nils-herrmann/clean_scirepeval huggingface dataset:
The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow-up study.

The efficacy of male circumcision for HIV prevention over 2 years has been demonstrated in three randomized trials, but the longer-term effectiveness of male circumcision is unknown.



We conducted a randomized trial of male circumcision in 4996 HIV-negative men aged 15-49 in Rakai, Uganda. Following trial closure, we offered male circumcision to control participants and have maintained surveillance for up to 4.79 years. HIV incidence per 100 person-years was assessed in an as-treated analysis, and the effectiveness of male circumcision was estimated using Cox regression models, adjusted for sociodemographic and time-dependent sexual behaviors. For men uncircumcised at trial closure, sexual risk behaviors at the last trial and first posttrial visits were assessed by subsequent circumcision acceptance to detect behavioral risk compensation.



By 15 December 2010, 78.4% of uncircumcised trial participants accepted male circumcision following trial closure. During posttrial surveillance, overall HIV incidence was 0.50/100 person-years in circumcised men and 1.93/100 person-years in uncircumcised men {adjusted effectiveness 73% [95% confidence interval (CI) 55-84%]}. In control arm participants, posttrial HIV incidence was 0.54/100 person-years in circumcised and 1.71/100 person-years in uncircumcised men [adjusted effectiveness 67% (95% CI 38-83%)]. There were no significant differences in sociodemographic characteristics and sexual behaviors between controls accepting male circumcision and those remaining uncircumcised.



High effectiveness of male circumcision for HIV prevention was maintained for almost 5 years following trial closure. There was no self-selection or evidence of behavioral risk compensation associated with posttrial male circumcision acceptance.
The use of Continuous Subcutaneous Insulin Infusion (CSII): parental and professional perceptions of self-care mastery and autonomy in children and adolescents.

To describe parent-perceived mastery of Continuous Subcutaneous Insulin Infusion (CSII) specific skills and level of autonomy for these tasks among youth with type 1 diabetes.



One hundred and sixty-three parents of youth using CSII and 142 diabetes clinicians participated. Parents reported their child's mastery and autonomy of CSII-specific skills. Clinicians indicated the age at which 50% of their patients mastered these skills.



Parents report CSII skill mastery between 10.9 and 12.8 years. Very few achieved skill mastery on all CSII-related tasks. Parent- and clinician-expectations for age of skill acquisition were consistent with one another. Parents shared CSII task responsibility with their children even after their children have attained skill mastery.



The recent emphasis on maintaining parental involvement in diabetes care seems to have been translated into clinical practice. Parents remain involved in their child's CSII care even after they believe their child has mastered these skills.
Acute Kidney Injury in Patients Undergoing Open Abdominal Aortic Aneurysm Repair: A Pilot Observational Trial.

Acute kidney injury (AKI) is a frequent complication after open repair of abdominal aortic aneurysms (AAA). Little research has been done to determine whether intraoperative hemodynamic events may precipitate AKI. Novel biomarkers also may aid in the earlier diagnosis of AKI.



A pilot prospective observational trial.



A single tertiary academic medical center.



Participants were 40 adult patients undergoing open repair of infrarenal AAA.



Intraoperative hemodynamic monitoring of heart rate, mean arterial pressure, central venous pressure, and cardiac index was performed on a continuous basis. Blood samples were obtained at baseline and at 24 hours postoperatively for inflammatory biomarkers, including neutrophil gelatinase-associated lipocalin (NGAL).



AKI occurred in 20% of patients (8 of 40). Hypotension, including duration (defined as the length of time mean arterial pressure was<65 mmHg) and magnitude (the area under the curve of a mean arterial pressure<65 mmHg), was the only factor associated with postoperative AKI. Urinary NGAL at the conclusion of surgery had excellent ability to predict the development of AKI (area under the curve 0.84, 95% confidence interval = 0.70-0.97). The cytokines pentraxin 3 (PTX3), interleukin-1 receptor antagonist (IL1-RA), macrophage chemotactic protein (MCP), suppressor of tumorigenicity 2 (ST-2), and interleukin-10 (IL-10) also had good ability to predict the development of AKI in the immediate postoperative period.



AKI occurs frequently in patients undergoing open repair of AAA. Intraoperative hypotension was the only factor that predicted the development of subsequent AKI. Urinary NGAL and several novel inflammatory biomarkers demonstrated good ability to predict its development. Novel biomarkers also may aid in the early diagnosis of AKI.
A breast cancer nutrition adjuvant study (NAS): Protocol design and initial patient adherence

To evaluate the feasibility of using a reduction in dietary fat intake as a component of treatment regimens for patients with resected breast cancer, a multi-disciplinary cooperative group protocol was developed. Females 50 to 75 years of age with stage II breast cancer who completed primary local therapy were eligible for randomization to a Control Dietary Group in which dietary fat intake was to remain unchanged from baseline level (at approximately 38% of calories derived from fat) and an Intensive Intervention Dietary Group designed to reduce dietary fat intake. Both Dietary Groups were given tamoxifen 20 mg/day. To facilitate early experience with dietary regimen delivery, patients entered during an initial pilot phase could receive any chemotherapy and/or hormonal treatment. A prerandomization nutrition ‘run-in’ of clinically eligible patients assessed adherence to nutrition data collection procedures and screened patients for nutrition eligibility criteria. Of 59 patients beginning ‘run-in’, 49 were randomized and, at present, 32 have completed at least three months follow-up. The change in dietary fat intake (as assessed by Four Day Food Records) seen in both arms is outlined below.
Modified citrus pectin (MCP) increases the prostate-specific antigen doubling time in men with prostate cancer: a phase II pilot study

This trial investigated the tolerability and effect of modified citrus pectin (Pecta-Sol®) in 13 men with prostate cancer and biochemical prostate-specific antigen (PSA) failure after localized treatment, that is, radical prostatectomy, radiation, or cryosurgery. A total of 13 men were evaluated for tolerability and 10 for efficacy. Changes in the prostate-specific antigen doubling time (PSADT) of the 10 men were the primary end point in the study. We found that the PSADT increased (P-value<0.05) in seven (70%) of 10 men after taking MCP for 12 months compared to before taking MCP. This study suggests that MCP may lengthen the PSADT in men with recurrent prostate cancer.
Effect of bepridil in patients with chronic stable angina: results of a multicenter trial.

The effects of bepridil, a calcium antagonist with a half-life of approximately 42 hr, were assessed in a double-blind, randomized, placebo-controlled crossover trial. Forty-four patients (39 men, five women) with exercise-induced angina pectoris and ST segment depression with exercise testing (modified Bruce protocol) were studied. Compared with placebo bepridil (400 mg daily) increased total exercise time, time to onset of angina, time to 1 mm of ST segment depression, time to 2 mm of ST segment depression, and total work achieved (all p less than or equal to .001). Both frequency of angina and nitroglycerin consumption decreased during the bepridil compared with the placebo period (p = .02 and .03, respectively). Minor side effects were noted during both the bepridil and placebo phases. Four patients experienced side effects that limited therapy (dizziness in three and abnormal results of liver function tests in one) and one patient died during the bepridil phase. This study suggests that bepridil, 400 mg daily, is effective for the treatment of exercise-induced myocardial ischemia and angina pectoris.
Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE).



A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups.



Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p < .05). The median survival time for patients in Group A and Group B were 8.9 and 6.2 months, respectively (p > .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05).



In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.
Translation and discriminative validation of the STarT Back Screening Tool into Danish

The STarT Back Screening Tool (STarT) is a nine-item patient self-report questionnaire that classifies low back pain patients into low, medium or high risk of poor prognosis. When assessed by GPs, these subgroups can be used to triage patients into different evidence-based treatment pathways. The objective of this study was to translate the English version of STarT into Danish (STarT-dk) and test its discriminative validity. Translation was performed using methods recommended by best practice translation guidelines. Psychometric validation of the discriminative ability was performed using the Area Under the Curve statistic. The Area Under the Curve was calculated for seven of the nine items where reference standards were available and compared with the original English version. The linguistic translation required minor semantic and layout alterations. The response options were changed from “agree/disagree” to “yes/no” for four items. No patients reported item ambiguity using the final version. The Area Under the Curve ranged from 0.735 to 0.855 (CI95% 0.678–0.897) in a Danish cohort (n = 311) and 0.840 to 0.925 (CI95% 0.772–0.948) in the original English cohort (n = 500). On four items, the Area Under the Curve was statistically similar between the two cohorts but lower on three psychosocial sub-score items. The translation was linguistically accurate and the discriminative validity broadly similar, with some differences probably due to differences in severity between the cohorts and the Danish reference standard questionnaires not having been validated. Despite those differences, we believe the results show that the STarT-dk has sufficient patient acceptability and discriminative validity to be used in Denmark.
Hilft die Irisdiagnose bei der Erkennung des kolorektalen Karzinoms?

Die Irisdiagnose ist ein noninvasives Verfahren aus dem Bereich der Komplementärmedizin, durch das Erkrankungen anhand von Veränderungen der Pigmentation und Struktur der Iris erkannt werden sollen. Das kolorektale Karzinom ist wegen seiner langsamen Entwicklungstendenz ein ideales Einsatzgebiet für Vorsorgeuntersuchungen. In der folgenden Studie wurde die Eignung der Iridologie als alternative Screeningmethode untersucht. Es wurden Irisphotographien von jeweils 29 Patienten mit und ohne Kolonkarzinom angefertigt. Jedem Tumorpatienten wurde ein Patient der Kontrollgruppe mit entsprechendem Alter, Geschlecht sowie Vorerkrankungsprofil zugeordnet. Diese Photos wurden anerkannten Iridologen in zufälliger Reihenfolge zur Auswertung vorgelegt. Bei 51,7% bzw. 53,4% der Patienten konnten die Irisphotos korrekt zugeordnet werden. Die Sensitivität lag bei 58,6% bzw. 55,2%, die Spezifität bei 44,8% bzw. 51,7%. Die Irisdiagnose ist für die Erkennung des kolorektalen Karzinoms unbrauchbar. Darüber hinaus ist sie nach derzeitiger Datenlage zur Stellung klinischer Diagnosen generell ungeeignet. Iridology is a noninvasive method from the field of complementary medicine that is said to detect diseases by looking for abnormalities of pigmentation and structure in the iris. Colorectal cancer is an ideal opportunity for screening programs because of its long period of development. Our study investigated the applicability of iridology as an alternative screening method for colorectal cancer. Digital color slides were obtained from both eyes of 29 patients with histologically diagnosed colorectal cancer and from 29 age- and gender-matched healthy control subjects. The slides were presented in random order to acknowledged iridologists without knowledge of the number of patients in the two categories. The iridologists correctly detected 51.7% and 53.4%, respectively, of the patients’ slides; therefore, the likelihood was statistically no better than chance. Sensitivity was, respectively, 58.6% and 55.2%, and specificity was 44.8% and 51.7%. Iridology had no validity as a diagnostic tool for detecting colorectal cancer in this study.
Clinical implications of internal carotid artery flow impairment caused by filter occlusion during carotid artery stenting.

Membrane filters are EPDs, which preserve ICA flow during CAS. However, ICA flow arrest may occur with filter use. This report describes the angiographic, clinical, and histopathologic features of the filter occlusion.



Sixty-one consecutive patients with cervical carotid stenosis treated by CAS by using a single type of filter device were evaluated. All patients were on dual antiplatelet treatment and fully heparinized. Prestent dilation was performed in all patients. Poststent dilation was performed in 15 patients. Control angiograms were obtained and evaluated after each step of the CAS procedure. All filters were inspected for debris, and if present, histology was obtained.



CAS was successfully performed in all cases with <20% residual stenosis. Filter occlusion occurred in 6 patients (9.8%). It developed immediately after stent deployment in 4, and after a second prestent dilation in 2. Five of the 6 had severe carotid stenosis. In all patients, filter withdrawal led to immediate and complete restoration of ICA flow. In 1 patient, acute embolic M1 occlusion occurred immediately after filter withdrawal but was successfully treated with thrombolysis. None of filter-occlusion group had permanent neurologic deficits. Gross and microscopic examinations demonstrated that the pores of the filters were occluded mainly by fibrin. Postoperative diffusion MR imaging revealed no difference between filter-occlusion and non-filter-occlusion groups.



ICA flow arrest due to filter occlusion during CAS is relatively common and occurs more frequently in severe stenosis. It resolves rapidly after filter removal and does not appear to worsen outcome.
The cardiovascular effects of upper-limb aerobic exercise in hypertensive patients.

Aerobic exercise is broadly recommended as a helpful adjunct to obtain blood pressure control in hypertension. Several hypertensive patients, however, are limited by musculoskeletal complaints or vascular occlusive disease from lower-limb exercise such as jogging or cycling. In the present randomized-controlled study, we evaluate whether an aerobic arm-cycling program provides a measurable cardiovascular benefit.



Twenty-four probands were randomly assigned to sedentary activity or a heart rate controlled 12 week exercise program, consisting of arm-cycling at target lactate concentrations of 2.0 +/- 0.5 mmol/l. Endothelial function was assessed by flow-mediated dilation of the brachial artery. Augmentation index and large/small artery compliance (C(1) and C(2)) were measured by computerized pulse-wave analysis of the radial artery.



The exercise program led to a significant reduction in systolic (134.0 +/- 20.0 to 127.0 +/- 16.4 mmHg; P = 0.03) and diastolic blood pressure (73.0 +/- 21.6 to 67.1 +/- 8.2 mmHg; P = 0.02) accompanied by a significant improvement in C(2) (3.5 +/- 1.6 to 4.8 +/- 2.0 ml/mmHg x 100; P = 0.004). Flow-mediated dilation, augmentation index, and C(2) were not significantly affected (P > 0.05). Physical performance as derived from lactate and heart rate curves of lower-limb stress tests was unchanged, whereas maximal workload in an upper-limb ergometry significantly increased (P = 0.005). Blood pressure and vascular parameters remained unchanged in the control group.



Regular arm aerobic exercise leads to a marked reduction in systolic and diastolic blood pressures and an improvement in small artery compliance. Arm-cycling is a reasonable option for hypertensive patients who want to support blood pressure control by sports despite having coxarthrosis, gonarthrosis, or intermittent claudication.
The impact of an empowering Internet-based Breast Cancer Patient Pathway programme on breast cancer patients' knowledge: a randomised control trial.

The aim of this study was to analyse the effect of Breast Cancer Patient Pathway program.



In one Finnish university hospital during 2008-10 newly diagnosed breast cancer patients were randomised to the intervention (n = 50) and the control groups (n = 48). The breast cancer patient's knowledge expectations and perception of received knowledge, knowledge, the source of information and satisfaction in received patient education were measured. Baseline and one year follow up data collection was conducted.



No differences were found in knowledge expectations between the groups at baseline. Patients in the control group evaluated their perception of received knowledge to be higher and they were more satisfied with the patient education they received from the hospital staff. However, the Intervention group's knowledge level was higher. The most important source of information was the healthcare professionals in both groups.



The results of study indicate that when patient education increases, patients' knowledge expectations increase as well, while their perceptions of received knowledge decrease. Future research is needed to examine the relationship between patients' knowledge expectations and perception of received knowledge as patients' knowledge level increases.



Patient education has to be individually adjusted, taking patients' expectations into account.
Development of a MALDI MS‐based platform for early detection of acute kidney injury

Septic acute kidney injury (AKI) is associated with poor outcome. This can partly be attributed to delayed diagnosis and incomplete understanding of the underlying pathophysiology. Our aim was to develop an early predictive test for AKI based on the analysis of urinary peptide biomarkers by MALDI-MS.



Urine samples from 95 patients with sepsis were analyzed by MALDI-MS. Marker search and multimarker model establishment were performed using the peptide profiles from 17 patients with existing or within the next 5 days developing AKI and 17 with no change in renal function. Replicates of urine sample pools from the AKI and non-AKI patient groups and normal controls were also included to select the analytically most robust AKI markers.



Thirty-nine urinary peptides were selected by cross-validated variable selection to generate a support vector machine multidimensional AKI classifier. Prognostic performance of the AKI classifier on an independent validation set including the remaining 61 patients of the study population (17 controls and 44 cases) was good with an area under the receiver operating characteristics curve of 0.82 and a sensitivity and specificity of 86% and 76%, respectively.



A urinary peptide marker model detects onset of AKI with acceptable accuracy in septic patients. Such a platform can eventually be transferred to the clinic as fast MALDI-MS test format.
A single-tube quantitative assay for mRNA levels of hormonal and growth factor receptors in breast cancer specimens.

Knowledge of estrogen receptor (ER) and progesterone receptor (PR) status has been critical in the evolution of modern targeted therapy of breast cancer and remains essential for making informed therapeutic decisions. Recently, growth factor receptor HER2/neu (ERBB2) status has made it possible to provide another form of targeted therapy linked to the overexpression of this protein. Presently, pathologists determine the receptor status in formalin-fixed, paraffin-embedded sections using subjective, semiquantitative immunohistochemistry (IHC) assays and quantitative fluorescence in situ hybridization for HER2. We developed a single-tube multiplex TaqMan (mERPR+HER2) assay to quantitate mRNA levels of ER, PR, HER2, and two housekeeping genes for breast cancer formalin-fixed, paraffin-embedded sections. Using data from the discovery sample sets, we evaluated IHC-status-dependent cutoff-point and IHC-status-independent clustering methods for the classification of receptor status and then validated these results with independent sample sets. Compared with IHC-status, the accuracies of the mERPR+HER2 assay with the cutoff-point classification method were 0.98 (95% CI: 0.97-1.00), 0.92 (95% CI: 0.88-0.95), and 0.97 (95% CI: 0.95-0.99) for ER, PR, and HER2, respectively, for the validation sets. Furthermore, the areas under the receiver operating-characteristic curves were 0.997 (95% CI: 0.994-1.000), 0.967 (95% CI: 0.949-0.985), and 0.968 (95% CI: 0.915-1.000) for ER, PR, and HER2, respectively. This multiplex assay provides a sensitive and reliable method to quantitate hormonal and growth factor receptors.