nils-herrmann/clean_scirepeval huggingface dataset:
Improvement of platelets after SVR among patients with chronic HCV infection and advanced hepatic fibrosis.

Patients with chronic hepatitis C virus (HCV) infection may develop cirrhosis with portal hypertension, reflected by decreased platelet count and splenomegaly. This retrospective cohort study aimed to assess changes in platelet counts after antiviral therapy among chronic HCV-infected patients with advanced fibrosis.



Platelet counts and spleen sizes were recorded in an international cohort of patients with Ishak 4-6 fibrosis who started antiviral therapy between 1990 and 2003. Last measured platelet counts and spleen sizes were compared with their pre-treatment values (within 6 months prior to the start of therapy). All registered platelet count measurements from 24-week following cessation of antiviral therapy were included in repeated measurement analyses.



This study included 464 patients; 353 (76%) had cirrhosis and 187 (40%) attained sustained virological response (SVR). Among patients with SVR, median platelet count, increased by 35 × 10(9) /L (IQR 7-62, P < 0.001). In comparison, patients without SVR showed a median decline of 17 × 10(9) /L (IQR -5-47, P < 0.001). In a subgroup of 209 patients, median decrease in spleen size was 1.0 cm (IQR 0.3-2.0) for patients with SVR, while median spleen size increased with 0.6 cm (IQR -0.1-2.0, P < 0.001) among those without SVR. The changes in spleen size and platelet count were significantly correlated (R = -0.41, P < 0.001).



Among chronic HCV-infected patients with advanced hepatic fibrosis, the platelet counts improved following SVR and the change in platelets correlated with the change in spleen size following antiviral therapy. These results suggest that HCV eradication leads to reduced portal pressure.
Mortality after pediatric kidney transplantation in England--a population-based cohort study.

The aim of this study was to explore mortality after pediatric kidney transplantation in England over the last decade. We used data from HES to select all kidney transplant procedures performed in England between April 2001 and March 2012. Data linkage analysis was performed with the ONS to identify all deaths occurring among this study cohort. Data for 1189 pediatric recipients were compared to 17 914 adult recipients (number of deaths, 33 vs. 2052, respectively, p < 0.001), with median follow-up 4.4 yr (interquartile range 2.2-7.3 yr). There was no difference in mortality within the pediatric cohort; age 0-1 (n = 25, patient survival 100.0%), age 2-5 (n = 198, patient survival 96.0%), age 6-12 (n = 359, patient survival 97.5%), and age 13-18 (n = 607, patient survival 97.4%), respectively (p = 0.567). The most common causes of death were renal (n = 8, 24.2%), infection (n = 6, 18.2%), and malignancy (n = 5, 15.2%). All deaths from malignancy were secondary to PTLD. In a fully adjusted Cox regression model, only white ethnicity was significantly associated with risk of pediatric mortality post-kidney transplantation (hazard ratio 2.7, 95% confidence interval [1.0-7.3], p = 0.047). To conclude, this population-based cohort study confirms low mortality after pediatric kidney transplantation with short follow-up.
Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand.

Rapid easy-to-use HIV tests offer opportunities to increase HIV testing among populations at risk of infection. We used the OraQuick Rapid HIV-1/2 antibody test (OraQuick) in the Bangkok Tenofovir Study, an HIV pre-exposure prophylaxis trial among people who inject drugs.



The Bangkok Tenofovir Study was a randomized, double-blind, placebo-controlled trial. We tested participants' oral fluid for HIV using OraQuick monthly and blood using a nucleic-acid amplification test (NAAT) every 3 months. We used Kaplan-Meier methods to estimate the duration from a positive HIV NAAT until the mid-point between the last non-reactive and first reactive oral fluid test and proportional hazards to examine factors associated with the time until the test was reactive.



We screened 3678 people for HIV using OraQuick. Among 447 with reactive results, 436 (97.5%) were confirmed HIV-infected, 10 (2.2%) HIV-uninfected, and one (0.2%) had indeterminate results. Two participants with non-reactive OraQuick results were, in fact, HIV-infected at screening yielding 99.5% sensitivity, 99.7% specificity, a 97.8% positive predictive value, and a 99.9% negative predictive value. Participants receiving tenofovir took longer to develop a reactive OraQuick (191.8 days) than participants receiving placebo (16.8 days) (p = 0.02) and participants infected with HIV CRF01_AE developed a reactive OraQuick earlier than participants infected with other subtypes (p = 0.04).



The oral fluid HIV test performed well at screening, suggesting it can be used when rapid results and non-invasive tools are preferred. However, participants receiving tenofovir took longer to develop a reactive oral fluid test result than those receiving placebo. Thus, among people using pre-exposure prophylaxis, a blood-based HIV test may be an appropriate choice.
Assessing the Prognostic Significance of Histologic Response in Osteosarcoma: A Comparison of Outcomes on CCG-782 and INT0133-A Report From the Children's Oncology Group Bone Tumor Committee.

The prognostic value of histologic response for osteosarcoma may have changed with induction chemotherapy schedules over time. We hypothesized that the increased intensity of induction therapy provided on INT0133 compared to the Children's Cancer Group study CCG-782 would diminish the impact of histologic response on the risk of events after definitive surgery.



Retrospective analysis was performed for patients aged <22 with newly diagnosed nonmetastatic osteosarcoma enrolled on CCG-782 and INT0133. Clinical factors were evaluated for association with response and outcome. Good response was defined as <5% viable tumor at resection. Associations of response, study, and postdefinitive surgery event-free survival (EFS-DS) were determined using Cox proportional hazard models. EFS-DS was estimated by Kaplan-Meier methodology.



Data were available for 814 patients (206 CCG-782, 608 INT0133). For good responders, 10-year EFS-DS (±SE) was 75.4% ± 7.7% for CCG-782 and 70.8% ± 3.1% for INT0133. For poor responders, 10-year EFS-DS was 39.9% ± 4.9% for CCG-782 and 58.4% ± 3.1% for INT0133. Histologic response predicted outcome across studies (P < 0.0001). Significant interaction between study and histologic response was observed for EFS-DS (P = 0.011). Using proportional hazards regression, INT0133 poor responders had less risk of events compared to CCG-782 poor responders (relative hazard ratio (RHR) = 0.6:1), but good responders on INT0133 had a greater risk of events compared to CCG-782 good responders (RHR = 1.53:1).



We observed an inverse relationship between the predictive value of tumor necrosis and intensity of induction therapy, raising questions about the true prognostic value of histologic response. This highlights the need for novel markers to develop strategies for treatment in future trials.
Depressive symptoms among HIV-positive postpartum women in Thailand.

Depressive symptoms have been linked to faster progression to AIDS in HIV-positive individuals. The purpose of this correlational, cross-sectional study was to examine the prevalence and predictors of depressive symptoms among postpartum women in Thailand who are HIV-positive. Data were collected at postpartum outpatient units in four hospitals in Thailand from June 2005 to December 2007. Eighty-five HIV-positive postpartum women completed questionnaires on depressive symptoms, self-esteem, emotional support, physical symptoms, infant health status, and demographics. Results showed that 74.1% of the participants reported depressive symptoms. Self-esteem, infant health status, and education were negatively associated with depressive symptoms. Because of the high rates of depression in our study, all HIV-positive postpartum women in Thailand should be screened for depressive symptoms.
Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial.

Maintenance therapy has become a hot field in myeloma, and it may be particularly relevant in elderly patients because the major benefit results from the initial therapy. We report the results of a randomized comparison of maintenance with bortezomib plus thalidomide (VT) or prednisone (VP) in 178 elderly untreated myeloma patients who had received 6 induction cycles with bortezomib plus either melphalan and prednisone or thalidomide and prednisone. The complete response (CR) rate increased from 24% after induction up to 42%, higher for VT versus VP (46% vs 39%). Median progression-free survival (PFS) was superior for VT (39 months) compared with VP (32 months) and overall survival (OS) was also longer in VT patients compared with VP (5-year OS of 69% and 50%, respectively) but the differences did not reach statistical significance. CR achievement was associated with a significantly longer PFS (P < .001) and 5-year OS (P < .001). The incidence of G3-4 peripheral neuropathy was 9% for VT and 3% for VP. Unfortunately, this approach was not able to overcome the adverse prognosis of cytogenetic abnormalities. In summary, these maintenance regimens result in a significant increase in CR rate, remarkably long PFS, and acceptable toxicity profile. The trial is registered at www.clinicaltrials.gov as NCT00443235.
Prescription omega-3-acid ethyl esters reduce fasting and postprandial triglycerides and modestly reduce pancreatic β-cell response in subjects with primary hypertriglyceridemia.

Treatment with prescription omega-3-acid ethyl esters (POM3) reduces triglycerides (TG) and TG-rich lipoprotein particles, but has been associated with increased fasting glucose (2-6mg/dL). This double-blind, randomized, controlled crossover trial in 19 men and women with hypertriglyceridemia (fasting TG ≥150 and ≤499mg/dL) examined lipid responses and indices of insulin sensitivity and secretion following a liquid meal tolerance test. Six weeks treatment with POM3 vs. corn oil resulted in significant lower mean fasting (-50.1mg/dL, p<0.001) and postprandial TG (-76.1mg/dL, p<0.001), higher mean fasting glucose (2.8mg/dL, p=0.062), reduced mean disposition index (2.1 vs. 2.4, p=0.037), and no change in the median Matsuda composite insulin sensitivity index (3.3 vs. 3.2, p=0.959). These results suggest that POM3 slightly reduces pancreatic β-cell responsiveness to plasma glucose elevation, which may contribute to the rise in fasting glucose sometimes observed with POM3.
Natriuretic Effect of Nitrendipine Is Preceded by Transient Systemic and Renal Hemodynamic Effects

This study investigated whether the acute natriuretic effect of nitrendipine is related to its initial renal hemodynamic effects. We investigated 16 patients (10 men and 6 women, mean age 52 ± 2 years) with essential hypertension, whose treatment, if any, was stopped 3 weeks before the study. They were admitted to a metabolic ward for 9 days and kept on a constant sodium diet of 55 mmol/day. During two 24-hour experiments, subjects randomly received a single oral dose of placebo/nitrendipine 10 mg (group 1, n = 8) or placebo/nitrendipine 20 mg (group 2, n = 8), according to a double-blind crossover study design. Patients fasted during the experiments, but their sodium intake was ensured by a constant intravenous saline infusion of 2.3 mmol/hr. Mean arterial pressure (MAP) and heart rate were determined for 5 hours following the administration of nitrendipine or placebo. Effective renal plasma flow (ERPF), glomerular filtration rate, active plasma renin concentration, angiotensin II, aldosterone, atrial natriuretic peptide, and catecholamines were determined every hour for 5 hours. Hourly urine collections were used to assess sodium, potassium, and creatinine excretions. Relative to placebo, only in group 2 (nitrendipine 20 mg) was a fall in MAP and a rise in ERPF observed 2 hours after the start of the experiment. The effects, however, lasted only for 1 hour. No such changes were seen in group 1. In neither group did nitrendipine affect hormonal concentrations. Sodium excretion was enhanced after the 20-mg dose of nitrendipine only (p < 0.05). Nitrendipine 20 mg induced a significant increase in sodium excretion, which may be dissociated from its acute hemodynamic effects.
Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial.

BACKGROUND, AIM, AND METHODS: Alpha interferon is the generally approved therapy for HBe antigen positive patients with chronic hepatitis B, but its efficacy is limited. Lamivudine is a new oral nucleoside analogue which potently inhibits hepatitis B virus (HBV) DNA replication. To investigate the possibility of an additive effect of interferon-lamivudine combination therapy compared with interferon or lamivudine monotherapy, we conducted a randomised controlled trial in 230 predominantly Caucasian patients with hepatitis B e antigen (HBeAg) and HBV DNA positive chronic hepatitis B. Previously untreated patients were randomised to receive: combination therapy of lamivudine 100 mg daily with alpha interferon 10 million units three times weekly for 16 weeks after pretreatment with lamivudine for eight weeks (n=75); alpha interferon 10 million units three times weekly for 16 weeks (n=69); or lamivudine 100 mg daily for 52 weeks (n=82). The primary efficacy end point was the HBeAg seroconversion rate at week 52 (loss of HBeAg, development of antibodies to HBeAg and undetectable HBV DNA).



The HBeAg seroconversion rate at week 52 was 29% for the combination therapy, 19% for interferon monotherapy, and 18% for lamivudine monotherapy (p=0.12 and p=0.10, respectively, for comparison of the combination therapy with interferon or lamivudine monotherapy). The HBeAg seroconversion rates at week 52 for the combination therapy and lamivudine monotherapy were significantly different in the per protocol analysis (36% (20/56) v 19% (13/70), respectively; p=0.02). The effect of combining lamivudine and interferon appeared to be most useful in patients with moderately elevated alanine aminotransferase levels at baseline. Adverse events with the combination therapy were similar to interferon monotherapy; patients receiving lamivudine monotherapy had significantly fewer adverse events.



HBeAg seroconversion rates at one year were similar for lamivudine monotherapy (52 weeks) and standard alpha interferon therapy (16 weeks). The combination of lamivudine and interferon appeared to increase the HBeAg seroconversion rate, particularly in patients with moderately elevated baseline aminotransferase levels. The potential benefit of combining lamivudine and interferon should be investigated further in studies with different regimens of combination therapy.
A palatability study of a flavored dexamethasone preparation versus prednisolone liquid in children.

Palatability is an important factor in medication compliance for children where the acceptability of a liquid medication and its ease of administration will be greatly affected by its taste.



The objective of this study was to determine which, if any of two steroid preparations, oral dexamethasone or oral prednisolone, was more palatable to children requiring steroid treatment for asthma.



A single-blind taste test of 2 different steroid suspensions, liquid prednisolone (1mg/ml) versus liquid dexamethasone (1mg/ml), was conducted in children aged 5-12 years, presenting to the pediatric emergency department with an exacerbation of asthma requiring steroid treatment. Children received 2.5mls of either prednisolone or dexamethasone and were asked to score their impression of taste on a 10 cm visual analog scale. After cleansing of the palate they were given the other steroid and scored its taste.



Thirty-nine children (54% male) were enrolled in the study. The mean age was 7.1 years (SD=2.0). The median visual analog scale measurement for dexamethasone was 8.2 cm (IQR= 5.2) whilst the median measurement for prednisolone was 5.0 cm (IQR= 7.3), p=0.03. Male children were more likely to prefer dexamethasone than females with a median score of 9.9 cm (IQR=3.8) for males vs. 5.9 cm (IQR=9.3) for females, p=0.005. There was no gender preference for prednisolone.



There was a statistically significant difference between the taste of dexamethasone and prednisolone, with dexamethasone being the preferred steroid among pediatric patients with asthma. Males were much more likely to prefer dexamethasone than females.
Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin® LA) in school children under daily practice conditions

Long-acting (LA) preparations of methylphenidate allow for once-daily dosing; however, pharmacokinetics may vary and depend on food intake. The objective was to evaluate effectiveness of a two-phase release formulation (Ritalin(®) LA) under daily practice conditions. This was a prospective, multicenter, observational study in Germany. Eligibility and dosing were determined by the physician based on the drug label. Outcomes included changes over 3 months of treatment in assessments of effect duration, clinical global impression (CGI), and quality of life (ILK). In 101 sites, 262 patients (197 boys, 63 girls, and two unknown) with a mean age of 10.9 years were enrolled; 50 were treated for the first time; 212 switched medication to Ritalin(®) LA. After 3 months, CGI improved in 59.4 % of patients, and well-being overall was rated as good by 61.0 % of parents and 63.7 % of children. Based on parents' assessment, the proportion of children suffering from strong disease burden decreased from 40.7 to 15.1 %. In 123 insufficient responders to previous ADHD medications, benefit from Ritalin(®) LA was above average and effect duration was significantly prolonged as compared to pretreatment. Overall, 28 patients (10.7 %) had treatment-related adverse events with one case being serious; 23 patients (8.8 %) discontinued therapy, 7 (2.7 %) due to poor treatment response; and 212 patients (81 %) continued treatment beyond the study. In line with clinical trial data, Ritalin(®) LA provides significant benefit also under routine practice conditions.
"Short course" bortezomib plus melphalan and prednisone as induction prior to transplant or as frontline therapy for nontransplant candidates in patients with previously untreated multiple myeloma.

The purpose of this study was to evaluate the efficacy and safety of short-course bortezomib, melphalan, prednisone (VMP) in previously untreated multiple myeloma as frontline therapy for transplant-ineligible patients and induction prior to autologous stem cell transplantation (ASCT). Patients received up to 6 28-day cycles of bortezomib 1.3 mg/m(2), days 1, 4, 8, and 11, plus melphalan 6 mg/m(2) and prednisone 60 mg/m(2), days 1-7. After 2-6 cycles, eligible and consenting patients could proceed to ASCT. Responses were assessed by International Uniform Response Criteria. The primary endpoint was complete response (CR) rate with VMP. Forty-five patients were enrolled. Among 44 evaluable patients, response rate was 95%, including 18% >or=CR (9% stringent CR), 27% very good partial responses (VGPR), and 50% partial responses (PR). Twenty patients proceeded to ASCT. Stem cell collection was successful in all; median yield was 5.6 x 10(6) CD34(+) cells/kg. Posttransplant response rates were 30% >or=CR (10% stringent CR), 65% VGPR, and 5% PR. After median follow-up of 14.0/14.6 months, median time to progression and progression-free survival were both 19.8/27.9 months in non-ASCT/ASCT patients. Seven patients have died; 1-year survival rates were 82%/95% in non-ASCT/ASCT patients. The most common grade 3/4 toxicities were thrombocytopenia (20%), neutropenia (28%), and infection (9%). Peripheral neuropathy grade 2-4 was the most common nonhematopoietic side effect occurring 17 patients (38%), although it was typically reversible, and only 5 patients (11%) discontinued therapy as a result of it. Short-course VMP is highly effective and generally well tolerated, both as initial treatment in non-ASCT patients and induction prior to ASCT. VMP did not negatively affect stem cell collection. Longer follow-up and prospective phase III trials are required to validate these initial observations.
Serum biomarkers of bone metabolism in castration-resistant prostate cancer patients with skeletal metastases: results from SWOG 0421.

Prior studies suggest that elevated markers of bone turnover are prognostic for poor survival in castration-resistant prostate cancer (CRPC). The predictive role of these markers relative to bone-targeted therapy is unknown. We prospectively evaluated the prognostic and predictive value of bone biomarkers in sera from CRPC patients treated on a placebo-controlled phase III trial of docetaxel with or without the bone targeted endothelin-A receptor antagonist atrasentan (SWOG S0421).



Markers for bone resorption (N-telopeptide and pyridinoline) and formation (C-terminal collagen propeptide and bone alkaline phosphatase) were assayed in pretreatment and serial sera. Cox proportional hazards regression models were fit for overall survival. Models were fit with main effects for marker levels and with/without terms for marker-treatment interaction, adjusted for clinical variables, to assess the prognostic and predictive value of atrasentan. Analysis was adjusted for multiple comparisons. Two-sided P values were calculated using the Wald test.



Sera from 778 patients were analyzed. Elevated baseline levels of each of the markers were associated with worse survival (P < .001). Increasing marker levels by week nine of therapy were also associated with subsequent poor survival (P < .001). Patients with the highest marker levels (upper 25th percentile for all markers) not only had a poor prognosis (hazard ratio [HR] = 4.3; 95% confidence interval [CI] = 2.41 to 7.65; P < .001) but also had a survival benefit from atrasentan (HR = 0.33; 95% CI = 0.15 to 0.71; median survival = 13 [atrasentan] vs 5 months [placebo]; P interaction = .005).



Serum bone metabolism markers have statistically significant independent prognostic value in CRPC. Importantly, a small group of patients (6%) with highly elevated markers of bone turnover appear to preferentially benefit from atrasentan therapy.
Assessment of speech in neurological disorders: development of a Swahili screening test.

Assessments for acquired motor-speech disorders that look at movements of the articulators would appear at first glance to be universal. This may be true for the most basic non-speech aspects of movement. We argue that assessments for speech motor control must be attuned to language-specific variables to be fully valid. We describe the rationale for, and development of a motor-speech-disorder screening test for Swahili speakers which includes impairment measures as well as measures of intelligibility and speech-voice naturalness. We further describe its initial validation in terms of content validity, feasibility of administration and scoring without requirements for lengthy training and technical expertise and application to groups of people with and without Parkinson's disease in Tanzania. Results indicate that the protocol is ready to use in so far as it is acceptable to users (clinicians, patients), is feasible to use, shows good interrater reliability, and is capable of differentiating performance in healthy speakers and those whose speech is disordered. We highlight needs for further development, including issues around training, development of local norms for healthy speakers and for speakers with a variety of neurological disturbances, and extension of the tool to cover culturally valid assessment of impact of communication disorders.