nils-herrmann/clean_scirepeval huggingface dataset:
Effects of the Zhikang capsule on healing of the flap after radical breast cancer surgery.

This study aimed to investigate the effect and mechanism of trauma flap healing promoted by the Zhikang capsule after radical breast cancer surgery. The enrolled breast cancer patients were randomly divided into two groups: treatment and observation. The patients in the treatment group were treated with the Zhikang capsule in addition to the conventional dressing changes, while patients in the observation group underwent only the regular dressing changes. Serum samples of 98 breast cancer patients (with complete clinical data) who underwent modified radical mastectomy were collected and analyzed for expressions of transforming growth factor beta (TGF-β) and basic fibroblast growth factor (bFGF). The drainage fluid amount and tissue necrosis rate were found to be lower in the treatment group than in the observation group. Moreover, bFGF expression in peripheral blood was higher in the treatment group than in the observation group. However, no significant difference was found between the two groups in the expression of TGF-β in peripheral blood. In conclusion, Zhikang capsule is effective in promoting flap healing after radical breast cancer surgery, and the increase of bFGF expression in peripheral blood may be the underlying mechanism.
Understanding process in group cognitive behaviour therapy for psychosis.

Group cognitive behaviour therapy for psychosis (GCBTp) has shown to be effective in diminishing symptoms, as well as in improving other psychosocial dimensions such as self-esteem. But little is known regarding the processes that generate these therapeutic improvements and might be harnessed to further improve its effectiveness.



The current study aimed at investigating these processes, particularly those linked to interpersonal relationships.



The participants were all assessed at baseline, were given 24 sessions of GCBTp over the course of 3 months and were assessed again at post-treatment as well as 6 months later (9 months from baseline).



Sixty-six individuals with early psychosis took part in a study of GCBTp where therapist alliance and group cohesion were assessed at three time points during the therapy, and punctual (each session) self-perceptions on symptoms and optimism were collected.



Improvements in symptoms (BPRS), self-esteem (SERS-SF) and in self-perceived therapeutic improvements (CHOICE) were linked to specific aspects of the alliance, group cohesion, as well as optimism. The variables retained were not always overall scores, suggesting the importance of the variables at key moments during the therapy.



The results clearly demonstrate the importance of the alliance and group cohesion, together significantly explaining improvements measured at post-therapy or follow-up.



This study has attempted to focus mostly on relational aspects, as well as on self-perceptions, in the context of a GCBTp for individuals with early psychosis. This study also showed that these therapeutic relationships are especially useful when they are more stable and at specific moments during the therapy, namely when more difficult psychological work is done.
Effect of HIV-specific immune-based therapy in subjects infected with HIV-1 subtype E in Thailand.

To examine the effect of treatment with an inactivated, gp120-depleted, HIV-1 immunogen (Remune) in 30 Thai subjects infected with HIV-1 subtype E.



Sixty-week open-label study.



Thirty HIV-positive volunteers with CD4 cell counts > or = 300 x 10(6)/l were given intramuscular injections of Remune into the triceps muscle on day 1 and then at weeks 4, 8, 12, 24, 36, 48 and 60.



Treatment with Remune was well-tolerated and augmented HIV-1-specific immune responses. Furthermore, subjects had a significant increase in CD4 cell count (P < 0.0001), CD4 cell percentage (P < 0.0001), CD8 cell percentage (P < 0.0001), and body weight (P < 0.0001) compared with pretreatment levels. Fourteen subjects with detectable viral load at day 1 showed a decrease at week 60 (P=0.04). Retrospective Western blot analysis showed 23 subjects with increased intensity of antibody bands and 15 patients showed development of new reactivities to HIV proteins, especially towards p17 and p15.



These results indicate that HIV-specific immune-based therapeutic approaches such as Remune should be further examined in countries with different clades of HIV-1 and where access to antiviral drug therapies is limited.
Incidence and Predictors of First Line Antiretroviral Regimen Modification in Western Kenya

Limited antiretroviral treatment regimens in resource-limited settings require long-term sustainability of patients on the few available options. We evaluated the incidence and predictors of combined antiretroviral treatment (cART) modifications, in an outpatient cohort of 955 patients who initiated cART between January 2009 and January 2011 in western Kenya.



cART modification was defined as either first time single drug substitution or switch. Incidence rates were determined by Poisson regression and risk factor analysis assessed using multivariate Cox regression modeling.



Over a median follow-up period of 10.7 months, 178 (18.7%) patients modified regimens (incidence rate (IR); 18.6 per 100 person years [95% CI: 16.2-21.8]). Toxicity was the most common cited reason (66.3%). In adjusted multivariate Cox piecewise regression model, WHO disease stage III/IV (aHR; 1.82, 95%CI: 1.25-2.66), stavudine (d4T) use (aHR; 2.21 95%CI: 1.49-3.30) and increase in age (aHR; 1.02, 95%CI: 1.0-1.04) were associated with increased risk of treatment modification within the first year post-cART. Zidovudine (AZT) and tenofovir (TDF) use had a reduced risk for modification (aHR; 0.60 95%CI: 0.38-0.96 and aHR; 0.51 95%CI: 0.29-0.91 respectively). Beyond one year of treatment, d4T use (aHR; 2.75, 95% CI: 1.25-6.05), baseline CD4 counts ≤350 cells/mm3 (aHR; 2.45, 95%CI: 1.14-5.26), increase in age (aHR; 1.05 95%CI: 1.02-1.07) and high baseline weight >60kg aHR; 2.69 95% CI: 1.58-4.59) were associated with risk of cART modification.



Early treatment initiation at higher CD4 counts and avoiding d4T use may reduce treatment modification and subsequently improve sustainability of patients on the available limited options.
Development of Japanese version of the UCLA Prostate Cancer Index: a pilot validation study

The Japanese version (version 1.2) of the UCLA PCI was developed through a process of translation, back-translation, and refinement after interviewing patients. Reliability and validity were examined for 125 Japanese patients with localized prostate cancer. The patients simultaneously responded to the Japanese version of the RAND 36-Item Health Survey (SF-36) and five representative questions from the International Index of Erectile Function (IIEF).  Internal consistency reliability was very high for both urinary and sexual function scales, and lower for bowel function. The test-retest reliability of the urinary and sexual function scales and the urinary bother scales was stable, while that of the bowel function and bother scales was relatively unstable. Sexual function scores did not correlate highly with sexual bother scores. Furthermore, poor sexual function and bother had little association with the SF-36 scores. Missing data as to urinary and bowel function/bother scales were minimal (0.8%–2.4%), while those for sexual function and bother were relatively high (4.8%–11.2%).  The results of this pilot study, together with the previous American study, suggest ethnic or cultural difference in how impaired sexual function is integrated into overall QOL. A future cross-cultural comparative study using the UCLA PCI and SF-36 will provide useful information about the influence of cultural or ethnic differences on health-related QOL in prostate cancer patients.
Parameterization of fail-operational architectural patterns

In today's cyber physical systems, adaptability concepts can be used to fulfill fail-operational requirements while enabling optimized resource utilization. However, the applicability of such concepts highly depends on the support for the engineering during system development. We propose an approach to cope with the challenges of fail-operational behavior of CPS in which engineers are supported by design concepts for realizing safety, reliability, and adaptability requirements through the use of architectural patterns. The approach allows expressing concepts for fail-operational behavior at the software architecture level. By our approach, the effort for developing adaptive CPS can be kept low by utilizing fail-operational architectural patterns for general and reoccurring safety-relevant mechanisms. This is demonstrated by an application to an automotive case system.
A comparison of dietary and non-dietary factors of hypertension and normal blood pressure in a Chinese population

The aim of this study was to compare the differences of dietary and non-dietary factors in hypertension and normal blood pressure (BP) of Chinese urban people. Two cross-sectional population surveys were carried out in Tianjin, one of the three largest cities in China. A total of 2068 subjects aged 35–64 years were selected by a random stratified cluster sampling, 367 men and 395 women were hypertensive, and 623 men and 683 women had normal BP. The diet was assessed by food weighing plus consecutive individual 3-day food records. Health status, health behaviours and anthropomentry were assessed. The whole population had a high sodium and low potassium consumption level. Hypertensive men and women had significantly higher daily dietary sodium intake (P < 0.05) and hypertensive women had higher dietary sodium-to-potassium ratio (P < 0.01) than men and women with normal BP. Age, body mass index, overweight and family history of hypertension were positively related to high BP. dietary sodium intake and dietary sodium-to-potassium ratio were positively associated with high BP. Education level in women and commuting physical activity in men were inversely associated with high BP.
ADP-induced platelet aggregation frequently fails to detect impaired clopidogrel-responsiveness in patients with coronary artery disease compared to a P2Y12-specific assay.

Incomplete P2Y(12)-inhibition during clopidogrel treatment is associated with increased cardiovascular events and mortality after coronary intervention. We investigated the incidence of impaired individual clopidogrel-responsiveness using a P2Y(12)-specific and pre-treatment-independent assay in a real world situation. One hundred consecutive patients with coronary artery disease (CAD) on combined acetylsalicylic acid and clopidogrel treatment (75 mg/d) and 33 patients on aspirin only were screened for platelet ADP-induced signalling by conventional aggregometry, platelet P-selectin expression and the platelet reactivity index (PRI). Impaired P2Y(12)-specific inhibition by clopidogrel was defined as a PRI>50%. Functional platelet reactivity was significantly lower in clopidogrel-treated patients compared to controls. Impaired individual response to treatment was diagnosed in 69% of clopidogrel-treated patients. Conventional assessment of maximum ADP-induced platelet aggregation failed to detect impaired P2Y(12) inhibition in 36% of patients identified by PRI to have an impaired clopidogrel response. Impaired clopidogrel response was associated with lower HDL levels and a history of hyperlipidaemia. In conclusion, PRI as a P2Y(12)-specific assay to evaluate the treatment effect of clopidogrel in patients with CAD revealed insufficient P2Y(12)-inhibition in two thirds of patients in a real-world scenario indicating a markedly higher incidence than previously assumed. PRI detected significantly more patients with impaired response than conventional platelet aggregation.
Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study.

Well-tolerated and effective therapies for bipolar mania are required.



To evaluate the efficacy and tolerability of aripiprazole as acute and maintenance of effect therapy in patients with bipolar I disorder experiencing manic or mixed episodes.



Patients were randomised to double-blind aripiprazole (15 or 30 mg/day; n=167), placebo (n=153) or haloperidol (5-15 mg/day, n=165) for 3 weeks (trial registration NCT00097266). Aripiprazole- and haloperidol-treated patients remained on masked treatment for 9 additional weeks.



Mean change in Young Mania Rating Scale Total score (primary end-point) at week 3 was significantly greater with aripiprazole (-12.0; P<0.05) and haloperidol (-12.8; P<0.01) than with placebo (-9.7). Improvements were maintained to week 12 for aripiprazole (-17.2) and haloperidol (-17.8). Aripiprazole was well tolerated. Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (53.3% v. 23.5%).



Clinical improvements with aripiprazole were sustained to week 12. Aripiprazole was generally well tolerated.
Satisfaction with information provided to Danish cancer patients: validation and survey results.

To validate five items (CPWQ-inf) regarding satisfaction with information provided to cancer patients from health care staff, assess the prevalence of dissatisfaction with this information, and identify factors predicting dissatisfaction.



The questionnaire was validated by patient-observer agreement and cognitive interviews. The prevalence of dissatisfaction was assessed in a cross-sectional sample of all cancer patients in contact with hospitals during the past year in three Danish counties.



The validation showed that the CPWQ performed well. Between 3 and 23% of the 1490 participating patients were dissatisfied with each of the measured aspects of information. The highest level of dissatisfaction was reported regarding the guidance, support and help provided when the diagnosis was given. Younger patients were consistently more dissatisfied than older patients.



The brief CPWQ performs well for survey purposes. The survey depicts the heterogeneous patient population encountered by hospital staff and showed that younger patients probably had higher expectations or a higher need for information and that those with more severe diagnoses/prognoses require extra care in providing information.



Four brief questions can efficiently assess information needs. With increasing demands for information, a wide range of innovative initiatives is needed.
Kinetic Oscillation Stimulation as Treatment of Acute Migraine: A Randomized, Controlled Pilot Study

To assess the relief of migraine pain, especially in the acute phase, by comparing active treatment, ie, kinetic oscillation stimulation (KOS) in the nasal cavity, with placebo.



Exploratory trials testing the efficacy of KOS on migraine patients indicated that this treatment could be a fast-acting remedy for acute migraine pain.



Thirty-six patients were randomized 1:1 using a placebo module to active or placebo treatment in this double-blinded parallel design study. Treatment was administered with a minimally invasive inflatable tip oscillating catheter. Symptom scores (0-10 visual analog scale) were obtained before treatment, every 5 minutes during treatment, at 15 minutes, 2, and 24 hours post-treatment, as well as daily (0-3 migraine pain scale) from 30 days pretreatment until Day 60 post. Thirty-five patients were evaluated (active n=18, placebo n=17). The primary end-point was the change in average pain score from before treatment to 15 minutes after treatment.



Patients who received active treatment reported reduced pain, eg, average visual analog scale pain scores fell from 5.5 before treatment to 1.2 15 minutes after, while the corresponding scores for recipients of placebo fell from 4.9 to 3.9. The changes in pain scores differed between the 2 treatments by 3.3 points (95% confidence interval: 2.3, 4.4), P<.001. Already 5 minutes into the treatment, the difference (1.9 points) was significant (P=.007). The difference was likewise significant at 2 hours post-treatment (3.7 points, P<.001). One patient experienced an adverse event (a vasovagal reaction with full spontaneous recovery) during placebo treatment.



KOS is an effective and safe treatment for acute migraine pain.
Accuracy of screening mammography varies by week of menstrual cycle.

To investigate sensitivity, specificity, and cancer detection rate of screening mammography according to week of menstrual cycle among premenopausal women.



In this institutional review board-approved HIPAA-compliant study, sensitivity, specificity, and cancer detection rate of 387,218 screening mammograms linked to 1283 breast cancers in premenopausal women according to week of menstrual cycle were studied by using prospectively collected information from the Breast Cancer Surveillance Consortium. Logistic regression analysis was used to test for differences in mammography performance according to week of menstrual cycle, adjusting for age and registry.



Overall, screening mammography performance did not differ according to week of menstrual cycle. However, when analyses were subdivided according to prior mammography, different patterns emerged. For the 66.6% of women who had undergone regular screening (mammography had been performed within the past 2 years), sensitivity was higher in week 1 (79.5%) than in subsequent weeks (week 2, 70.3%; week 3, 67.4%; week 4, 73.0%; P = .041). In the 17.8% of women who underwent mammography for the first time in this study, sensitivity tended to be lower during the follicular phase (week 1, 72.1%; week 2, 80.4%; week 3, 84.6%; week 4, 93.8%; P = .051). Sensitivity did not vary significantly by week in menstrual cycle in women who had undergone mammography more than 3 years earlier. There were no clinically meaningful differences in specificity or cancer detection rate.



Premenopausal women who undergo regular screening may benefit from higher sensitivity of mammography if they schedule screening mammography during the 1st week of their menstrual cycle.



http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100974/-/DC1.
Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial

We set out to investigate the benefit of distal main or side branch treatment with a DCB compared to POBA in coronary bifurcation lesions. The standard treatment of bifurcation lesions is application of a DES to the main branch with provisional side branch stenting. While this resulted in considerable improvement in overall MACE rate suboptimal side branch results remained a problem. The study was performed from 2011 to 2013 in six German centers. Native bifurcation lesions were included if side branch vessel diameter was ≥2 and ≤3.5 mm and no proximal main branch lesions was found. After successful predilatation randomization was performed to either DCB application or no further treatment. Follow-up angiograms for QCA analysis were done after 9 months. Primary endpoint was late lumen loss (LLL). 64 patients were successfully randomized. Minimal lumen diameter and grade of stenosis were equal in both groups. Only five stents were used as bail out. Angiographic follow-up was achieved in 75 % of patients. No patient died. There was one NSTEMI in the POBA group. Restenosis rate was 6 % in the DCB group vs 26 % in the POBA group (p = 0.045). TLR was necessary in one patient of the DCB group vs three patients of the POBA. The primary endpoint LLL was 0.13 mm in the DCB vs 0.51 mm in the POBA group (p = 0.013). In bifurcation lesions that show only class A or B dissection and recoil not beyond 30 % the use of DCBs is a sound strategy.
Low-angle vascular access for neurovascular procedures using the Arstasis AXERA access device.

To evaluate the safety and efficacy of the Arstasis AXERA access device in patients undergoing neuroendovascular procedures.



A single-center retrospective study of 94 patients undergoing neurovascular procedures with the use of an AXERA arterial access device was performed. The procedures were performed with 5-6-F vascular sheaths, and hemostasis was obtained with manual compression.



A total of 104 neurovascular procedures (81 diagnostic, 23 interventional) were performed in 94 subjects. Eighty-seven procedures (83%) were performed with a 5-F sheath, and 17 procedures (16%) used a 6-F sheath. Intravenous heparin was administered in 64 procedures (61%), and 32 patients (30%) were taking antiplatelet medications at the time of the procedure. Median time to hemostasis was 4 minutes with manual compression, and outpatients undergoing diagnostic angiography were permitted to ambulate at 1 hour. Complications occurred in a total of 3% of cases; these included one local hematoma (1%) and two failed procedures (2%).



The new AXERA arterial access device modifies the arterial puncture angle in an attempt to reduce manual compression and ambulation times.
Drug, doctor's verbal attitude and clinic setting in the symptomatic response to pharmacotherapy

138 psychoneurotic outpatients manifesting anxiety were treated for 6 weeks with medication and brief, supportive interviews every 2 weeks with a psychiatric resident. The patients were divided among 12 different treatment conditions composed of 1. meprobamate 1,600 mg q.i.d. versus an identical placebo in a double-blind arrangement, 2. a doctor expressing an enthusiastic attitude toward the medication versus a doctor expressing a skeptical attitude toward the medication and 3. three different psychiatric outpatient clinics. The patient's symptomatic condition was assessed at each visit by means of five ratings made by the patient before each interview and three ratings made by his doctor afterward. These ratings included an overall judgment of change, a checklist of 64 common symptoms, a score based on the patient's presenting complaints and adjective checklists for registering anxiety and depression. The results at one clinic showed the expected interaction between medication and doctor's expressed attitude: with the enthusiastic doctors, patients taking meprobamate improved more than patients taking placebo; whereas with the skeptical doctors, patients taking placebo tended to improve more than patients taking meprobamate. At the other two clinics, however, this interaction was absent or possibly reversed, with meprobamate tending to be superior to placebo with skeptical doctors. Some striking clinic differences among the characteristics of patients were found, particularly in social class status and the commonly associated styles of complaint and goals and expectations regarding treatment. The clinic showing the anticipated interaction between medication and doctor's verbal attitude had patients with the lowest social class standing. The doctors at this clinic also came from backgrounds of lower social class than the doctors at the other two clinics. These differences suggest that the participants at this clinic may have assigned meanings to the enthusiastic and the skeptical attitudes contrasting with the meanings assigned at the other two clinics. The possible relevenace of these differences to the results is discussed.