nils-herrmann/clean_scirepeval huggingface dataset:
P18-14 LB. Vacc-4x HIV p24-like peptide vaccine-associated increase of CD4 T-cells in chronically infected HIV-1 patients on antiretroviral therapy

Since its implementation more than a decade ago combination Antiretroviral Therapy (ART) has had a dramatic effect on HIV-1 induced mortality and morbidity. However, 15-20% of the patients initiating ART do not regain CD4 T-cells despite an effective suppression of HIV1mRNA levels in blood. The incomplete therapeutic effect leaves these patients at elevated risk of disease complications and death. Attempts to reduce clinical events through IL-2 induced stimulation of CD4 T-cells in the ESPRIT and SILCAAT studies have not proven to be successful. Until further research has given better opportunities for a successful direct induction of functional CD4 cells a logical alternative may be to increase CD4 counts indirectly by improving anti-HIV effect while on ART using antigen-specific immune stimulation with an effective HIV-vaccine.
Enhanced T cell recovery in HIV-1-infected adults through IL-7 treatment.

HIV infection results in CD4+ T cell deficiency, but efficient combination antiretroviral therapy (c-ART) restores T cells and decreases morbidity and mortality. However, immune restoration by c-ART remains variable, and prolonged T cell deficiency remains in a substantial proportion of patients. In a prospective open-label phase I/IIa trial, we evaluated the safety and efficacy of administration of the T cell regulator IL-7. The trial included 13 c-ART-treated HIV-infected patients whose CD4+ cell counts were between 100 and 400 cells/microl and plasma HIV RNA levels were less than 50 copies/ml. Patients received a total of 8 subcutaneous injections of 2 different doses of recombinant human IL-7 (rhIL-7; 3 or 10 microg/kg) 3 times per week over a 16-day period. rhIL-7 was well tolerated and induced a sustained increase of naive and central memory CD4+ and CD8+ T cells. In the highest dose group, 4 patients experienced transient increases in viral replication. However, functional assays showed that the expanded T cells responded to HIV antigen by producing IFN-gamma and/or IL-2. In conclusion, in lymphopenic HIV-infected patients, rhIL-7 therapy induced substantial functional and quantitative changes in T cells for 48 weeks. Therefore, patients may benefit from intermittent therapy with IL-7 in combination with c-ART.
Sentinel lymph node detection following the hysteroscopic peritumoural injection of 99mTc-labelled albumin nanocolloid in endometrial cancer

The purpose of this study was to assess the feasibility of sentinel lymph node (SLN) detection in endometrial cancer patients with a dual-tracer procedure after hysteroscopic peritumoural injection. Twenty-six women with previously untreated endometrial adenocarcinoma underwent the hysteroscopic injection of 111 MBq 99mTc-Nanocoll and blue dye administered subendometrially around the lesion. On the same day, all 26 patients underwent lymphoscintigraphy, followed 3–4 h later by hysterotomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy. Para-aortic lymphadenectomy was also performed in cases of either serous or papillary carcinoma (n=7/26). All SLNs were removed and examined with haematoxylin and eosin staining and immunohistochemical techniques. The procedure was well tolerated by patients, only two experiencing transient vagal symptoms. The sensitivity of this technique for correct identification of SLNs was 100%. Lymph node metastases were found in 4 out of the 26 patients (15%), bilaterally in the external iliac region (n=1), unilaterally in the external iliac region (n=1), unilaterally in the common iliac region (n=1) and unilaterally in the para-aortic region (n=1). In all four cases, nodal metastases were located within SLNs detected by lymphoscintigraphy. Only 10 of the 26 patients (38%) had significant blue dye staining. All blue-stained SLNs were radioactive. In patients with endometrial cancer, it is feasible to use lymphatic mapping and SLN biopsy to define the topographic distribution of the lymphatic network and also to accurately detect lumbo-aortic and pelvic metastases within SLNs. In the majority of patients with early stage endometrial cancer, this procedure may avoid unnecessary radical pelvic lymphadenectomy. It may also guide para-aortic lymph node dissection on the basis of the SLN status.
Change in heart rate variability in relation to a significant ST-event associates with newborn metabolic acidosis.

To find whether low-to-high frequency (LF/HF) ratio of fetal heart rate (FHR) variability changes in relation to a significant ST-event during delivery, and if the change is predictive of metabolic acidosis of the newborn.



A case-control study.



Data from a multicentre project.



Acidotic and control fetuses with abnormal cardiotocography together with a ST-event in fetal electrocardiogram (ECG).



We studied intrapartum FHR variability with spectral analysis from 34 fetuses with a significant ST-event in the fetal ECG. LF/HF ratio of FHR variability was measured within a period of 1 hour before and 1 hour after a significant ST-event. Sensitivity and specificity of the change in LF/HF ratio of FHR variability in prediction of metabolic acidosis (pH < or = 7.05 and base deficit value > 12.0 mmol/l) of the newborn were described by means of the receiver operating characteristic curve.



Change in LF/HF ratio of FHR in relation to a significant ST-event.



We found that a relative change in LF/HF ratio greater than 30% in relation to a significant ST-event predicted cord arterial metabolic acidosis with a sensitivity of 89% (95% CI 68-100%) and specificity of 80% (95% CI 64-96%).



Relative changes in LF/HF ratio of FHR variability in relation to a significant ST-event are more pronounced in fetuses born with metabolic acidosis.
Late radiation toxicity after intraoperative radiotherapy (IORT) for breast cancer: results from the randomized phase III trial TARGIT A

The randomized phase III trial TARGIT A showed non-inferiority regarding local control after intraoperative radiotherapy (IORT 20 Gy which was followed by whole breast radiotherapy (WBRT) in patients with risk factors only) in comparison to standard WBRT (50–56 Gy) after breast-conserving surgery in selected patients. This is the first analysis of long-term toxicities in the setting of TARGIT. Between 02/2002 and 12/2008, 305 patients were treated within TARGIT A (Arm A: n = 34 IORT, n = 20 IORT + WBRT for risk factors; Arm B WBRT: n = 55) or received IORT as a planned boost (control group: n = 196) at a single center. Toxicity was assessed according to the LENT SOMA scales. No significant differences were seen between Arm A and Arm B regarding fibrosis, breast edema, retraction, ulceration, lymphedema, hyperpigmentation, and pain. Arm A had significantly less telangiectases compared to Arm B (p = 0.049). In the subanalysis (Arm A IORT vs. Arm A IORT + WBRT vs. Arm B), fibrosis had a cumulative rate of 5.9 versus 37.5 versus 18.4 %, respectively (38.2 % IORT boost control group), at 3 years. No telangiectases were seen after IORT alone (0 % Arm A IORT vs. 17.5 % Arm A IORT + WBRT vs. 17.7 % Arm B). The hazard ratio of higher grade toxicity as first event was 0.46 (95 % CI, 0.26–0.83) for Arm A IORT as compared to Arm B (p = 0.010). No recurrences were seen after a median follow-up of 40 months (Arm A) and 42 months (Arm B). With its very low chronic skin toxicity rates and outstanding long-term results regarding toxicity and local control, IORT with 50 kV X-rays is a safe and effective method for treatment of selected breast cancer patients.
Hepatitis B and Schistosoma co-infection in a non-endemic area

Schistosomiasis is related to the development of liver fibrosis and portal hypertension. Chronic co-infection with HBV and Schistosoma has been associated in endemic areas with a higher risk for a more severe liver disease. However, no studies have assessed the real importance of this co-infection in non-endemic regions. This is a retrospective observational study of Sub-Saharan immigrants attending between October 2004 and February 2014. Patients with chronic HBV infection with and without evidence of schistosomal infection were compared. Epidemiological, analytical, and microbiological data were analysed. Likelihood of liver fibrosis based on APRI and FIB-4 indexes was established. A total of 507 patients were included in the study, 170 (33.5 %) of them harbouring evidence of schistosome infection. No differences were found in transaminase, GGT, and ALP levels. In fibrosis tests, a higher proportion of patients with HVB and S. mansoni detection reached possible fibrosis scores (F > 2) when compared to patients without schistosomiasis: 17.4 vs 14.2 % and 4.3 % vs 4.2 % (using high sensitivity and high specificity cut-offs respectively), although differences were not statistically significant (p = 0.69, p = 0.96). For possible cirrhosis (F4) score, similar results were observed: 4.3 % of co-infected patients vs 2.1 % of mono-infected ones, p = 0.46. According to these datas, in non-endemic regions the degree of hepatic fibrosis in patients with chronic hepatitis B is not substantially modified by schistosome co-infection.
A phase II study of bevacizumab plus erlotinib for gemcitabine-refractory metastatic pancreatic cancer

No standard of care exists for patients with metastatic pancreatic cancer following progression on first-line chemotherapy. Based on potential for additive or synergistic activity by concurrent inhibition of VEGF and EGFR, we conducted a phase II study evaluating the combination of bevacizumab plus erlotinib in this patient population. Patients with metastatic pancreatic adenocarcinoma, ECOG performance status 0–1, and previous exposure to 1–3 systemic therapies (at least one gemcitabine-based) were eligible. Treatment consisted of bevacizumab 15 mg/kg every 21 days plus erlotinib 150 mg daily. Thirty-six patients were enrolled, including eight who had previously received VEGF-targeted therapy and nine prior erlotinib. Median number of treatment cycles was 2 (range, 1–7). Common toxicities included rash (72%), diarrhea (25%), venous thromboembolic events (15%), and hypertension (11%). One patient demonstrated partial response and seven others stable disease for >2 cycles. CA19-9 decline ≥25% was observed in 4/26 patients with baseline levels >2x ULN. Estimated median time to progression was 40 days (95% CI, 35–41 days) and median survival 102 days (95% CI, 74–117 days), with a 6-month survival rate of 22%. Baseline concentration of circulating endothelial cells (CD45−/CD34+/CD31+) was inversely associated with overall survival. The combination of bevacizumab and erlotinib is safe but relatively ineffective in patients with gemcitabine-refractory metastatic pancreatic cancer. Future studies should focus on refining subsets of patients in this challenging population likely to benefit from treatment beyond first-line.
Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed.
A randomized study of mitoxantrone plus cytarabine versus daunomycin plus cytarabine in the treatment of previously untreated adult patients with acute nonlymphocytic leukemia

Between May 1985 and November 1988, 143 adult patients with previously untreated acute nonlymphocytic leukemia were randomized to receive mitoxantrone and cytarabine (MTT+Ara-C) or daunomycin and cytarabine (DNM+Ara-C) in order to compare the efficacy and acute and chronic toxicities. Therapy consisted of 3 days of MTT 12 mg/m2/i.v. or DNM 45 mg/m2/i.v.; both groups received Ara-C 100 mg/m2 daily by continuous infusion (CI) for 7 days. Those who failed to achieve a complete remission after one induction course received a second induction course for 2 and 5 days at the same doses. All the patients who achieved complete remission received two consolidations of 2 days of MTT or DNM and 5 days of Ara-C in CI at the same dose as for induction. Of the 72 patients on MTT+Ara-C, 38 (53%) achieved complete remission, compared with 29 (43%) of 67 treated with DNM+Ara-C. Three and 5 patients had partial remission, 7 and 18 failed to respond, 24 and 15 died in the first 21 days of induction, of those treated with MTT+Ara-C or DNM+Ara-C, respectively (p=0.34). Median duration of complete remission and survival was 185 and 103 days or 165 and 160 days, respectively (p=0.85). More early deaths were observed with MTT+Ara-C due to greater myelosuppression, and a higher incidence of failure with DNM+Ara-C. No significant differences between treatment groups were observed in 21 categories of adverse events. The results demonstrate similar incidence of complete response, length of duration of complete remission, overall survival, and toxicity with MTT+Ara-C and DNM+Ara-C.
Predictors of fibromyalgia: a population-based twin cohort study

Fibromyalgia (FM) is a pain syndrome, the mechanisms and predictors of which are still unclear. We have earlier validated a set of FM-symptom questions for detecting possible FM in an epidemiological survey and thereby identified a cluster with "possible FM". This study explores prospectively predictors for membership of that FM-symptom cluster.



A population-based sample of 8343 subjects of the older Finnish Twin Cohort replied to health questionnaires in 1975, 1981, and 1990. Their answers to the set of FM-symptom questions in 1990 classified them in three latent classes (LC): LC1 with no or few symptoms, LC2 with some symptoms, and LC3 with many FM symptoms. We analysed putative predictors for these symptom classes using baseline (1975 and 1981) data on regional pain, headache, migraine, sleeping, body mass index (BMI), physical activity, smoking, and zygosity, adjusted for age, gender, and education. Those with a high likelihood of having fibromyalgia at baseline were excluded from the analysis. In the final multivariate regression model, regional pain, sleeping problems, and overweight were all predictors for membership in the class with many FM symptoms.



The strongest non-genetic predictor was frequent headache (OR 8.6, CI 95% 3.8-19.2), followed by persistent back pain (OR 4.7, CI 95% 3.3-6.7) and persistent neck pain (OR 3.3, CI 95% 1.8-6.0).



Regional pain, frequent headache, and persistent back or neck pain, sleeping problems, and overweight are predictors for having a cluster of symptoms consistent with fibromyalgia.
Multi-laboratory inter-institute reproducibility study of IVOCT and IVUS assessments using published consensus document definitions.

The aim of this study was to investigate the reproducibility of intravascular optical coherence tomography (IVOCT) assessments, including a comparison to intravascular ultrasound (IVUS). Intra-observer and inter-observer variabilities of IVOCT have been previously described, whereas inter-institute reliability in multiple laboratories has never been systematically studied.



In 2 independent laboratories with intravascular imaging expertise, 100 randomized matched data sets of IVOCT and IVUS images were analysed by 4 independent observers according to published consensus document definitions. Intra-observer, inter-observer, and inter-institute variabilities of IVOCT qualitative and quantitative measurements vs. IVUS measurements were assessed. Minor inter- and intra-observer variability of both imaging techniques was observed for detailed qualitative and geometric analysis, except for inter-observer mixed plaque identification on IVUS (κ = 0.70) and for inter-observer fibrous cap thickness measurement reproducibility on IVOCT (ICC = 0.48). The magnitude of inter-institute measurement differences for IVOCT was statistically significantly less than that for IVUS concerning lumen cross-sectional area (CSA), maximum and minimum lumen diameters, stent CSA, and maximum and minimum stent diameters (P < 0.001, P < 0.001, P < 0.001, P = 0.02, P < 0.001, and P = 0.01, respectively). Minor inter-institute measurement variabilities using both techniques were also found for plaque identification.



In the measurement of lumen CSA, maximum and minimum lumen diameters, stent CSA, and maximum and minimum stent diameters by analysts from two different laboratories, reproducibility of IVOCT was more consistent than that of IVUS.
Randomized comparison of ABVD chemotherapy with a strategy that includes radiation therapy in patients with limited-stage Hodgkin's lymphoma: National Cancer Institute of Canada Clinical Trials Group and the Eastern Cooperative Oncology Group.

We report results of a randomized trial comparing ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy alone with treatment that includes radiation therapy in patients with limited-stage Hodgkin's lymphoma.



Patients with nonbulky clinical stage I to IIA Hodgkin's lymphoma were stratified into favorable and unfavorable risk cohorts. Patients allocated to radiation-containing therapy received subtotal nodal radiation if favorable risk or combined-modality therapy if unfavorable risk. Patients allocated to ABVD received four to six treatment cycles.



We evaluated 399 patients. Median follow-up is 4.2 years. In comparison with ABVD alone, 5-year freedom from disease progression is superior in patients allocated to radiation therapy (P = .006; 93% v 87%); no differences in event-free survival (P = .06; 88% v 86%) or overall survival (P = .4; 94% v 96%) were detected. In a subset analyses comparing patients stratified into the unfavorable cohort, freedom from disease progression was superior in patients allocated to combined-modality treatment (P = .004; 95% v 88%); no difference in overall survival was detected (P = .3; 92% v 95%). Of 15 deaths observed, nine were attributed to causes other than Hodgkin's lymphoma or acute treatment-related toxicity.



In patients with limited-stage Hodgkin's lymphoma, no difference in overall survival was detected between patients randomly assigned to receive treatment that includes radiation therapy or ABVD alone. Although 5-year freedom from disease progression was superior in patients receiving radiation therapy, this advantage is offset by deaths due to causes other than progressive Hodgkin's lymphoma or acute treatment-related toxicity.
Efficacy of tenofovir and efavirenz in combination with lamivudine or emtricitabine in antiretroviral-naive patients in Europe.

The combination of tenofovir and efavirenz with either lamivudine or emtricitabine (TELE) has proved to be highly effective in clinical trials for first-line treatment of HIV-1 infection. However, limited data are available on its efficacy in routine clinical practice.



A multicentre cohort study was performed in therapy-naive patients initiating ART with TELE before July 2009. Efficacy was studied using ITT (missing or switch = failure) and on-treatment (OT) analyses. Genotypic susceptibility scores (GSSs) were determined using the Stanford HIVdb algorithm.



Efficacy analysis of 1608 patients showed virological suppression to <50 copies/mL at 48 weeks in 91.5% (OT) and 70.6% (ITT). Almost a quarter of all patients (22.9%) had discontinued TELE at week 48, mainly due to CNS toxicity. Virological failure within 48 weeks was rarely observed (3.3%, n = 53). In multilevel, multivariate analysis, infection with subtype B (P = 0.011), baseline CD4 count <200 cells/mm³ (P < 0.001), GSS <3 (P = 0.002) and use of lamivudine (P < 0.001) were associated with a higher risk of virological failure. After exclusion of patients using co-formulated compounds, virological failure was still more often observed with lamivudine. Following virological failure, three-quarters of patients switched to a PI-based regimen with GSS <3. After 1 year of second-line therapy, viral load was suppressed to <50 copies/mL in 73.5% (OT).



In clinical practice, treatment failure on TELE regimens is relatively frequent due to toxicity. Virological failure is rare and more often observed with lamivudine than with emtricitabine. Following virological failure on TELE, PI-based second-line therapy was often successful despite GSS <3.
Regular consumption of cocoa powder with milk increases HDL cholesterol and reduces oxidized LDL levels in subjects at high-risk of cardiovascular disease.

Epidemiological studies suggest that regular consumption of cocoa-containing products may confer cardiovascular protection, reducing the risk of coronary heart disease (CHD). However, studies on the effects of cocoa on different cardiovascular risk factors are still scarce. The aim of this study was too evaluate the effects of chronic cocoa consumption on lipid profile, oxidized low-density lipoprotein (oxLDL) particles and plasma antioxidant vitamin concentrations in high-risk patients.



Forty-two high-risk volunteers (19 men and 23 women, mean age 69.7 ± 11.5 years) were included in a randomized, crossover feeding trial. All received 40g of cocoa powder with 500 mL of skimmed milk/day(C + M) or only 500 mL/day of skimmed milk (M) for 4 weeks in a random order. Before and after each intervention period, plasma lipids, oxLDL and antioxidant vitamin concentrations were measured, as well as urinary cocoa polyphenols metabolites derived from phase II and microbial metabolisms. Compared to M, C + M intervention increases HDLc [2.67 mg/dL (95% confidence intervals, CI, 0.58-4.73; P = 0.008)] and decreases oxLDL levels [-12.3 U/L (CI,-19.3 to -5.2;P = 0.001)]. No changes between intervention groups were observed in vitamins B1, B6, B12, C and E, or folic acid concentrations. In addition, subjects who showed higher increments in urinary cocoa polyphenol metabolites exhibited significant increases in HDLc and significant decreases in oxLDL levels (P < 0.05; all).



Consumption of cocoa power with milk modulates the lipid profile in high-risk subjects for CHD. In addition, the relationship observed between the urinary excretion of cocoa polyphenol metabolites and plasma HDLc and oxLDL levels suggests a beneficial role for cocoa polyphenols in lipid metabolism.