nils-herrmann/clean_scirepeval huggingface dataset:
The Reduction of Chronic, Nonspecific Low Back Pain Through the Control of Early Morning Lumbar Flexion: 3-Year Follow-Up

Three years ago, an 18-month randomized controlled trial of chronic, nonspecific low back pain investigated the effectiveness of instructing subjects to restrict bending activities in the early morning, when the fluid content in the disc is increased. Pain days (as recorded by daily diaries) were reduced 23% in the treatment group, compared to a 2% reduction in the control (sham treatment) group. The purpose of the current follow-up study was to determine whether the results of that trial were maintained during the 3 years following completion of the trial. A questionnaire was mailed to the 60 subjects who completed the original trial. Fifty subjects completed the questionnaire for a response rate of 83%. Thirty-one subjects (62%) continued to restrict bending activities in the early morning, and experienced a further reduction of 10.1 pain days per month (51%) since the completion of the experiment. However, some of the subjects who did not continue to comply also improved. Several possible explanations for the improvement of noncompliant subjects are offered.
The role of exercise in blood pressure control: supportive evidence.

Epidemiological studies suggest an inverse relationship between physical activity or fitness and blood pressure. In controlled intervention studies, the weighted net change in conventional blood pressure caused by dynamic aerobic training averaged -5.3 mmHg for systolic and -4.8 mmHg for diastolic blood pressure. The considerable interstudy variation in the blood pressure response can be partly explained by the more pronounced effect in hypertensive patients compared with the results in normotensive subjects. When only studies that used a random procedure and some follow-up study of the controls were included, the blood pressure-lowering effect of training was significant only in hypertensives. The same pattern is emerging for daytime blood pressure in studies that applied ambulatory pressure monitoring: night-time pressure was usually not affected by training. In conclusion, despite shortcomings in many individual studies, the overall results suggest that dynamic aerobic training may lower conventional and daytime blood pressure in adults with elevated blood pressure at baseline.
The relation of postmenopausal hormone therapy to serum uric acid and the risk of coronary heart disease events: the Heart and Estrogen-Progestin Replacement Study (HERS).

To determine whether baseline serum uric acid (UA) levels and estrogen-progestin (E+P)-associated change in serum UA in postmenopausal women with coronary disease are associated with recurrent coronary heart disease (CHD) events.



2763 postmenopausal women enrolled in the Heart and Estrogen-Progestin Replacement Study (HERS) were randomly assigned to take conjugated E+P or placebo in a secondary CHD prevention study. The primary outcome for these analyses was nonfatal myocardial infarction or CHD death during a mean follow up of 4.1 years.



The baseline serum UA for the cohort was 5.4 mg/dl and, compared with placebo, E+P on average lowered serum UA levels slightly (0.2 mg/dl) at one year of follow up (p<0.0001). Baseline serum UA levels were associated in simple proportional hazards models with CHD events; each standard deviation increase (1.3 mg/dl) was associated with a 22% increased risk of primary CHD events (p=.0001). This association, however, was no longer statistically significant after multivariable adjustment (p=0.36). There was no association between on-study change in serum UA level and any CHD outcome.



Treatment with E+P lowered serum UA levels slightly, but neither baseline UA nor change in UA affected CHD risk.
Adjuvant chemotherapy in the treatment of colon cancer: randomized multicenter trial of the Italian National Intergroup of Adjuvant Chemotherapy in Colon Cancer (INTACC).

To determine whether the addition of leucovorin to the combination 5-fluorouracil plus levamisole prolongs disease-free survival and overall survival in patients with radically resected colon cancer (Dukes' B(2-3) and C).



Patients (1703) were accrued between March 1992 and February 1995 in a large-scale clinical trial within five Italian cooperative groups. After stratification for center, patients were randomized as follows: arm A, 5-fluorouracil [450 mg/m(2) intravenous (i.v.) bolus on days 1-5] and levamisole (150 mg orally for 3 days, every 14 days for 6 months) versus arm B, 6-S-leucovorin (100 mg/m(2) i.v. bolus on days 1-5) followed by 5-fluorouracil (370 mg/m(2) i.v. bolus on days 1-5), plus levamisole (as arm A), every 4 weeks for six cycles.



After a median follow-up of 6.4 years no significant difference was seen for either disease-free survival (58% versus 60%, not significant) or 5-year overall survival (68% versus 71%, not significant), respectively. Gastrointestinal toxicity (World Health Organization grade 3/4) was more frequent in arm B (8% versus 18%, not significant).



In this trial the schedules used showed no statistically significant differences in terms of disease-free survival or overall survival in the treatment of colorectal cancer.
Reduced peripheral vascular symptoms in elderly patients treated with α-methyldopa — A comparison with propranolol

A multicentre study of 6–10 weeks duration was performed in 60 ambulant hypertensive patients aged over 60 years to compare the efficacy of methyldopa and propranolol with particular reference to the occurrence of cold extremities and sleep disturbances. Blood pressure was effectively controlled by both drugs being reduced from a mean of 180/108 mmHg to 161/93 with methyldopa and 180/108 to 162/94 with propranolol. More patients treated with methyldopa (74%) achieved the target diastolic blood pressure of 95 mmHg or below compared with those treated with propranolol (58%). Side effects were more frequent in the propranolol group necessitating the withdrawal of four patients from the study. Only one patient on methyldopa was withdrawn. The incidence of cold extremities was significantly greater with propranolol. The occurrence of sleep disturbances was similar in both groups. In this group of elderly patients methyldopa was better tolerated than propranolol.
Initiation and gradual intensification of premixed insulin lispro therapy versus Basal {+/-} mealtime insulin in patients with type 2 diabetes eating light breakfasts.

We compared two strategies initiating and intensifying insulin treatment and tested for noninferiority of premixed insulin to basal ± mealtime insulin analog in patients eating light breakfasts.



This randomized, open-label, 48-week study compared two algorithms. Up to three injections of insulin lispro mix 25 and/or insulin lispro mix 50 (premix; premixed insulin lispro) or basal insulin glargine plus up to three injections of insulin lispro (basal+; glargine + insulin lispro) were used in type 2 diabetic patients uncontrolled with oral antihyperglycemic medication and consuming <15% daily calories at breakfast. The hypothesis was to test noninferiority of premix to basal+ for glycemic control measured by HbA1c after 48 weeks, assessed using ANCOVA with a 0.4% margin.



Patients (n = 344; 176 [51%] females; mean [SD] age 54.3 [8.8] years; BMI 29.4 [4.6] kg/m(2); baseline HbA1c 9.02 [0.97]%) were randomized to premix (n = 171) or basal+ (n = 173). In the per-protocol analysis (n = 230), least squares means (95% CI) end point HbA1c were 7.40% (7.15-7.65) and 7.55% (7.27-7.82) in respective arms. Between-treatment difference was -0.14% (-0.42 to 0.13), with noninferiority met. Significantly more patients in premix achieved HbA1c targets of <7.0% compared with basal+ (48.2 vs. 36.2%; P = 0.024). Self-monitored blood glucose profiles, body weight changes, total insulin doses, and overall hypoglycemia (65 vs. 60%) were similar in premix and basal+ (P = 0.494), except nocturnal episodes (34.3 vs. 23.7%; P = 0.018) were more common in premix.



Both intensive insulin strategies improved glycemic control; however, final HbA1c levels were seen above those achieved in previous treat-to-target trials, likely due to the inadequate insulin titrations and probably due to the complexity of tested insulin regimens. A higher percentage of patients achieved target HbA1c <7% with multiple premixed insulins, but this treatment resulted in more nocturnal hypoglycemia than a basal-bolus regimen.
Diagnostic utility of flexible bronchoscopy in elderly patients.

In the elderly population, diagnosis and initial treatment should be considered as soon as possible because of high disease incidence and complications. We aimed to evaluate the findings of flexible bronchoscopy (FB) and determine the diagnostic utility of FB in patients 65 years old and older.



We retrospectively evaluated FB results. Demographic data, clinical and bronchoscopic findings, diagnostic procedures during FB and incidence of accurate diagnosis with FB both in patients 65 years old and older and in younger patients were determined.



A total of 745 patients [younger patients (<65 years, n = 378, F/M: 120/258) and older patients (≥65 years, n = 367, F/M: 88/279)] who underwent FB at our clinic between 2009 and 2012 were included. The mean age of older patients was 72.6 ± 5.8 years, while the mean age of younger patients was 50.9 ± 11.7 years. Overall, 188 older patients (51.2%) had an accurate diagnosis with the procedures used during bronchoscopy, and 179 younger patients (47.3%) had a final diagnosis with these procedures. The diagnostic utility of FB did not differ significantly between study groups (P = 0.291). During FB, 326 older patients (88.8%) had no complication, and 343 younger patients (90.7%) had no complications. No statistically significant difference was found between older and younger patients in terms of complications during FB (P = 0.389).



The results of this study indicate the high diagnostic value of FB together with low complication rates in patients aged 65 years and older.
Sulphinpyrazone and renal function following myocardial infarction

The effects of sulphinpyrazone 800 mg daily on renal excretory function were studied in a double-blind placebo-controlled randomised trial of incremental and full doses of the drug in 28 patients with plasma urea concentration <10 mmol/l in the period 2–28 days following uncomplicated acute myocardial infarction. Sulphinpyrazone in both dosage regimens increased uric acid excretion and lowered plasma urate concentration. There was no evidence that the drug reduced glomerular filtration rate or damaged the renal tubules. These results suggest that sulphinpyrazone in the doses used in this study is not contraindicated in patients early after acute myocardial infarction even though they may have a moderate rise in the blood urea.
Deferoxamine improves coronary vascular responses to sympathetic stimulation in patients with type 1 diabetes mellitus

Effects of oxygen-derived free radicals are suggested to be a potential pathogenic factor for endothelial dysfunction. In this study we sought to evaluate the effect of hydroxyl radicals on the human coronary vascular bed in type I diabetes mellitus using positron emission tomography (PET). Thirteen patients with type 1 diabetes underwent PET using nitrogen-13 ammonia at rest and during sympathetic stimulation with the cold pressor test (CPT). The rest-stress study protocol was repeated twice (on different days) using pre-stress infusion of either saline as placebo or deferoxamine, an iron chelator which inhibits generation of hydroxyl radicals. At rest, global MBF was higher in diabetics than in normal controls (78.1±17.5 vs 63.2±14.9 mg 100 g–1 min–1, P<0.05) and myocardial vascular resistance (MVR) showed a trend towards lower values (patients, 1.28±0.35; controls, 1.55±0.32, P=NS). CPT increased MBF in all controls while 7/13 diabetics responded normally. CPT decreased MVR in 10/13 controls but in only 4/13 diabetics. There was no significant difference in the duration of diabetes, HbA1c, daily insulin dose, body mass index, or lipid profiles between patients with and patients without abnormal MBF or MVR responses. Pre-stress infusion of deferoxamine normalized MBF response in all six patients, and MVR response in six of the nine patients. Another group consisting of seven patients underwent a rest-rest protocol after infusion of deferoxamine and saline to investigate the effect of deferoxamine on resting MBF. Deferoxamine did not change the resting MBF (deferoxamine, 81±17 ml 100 g–1 min–1; saline, 75±19 ml 100 g–1 min–1, P=NS) or MVR (deferoxamine, 1.0±0.5 mmHg ml–1 100 g–1 min–1; saline, 1.2±0.6 mmHg ml–1 100 g–1 min–1, P=NS). In conclusion, inhibition of hydroxyl radical formation using deferoxamine significantly improved the responses of coronary microvasculature to sympathetic stimulation. Hydroxyl radicals may play a role in the pathogenesis of flow abnormalities in type 1 diabetes.
The pharmacokinetics and safety of adefovir dipivoxil in children and adolescents with chronic hepatitis B virus infection.

There is a continued need for safe and effective treatments for children and adolescents with chronic hepatitis B. Adefovir dipivoxil (ADV) is a licensed treatment for chronic hepatitis B in adults. This study was designed to characterize the pharmacokinetic profile of adefovir following the administration of 0.14 mg/kg and 0.3 mg/kg of ADV (oral solution) in children aged 2 to 11 years and of ADV 10 mg in adolescents aged 12 to 17 years. Forty-five subjects were included in the pharmacokinetic and safety evaluations. Adefovir was rapidly absorbed. Adefovir levels rose rapidly in the first hour and then declined in a biphasic manner. Dose-proportional pharmacokinetics was observed in the 0.14-mg/kg and 0.3-mg/kg groups. The 0.3-mg/kg dose in children aged 2 to 6 and the 10-mg dose in adolescents resulted in exposures that were comparable to those seen previously in adults given ADV 10 mg. Adefovir dipivoxil was well tolerated at the doses evaluated in this study. Adverse events were generally mild and reported as being unrelated to study medication. There was 1 serious adverse event reported that was not related to study medication. No patient discontinued the study prematurely due to an adverse event related to the study drug.
Family history and lung cancer risk: international multicentre case–control study in Eastern and Central Europe and meta-analyses

Lung cancer is the most common neoplastic disease in Eastern and Central Europe. The role of hereditary factors in lung carcinogenesis is not fully understood. Family history (FH) of lung cancer and other tobacco-related cancers might be a strong predictor of the lung cancer risk. We investigated family history of cancer among first-degree relatives of 2,861 patients with lung cancer and 3,118 controls from the Czech Republic, Hungary, Poland, Romania, Russia, Slovakia, and United Kingdom within the IARC Multicenter Case–Control Study. Odds ratios (ORs) and 95% CI were calculated using logistic regression, adjusting for age, gender, study center, education, tobacco smoking, and number of first-degree relatives. In addition, we conducted a meta-analysis of 41 studies on FH of cancer and lung cancer risk. Positive FH of lung cancer increased risk of lung cancer with OR of 1.63 (95%CI: 1.31–2.01), and having two or more affected relatives with lung cancer further increased the risk of lung cancer with OR 3.60 (95%CI: 1.56–8.31). Among subjects aged less than 50, the OR for FH of lung cancer was 2.08 (95%CI: 1.18–3.63). The associations were generally stronger for squamous cell carcinoma and large cell carcinoma subtypes. Heterogeneity in results was not found with respect to smoking status and gender. A significant association was not observed for FH of other smoking-related tumors. The results of meta-analysis were consistent with that of our study with regard to young onset, non-smokers and histology. FH of lung cancer is a predictor of an increased risk of lung cancer, especially in subjects aged less than 50.
Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN I first-in-human study using a multi-electrode ablation system.

Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited.



We studied 46 patients (age: 60 ± 10 years, 4.7 ± 1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24 months from baseline was -29/-13 mmHg, while the reduction in 24-hour ambulatory BP and in home BP at 24 months were -13/-7 mmHg and -11/-6 mmHg respectively (p<0.05 for all). A correlation analysis revealed that baseline office and ambulatory BP were related to the extent of office and ambulatory BP drop. Apart from higher body mass index (33.3 ± 4.7 vs 29.5 ± 6.2 kg/m(2), p<0.05), there were no differences in patients that were RDN responders defined as ≥10 mmHg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24 months there were no new serious device or procedure related adverse events.



The EnligHTN I study shows that the multi-electrode ablation system provides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction.
Laparoscopic partial nephrectomy in duplex kidneys in infants and children: results of an European multicentric survey

We aim to report a 5-year retrospective multicentric European survey about the outcome of laparoscopic partial nephrectomy in infants and children with duplex kidneys. The data of fifty-two children underwent laparoscopic partial nephrectomy (42 upper-pole nephrectomies and 10 lower-pole nephrectomies) in six European centers of Pediatric Surgery, were collected and analyzed. Median age at surgery was 5.1 years (range 6 months–9.7 years). There were 32 girls and 20 boys. In 37 patients, the left side was affected and in 15 patients the right side. For the right side, 4 trocars were used and for the left side 3/4 trocars. Special hemostatic devices were used for dissection and parenchymal section in all centers. We assessed intraoperative and postoperative morbidity. Median length of surgery was 166.2 min (70–215 min). No conversion to open surgery nor intraoperative bleeding was reported. Mean hospitalization was 3.5 days. We recorded 10/52 complications (4 urinomas, 2 recurrent UTIs, 4 prolonged urinary leakage), all managed conservatively. Reoperation rate was 0 %. No loss of renal function on the residual kidney moiety was recorded in all operated patients. Laparoscopic partial nephrectomy remains a technically challenging procedure performed only in pediatric centers with high experience in minimally invasive surgery. Although the median operative time was higher than 2 h, we recorded no conversions in our series. The complication rate remains high (10/52–19.2 %). All were II grade complications according to Clavien–Dindo classification and were treated conservatively without the need of other surgical procedures.
Neural activation during response inhibition differentiates blast from mechanical causes of mild to moderate traumatic brain injury.

Military personnel involved in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) commonly experience blast-induced mild to moderate traumatic brain injury (TBI). In this study, we used task-activated functional MRI (fMRI) to determine if blast-related TBI has a differential impact on brain activation in comparison with TBI caused primarily by mechanical forces in civilian settings. Four groups participated: (1) blast-related military TBI (milTBI; n=21); (2) military controls (milCON; n=22); (3) non-blast civilian TBI (civTBI; n=21); and (4) civilian controls (civCON; n=23) with orthopedic injuries. Mild to moderate TBI (MTBI) occurred 1 to 6 years before enrollment. Participants completed the Stop Signal Task (SST), a measure of inhibitory control, while undergoing fMRI. Brain activation was evaluated with 2 (mil, civ)×2 (TBI, CON) analyses of variance, corrected for multiple comparisons. During correct inhibitions, fMRI activation was lower in the TBI than CON subjects in regions commonly associated with inhibitory control and the default mode network. In contrast, inhibitory failures showed significant interaction effects in the bilateral inferior temporal, left superior temporal, caudate, and cerebellar regions. Specifically, the milTBI group demonstrated more activation than the milCON group when failing to inhibit; in contrast, the civTBI group exhibited less activation than the civCON group. Covariance analyses controlling for the effects of education and self-reported psychological symptoms did not alter the brain activation findings. These results indicate that the chronic effects of TBI are associated with abnormal brain activation during successful response inhibition. During failed inhibition, the pattern of activation distinguished military from civilian TBI, suggesting that blast-related TBI has a unique effect on brain function that can be distinguished from TBI resulting from mechanical forces associated with sports or motor vehicle accidents. The implications of these findings for diagnosis and treatment of TBI are discussed.
Effect of selenium supplementation for protection of salivary glands from iodine-131 radiation damage in patients with differentiated thyroid cancer.

In the current study, we examined whether selenium supplementation during iodine-131 (131I) treatment had a radio-protective effect on salivary glands.



Sixteen patients with differentiated thyroid cancer were prospectively enrolled in the study. Patients after total thyroidectomy, before 131I treatment, were divided into two groups; 8 patients in the selenium group and 8 patients in the control group. Patients in the selenium group received 300νg of selenium orally for 10 days, from 3 days before to 6 days after 131I treatment. The control group received a placebo over the same period. To assess salivary gland function, salivary gland scintigraphy was performed before and 6 months after 131I treatment. Serum amylase and whole blood selenium levels were measured before and 2 days and 6 months after 131I treatment. Using salivary gland scintigraphy, maximum uptake ratio (MUR), maximum secretion percentage (MSP), and ejection fraction (EF) of each salivary gland were calculated.



Baseline clinical characteristics, baseline amylase and selenium levels, and parameters of baseline salivary gland scintigraphy were not significantly different between selenium and control groups (P>0.05). On a blood test performed 2 days after 131I treatment, the selenium group showed a significantly higher whole blood selenium level (P=0.008) and significantly lower serum amylase level (P=0.009) than the control group. On follow-up salivary gland scintigraphy, the control group showed significantly decreased, MUR of the bilateral parotid and left submandibular glands, MSP of the bilateral parotid and submandibular glands, and EF of the left submandibular glands (P<0.05), while the selenium group only had a significant decrease in MSP of the right submandibular gland and EF of the left submandibular gland (P<0.05).



Selenium supplementation during 131I treatment was effective to reduce salivary glands damage by 131I radiation in patients with differentiated thyroid cancer.