nils-herrmann/clean_scirepeval huggingface dataset:
Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions.

The monoclonal anti-CD20 antibody rituximab, combined with chemotherapeutic agents, has been shown to prolong overall survival in physically fit patients with previously untreated chronic lymphocytic leukemia (CLL) but not in those with coexisting conditions. We investigated the benefit of the type 2, glycoengineered antibody obinutuzumab (also known as GA101) as compared with that of rituximab, each combined with chlorambucil, in patients with previously untreated CLL and coexisting conditions.



We randomly assigned 781 patients with previously untreated CLL and a score higher than 6 on the Cumulative Illness Rating Scale (CIRS) (range, 0 to 56, with higher scores indicating worse health status) or an estimated creatinine clearance of 30 to 69 ml per minute to receive chlorambucil, obinutuzumab plus chlorambucil, or rituximab plus chlorambucil. The primary end point was investigator-assessed progression-free survival.



The patients had a median age of 73 years, creatinine clearance of 62 ml per minute, and CIRS score of 8 at baseline. Treatment with obinutuzumab-chlorambucil or rituximab-chlorambucil, as compared with chlorambucil monotherapy, increased response rates and prolonged progression-free survival (median progression-free survival, 26.7 months with obinutuzumab-chlorambucil vs. 11.1 months with chlorambucil alone; hazard ratio for progression or death, 0.18; 95% confidence interval [CI], 0.13 to 0.24; P<0.001; and 16.3 months with rituximab-chlorambucil vs. 11.1 months with chlorambucil alone; hazard ratio, 0.44; 95% CI, 0.34 to 0.57; P<0.001). Treatment with obinutuzumab-chlorambucil, as compared with chlorambucil alone, prolonged overall survival (hazard ratio for death, 0.41; 95% CI, 0.23 to 0.74; P=0.002). Treatment with obinutuzumab-chlorambucil, as compared with rituximab-chlorambucil, resulted in prolongation of progression-free survival (hazard ratio, 0.39; 95% CI, 0.31 to 0.49; P<0.001) and higher rates of complete response (20.7% vs. 7.0%) and molecular response. Infusion-related reactions and neutropenia were more common with obinutuzumab-chlorambucil than with rituximab-chlorambucil, but the risk of infection was not increased.



Combining an anti-CD20 antibody with chemotherapy improved outcomes in patients with CLL and coexisting conditions. In this patient population, obinutuzumab was superior to rituximab when each was combined with chlorambucil. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT01010061.).
Factors affecting completion of the SF-36 in older people.

to examine the influence of specific clinical impairments and disabilities on the completion of the SF-36 health status measure among older people.



Prospective observational study.



An SF-36 was administered to 245 subjects aged 65 years and older. Subjects were chosen by sampling from a variety of inpatient, outpatient and community sources to ensure a range of relevant disabilities.



response rates, overall rates of completion, completion of individual questions and time taken to complete.



severe functional impairment (Barthel index < or = 12) was found in 22.4% (51/228), cognitive impairment in 54.1% (132/244), depressed mood in 77.0% (151/196) and visuospatial dysfunction in 71.3% (134/188). The median number of impairments was three (interquartile range 1-4). Specific physical impairments were visual in 13.2% (31/235), hearing in 30.2% (74/245), impaired manual dexterity in 18.0% (44/245) and dysphasia in 23% (55/239). In multivariate analyses, global functional impairment (P = 0.006), cognitive impairment (P = 0.0001) and impaired manual dexterity (P = 0.005) were significantly associated with more dimensions uncompleted, whilst cognitive impairment (P = 0.001), age (P = 0.006) and visuospatial dysfunction (P = 0.0003) were significantly associated with longer completion times.



the most striking finding of the study was that global rather than specific physical and mental dysfunction was associated with the inability to complete the SF-36 questionnaire. The difficulty appears to lie in the performance of a complex task, rather than with specific aspects of the task which could be overcome by adaptation or aids. Our experience is that this relatively complex questionnaire does not adequately measure functional health status in disabled older people because of non-completion and may therefore overestimate the health of populations.
Inconsistent condom use among HIV-positive women in the “Treatment as Prevention Era”: data from the Italian DIDI study

Translation of the evidence regarding the protective role of highly active antiretroviral therapy (HAART) on HIV sexual transmission rates into sexual behaviour patterns of HIV-infected subjects remains largely unexplored. This study aims to describe frequency of self-reported condom use among women living with HIV in Italy and to investigate the variables associated with inconsistent condom use (ICU).



DIDI (Donne con Infezione Da HIV) is an Italian multicentre study based on a questionnaire survey performed during November 2010 and February 2011. Women-reported frequency of condom use was dichotomized in "always" versus "at times"/"never" (ICU).



Among 343 women, prevalence of ICU was 44.3%. Women declared a stable partnership with an HIV-negative (38%) and with an HIV-positive person (43%), or an occasional sexual partner (19%). Among the 194 women engaged in a stable HIV-negative or an occasional partnership, 51% reported fear of infecting the partner. Nonetheless, 43% did not disclose HIV-positive status. Less than 5% of women used contraceptive methods other than condoms. At multivariable analysis, variables associated with ICU in the subgroup of women with a stable HIV-negative or an occasional HIV-unknown partner were: having an occasional partner (AOR 3.51, 95% confidence interval [CI] 1.44-8.54, p=0.005), and reporting fear of infecting the sexual partner (AOR 3.20, 95% CI 1.43-7.16, p=0.004). Current use of HAART together with virological control in plasma level did not predict ICU after adjusting for demographic, behavioural and HIV-related factors. With regard to socio-demographic factors, lower education was the only variable significantly associated with ICU in the multivariate analysis (AOR 2.27, 95% CI 1.07-4.82, p=0.03). No association was found between high adherence to HAART and ICU after adjusting for potential confounders (AOR 0.89, 95% CI 0.39-2.01, p=0.78).



Currently in Italy, the use of HAART with undetectable HIV RNA in plasma as well as antiretroviral adherence is not associated with a specific condom use pattern in women living with HIV and engaged with a sero-discordant or an HIV-unknown partner. This might suggest that the awareness of the protective role of antiretroviral treatment on HIV sexual transmission is still limited among HIV-infected persons, at least in this country.
Assessing the initiation of cocaine self-administration in humans during abstinence: effects of dose, alternative reinforcement, and priming

Impaired ability to refrain from initiating cocaine-taking is a central feature of cocaine dependence and an important target for behavioral and pharmacological interventions. One potential trigger of cocaine-taking is exposure to cocaine (i.e. priming). Here, we report a model of human cocaine self-administration that quantifies the ability to refrain from initiating cocaine self-administration during abstinence and after cocaine administration. In a double-blind, within-subject, residential laboratory study, we assessed cocaine-taking as a function of the choice dose, priming dose, and the magnitude of alternative reinforcement. During each of 3 weeks, cocaine-dependent volunteers participated in one sample and three choice sessions. During sample sessions, participants were administered the dose of cocaine (0, 15 or 30 mg/70 kg IV) available during subsequent choice sessions that week. During choice sessions, participants chose between cocaine and decreasing amounts of money ($19, $16, $13, $10, $7, $4, $1). A priming dose of cocaine (0, 15 or 30 mg/70 kg) was administered 30 min prior to the first choice trial during each of three choice sessions each week. Cocaine-taking was moderate, dose-dependent, and negatively related to the monetary alternative. An active priming injection of cocaine compared to placebo shifted choice to cocaine over money earlier in the session. A descending schedule of alternative reinforcement provided a measure of cocaine-taking during abstinence that was sensitive to cocaine choice dose, magnitude of alternative reinforcement, and priming. This procedure may be a useful tool for assessing potential therapies for cocaine dependence.
Effect on attendance at breast cancer screening of adding a self administered questionnaire to the usual invitation to breast screening in southern England.

The primary aim of the research described in this paper was to ascertain whether inclusion of a self administered questionnaire with the usual invitation to routine breast screening affected screening uptake. Secondary aims included establishing appropriate questionnaire distribution and collection methods within the framework of the National Health Service Breast Screening Programme and optimisation of questionnaire design.



Randomised study.



Oxfordshire and West of London Breast Screening Units.



6400 women invited for routine screening mammography were individually randomised to receive either the usual breast screening invitation alone, or to receive the usual invitation accompanied by a self administered questionnaire, to be returned at the time of screening. Participants were then followed up and attendance rates at screening were compared between groups.



Screening attendance rates were similar in women who did and did not receive a questionnaire (71% in each group). Of those who were sent a questionnaire and attended for screening, 77% returned a completed questionnaire. Screening uptake was not affected by the way in which the questionnaire was returned or by whether or not personal details and signed permission for follow up were requested.



The inclusion of a self administered questionnaire accompanying the invitation to breast screening did not adversely affect screening uptake. A high proportion of women completed the questionnaire.
Renal Lymphangiectasia: A Curious Cause of Pleural Effusion

Renal lymphangiectasia is a disorder of the lymphatic system of the kidneys, which can be congenital or acquired. Although the exact etiology remains unknown, an obstructive process resulting from several causes, including infection, inflammation or malignant infiltration, has been suggested to be responsible for the acquired form. This disorder may be associated with several pathologies. We report a case of a 24-year-old man with renal lymphangiectasia presenting with polycythemia, ascites and pleural effusion associated with hepatitis C virus (HCV) infection in an intravenous (IV) drug user. Our case is the first in the literature that shows an association between HCV infection and IV drug use.
Study protocol for a randomized controlled trial of humor therapy in residential care: the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE).

Humor therapy is a non-pharmacological intervention with potential to improve mood and quality of life for institutionalized older persons, including those with dementia. The primary aims of the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) are to examine the effects of humor therapy on residents' mood, quality of life, social engagement, and agitation.



SMILE is a single-blinded cluster-randomized controlled trial where 398 consented residents in 35 residential aged care facilities will be allocated to receive humor therapy or usual care. Residents allocated to the intervention group will engage in humor therapy with professional performers (ElderClowns) and trained facility staff (LaughterBosses) for a minimum of nine two-hour sessions over 12 weeks as well as engaging humorously with LaughterBosses during the course of daily care. The usual care control group will not engage in any formal humor therapy. Researchers, blind to treatment allocation, will assess residents at baseline (week 0), post-intervention (week 13), and follow-up (week 26). The measurement suite includes the Cornell Scale for Depression in Dementia, the Dementia Quality of Life Scale, the Multidimensional Observation Scale for Elderly Subjects, the Cohen-Mansfield Agitation Inventory, and the Neuropsychiatric Inventory. Observations of residents' engagement will be recorded at each humor therapy session.



SMILE is the first large rigorous study of humor therapy in aged care.
Dacarbazine (DTIC)-based chemotherapy or chemoimmunotherapy of patients with disseminated malignant melanoma.

Combinations of dacarbazine (DTIC) and other cytotoxic agents or alpha-interferon were given to 136 patients in five different regimens. The total response rate was 32% (95% confidence interval 24-40%); 13% had a complete remission. Female patients had a significantly higher chance of response than male patients: 46% vs 23%. There was also a difference in complete response rate: 25% vs 9%. The overall survival was 6 months; 8% of patients had a response of more than 6 months and 2% of more than 2 years. Although response rates vary among the various regimens described in the literature, the complete response rates are quite similar and the long-term disease-free survival of these combinations may be similar to that of dacarbazine alone.
Diet, growth, and the risk for type 1 diabetes in childhood: a matched case-referent study.

To study the association between type 1 diabetes risk and previous intake of energy, accounting for body size and previous intake of nutrients and foods, accounting for the energy intake.



We conducted an incident population-based case-referent study in Stockholm, Sweden, including 99 of 100 eligible 7- to 14-year-old diabetic children and 180 of 200 age-, sex-, and area-matched referent children identified through the Swedish population register. Average daily energy and nutrient intake 1 year before diabetes diagnosis/interview was estimated using the food frequency questionnaire with assessment of consumed food amounts. Mean SD scores of growth measurements taken during the last 4 years before the diagnosis were used. Odds ratios (ORs) were calculated by conditional logistic regression.



Average intake of energy, carbohydrate, fat, and protein was significantly higher among the case subjects as well as mean weight-for-age SD score. Higher energy intake and weight-for-age were both associated with increased diabetes risk after adjustment for each other: OR (95% CI) for medium and high levels of energy intake were 1.33 (0.52-3.42) and 5.23 (1.67-16.38), respectively, and for weight-for-age were 3.20 (1.30-7.88) and 3.09 (1.16-8.22), respectively. High intake of carbohydrates, especially disaccharides and sucrose, increased diabetes risk.



Higher energy intake and larger body size were independently associated with increased diabetes risk. Of the different nutrients, higher intake of carbohydrates, particularly disaccharides and sucrose, increased the risk. Lifestyle habits leading to higher energy intake and more rapid growth in childhood may contribute to the increase of childhood-onset type 1 diabetes by different mechanisms.
Designing a theory- and evidence-based tailored eHealth rehabilitation aftercare program in Germany and the Netherlands: study protocol

Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events. Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work. This includes physical activity as well as fruit and vegetable consumption. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation.



The study will have a randomized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation. The study will consist of one intervention group which will be compared to a waiting list control group. During the eight week duration of the intervention, participants will be invited to participate in the online after-care program once per week. The intervention encourages participants to define individual health behavior goals as well as action, and coping plans to reach these self-determined goals. The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change, antecedents of behavior change (e.g., self-efficacy), ability to return to work and increased well-being. Further, subgroup-differences will be assessed including differences between the two countries, socioeconomic inequalities and across age groups.



The present study will make a contribution to understanding how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle. Implications can include how such an online program could enrich cardiac rehabilitation aftercare further.
Combination of metoprolol with molsidomine in the treatment of angina pectoris

In a randomized controlled trial 31 patients, who were unsuccesfully being treated with metoprolol for severe angina pectoris, were also given molsidomine or placebo. During an exercise test, there was no difference between the groups in heart rate or blood pressure. There was a tendency towards a mild, significant improvement in exercise performance in the molsidomine-treated group, in whom both workload and exercise duration increased after two weeks of treatment. In the placebotreated group, these parameters decreased.
Assessment of left atrial functional parameters using a novel dedicated analysis tool for real-time three-dimensional echocardiography: validation in comparison to magnetic resonance imaging

Real-time three-dimensional echocardiography (RT3DE) is superior to two-dimensional echocardiography in assessing left atrial (LA) parameters, but to date algorithms developed for the left ventricle were applied due to a lack of dedicated LA software. In addition, no data are available on RT3DE assessment of active atrial contraction. The aim of this study was to validate a novel RT3DE analysis tool specifically dedicated to evaluate the LA. Cardiac magnetic resonance imaging (MRI) served as standard of reference. Fifty-five patients scheduled for pulmonary vein isolation underwent cardiac MRI and RT3DE. On ultrasound image datasets, a dynamic polyhedron model of the LA was generated from which LA maximum and minimum volumes (LAmax and LAmin), passive atrial emptying fraction (LAEF), and active atrial ejection fraction (LAEFtrue) were derived and compared to values obtained from cardiac MRI. High intraclass correlations between RT3DE and MRI were found for LAmax (r = 0.94, p < 0.001), LAmin (r = 0.95, p < 0.001), LAEF (r = 0.92, p < 0.001), and LAEFtrue (r = 0.87, p < 0.001). Similarly, Bland–Altman analysis revealed narrow limits of agreement for LAmax (−28.6 to 14.1 ml), LAmin (−26.8 to 12.4 ml), LAEF (−11.2 to 14.9 %), and LAEFtrue (−10.6 to 6.8 %). LAmax, LAmin and LAEFtrue were measured significantly (p < 0.05) lower by RT3DE (111 ± 38 ml vs. 118 ± 39 ml, 73 ± 38 ml vs. 80 ± 41 ml, and 23 ± 14 % vs. 27 ± 14 %, respectively). Interobserver and intraobserver RT3DE measurements correlated closely. RT3DE using a novel dedicated software tool is valid, accurate and reproducible for assessing LA dimensional and functional parameters. This study corroborates previous reports and extends its validity to the assessment of active LA contraction.
Preventive effect of greater occipital nerve block on severity and frequency of migraine headache.

Despite a favorable clinical experience, little evidence exists for the efficacy of greater occipital nerve block (GONB) in migraine treatment. Considering such a premise, we wished to evaluate the therapeutic efficacy of GONB in patients affected by migraine headaches.



A randomized double-blinded controlled trial was conducted on 48 patients suffering from migraine headaches. A syringe containing 1.0 mL of lidocaine 2%, 0.5 mL of either saline (control group, N = 24) or triamcinolone 0.5 mL (intervention group, N = 24) was prepared for each patient. Patients were assessed prior to the injection, and also 2 weeks, 1 month, and 2 months thereafter for severity and frequency of pain, times to use analgesics and any appeared side effects.



No significant differences were revealed in pain severity, pain frequency, and analgesics use between the two groups at the four study time points including at baseline, and 2, 4, and 8 weeks after the intervention. However, in both groups, the indices of pain severity, pain frequency, and analgesics use were significantly reduced at the three time points after the intervention compared with before the intervention.



GONB with triamcinolone in combination with lidocaine or normal saline with lidocaine results in reducing pain severity and frequency as well as use of analgesics up to two months after the intervention, however any difference attributed to the drug regimens by assessing of the trend of pain characteristics changes.