nils-herrmann/clean_scirepeval huggingface dataset:
Correlation of clinical score to pulmonary function and oxygen saturation in children with asthma attack.

The aim of this study is to demonstrate the importance of the relation between clinical score, pulse oximetry and spirometric tests in an asthma attack.



In this randomized, double blind, observational study, 110 children (age 2-15 years) with an asthma attack who were admitted to emergency room were evaluated. Patient history, physical examination, clinical score and oxygen saturation were recorded in all patients; however pulmonary function tests were obtained only in 54 children who were over 5 years of age. The clinical score was derived from respiratory rate, wheezing, dyspnea and retractions.



Both oxygen saturation and spirometric tests were found to be significantly correlated with the clinical score in children.



The clinical score could be used for assessing the severity of the asthma attack particularly in developing countries where laboratory facilities are not available or pulmonary function tests are not feasible.
Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial

To study the effects of metformin on the incidence of vitamin B-12 deficiency (<150 pmol/l), low concentrations of vitamin B-12 (150-220 pmol/l), and folate and homocysteine concentrations in patients with type 2 diabetes receiving treatment with insulin.



Multicentre randomised placebo controlled trial.



Outpatient clinics of three non-academic hospitals in the Netherlands.



390 patients with type 2 diabetes receiving treatment with insulin.



850 mg metformin or placebo three times a day for 4.3 years.



Percentage change in vitamin B-12, folate, and homocysteine concentrations from baseline at 4, 17, 30, 43, and 52 months.



Compared with placebo, metformin treatment was associated with a mean decrease in vitamin B-12 concentration of -19% (95% confidence interval -24% to -14%; P<0.001) and in folate concentration of -5% (95% CI -10% to -0.4%; P=0.033), and an increase in homocysteine concentration of 5% (95% CI -1% to 11%; P=0.091). After adjustment for body mass index and smoking, no significant effect of metformin on folate concentrations was found. The absolute risk of vitamin B-12 deficiency (<150 pmol/l) at study end was 7.2 percentage points higher in the metformin group than in the placebo group (95% CI 2.3 to 12.1; P=0.004), with a number needed to harm of 13.8 per 4.3 years (95% CI 43.5 to 8.3). The absolute risk of low vitamin B-12 concentration (150-220 pmol/l) at study end was 11.2 percentage points higher in the metformin group (95% CI 4.6 to 17.9; P=0.001), with a number needed to harm of 8.9 per 4.3 years (95% CI 21.7 to 5.6). Patients with vitamin B-12 deficiency at study end had a mean homocysteine level of 23.7 micromol/l (95% CI 18.8 to 30.0 micromol/l), compared with a mean homocysteine level of 18.1 micromol/l (95% CI 16.7 to 19.6 micromol/l; P=0.003) for patients with a low vitamin B-12 concentration and 14.9 micromol/l (95% CI 14.3 to 15.5 micromol/l; P<0.001 compared with vitamin B-12 deficiency; P=0.005 compared with low vitamin B-12) for patients with a normal vitamin B-12 concentration (>220 pmol/l).



Long term treatment with metformin increases the risk of vitamin B-12 deficiency, which results in raised homocysteine concentrations. Vitamin B-12 deficiency is preventable; therefore, our findings suggest that regular measurement of vitamin B-12 concentrations during long term metformin treatment should be strongly considered.
Sentence Processing in Frontotemporal Dementia

Patients with frontotemporal dementia (FTD) have sentence comprehension difficulty. We examined the hypothesis that both grammatical and resource factors contribute to their impaired sentence comprehension with a traditional, off-line sentence comprehension task, and an on-line sentence processing procedure that minimizes task-related resources. This was investigated in subgroups of FTD patients with Progressive Non-fluent Aphasia (PNFA; n = 5) who have effortful speech; non-aphasic patients with an executive deficit (EXEC; n = 8); and Semantic Dementia (SD; n = 3) patients with poor single word comprehension. The results were correlated with measures of executive resources. We found that PNFA patients are significantly impaired in their off-line sentence comprehension, and that their performance correlated with auditory-verbal short-term memory. PNFA patients also demonstrated a pattern of slowed processing for the on-line sentence measure. This is consistent with the hypothesis that information relevant for constructing sentence representations during comprehension degrades in working memory as it is activated over an abnormally slowed time course. EXEC patients had modest off-line sentence comprehension difficulty, and this correlated with performance on measures of working memory, planning, and inhibitory control. On-line processing in EXEC patients demonstrated their insensitivity to sentence-based information. This raises the possibility that a limitation in material-neutral executive resources not dedicated to grammatical processing may play a role in their sentence comprehension deficit. SD patients' pattern of on-line sentence comprehension paralleled control subjects' performance. We conclude that grammatical and executive components both contribute to sentence comprehension, and that the profile of sentence comprehension difficulty varies across FTD subgroups depending on the sentence processing component that is impaired.
Incorporating family therapy into asthma group intervention: a randomized waitlist-controlled trial.

Asthma psychoeducational programs have been found to be effective in terms of symptom-related outcome. They are mostly illness-focused, and pay minimal attention to systemic/familial factors. This study evaluated a novel asthma psychoeducation program that adopted a parallel group design and incorporated family therapy. A randomized waitlist-controlled crossover clinical trial design was adopted. Children with stable asthma and their parents were recruited from a pediatric chest clinic. Outcome measures included, for the patients: exhaled nitric oxide (eNO), spirometry, and adjustment to asthma; and for the parents: perceived efficacy in asthma management, Hospital Anxiety and Depression Scale anxiety subscale, Body Mind Spirit Well-being Inventory emotion subscale, and Short Form 12 health-related quality of life scale. Forty-six patients participated in the study. Attrition rates were 13.0% and 26.0% for the active and control groups, respectively. Repeated-measures ANOVA revealed a significant decrease in airway inflammation, as indicated by eNO levels, and an increase in patient's adjustment to asthma and parents' perceived efficacy in asthma management. Serial trend analysis revealed that most psychosocial measures continued to progress steadily after intervention. Significant improvements in both symptom-related measures and mental health and relationship measures were observed. The findings supported the value of incorporating family therapy into asthma psychoeducation programs.
The PETALE study: Late adverse effects and biomarkers in childhood acute lymphoblastic leukemia survivors.

Childhood cancer survivorship issues represent an established public health challenge. Most late adverse effects (LAEs) have been demonstrated to be time and treatment dependent. The PETALE study is a multidisciplinary research project aiming to comprehensively characterize LAEs and identify associated predictive biomarkers in childhood acute lymphoblastic leukemia (cALL) survivors.



cALL survivors treated at Sainte-Justine University Health Center with Dana-Farber Cancer Institution-ALL protocols 87-01 through 2005-01 were eligible. During Phase I of the study, the participants underwent comprehensive clinical, biologic, and psychosocial investigation targeting metabolic syndrome, cardiotoxicity, bone morbidity, neurocognitive problems, and quality of life issues. Whole-exome sequencing was performed for all participants. Subjects identified with an extreme phenotype during Phase I were recalled for additional testing (Phase II).



Phase I included 246 survivors (recall rate 71.9%). Of those, 85 participants completed Phase II (recall rate 88.5%). Survivors agreeing to participate in Phase I (n = 251) were similar to those who refused (n = 31) in terms of relapse risk profile, radiotherapy exposure, and age at the time of study. Participants, however, tended to be slightly older at diagnosis (6.1 vs. 4.7 years old, P = 0.08), with a higher proportion of female agreeing to participate compared with males (93.2 vs. 86.5%, P = 0.07).



The PETALE study will contribute to comprehensively characterize clinical, psychosocial, biologic, and genomic features of cALL survivors using an integrated approach. Expected outcomes include LAE early detection biomarkers, long-term follow-up guidelines, and recommendations for physicians and health professionals.
Right ventricular remodeling due to pulmonary regurgitation is associated with reduced left ventricular free wall strain in surgically repaired tetralogy of fallot.

The aim of the present study was to assess the impact of pulmonary regurgitation (PR) and right ventricle (RV) volume on left ventricle (LV) longitudinal strain (LS) in patients with surgically repaired tetralogy of Fallot (r-TOF).



The study subjects were 32 adolescent asymptomatic r-TOF subjects and 30 adolescent healthy controls. Two-dimensional (2-D) and 3-dimensional (3-D) echocardiography were performed in all subjects using Vivid E9 (GE Healthcare). On 3-D analysis, LV and RV volumes were measured using 4D auto LVEF and TomTec RV analysis. PR fraction (PRF) was calculated by the volumetric method (PRF=[RV stroke volume-LV stroke volume]/RV stroke volume). LV-LS was assessed on 2-D speckle tracking echocardiography, and "free wall LS" represented the average of 3 lateral segments. Although RVEF and LVEF were not different between the 2 groups, free wall LS (-17.1 ± 3.2%) was reduced significantly in the r-TOF group compared to the control (-20.5 ± 4.9%, P=0.008), and correlated with the RV variables RVEDVI, RV/LV EDVI ratio and PRF. On multivariate stepwise linear regression analysis, RVEDVI was the only risk factor for the reduction of free wall LS (P=0.004).



Free wall LS was significantly reduced despite preserved LVEF. The severity of LS reduction was correlated with RV dilation even in asymptomatic r-TOF patients.
Airway and systemic effects of hydrofluoroalkane fluticasone and beclomethasone in patients with asthma.

With the transition to hydrofluoroalkane-134a propellants in metered dose inhalers, it is important to consider the efficacy and safety profiles of formulations containing inhaled corticosteroids. We examined the airway and systemic effects of hydrofluoroalkane-134a fluticasone propionate (FLU-HFA) and beclomethasone dipropionate (BEC-HFA) at recommended labelled doses.



Twenty mild to moderate asthmatics were randomised in crossover fashion to receive 6 weeks of 500 micro g/day followed by 1000 micro g/day FLU-HFA and BEC-HFA. Measurements were made at baseline after placebo run in and washout, and after each randomised treatment. The primary airway outcome for benefit was the dose of methacholine provoking a fall in forced expiratory volume in 1 second (FEV(1)) of 20% or more (methacholine PD(20)) and for systemic adverse effects was overnight urinary cortisol/creatinine (OUCC).



For mean responses, both doses of BEC-HFA and FLU-HFA produced significant improvements in PD(20) compared with baseline. The improvement was not significantly greater with 1000 micro g/day FLU-HFA versus BEC-HFA, a 1.69 fold difference (95% CI 0.94 to 3.04). Both doses of BEC-HFA but not FLU-HFA caused significant suppression of OUCC compared with baseline, with significantly (p<0.05) lower values at 1000 micro g/day for BEC-HFA versus FLU-HFA (1.97 fold difference (95% CI 1.28 to 3.02)).



There was no difference in the airway and systemic effects in patients with mild to moderate asthma between FLU-HFA and BEC-HFA at a dose of 500 micro g/day. At 1000 micro g/day there was increased systemic bioactivity with BEC-HFA compared with FLU-HFA, without any gain in airway efficacy.
HIV-1 genital shedding in HIV-infected patients randomized to second-line lopinavir/ritonavir monotherapy versus tenofovir/lamivudine/lopinavir/ritonavir.

HIV-1 shedding in genital secretions is associated with HIV transmission risk. Limited data exist on the effect of second-line lopinavir/ritonavir monotherapy (mLPV/r) on genital secretion of HIV RNA.



We measured HIV-1 in genital secretions of HIV-infected adults at time of failure from non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens and at 48 weeks after being randomized to second-line mLPV/r versus tenofovir/lamivudine/LPV/r (TDF/3TC/LPV/r). Plasma and genital secretion (semen, vaginal swab) HIV RNA was quantified by the CobasAmpliprep/TaqMan assay.



Forty enrolled (15 on mLPV/r and 25 on TDF/3TC/LPV/r). Median age was 37.8 years and 35% were male. Median baseline CD4(+) T-cell count was 222 cells/mm(3), plasma HIV RNA was 4.1 log10 copies/ml and genital secretion HIV RNA was 2.3 log10 copies/ml. At week 48, the proportion of patients with plasma HIV RNA<50 copies/ml was 13/15 (87%) in mLPV/r and 21/25 (84%) in TDF/3TC/LPV/r arms. Median genital HIV RNA was significantly decreased from baseline in both arms (P=0.009 in mLPV/r and P=0.001 in TDF/3TC/LPV/r). In subjects with suppressed plasma HIV RNA, 12/34 (35%; 6/13 [46%] in the mLPV/r and 6/21 [29%] in the TDF/3TC/LPV/r arms) had detectable HIV RNA (range 74-957 copies/ml) in the genital secretions (P=0.41). By multivariate analysis, the only predictor of having genital HIV RNA>50 copies/ml at week 48 was baseline genital secretion HIV RNA>50 copies/ml (P=0.049).



LPV/r either given alone or in combination with TDF/3TC as second-line treatment achieved high genital secretion HIV RNA suppression rate. Genital secretion HIV RNA remained detectable at low levels in one-third of patients with suppressed plasma viraemia.
Laboratory assessment of fitness to fly in patients with lung disease: a practical approach.

To identify patients with respiratory disease, who may be at risk of developing respiratory distress during commercial air travel, a hypoxia inhalation test (HIT) can be performed. This paper reports our experience of using such a test combined with an interpretation algorithm in a routine respiratory function laboratory. Twenty-eight patients were studied. Baseline oxygen saturation (Sa,O2) was measured using a pulse oximeter. If Sa,O2 was < 90% no HIT was performed and the patient was assessed as unfit for air travel. If baseline Sa,O2 was > or = 90% an HIT was performed by the patient breathing through a 35% Venturi mask supplied with 100% nitrogen which reduced inspiratory oxygen fraction to 15.1+/-0.2%. Results were interpreted using a locally derived algorithm, and validation was attempted using a questionnaire to investigate subsequent symptoms during travel. All patients tolerated the assessment well. Twenty-two patients were assessed as "fit to fly" with a further two patients "fit to fly with supplemental O2". Four patients were considered unfit to fly. Hypoxic response could not be predicted from either forced expiratory volume in one second, or pretest saturation. Validation of such protocols is difficult, but the hypoxia inhalation test may be a useful tool for predicting hypoxia during air travel in patients with chronic respiratory disease.
Long-term treatment with oxcarbazepine in clinical practice.

Oxcarbazepine (up to 1800 mg daily orally) was given for 12 months to 61 adult epileptic patients in clinical practice, as monotherapy (n=52) or adjunctive therapy (n=9). Patients on monotherapy became seizure-free (76.9%) or experienced > or = 75% seizure rate reduction, with two exceptions. In the adjunctive therapy group, one patient became seizure-free and two experienced a 50-75% seizure rate reduction. These seizure-free rates are higher than those reported in the literature. The drug was well tolerated; only two patients withdrew because of intolerance (3.3%). Long-term data is essential when evaluating a drug for lifelong treatment. This study contributes to the growing body of 12-month evidence on oxcarbazepine.
Sociodemographic indicators and risk of brain tumours.

To better understand patterns of occurrence or diagnosis of brain tumours in different segments of the population, we evaluated associations between sociodemographic variables and the relative incidence of brain tumours as part of a multi-faceted case-control study.



The study was conducted at hospitals in three US cities between 1994 and 1998. In all, 489 glioma cases (354 high-grade, 135 low-grade), 197 meningioma cases, 96 acoustic neuroma cases, and 799 controls admitted to the same hospitals for any of a variety of non-neoplastic diseases or conditions were enrolled and interviewed. Logistic regression was used to estimate odds ratios (OR), calculate 95% CI, and test for trends.



The OR showed significant positive associations with household income for low-grade glioma, meningioma, and acoustic neuroma, but not for high-grade glioma. Positive associations were observed with level of education for low-grade glioma and acoustic neuroma, but not for high-grade glioma or meningioma. Jewish religion was associated with a significantly elevated risk for meningioma (OR = 4.3; 95% CI: 2.0-9.0). Being single at the time of tumour diagnosis or enrolment was associated with significantly reduced risks for meningioma (OR = 0.4; 95% CI: 0.3-0.6) and low- or high-grade glioma (OR = 0.6; 95% CI: 0.5-0.8), but not for acoustic neuroma.



Associations with sociodemographic variables varied considerably among the different subtypes of brain tumour, including between low-grade and high-grade glioma. The general pattern was for associations with indicators of affluence and education to be stronger for tumours that tend to grow more slowly and have less catastrophic effects, although the evidence was mixed for meningioma. We cannot isolate the specific factors underlying the observed associations, but intrapopulation differences in the completeness or timing of diagnosis may have played a role. There is less opportunity for such influences to operate for the rapidly progressing, high-grade gliomas than for more slowly growing tumours.
Single arm NCRI phase II study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter’s syndrome

Transformation of B-cell chronic lymphocytic leukaemia (B-CLL) to diffuse large B cell lymphoma (DLBCL) (Richter’s syndrome (RS)) is a rare (2-15% of patients) but catastrophic complication of B-CLL. Dose-intense chemotherapy regimens investigated in small single institution trials, but with the exception of bone marrow transplantation for a minority of patients, little has improved the median overall survival of patients with RS beyond eight months. Patients are often elderly, immunosuppressed, possess co-morbidities and have a deteriorating performance status. TP53 disruption is a common molecular abnormality noted in RS and contributes to the tumour’s chemotherapy resistance. Ofatumumab is a fully human anti-CD20 monoclonal IgG1κ antibody that targets a unique epitope on B lymphocytes. It has displayed increased binding affinity and a longer dissociation time when compared to rituximab resulting in improved complement dependent cellular cytotoxicity (CDCC); a mechanism with the potential to overcome apoptosis-resistance in TP53 disruption. Given the prevalence of TP53 disruption in RS, Ofatumumab was considered a relatively non-toxic agent with a sound rationale to test in a prospective multicentre trial as an adjunct to CHOP induction and subsequent ofatumumab maintenance therapy in responding patients. The CHOP-OR study is a prospective phase II study to evaluate the safety, feasibility and activity of a CHOP chemotherapy in combination with ofatumumab in induction and subsequent maintenance for patients with newly diagnosed RS. The primary objective will be the overall response rate (ORR) in patients with RS after six cycles of CHOP-O. The secondary objectives include feasibility of recruitment, progression free survival (PFS), overall survival (OS) and toxicity. The study will be accompanied by exploratory analysis of the genomic landscape of RS in newly diagnosed patients. The CHOP-OR trial evaluates the safety, feasibility and activity of CHOP plus Ofatumumab induction and Ofatumumab maintenance in new RS patients. The study is currently recruiting and has met the interim analysis criteria, with more than 7 of the first 25 participants achieving a CR or PR after six cycles of CHOP-O. The study has the potential to identify predictive biomarkers for this treatment modality. NCT01171378 .
First-in-human phase 1/2a trial of CRLX101, a cyclodextrin-containing polymer-camptothecin nanopharmaceutical in patients with advanced solid tumor malignancies

Patients with advanced solid malignancies were enrolled to an open-label, single-arm, dose-escalation study, in which CRLX101 was administered intravenously over 60 min among two dosing schedules, initially weekly at 6, 12, and 18 mg/m2 and later bi-weekly at 12, 15, and 18 mg/m2. The maximum tolerated dose (MTD) was determined at 15 mg/m2 bi-weekly, and an expansion phase 2a study was completed. Patient samples were obtained for pharmacokinetic (PK) and pharmacodynamic (PD) assessments. Response was evaluated per RECIST criteria v1.0 every 8 weeks. Sixty-two patients (31 male; median age 63 years, range 39–79) received treatment. Bi-weekly dosing was generally well tolerated with myelosuppression being the dose-limiting toxicity. Among all phase 1/2a patients receiving the MTD (n = 44), most common grade 3/4 adverse events were neutropenia and fatigue. Evidence of systemic plasma exposure to both the polymer-conjugated and unconjugated CPT was observed in all treated patients. Mean elimination unconjugated CPT Tmax values ranged from 17.7 to 24.5 h, and maximum plasma concentrations and areas under the curve were generally proportional to dose for both polymer-conjugated and unconjugated CPT. Best overall response was stable disease in 28 patients (64 %) treated at the MTD and 16 (73 %) of a subset of NSCLC patients. Median progression-free survival (PFS) for patients treated at the MTD was 3.7 months and for the subset of NSCLC patients was 4.4 months. These combined phase 1/2a data demonstrate encouraging safety, pharmacokinetic, and efficacy results. Multinational phase 2 clinical development of CRLX101 across multiple tumor types is ongoing.