcium) versus −0.2% (placebo plus calcium) a nonsignificant difference despite the high mean cumulative corticosteroid doses of 5371 mg and 4680 mg, respectively (NS). The incidence of vertebral fracture was 12.5% (calcitonin plus calcium: 11%, versus placebo plus calcium: 14%, NS), with four fractures in the first year and one fracture in the second year. Higher cumulative corticosteroid dose was associated with a greater loss in bone density. In rheumatic disease patients starting high-dose, long-term corticosteroids, salmon calcitonin with calcium and vitamin D3 provided no greater bone preservation than that observed with calcium and vitamin D3 alone.
The validation of the Turkish version of Asthma Control Test

Current guidelines focus more on levels of asthma control than on severity of asthma. The original version of the Asthma Control Test (ACT), a self-administered instrument to determine asthma control levels, was designed for English-speaking patients. More recently, the ACT has been translated into many languages and has been validated for many cultures, but this is the first study to evaluate the Turkish version. We aimed to evaluate the reliability, validity, and responsiveness of the Turkish version of the ACT among outpatients with asthma. This multicenter prospective study included 220 asthma patients in outpatient clinics in Turkey. The ACT was completed at admission (Visit 1), after 10 ± 2 days (Visit 2), and at 5 ± 1 weeks (Visit 3). At each visit, physicians assessed patients’ asthma control levels. The Turkish version of the ACT showed an internal consistency reliability of 0.84 (Cronbach’s alpha). Test–retest reliability was 0.85 in stable patients. There was a significant correlation between the ACT and physicians’ assessments at admission (r = 0.68, p < 0.001). The AUC was 0.91, with a sensitivity of 89.06 % and a specificity of 78.26 % for a score of ≤19 for screening “uncontrolled” asthma. A minimally important difference of three points on the ACT was consistent with the GINA physician assessment scores between the baseline and the follow-up visits. The Turkish version of the ACT is a valid and reliable tool for assessing asthma control in patients in outpatient settings. The test may facilitate the designation of asthma patients’ symptoms as either controlled or uncontrolled.
High field <ce:sup loc=pre>1</ce:sup>H MRS of the hippocampus after donepezil treatment in Alzheimer disease

The purpose of this study was to measure metabolite level changes in patients with newly diagnosed Alzheimer Disease (AD) following four months of donepezil treatment. A small number of cognitively normal elderly subjects were also scanned longitudinally (twice within one year) to assess the reproducibility. Short echo-time (1)H magnetic resonance spectra were acquired at 4.0 T in the right hippocampus. Subjects were scanned at the time of first diagnosis (prior to receiving donepezil) and then following four months of donepezil treatment (5 mg/day for the first month, 10 mg/day thereafter). Changes in absolute metabolite levels and metabolite ratios were quantified and compared. There was no change in measured cognitive function following four months of donepezil treatment in the AD patients. Decreased levels of N-acetylaspartate, choline, N-acetylaspartate/creatine, choline/creatine, and myo-inositol/creatine were observed in AD patients after four months of treatment. Cognitively normal elderly subjects showed an increase in myo-inositol/choline ratio following one year. The reduced levels of N-acetylaspartate in AD patients indicates continued decline in neuronal function and/or integrity. However decreased levels of choline and myo-inositol/creatine ratio may indicate a positive treatment effect.
International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol

Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators.



The International Study to Predict Optimized Treatment - in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65) from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls). Study-eligible patients are antidepressant medication (ADM) naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary). Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm.



First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide.
Kinematic, Dynamic, and Energy Characteristics of Diastolic Flow in the Left Ventricle

Blood flow characteristics in the normal left ventricle are studied by using the magnetic resonance imaging, the Navier-Stokes equations, and the work-energy equation. Vortices produced during the mitral valve opening and closing are modeled in a two-dimensional analysis and correlated with temporal variations of the Reynolds number and pressure drop. Low shear stress and net pressures on the mitral valve are obtained for flow acceleration and deceleration. Bernoulli energy flux delivered to blood from ventricular dilation is practically balanced by the energy influx and the rate change of kinetic energy in the ventricle. The rates of work done by shear and energy dissipation are small. The dynamic and energy characteristics of the 2D results are comparable to those of a 3D model.
Predictors and effects of alcohol use on liver function among young HCV-infected injection drug users in a behavioral intervention.

Hepatitis C virus (HCV) screening can provide opportunities to reduce disease progression through counseling against alcohol use, but empirical data on this issue are sparse. We determined the efficacy of a behavioral intervention in reducing alcohol use among young, HCV-infected injection drug users (IDUs) (n=355) and assessed whether changes in liver enzymes were associated with changes in alcohol consumption.



Both the intervention and attention-control groups were counseled to avoid alcohol use, but the intervention group received enhanced counseling. Logistic regression, ANOVA, and continuous time Markov models were used to identify factors associated with alcohol use, changes in mean ALT and AST levels, and change in alcohol use post-intervention.



Six months post-intervention, alcohol abstinence increased 22.7% in both groups, with no difference by intervention arm. Transition from alcohol use to abstinence was associated with a decrease in liver enzymes, with a marginally greater decrease in the intervention group (p=0.05 for ALT; p=0.06 for AST). In multivariate Markov models, those who used marijuana transitioned from alcohol abstinence to consumption more rapidly than non-users (RR=3.11); those who were homeless transitioned more slowly to alcohol abstinence (RR=0.47); and those who had ever received a clinical diagnosis of liver disease transitioned more rapidly to abstinence (RR=1.88).



Although, behavioral counseling to reduce alcohol consumption among HCV-infected IDUs had a modest effect, reductions in alcohol consumption were associated with marked improvements in liver function. Interventions to reduce alcohol use among HCV-infected IDUs may benefit from being integrated into clinical care and monitoring of HCV infection.
Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty

This is a randomised controlled trial to examine whether intra-articular injection of tranexamic acid (TXA) decreases blood loss, as well as reducing leg swelling after total knee arthroplasty (TKA). We performed 100 TKA in osteoarthritis patients. At closure, a total of 2,000 mg/20 ml TXA was injected into the knee joint through a closed suction drain (TXA group). For the control group, the same volume of physiological saline was injected. The pre-operative condition of the patients, post-operative haemoglobin (Hb) levels, discharge volumes from drain, D-dimer and needs for transfusion were compared between these two groups. Furthermore, leg diameters (thigh, suprapatellar portion and calf girth) were measured pre- and post-operatively to investigate whether TXA has an influence on leg swelling after surgery. The results revealed that post-operative decrease in Hb level was significantly reduced in the TXA group. Furthermore, knee joint swelling after operation was significantly suppressed in the TXA group compared to the control group. The results revealed intra-articular administration of TXA decreased not only blood loss, but also knee joint swelling after TKA.
A comparative analysis of primary stenting and optimal balloon coronary angioplasty in acute myocardial infarction. Six month results from the STENT PAMI trial.

To compare the outcome of balloon PTCA with final coronary stenosis diameter (SD) < or =30 %, with elective coronary stenting.



We performed a comparative analysis of the 6 month outcomes in patients treated with primary stenting and those who obtained an optimal balloon PTCA result treated during the first 12 hours of AMI onset included in the STENT PAMI randomized trial.



The results were analysed into 3 groups: primary stenting (441 patients, SD=22+/-6 %), optimal PTCA (245 patients), and non-optimal PTCA (182 patients, SD= 37+/-5 %). At the end of the 6 months primary stent group presented with the lowest restenosis(23 vs. 31 vs. 45 %, p=0.001, respectively). Ischemia-driven target vessel revascularization rate (TVR) (7 vs. 15.5 vs. 19 %, p=0.001, respectively).



At the 6 month follow-up, primary stenting offered the lowest restenosis and ischemia-driven TVR rates. Compared to optimal balloon PTCA. Non-optimal primary balloon PTCA pts (SD=31-50 %), had the worst late angiographic outcomes and should be treated more actively with coronary stent implantation.
Spot fluoroscopy: a novel innovative approach to reduce radiation dose in neurointerventional procedures

Increased interest in radiation dose reduction in neurointerventional procedures has led to the development of a method called "spot fluoroscopy" (SF), which enables the operator to collimate a rectangular or square region of interest anywhere within the general field of view. This has potential advantages over conventional collimation, which is limited to symmetric collimation centered over the field of view.  To evaluate the effect of SF on the radiation dose.  Thirty-five patients with intracranial aneurysms were treated with endovascular coiling. SF was used in 16 patients and conventional fluoroscopy in 19. The following parameters were analyzed: the total fluoroscopic time, the total air kerma, the total fluoroscopic dose-area product, and the fluoroscopic dose-area product rate. Statistical differences were determined using the Welch's t-test.  The use of SF led to a reduction of 50% of the total fluoroscopic dose-area product (CF = 106.21 Gycm2, SD = 99.06 Gycm2 versus SF = 51.80 Gycm2, SD = 21.03 Gycm2, p = 0.003884) and significant reduction of the total fluoroscopic dose-area product rate (CF = 1.42 Gycm2/min, SD = 0.57 Gycm2/s versus SF = 0.83 Gycm2/min, SD = 0.37 Gycm2/min, p = 0.00106). The use of SF did not lead to an increase in fluoroscopy time or an increase in total fluoroscopic cumulative air kerma, regardless of collimation.  The SF function is a new and promising tool for reduction of the radiation dose during neurointerventional procedures.
Characterization of autotransplant-related thrombocytopenia by evaluation of glycocalicin and reticulated platelets

Thrombocytopoiesis of 21 multiple myeloma patients undergoing single or double transplant regimen was characterized by measuring the level of reticulated platelets and plasma glycocalicin. Since reticulated platelets are an index of thrombopoietic activity and glycocalicin plasma values are related to platelet damage and turnover, it may be possible to perform a novel type of analysis of the thrombopoietic compartment during the mobilizing regimen and during transplant-related chemotherapy. Patients underwent mobilizing therapy and first transplant. Some randomized patients also underwent a second transplant with mobilized peripheral blood stem cells. The results show that the percentage of reticulated platelets decreased after therapy and then gradually increased in the recovery phase either during first or second transplant. By contrast, the percentage of reticulated platelets increased until day +8 and then gradually decreased during the mobilizing regimen. The glycocalicin index (glycocalicin plasma value normalized for the individual platelet count) increased significantly both during the course of mobilization and after transplant-related chemotherapy when the platelet number was at its nadir. However, the glycocalicin index was more elevated after transplant-related chemotherapy than after the mobilizing regimen. Our findings suggest that chemotherapy-related thrombocytopenia may be due to a dual mechanism: thrombocytopenia results from decreased platelet production in addition to increased platelet damage and possible destruction.