nils-herrmann/clean_scirepeval huggingface dataset:
HIV Replication Alters the Composition of Extrinsic Pathway Coagulation Factors and Increases Thrombin Generation

HIV infection leads to activation of coagulation, which may increase the risk for atherosclerosis and venous thromboembolic disease. We hypothesized that HIV replication increases coagulation potentially through alterations in extrinsic pathway factors.



Extrinsic pathway factors were measured among a subset of HIV participants from the Strategies for Management of Anti-Retroviral Therapy (SMART) trial. Thrombin generation was estimated using validated computational modeling based on factor composition. We characterized the effect of antiretroviral therapy (ART) treatment versus the untreated state (HIV replication) via 3 separate analyses: (1) a cross-sectional comparison of those on and off ART (n=717); (2) a randomized comparison of deferring versus starting ART (n=217); and (3) a randomized comparison of stopping versus continuing ART (n=500). Compared with viral suppression, HIV replication consistently showed short-term increases in some procoagulants (eg, 15% to 23% higher FVIII; P<0.001) and decreases in key anticoagulants (eg, 5% to 9% lower antithrombin [AT] and 6% to 10% lower protein C; P<0.01). The net effect of HIV replication was to increase coagulation potential (eg, 24% to 48% greater thrombin generation from computational models; P<0.01 for all). The pattern of changes from HIV replication was reversed with ART treatment and consistent across all 3 independent comparisons.



HIV replication leads to complex changes in extrinsic pathway factors, with the net effect of increasing coagulation potential to a degree that may be clinically relevant. The key influence of changes in FVIII and AT suggests that HIV-related coagulation abnormalities may involve changes in hepatocyte function in the context of systemic inflammation.
Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWO

To determine the effect of posttransplantation immunotherapy with IL-2 on the progression-free survival (PFS) and overall survival (OS) of patients with non-Hodgkin lymphoma (NHL) after autologous stem-cell transplantation (PBSCT), patients with previously treated NHL were treated with cyclophosphamide, etoposide, total body irradiation (TBI), and PBSCT. Twenty-eight to 80 days after PBSCT, patients were randomized to IL-2 versus observation. Three hundred seventy-six eligible patients were registered (with 4-year PFS of 34% and 4-year OS of 52%), and 194 eligible patients were randomized to continuous infusion intravenous IL-2 (9 million units/m(2)/day for 4 days followed 5 days later by 1.6 million units/m(2)/day for 10 days) versus observation. In randomized patients, there was no significant difference in PFS (hazard ratio of IL-2 to observation = 0.90; P =.56) or in OS (hazard ratio of IL-2 to observation = 0.88; P =.55). There were no deaths related to IL-2 treatment. Grade 4 IL-2-related toxicities (n = 14) were reversible. These results confirm earlier SWOG findings that cyclophosphamide, etoposide, TBI, and PBSCT can be administered to patients with relapsed/refractory NHL with encouraging PFS and OS. Posttransplantation IL-2 given at this dose and schedule of administration had no significant effect on PFS or OS.
Cost-effectiveness of preoperative radiotherapy in rectal cancer: results from the Swedish Rectal Cancer Trial.

The Swedish Rectal Cancer Trial (SRCT) demonstrated that a short-term regimen of high-dose fractionated preoperative radiotherapy (5 x 5 Gy) reduced the local recurrence rates and improved overall survival. This has had an impact on the primary treatment of rectal cancer. The current study investigated the cost-effectiveness of the new combined approach.



After an 8-year follow-up, in-hospital and outpatient costs related to the treatment of rectal cancer and its complications were analyzed for 98 randomly allocated patients who participated in the SRCT from a single Swedish health care region. The costs were then related to the clinical data from the SRCT regarding complications, local and distant recurrences, and survival.



The total cost for a nonirradiated patient was US$30,080 compared with US$35,268 for an irradiated patient. The surgery-alone group had increased costs related to local recurrences, and the radiotherapy group had increased costs for irradiation and complications. With a survival benefit of 21 months (retrieved from the SRCT), the cost for a saved year was US$3654. Sensitivity analyses for different rates of local recurrences, the costs related to complications and less marked survival benefit showed that this figure could vary up to US$15,228.



The cost for a life-year saved in these data was US$3654. This figure could reach US$15,228 in the most pessimistic setting of the sensitivity tests, a cost still comparable with other well-accepted medical interventions.
Magnetic resonance imaging in multiple myeloma: diagnostic and clinical implications.

Magnetic resonance imaging (MRI) permits the detection of diffuse and focal bone marrow infiltration in the absence of osteopenia or focal osteolysis on standard metastatic bone surveys (MBSs).



Both baseline MBS and MRI were available in 611 of 668 myeloma patients who were treated uniformly with a tandem autologous transplantation-based protocol and were evaluated to determine their respective merits for disease staging, response assessment, and outcome prediction.



MRI detected focal lesions (FLs) in 74% and MBS in 56% of imaged anatomic sites; 52% of 267 patients with normal MBS results and 20% of 160 with normal MRI results had FL on MRI and MBS, respectively. MRI- but not MBS-defined FL independently affected survival. Cytogenetic abnormalities (CAs) and more than seven FLs on MRI (MRI-FLs) distinguished three risk groups: 5-year survival was 76% in the absence of both more than seven MRI-FLs and CA (n = 276), 61% in the presence of one MRI-FL (n = 262), and 37% in the presence of both unfavorable parameters (n = 67). MRI-FL correlated with low albumin and elevated levels of C-reactive protein, lactate dehydrogenase, and creatinine, but did not correlate with age, beta-2-microglobulin, and CA. Resolution of MRI-FL, occurring in 60% of cases and not seen with MBS-defined FL, conferred superior survival.



MRI is a more powerful tool for detection of FLs than is MBS. MRI-FL number had independent prognostic implications; additionally, MRI-FL resolution identified a subgroup with superior survival. We therefore recommend that, in addition to MBS, MRI be used routinely for staging, prognosis, and response assessment in myeloma.
Added value of an intensive multidisciplinary functional rehabilitation programme for chronic low back pain patients.

Several treatments exist for chronic low back pain (cLBP) patients although none has shown superiority. Among group treatments, muscle reconditioning programmes (MRPs) are the most commonly used. Multidisciplinary functional rehabilitation programmes (MFRPs) are an alternative.



To compare a MFRP with a MRP as few studies compare these treatments



This was a prospective, nonrandomised, controlled study comparing cLBP patients participating in a MRP or MFRP in an outpatient setting. The predetermined primary outcome measure was the daily life activity subscale (DLA) of the Dallas Pain Questionnaire (DPQ) within one year after the end of the treatment.



Twenty-one patients were included in the MRP and 24 in the MFRP. At inclusion, the groups were similar in terms of age (mean 40 years), sex (50%-60% males), sick leave duration (mean 6.0 months, standard deviation (SD) 4.4 months) and follow up (mean 9.0 months, SD 2.0 months). The DLA score decreased from 59.5% (SD 16.9) to 44.8% (SD 25.4), p <0.01, in the MFRP and from 62.3 (SD 20.3) to 58.8 (SD 20.7), p = 0.3, in the MRP. The between-groups difference at follow-up was 13.8, p = 0.05, and the difference in the mean improvement was -11.5 (5.9), p = 0.058. Seventy-eight percent of MFRP patients versus 47 % in the MRP group returned to work (p = 0.08).



In a population of highly disabled cLBP patients, MFRP seems more effective in increasing function and return to work. Interpretation is limited by the small population included and by the type of trial.



Randomised studies are needed to confirm these results and explore the cost-effectiveness of MFRP.
Transmission of drug-resistant HIV-1 in Europe remains limited to single classes.

The spread of drug-resistant HIV-1 might compromise the future success of current first-line regimens.



To analyse the extent and impact of transmission of drug-resistant HIV-1 variants in Europe.



The European prospective programme (SPREAD) collected demographic, clinical and virological data from 1245 HIV-1-infected individuals in 17 countries diagnosed in 2002-2003. The potential impact of transmitted drug resistance mutations (TDRMs) on therapy response was determined by using genotypic interpretation algorithms.



The overall prevalence of viruses with drug-resistance mutations was 9.1% [96/1050; 95% confidence interval: 7.5-11.1]. The majority (71%) harboured only a single amino acid substitution with limited effect on predicted drug susceptibility. Mutations associated with resistance to nucleoside reverse transcriptase inhibitors were observed most frequently [57/1050 (5.4%)], followed by mutations related to protease inhibitors [32/1050 (3.0%)] and mutations related to non-nucleoside reverse transcriptase inhibitors (NNRTIs) [27/1050 (2.6%)]. In some cases, however, resistance was quite extensive. Four individuals were infected with viruses with reduced susceptibility to all nucleoside reverse transcriptase inhibitors, 3 to all protease inhibitors and 20 to both NNRTIs. Remarkably, in one individual, the resistance pattern was so extensive that none of the available current antiretroviral drugs was predicted to be fully active.



The prevalence of TDRM-HIV is quite prominent (9.1%) but did not increase in comparison with a large retrospective European study. Particularly the presence of single NNRTI mutations may impact the efficacy of the first-line regimens. Continuous prospective monitoring remains indicated to explore the patterns and factors contributing to the transmission of TDRMs as well as the potential clinical consequences.
A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial

Latinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites. While poor adherence is a major contributor to disparities in blood pressure control, data in Latino patients are scant. More importantly, translation of interventions to improve medication adherence in community-based primary care practices, where the majority of Latino patients receive their care is non-existent.



Using a randomized controlled design, this study evaluates the effectiveness of a culturally tailored, practice-based intervention compared to usual care on medication adherence, among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications. Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script. Patients randomized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors. Health Coach sessions are held biweekly for the first 3 months (6 sessions total) and then monthly for the remaining 3 months (3 sessions total). Patients randomized to the usual care group receive standard hypertension treatment recommendations as determined by their primary care providers. The primary outcome is the rate of medication adherence at 6 months. The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months.



If successful, findings from this study will provide salient information on the translation of culturally tailored, evidence-based interventions targeted at medication adherence and blood pressure control into practice-based settings for this high-risk population.
Assessment of hearing in children with type 1 diabetes mellitus.

To evaluate auditory function in a group of Egyptian type 1 diabetic children.



This was a cross sectional observational study, which included 40 patients with type 1 diabetes and 40 controls. HbA1, urinary albumin/creatinine ratio, and auditory assessments (including dizziness questionnaire, pure tone audiometry, speech audiometry, tympanometry, and auto-acoustic cochlear emission) were completed for all patients and controls. Mann-Whitney U-test, χ2-test and Spearman's correlation were used for statistical analyses.



Assessment of pure tone audiometry revealed that the diabetics had a significantly higher reading in high frequency at 8000 Hz, 16,000 Hz, 17,000 Hz, and 18,000 Hz on the right side and at 4000 Hz, 8000 Hz, 16,000 Hz, 17,000 Hz, and 18,000 Hz on the left side. There was a significantly lower level in speech reception threshold, repetition of words, and masking level of diabetics on the left side. Evaluation of transient otoacoustic emission revealed that diabetics recorded significantly lower signal to noise ratio at 4000 Hz on the right side and at 1000, 1500, 4000, and all Hz on left side. There was significant lower emission amplitude in the right side of the diabetics group at 1500 and 4000 Hz and at 1000, 1500, and 4000 Hz on the left side. Patients with failed otoacoustic emission were significantly higher in disease duration >10 years.



Type 1 diabetes is associated with high/extended high frequency hearing loss, more prominent on the left side and with longer disease duration.
Effects of a Cognitive-Behavioral Self-Help Program on Depressed Mood for People with Peripheral Arterial Disease

The aim of the present study was to examine whether a new low-cost psychological self-help intervention program with minimal coaching could be effective in improving depressed mood in people with peripheral arterial disease (PAD). Thirteen persons with PAD and depressive symptoms participated in the self-help program, grounded in cognitive-behavioral therapy. They completed pre-test, post-test and follow-up questionnaires, including the PHQ-9, to measure symptoms of depression. To evaluate changes in depression scores from pre- to post-test to follow-up measurement, non-parametric repeated measures Wilcoxon signed rank tests were performed. The results showed that participants’ depression scores significantly improved from pre-test to post-test and that there was no relapse from post-test to follow-up. The cognitive-behavioral self-help intervention could be an effective tool in people with PAD, to reduce symptoms of depression.
Implementation of guidelines for the treatment of acute ST-elevation myocardial infarction: the Cologne Infarction Model Registry.

The aim of the Köln (Cologne) Infarction Model is to examine the feasibility of obligatory treatment of ST-segment-elevation myocardial infarction (STEMI) by first-line percutaneous coronary intervention.



The study was performed in Cologne with >1 million citizens, 5 coronary intervention centers, and 11 primary care hospitals. Twelve-lead ECG was available for all emergency medical service (EMS) teams. Partners guaranteed direct transfer of STEMI patients to a catheterization laboratory. A total of 519 patients treated within KIM in 2006 were included in the study. Of these, 24% presented at a primary care hospital, 11% presented directly at a coronary intervention center, 5% were transferred by EMS to primary care hospitals, and 60% were directly transferred by EMS to a catheterization laboratory. In 91% of cases, the catheterization laboratory was notified of the patient's arrival in advance. False-positive ECG diagnosis of STEMI by EMS accounted for 6%. Median treatment times were as follows: from the start of symptoms to first medical contact, 120 minutes; phone to balloon, 70 minutes; and door to balloon, 49 minutes. Of all patients, 93% underwent angiography; 409 patients were treated by coronary intervention, and 24 underwent emergency coronary artery bypass graft. Thrombolysis in Myocardial Infarction grade 3 flow was obtained in 89%. In the hospitals, deaths and new myocardial infarctions were observed in 12.1% and in 1.9% of all patients, respectively.



The Cologne Infarction Model provides evidence for the feasibility of obligatory treatment of STEMI by primary coronary intervention in a metropolitan setting. Acceptance of treatment pathways allowed nearly all STEMI patients to undergo coronary angiography. ECG competence of EMS was excellent. Treatment times were within postulated limits. Results, including mortality, were within a high quality range.
Low doses of scopolamine increase cardiac vagal tone in the acute phase of myocardial infarction.

Reduced cardiac vagal tone in patients with myocardial infarction (MI) is associated with a high risk of sudden death. Muscarinic blocking agents in small doses induce a paradoxical increase in cardiac vagal activity in normal subjects. We tested whether low doses of scopolamine delivered transdermally enhance tonic and reflex cardiac vagal activity in patients in the acute phase of MI.



Patients were randomized to a scopolamine (n = 17) or a placebo patch (n = 19) in a double-blind fashion 4.20 +/- 0.18 days after acute MI. Cardiac vagal activity was assessed by testing the arterial baroreflex sensitivity (BRS) using the phenylephrine method and by power spectral analysis of the RR interval variability. Twenty-four hours after scopolamine, we found a significant increase in BRS (from 7.05 +/- 1.21 to 13.99 +/- 2.33 ms/mm Hg, P < .05) and in RR variability, expressed as the mean standard deviation of 512 normal consecutive RR intervals (from 18.09 +/- 2.64 to 31.16 +/- 4.16 milliseconds, P < .05). The amplitude of respiratory sinus arrhythmia, measured by the absolute power of the high-frequency spectral component, was also enhanced (from 62.55 +/- 21.49 to 305.33 +/- 95.68 milliseconds squared, P < .05), whereas the power in the low-frequency spectral component of the RR variability, which results from the interaction between cardiac sympathetic and vagal activity, did not change significantly (from 73.12 +/- 24.44 to 126.46 +/- 44.29 milliseconds squared, P = .93).



In patients in the acute phase of MI, low doses of scopolamine cause a sustained increase in cardiac vagal tone and improve the autonomic indices associated with mortality.
Therapeutic effect of continuous exercise training program on serum creatinine concentration in men with hypertension: a randomized controlled trial.

Creatinine (Cr) has been implicated as an independent predictor of hypertension and exercise has been reported as adjunct therapy for hypertension. The purpose of the present study was to investigate the effect of continuous training programme on blood pressure and serum creatinine concentration in black African subjects with hypertension.



Three hundred and fifty seven male patients with mild to moderate (systolic blood pressure [SBP] between 140-180 & diastolic blood pressure [DBP] between 90-109 mmHg) essential hypertension were age matched and randomly grouped into continuous & control groups. The continuous group involved in an 8 weeks continuous training (60-79% HR reserve) of between 45 minutes to 60 minutes, 3 times per week, while the control group remain sedentary. SBP, DBP, VO2max, serum Cr, body mass index (BMI), waist hip ratio (WHR) and percent (%) body fat. Analysis of covariance (ANCOVA) and Pearson correlation tests were used in data analysis.



Findings of the study revealed significant decreased effects of continuous training programme on SBP, DBP, Cr, BMI, WHR, % body fat and significant increase in VO2max at p< 0.05. Serum Cr is significantly and negatively correlated with SBP (-.335), DBP (.194), BMI (.268), WHR (-.258) and % body fat (-.190) at p<0.05.



The present study demonstrated a rationale bases for the adjunct therapeutic role of moderate intensity continuous exercise training as a multi-therapy in the down regulation of blood pressure, serum Cr, body size and body fat in hypertension.
Midterm Outcome of Coronary Artery Bypass Grafting in Young Patients: A Multicenter Italian Study.

Myocardial revascularization in young patients should be durable enough to avoid new cardiovascular events or repeated revascularization procedures. The aim of this study was to evaluate the late outcomes of patients less than 50 years of age undergoing coronary artery bypass grafting (CABG) in comparison with older patients.



This study was a survival analysis of a pooled multicenter prospective cohort of patients who underwent CABG.



Five percent of patients (572 of 11,087) were less than 50 years of age. The prevalence of female sex, pulmonary disease, diabetes, stroke, and extracardiac arteriopathy was lower compared with that in older patients. Left ventricular function was more well preserved in patients less than 50 years of age, but the prevalence of recent myocardial infarction and the need for emergency surgical intervention was significantly higher in young patients. Multiple propensity score-adjusted analysis showed that patients aged less than 50 years had a significantly lower risk of mortality, even when compared with the 50- to 59-year stratum. In the propensity score-matched population (544 pairs), patients less than 50 years of age had significantly better 7-year outcomes compared with patients aged 50 years or more: survival (95.6% versus 81.1%; p < 0.0001), freedom from stroke (97.4% versus 95.3%; p = 0.009), freedom from major adverse cardiac and cerebrovascular events (MACCE) (76.6% versus 63.9%; p = 0.002). Similar freedom from myocardial infarction (90.1% versus 90.1%; p = 0.68) and repeated revascularization (87.1% versus 87.2%; p = 0.65) was observed in patients less than 50 years of age and those older than 50 years.



Patients less than 50 years of age undergoing CABG have an excellent outcome compared with elderly patients. These data indicate that despite its premature onset, coronary artery disease in young patients does not have a more aggressive course than that in older patients.