nils-herrmann/clean_scirepeval huggingface dataset:
Ethnicity and weight status affect the accuracy of proxy indices of insulin sensitivity.

This study tested the hypotheses that correlations between direct measures of insulin sensitivity and proxy indices of insulin sensitivity derived from fasting values, (i) would not be affected by ethnicity, and (ii) would be stronger in overweight vs. weight-reduced states. We further hypothesized that associations between proxy indices and fat distribution would be similar to those between directly measured insulin sensitivity and fat distribution. Testing was performed in weight-stable conditions in 59 African-American (AA) and 62 white-American (WA) overweight, premenopausal women before and after a weight loss intervention. Subjects were retested 1 year following weight loss. Proxy indices were correlated against the insulin sensitivity index S(I) determined via minimal modeling. Fat distribution was assessed using computed tomography. Correlations between Si and proxy indices were consistently stronger among overweight women (r = 0.44-0.52) vs. weight-reduced women (r = 0.18-0.32), and among AA (r = 0.49-0.56, baseline; 0.24-0.36, weight-reduced) vs. WA (r = 0.38-0.46, baseline; 0.19-0.31, weight-reduced). Among subjects who regained >3 kg after 1 year, correlations between S(I) and proxy indices were similar to those observed at baseline, whereas correlations were weak among women who maintained their reduced body weight. S(I) and all proxy indices were similarly correlated with intra-abdominal adipose tissue (IAAT) at baseline, but not after weight loss. In conclusion, correlations between S(I) and proxy indices were affected by both ethnicity and weight status. If proxy indices are used in multiethnic populations, or in populations including both lean and overweight/obese subjects, data should be interpreted with caution.
Change of Virchow-Robin spaces in idiopathic normal pressure hydrocephalus and its pathogenetic significance

Idiopathic normal pressure hydrocephalus (iNPH) is a disorder of aged adults, but it pathogenesis is still unknown. Recently, Virchow-Robin Spaces (VRS) are interested in anatomical structure for interaction between interstitial fluid (ISF) and cerebrospinal fluid (CSF). VRS are known to observe mainly in the basal ganglia and the subcortical white matter and they increase in number with aging. In the present study, we investigated morphological features of VRS in the brain in the aged healthy adults and patients with probable iNPH.
Idiopathic hypovolemia: a self-perpetuating autonomic dysfunction?

Unexplained episodic hypertension, hypotension, or orthostatic intolerance, tachycardia, anxiety, and flushing in 21 patients were investigated for the possibility of hypovolemia by blood volume and individual plasma catecholamines (including autocrine paracrine-born dopamine), determinations baseline, in response to upright posture and catecholamines only during the episodic blood pressure swings. Blood volume was determined by Cr51 fixed to patients' hemoglobin, free norepinephrine, epinephrine, and dopamine with dopamine sulfate following sulfatase hydrolysis, radioenzymatically. The recumbent mean 27.4±3% (SE) blood volume decrease from predicted values accentuating to 33.5±4% upright was associated with normal baseline plasma free norepinephrine, epinephrine, dopamine, dopamine sulfate, plasma renin activity, and aldosterone with normal mean postural responses from all patients except a hyperresponsive compared to controls (p<0.04), plasma renin activity increase from 0.657±0.1 to 4.47±1.8 ng/mL/hr. During the hypertensive, hypotensive, or tachycardic episodes the moderate increase of free norepinephrine and epinephrine (p<0.04) (but not free dopamine) contrasted with an increase of dopamine sulfate from 2.5±0.9 to clearly pathological values of 16.8±8.3 ng/mL (p<0.0003 on % increase of individual values). We conclude that the normal (but to the degree of hypovolemia inappropriately low orthostatism- and episodes-associated sympathetic arousal) is outpaced by considerable episodic dopamine sulfate surges, reflecting extraneuronal dopamine discharge. Whether this increase contributes to the increased natriuresis directly or by inhibiting aldosterone response to renin-angiotensin, perpetuating hypovolemia, remains to be established.
Variation in the UCP2-UCP3 gene cluster predicts the development of type 2 diabetes in healthy middle-aged men.

The impact of the UCP2 -866G>A and UCP3 -55C>T variants on prospective risk of type 2 diabetes was examined over 15 years in 2,936 healthy middle-aged men (mean age 56 years). Conversion to diabetes (n = 169) was associated with higher BMI, blood pressure, cholesterol, triglycerides and C-reactive protein. The hazard ratio (HR) for diabetes of a BMI >30 kg/m(2) was 3.96 (95% CI 2.87-5.47). Homozygosity for the UCP2A or UCP3T alleles accelerated the onset of diabetes, with significant differences in risk of diabetes at 10 years (HR [95% CI] UCP2AA vs. GA+GG 1.94 [1.18-3.19], P = 0.009; UCP3TT vs. CC+ CT 2.06 [1.06-3.99], P = 0.03) but less so at 15 years (UCP2AA 1.42 [0.92-2.19], P = 0.1; UCP3TT 1.57 [0.87-2.04], P = 0.13). Men who were homozygous for both UCP2AA and UCP3TT (1.5% of men) had a risk for diabetes at 10 years of 4.20 (1.70-10.37), P = 0.002. These genotype effects were additive with obesity, and men with a BMI >30 kg/m(2) and this genotype combination had a 10-year risk of diabetes of 19.23 [5.63-63.69], P < 0.0001. Functional promoter variants UCP2 and UCP3 increase the prospective risk of diabetes. Although the mechanism of the UCP2 effect is likely to be caused by increased expression in the pancreas and subsequent reduced insulin secretion, the mechanism of the UCP3 effect is currently unknown. Both effects are exacerbated by obesity.
Safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults on anti-retroviral therapy in Uganda (COSTOP trial): Design

Cotrimoxazole (CTX) prophylaxis is recommended by the World Health Organisation for HIV infected persons. However, once HIV infected patients have commenced ART in resource limited settings, the benefits of continued CTX prophylaxis are not known. The few studies that investigated the safety of discontinuing CTX prophylaxis in these settings had limitations due to their design.



COSTOP is a randomised double blind placebo controlled non-inferiority trial among HIV infected Ugandan adults stabilised on anti-retroviral treatment (ART). Participants with CD4 count of 250 or more cells/mm(3) are randomised to two arms: the intervention arm in which CTX is discontinued and the control arm in which CTX prophylaxis is continued. The study aims to assess whether the intervention regimen is not inferior, with respect to the incidence of pre-defined CTX-preventable events, to the control regimen and superior with respect to the incidence of haematological adverse events.



Studies that have previously evaluated the safety of discontinuing CTX prophylaxis among HIV infected adults in resource limited settings have provided moderate to low quality evidence owing in part to methodological limitations. COSTOP is designed and conducted with sufficient rigour to answer this question. The results of the trial will assist in guiding policy recommendations.



This paper describes the design and methodological considerations important for the conduct of CTX cessation studies.
Optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with modified FOLFOX6: a randomized pilot study.

Indisetron is a serotonin (5-hydroxytryptamine type 3) receptor antagonist that also antagonizes 5-hydroxytryptamine type 4 receptors. We designed a pilot study in order to explore the optimal dosing period for indisetron during modified FOLFOX6 (mFOLFOX6).



Forty-two chemotherapy-naive patients with advanced colorectal cancer scheduled to receive mFOLFOX6 were randomly assigned to either a 1- or 3-day indisetron regimen arm. The primary endpoint was complete protection from vomiting.



Proportions of patients with complete protection from vomiting were 85.7% [95% confidence interval (CI) 63.7-97.0] with the 3-day regimen and 81.0% (95% CI 58.1-94.6) with the 1-day regimen. Proportions of patients with complete protection from nausea were 47.6% in each arm (95% CI 25.7-70.2). No rescue therapy rates were 66.7% (95% CI 43.0-85.4) versus 57.1% (95% CI 34.0-78.2). No severe adverse events were observed in either arm.



Both 1- and 3-day indisetron regimens were feasible for preventing nausea and vomiting induced by mFOLFOX6.
Cost-effectiveness of a tailored intervention designed to increase breast cancer screening among a non-adherent population: a randomized controlled trial

Although the percentage of women who initiate breast cancer screening is rising, the rate of continued adherence is poor. The purpose of this study was to examine the effectiveness and cost-effectiveness of a tailored print intervention compared with a non-tailored print intervention for increasing the breast cancer screening rate among a non-adherent population.



In total, 1859 participants aged 51-59 years (except those aged 55 years) were recruited from a Japanese urban community setting. Participants were randomly assigned to receive either a tailored print reminder (tailored intervention group) or non-tailored print reminder (non-tailored intervention group). The primary outcome was improvement in the breast cancer screening rate. The screening rates and cost-effectiveness were examined for each treatment group (tailored vs. non-tailored) and each intervention subgroup during a follow-up period of five months. All analyses followed the intention-to-treat principle.



The number of women who underwent a screening mammogram following the reminder was 277 (19.9%) in the tailored reminder group and 27 (5.8%) in the non-tailored reminder group. A logistic regression model revealed that the odds of a woman who received a tailored print reminder undergoing mammography was 4.02 times those of a women who had received a non-tailored print reminder (95% confidence interval, 2.67-6.06). The cost of one mammography screening increase was 2,544 JPY or 30 USD in the tailored intervention group and 4,366 JPY or 52 USD in the non-tailored intervention group.



Providing a tailored print reminder was an effective and cost-effective strategy for improving breast cancer screening rates among non-adherent women.
A Randomized Clinical Trial of Alcohol Care Management Delivered in Department of Veterans Affairs Primary Care Clinics Versus Specialty Addiction Treatment

Alcohol use disorder is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments, few individuals with an alcohol use disorder are actively engaged in treatment. Available evidence suggests that primary care may play a crucial role in the identification of patients with an alcohol use disorder, delivery of interventions, and the success of treatment. The principal aims of this study were to test the effectiveness of a primary care-based Alcohol Care Management (ACM) program for alcohol use disorder and treatment engagement in veterans. The design of the study was a 26-week single-blind randomized clinical trial. The study was conducted in the primary care practices at three VA medical centers. Participants were randomly assigned to treatment in ACM or standard treatment in a specialty outpatient addiction treatment program. One hundred and sixty-three alcohol-dependent veterans were randomized. ACM focused on the use of pharmacotherapy and psychosocial support. ACM was delivered in-person or by telephone within the primary care clinic. Engagement in treatment and heavy alcohol consumption. The ACM condition had a significantly higher proportion of participants engaged in treatment over the 26 weeks [OR = 5.36, 95 % CI = (2.99, 9.59)]. The percentage of heavy drinking days were significantly lower in the ACM condition [OR = 2.16, 95 % CI = (1.27, 3.66)], while overall abstinence did not differ between groups. Results demonstrate that treatment for an alcohol use disorder can be delivered effectively within primary care, leading to greater rates of engagement in treatment and greater reductions in heavy drinking.
Implant survival of the most common cemented total hip devices from the Nordic Arthroplasty Register Association database

According to previous Nordic Arthroplasty Register Association (NARA) data, the 10-year implant survival of cemented total hip arthroplasties (THAs) is 94% in patients aged 65-74 and 96% in patients aged 75 or more. Here we report a brand-level comparison of cemented THA based on the NARA database, which has not been done previously.  We determined the rate of implant survival of the 9 most common cemented THAs in the NARA database. We used Kaplan-Meier analysis with 95% CI to study implant survival at 10 and 15 years, and Cox multiple regression to assess survival and hazard ratios (HRs), with revision for any reason as endpoint and with adjustment for age, sex, diagnosis, and femoral head material.  Spectron EF THA (89.9% (CI: 89.3-90.5)) and Elite THA (89.8% (CI: 89.0-90.6)) had the lowest 10-year survivorship. Lubinus (95.7% survival, CI: 95.5-95.9), MS 30 (96.6%, CI: 95.8-97.4), and C-stem THA (95.8%, CI: 94.8-96.8) had a 10-year survivorship of at least 95%. Lubinus (revision risk (RR) = 0.77, CI: 0.73-0.81), Müller (RR =0.83, CI: 0.70-0.99), MS-30 (RR =0.73, CI: 0.63-0.86), C-stem (RR =0.70, CI: 0.55-0.90), and Exeter Duration THA (RR =0.84, CI: 0.77-0.90) had a lower risk of revision than Charnley THA, the reference implant.  The Spectron EF THA and the Elite THA had a lower implant survival than the Charnley, Exeter, and Lubinus THAs. Implant survival of the Müller, MS 30, CPT, and C-stem THAs was above the acceptable limit for 10-year survival.
Impact of educational mailing on the blood pressure of primary care patients with mild hypertension

To assess the effectiveness of mailed hypertension educational materials.  Prospective, randomized, controlled single-blind trial.  Primary care practice-based research network in which 9 clinics located in Portland, Oregon participated.  Patients with mildly uncontrolled hypertension as defined as a last blood pressure of 140 to 159/90 to 99 mmHg from query of an electronic medical record database.  Patients randomized to intervention were mailed 2 educational packets approximately 3 months apart. The first mailer included a letter from each patient’s primary care provider. The mailer included a booklet providing an overview of hypertension and lifestyle modification and a refrigerator magnet noting target blood pressure. The second mailing also included a letter from the patient’s primary care provider, a second educational booklet focused on medication compliance and home blood pressure monitoring, and a blood pressure logbook. The control group consisted of similar patients receiving usual care for hypertension.  Patients from each group were randomly selected for invitation to participate in a study visit to measure blood pressure and complete a survey (intervention n=162; control n=150). No significant difference was found in mean blood pressure between intervention and control patients (135/77 mmHg vs 137/77 mmHg; P=.229). Patients in the intervention arm scored higher on a hypertension knowledge quiz (7.48 ± 1.6 vs 7.06 ± 1.6; P=.019), and reported higher satisfaction with several aspects of their care. No significant difference was seen in the prevalence of home blood pressure monitoring ownership or use.  In patients with mildly uncontrolled hypertension, educational mailers did not yield a significant decrease in blood pressure. However, significant improvement in patient knowledge, frequency of home monitoring, and satisfaction with care were demonstrated.
Two-year follow-up of a randomized controlled trial of a clinical nurse specialist intervention, inpatient, and day patient team care in rheumatoid arthritis.

To compare the long-term effectiveness of care delivered by a clinical nurse specialist (CNS) with inpatient team care and day patient team care in patients with rheumatoid arthritis and increasing functional limitations.  The role of CNSs in the management of patients with rheumatoid arthritis (RA) is evolving, and their effectiveness in comparison with care provided by a rheumatologist alone has been established. However, long-term controlled studies showing how the effectiveness of CNSs compares with that of other forms of co-ordinated care, such as multidisciplinary team care, are lacking.



Two hundred and ten patients rheumatoid arthritis patients were randomized to care delivered by a CNS in a rheumatology outpatient clinic (12 weeks), inpatient team care (2 weeks) and day patient team care (3 weeks). Clinical assessments recorded on study entry, weeks 12, 26, 52, 78 and 104 comprised the health assessment questionnaire (HAQ) and MacMaster Toronto Arthritis (MACTAR) patient preference interview as primary outcome measures. Grip strength, walk test, RAND-36, Rheumatoid Arthritis Quality of Life questionnaire and disease activity score (DAS) were applied as secondary outcome measures.



No significant differences in medical treatment, use of services of other health professionals, introduction of adaptive equipment or number of hospitalizations were observed between the three treatment groups during 2 year follow-up, except that visits to nurse specialists were more frequent and home help was less frequent in the CNS group. A comparison of clinical outcomes among the three groups and a comparison between the nurse specialist and inpatient and day patient care groups together did not show any significant differences. Within all three groups functional status, quality of life and disease activity improved significantly (P < 0.05). In general, the results obtained after 12 weeks remained stable until 104 weeks after the start of the study.



Care provided by a CNS in an outpatient rheumatology clinic has a similar long-term clinical outcome to inpatient and day patient team care in patients with rheumatoid arthritis. A CNS intervention appears to be an effective innovation in the care for patients with rheumatoid arthritis.
Bone mineral density in subjects with mild asthma randomised to treatment with inhaled corticosteroids or non-corticosteroid treatment for two years.

Inhaled corticosteroids are clearly beneficial for patients with asthma of moderate severity, but the risks and benefits of using them in patients with milder asthma are less clear. We have compared the change in bone mineral density over 2 years in adults with mild asthma randomised to receive an inhaled corticosteroid or non-corticosteroid treatment.



Subjects with mild asthma (mean forced expiratory volume in one second (FEV(1)) 86% predicted, mean age 35 years, taking beta agonists only) were randomised to receive inhaled budesonide, inhaled beclomethasone dipropionate, or non-corticosteroid treatment for 2 years in a prospective randomised open study in 19 centres in France, New Zealand, Spain, and the UK. The corticosteroid dose was adjusted according to a written self-management plan. The main outcome measure-change in bone mineral density after 6, 12, and 24 months-was measured "blind". Secondary outcomes included lung function, the relation between change in bone density and inhaled steroid dose and change in biochemical markers of bone metabolism.



Of 374 subjects randomised, 239 (64%) completed the study and were included in the analysis. The median daily doses of inhaled budesonide (n=87) and beclomethasone (n=74) were 389 microg and 499 microg, respectively. Subjects treated with an inhaled corticosteroid had better asthma control than those in the reference group (n=78). Change in bone mineral density did not differ between the three groups over the 2 years, nor did it correlate with changes in markers of bone metabolism. The mean change in bone mineral density over 2 years in the budesonide, beclomethasone dipropionate, and reference groups was 0.1%, -0.4%, and 0.4% for the lumbar spine and -0.9%, -0.9%, and -0.4% for neck of the femur. Mean daily dose of inhaled steroid was related to reduction in bone mineral density at the lumbar spine but not at the femoral neck.



In subjects with mild asthma an inhaled corticosteroid provided better asthma control than alternative non-corticosteroid treatment with no difference in change in bone mineral density over 2 years. The relation between dose of inhaled corticosteroid and change in bone density at the lumbar spine may be due to a direct effect of inhaled corticosteroids on bone. Since inhaled steroid dose is also related inversely to lung function, an effect of asthma severity on bone density was also possible.
High prevalence of inactivity among young patients with type 1 diabetes in south Spain.

To describe usual physical activity level and analyze its association with metabolic control and presence of microvascular complications in a cohort of patients with type 1 diabetes (DM-1) in south Spain.



Observational, cross-sectional study that included one hundred thirty patients, aged 33.9 ± 11.5 years-old with disease duration of 16.5 ± 9.5 years that consecutively were recruited among patients attending the Endocrinology Service of Puerta del Mar University Hospital (Cádiz, Spain). Usual physical activity level was assessed using the "General Practice Physical Activity Questionnaire" (GPPAQ) together with clinical, anthropometric, metabolic parameters and microvascular complications.



DM-1 patients were grouped in four categories of physical activity level: inactive (n = 33; 25.3%), moderately inactive (n = 31; 23.8%), moderately active (n = 26; 20.0%) and active (n = 40; 30.9%). We observed no significant differences in glycated haemoglobin (HbA1c) level between the different physical activity groups analyzed. Patients classified as moderately active and active were more often men, significantly younger and presented lower plasmatic levels of triglycerides than patients classified as inactive or moderately inactive, with no differences in other clinical or anthropometric variables. In addition, active and moderately active patients had a lower prevalence of diabetic retinopathy and microvascular complications in general compared to inactive or moderately inactive patients.



Half of patients with type 1 diabetes evaluated were classified as inactive and these patients had a higher prevalence of diabetic retinopathy than active patients. No difference in HbA1c levels was documented among different groups of physical activity.