nils-herrmann/clean_scirepeval huggingface dataset:
Withdrawal of immunosuppression in Crohn's disease treated with scheduled infliximab maintenance: a randomized trial.

The benefit to risk ratio of concomitant immunosuppressives with scheduled infliximab (IFX) maintenance therapy for Crohn's disease is an issue of debate. We aimed to study the influence of immunosuppressives discontinuation in patients in remission with combination therapy in an open-label, randomized, controlled trial.



Patients with controlled disease > or = 6 months after the start of IFX (5 mg/kg intravenously) combined with immunosuppressives were randomized to continue (Con) or to interrupt (Dis) immunosuppressives, while all patients received scheduled IFX maintenance therapy for 104 weeks. Primary end point was the proportion of patients who required a decrease in IFX dosing interval or stopped IFX therapy. Secondary end points included IFX trough levels, safety, and mucosal healing.



A similar proportion (24/40, 60% Con) and (22/40, 55% Dis) of patients needed a change in IFX dosing interval or stopped IFX therapy (11/40 Con, 9/40 Dis). C-reactive protein (CRP) was higher and IFX trough levels were lower in the Dis group (Dis: CRP, 2.8 mg/L; interquartile range [IQR], 1.0-8.0; Con: CRP, 1.6 mg/L; IQR, 1.0-5.6, P < .005; trough IFX: Dis: 1.65 microg/mL; IQR, 0.54-3.68; Con: 2.87 microg/mL; IQR, 1.35-4.72, P < .0001). Low IFX trough levels correlated with increased CRP and clinical score. Mucosal ulcers were absent at week 104 in 64% (Con) and 61% (Dis) of evaluated patients with ongoing response to IFX.



Continuation of immunosuppressives beyond 6 months offers no clear benefit over scheduled IFX monotherapy but is associated with higher median IFX trough and decreased CRP levels. The impact of these observations on long-term outcomes needs to be explored further.
Clinical implications of a reduction in psychological distress on cardiac prognosis in patients participating in a psychosocial intervention program.

The objective of this secondary analysis was to examine the relationships between a reduction in psychological distress and long-term cardiac and psychological outcomes in post-myocardial infarction patients who participated in a randomized trial of home-based psychosocial nursing interventions (the Montreal Heart Attack Readjustment Trial [M-HART]). Gender differences were considered.



We studied 433 patients (36.0% women) from the M-HART treatment group who received two home visits after achieving a high psychological distress score (ie, > or =5) on the General Health Questionnaire (GHQ). Short-term GHQ success was determined by a return to a normal GHQ score (<5) or a reduction of > or =50% after the two visits. Patients with short-term successful and unsuccessful GHQ outcomes were compared for mid-term maintenance of success, 1-year death and readmission rates, and 1-year depression and anxiety symptoms.



Patients with short-term GHQ success were more likely to show mid-term GHQ success (p < .001), marginally less likely to die of any causes (p = .087), less likely to die of cardiac causes (p = .043), less likely to be readmitted for any reason (p < .001) and for cardiac reasons (p < .001), and less likely to have high depression (p < .001) and anxiety (p < .001) at 1-year than patients with short-term unsuccessful GHQ outcomes.  for men and women and were not altered by controlling for potential confounders. However, the number of deaths prevented analysis with statistical controls.



Post-myocardial infarction interventions that reduce psychological distress have the potential to improve long-term prognosis and psychological status for both men and women.
Effects of aerobic training during hemodialysis on heart rate variability and left ventricular function in end-stage renal disease patients.

Decreased heart rate variability (HRV) in patients with end stage renal disease (ESRD) undergoing hemodialysis is predictive of cardiac death, especially due to sudden death.



To evaluate the effects of aerobic training during hemodialysis on HRV and left ventricular function in ESRD patients.



Twenty two patients were randomized into two groups: exercise (n = 11; 49.6 ± 10.6 years; 4 men) and control (n = 11; 43.5 ± 12.8; 4 men). Patients assigned to the exercise group were submitted to aerobic training, performed during the first two hours of hemodialysis, three times weekly, for 12 weeks. HRV and left ventricular function were assessed by 24 hours Holter monitoring and echocardiography, respectively.



After 12 weeks of protocol, no significant differences were observed in time and frequency domains measures of HRV in both groups. The ejection fraction improved non-significantly in exercise group (67.5 ± 12.6% vs. 70.4 ± 12%) and decreased non-significantly in control group (73.6 ± 8.4% vs. 71.4 ± 7.6%).



A 12-week aerobic training program performed during hemodialysis did not modify HRV and did not significantly improve the left ventricular function.
Does age really matter? Recall of information presented to newly referred patients with cancer.

To examine age- and age-related differences in recall of information provided during oncology consultations.



Two hundred sixty patients with cancer diagnosed with heterogeneous cancers, seeing a medical or radiation oncologist for the first time, participated in the study. Patients completed questionnaires assessing information needs and anxiety. Recall of information provided was measured using a structured telephone interview in which patients were prompted to remember details physicians gave about diagnosis, prognosis, and treatment. Recall was checked against the actual communication in audio-recordings of the consultations.



Recall decreased significantly with age, but only when total amount of information presented was taken into account. This indicates that if more information is discussed, older patients have more trouble remembering the information than younger ones. In addition, recall was selectively influenced by prognosis. First, patients with a poorer prognosis recalled less. Next, the more information was provided about prognosis, the less information patients recalled, regardless of their actual prognosis.



Recall is not simply a function of patient age. Age only predicts recall when controlling for amount of information presented. Both prognosis and information about prognosis are better predictors of recall than age. These results provide important insights into intervention strategies to improve information recall in patients with cancer.
Long-term efficacy results of EORTC genito-urinary group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladd

Intravesical chemotherapy and bacillus Calmette-Guérin (BCG) reduce the recurrence rate in patients with stage Ta T1 urothelial bladder cancer; however, the benefit of BCG relative to chemotherapy for long-term end points is controversial, especially in intermediate-risk patients.



The aim of the study was to compare the long-term efficacy of BCG and epirubicin.



From January 1992 to February 1997, 957 patients with intermediate- or high-risk stage Ta T1 urothelial bladder cancer were randomized after transurethral resection to one of three treatment groups in the European Organization for Research and Treatment of Cancer Genito-Urinary Group phase 3 trial 30911.



Patients received six weekly instillations of epirubicin, BCG, or BCG plus isoniazid (INH) followed by three weekly maintenance instillations at months 3, 6, 12, 18, 24, 30, and 36.



End points were time to recurrence, progression, distant metastases, overall survival, and disease-specific survival.



With 837 eligible patients and a median follow-up of 9.2 yr, time to first recurrence (p<0.001), distant metastases (p=0.046), overall survival (p=0.023), and disease-specific survival (p=0.026) were significantly longer in the two BCG arms combined as compared with epirubicin; however, there was no difference for progression. Three hundred twenty-three patients with stage T1 or grade 3 tumors were high risk, and the remaining 497 patients were intermediate risk. The observed treatment benefit was at least as large, if not larger, in the intermediate-risk patients compared with the high-risk patients.



In patients with intermediate- and high-risk stage Ta and T1 urothelial bladder cancer, intravesical BCG with or without INH is superior to intravesical epirubicin not only for time to first recurrence but also for time to distant metastases, overall survival, and disease-specific survival. The benefit of BCG is not limited to just high-risk patients; intermediate-risk patients also benefit from BCG.
Preoperative color duplex echographical venous mapping before autologous fat graft for calf augmentation: a case report of superficial vein thrombosis and prevalence of intersaphenic anastomosis.

Autologous fat grafting for calf augmentation is considered an easy and safe technique. Only few cases of potential complications have been described in literature; among them, vein thrombosis was never reported. We report a case of superficial vein thrombosis of the intersaphenic anastomosis after fat graft for calf symmetrization in club-foot syndrome. A color duplex echographical study showed that such intersaphenic anastomoses are present in all patients, but they have an ectatic diameter in 70% of patients with great saphenous vein insufficiency and in 50% of patients without insufficiency. The plastic surgeon should be aware of the presence and topography of such anatomical variations before performing the procedure. Moreover, a preoperative color duplex echographical venous mapping may help the surgeon in avoiding the trauma on vein variants and subsequent complications.
Comparison of quantitative angiographic parameters with the magnitude of neointimal hyperplasia measured by volumetric intravascular ultrasound in patients treated with bare metal and nonpolymeric paclitaxel-coated stents.

We used data from the ASian Paclitaxel-Eluting Stent Clinical Trial (a 3-center, randomized, placebo-controlled trial of nonpolymeric paclitaxel-coated stents with a single-center intravascular ultrasound substudy) to compare angiographic indexes of drug-eluting stent efficacy with the magnitude of intimal hyperplasia (IH) assessed by intravascular ultrasound. Overall, percent IH (IH volume divided by stent volume) was larger in restenotic lesions than in nonrestenotic lesions (46 +/- 19% vs 15 +/- 13%, p <0.0001); angiographic late loss and follow-up diameter stenoses correlated strongly with percent IH.
Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study.

To investigate the safety and efficacy of long-term administration (52 weeks) of donepezil in patients with dementia with Lewy bodies (DLB).



This was a 52-week, multicenter, open-label extension study. Up to 8 weeks after the completion of the preceding randomized, placebo-controlled trial (RCT), patients started treatment with 3 mg of donepezil daily for 2 weeks, followed by 5 mg daily for the remaining 50 weeks. Cognitive function, behavioral and psychiatric symptoms, cognitive fluctuations, and caregiver burden were assessed using the Mini-Mental State Examination, Neuropsychiatric Inventory, Cognitive Fluctuation Inventory, and the Zarit Caregiver Burden Interview, respectively. Safety parameters were monitored throughout.



In total, 108 patients were enrolled in the study. Cognitive function and dementia-related behavioral symptoms, including cognitive fluctuations, were improved after the start of donepezil treatment, and improvement was maintained for 52 weeks. Reduction in caregiver burden observed in the preceding RCT returned to the baseline level at 52 weeks. There was no significant imbalance in the incidence of adverse events (AEs) by onset time, and delayed AE onset induced by the long-term administration of donepezil was unlikely to appear.



The long-term administration of donepezil at 5 mg/day was well tolerated in patients with DLB and is expected to exhibit lasting effects, improving impaired cognitive function and psychiatric symptoms up to 52 weeks.
Colposcopy referral rate can be reduced by high-risk human papillomavirus triage in the management of recurrent atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion cytology in Finland.

The aim of this study was to establish whether a combination of high-risk human papillomavirus (hrHPV) testing and cervical cytology could reduce colposcopy referral among women with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion cytology. We randomized 598 women in the Helsinki area, Finland into three study groups. Different strategies of hrHPV testing, cytology and colposcopy with biopsy were used; subsequent hrHPV test results and cytological findings were compared with histology. The rates of hrHPV positivity and CIN2+ were compared. In total, 62.5% of all samples were hrHPV-positive. Altogether 45 (12.7%) CIN2 or worse (CIN2+) lesions were found in study groups A and B. Among hrHPV-positive women the rate of CIN2+ was 19.0% (n = 43), in contrast with 1.6% (n = 2) among hrHPV-negative women (relative risk = 12.2, 95% confidence interval [CI] 3.6-81.1, P < 0.001). Among all hrHPV-negative women whose cytological findings were normal or ASCUS, dysplastic lesions were uncommon (n = 4/119, 3.4%), and all were CIN1. If these women had not been referred to colposcopy, the number of colposcopies would have been reduced by 33.6%. We conclude that hrHPV testing combined with repeat cervical cytology had a high negative predictive value in patients with recurrent low-grade cervical cytology. This could reduce the referral rate to colposcopy without jeopardizing patient safety.
A double-blind placebo-controlled study of the effect of influenza vaccination on airway responsiveness in asthma.

Influenza A infection may cause severe exacerbations of asthma with increased airway responsiveness and airflow obstruction (1). Annual vaccination against influenza is therefore recommended for patients with asthma by the Chief Medical Officer of the Department of Health. However, some patients report exacerbations of their asthma, apparently related to influenza vaccination, and there is reluctance to adhere to the recommended vaccination policy (2). We therefore studied the effect of a current subunit vaccine on symptoms, medication use, spirometry and airway responsiveness in patients with stable asthma.
Plea against cultural stereotypes

The paper discusses, critically, the vogue of Hofstede's system in cross-cultural research, and reveals the traps of classifying cultures, generating, thus, neo-stereotypes. Starting from a content analysis of last years' scientific production in the field of cultural encounters, with a special emphasis on the European East - Asian East (People's Republic of China and Japan, in particular) relationships, the paper develops a review by exception, as the authors present "a-typical" case studies of cultural interactions, dismissing the cultural dimensions paradigm. Historical and political circumstances of the relationships between the two aforementioned regions, corroborated with cultural stereotypes, create a certain horizon of expectation, which is contradicted by the way things really happen. Concise and informative explanations are provided for each of the "a-typical" situations, based on the authors' cultural understanding, and especially on one of the authors' valuable expertise in the field of Chinese culture. The multiple embedded case studies analyzed articulate into a discourse against simplification and narrow classification of cultures, whose patterns of overlapping are far more subtle. Lessons learned, and insights from literature are brought together in a discussions and conclusions section, which creates awareness of "a-typical" behaviors, linked to "a-typical" situations, or relational backgrounds. The quasi-dogmatic framework of cultural dimension is, thus, challenged by a more fluid, exception-inclusive manner of approaching and understanding cross-cultural dialogue.
Bone Mineral Density Changes Among Young, Healthy African Women Receiving Oral Tenofovir for HIV Preexposure Prophylaxis

Limited data exist on effect of tenofovir disoproxil fumarate (TDF) when used for preexposure prophylaxis (PrEP) on bone mineral density (BMD) in HIV-negative women. We evaluated the effect of daily oral TDF and emtricitabine/TDF compared with placebo on BMD among women enrolled in an HIV-1 PrEP trial.



HIV-uninfected women in Uganda and Zimbabwe had BMD measurements of lumbar spine (LS) and total hip (TH) by dual-energy x-ray absorptiometry at baseline and every 24 weeks for 48 weeks of active treatment and for 48 weeks after discontinuation of study medication. Plasma tenofovir levels were assessed every 12 weeks for the first 48 weeks.



Of 518 women enrolled, 432 had dual-energy x-ray absorptiometry results at baseline and week 48. In the primary analysis, no significant differences in percent BMD change in hip or spine between arms observed, likely because of low product adherence. Among the subset with tenofovir detection in 75%-100% of plasma samples, the mean percent BMD change from baseline to week 48 in the LS was 1.4% lower for TDF or emtricitabine/TDF recipients than for placebo (P = 0.002) and TH BMD was 0.9% lower (P = 0.018). BMD changes from end of active treatment to 48 weeks were significantly greater in the active arm participants compared with placebo participants with a net difference of approximately +0.9% at the LS (P = 0.007) and +0.7% (P = 0.003) at the TH.



TDF-containing oral PrEP resulted in small but significant reversible decreases in hip and spine BMD among young African women.
Effectiveness of relaxation training in reducing adverse reactions to cancer chemotherapy

Cancer patients who had developed negative conditioned responses to their chemotherapy either did (relaxation training) or did not (no relaxation training) receive progressive muscle relaxation training and guided relaxation imagery instructions immediately before and during their chemotherapy treatments. Physiological (blood pressure and pulse rate) measures of arousal, frequency of vomiting, and patient-reported and nurse-reported indices of negative affect and nausea were collected during pretraining, training, and posttraining chemotherapy sessions. Results indicated that during both the training and the posttraining sessions, patients in the relaxation training condition reported feeling less emotionally distressed and nauseated, and showed less physiological arousal following the chemotherapy infusion, than patients in the no relaxation training condition. The attending nurses' observations confirmed the patients' self-reports. No differences were found in frequency of vomiting between conditions. These data clearly suggest that the use of relaxation procedures may be an effective means of reducing several of the adverse side effects of cancer chemotherapy.
Intracoronary versus intravenous abciximab bolus in patients with ST-segment elevation myocardial infarction: 1-year results of the randomized AIDA STEMI trial.

In patients with ST-segment elevation myocardial infarction (STEMI), direct intracoronary as compared with standard intravenous bolus administration of the glycoprotein IIb/IIIa receptor antagonist abciximab acutely causes higher local drug concentrations, greater glycoprotein IIb/IIIa receptor occupancy, and enhanced inhibition of platelet aggregation at the site of thrombus and downstream within the coronary capillary bed (1). These effects might exert a protective effect on the myocardial microcirculation at the time of reperfusion. At short-term follow-up (90 days), the largest randomized trial to date (AIDA STEMI [Abciximab Intracoronary Versus Intravenously Drug Application in STEMI]) comparing intracoronary and intravenous abciximab bolus application in patients with STEMI undergoing primary percutaneous coronary intervention (PCI) could not show a significant difference in a compositemajor adverse cardiac events endpoint, mortality, reinfarction, or bleeding between the 2 delivery routes (2). However, there were significantly fewer episodes of new congestive heart failure in patients randomized to intracoronary abciximab bolus administration. The present analysis reports 12 months of clinical results of the AIDA STEMI trial. In brief, AIDA STEMI randomized 2,065 patients with acute STEMI undergoing primary PCI to either intracoronary or intravenous abciximab bolus application with subsequent 12-h intravenous infusion. All patients received dual oral antiplatelet therapy (aspirin and either clopidogrel or prasugrel). The primary endpoint was a composite of all-cause death, reinfarction, or new congestive heart failure at 90 days. For the predefined 12-month follow-up, the primary analysis was performed for all patients who underwent randomization and had follow-up information according to the intention-to-treat principle. Predefined subgroup analyses were performed for patient age, infarct location, Killip class, post-procedural Thrombolysis In Myocardial Infarction (TIMI) flow, time from symptom onset to randomization, and thrombectomy versus no thrombectomy. Exploratory post hoc
Reversal of small, dense LDL subclass phenotype by weight loss is associated with impaired fat oxidation.

Adiposity is more prevalent among individuals with a predominance of small, dense low-density lipoprotein (LDL) (pattern B) particles than among those with larger LDL (pattern A). We tested for differences in resting energy expenditure (REE) and respiratory quotient (RQ) in overweight men with pattern A (n = 36) or pattern B (n = 60). Men consumed a standardized isoenergetic diet for 3 weeks after which a ~9 kg weight loss was induced by caloric deficit for 9 weeks, followed by 4 weeks of weight stabilization. REE and RQ were measured by indirect calorimetry before and after weight loss. Results were analyzed separately in pattern B men who converted to pattern A (B→A; n = 35) and those who did not (B→B; n = 25). At baseline, B→B men had higher trunk fat, triacylglycerol (TG) and insulin concentrations, homeostasis model assessment of insulin resistance (HOMA(IR)), and smaller LDL particles compared to B→A men and baseline pattern A men who remained pattern A (A→A; n = 35). REE normalized to fat-free mass did not change after weight loss. RQ decreased in A→A men, increased in B→A men, and did not change significantly in B→B men after weight loss. Calculated fat oxidation rates paralleled the RQ results. Baseline plasma TG concentrations were positively correlated with RQ and inversely correlated with the magnitude of weight loss achieved for a given prescribed energy reduction in the entire study population. Pattern B men who converted to pattern A with weight loss may have an underlying impairment in fat oxidation that predisposes to both dyslipidemia and an impaired ability to achieve weight loss by energy restriction.