nils-herrmann/clean_scirepeval huggingface dataset:
Allo-SCT conditioning for myelodysplastic syndrome and acute myeloid leukemia with clofarabine, cytarabine and ATG

The application of myeloablative Allo-SCT is limited by its associated morbidity and mortality. Reduced-intensity conditioning regimens attempt to diminish these, but are associated with a higher risk of disease relapse. Given the evidence of activity of clofarabine and cytarabine in myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), we explored a novel reduced-intensity conditioning regimen based on this backbone. Patients received clofarabine 40 mg/m2 i.v. on days –6 to –2, cytarabine 1 g/m2 i.v. on days –6 to –2 and anti-thymocyte globulin (ATG) 1 mg/kg on day –4 and 2.5 mg/kg × 2 days on days –3 and –2. Seven patients were enrolled. Their median age was 54 years; three were with MDS and four with AML. The median duration of neutropenia was 14 days and that of thrombocytopenia was 22 days. Toxicities included hand–foot syndrome (57% grade 2), elevated alanine aminotransferase (ALT) (57% grade 3), elevated aspartate aminotransferase (AST) (86% grade 3) and hyperbilirubinemia (29% grade 3–5). No acute GVHD was observed. Enrollment to the trial was halted after three of the first seven patients expired on days +15, +26 and +32. Three of the four surviving patients have relapsed with a median TTP of 152 days. This regimen was not sufficiently immunosuppressive to ensure engraftment, and was associated with substantial morbidity and mortality.
Safety, efficacy and biological predictors of response to sequential azacitidine and lenalidomide for elderly patients with acute myeloid leukemia

Acute myeloid leukemia (AML) is a disease of the elderly. Poor outcomes with standard therapies necessitate novel approaches. Outpatient regimens sufficiently potent and well tolerated to induce remissions and enable continuation therapy may be beneficial. In this phase-1 study, we determined the maximum tolerated dose (MTD) and the efficacy for sequential azacitidine and lenalidomide as remission induction and continuation therapy in elderly, previously untreated patients. We investigated the impact on global DNA methylation and bone marrow cytokines, and sought biological predictors of response. Eighteen patients were enrolled. The MTD was not reached. Median follow-up was 8.2 months (10.3 months for survivors). Common adverse events included fatigue, injection site reactions, constipation, nausea, pruritus and febrile neutropenia. Ten patients responded (56%), and the rate of complete remissions (CRs) or CRs with incomplete recovery of blood counts for evaluable patients was 44% (7/16). The median response duration was 6.2 months. DNA demethylation and changes in bone marrow cytokines were observed; responders had a unique cytokine profile and a trend towards lower methylation levels. Sequential azacitidine and lenalidomide was well tolerated with encouraging clinical and biological activity in previously untreated elderly AML patients.
Ultrasonographic features in symptomatic osteoarthritis of the knee and relation with pain.

Radiographic knee OA is moderately associated with pain. As OA is a disease of the entire joint, ultrasonography visualizing cartilage and soft tissue structures might provide more insight into the complex process of pain in knee OA. The objective of this study was to investigate the cross-sectional association between US findings and pain in knee OA.



In this observational study, 180 patients fulfilling the ACR clinical criteria for knee OA underwent US examination of the most symptomatic knee. The US protocol comprised assessment of synovial hypertrophy, joint effusion, infrapatellar bursitis and Baker's cyst, medial meniscus protrusion and cartilage thickness. To evaluate the association between US features and pain (Numerated Rating Scale from 0 to 10 and the Knee Injury and Osteoarthritis Outcome Score pain subscale), regression analysis was performed.



In regression analysis, no association between US or clinical or demographic features and the level of knee pain was found.



In this cohort, no association between US features and the degree of knee pain was found. Despite the attractiveness of US (easy accessible, inexpensive and no radiation involvement) and the fact that previous research suggested otherwise, it remains uncertain which part of pain in knee OA is explained by pathology in soft tissue structures and whether US of the knee is the imaging tool of choice to visualize this pathology.
Effectiveness of peer assessment for implementing a Dutch physical therapy low back pain guideline: cluster randomized controlled trial.

Clinical practice guidelines are considered important instruments to improve quality of care. However, success is dependent on adherence, which may be improved using peer assessment, a strategy in which professionals assess performance of their peers in a simulated setting.



The aim of this study was to determine whether peer assessment is more effective than case-based discussions to improve knowledge and guideline-consistent clinical reasoning in the Dutch physical therapy guideline for low back pain (LBP).



A cluster randomized controlled trial was conducted.



Ten communities of practice (CoPs) of physical therapists were cluster randomized (N=90): 6 CoPs in the peer-assessment group (n=49) and 4 CoPs in the case-based discussion group (control group) (n=41).



Both groups participated in 4 educational sessions and used clinical patient cases. The peer-assessment group reflected on performed LBP management in different roles. The control group used structured discussions.



Outcomes were assessed at baseline and at 6 months. The primary outcome measure was knowledge and guideline-consistent reasoning, measured with 12 performance indicators using 4 vignettes with specific guideline-related patient profiles. For each participant, the total score was calculated by adding up the percentage scores (0-100) per vignette, divided by 4. The secondary outcome measure was reflective practice, as measured by the Self-Reflection and Insight Scale (20-100).



Vignettes were completed by 78 participants (87%). Multilevel analysis showed an increase in guideline-consistent clinical reasoning of 8.4% in the peer-assessment group, whereas the control group showed a decline of 0.1% (estimated group difference=8.7%, 95% confidence interval=3.9 to 13.4). No group differences were found on self-reflection.



The small sample size, a short-term follow-up, and the use of vignettes as a proxy for behavior were limitations of the study.



Peer assessment leads to an increase in knowledge and guideline-consistent clinical reasoning.
The Challenges of Staying Together While Moving Fast: An Exploratory Study

We report on the results of an empirical study conducted with 35 experienced software developers from 22 high-tech companies, including Google, Facebook, Microsoft, Intel, and others. The goal of the study was to elicit challenges that these developers face, potential solutions that they envision to these challenges, and research initiatives that they think would deliver useful results.
 Challenges identified by the majority of the study participants relate to the collaborative nature of the work: the availability and discoverability of information, communication, collaborative planning and integration with work of others. Almost all participants also addressed the advantages and disadvantages of the current "fast to the market" trend, and the toll it takes on the quality of the software that they are able to deliver and on their professional and personal satisfaction as software engineers.
 We describe in depth the identified challenges, supporting our findings with explicit quotes from the study participants. We also put these findings in context of work done by the software engineering community and outline a roadmap for possible future research initiatives.
[Regadenoson as a new stress agent in myocardial perfusion imaging. Initial experience in The Netherlands].

Regadenoson is a recently approved selective adenosine-2A receptor agonist to induce pharmacological stress in myocardial perfusion imaging (MPI) procedures using a single bolus injection.



We included 123 patients referred for MPI because of suspected coronary arterial disease (CAD). Of these, 66 patients underwent a regadenoson stress test and 57 patients underwent an adenosine stress test preceding standard myocardial SPECT imaging. Technicians, physicians and patients were asked to report their experience using questionnaires.



As compared to adenosine, regadenoson did not produce any atrio-ventricular block (0 vs. 10% with adenosine), but did produce minor tachycardia and minimal blood pressure changes while all other side effects were milder and shorter. There were fewer patients with severe complaints after taking regadenoson than adenosine (17% vs. 32%, respectively, p<0.01). The most frequent complaint reported was dyspnea, followed by flushing and chest pain. However, when they did occur, they usually disappeared rapidly. The overall symptom score, including severity and duration of side effects, was significantly lower after regadenoson than after adenosine (6.7±6.3 vs. 10.0±7.9, respectively; p<0.01.) SPECT imaging results were similar. The regadenoson procedure was faster and more practical.



Regadenoson, the new selective adenosine-2A receptor agonist, is a stress agent for MPI with a patient- and department friendly profile.
Usefulness of narrow-band imaging with dual-focus magnification for differential diagnosis of small colorectal polyps

Many authors have already reported the usefulness of narrow-band imaging (NBI) for the differential diagnosis of non-neoplastic and neoplastic colorectal lesions. However, it is not clear whether magnification is required for differential diagnosis. The aim of this prospective study was to clarify the clinical usefulness of a newly developed NBI system with a dual focus function (dual-focus NBI) compared with conventional white-light imaging (WLI) and NBI without magnification for distinguishing between non-neoplastic and neoplastic lesions. Thirty-seven consecutive patients who underwent screening colonoscopy with the novel system between July and December 2013 were analyzed. Patients with polyps >10 mm and those with polyps previously evaluated by histologic examination or colonoscopy were excluded. Lesions were diagnosed in real time with WLI, NBI without magnification, and dual-focus NBI, and then excised endoscopically. Each diagnosis was compared to that in the final histopathology reports. The primary endpoint was the diagnostic accuracy and the confidence level assigned to each modality by the endoscopists. The secondary endpoint was the differentiation ability according to the size of the lesion (≤5 and 6–10 mm). In all, 100 lesions including 76 adenomatous polyps and 24 hyperplastic polyps were analyzed in 37 patients. The overall diagnostic accuracy, sensitivity, and specificity for differentiating adenomatous from hyperplastic polyps were 87.0, 89.5, and 79.2 % for WLI, 93.0, 94.7, and 87.5 % for NBI without magnification, and 94.0, 96.1, and 87.5 % for dual-focus NBI, respectively. The level of confidence was significantly different between dual-focus NBI and WLI and NBI without magnification for diminutive (≤5 mm) lesions (p < 0.001 and p < 0.01). Dual-focus NBI is especially useful for differential diagnosis of diminutive colorectal lesions.
Six-month angiographic outcome after successful repeat percutaneous intervention for in-stent restenosis.

In-stent restenosis is an increasing clinical problem. Discordant results have been published regarding the risk of recurrent restenosis after repeat angioplasty for the treatment of in-stent restenosis.



One hundred three consecutive patients (107 vessels) underwent repeat percutaneous intervention for the treatment of in-stent restenosis and were entered in a prospective angiographic follow-up program. Repeat balloon angioplasty was performed at 93 lesions (87%) and additional stenting at 14 lesions (13%). The primary success rate was 98%. Six-month angiographic follow-up was performed in 85% of eligible patients. Restenosis was determined by quantitative angiography. Restenosis defined as a >50% diameter stenosis at follow-up was observed at 22% of lesions. The rate of target-lesion revascularization at 6 months was 17%. Repeat intervention for diffuse in-stent restenosis and severe stenosis before repeat intervention were associated with significantly higher rates of recurrent restenosis.



The overall restenosis rate after repeat intervention for in-stent restenosis is low. The subgroup of patients with diffuse and/or severe in-stent restenosis, however, is at higher risk of recurrent restenosis and may benefit from alternative therapeutic strategies.
Intervention with dietary fiber to treat constipation and reduce laxative use in residents of nursing homes.

Residents of nursing homes have lost their independence. Recent studies reported that nutritional problems arise in nursing homes. These problems are correlated with changed eating habits and geriatric constipation which is predominantly treated with laxatives. These interventions are not always without risk since frequent usage of laxatives may be accompanied by several side effects. Dietary fibers also affect stool weight and transit time. Therefore, oat-bran effectiveness in reducing the need for bowel medication was examined.



To develop diets with the addition of oat bran for reduction of laxatives and to improve the inhabitants' well-being in a long-term-care facility.



A controlled blind parallel intervention trial among 30 frail inhabitants of a geriatric ward aged 57-100 years with laxative use. An intervention and a control group were formed. 15 of them received oat bran for 12 weeks (fiber group) mixed up in the daily common diet of the ward and 15 served as control (control group). Laxative use, body weight and the observations concerning the eating habits of the elderly were documented.



A cake with the required dietary fibers and the complaisant acceptance of the seniors was developed. Laxatives were successfully discontinued by 59% (p < 0.001) in the fiber group. Body weight remained constant in the fiber group and decreased in the control group (p < 0.005).



Fiber supplementation in the form of a cake allows discontinuation of laxatives and increases the seniors' well-being in a nursing home.
A multi-site randomized study to compare the effects of Eye Movement Desensitization and Reprocessing (EMDR) added to TAU versus TAU to reduce craving and drinking behavior in alcohol dependent outpatients: study protocol

Addiction constitutes a major public health problem, and despite treatment, relapse rates remain very high. Preliminary findings suggest that Eye Movement Desensitization and Reprocessing (EMDR), an evidence-based treatment for PTSD, may also reduce craving and relapse rates when applied in substance abuse. This study aims to determine the feasibility, efficacy and effectiveness of EMDR when added to treatment as usual (TAU) for addiction in alcohol dependent outpatients, compared to TAU only.



A single blinded study in which 100 adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites, will be enrolled. After baseline assessment participants will be allocated to one of two treatment conditions (allocation ratio of 1:1) using a stratified (per site, per care pathway), blocked randomization procedure. The intervention consists of EMDR (seven weekly 90 minute sessions) + TAU or TAU only. Assessments are scheduled pre-treatment (t0), post-treatment (t0 + eight weeks), and one and six months post treatment. The effects of both treatment arms are compared on indices of (a) drinking behavior, (b) mediators, moderators and predictors of treatment outcome, (c) quality of life and d) safety, acceptability and feasibility of treatment. Repeated measures ANOVA's will be conducted using an intention-to-treat and per-protocol approach. Multiple imputation will be used to deal with missing values when possible.



This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma.
A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial

This article provides a description of the rationale, design, and methods of a multisite clinical trial which evaluates the potential benefits of an evidence-based psychosocial treatment, STAIR Narrative Therapy, among women with posttraumatic stress disorder (PTSD) related to interpersonal violence who are seeking services in public sector community mental health clinics. This is the first large multisite trial of an evidence-based treatment for PTSD provided in the context of community settings that are dedicated to the treatment of poverty-level patient populations.



The study is enrolling 352 participants in a minimum of 4 community clinics. Participants are randomized into either STAIR Narrative Therapy or Treatment As Usual (TAU). Primary outcomes are PTSD, emotion management and interpersonal problems. The study will allow a flexible application of the protocol determined by patient need and preferences. Secondary analyses will assess the relationship of outcomes to different patterns of treatment implementation for different levels of baseline symptom severity.



The article discusses the rationale and study issues related to the use of a flexible delivery of a protocol treatment and of the selection of treatment as it is actually practiced in the community as the comparator.
Biological standardization and maximum tolerated dose estimation of an Alternaria alternata allergenic extract.

The manufacture of allergenic extracts from the mold Alternaria alternata is influenced by factors such as strain variability, allergenic origin, culturing conditions and extraction process, which affect the reproducibility of the preparations intended for diagnostic and therapeutic use.



To select the most adequate antigenic source of A. alternata extracts and determine its maximum tolerated dose (MTD) to be used in a subsequent immunotherapy efficacy clinical trial.



Twenty-one patients monosensitized to A. alternata were involved in a biological standardization process of A. alternata extracts. Four different mold strains were cultured and used to produce extracts by three different methods, each incorporating proteins from different origins: culture filtrate, buffer extractable fraction and cellular antigens. The selected extract, characterized as in-house reference (IHR) preparation was used in a MTD finding immunotherapy study. Serum IgE, IgG, IgG1 and IgG4 specific of complete extract and purified natural and recombinant forms of Alt a 1 were determined by different EIA methods.



Culture filtrate extract containing the allergens secreted to the spent medium was shown to be the most adequate option for establishing an IHR preparation for A. alternata extract manufacturing. A maximum dose of 1670 UBE, equivalent to 0.1 microg Alt a 1, was determined as MTD for immunotherapy. One year of administration of such a dose at monthly intervals elicited pronounced immunological changes with statistically significant decreases in IgE and increases in IgG4, both estimated with whole extract or purified Alt a 1.



A high quality natural A. alternata extract has been developed and preliminarily tested to define its MTD for subsequent determination of the optimal dose in an immunotherapy efficacy clinical trial.
Does a Simple Intervention Enhance Memory and Adherence for Neuropsychological Recommendations?

The variables that influence the extent to which patients and their families remember and follow neuropsychological recommendations after their appointments are unclear. There has been limited research on this topic. The current study was designed to address this knowledge gap. Patients (n = 79) and caregivers (n = 36) were randomized into 1 of 2 groups, letter or no-letter, to investigate whether providing a supplemental written reminder of the recommendations given (in addition to routine feedback procedures in our clinic) would improve memory for and adherence to recommendations. We found that recall of recommendations was better in the letter condition, although this effect was observed in the caregivers and not in the patients. Adherence to recommendations did not differ significantly between the letter and no-letter conditions. These findings show that a simple intervention can improve caregiver memory for recommendations. Future research could help determine how to translate improvements in memory into greater adherence.
Impact of Communicating Familial Risk of Diabetes on Illness Perceptions and Self-Reported Behavioral Outcomes

To assess the potential effectiveness of communicating familial risk of diabetes on illness perceptions and self-reported behavioral outcomes.



Individuals with a family history of diabetes were randomized to receive risk information based on familial and general risk factors (n = 59) or general risk factors alone (n = 59). Outcomes were assessed using questionnaires at baseline, 1 week, and 3 months.



Compared with individuals receiving general risk information, those receiving familial risk information perceived heredity to be a more important cause of diabetes (P < 0.01) at 1-week follow-up, perceived greater control over preventing diabetes (P < 0.05), and reported having eaten more healthily (P = 0.01) after 3 months. Behavioral intentions did not differ between the groups.



Communicating familial risk increased personal control and, thus, did not result in fatalism. Although the intervention did not influence intentions to change behavior, there was some evidence to suggest it increases healthy behavior.
Protein biomarkers identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillators: findings from the Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSE-ICD).

Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality, but the benefits are heterogeneous. Current risk stratification based on left ventricular ejection fraction has limited discrimination power. We hypothesize that biomarkers for inflammation, neurohumoral activation, and cardiac injury can predict appropriate shocks and all-cause mortality in patients with primary prevention ICDs.



The Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSe-ICD) enrolled 1189 patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end point was an ICD shock for adjudicated ventricular tachyarrhythmia. The secondary end point was all-cause mortality. After a median follow-up of 4.0 years, 137 subjects experienced an appropriate ICD shock and 343 participants died (incidence rates of 3.2 and 5.8 per 100 person-years, respectively). In multivariable-adjusted models, higher interleukin-6 levels increased the risk of appropriate ICD shocks. In contrast, C-reactive protein, interleukin-6, tumor necrosis factor-α receptor II, pro-brain natriuretic peptide (pro-BNP), and cardiac troponin T showed significant linear trends for increased risk of all-cause mortality across quartiles. A score combining these 5 biomarkers identified patients who were much more likely to die than to receive an appropriate shock from the ICD.



An increase in serum biomarkers of inflammation, neurohumoral activation, and myocardial injury increased the risk for death but poorly predicted the likelihood of an ICD shock. These findings highlight the potential importance of serum-based biomarkers in identifying patients who are unlikely to benefit from primary prevention ICDs.