nils-herrmann/clean_scirepeval huggingface dataset:
Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs.

Performance criteria have been established for in vitro blood glucose monitoring, particularly for the self-monitoring of blood glucose using glucose meters. Devices intended for use in the future, such as the continuous glucose monitoring system (CGMS), should satisfy similar criteria, particularly in diabetic patients under intensive therapy.



The analysis was conducted on 18 type 1 diabetic patients (not controlled, HbA(1c) >7.5%) treated by external pump using insulin analogs. Each patient received a glucose sensor for 3 days during his/her hospitalization and was instructed in its operation. Medtronic criteria were used to determine the accuracy of the CGMS. In addition, the data were analyzed according to American Diabetes Association (ADA) criteria, Clarke Error Grid analysis, and method of residuals, with the glucose oxidase method using a Beckman analyzer used as the reference method. Specificity and sensitivity were evaluated from the viewpoint of accuracy in the detection of hypoglycemia. For nine patients, two glucose sensors were simultaneously inserted into an abdominal site to determine the reproducibility of the system. Among the 33 glucose sensors inserted, 6 (18%) were nonfunctional. The mean duration of CGMS recording was 63 +/- 12 h. From all of the 692 sets of data that paired glucose readings and CGMS, the coefficients of correlation ranged from 0.87 to 0.92 and the mean absolute error ranged from 12.8 to 15.7%. The time experienced in hypoglycemia (<55 mg/dl) was reported at 86 +/- 62 min/day. Only 39% of the CGMS values satisfied the ADA precision criteria to within +/-10%, and 19% of these values satisfied the future ADA precision criteria of accuracy to within +/-5%. The means of difference method showed that the CGMS slightly underestimated the plasma glucose values (mean = -12 mg/dl). Error grid analysis showed only 77% of the glucose sensor values were in zone A, and 98.9% were in zones A and B. Two values fell in zone C and a single value fell in zone D. The sensitivity and specificity of the CGMS to detect hypoglycemia were 33 and 96%, respectively. A total of 6666 paired sensor values were recorded with a coefficient of correlation of 0.84 with a coefficient of variation of 8.25%.



CGMS could be useful in routine clinical practice to provide much more information on the glucose profile than intermittent self-monitoring of blood glucose (SMBG). However, CGMS cannot be used as a replacement for glucose meters because it does not satisfy the conventional performance goals set down for in vitro glucose measurements and could therefore lead to clinically incorrect treatment decisions.
The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy.

Despite recent progress in the treatment of ovarian cancer, the majority of patients eventually relapse. There is little information on the effectiveness of chemotherapy in higher treatment lines.



Characterization of the second to sixth line therapy and its effects on survival was carried out, based on data of n = 1620 patients from three large randomized phase III trials investigating primary therapy.



Median progression-free survival (PFS) after the first, second, third, fourth and fifth relapse was 10.2 [95% confidence interval (CI) 9.6-10.7], 6.4 (5.9-7.0), 5.6 (4.8-6.2), 4.4 (3.7-4.9) and 4.1 (3.0-5.1) months, respectively. Median overall survival (OS) after the first, second, third, fourth and fifth relapse was 17.6 (95% CI 16.4-18.6), 11.3 (10.4-12.9), 8.9 (7.8-9.9), 6.2 (5.1-7.7) and 5.0 (3.8-10.4) months, respectively. The most frequent second and third line chemotherapy was platinum combination (n = 313, 24.5%) and topotecan (n = 118, 23.6%), respectively. Relapse treatment improved PFS and OS at the second to fourth recurrence, although frequently not performed according to the standard of care. In multivariate analysis, platinum sensitivity and optimal primary tumor debulking were revealed as independent prognostic factors for PFS up to third relapse.



A maximum of three lines of subsequent relapse treatment seems to be beneficial for patients with recurrent ovarian cancer. Optimal primary tumor debulking and platinum sensitivity remain independent prognostic factors even after more frequent relapses.
Bortezomib-containing regimens are effective in multiple myeloma--results of a non-interventional phase IV study.

The incorporation of bortezomib into the chemotherapeutic regimens for non-transplant patients with multiple myeloma resulted in improved outcomes in controlled studies. This prospective, non-interventional study assessed the effectiveness and safety of bortezomib-containing regimens in daily practice.



Patients with untreated or relapsed multiple myeloma not eligible for high-dose chemotherapy followed by autologous stem cell transplantation and who were scheduled for bortezomib mono- or combination therapy or melphalan-prednisone (MP) alone were included in this study. Dosage and treatment decisions were at the discretion of the physicians.



353 patients received bortezomib-containing therapies and 37 patients MP alone. Overall response rates at treatment end were 65.9% for bortezomib-containing therapies and 50.0% for MP. Partial or complete remissions considered best responses were achieved in 82.6% (first line) and 63.8% (second or later line) of the bortezomib-treated patients. The median duration of response to bortezomib-containing therapies was 18.2 months in 109 first-line and 11.3 months in 110 second- or later-line patients. Adverse drug reactions of any grade were reported during the treatment phase in 79.6% (bortezomib) and 70.3% (MP) of treated patients.



Bortezomib-containing therapies were effective in patients with multiple myeloma in a real-life setting. The increasingly individualized treatment regimens of multiple myeloma require standardized assessments of response in daily practice.
Cimetidine for recurrent ulcer after vagotomy or gastrectomy: a randomised controlled trial.

In a randomised controlled trial cimetidine 1 g daily for six weeks was compared with placebo in the treatment of recurrent ulcers after gastrectomy or vagotomy for duodenal ulcer. Healing, assessed endoscopically, was seen in seven out of 12 patients given cimetidine and in five out of 12 controls. Four of the controls whose ulcers did not heal were subsequently treated with cimetidine, and in two the ulcers healed after six weeks. Pain recorded by the patient and consumption of alkalis were each slightly but not significantly less in the cimetidine-treated patients. When cimetidine is to be used for recurrent ulceration probably the dosage and duration of treatment should be increased.
Genetic variants associated with VLDL, LDL and HDL particle size differ with race/ethnicity

Specific constellations of lipoprotein particle features, reflected as differences in mean lipoprotein particle diameters, are associated with risk of insulin resistance (IR) and cardiovascular disease (CVD). The associations of lipid profiles with disease risk differ by race/ethnicity, the reason for this is not clear. We aimed to examine whether there were additional genetic differences between racial/ethnic groups on lipoprotein profile. Genotypes were assessed using the Affymetrix 6.0 array in 817 related Caucasian participants of the Genetics of Lipid Lowering Drugs and Diet Network (GOLDN). Association analysis was conducted on fasting mean particle diameters using linear models, adjusted for age, sex and study center as fixed effects, and pedigree as a random effect. Replication of associations reaching P < 1.97 × 10−05 (the level at which we achieved at least 80 % power to replicate SNP-phenotype associations) was conducted in the Caucasian population of the Multi-Ethnic Study of Atherosclerosis (MESA; N = 2,430). Variants which replicated across both Caucasian populations were subsequently tested for association in the African-American (N = 1,594), Chinese (N = 758), and Hispanic (N = 1,422) populations of MESA. Variants in the APOB gene region were significantly associated with mean VLDL diameter in GOLDN, and in the Caucasian and Hispanic populations of MESA, while variation in the hepatic lipase (LIPC) gene was associated with mean HDL diameter in both Caucasians populations only. Our findings suggest that the genetic underpinnings of mean lipoprotein diameter differ by race/ethnicity. As lipoprotein diameters are modifiable, this may lead new strategies to modify lipoprotein profiles during the reduction of IR that are sensitive to race/ethnicity.
Bisoprolol in the treatment of hypertension in the elderly

The aim of the study was to examine the hypotensive efficacy and tolerance of bisoprolol in elderly patients. Sixty patients (40 <65 years and 20 >65 years) with mild-to-moderate essential hypertension (diastolic blood pressure (DBP) between 95 and 109 mm Hg) were included in the study. After a 2-week run-in period on placebo, patients began bisoprolol therapy (5 mg/d) for 12 weeks. After 4 weeks the dose was increased to 10 mg/d in those with a DBP ⩾95 mm Hg. Additionally, in 10 patients over 65 years old, 24-h ambulatory BP monitoring (ABPM) was performed, after placebo and after bisoprolol (5 mg) administration. The hypotensive efficacy of bisoprolol in the elderly and younger patients was similar. Before and after treatment the mean difference of systolic BP (SBP) was 19.6 ± 12.5 mm Hg and DBP 9.6 ± 6.2 mm Hg in the younger patients and 16.1 ± 13.6 mm Hg and 9.5 ± 6.0 mm Hg in the elderly patients. Bisoprolol produced a similar reduction in heart rate (23.1% vs 17.1%) in the estimated groups. The tolerance of bisoprolol was good in both groups. There were no significant differences in adverse drug reactions between the groups.
Effect of Afobazole on DNA Damage in Patients with Systemic Lupus Erythematosus

Using comet assay we studied the effect of anxiolytic afobazole, exhibiting also antioxidant and antimutagenic properties, on spontaneous and ex-vivo hydrogen peroxide-induced DNA damage in blood cells from patients with systemic lupus erythematosus. Afobazole treatment (30-60 mg/day for 1 month) in addition to standard therapy decreased spontaneous level of DNA damage in blood cells. The level of ex vivo hydrogen peroxide-induced DNA damage decreased by 49% in this group of patients. The number of cells hypersensitive to hydrogen peroxide yielding DNA comets with highly damaged DNA also decreased by 51%. No significant changes in the analyzed parameters were found in the placebo group. Addition of afobazole to complex therapy of patients with systemic lupus erythematosus reduced the level of DNA damage in blood cells and improved cell resistance to oxidative genotoxic exposure.
The use of chemotherapy in patients with gliomas: Patterns of care in Victoria from 1998–2000

Chemotherapy has an increasing role in the management of gliomas. In particular, chemotherapy provides survival and quality of life benefits in the setting of recurrent high-grade gliomas and in patients with newly diagnosed glioblastoma multiforme. We have previously reported details on patterns of care regarding 828 patients diagnosed with a glioma in the state of Victoria for the period 1998-2000. We observed that 250 patients (30%) received chemotherapy at some stage of their illness, including neo-adjuvant, adjuvant and recurrent clinical settings. There was significant variation in the agents used and their scheduling. Chemotherapy was given at any time in only 15% of patients aged over 60 years. Eight percent of patients were enrolled on a chemotherapy clinical trial. As chemotherapy for gliomas becomes entrenched as the standard of care, this survey will provide an insight into changing patterns of care for the future and points to areas of need in management of these tumours.
Training care givers of stroke patients: economic evaluation.

Training care givers reduces their burden and improves psychosocial outcomes in care givers and patients at one year. However, the cost effectiveness of this approach has not been investigated.



To evaluate the cost effectiveness of caregiver training by examining health and social care costs, informal care costs, and quality adjusted life years in care givers.



A single, blind, randomised controlled trial.



Stroke rehabilitation unit.



300 stroke patients and their care givers.



Caregiver training in basic nursing and facilitation of personal care techniques compared with no care giver training.



Health and social care costs, informal care costs, and quality adjusted life years in care givers over one year after stroke.



Total health and social care costs over one year for patients whose care givers received training were significantly lower (mean difference -4043 pounds sterling (7249 dollars; 6072 euros), 95% confidence interval -6544 pounds sterling to -595 pounds sterling). Inclusion of informal care costs, which were similar between the two groups, did not alter this conclusion. The cost difference was largely due to differences in length of hospital stay. The EQ-5D did not detect changes in quality adjusted life years in care givers.



Compared with no training, caregiver training during rehabilitation of patients reduced costs of care while improving overall quality of life in care givers at one year.
Effects of liraglutide on neurodegeneration, blood flow and cognition in Alzheimer´s disease - protocol for a controlled, randomized double-blinded trial.

Type 2 diabetes (DM-2) increases the risk of developing Alzheimer´s disease (AD), and patients with AD are more likely to develop DM-2. DM-2 and AD share some pathophysiological features. In AD, amyloid-β (Aβ) is accumulated as extracellular plaques in the gray matter of the brain, while in DM-2 islet amyloid polypeptide (IAPP) is accumulated in the pancreas. Premature cellular degeneration is seen in both diseases. Glucagon-like peptide-1 (GLP-1) reduces the amount of Aβ and improves cognition in animal studies. The present study tests the hypothesis that treatment with the long-acting GLP-1 receptor agonist liraglutide affects the accumulation of Aβ in patients with AD.



This is a randomized, controlled, double-blinded intervention study with AD patients treated for six months with liraglutide (n = 20) or placebo (n = 20). The primary outcome is change in deposition of Aβ in the central nervous system (CNS) by Pittsburgh compound B positron emission tomography (PET). The secondary outcome is evaluation of cognition using a neuro-psychological test battery, and examination of changes in glucose uptake in the CNS by 18F-fluoro-deoxy-glucose PET. Finally, a perfusion-weighted magnetic resonance imaging with contrast will be performed to evaluate blood flow.



No registered drug affects the deposition of Aβ in the brain of AD patients. Our goal is to find a new therapeutic agent that alters the pathophysiology in AD patients by decreasing the formation of Aβ plaques and thereby presumably improves the cognitive function.



The trial is investigator-initiated and investigator-driven and is supported by Novo Nordisk Scandinavia.
Validation of the MEDFICTS dietary assessment questionnaire in a diverse population.

The National Cholesterol Education Program (NCEP) recommends MEDFICTS, a rapid screening instrument for dietary fat, to assess adherence to the Adult Treatment Panel (ATP) III Therapeutic Lifestyle Changes (TLC) diet (score <40 points indicates intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day). MEDFICTS has only been validated in small, select populations and its utility in diverse clinical settings is unknown.



To evaluate the ability of MEDFICTS to identify individuals who are nonadherent to a TLC diet in an ethnically diverse population that includes both English- and Spanish-speakers.



MEDFICTS was administered concurrently with the Gladys Block Food Frequency Questionnaire to participants (n=501; mean age 48+/-13.5 years; 36% nonwhite; 66% female) in the National Heart, Lung, and Blood Institute Family Intervention Trial for Heart Health (FIT Heart) at the baseline screening visit. Reliability and validity analyses were conducted overall and by sex, age, and race/ethnicity.



MEDFICTS score correlated significantly with percentage of energy from saturated fat (r=0.52, P<0.0001), percentage of energy from total fat (r=0.31, P<0.0001), and milligrams per day of dietary cholesterol (r=0.54, P<0.0001). Sensitivity of MEDFICTS to correctly identify TLC diet adherence was 85.7% and did not differ significantly by sex, age, or race/ethnicity. Specificity of MEDFICTS to correctly identify nonadherence to the TLC diet was low (56.9%) and significantly worse for women than men (48.4% vs 72.9%; P<0.0001), but did not differ significantly in older vs younger participants or among white, black, or Hispanic participants.



Our data suggest that sex-specific recalibration of MEDFICTS may improve specificity and clinical utility.
Both ramipril and telmisartan reverse indices of early diabetic cardiomyopathy: a comparative study.

We tested the hypothesis that renin-angiotensin system inhibition could reverse left ventricular diastolic dysfunction in patients with type 2 diabetes.



Forty asymptomatic patients with type 2 diabetes were recruited in this double-blind cross-over trial. Left ventricular diastolic function was assessed at baseline with Doppler echocardiography; ratios of early to late peak flow velocity through the mitral orifice (E/A) and velocity time integral of early to late transmitral diastolic flow (VTIE/VTIA) were evaluated. In addition, plasma brain natriuretic peptide (BNP) was measured. Patients received randomly either ramipril (2.5 mg/day), or telmisartan (40 mg/day) or their combination for 3 months. Subsequently, every patient was crossed over to alternative regimens after a 2-week washout period. Measurements were repeated at the end of each treatment period. Both E/A and VTIE/VTIA ratios were increased (29 and 20% with ramipril, 25 and 23% with telmisartan and 36 and 28% with combination treatment, respectively, p < 0.001), whereas plasma BNP levels were significantly reduced with all 3 regimens (9% with ramipril, 25% with telmisartan and 36% with combination, p < 0.001).



Both ramipril and telmisartan improve echocardiographic left ventricular diastolic indices and reduce plasma BNP levels in diabetic patients; their combination yields an even better therapeutic effect.
Prognostic value of six minute walk test in cystic fibrosis adults.

The 6 min walk test (6MWT) provides prognostic information in various respiratory diseases, but limited data exist in cystic fibrosis (CF) adults.



Consecutive CF adults who performed 6MWT at Cochin Hospital (Paris, France) over 12 years were analyzed. The cut-off 6 min walking distance (6MWD) value that best predicted a combined endpoint (death without transplant or lung transplant) was established using a receiver operating curve. Determinants of low 6MWD or of desaturation (SpO2 ≤ 90%) during 6MWT were examined using multivariate logistic regressions. Prognostic value of these variables was assessed using Kaplan-Meier and Cox analyses.



6MWT was performed in 286 CF adults (median: age, 28 yr; FEV1, 45% predicted) of whom 14% (n = 40) had lung transplant and 6% (n = 18) died without transplant. 6MWD correlated with FEV1% predicted (r = 0.43; P < 0.001), but markedly differed in subjects within the same range of FEV1. A 6MWD ≤ 475 m predicted death or transplant and was mostly found in patients with FEV1 ≤ 60% predicted. Desaturation during the 6MWT occurred in 29% of patients, exclusively in subjects with FEV1 ≤ 60% predicted. Both 6MWD ≤ 475 m and desaturation during the 6MWT were independent predictors of death or transplant.



The 6MWT provides prognostic information in CF adults, especially in subjects with FEV1 ≤ 60% predicted.
Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression.

The purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study.



TOSCA was a randomized clinical trial of psychostimulant plus parent training plus placebo (basic treatment) versus psychostimulant plus parent training plus risperidone (augmented treatment) for children with severe physical aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. Parents completed a standardized Parent Satisfaction Questionnaire (PSQ).



Of the 168 families randomized, 150 (89.3%) provided consumer satisfaction data. When they were asked if they would join the study again if they had the option to repeat, 136 (91%) said "yes," 11 (7%) said "maybe," and one (<1%) said "no." When asked if they would recommend the study to other parents with children having similar problems, 147 (98%) said "yes" and 3 (2%) said "maybe." Between 71% (rating one aspect of the Parent Training) and 96% (regarding the diagnostic interview) endorsed study procedures using the most positive response option. Asked if there were certain aspects of the study that they especially liked, 64 (43%) spontaneously reported parent training. Treatment assignment (basic vs. augmented) and responder status were not associated with reported satisfaction. However, responder status was strongly associated with parent confidence in managing present (p<0.001) and future (p<0.005) problem behaviors.



These findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience. These findings may inform research bioethics and may have implications for deliberations of institutional review boards.
Randomised clinical trial: gluten may cause depression in subjects with non-coeliac gluten sensitivity - an exploratory clinical study.

Current evidence suggests that many patients with self-reported non-coeliac gluten sensitivity (NCGS) retain gastrointestinal symptoms on a gluten-free diet (GFD) but continue to restrict gluten as they report 'feeling better'.



To investigate the notion that a major effect of gluten in those with NCGS is on mental state and not necessarily on gastrointestinal symptoms.



Twenty-two subjects (24-62 years, five male) with irritable bowel syndrome who had coeliac disease excluded but were symptomatically controlled on a GFD, undertook a double-blind cross-over study. Participants randomly received one of three dietary challenges for 3 days, followed by a minimum 3-day washout before crossing over to the next diet. Challenge gluten-free food was supplemented with gluten (16 g/day), whey (16 g/day) or not supplemented (placebo). End-points included mental state as assessed by the Spielberger State Trait Personality Inventory (STPI), cortisol secretion and gastrointestinal symptoms.



Gluten ingestion was associated with higher overall STPI state depression scores compared to placebo [M = 2.03, 95% CI (0.55-3.51), P = 0.010] but not whey [M = 1.48, 95% CI (-0.14 to 3.10), P = 0.07]. No differences were found for other STPI state indices or for any STPI trait measures. No difference in cortisol secretion was identified between challenges. Gastrointestinal symptoms were induced similarly across all dietary challenges.



Short-term exposure to gluten specifically induced current feelings of depression with no effect on other indices or on emotional disposition. Gluten-specific induction of gastrointestinal symptoms was not identified. Such findings might explain why patients with non-coeliac gluten sensitivity feel better on a gluten-free diet despite the continuation of gastrointestinal symptoms.