nils-herrmann/clean_scirepeval huggingface dataset:
Lopinavir/Ritonavir Versus Darunavir Plus Ritonavir for HIV Infection: A Cost-Effectiveness Analysis for the United States

The ARTEMIS trial compared first-line antiretroviral therapy (ART) with lopinavir/ritonavir (LPV/r) to darunavir plus ritonavir (DRV + RTV) for HIV-1-infected subjects. In order to fully assess the implications of this study, economic modelling extrapolating over a longer term is required. The aim of this study was to simulate the course of HIV and its management, including the multiple factors known to be of importance in ART. A comprehensive discrete event simulation was created to represent, as realistically as possible, ART management and HIV outcomes. The model was focused on patients for whom clinicians believed that LPV/r or DRV + RTV were good options as a first regimen. Prognosis was determined by the impact of initial treatment on baseline CD4+ T-cell count and viral load, adherence, virological suppression/failure/rebound, acquired resistance mutations, and ensuing treatment changes. Inputs were taken from trial data (ARTEMIS), literature and, where necessary, stated assumptions. Clinical measures included AIDS events, side effects, time on sequential therapies, cardiovascular events, and expected life-years lost as a result of HIV infection. The model underwent face, technical and partial predictive validation. Treatment-naive individuals similar to those in the ARTEMIS trial were modelled over a lifetime, and outcomes with first-line DRV + RTV were compared with those with LPV/r, both paired with tenofovir and emtricitabine. Up to three regimen changes were permitted. Drug prices were based on wholesale acquisition cost. Outcomes were lifetime healthcare costs (in 2011 US dollars) from the US healthcare system perspective and quality-adjusted life-years (QALYs) (discounted at 3 % per annum). Choice of LPV/r over DRV + RTV as initial ART resulted in nearly identical clinical outcomes, but distinctly different economic consequences. Starting with an LPV/r regimen potentially results in approximately US$25,000 discounted lifetime savings. Accumulated QALYs for LPV/r and DRV + RTV were 12.130 and 12.083, respectively (a 19-day difference). In sensitivity analyses, net monetary benefit ranged from US$12,000 to US$31,000, favouring LPV/r (base case US$27,762). A comprehensive simulation of lifetime course of HIV in the USA indicated that using LPV/r as first-line therapy compared with DRV + RTV may result in cost savings, with similar clinical outcomes.
[Clinical observation of sophocarpidine combined with Salviae miltiorrhizae injection in treating chronic hepatitis B].

1 Whittaker P . Laser acupuncture : past , present , and fu ture .  2004 , 19(2) : 6980 . 2 高建平 ,卞蓓亚 ,陈惠民 ,等 .卤化银多晶光纤传输 CO2激光性能的研究 .无机材料学报 , 2000 , 15 (1) : 119123 . 3 朱 愉 ,多秀瀛 .实验动物的基本模型 .天津 :天津科 技翻译出版公司 ,1997 . 158 . 4 邓春雷 ,殷克敬 .实验针灸学 .北京 :人民卫生出版 社 , 1998 .142143 . 5 李忠明 ,张镇西 .激光针灸治疗机理探讨 .激光生物学 报 , 2005 ,14(1) : 811 . 6 Stadle r I ,Lanzafame RJ ,Oskoui P , et al .Alte ration o f skin temperature during lowlevel laser irradiation a t 830 nm in a mouse model . Pho tomed Laser Surg , 2004 , 22 (3) :227231 . 7 沈雪勇 ,丁光宏 ,褚君浩 ,等 .传统艾灸与替代物灸和 人体穴位红外辐射光谱比较 .红外与毫米波学报 , 2003 , 22(2) :123126 . 8 沈 恂 .生命科学中的物理问题讲座 ,第九讲 ,生物光 子的相干性 .物理 ,1995 ,24(3) : 166171 . 9 邓海平 ,沈雪勇 ,丁光宏 ,等 .冠心病患者神门穴红外 辐射光谱检测 .上海针灸杂志 , 2004 ,  3134 . 10 魏建子 ,沈雪勇 ,丁光宏 ,等 .太渊穴自发红外辐射光 谱研究 .上海中医药大学学报 , 2004 , 18(4) : 3335 . 11 应 荐 ,沈雪勇 ,刘汉平 ,等 .冠心病患者与正常人太 冲穴红外辐射光谱比较 .浙江中医杂志 ,2005 ,40(3) : 100101 . 12 李忠明 .激光针灸的物理基础 .应用激光 , 1999 , 19 (6) :376378 . 13 Makihara E ,Makihara M ,Masumi S , et al .Evaluation of facial the rmographic changes bef ore and after low level laser irradiation . Photomed Laser Surg , 2005 , 23 (2) :191195 .
Heel compressions quadruple the number of bystanders who can perform chest compressions for 10 minutes.

The objective of the study is to evaluate whether chest compressions using the heel provide a more effective method than manual compressions for bystanders.



This is a cross-sectional observational comparison study where each subject acted as his or her own control. A 49-person cohort whose age distribution approximated that of sudden cardiac arrest victims were asked to perform 10 minutes of 5-cm manual compressions on a cardiopulmonary resuscitation manikin at 100 compressions per minute. The compression rate and the endurance of each subject were recorded. The same subject was then asked to perform 10 minutes of heel compressions at the same depth and rate.



Sixteen percent of the cohort performed compliant manual compressions for 10 minutes vs 65% using heel compressions. Twenty-four percent of the subjects were not heavy enough to get compliant depth with manual vs 2% with heel compressions, and 6% could not get down on the floor to attempt manual compressions.



Most cardiac arrests occur in private residences. If there is a witness, his or her age usually approximates that of the victim. Heel compressions are useful in situations where a lone rescuer cannot get down on the floor, cannot compress the chest to guideline depth because of an infirmity or lack of weight, or becomes too tired to continue manual compressions. Heel compressions significantly increase the bystander population's ability to provide effective, uninterrupted compressions until EMS arrival.
Effect of finasteride on the sensitivity of PSA for detecting prostate cancer.

In the Prostate Cancer Prevention Trial (PCPT), men receiving finasteride had a 24.8% lower risk of prostate cancer than men receiving placebo but a higher risk of high-grade cancer. We examined the impact of finasteride on the sensitivity and area under the receiver operating characteristic curve (AUC) of prostate-specific antigen (PSA) for detecting prostate cancer.



We studied men in the placebo and finasteride groups of the PCPT who had a prostate biopsy and concurrent PSA tests during the 7-year study. We compared the placebo and finasteride groups for sensitivity and AUC of PSA for the detection of all prostate cancer, of Gleason grade 7 or higher prostate cancer, and of Gleason grade 8 or higher prostate cancer. All statistical tests were two-sided.



Of 5112 men in the placebo group, prostate cancer was detected in 1111. Gleason tumor grade was available for 1100 men, of whom 240 had grade 7 or higher and 55 had grade 8 or higher. Of 4579 men in the finasteride group, 695 had prostate cancer. Gleason grade was available for 686 men, of whom 264 had grade 7 or higher and 81 had grade 8 or higher. The AUC of PSA for all outcomes was greater for the finasteride group than the placebo group. For detecting prostate cancer versus no cancer, the AUCs were 0.757 and 0.681, respectively (P < .001); for detecting Gleason grade > or = 7 versus < or = 6 or no cancer, the AUCs were 0.838 and 0.781, respectively (P = .003); and for detecting Gleason grade > or = 8 versus < or = 7 or no cancer, the AUCs were 0.886 and 0.824, respectively (P = .071). The sensitivity of PSA was higher for men in the finasteride group than in the placebo group at all PSA cutoffs matched by specificity.



PSA had statistically significantly better sensitivity and AUC for detecting prostate cancer in the finasteride arm of the PCPT than in the placebo arm. This bias would be expected to contribute to greater detection of all grades of prostate cancer with finasteride.
Clinical response to therapy with thymopoietin pentapeptide (TP-5) in rheumatoid arthritis.

The effect of thymopoietin pentapeptide (TP-5) was evaluated in patients with rheumatoid arthritis (RA). Ninety-two patients were divided into 3 groups, namely, placebo, TP-5 intramuscularly (IM) 1 mg, TP-5 intravenously (IV) 50 mg, and were evaluated for 6 measures of disease activity at the beginning of the study and at 3 and 6 months. No difference was observed between the placebo group and the group treated with TP-5 IM 1 mg. However, in the group treated with TP-5 IV 50 mg a statistically significant improvement of all parameters except the ESR was observed.
Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study.

To understand the effects of long-term BLyS inhibition in human systemic lupus erythematosus (SLE).



Seventeen patients with SLE who were enrolled in a clinical trial of belimumab, a BLyS-specific inhibitor, plus standard of care therapy were studied. Phenotypic analysis of lymphocytes was performed using flow cytometry. Circulating antibody-secreting cells were enumerated using enzyme-linked immunospot assay. Serum was analyzed by enzyme-linked immunosorbent assay using an antibody that recognizes products of the V(H)4-34 gene. Lymphocyte counts, Ig levels, and anti-double-stranded DNA antibody levels were available as part of the clinical trial analyses.



Samples were collected on days 0, 84, 168, 365, and 532 and after day 730. The total number of B cells started to decrease from baseline between days 84 and 168. This was due to a decrease in naive and transitional B cells. CD27+IgD+ memory B cells and plasmablasts decreased only after 532 days, whereas CD27+IgD- memory B cells were not affected, and there were no changes in T cells. Serum IgM levels began to decline between days 84 and 168, but there were no changes in serum levels of IgG, IgG anti-DNA antibodies, or V(H)4-34 antibodies during the study. SLE patients had more IgM-, IgG-, and autoantibody-producing B cells than did normal controls on day 0. There was only a modest decrease in the frequency of total IgM-producing, but not IgG-producing, cells on days 365 and 532, consistent with the phenotypic and serologic data.



Our data confirm the dependence of newly formed B cells on BLyS for survival in humans. In contrast, memory B cells and plasma cells are less susceptible to selective BLyS inhibition.
Postoperative small bowel and colonic anastomotic bleeding. Therapeutic management and complications.

Postoperative small bowel or colic anastomotic bleeding (PSCAB) is often a mild complication and is generally treated by a conservative approach. Other therapeutic options are surgery, endoscopic management and angiographic embolization. Our aim is to review our cases of postoperative anastomotic bleeding in patients with small bowel or colic anastomosis, with special attention to their treatment and complications.



Observational retrospective study including patients with PSCAB in the department of General and Digestive Surgery in Vall d'Hebron University Hospital, between 2007 and 2012. Demographic and bleeding characteristics as well as therapeutic management were reviewed, including complications derived from the different therapeutic options.



There were 44 cases of bleeding after performing small bowel or colic anastomosis, 25 patients were men (56.8%), with a mean age of 68.2 years (R: 28-92). The mean hematocrit decrease was 8 points (R: 0-17), and hemodynamic instability was detected in 13 patients (29.5%). A conservative management was undertaken in 27 patients (61.3%), surgery in 6 (13.6%), endoscopic treatment in 2 (4.5%) and embolization in 9 (20.5%). 4 patients of cases treated with embolization presented anastomotic leak (44.5%). Mortality was 13.6% (6 patients). A total of 4 of 6 deaths were in the group of patients treated with embolization.



Most patients with PSCAB have a good response to conservative management. When there is failure of this approach, there are different therapeutic options, including angiographic embolization. In our series, we have seen a high incidence of post embolization anastomotic leak; further trials will be necessary to provide valuable evidence of the risk of this therapeutic option.
The Effect of DPT-1 Intravenous Insulin Infusion and Daily Subcutaneous Insulin on Endogenous Insulin Secretion and Postprandial Glucose Tolerance

To investigate the effect of parenteral insulin therapy on endogenous insulin secretion in the Diabetes Prevention Trial-Type 1 (DPT-1).



In the parenteral insulin arm of DPT-1, subjects without diabetes at high risk of future type 1 diabetes randomized to active treatment received a yearly 4-day intravenous insulin infusion (IV-I) and daily subcutaneous insulin (SC-I). To examine the effects of these insulin therapies on endogenous insulin secretion, C-peptide and glucose levels were compared during oral glucose tolerance tests (OGTTs) performed on and off IV-I and SC-I. Forty-six paired OGTTs were performed in 30 subjects from DPT-1 to determine the effect of IV-I. Twenty paired OGTTs were performed in 15 subjects from DPT-1 to determine the effect of SC-I.



IV-I suppressed fasting and OGTT-stimulated C-peptide (62% and 40%, respectively), and it significantly lowered fasting glucose (67.4 ± 4.5 mg/dL during IV-I vs. 90.9 ± 1.8 mg/dL off insulin; P < 0.05). By contrast, post-OGTT glucose levels were significantly higher during IV-I: Glucose during IV-I versus off insulin at 120 min was 203.9 ± 15.1 vs. 151.6 ± 10.2 mg/dL, respectively (P < 0.05); 49% of OGTTs became transiently diabetic (>200 mg/dL at 120 min) when receiving IV-I. Fasting glucose was significantly lower when receiving SC-I versus when off insulin (85 ± 3 vs. 94 ± 2 mg/dL, respectively; P < 0.05), but SC-I did not significantly alter fasting or OGTT-stimulated C-peptide compared with being off insulin.



These data demonstrate that the IV-I used in the DPT-1 markedly suppressed endogenous insulin secretion, which was frequently associated with postprandial glucose intolerance. SC-I, however, did not.
Presence of plaques predicts worse outcomes in multi-detector computed tomography in patients with stable chest pain syndrome.

myocardial infarction and myocarditis were females (81%). Only one out of 21 patients with myocardial infarction and myocarditis had a stressful event preceding the acute cardiac illness. Consequently, patients with myocardial infarction and myocarditis had typical other clinical features of TS, and were predominantly females without a preceding stressor. It will be reasonable to conclude that myocarditis may have triggered TS in this group of patients or the myocarditis changes were parts of the pathology of TS. In conclusion, in spite of certain progress in the revised TIN diagnostic criteria for TS, there are many points in the previously existing and the new revised TIN criteria, which may encage the thoughts and create problems for the clinicians; they are the main reasons for exclusion of substantial numbers of patients who actually have TS. Acute coronary syndrome (caused by plaque rupture, dissection, thrombosis or spasm) may trigger rather than exclude TS. Acute chemical (noradrenaline) myocarditis may be a manifestation of a phase of the broad clinical continuum of TS. The author of this manuscript has certified that he complies with the principles of ethical publishing in the international journal of cardiology.
Relationship of Mania Symptomatology to Maintenance Treatment Response with Divalproex, Lithium, or Placebo

Euphoric and mixed (dysphoric) manic symptoms have different response patterns to divalproex and lithium in acute mania treatment, but have not been studied in relationship to maintenance treatment outcomes. We examined the impact of initial euphoric or dysphoric manic symptomatology on maintenance outcome. Randomized maintenance treatment with divalproex, lithium, or placebo was provided for 372 bipolar I patients, who met improvement criteria during open phase treatment for an index manic episode. The current analysis grouped patients according to the index manic episode subtype (euphoric or dysphoric), and evaluated the impact on maintenance treatment outcome. The rate of early discontinuation due to intolerance during maintenance treatment was higher for initially dysphoric patients (N=249) than euphoric patients (N=123; 15.7 vs 7.3%, respectively; p=0.032). Both lithium (23.2%) and divalproex (17.1%) were associated with more premature discontinuations due to intolerance than placebo (4.8%; p=0.003 and 0.02, respectively) in the initially dysphoric patients. Among initially euphoric patients, treatment with lithium was associated with significantly more premature discontinuations due to intolerance compared to placebo (18.2 vs 0%; p=0.03), and divalproex was significantly (p=0.05) more effective than lithium, but not placebo in delaying time to a depressive episode. Initial euphoric mania appeared to predispose to better outcomes on indices of depression and overall function with divalproex maintenance than with either placebo or lithium. Dysphoric mania appeared to predispose patients to more side effects when treated with either divalproex or lithium during maintenance therapy.
The effect of cholecystectomy on plasma cholecystokinin

Gallbladder removal is associated with an increased incidence of gastroesophageal reflux, but the mechanism is unclear. Cholecystokinin (CCK) release, which causes gallbladder contraction, is inhibited by bile in the duodenum. This study investigates the effect of cholecystectomy on meal-stimulated CCK secretion.Three groups of patients were studied. Group 1 (n = 15) were normal controls. Group 2 (n = 27) were patients with symptomatic gallstones. Group 3 (n = 25) were patients who had undergone cholecystectomy. Meal-stimulated CCK levels were measured by radioimmunoassay at defined time points for 60 min after a standard corn oil-based meal.Fasting CCK levels were similar in all three groups. In postcholecystectomy patients, meal-stimulated plasma CCK levels were significantly elevated compared with controls: median (range) integrated CCK values for 60 min were 116 (28–209) in controls, 123 (20–501) in gallstone patients, and 176 (63–502) after cholecystectomy.This study suggests that cholecystectomy causes an exaggerated meal-stimulated CCK response. Because CCK is known to relax the lower esophageal sphincter, these findings may help explain the increased incidence of gastroesophageal reflux seen after cholecystectomy.
A clinic-based mammography intervention targeting inner-city women

The objective was to evaluate the effect of a clinic-based intervention program on mammography use by inner-city women. A randomized controlled trial employing firm system methodology was conducted. The study setting was a general internal medicine clinic in the university-affiliated county hospital serving metropolitan Seattle. Women aged 50 to 74 years with at least one routine clinic appointment (when they were due for mammography) during the study period were enrolled in the trial (n=314). The intervention program emphasized nursing involvement and included physician education, provider prompts, use of audiovisual an printed patient education materials, transportation assistance in the form of bus passes, preppointment telephone or postcard reminders, and rescheduling assistance. Control firm women received usual care. Mammography completion within 8 weeks of clinic visits was significantly higher among intervention (49%) than control (22%) firm women (p<.001). These effects persisted after adjustment for potential confounding by age, race, medical insurance coverage, and previous mammography experience at the hospital (odds ratio 3.5; 95% confidence interval 1.9, 6.5). The intervention effect was modified by type of insurance coverage as well as prior mammography history. Process evaluation indicated that bus passes and rescheduling efforts did not contribute to the observed increases in screening participation. A clinic-based program incorporating physician education, provider prompts, patient education materials, and appointment reminders and emphasizing nursing involvement can facilitate adherence to breast cancer screening guidelines among inner-city women.
Neoadjuvant sequential epirubicin and docetaxel followed by surgery-radiotherapy and post-operative docetaxel or gemcitabine/vinorelbine combination based on primary response: a multimodality approach for locally advanced breast cancer

Locally advanced breast cancer (LABC) remains a major clinical issue despite progress achieved in recent years. Herein, we present the mature results of a multimodality treatment program tailoring epirubicin (EPI), docetaxel (DOC) and gemcitabine–vinorelbine (GEV) peri-operatively in LABC. Stage III, Eastern Cooperative Oncology Group-Performance status ≤2 patients were eligible. A biopsy documentation had to be performed before the start of chemotherapy (CT). Treatment consisted of four EPI (100 mg/m2, d1q2w) followed by three DOC (100 mg/m2, d1q3w); surgery 3–4 weeks from CT completion, followed by radiation therapy (RT) and CT according to response; partial or complete (PR/CR):DOC, no change or progressive disease (NC/PD):GEV. Primary endpoints were: (a) response and conversion to operability/conservative surgery and (b) overall survival (OS) and time to recurrence (TTR). Fifty-six women, aged 32–75 (median 52 years), 24 IIIA and 32 IIIB were enrolled; 53 patients completed the entire program. Toxicity was acceptable and no treatment-related death was observed. Efficacy: clinical response rate (RR) 71.4% (40 patients); clinical complete response rate 33.9% (19 patients). Pathological response rate (RR) 67.8% (38 patients); pathological complete response rate 21.4% (12 patients). 33 (58.9%) and 19 (33.9%) patients, respectively, had radical and conservative operations without increased morbidity. After a median follow-up of 62 months, median OS has not yet been reached, while median TTR was 42 months. OS was longer in patients with clinical (p = 0.004) and pathological response (p = 0.002), RT (p < 0.0001) and post-operative DOC (p = 0.038). TTR was favorably affected by pR (p < 0.0001), RT (p < 0.0004) and post-operative DOC (p = 0.005). Pre-operative CT seemed to be equally active throughout all subgroups according to histology, ER/PR and HER2 status. The treatment program of the present study allowed for the completion of an effective therapy at the cost of acceptable toxicity. The results of this study suggest a central role of CT for LABC and the value of eventually dose-dense, EPI- and DOC-based CT in a large proportion of LABC patients, regardless of biological tumor profile. Furthermore, tumor response (cR, pR) is an important surrogate for patients survival and further therapy management.
Repaglinide/troglitazone combination therapy: improved glycemic control in type 2 diabetes.

This multicenter open-label clinical trial compared the efficacy and safety of repaglinide/troglitazone combination therapy, repaglinide monotherapy, and troglitazone monotherapy in type 2 diabetes that had been inadequately controlled by sulfonylureas, acarbose, or metformin alone.



Patients with type 2 diabetes (n = 256) who had inadequate glycemic control (HbA1c > or =7.0%) during previous monotherapy were randomly assigned to receive repaglinide (0.5-4.0 mg at meals), troglitazone (200-600 mg once daily), or a combination of repaglinide (1-4 mg at meals) and troglitazone (200-600 mg once daily). After a 4-6 week washout period, the trial assessed 22 weeks of treatment: 3 weeks (weeks 0-2) of forced titration, 11 weeks of fixed-dose treatment (weeks 3-13), and 8 weeks (weeks 14-21) of titration to maximum dose. Changes in HbA1c and fasting plasma glucose (FPG) values were measured.



The combination therapy showed a significant reduction in mean HbA1c values (-1.7%) that was greater than with either type of monotherapy Repaglinide monotherapy resulted in a reduction of HbA1c values that was significantly greater than troglitazone (-0.8 vs. -0.4%) (P < 0.05). Combination therapy was more effective in reducing FPG values (-80 mg/dl) than either repaglinide (-43 mg/dl) or troglitazone (-46 mg/dl) monotherapies. Adverse events were similar in all groups.



Combination therapy with repaglinide and troglitazone leads to better glycemic control than monotherapy with either agent alone. Repaglinide monotherapy was more effective in lowering HbA1c levels than troglitazone monotherapy Repaglinide/troglitazone combination therapy was effective and did not show unexpected adverse events.