nils-herrmann/clean_scirepeval huggingface dataset:
Randomized Phase III Trial Comparing ABVD Plus Radiotherapy With the Stanford V Regimen in Patients With Stages I or II Locally Extensive, Bulky Mediastinal Hodgkin Lymphoma: A Subset Analysis of the North American Intergroup E2496 Trial.

The phase III North American Intergroup E2496 Trial (Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma) compared doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with mechlorethamine, doxorubicin, vincristine, bleomycin, vinblastine, etoposide, and prednisone (Stanford V). We report results of a planned subgroup analysis in patients with stage I or II bulky mediastinal Hodgkin lymphoma (HL).



Patients were randomly assigned to six to eight cycles of ABVD every 28 days or Stanford V once per week for 12 weeks. Two to 3 weeks after completion of chemotherapy, all patients received 36 Gy of modified involved field radiotherapy (IFRT) to the mediastinum, hila, and supraclavicular regions. Patients on the Stanford V arm received IFRT to additional sites ≥ 5 cm at diagnosis. Primary end points were failure-free survival (FFS) and overall survival (OS).



Of 794 eligible patients, 264 had stage I or II bulky disease, 135 received ABVD, and 129 received Stanford V. Patient characteristics were matched. The overall response rate was 83% with ABVD and 88% with Stanford V. At a median follow-up of 6.5 years, the study excluded a difference of more than 21% in 5-year FFS and more than 16% in 5-year OS between ABVD and Stanford V (5-year FFS: 85% v 79%; HR, 0.68; 95% CI, 0.37 to 1.25; P = .22; 5-year OS: 96% v 92%; HR, 0.49; 95% CI, 0.16 to 1.47; P = .19). In-field relapses occurred in < 10% of the patients in each arm.



For patients with stage I or II bulky mediastinal HL, no substantial statistically significant differences were detected between the two regimens, although power was limited. To the best of our knowledge, this is the first prospective trial reporting outcomes specific to this subgroup, and it sets a benchmark for comparison of ongoing and future studies.
CT-scan prediction of thyroid cartilage invasion for early laryngeal squamous cell carcinoma

Treatment choice for laryngeal cancer may be influenced by the diagnosis of thyroid cartilage invasion on preoperative computed tomography (CT). Our objective was to determine the predictive value of CT for thyroid cartilage invasion in early- to mid-stage laryngeal cancer. Retrospective study (1992–2008) of laryngeal squamous cell carcinoma treated with open partial laryngectomy and resection of at least part of the thyroid cartilage. Previous laser surgery, radiation therapy, chemotherapy and second primaries were excluded. CT prediction of thyroid cartilage invasion was determined by specialized radiologists. Tumor characteristics and pathologic thyroid cartilage invasion were compared to the radiologic assessment. 236 patients were treated by vertical (20 %), supracricoid (67 %) or supraglottic partial laryngectomy (13 %) for tumors staged cT1 (26 %), cT2 (55 %), and cT3 (19 %). The thyroid cartilage was invaded on pathology in 19 cases (8 %). CT’s sensitivity was 10.5 %, specificity 94 %, positive predictive value 13 %, and negative predictive value 92 %. CT correctly predicted thyroid cartilage invasion in only two cases for an overall accuracy of 87 %. Among the false-positive CT’s, tumors involving the anterior commissure were significantly over-represented (61.5 % vs. 27 %, p = .004). Tumors with decreased vocal fold (VF) mobility were significantly over-represented in the group of false-negatives (41 vs. 13 %, p = .0035). Preoperative CT was not effective in predicting thyroid cartilage invasion in these early- to mid-stage lesions, overestimating cartilage invasion for AC lesions and underestimating invasion for lesions with decreased VF mobility.
Motivational Interviewing With and Without Normative Feedback for Adolescents With Substance Use Problems: A Preliminary Study.

Many adolescents in need of substance use disorder treatments never engage in treatment. Further, the most promising interventions that could be adapted to target treatment engagement often use normative feedback (NF) despite concerns about its appropriateness for adolescents. This preliminary study will inform a larger trial designed to isolate whether NF is an inert, helpful, or harmful active ingredient within pretreatment motivational interviewing (MI) interventions designed to increase treatment engagement.



Adolescents (N = 48) presenting for treatment intake assessments were randomized to receive MI (n = 22) or MI+NF (n = 26) immediately following their assessments. Three-month outcomes included the percentage of youth engaged in treatment, the percentage of youth reporting past-month binge drinking, and the percentage of days of abstinence.



Treatments were delivered with high fidelity, and a high proportion of eligible participants were recruited and retained in this study. Participants significantly increased their percentage of days of abstinence by approximately 10% at follow-up (d = .32, P =.03), with no significant differences between groups. Fifty-five percent of youth in MI and 41.7% of youth in MI+NF engaged in treatment (odds ratio [OR] = .60, nonsignificant; 95% confidence interval, CI [0.136-2.68]).



Larger trials should test whether NF is an active ingredient in adolescent MI interventions, and should also determine the mechanisms through which MI+NF may produce effects.
Behavior of Quality of Life (SGRQ) in COPD Patients According to BODE Scores.

To evaluate if the association between the BODE index and deterioration in health-related quality of life is linear. To determine possible associations between the BODE index and health status evaluated by the Saint George's Respiratory Questionnaire (SGRQ) at all levels of disease severity in COPD.



A cross-sectional study was carried out on 253 patients from two Latin American respiratory centers (Brazil and Chile) with a clinical diagnosis of COPD, based on GOLD criteria. Assessment included the BODE index and the SGRQ questionnaire.



Patients had a BODE index of 3.1±2.0; FEV1 (%) of 49±19.2; BMI (kg/m(2)) of 24.7±5.1; 6MWT distance (meters) of 444±96. Significant correlations were found between the BODE index and SGRQ total scores (r=0.5; <0.001), impact (r=0.45; <0.001) and activity (r=0.5; <0.001). From BODE score zero, HRQOL was already compromised in all SGRQ domains. SGRQ scores (total and domain) increased progressively for individual components of the BODE index, with the decrease in airflow limitation (<0.05), BMI (<0.002) and 6MWT (<0.05), and with the increase in the Modified Medical Research Council (MMRC) score (<0.05).



There is an association between health-related quality of life, as assessed by the SGRQ and the BODE index within the entire spectrum of COPD severity. Even in early disease stages and BODE index zero, health-related quality of life is already impaired.
Identification and prospective validation of clinically relevant chronic obstructive pulmonary disease (COPD) subtypes.

Chronic obstructive pulmonary disease (COPD) is increasingly considered a heterogeneous condition. It was hypothesised that COPD, as currently defined, includes different clinically relevant subtypes.



To identify and validate COPD subtypes, 342 subjects hospitalised for the first time because of a COPD exacerbation were recruited. Three months after discharge, when clinically stable, symptoms and quality of life, lung function, exercise capacity, nutritional status, biomarkers of systemic and bronchial inflammation, sputum microbiology, CT of the thorax and echocardiography were assessed. COPD groups were identified by partitioning cluster analysis and validated prospectively against cause-specific hospitalisations and all-cause mortality during a 4 year follow-up.



Three COPD groups were identified: group 1 (n=126, 67 years) was characterised by severe airflow limitation (postbronchodilator forced expiratory volume in 1 s (FEV(1)) 38% predicted) and worse performance in most of the respiratory domains of the disease; group 2 (n=125, 69 years) showed milder airflow limitation (FEV(1) 63% predicted); and group 3 (n=91, 67 years) combined a similarly milder airflow limitation (FEV(1) 58% predicted) with a high proportion of obesity, cardiovascular disorders, diabetes and systemic inflammation. During follow-up, group 1 had more frequent hospitalisations due to COPD (HR 3.28, p<0.001) and higher all-cause mortality (HR 2.36, p=0.018) than the other two groups, whereas group 3 had more admissions due to cardiovascular disease (HR 2.87, p=0.014).



In patients with COPD recruited at their first hospitalisation, three different COPD subtypes were identified and prospectively validated: 'severe respiratory COPD', 'moderate respiratory COPD', and 'systemic COPD'.
Impact of high dose n-3 polyunsaturated fatty acid treatment on measures of microvascular function and vibration perception in non-alcoholic fatty liver disease: results from the randomised WELCOME trial

The effect of n-3 fatty acid treatment on vibration perception thresholds (VPTs) and cutaneous microvascular reactivity is not known. We tested whether: (1) a 15–18 month treatment with high dose (4 g/day) docosahexaenoic (DHA) plus eicosapentaenoic (EPA) acid improved VPT and microvascular reactivity in patients with non-alcoholic fatty liver disease; and (2) there are associations between VPT, microvascular reactivity and metabolic variables. In the completed single centre, randomised, parallel group, placebo controlled Wessex Evaluation of fatty Liver and Cardiovascular markers in non-alcoholic fatty liver disease with OMacor thErapy (WELCOME) trial, we tested the effect of DHA+EPA on VPT at 125 Hz (big toe) and the cutaneous hyperaemic response (forearm) to arterial occlusion (ratio of maximum to resting blood flux [MF/RF]). Allocation and dispensing was carried out by an independent research pharmacist; all participants and research team members were blinded to group assignment. In all, 51 and 49 patients were randomised to placebo and DHA+EPA, respectively (mean age 51.4 years). Of these, 32 had type 2 diabetes. Forty-six (placebo) and 47 (DHA+EPA) patients completed the study; there were no important adverse (or unexpected) effects or side effects. In multivariable-adjusted regression models (intention-to-treat analyses), DHA+EPA treatment was associated with an increase in VPT (β coefficient 1.49 [95% CI 0.04, 2.94], p = 0.04). For VPT, the adjusted mean differences (95% CIs) in the placebo and DHA+EPA treatment groups were −0.725 (−1.71, 0.25) and 0.767 (−0.21, 1.75) m/s2, respectively. With DHA+EPA treatment, there was no change in MF/RF (β coefficient 0.07 [95% CI −0.56, 0.70], p = 0.84), the adjusted mean differences (95% CIs) in the placebo and DHA+EPA treatment groups were −0.549 (−1.03, −0.07) and −0.295 (−0.77, 0.18) respectively. VPT was independently associated with age (β coefficient 0.019 [95% CI 0.010, 0.029], p < 0.0001) and MF/RF (β coefficient −0.074 [95% CI −0.132, −0.016], p = 0.013), but not with diabetes (p = 0.38). High dose n-3 fatty acid treatment did not improve measures of microvascular function or vibration perception. Ageing and microvascular reactivity are associated with a measure of peripheral nerve function.
Atheroma progression in chronic kidney disease.

Cardiovascular events are 10 to 100 times more frequent in chronic kidney disease (CKD). We tested the hypothesis that the rate of atherosclerotic plaque growth is faster in severe versus moderate CKD.



We performed a prospective cohort study in 318 prevalent CKD patients with initial creatinine clearance (CCr) between 20 and 50 ml/min/1.73 m(2). Baseline clinical and laboratory data were obtained on all patients. Plaque area was determined every 6 mo using bilateral carotid ultrasonography. Plaque area distribution was normalized using a cube root transformation. Unadjusted and adjusted associations between CCr quintiles and rate of change in the transformed plaque area were assessed using multiple linear regression.



The rate of plaque progression appeared lower in patients with the lowest CCr. Median rate of plaque growth was 0.4 mm(2)/yr in the lowest quintile of CCr (< 23 ml/min/1.73 m(2)) versus 5.0 mm(2)/yr in the highest quintile (> 43 ml/min/1.73 m(2)). This association remained significant after adjustment for potential confounders. A secondary analysis using quintiles of Modification of Diet in Renal Disease (MDRD) GFR confirmed the absence of increased plaque growth at low GFR, although a reduced rate of growth in the lowest quintile of MDRD GFR was not observed.



We did not observe accelerated plaque growth at low levels of renal function. We suggest that mechanisms other than plaque growth are responsible for the observed excess of cardiovascular disease in CKD patients.
Adherence counseling and reminder text messages improve uptake of antiretroviral therapy in a tertiary hospital in Nigeria.

Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) is one of the world's most challenging pandemics. For treatment with Highly Active Anti-Retroviral Therapy (HAART) to be effective, high rate of adherence is essential.



To demonstrate the effect of adherence counseling and text message reminders in improving patients' adherence to HAART.



A randomized control trial among non-adherents was carried out in a tertiary hospital in Nigeria between March and July, 2011.



A total of 104 patients: 45 males (43.3%) and 59 females (56.7%) participated in the study. They were randomized into intervention and control groups. The intervention group received monthly adherence counseling and twice weekly short message reminders for four months, while the control group received only standard care. Self-reported adherence and CD4+ cell counts were measured pre- and post-intervention.


 USED
Data was analysed using Statistical Package for Social Sciences (SPSS) version 18. Risk rates, Chi-square, Mann-Whitney U test and Cohen's effect size were calculated. Level of significance was set at P = 0.05.



At post-intervention, 76.9% of the intervention group and 55.8% of the control group achieved adherence (χ2 = 5.211, P = 0.022, RR = 0.75 (0.55-0.96), Cohen's w = 0.224). Also, median CD4+ cell count of the intervention group increased from 193 cells/ml to 575.0 cells/ml against 131.0 cells/ml to 361.5 cells/ml in the control group (P = 0.007).



Adherence counseling and text message reminders improved adherence among HIV patients. Its adoption for HIV patient management is advocated.
Dapagliflozin Monotherapy in Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise

Dapagliflozin, a highly selective inhibitor of the renal sodium-glucose cotransporter-2, increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner. We evaluated the efficacy and safety of dapagliflozin in treatment-naive patients with type 2 diabetes.



This was a 24-week parallel-group, double-blind, placebo-controlled phase 3 trial. Patients with A1C 7.0-10% (n = 485) were randomly assigned to one of seven arms to receive once-daily placebo or 2.5, 5, or 10 mg dapagliflozin once daily in the morning (main cohort) or evening (exploratory cohort). Patients with A1C 10.1-12% (high-A1C exploratory cohort; n = 73) were randomly assigned 1:1 to receive blinded treatment with a morning dose of 5 or 10 mg/day dapagliflozin. The primary end point was change from baseline in A1C in the main cohort, statistically tested using an ANCOVA.



In the main cohort, mean A1C changes from baseline at week 24 were -0.23% with placebo and -0.58, -0.77 (P = 0.0005 vs. placebo), and -0.89% (P < 0.0001 vs. placebo) with 2.5, 5, and 10 mg dapagliflozin, respectively. Signs, symptoms, and other reports suggestive of urinary tract infections and genital infection were more frequently noted in the dapagliflozin arms. There were no major episodes of hypoglycemia. Data from exploratory cohorts were consistent with these results.



Dapagliflozin lowered hyperglycemia in treatment-naive patients with newly diagnosed type 2 diabetes. The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for type 2 diabetes.
Effects of caffeine and caffeine withdrawal on mood and cognitive performance degraded by sleep restriction

It has been suggested that caffeine is most likely to benefit mood and performance when alertness is low. To measure the effects of caffeine on psychomotor and cognitive performance, mood, blood pressure and heart rate in sleep-restricted participants. To do this in a group of participants who had also been previously deprived of caffeine for 3 weeks, thereby potentially removing the confounding effects of acute caffeine withdrawal. Participants were moderate to moderate–high caffeine consumers who were provided with either decaffeinated tea and/or coffee for 3 weeks (LTW) or regular tea and/or coffee for 3 weeks (overnight caffeine-withdrawn participants, ONW). Then, following overnight caffeine abstinence, they were tested on a battery of tasks assessing mood, cognitive performance, etc. before and after receiving caffeine (1.2 mg/kg) or on another day after receiving placebo. Final analyses were based on 17 long-term caffeine-withdrawn participants (LTW) and 17 ONW participants whose salivary caffeine levels on each test day confirmed probable compliance with the instructions concerning restrictions on consumption of caffeine-containing drinks. Acute caffeine withdrawal (ONW) had a number of negative effects, including impairment of cognitive performance, increased headache, and reduced alertness and clear-headedness. Caffeine (versus placebo) did not significantly improve cognitive performance in LTW participants, although it prevented further deterioration of performance in ONW participants. Caffeine increased tapping speed (but tended to impair hand steadiness), increased blood pressure, and had some effects on mood in both groups. The findings provide strong support for the withdrawal reversal hypothesis. In particular, cognitive performance was found to be affected adversely by acute caffeine withdrawal and, even in the context of alertness lowered by sleep restriction, cognitive performance was not improved by caffeine in the absence of these withdrawal effects. Different patterns of effects (or lack of effects) of caffeine and caffeine withdrawal were found for other variables, but overall these results also suggest that there is little benefit to be gained from caffeine consumption.
Combining high-frequency oscillatory ventilation and recruitment maneuvers in adults with early acute respiratory distress syndrome: the Treatment with Oscillation and an Open Lung Strategy (TOOLS) Trial pilot study.

To determine the safety, feasibility, and lung-recruitment efficacy of an explicit ventilation protocol combining high-frequency oscillatory ventilation and recruitment maneuvers.



Prospective, multiple-center, single-intervention pilot study.



Four university-affiliated intensive care units.



Twenty-five patients with early acute respiratory distress syndrome and severe oxygenation failure.



Patients were transitioned from standardized conventional ventilation to high-frequency oscillatory ventilation beginning with an initial cycle of up to three sustained inflation recruitment maneuvers (40 cm H2O x 40 secs), followed by a decremental titration of Fio2 and then mean airway pressure. Recruitment maneuvers were repeated for hypoxemia and routinely at least twice daily if the Fio2 was >0.4. A specific protocol was used for weaning high-frequency oscillatory ventilation, for transitioning to conventional ventilation, and for judging intolerance of conventional ventilation whereby patients should be put back on high-frequency oscillatory ventilation.



Patients (median [interquartile range] Acute Physiology and Chronic Health Evaluation II, 24 [19-32]; age, 50 [41-64]) were enrolled after 13 (range, 6-51) hrs of conventional ventilation. Following the initial cycle of recruitment, the mean (+/-sd) Pao2/Fio2 increased significantly compared with standardized conventional ventilation (200 +/- 117 vs. 92 +/- 36 mm Hg, p < .001). After a mean of 12 hrs of high-frequency oscillatory ventilation, the mean Fio2 was significantly reduced compared with prestudy levels (0.5 +/- 0.2 vs. 0.9 +/- 0.1, p < .001). A median of seven (four to 11) recruitment maneuvers was performed per patient over the study period, with only eight of 244 (3.3%) being aborted. Six of 19 patients transitioned to conventional ventilation (32%) were deemed intolerant and were switched back to high-frequency oscillatory ventilation. Protocol adherence was excellent with documented rates >90%.



The combination of high-frequency oscillatory ventilation and recruitment maneuvers resulted in rapid and sustained improvement in oxygenation, likely through lung recruitment. This explicit high-frequency oscillatory ventilation protocol appears well tolerated, feasible, and physiologically sound.
Children as partners with adults in their medical care.

To investigate the seldom published views of children with type 1 diabetes about their condition and ways in which they share in managing their medical and health care with adults.



Semi-structured, tape recorded interviews, during 2003, with a purposive sample of 24 children aged 3-12 years who have type I diabetes and who attend two inner London hospitals and one hospital in a commuter town.



The children reported high levels of understanding, knowledge, and skill gained from their experience of living with diabetes and constantly having to take account of the condition and their paediatrician's guidance. Their key goals were to be "normal" and "just get on with their lives".



The interviews showed that children's experiences of diabetes tended to enable them to make informed, "wise" decisions in their own best interests, even at a young age. They achieved a complicated balance between the sometimes competing goals of social health "being normal" and physiological health in controlling glycaemia. Their competence supports approaches in children's rights and in policy makers' aims that people with diabetes--including children--gain more knowledge, skills, and responsibility for their own care in partnership with healthcare professionals. Consent is usually considered in relation to surgery; however the children showed how they constantly dealt with decisions about consent or refusal, compliance with, or resistance to their prescribed treatment. Their health depends on their informed commitment to medical guidance; more research is needed about the daily realities of children's committed and responsible co-management of their chronic illness.
The economic and workload impact of 'backdoor' prostate-specific antigen screening on the UK National Health Service: a single-centre experience.

To determine the economic burden and additional cost on one hospital within the UK National Health Service secondary to prostate-specific antigen screening by a private recruitment company for a clinical drug trial.



Data were reviewed from all patients who were excluded from the trial and referred across by the recruitment company between May 2004 and April 2005. The additional cost for all their investigation and treatment was calculated.



There were 87 interventional procedures (transrectal prostate biopsy, radical prostatectomy and radical radiotherapy), 27 diagnostic scans (magnetic resonance Imaging and bone scan) and 240 additional outpatient visits (new and follow-up) over the 1-year period. The calculated cost was approximately pound 271 500.



This study highlights the significant increase in the workload and financial burden in one centre within the UK National Health Service. Many other hospitals are likely to be in a similar situation and the total cost to the health service will be much greater.