nils-herrmann/clean_scirepeval huggingface dataset:
Is prophylactic breast radiotherapy necessary in all patients with prostate cancer and gynecomastia and/or breast pain?

We investigated the efficacy of prophylactic radiotherapy for gynecomastia/breast pain induced by 150 mg bicalutamide in a prospective, randomized, multi-institutional trial.



After definitive treatment for localized prostate cancer 125 patients were randomized to 12 Gy radiotherapy before bicalutamide as prophylactic radiotherapy (53) or bicalutamide only for nonprophylactic radiotherapy (72). The incidence of gynecomastia, breast pain and tenderness, and discomfort perceived by the patients was assessed by physical examination and direct questioning at 3, 6 and 12 months of followup.



At the end of 12 months the gynecomastia rate was 15.8% in the prophylactic group and 50.8% in the nonprophylactic group (p <0.001). On patient evaluation the breast enlargement rate was 34.4%. The severity of breast pain and tenderness was not different between the groups. The breast pain rate was 36.4% and 49.2% by 12 months in the prophylactic and nonprophylactic groups, and the rate of patients who felt discomfort from gynecomastia was 11.4% and 29.5%, respectively.



In this prospective study the incidence of gynecomastia was not as high as previously believed. Although prophylactic breast irradiation seemed to decrease the gynecomastia rate in patients on 150 mg bicalutamide, our study proves that not all patients need prophylaxis since only 52% were significantly bothered by gynecomastia. Thus, individual assessment is needed to select patients who need prophylactic radiation while on 150 mg bicalutamide.
Outcome is not improved by the use of alternating chemotherapy in elderly patients with aggressive lymphoma.

A prospective randomised study involving 810 elderly patients was conducted in an attempt to compare alternating chemotherapy with conventional first-line chemotherapy in aggressive non-Hodgkin's lymphoma in order to improve prognosis with an acceptable toxicity for elderly patients.



Patients included were 55-69 years old and had at least one adverse prognostic factor. Patients were treated either with ACVBP followed by consolidation (n = 396) or with an alternating regimen (n = 414). This regimen was an association of active drugs in NHL relapsing patients, alternating VIMMM with ACVBP for induction and alternation of VIM and ACVM in consolidation. Eight hundred and sixty-six patients were randomised. After histological review, 810 patients met the inclusion criteria: 396 in arm A, 414 in arm B.



The complete response rate after induction was superior for conventional first-line therapy (58.5% vs 48%, P = 0.003) but at the end of treatment, the CR rate was not statistically different (52% vs 48%, P = 0.19). Conventional chemotherapy had a better five-year event-free survival than alternating regimen (33% (95% CI: 30-36%) vs 28% (95% CI: 26-30%), P = 0.0289) but overall survival was not statistically different (40% (CI 95% 38-42%) vs 36% (CI 95% 34-38%), P = 0.068). In this elderly high risk population, the toxicity was very high: 19% in arm A and 26% in arm B died during treatment.



Alternating regimen did not improve outcome, was less efficient and more toxic.
Effect of preoperative abstinence on poor postoperative outcome in alcohol misusers: randomised controlled trial.

To evaluate the influence of preoperative abstinence on postoperative outcome in alcohol misusers with no symptoms who were drinking the equivalent of at least 60 g ethanol/day.



Randomised controlled trial.



Copenhagen, Denmark.



42 alcoholic patients without liver disease admitted for elective colorectal surgery.



Withdrawal from alcohol consumption for 1 month before operation (disulfiram controlled) compared with continuous drinking.



Postoperative complications requiring treatment within the first month after surgery. Perioperative immunosuppression measured by delayed type hypersensitivity; myocardial ischaemia and arrhythmias measured by Holter tape recording; episodes of hypoxaemia measured by pulse oximetry. Response to stress during the operation were assessed by heart rate, blood pressure, serum concentration of cortisol, and plasma concentrations of glucose, interleukin 6, and catecholamines.



The intervention group developed significantly fewer postoperative complications than the continuous drinkers (31% v 74%, P=0.02). Delayed type hypersensitivity responses were better in the intervention group before (37 mm2 v 12 mm2, P=0.04), but not after surgery (3 mm2 v 3 mm2). Development of postoperative myocardial ischaemia (23% v 85%) and arrhythmias (33% v 86%) on the second postoperative day as well as nightly hypoxaemic episodes (4 v 18 on the second postoperative night) occurred significantly less often in the intervention group. Surgical stress responses were lower in the intervention group (P</=0.05).



One month of preoperative abstinence reduces postoperative morbidity in alcohol abusers. The mechanism is probably reduced preclinical organ dysfunction and reduction of the exaggerated response to surgical stress.
Effects of mud therapy on perceived pain and quality of life related to health in patients with knee osteoarthritis.

To analyze the effects of mud therapy on perceived pain, Health Related Quality of Life (HRQL) and drug use in patients diagnosed with knee osteoarthritis.



A prospective, controlled clinical trial. The sample (n=147) was divided into an experimental group (EG) of 61 subjects (69.13 ± 5,60 years) who received 11 consecutive sessions of peloids in the knee/s affected by the process described and a control group (CG) of 60 subjects (73.08 ± 8,90 years) who continued routine drug treatment. The sample was assessed before and after intervention using the SF-36, Visual Analogue Scale and changes in drug use, setting a significance level of P ≤ .05.



After the intervention, there were statistically significant differences (P<.05) in all parameters analyzed between EG and CG, reduced drug use in the EG versus no change in the CG. The general health, bodily pain and perceived pain are those that show major changes between the two groups.



Mud therapy in patients diagnosed with knee osteoarthritis attains immediate effects on perceived pain and HRQOL, reducing the consumption of specific drugs. Studies are needed to evaluate the scientific evidence from the effects of such intervention.
Predictors of discordant tuberculin skin test and QuantiFERON®-TB Gold In-Tube results in various high-risk groups.

Persons in whom targeted testing for latent tuberculosis infection (LTBI) is recommended in Seattle, Washington; Atlanta, Georgia; and central North Carolina, United States.



To compare the performance of an interferon-gamma release assay (QuantiFERON®-TB Gold In-Tube [QFT-GIT]) with the tuberculin skin test (TST) among foreign-born, homeless, human immunodeficiency virus (HIV) infected and substance abuse persons tested for LTBI.



A cross-sectional study requiring participants to have a blood test, a TST and data collected.



Of 1653 persons, 19.5% were TST-positive and 14.0% were QFT-GIT-positive. Overall concordance was moderate (kappa 0.53; 95%CI 0.47-0.58). Compared to concordant positive results, TST+/QFT-GIT- discordance was associated with HIV infection and sex, while TST-/QFT-GIT+ discordance was associated with HIV and inversely associated with foreign birth. Compared to concordant negative results, TST-/QFT-GIT+ discordance was associated with foreign birth and age ≥50 years, while TST+/QFT-GIT-discordance was associated with foreign birth, age 30-49 years, being Black and inversely associated with HIV. HIV infection was significantly associated with indeterminate QFT-GIT results.



QFT-GIT may be an improvement over the TST for diagnosing LTBI in foreign-born and older persons, and may be as useful as the TST in HIV-infected persons. The sensitivity of both tests may be low in HIV-infected persons.
In vivo validation of CAAS QCA-3D coronary reconstruction using fusion of angiography and intravascular ultrasound (ANGUS).

The CAAS QCA-3D system (Pie Medical Imaging BV, the Netherlands) was validated against 3D reconstructions based on fusion of angiography and intravascular ultrasound (ANGUS), allowing slice by slice validation of the lumen areas and 3D geometric values.



Accurate online 3D reconstruction of human coronary arteries is of outmost importance during clinical practice in the catheterization laboratory. The CAAS QCA-3D system provides technology to 3D reconstruct human coronary arteries based on two or more angiographic images, but was not validated in realistic arteries before.



Ten patients were imaged using biplane angiography and an ECG gated (TomTec) intravascular ultrasound (IVUS) pullback (stepsize 0.5 mm, Boston Scientific). The coronary arteries were 3D reconstructed based on (a) fusion of biplane angiography and IVUS (ANGUS) and (b) CAAS QCA-3D using the biplane angiography images. For both systems the length, the curvature and the lumen areas at 0.5 mm spacing were calculated and compared.



Bland-Altman analysis indicated that the CAAS QCA-3D system underestimated the lumen areas systematically by 0.45 +/- 1.49 mm2. The segment length was slightly underestimated by the CAAS QCA-3D system (62.1 +/- 11.3 vs. 63.2 +/- 11.4 mm; P < 0.05), while the curvature of the analyzed segments were not statistically different.



The CAAS QCA-3D system allows 3D reconstruction of human coronary arteries based on biplane angiography. Validation against the ANGUS system showed that both the 3D geometry and lumen areas are highly correlated which makes the CAAS QCA-3D system a promising tool for applications in the catheterization laboratory and opens possibilities for computational fluid dynamics.
Lung microcytoma: a multidisciplinary therapeutic approach.

This report is of 26 patients diagnosed with microcytoma of the lung in stages I, II, and IIIa. All patients received surgical treatment as well as postoperative chemoradiotherapy when indicated by stage. Mean survival rates were 16 months for stage 1, 10 months for stage II and 6 months for stage IIIa disease. For many years surgery was considered contraindicated in the treatment of pulmonary microcytoma. Now a multidisciplinary approach is being used in which surgery has a crucial role. Microcytoma of the lung has a poor prognosis due to its early metastasis and rapid growth. It is crucial to have early diagnosis and accurate, consistent staging as the basis for treatment. A review of literature shows that the use of surgery, chemotherapy and radiotherapy are all important in treatment of microcytoma. Chemotherapy is successfully utilized preoperatively to improve local control, decrease neoplastic mass, induce histological regression and as postoperative adjuvant therapy. Radiotherapy has been shown to be effective preoperatively to reduce local mass and prophylactically for cerebral metastasis. Surgery is crucial to irradicate the neoplastic mass, improve staging accuracy, decrease the possible selection of neoplastic clones resistant to postoperative therapy, decrease local recurrence and allow less aggressive chemoradiotherapy. We feel the most effective protocol for pulmonary microcytoma includes preoperative chemotherapy and radiotherapy when indicated followed by surgical intervention and finally successive adjuvant therapy. The limited number of our cases does not consent a statistically significative conclusion. Our data confirm the importance of the surgical procedure in stages I and II, where according also to other authors, the best results are obtained. Surgical indication in stage IIIa is still discussed due to precocius lymphnode dissemination that significantly affects long-term survival.
Three-year follow-up of lanthanum carbonate therapy in hemodialysis patients.

For 3 years following the start of lanthanum carbonate therapy, effects on other pharmaceutical treatment with sevelamer hydrochloride (SH), calcium carbonate (CC), and vitamin D, and those on clinical condition were examined. Dialysis patients with hyperphosphatemia (89 cases; average age 55.2 years; dialysis history of 10 years; 50 male and 39 female), who agreed to start lanthanum carbonate (LC) administration, were observed for a mean period of 32.6 ± 6.2 months. Mean daily dosages of CC and SH before starting LC were 2.68 g and 0.73 g; mean daily dosage amounts of LC, CC, and SH at the time of final evaluation were 0.87 g, 2.30 g, and 0.99 g, respectively. After the application of LC, serum phosphate as well as serum calcium controls were significantly improved, and the amounts of active vitamin D agents applied was significantly increased. In conclusion, LC is useful in managing serum phosphorus levels (P levels), and little incidence of hypercalcemia suggests favorable concomitant use with active vitamin D agents in LC therapy.
The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity.

This study investigated the effect of a low-fat, plant-based diet on body weight, metabolism, and insulin sensitivity, while controlling for exercise in free-living individuals.



In an outpatient setting, 64 overweight, postmenopausal women were randomly assigned to a low-fat, vegan diet or a control diet based on National Cholesterol Education Program guidelines, without energy intake limits, and were asked to maintain exercise unchanged. Dietary intake, body weight and composition, resting metabolic rate, thermic effect of food, and insulin sensitivity were measured at baseline and 14 weeks.



Mean +/- standard deviation intervention-group body weight decreased 5.8 +/- 3.2 kg, compared with 3.8 +/- 2.8 kg in the control group (P = .012). In a regression model of predictors of weight change, including diet group and changes in energy intake, thermic effect of food, resting metabolic rate, and reported energy expenditure, significant effects were found for diet group (P < .05), thermic effect of food (P < .05), and resting metabolic rate (P < .001). An index of insulin sensitivity increased from 4.6 +/- 2.9 to 5.7 +/- 3.9 (P = .017) in the intervention group, but the difference between groups was not significant (P = .17).



Adoption of a low-fat, vegan diet was associated with significant weight loss in overweight postmenopausal women, despite the absence of prescribed limits on portion size or energy intake.
Changes in serum sex hormone profiles after short-term low-dose administration of dehydroepiandrosterone (DHEA) to young and elderly persons.

In man, serum concentrations of dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) decrease with age after the twenties. For this reason, the decline in DHEA and DHEAS concentrations may be related to the development of some chronic diseases that are prevalent in the older age population. In this study, we evaluate the benefit and safety level of DHEA administration to men as a hormone replacement therapy. Twenty-two healthy Japanese males (age 26-63; mean +/- SD, 41.0 +/- 10.0 yrs.) received 25 mg DHEA once a day orally in the morning for two weeks. Serum concentrations of steroid hormones and cytokines were measured before and after the DHEA administration. Glucose tolerance and insulin resistance were also assessed before and after the DHEA administration using a 75 g oral glucose tolerance test and homeostasis model assessment (HOMA-R), respectively. Serum DHEA and DHEAS levels were significantly elevated after the DHEA administration for all ages of test subjects. In subjects who were older than 41 yrs. (older group) serum androstenedione and estradiol levels were elevated after the DHEA administration. Significant negative correlations were observed between the serum DHEA concentration and the serum concentration of fasting insulin, HOMA-R, leptin, and high-sensitivity C-reactive protein for all subjects. Daily administration of 25 mg DHEA increased the serum DHEA, DHEAS, androstenedione, and estradiol levels of the subjects of the older group to the same level as that of younger subjects.
Reconstruction Patterns in a Single Institution Cohort of Women Undergoing Mastectomy for Breast Cancer

The purpose of the current study was to conduct a patient-centered investigation of reconstruction practices following mastectomy at our institution. A questionnaire was administered to patients who underwent unilateral or bilateral mastectomy for breast cancer from 2006 to 2010. The survey queried on demographics, surgical choices, and rationale for those choices. Data were summarized by contingency tables and compared by chi-square test or Fisher’s exact test, as appropriate. Of 321 patients queried, 185 (58 %) underwent unilateral mastectomy and 136 (42 %) underwent bilateral mastectomy (mean age 56 ± 12 years). Overall, 189 (59 %) women underwent breast reconstruction, and 132 (41 %) did not. Immediate breast reconstruction was performed in 125 of 189 (69 %) women, whereas 67 of 189 (31 %) underwent delayed reconstruction. The method of definitive reconstruction included 143 of 189 (75 %) prostheses, 32 of 189 (17 %) abdominal tissue flap, 12 of 189 (6 %) latissimus flap (±implant), and 5 of 189 (2 %) with a combination of prostheses and tissue flaps. Of the 114 patients who did not undergo reconstruction, 68 (60 %) reported lack of desire for reconstruction as their motive, and the remaining 46 (40 %) reported medical contraindications for reconstruction or did not report a specific reason. A significant percentage of women undergoing unilateral or bilateral mastectomy for breast cancer at our institution elect to undergo reconstruction. Prosthetic reconstruction was the most common method utilized. The impetus for referral to the reconstructive surgeon was nearly always initiated by the surgical oncologist.
Effect of 23-Valent Pneumococcal Polysaccharide Vaccine Inoculated During Anti-Cancer Treatment Period in Elderly Lung Cancer Patients on Community-Acquired Pneumonia Hospitalization

To evaluate effectiveness of 23-valent pneumococcal polysaccharide vaccine (PPSV23) inoculated during defined "vaccination period," first 6 months post cancer diagnosis (ie, an anti-cancer treatment period), in elderly lung cancer patients on community-acquired pneumonia (CAP) hospitalization incidence.This was a nationwide population-based cohort study of 157 newly diagnosed elderly lung cancer patients receiving PPSV23 during "vaccination period", and 628 age and sex one-to-one matched controls enrolled in the National Health Insurance Research Database (NHIRD) of Taiwan between 2007 and 2010. All patients were ≥75 years old and still survival post "vaccination period." Incidence density (ID) of all-cause inpatient CAP and cumulative survival risk were analyzed by multivariate Poisson regression and Kaplan-Meier method, respectively.After a 4-year follow-up, IDs of all-cause inpatient CAP for vaccination and control cohorts were 297 and 444 per 1000 PYs, respectively. Less vaccinated patients had CAP incidence density >1 time per PY (12.7% vs 21.2%) than non-vaccinated patients. After adjusting for potential confounding variables, like influenza vaccination, comorbidities, cancer treatment modalities, and socioeconomic status, adjusted inpatient CAP incidence rate in PPSV23 vaccination cohort was 0.74 times lower than control cohort (incidence rate ratio [IRR] = 0.740, P = 0.0339). Two-year cumulative CAP hospitalization rates and overall survival rates were 37.1% vs. 55.4%, and 46.6% vs. 26.2%, respectively, for lung cancer patients with and without PPSV23 (both P < 0.001). Subgroup analysis showed that for elderly lung cancer patients not ever receiving influenza vaccine, PPSV23 still had trend to reduce all-cause inpatient CAP.For elderly lung cancer patients aged ≥75 years, PPSV23 inoculated during anti-cancer treatment period could reduce CAP hospitalizations and improve survival.
Phase 1b dose-finding study of motesanib with docetaxel or paclitaxel in patients with metastatic breast cancer

The purpose of this study was to investigate the safety, tolerability, and pharmacokinetics of motesanib when combined with docetaxel or paclitaxel in patients with metastatic breast cancer. In this open-label, dose-finding, phase 1b study, patients received motesanib 50 or 125-mg orally once daily (QD), beginning day 3 of cycle 1 of chemotherapy, continuously in combination with either paclitaxel 90 mg/m2 on days 1, 8, and 15 every 28-day cycle (Arm A) or docetaxel 100 mg/m2 on day 1 every 21-day cycle (Arm B). Dose escalation to motesanib 125 mg QD occurred if the incidence of dose-limiting toxicities (DLTs, primary endpoint) was ≤33 %. If the maximum tolerated dose (MTD) of motesanib was established in Arm B, additional patients could receive motesanib at the MTD plus docetaxel 75 mg/m2. Forty-six patients were enrolled and 45 received ≥1 dose of motesanib. The incidence of DLTs was <33 % in all cohorts; thus, motesanib 125 mg QD was established as the MTD. Seven patients (16 %) had grade 3 motesanib-related adverse events including cholecystitis (2 patients) and hypertension (2 patients). Pharmacokinetic parameters of motesanib were similar to those reported in previous studies. The objective response rate was 56 % among patients with measurable disease at baseline who received motesanib in combination with taxane-based chemotherapy. The addition of motesanib to either paclitaxel or docetaxel was generally tolerable up to the 125-mg QD dose of motesanib. The objective response rate of 56 % suggests a potential benefit of motesanib in combination with taxane-based chemotherapy.
Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults.

Administration of traditional chloride-liberal intravenous fluids may precipitate acute kidney injury (AKI).



To assess the association of a chloride-restrictive (vs chloride-liberal) intravenous fluid strategy with AKI in critically ill patients.



Prospective, open-label, sequential period pilot study of 760 patients admitted consecutively to the intensive care unit (ICU) during the control period (February 18 to August 17, 2008) compared with 773 patients admitted consecutively during the intervention period (February 18 to August 17, 2009) at a university-affiliated hospital in Melbourne, 
During the control period, patients received standard intravenous fluids. After a 6-month phase-out period (August 18, 2008, to February 17, 2009), any use of chloride-rich intravenous fluids (0.9% saline, 4% succinylated gelatin solution, or 4% albumin solution) was restricted to attending specialist approval only during the intervention period; patients instead received a lactated solution (Hartmann solution), a balanced solution (Plasma-Lyte 148), and chloride-poor 20% albumin.



The primary outcomes included increase from baseline to peak creatinine level in the ICU and incidence of AKI according to the risk, injury, failure, loss, end-stage (RIFLE) classification. Secondary post hoc analysis outcomes included the need for renal replacement therapy (RRT), length of stay in ICU and hospital, and survival.  Chloride administration decreased by 144 504 mmol (from 694 to 496 mmol/patient) from the control period to the intervention period. Comparing the control period with the intervention period, the mean serum creatinine level increase while in the ICU was 22.6 μmol/L (95% CI, 17.5-27.7 μmol/L) vs 14.8 μmol/L (95% CI, 9.8-19.9 μmol/L) (P = .03), the incidence of injury and failure class of RIFLE-defined AKI was 14% (95% CI, 11%-16%; n = 105) vs 8.4% (95% CI, 6.4%-10%; n = 65) (P <.001), and the use of RRT was 10% (95% CI, 8.1%-12%; n = 78) vs 6.3% (95% CI, 4.6%-8.1%; n = 49) (P = .005). After adjustment for covariates, this association remained for incidence of injury and failure class of RIFLE-defined AKI (odds ratio, 0.52 [95% CI, 0.37-0.75]; P <.001) and use of RRT (odds ratio, 0.52 [95% CI, 0.33-0.81]; P = .004). There were no differences in hospital mortality, hospital or ICU length of stay, or need for RRT after hospital discharge.  The implementation of a chloride-restrictive strategy in a tertiary ICU was associated with a significant decrease in the incidence of AKI and use of RRT.