nils-herrmann/clean_scirepeval huggingface dataset:
Ten-year results of a randomized trial comparing tacrolimus versus cyclosporine a in combination with mycophenolate mofetil after heart transplantation.

Long-term results of prospective randomized trials comparing triple immunosuppressive strategies combining tacrolimus (TAC) or cyclosporine A (CsA) with mycophenolate mofetil (MMF) and steroids after heart transplantation (HTX) are rarely published. Therefore, we collected long-term follow-up data of an intervention cohort 10 years after randomization.



Ten-year follow-up data of 60 patients included in a prospective, randomized trial between 1998 and 2000 were analyzed as intention-to-treat (TAC-MMF n=30; CsA-MMF n=30). Baseline characteristics were well balanced. Cardiac allograft vasculopathy (CAV) was graduated in accordance with the new ISHLT classification.



Survival at 1, 5, and 10 years was 96.7%, 80.0%, and 66.7% for TAC-MMF and 90.0%, 83.3%, and 80.0% for CsA-MMF (P=ns). Freedom from acute rejection (AR) was significantly higher in TAC-MMF versus CsA-MMF (65.5% vs. 21.7%, log-rank 8.3, P=0.004). Freedom from ISHLT≥CAV1 after 5 and 10 years was in TAC-MMF 64.0% and 45.8%, and in CsA-MMF 36.0% (log-rank 3.0, P=0.085) and 8.0% (log-rank 9.0, P=0.003). No difference in long-term results for freedom from coronary angioplasty or stenting, renal dysfunction, diabetes mellitus, CMV infection, or malignancy was detected.



Cross-over effects because of treatment switch may result in impairment of significance between the groups. The long-term analysis resulted in a significant difference in manifestation of CAV between the groups after 10 years. Less rejection in the TAC-group might have contributed to the lower incidence of CAV. Superior freedom from AR and CAV in the TAC-MMF group did not result in better long-term survival.
Role of glucocorticoids in management of malignant hypercalcaemia.

Anonymous. Bacteriuria-when does it matter ?  The search for asvmptomatic pyelonephritis. N EnglJ Med 1972;287: 563-4. Davidson AJ, Tainer LB. Urographic and angiographic abnormalities in adult onset acute bacterial nephritis. Radiology 1973;106:249-56. 'Cameron DD, Azimi F. The value of excretory urography in the diagnosis of acute pyelonephritis.  Urol 1974 1 12:546-9. -'Silver TM, Kass EJ, Thornbury JR, Konnak JW, Wolfman MG. The radiological spectrum of acute pyelonephritis in adults and adolescents. Radiology 1976;118: 65-71. Kessler WO, Gittes RF, Hurwitz SR, Green J. Gallium-67 scans in the diagnosis of pyelonephritis. West _ Med 1974;121 :91-3. Hurwitz SR, Kessler WO, Alazraki P, Ashburn WK. Gallium-67 imaging to localize urinary tract infections. Br J Radiol 1976;49:156-60. Kumar B, Coleman RE. Significance of delayed 67-Ga localization in the kidneys. J Nuci Med 1976;17:872-5. Mendez G Jr, Morillo G, Alonso M, Isikoff MB. Gallium 67 radionuclide imaging in acute pyelonephritis. AJR 1980;134:17-22. Handmaker H. Nuclear renal imaging in pyelonephritis.  Urinary 1%-microglobulin in upper and lower urinary tract infections. Lancet 1979;i: 805-7. 'Tsan MF, Chen WY, Scheffel U, Wagner HN. Studies on gallium accumulation in inflammatory lesions: gallium uptake by human polymorphonuclear leukocytes.JY Nuci Med 1978;19:36-43. Hoffer PB, Huberty J, Khayam-Bashi H. The association of Ga-67 and lactoferrin.  1977;18:713-7. Menon S, Wagner HN, Tsan MF. Studies on gallium accumulation in inflammatory lesions. Uptake by Staphylococcus aureus. 7 Nuci Med 1978;19:44-7. 5 Tsan MF. Studies on gallium accumulation in inflammatory lesions. Roles of polymorphonuclear leukocytes and bacteria. 7 Nucl Med 1978;19:492-5. 1Bekerman C, Vyas MI. Renal localization of gallium 67 citrate in renal amyloidosis.  Failure ofgallium-67 scintigraphy to identify reliably noninfectious interstitial nephritis.  1983;24:568-70. Ormrod D, Miller T, Stewart E. Detection of renal infection by gallium-67 localization. An experimental evaluation. Kidney Int 1977;12:157-63. 20 Biskjaer N, Thelle T. Pyelonefritiske parenchymdefekter hos b0rn bedomt ved 9""'Tc-DMSA nyrescintigrafi og iv urografi. Ugeskr Laeger 1983;145:1604-6. 2Thomas V, Shelokov A, Forland M. Antibody-coated bacteria in the urine and the site of urinary-tract infection. N EnglJ Med 1974;290:588-90. '! Rumans LW, Vosti KL. The relationship of antibody coated bacteria to clinical syndromes.  Int Med 1978;138:1077-81. 3Thomas VL, Forland M. Antibody coated bacteria in urinary tract infections. Kidney Ratner JJ, Thomas VL, Sanford BA, Forland M. Bacteria-specific antibody in the urine of patients with acute pyelonephritis and cystitis..7 Infect Dis 1981;143: 404-12. "Mundt KA, Polk BF. Identification of site of urinary tract infections by antibody coated bacteria assay. Lancet 1979 ;
Safe implementation of thrombolysis in stroke-monitoring study in Italy.

The safe implementation of thrombolysis in stroke-monitoring (SITS-MOST) study was an unique opportunity to test in Italy, where only few centres were expert in thrombolytic treatment before, safety and efficacy of i.v. alteplase within 3 h of ischaemic stroke outside the setting of clinical trials.



In Italy to participate in the study the clinical centres had to possess organizational and structural characteristics certified by Regional Health Authorities.



Seventy-one centres were activated, 56 (79%) treated patients of which 41 (73%) had never used thrombolysis before the study. Globally, 586 patients were included. Baseline median National Institute of Health Stroke Scale of Italian patients was 13 vs. 12 in other European centres (P = 0.0001). Symptomatic intracerebral haemorrhage as per the NINDS/Cochrane definition, mortality and independence (modified Rankin Scale 0-2) rates at 3 months occurred respectively in 6.7% (95% CI: 4.8-9.1), 11.7% (9.2-14.6) and 51.6% (47.4-55.7) of Italian patients compared with 7.3% (6.7-8.0) (P = 0.56), 11.2% (10.4-12.1) (P = 0.75) and 55.1% (53.8-56.4) (P = 0.09) in the European patients and in 8.6% (40/65; 6.3-11.6), 17.3% (14.1-21.1) and 50.1% (44.5-54.7) of the patients treated in the pooled randomized controlled trials.



The SITS-MOST study showed that in Italy i.v. alteplase is safe and effective in routine clinical use also in non-expert centres.
Intravenous versus intra-articular tranexamic acid in total knee arthroplasty: A double-blinded randomised controlled noninferiority trial.

Despite the proven efficacy of both intravenous (IV) and intra-articular (IA) tranexamic acid (TXA) in reducing blood loss during total knee arthroplasty (TKA), the ideal route of administration remained debatable. This study aimed to compare the effect of IV versus IA TXA on transfusion incidences, perioperative blood loss and postoperative lower limb swelling during TKA.



One hundred patients were prospectively randomised into two groups: 1) IV TXA; and 2) IA TXA. In both groups, TXA was administered intraoperatively after cementing the prostheses. The perioperative blood loss was calculated using the haemoglobin balance method. The thigh, suprapatellar, and calf girths were measured preoperatively and on postoperative day (POD) 4.



Two patients in the IV group and one patient in the IA group required blood transfusion (p=0.500). The median and interquartile range (IQR) of perioperative blood loss on POD1 and POD4 was 530 (IQR 386,704) and 730 (IQR 523,925) ml for the IV group, compared with 613 (IQR 506,703) and 799 (IQR 563,1067) ml for the IA group (p=0.090 and p=0.232 respectively). The median increment in thigh, suprapatellar, and calf girths were 1.5 (IQR 0, 3.0), 2.0 (IQR 0.5, 4.0) and 0 (IQR 0, 1.0) cm for the IV group, compared to 2.0 (IQR 1.0, 4.0), 2.0 (IQR 0, 4.5) and 0 (IQR 0, 1.5) cm for the IA group (p=0.246, p=0.562, and p=0.937 respectively).



Both IV and IA TXA had comparable effect on transfusion incidences, perioperative blood loss, and postoperative lower limb swelling during TKA. IA TXA is an alternative to IV TXA.
Cardiometabolic Risk Profiles in Patients With Impaired Fasting Glucose and/or Hemoglobin A1c 5.7% to 6.4%: Evidence for a Gradient According to Diagnostic Criteria

It has been suggested that the early detection of individuals with prediabetes can help prevent cardiovascular diseases. The purpose of the current study was to examine the cardiometabolic risk profile in patients with prediabetes according to fasting plasma glucose (FPG) and/or hemoglobin A1c (HbA1c) criteria.Cross-sectional analysis from the 2022 patients in the Cohort study in Primary Health Care on the Evolution of Patients with Prediabetes (PREDAPS Study) was developed. Four glycemic status groups were defined based on American Diabetes Association criteria. Information about cardiovascular risk factors-body mass index, waist circumference, blood pressure, cholesterol, triglycerides, uric acid, gamma-glutamyltransferase, glomerular filtration-and metabolic syndrome components were analyzed. Mean values of clinical and biochemical characteristics and frequencies of metabolic syndrome were estimated adjusting by age, sex, educational level, and family history of diabetes.A linear trend (P < 0.001) was observed in most of the cardiovascular risk factors and in all components of metabolic syndrome. Normoglycemic individuals had the best values, individuals with both criteria of prediabetes had the worst, and individuals with only one-HbA1c or FPG-criterion had an intermediate position. Metabolic syndrome was present in 15.0% (95% confidence interval: 12.6-17.4), 59.5% (54.0-64.9), 62.0% (56.0-68.0), and 76.2% (72.8-79.6) of individuals classified in normoglycemia, isolated HbA1c, isolated FPG, and both criteria groups, respectively.In conclusion, individuals with prediabetes, especially those with both criteria, have worse cardiometabolic risk profile than normoglycemic individuals. These results suggest the need to use both criteria in the clinical practice to identify those individuals with the highest cardiovascular risk, in order to offer them special attention with intensive lifestyle intervention programs.
Sketched menus and iconic gestures, techniques designed in the context of shareable interfaces

Suppose a user is interacting with other persons around a digital tabletop or in front of a digital wall. A user wants to launch a new graphical component or an application in the part of the screen next to him. Traditional methods such as popup menus allow him to first open the application and afterwards let him move, resize and orient the component appropriately. Meanwhile, the component may cover some objects the others users are looking at or interacting with. How to avoid this disruption of other persons' activity?
 This paper describes menu techniques for adding a new user's interface object on a shared device while preserving mutual awareness of the participants without disturbing them in their interaction. We present Sketched Menu, Abbreviated Sketched Menu and Iconic Gestures. These techniques let a user specify the shape, the size, the location and the orientation of the desired object before its creation.
 Sketched menus and iconic gestures preserve the mutual awareness. These techniques allow both adaptation of a user to the current context -the actions of the other users and the spatial arrangement of the objects on the tabletop-and the others to be aware of the foreseen action and the related space claim.
Reduction of arterial pressure and double product at rest after resistance exercise training in elderly hypertensive women.

Due to the existing controversies in literature about the potential benefits of resistance exercise training (RT) on arterial blood pressure (BP) at rest, and the lack of studies conducted with elderly hypertensive individuals, RT is seldom recommended as a non-pharmacological treatment for arterial hypertension.



To verify the effect of progressive RT on BP, HR, and RPP in elderly women with controlled hypertension.



20 elderly women (66.8 +/- 5.6 years of age), with a sedentary lifestyle, monitored with anti-hypertensive medication, participated in a 12-week RT program (resistance training group - RTG). Twenty-six elderly women (65.3 +/- 3.4 years of age) with controlled hypertension did not engage in physical exercise during the study period, and composed the control group.



After RT, there was a significant reduction in SBP, MBP, and DP values at rest. No significant drops in DBP and HR values at rest were observed after RT in both groups. The reduction in the RTG was 10.5 mmHg, 6.2 mmHg, and 2218.6 mmHg x bpm for SBP, MBP, and RPP, respectively.



Progressive RT reduced SBP, MBP, and RPP values at rest of hypertensive elderly women who were on anti-hypertensive treatment.
Glycoprotein YKL-40: A potential biomarker of disease activity in rheumatoid arthritis during intensive treatment with csDMARDs and infliximab. Evidence from the randomised controlled NEO-RACo trial

YKL-40, a chitinase-like glycoprotein associated with inflammation and tissue remodeling, is produced by joint tissues and recognized as a candidate auto-antigen in rheumatoid arthritis (RA). In the present study, we investigated YKL-40 as a potential biomarker of disease activity in patients with early RA at baseline and during intensive treatment aiming for early remission.



Ninety-nine patients with early DMARD-naïve RA participated in the NEO-RACo study. For the first four weeks, the patients were treated with the combination of sulphasalazine, methotrexate, hydroxychloroquine and low dose prednisolone (FIN-RACo DMARD combination), and subsequently randomized to receive placebo or infliximab added on the treatment for further 22 weeks. Disease activity was evaluated using the 28-joint disease activity score and plasma YKL-40 concentrations were measured by immunoassay.



At the baseline, plasma YKL-40 concentration was 57 ± 37 (mean ± SD) ng/ml. YKL-40 was significantly associated with the disease activity score, interleukin-6 and erythrocyte sedimentation rate both at the baseline and during the 26 weeks' treatment. The csDMARD combination decreased YKL-40 levels already during the first four weeks of treatment, and there was no further reduction when the tumour necrosis factor-α antagonist infliximab was added on the combination treatment.



High YKL-40 levels were found to be associated with disease activity in early DMARD-naïve RA and during intensive treat-to-target therapy. The present results suggest YKL-40 as a useful biomarker of disease activity in RA to be used to steer treatment towards remission.
Continuous glucose monitoring in children with glycogen storage disease type I

Glycogen storage disease type I (GSD I) is an autosomal recessive metabolic disorder caused by defects in the glucose-6-phosphatase complex. Deficient activity in the glucose-6-phosphatase-α catalytic unit characterizes GSD Ia and defects in the glucose-6-phosphate transporter protein characterize GSD Ib. Type Ia involves the liver, kidney and intestine (and Ib also leukocytes), and the clinical manifestations are hepatomegaly, failure to thrive, severe fasting hypoglycemia within 3-4 h after a meal, hyperlactatemia, hyperuricemia and hyperlipidemia. The aim of the present study was to examine the safety and efficacy of a continuous subcutaneous glucose monitoring system to determine the magnitude and significance of hypoglycemia in GSD I and to evaluate the efficacy of the revised dietary treatment.Sixteen children with GSD I were studied over a 72-h period. Continuous glucose monitoring (CGM) was repeated in all patients 3–6 months after the first monitoring to examine the effects of revised dietary instructions on glycemic control.All the patients completed the study without any major adverse events. Significant periods of asymptomatic hypoglycemia (below 4 mmol/l, 70 mg/dl) were noted. There was a close correlation between CGM sensor and capillary blood glucose values measured by a glucometer. CGM indicated a considerable reduction in duration of hypoglycemia, liver size and improvements in secondary metabolic derangements such as hyperlacticacidemia and hyperlipidemia.CGM could be applied in the clinical setting to help the physician to identify hypoglycemic events, and repeated CGM may serve as a safe and useful tool for the assessment of the long-term management of patients with GSD I.
Digital breast tomosynthesis at screening assessment: are two views always necessary?

The current recommendation from the UK National Health Service Breast Screening Programme is that digital breast tomosynthesis (DBT) can be used for further assessment of possible screen-detected soft-tissue abnormalities in place of spot compression views and when used should be performed in two projections. The aim of the study was to assess whether two-view DBT is necessary if the abnormality is seen only in one view on initial full-field digital mammography (FFDM).



617 cases with possible masses, distortions and asymmetrical densities visualized only in one view on screening FFDM were included. All of these females underwent two-view DBT, clinical examination and ultrasound. The FFDM and DBT findings on each view were compared and correlated with the histological diagnosis.



586 of 617 cases had normal or benign findings on further assessment, and no additional information was obtained on the other DBT view. There were 31 confirmed cancers. In 26 cases (84%), the cancer was seen on the corresponding DBT view. No cancer was seen on the other DBT view alone. Five cancers (16%) were not seen on either view on DBT owing to technical reasons. No cancers would have been missed if only the corresponding DBT view was performed.



Two-view DBT may not be necessary when used for further assessment of possible screen-detected soft-tissue abnormalities. Larger studies should be undertaken to investigate this further.


ADVANCES IN KNOWLEDGE
One-view DBT may be adequate in assessing soft-tissue abnormalities seen only on one FFDM view.
Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain

To compare the long-term effectiveness of surgical and non-surgical treatment in patients with chronic low back pain.



Two merged randomised clinical trials compared instrumented transpedicular fusion with cognitive intervention and exercises in 124 patients with disc degeneration and at least 1 year of symptoms after or without previous surgery for disc herniation. The main outcome measure was the Oswestry disability index.



At 4 years 14 (24%) patients randomly assigned to cognitive intervention and exercises had also undergone surgery. 15 (23%) patients assigned fusion had undergone re-surgery. The mean treatment effect for the primary outcome was 1.1; 95% CI -5.9 to 8.2, according to the intention-to-treat analysis and -1.6; 95% CI -8.9 to 5.6 in the as-treated analysis. There was no difference in return to work.



Long-term improvement was not better after instrumented transpedicular fusion compared with cognitive intervention and exercises.
A prospective, controlled phase II study of neoadjuvant exisulind therapy before radical prostatectomy: effect on apoptosis.

To evaluate the activity of exisulind against prostate cancer (CaP) in vivo through a prospective study of neoadjuvant exisulind in patients undergoing radical prostatectomy (RP). Exisulind and its analogs have been shown to induce apoptosis in vitro in many cancer cell lines, including CaP cell lines without affecting normal human cells.



Men with biopsy-proven, localized CaP (Gleason score ≥6) amenable to RP were offered enrollment into the trial. The treatment group (n = 44) was given oral exisulind (375-400 mg) daily for 4 weeks and then underwent RP. The control group underwent RP per routine (n = 49). The primary endpoint was change, from biopsy to prostatectomy specimens, in apoptosis biomarkers (bcl-2, Bax, par.-4, caspase 3, PTEN) between the 2 groups.



There were no significant effects of exisulind on biomarkers of cell death between biopsy specimen and posttreatment RP specimen. The drug was well tolerated and there were no drug-related serious adverse events or deaths.



Exisulind is a well-tolerated drug with minimal adverse events; however, we were unable to detect any significant differences in apoptotic biomarkers among those treated with neoadjuvant exisulind compared with controls at the dose and duration tested. Future studies should consider evaluating a higher dose or longer duration to better evaluate the role exisulind may play in the treatment of men with CaP.
United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care.

To assess the cost effectiveness of adding spinal manipulation, exercise classes, or manipulation followed by exercise ("combined treatment") to "best care" in general practice for patients consulting with low back pain.



Stochastic cost utility analysis alongside pragmatic randomised trial with factorial design.



181 general practices and 63 community settings for physical treatments around 14 centres across the United Kingdom.



1287 (96%) of 1334 trial participants.



Healthcare costs, quality adjusted life years (QALYs), and cost per QALY over 12 months.



Over one year, mean treatment costs relative to "best care" were 195 pounds sterling (360 dollars; 279 euros; 95% credibility interval 85 pounds sterling to 308 pounds sterling) for manipulation, 140 pounds sterling (3 pounds sterling to 278 pounds sterling) for exercise, and 125 pounds sterling (21 pounds sterling to 228 pounds sterling) for combined treatment. All three active treatments increased participants' average QALYs compared with best care alone. Each extra QALY that combined treatment yielded relative to best care cost 3800 pounds sterling; in economic terms it had an "incremental cost effectiveness ratio" of 3800 pounds sterling. Manipulation alone had a ratio of 8700 pounds sterling relative to combined treatment. If the NHS was prepared to pay at least 10,000 pounds sterling for each extra QALY (lower than previous recommendations in the United Kingdom), manipulation alone would probably be the best strategy. If manipulation was not available, exercise would have an incremental cost effectiveness ratio of 8300 pounds sterling relative to best care.



Spinal manipulation is a cost effective addition to "best care" for back pain in general practice. Manipulation alone probably gives better value for money than manipulation followed by exercise.