nils-herrmann/clean_scirepeval huggingface dataset:
Real-time magnetic resonance imaging-guided cryoablation of small renal tumors at 1.5 T.

Real-time magnetic resonance imaging (MRI)-guided cryoablation has been investigated in open MRI systems with low magnetic fields (0.2-0.5 T). More advanced imaging techniques and faster imaging rates are possible at higher magnetic fields, which often require a closed-bore magnet design. However, there is very little experience with real-time interventions in closed-bore 1.5-T MRI units. Herein, we report our initial experience with real-time MRI-guided cryoablation of small renal tumors using a prototype balanced steady-state free precession imaging sequence in a closed-bore 1.5-T MRI system.



From August 2008 to April 2012, 18 patients underwent MRI-guided cryoablation of small renal tumors. A 1.5-T cylindrical MRI scanner with a 125 cm × 70 cm bore and a prototype balanced steady-state free precession sequence (BEAT interactive real-time tip tracking) were used to guide the placement of 17-gauge cryoprobes in real time. Ice ball formation was monitored every 3 minutes in 1 or more imaging planes. Each ablation consisted of 2 freeze-thaw cycles. Contrast-enhanced MRI was performed after the second active thaw period. Follow-up consisted of clinical evaluation and renal protocol computed tomography (CT) or MRI performed at 1, 6, 12, 18, and 24 months and annually thereafter.



During the study period, we successfully ablated 18 tumors in 18 patients in 18 sessions. The mean tumor size was 2.2 cm (median, 2 cm; range, 1.2-4.4 cm). The number of cryoprobes used per patient was determined based on tumor size. The mean number of cryoprobes used per patient was 3 (median, 3 cryoprobes; range, 2-4 cryoprobes). Fifty-six cryoprobes, 9 biopsy needles, and 2 hydrodissection needles were successfully placed under real-time MRI guidance using BEAT interactive real-time tip tracking sequence. Hydrodissection under MRI guidance was successfully performed in 4 patients. In each patient, contrast-enhanced MRI performed after the second active thaw period revealed a sharply defined avascular zone surrounding the targeted tumor, which confirmed complete ablation of the tumor with adequate margins. Although contrast media slowly accumulated in the targeted tumor in 9 patients immediately after the procedure, follow-up imaging studies performed at a mean of 16.7 months revealed no contrast enhancement within the ablation zone in these patients. Disease-specific, metastasis-free, and local recurrence-free survival rates were all 100%.



Real-time placement and manipulation of cryoprobes during MRI-guided cryoablation of small renal tumors in a closed-bore, high-magnetic field scanner are feasible. Technical and clinical success rates are similar to those of patients who undergo CT-guided radiofrequency ablation or cryoablation of small renal tumors. Our findings suggest that MRI-guided ablation has several advantages over CT-guided ablation, including real-time guidance for probe placement, multiplanar imaging, exquisite soft tissue contrast, and lack of ionizing radiation.
Acute myocardial ischemia in adults secondary to missed Kawasaki disease in childhood.

Coronary artery aneurysms that occur in 25% of untreated Kawasaki disease (KD) patients may remain clinically silent for decades and then thrombose resulting in myocardial infarction. Although KD is now the most common cause of acquired heart disease in children in Asia, the United States, and Western Europe, the incidence of KD in Egypt is unknown. We tested the hypothesis that young adults in Egypt presenting with acute myocardial ischemia may have coronary artery lesions because of KD in childhood. We reviewed a total of 580 angiograms of patients ≤40 years presenting with symptoms of myocardial ischemia. Coronary artery aneurysms were noted in 46 patients (7.9%), of whom 9 presented with myocardial infarction. The likelihood of antecedent KD as the cause of the aneurysms was classified as definite (n = 10), probable (n = 29), or equivocal (n = 7). Compared with the definite and probable groups, the equivocal group had more traditional cardiovascular risk factors, smaller sized aneurysms, and fewer coronary arteries affected. In conclusion, in a major metropolitan center in Egypt, 6.7% of adults aged ≤40 years who underwent angiography for evaluation of possible myocardial ischemia had lesions consistent with antecedent KD. Because of the unique therapeutic challenges associated with these lesions, adult cardiologists should be aware that coronary artery aneurysms in young adults may be because of missed KD in childhood.
Laparoscopic or open surgery for the cancer of the middle and lower rectum short-term outcomes of a comparative non-randomised study

The study compares the short-term results of the laparoscopic and open approach for the surgical treatment of rectal cancer. Consecutive cases with rectal cancer operated upon with laparoscopy from 2004 to 2007 were compared to open rectal cancer cases. Total mesorectal excision (TME) was attempted in all cases. Forty-two cases were included in the OPEN and 45 in the LAP group and were matched for age, gender, disease stage and operation type. Duration of surgery was longer and blood transfusion requirements were less in the LAP group. Higher blood loss was observed in patients with neoadjuvant treatment in both groups. Patients with neoadjuvant treatment in the OPEN group had higher operation time, but that was not the case in the LAP group. There were three conversions (7%). Overall morbidity was higher in the OPEN group. LAP group patients were found to recover faster. R0 resection was achieved in 88% in the OPEN and 94% in the LAP group. Less morbidity and faster recovery is offered after laparoscopic TME. Quality of surgery assessed by histopathology is similar between the approaches. Neoadjuvant chemoradiation seems to have significant impact on blood loss but results in longer operation times of the OPEN group.
Concurrent use of complementary and alternative medicine with antiretroviral therapy reduces adherence to HIV medications.

Antiretroviral therapy requires strict adherence to ensure therapeutic success. Concurrent use of complementary and alternative medicine (CAM) could alter the adherence to and thereby effectiveness of antiretroviral drugs. This study examined the association of CAM use with adherence to antiretroviral therapy (ART) and CD4 count.



The study was conducted in two HIV clinics: one in a semi-urban, the other in a rural area. Adherence to ART was assessed using the Morisky Medication Adherence Scale (MMAS). Data on type of CAM used and MMAS adherence were collected by patient interview and demographic; clinical data were collected from hospital records.



Altogether 212 HIV patients participated in the exit study conducted over 3 months. Almost half (47.9%) used CAM concurrently with antiretroviral drugs. Dietary supplements (40.3%), healing systems (36.5%) and exercise (23.2%) were mainly used. The use of CAM significantly lowered adherence to ART (89.4% in non-CAM users versus 82.5% in CAM users, P = 0.01). Improvement in CD4 count was less in patients using CAM compared to non-CAM users although the difference was not statistically significant (310.5 ± 294.0 cells/L in CAM users versus 224.5 ± 220.0 cells/L in non-CAM users, P = 0.13). Patients attending the rural HIV clinic were more likely to use CAM compared to patients attending semi-urban hospital (χ(2) test = 7.0; P < 0.01).



Use of CAM could lower adherence to antiretroviral therapy. There is need to develop protocol which could help in monitoring CAM use in HIV patients especially those from rural settings.
The Addenbrooke's Cognitive Examination Revised (ACE-R): a brief cognitive test battery for dementia screening.

There is a clear need for brief, but sensitive and specific, cognitive screening instruments as evidenced by the popularity of the Addenbrooke's Cognitive Examination (ACE).



We aimed to validate an improved revision (the ACE-R) which incorporates five sub-domain scores (orientation/attention, memory, verbal fluency, language and visuo-spatial).



Standard tests for evaluating dementia screening tests were applied. A total of 241 subjects participated in this study (Alzheimer's disease=67, frontotemporal dementia=55, dementia of Lewy Bodies=20; mild cognitive impairment-MCI=36; controls=63).



Reliability of the ACE-R was very good (alpha coefficient=0.8). Correlation with the Clinical Dementia Scale was significant (r=-0.321, p<0.001). Two cut-offs were defined (88: sensitivity=0.94, specificity=0.89; 82: sensitivity=0.84, specificity=1.0). Likelihood ratios of dementia were generated for scores between 88 and 82: at a cut-off of 82 the likelihood of dementia is 100:1. A comparison of individual age and education matched groups of MCI, AD and controls placed the MCI group performance between controls and AD and revealed MCI patients to be impaired in areas other than memory (attention/orientation, verbal fluency and language).



The ACE-R accomplishes standards of a valid dementia screening test, sensitive to early cognitive dysfunction.
Botulinum toxin A: a new option for treatment of chronic migraine with medication overuse

The application of Botulinum toxin for several pathological conditions has been largely debated in the last decades and its use has been definitively consolidated for disorders related to increased muscle tone and hyperidrosis. Botulinum neurotoxin (BoNT-A) is a potent toxin produced by an anaerobic bacterium, Clostridium botulinum, which presents several pharmacological proprieties, but also different and serious contraindications. As chronic migraine (CM) is commonly reported as a serious and debilitating condition and a big challenge from the therapeutic point of view, in the last decades, after isolated observations, BoNT-A has been applied as preventive treatment for CM patients and, after randomized and rigorous studies, it has been accepted among the most effective pharmacological treatments for these problematic patients. In the present report, a group of patients suffering from CM with medication overuse was treated with BoNT-A to verify its efficacy for CM. The results confirmed the efficacy of BoNT-A when used at the dosage of 155 UI, according with the PREEMPT study protocol. Although these results are preliminary, in a limited group of patients, they led to intense efforts to enforce the use of BoNT-A for CM and to assess its clinical applicability.
Angioscopic comparison of arterial repair after second-generation drug-eluting stent implantation into vulnerable and stable coronary plaques.

Arterial repair after intracoronary stenting depends on stent types and plaque vulnerability. The aim of this study was angioscopic comparison of arterial repair after implantation of the second-generation drug-eluting stents (G2-DES) between the stable and vulnerable plaques.



Four types of G2-DES were successfully implanted into stable plaques (n=41) and vulnerable plaques (n=34): 13 and 9 Xience-everolimus-, 7 and 6 Endeavor-zotarolimus-, 15 and 9 Resolute-zotarolimus-, and 6 and 10 Nobori-biolimus-eluting stents (EES, E-ZES, R-ZES, and BES), respectively. Coronary angioscopy at 1-year follow-up revealed in-stent appearance, such as neointimal stent coverage (NSC), presence of yellow plaques (YP), and in-stent mural thrombus (MT). NSC was graded into poor and good coverage.



Yellow plaques and mural thrombi were found more frequently in the vulnerable plaques than in the stable plaques (29% vs. 12%, P=0.06; 12 vs. 0%, P=0.02; respectively). In EES, poor NSC was observed more frequently in the vulnerable plaques than in the stable plaques (54% vs. 11%, P=0.04). In BES, YP was observed more frequently in the vulnerable plaques than in the stable plaques (80% vs. 17%, P=0.01). In E-ZES and R-ZES, there were no significant differences with regards to angioscopic parameters between the stable and vulnerable plaques.



Arterial repair after EES and BES implantation into the vulnerable plaques remained vulnerable even at 1-year follow-up.
Differences in the topographic profiles of retinal thickening in eyes with and without serous macular detachment associated with diabetic macular oedema.

To investigate if cases of diabetic macular oedema (DMO) associated with serous macular detachment (SMD) have a different topographic profile of retinal thickening compared with DMO cases not associated with SMD.



Optical coherence tomography scans of 152 eyes from 152 patients with centre-involving DMO and central subfield thickness >350 µm were identified. Measurements were taken of the neural retina at the highest point of thickening within the central subfield (H) and lateral extent of retina thicker than 350 µm (W). Group means were compared between eyes with SMD and eyes without SMD.



SMD was present in 55 eyes (36%). H was lower in eyes with SMD than in eyes without SMD (396 µm vs 550 µm, p<0.001) while W was higher in eyes with SMD compared with eyes without SMD (4.74 mm vs 4.18 mm, p=0.011).



There were distinct differences in topographical profiles of retinal thickening between eyes with SMD and eyes without SMD. These findings suggest a possible mechanical basis for the pathogenesis of SMD in DMO.
Erratum to: Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial

There was an error in the eligibility criteria in ''Methods'' section. Instead of: ''Patients Male or female patients aged 20–80 years and weighing at least 50 kg were eligible if they had had a stroke at least 6 months prior to treatment and had equinus deformity (plantar flexion of the ankle) as demonstrated by a score of >3 for ankle flexors on the Modified Ashworth Scale (MAS).'' It should read: ''Patients Male or female patients aged 20–80 years and weighing at least 50 kg were eligible if they had had a stroke at least 6 months prior to treatment and had equinus deformity (plantar flexion of the ankle) as demonstrated by a score of 3 or 4 for ankle flexors on the Modified Ashworth Scale (MAS).'' On behalf of GSK1358820 Spasticity Study Group.
Quantitative changes in cytological molecular markers during primary medical treatment of breast cancer: A pilot study

To quantify the changes in biological molecular markers during primary medical treatment in patients with operable breast cancer and to assess their possible relationship with response to treatment.  The treatment group consisted of 31 patients with operable breast carcinomas, median age 57 years (range 41–67), treated with four 3‐weekly cycles of chemotherapy with Mitoxantrone, methotrexate (± mitomycin C), and tamoxifen before surgery. Fine needle aspiration (FNA) was used to obtain samples from patients prior to and at 10 or 21 days post‐treatment. The following molecular markers were assessed: estrogen receptor (ER), progesterone receptor (PgR), p53, Bcl‐2, and Ki67 measured by immunocytochemistry, and ploidy and S‐phase fraction (SPF) by flow cytometry. To evaluate the reproducibility of the technique, repeat FNA was performed in a separate non‐treatment control group of 20 patients and the same molecular markers assessed, two weeks after the first sample with no intervening treatment.  The non‐treatment control group showed a high reproducibility for the measurement of molecular markers from repeat FNA. In the treatment group there was a non‐significant reduction in SPF and a significant reduction (p = 0.005) in Ki67. Patients who responded to neoadjuvant therapy were more likely to have a reduction in these two markers than those who failed to respond. Similarly, a reduction in ER scores was observed between the first and second samples (p = 0.04). For PgR, the change between the first and second samples was not significant although there was a significant difference between responders and non‐responders (p = 0.03). All nine patients with an increase in PgR were responders. No significant changes in p53 or Bcl‐2 were observed during treatment.  Molecular markers can be adequately measured from FNA samples prior to and during neoadjuvant therapy. Changes in cellular proliferation and hormone receptors have been shown that may be related to tumour response. These relationships should be assessed in a larger cohort of patients.
Pravastatin therapy in hyperlipidemia: effects on thrombus formation and the systemic hemostatic profile.

The study sought to determine the effects of lipid-lowering with pravastatin on the systemic fibrinolytic profile and on thrombus formation under dynamic flow conditions.



Lowering cholesterol (C) decreases clinical events in coronary artery disease (CAD) patients, but an analysis of the effects of lipid-lowering on the entire hemostatic and thrombotic profile has not been conducted.



We prospectively studied 93 stable patients with untreated low-density lipoprotein cholesterol (LDL-C) >145 mg/dl. The CAD patients received pravastatin, and non-CAD patients were randomized to pravastatin versus placebo (double-blind). Thrombus formation upon an injured vascular surface was assessed in a substudy of 40 patients with a previously validated ex vivo perfusion chamber system. Systemic hemostatic markers and thrombus formation were evaluated at baseline, three and six months.



Placebo produced no changes in either the lipid profile, any of the hemostatic markers, or the ex vivo thrombus formation. Both pravastatin groups (CAD and non-CAD) showed decreased LDL-C by 30% within 6 weeks (188 to 126 mg/dl, p < 0.001 vs. baseline), and decreased plasminogen activator inhibitor-1 at 3- and 6-month follow-up compared to baseline (15% to 18% decrease at 3 months and 21% to 23% at 6 months). For the tissue plasminogen activator antigen, CAD and non-CAD groups showed significant decreases at 6 months compared to baseline (10% and 13%, respectively). No significant changes were observed with treatment in d-dimer, fibrinopeptide A, prothrombin fragment F1.2, factor VIIa, von Willebrand factor, or C-reactive protein. Fibrinogen levels were significantly increased at 6 months compared to baseline, though still below the upper normal limit. In the perfusion chamber substudy, there was a decrease in thrombus area in non-CAD patients treated with pravastatin at both 3 and 6 months compared to baseline (by 21% and 34%, respectively). The CAD patients showed decreases in thrombus formation by 13% at 3 months, and by 16% at 6 months. The change in LDL-C- correlated modestly with the change in thrombus formation (r = 0.49; p < 0.01).



Pravastatin therapy significantly decreased thrombus formation and improved the fibrinolytic profile in patients with and without CAD. These early effects may, in part, explain the benefit rendered in primary and secondary prevention of CAD.
Comparing recruitment strategies in a study of acupuncture for chronic back pain

Meeting recruitment goals is challenging for many clinical trials conducted in primary care populations. Little is known about how the use of different recruitment strategies affects the types of individuals choosing to participate or the conclusions of the study.



A secondary analysis was performed using data from participants recruited to a clinical trial evaluating acupuncture for chronic back pain among primary care patients in a large integrated health care organization. We used two recruitment methods: mailed letters of invitation and an advertisement in the health plan's magazine. For these two recruitment methods, we compared recruitment success (% randomized, treatment completers, drop outs and losses to follow-up), participant characteristics, and primary clinical outcomes. A linear regression model was used to test for interaction between treatment group and recruitment method.



Participants recruited via mailed letters closely resembled those responding to the advertisement in terms of demographic characteristics, most aspects of their back pain history and current episode and beliefs and expectations about acupuncture. No interaction between method of recruitment and treatment group was seen, suggesting that study outcomes were not affected by recruitment strategy.



In this trial, the two recruitment strategies yielded similar estimates of treatment effectiveness. However, because this finding may not apply to other recruitment strategies or trial circumstances, trials employing multiple recruitment strategies should evaluate the effect of recruitment strategy on outcome.
C-reactive protein lowering with rosuvastatin in the METEOR study.

In addition to its LDL-C-lowering effects, statin treatment reduces the level of C-reactive protein (CRP). Long-term data on this effect in low-risk populations are limited. Furthermore, whether the CRP reduction is a consequence of LDL-C lowering or occurs independently remains unclear. We studied these aspects in the Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) study, a randomized placebo-controlled trial amongst 984 low-risk subjects.



METEOR is a randomized placebo-controlled trial that evaluated the effect of 40 mg of rosuvastatin on 2-year change in carotid intima media thickness (CIMT) amongst 984 low-risk patients (10-year Framingham risk < 10%) with modest CIMT (CIMT > or = 1.2 and < 3.5 mm) and elevated LDL-C. CRP levels were measured at baseline and after 2 years of treatment.



Median baseline CRP was 1.4 mg L(-1). Rosuvastatin lowered CRP significantly compared with placebo: -36% in the rosuvastatin group versus no change in the placebo group. There was no relation between change in CRP and change in LDL-C (Spearman correlation: 0.08; SE: 0.04). Stratified analyses showed that the CRP-lowering effect was present amongst all strata of baseline characteristics, including baseline lipids and CRP levels. However, the magnitude of CRP reduction was larger amongst women and participants older than 60 years.



Rosuvastatin (40 mg) lowers CRP independently from its effects on LDL-C in low-risk subjects with normal baseline CRP levels and modest CIMT.
Patterns of mortality after prolonged follow-up of a randomised controlled trial using granulocyte colony-stimulating factor to maintain chemotherapy dose intensity in non-Hodgkin's lymphoma

The effect of utilising granulocyte colony-stimulating factor (G-CSF) to maintain chemotherapy dose intensity in non-Hodgkin's lymphoma (NHL) on long-term mortality patterns has not been formally evaluated. We analysed prolonged follow-up data from the first randomised controlled trial investigating this approach. Data on 10-year overall survival (OS), progression-free survival (PFS), freedom from progression (FFP) and incidence of second malignancies were collected for 80 patients with aggressive subtypes of NHL, who had been randomised to receive either VAPEC-B chemotherapy or VAPEC-B+G-CSF. Median follow-up was 15.7 years for surviving patients. No significant differences were found in PFS or OS. However, 10-year FFP was better in the G-CSF arm (68 vs 47%, P=0.037). Eleven deaths from causes unrelated to NHL or its treatment occurred in the G-CSF arm compared to five in controls. More deaths occurred from second malignancies (4 vs 2) and cardiovascular causes (5 vs 0) in the G-CSF arm. Although this pharmacovigilance study has insufficient statistical power to draw conclusions and is limited by the lack of data on smoking history and other cardiovascular risk factors, these unique long-term outcome data generate hypotheses that warrant further investigation.