nils-herrmann/clean_scirepeval huggingface dataset:
Clinical policies on the management of chronic kidney disease patients in Italy.

Recent studies have indicated that the implementation of international guidelines for the management of renal patients is suboptimal in Italy. The Italian Society of Nephrology (SIN) decided to undertake a multicentre study to obtain a clear picture of clinical policies on chronic kidney disease (CKD) in Italy.



A 76-item structured questionnaire, designed to evaluate the organization of clinical care, was administered to the director of each participating centre, within the context of a large observational trial in 100 Italian nephrology centres, collecting information on newly diagnosed CKD patients (K/DOQI stage 3-5) on conservative treatment. This paper reports the questionnaire results related to management of anaemia and bone metabolism disorders; assessment of renal function; creation of a vascular access for dialysis and referral of patients to a nephrologist.



Clinical policies at the centre level deviated from guideline recommendations in 70% (timing of vascular access creation) to 25% (assessment of iron deficiency) of centres. Assessment of renal function differed from the recommended approach in 30% of centres; clinical policies related to anaemia and bone disease did not coincide with guideline standards in 50 and 40% of centres, respectively. Directors of renal unit estimates indicate that the creation of a vascular access occurs very late in 38% of patients and that referral to a nephrologist is late in approximately 40% of cases.



This survey in Italy highlights important deviations of clinical policies at the centre level from guideline recommendations.
Life satisfaction in people with spinal cord injury during the first five years after discharge from inpatient rehabilitation.

To describe the course of life satisfaction in persons with spinal cord injury (SCI) during the first 5 years after discharge from inpatient rehabilitation and to examine its determinants.



Multi-centre prospective cohort study with four measurements, the first at discharge from inpatient rehabilitation, the last 5 years after discharge. Data of 162 persons with SCI were analyzed. Life satisfaction was measured as the sum score of 'current life satisfaction' and 'current life satisfaction compared to life satisfaction before SCI'. Lesion characteristics, functional independence, secondary impairments, pain, social support and self-efficacy were analyzed as possible determinants of life satisfaction. Random coefficient analysis was used for the analyses.



No significant changes in life satisfaction were found between discharge and 2 years later, however there were significant increases from two to 5 years post discharge. High functional independence, low pain, high everyday social support and high self-efficacy were significant determinants of a positive course of life satisfaction after discharge.



Increases in life satisfaction were found in persons with SCI in the long run. High functional status, low pain, good social skills and high self-efficacy were related to high life satisfaction.
Image-guided surgery for treatment of unruptured middle cerebral artery aneurysms.

Direct surgical clipping appears to be an efficient means for managing unruptured middle cerebral artery (MCA) aneurysms, owing to several angioanatomic features. Here, we present a minimally invasive technique that uses navigation guidance for the treatment of unruptured MCA aneurysms.



Between July of 2003 and June of 2005, we used image-guidance navigation to operate on 24 patients who were diagnosed with unruptured MCA aneurysm. Five men and 19 women were included in the study, and their ages ranged from 43 to 70 years (mean, 58 yr). We predetermined the transsylvian trajectory toward the aneurysm and planned a tailored craniotomy for each patient.



All aneurysms were readily identified and successfully clipped via craniotomies of less than 3 cm in diameter. We experienced no surgical complications, and each patient had an uneventful postoperative course.



With the aid of navigation, we were able to easily locate MCA aneurysms and perform minimally invasive surgeries such as mini-craniotomies, tailored sylvian dissections, and successful clippings of unruptured MCA aneurysms. In addition, we obtained satisfactory cosmetic results.
Interrogating a Multifactorial Model of Breast Conserving Therapy with Clinical Data

Most women with early stage breast cancer do not require removal of the entire breast to treat their cancer; instead, up to 70% of women can be effectively and safely treated by breast conserving therapy (BCT) with surgical removal of the tumor only (lumpectomy) followed by radiation treatment of the remaining breast tissue. Unfortunately, the final contour and cosmesis of the treated breast is suboptimal in approximately 30% of patients. The ability to accurately predict breast contour after BCT for breast cancer could significantly improve patient decision-making regarding the choice of surgery for breast cancer. Our overall hypothesis is that the complex interplay among mechanical forces due to gravity, breast tissue constitutive law distribution, inflammation induced by radiotherapy and internal stress generated by the healing process play a dominant role in determining the success or failure of lumpectomy in preserving the breast contour and cosmesis. We have shown here from a first patient study that even in the idealistic situation of excellent cosmetic outcome this problem requires multiscale modeling. We propose a method to decide which component of the model works best for each phase of healing and what parameters should be considered dominant and patient specific. This patient study is part of a clinical trial registered on ClinicalTrial.gov, identifier NCT02310711.
Exclusive enteral nutrition induces early clinical, mucosal and transmural remission in paediatric Crohn’s disease

Exclusive enteral nutrition (EEN) induces clinical and mucosal healing (MH) in Crohn’s disease (CD), with MH the best determinant of future outcome. We investigated efficacy of EEN for inducing early clinical, biochemical, mucosal and transmural remission of CD and related early endoscopic response to outcomes at 1 year. In a prospective, open label study 34 children (mean 13.1 years; 21 males) with new diagnosis CD were offered EEN, 26 completed a minimum 6 weeks EEN and underwent paired clinical, biochemical and endoscopic assessment at start and completion using PCDAI, BMI, CRP and Simple Endoscopic Score for CD (SES-CD). A subset, 16/26, had paired MR enterography scored. Early good endoscopic response (complete MH, or near complete, SES-CD 0–3) was related to outcome at 1 year. EEN improved mean PCDAI (37.88–7.01, p < 0.001; BMI Z scores (−1.54 to −0.54, p < 0.01); weight Z score (−0.79 to −0.08, p < 0.03); CRP (44.86–5.5, p < 0.001); endoscopy (SES-CD 14.28–3.88, p < 0.001) and MRE (5.14–2.79, p = 0.01). Of 26 children, 22 (84 %) achieved clinical remission; 20 (76 %) biochemical remission. Fifteen (58 %) had early good endoscopic response (11 complete, 4 near complete MH) and 3/14 (21 %) had complete transmural remission of ileal CD (MRE-CD: 0–1). Early good endoscopic response was associated with reduced endoscopic confirmed relapse (53 vs. 100 %, p = 0.02), anti-TNF use (33 vs. 88 %, p = 0.01) and hospitalisation (40 vs. 88 %) at 1 year. EEN is effective for inducing early clinical, biochemical, mucosal and transmural remission. Early endoscopic remission improves outcomes at 1 year.
Effect of Acarbose on Glycemic Variability in Patients with Poorly Controlled Type 2 Diabetes Mellitus Receiving Stable Background Therapy: A Placebo-Controlled Trial.

To evaluate the effect of acarbose on glycemic control and glycemic variability, using a continuous glucose-monitoring system, in patients with type 2 diabetes mellitus who were not well controlled on metformin and vildagliptin therapy.



Multicenter, randomized, double-blind, placebo-controlled study.



Clinical research units at three hospitals in Italy.



Fifty-three patients with type 2 diabetes who were taking stable dosages of metformin 850 mg 3 times/day and vildagliptin 50 mg twice/day for at least 3 months and who were not adequately controlled with these therapies.



Patients were randomized to either placebo or acarbose 100 mg 3 times/day to be added to their metformin-vildagliptin regimen.



Glycemic excursions were assessed by using a continuous glucose-monitoring system for 1 week. Glycemic control was estimated as the mean blood glucose (MBG) level, the area under the glucose concentration-time curve for a glucose level above 70 mg/dl (AUC above 70) or 180 mg/dl (AUC above 180), and the percentage of time that the glucose level was above 70 mg/dl (T above 70) or 180 mg/dl (T above 180). Intraday glycemic variability was assessed by the standard deviation of the blood glucose level, the mean amplitude of glycemic excursions (MAGE), the M value, and continuous overlapping net glycemic action. Day-to-day glycemic variability was assessed as the mean of daily difference (MODD). The MBG level was ~20 mg/dl lower in the acarbose group than in the placebo group (p<0.05), particularly during the postprandial period. The AUC above 70 did not significantly differ between the two groups, whereas the AUC above 180 was ~40% lower in the acarbose group than in the placebo group during the daytime (p<0.01). The T above 180 was significantly higher in the placebo group than in the acarbose group (31% vs 8%, p<0.01. Moreover, the standard deviation and MAGE values were significantly lower in the acarbose group. The MODD value was not significantly changed in either group, and no significant differences were recorded between groups. All adverse events were mild in both groups, with only a significantly greater frequency of flatulence noted in the acarbose group (5% with acarbose vs 0.5% with placebo, p<0.05).



The addition of acarbose to metformin and vildagliptin background therapy in patients with inadequately controlled type 2 diabetes decreased intraday glycemic variability, especially postprandial variability, but it was not associated with a significant change in interday glycemic variability.
Efficacy of electroacupuncture and tens in the rehabilitation of chronic low back pain patients

Fifty-four patients treated in a 3-week inpatient rehabilitation program were randomly assigned to and accepted treatment with electroacupuncture (n = 17), TENS (low intensity transcutaneous nerve stimulation, n = 18), and TENS dead-battery (placebo, n = 18). Outcome measures included estimates of pain (on a Visual Analogue Scale) and disability by both physician and patient, physical measures of trunk strength and spine range of motion, as well as the patient's perceptions of the relative contribution of the education, exercise training, and the electrical stimulation. Analyses of variance were utilized to determine effects of treatment (electroacupuncture, TENS, placebo) across time (admission, discharge, and return) for the outcome measures. There were no significant differences between treatment groups with respect to their overall rehabilitation. All 3 treatment groups ranked the contribution of the education as being greater than the electrical stimulation. However, the electroacupuncture group consistently demonstrated greater improvement on the outcome measures than the other treatment groups. For the visual analogue scale measure of average pain, there was a statistical trend at the return visit suggesting that the acupuncture group was experiencing less pain.
First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer’s disease

In the First-In-Human (FIH), 39-week, randomized, adaptive design study, safety, tolerability, pharmacokinetics and biomarkers were measured in patients with mild-to-moderate Alzheimer’s disease (AD) after infusion of a humanized monoclonal antibody to amyloid β, AAB-003 (NCT01193608; registered 19 August 2010). AAB-003 was developed by modifying bapineuzumab to reduce Fc-receptor-mediated effector function as a strategy to reduce the removal of amyloid from vessel walls associated with amyloid-related imaging abnormalities with edema/effusions (ARIA-E) without diminishing overall amyloid clearance. Eighty-eight patients with AD received up to three infusions of AAB-003 (or placebo) 13 weeks apart at doses of 0.5, 1, 2, 4 or 8 mg/kg in the FIH trial. Dose escalation was based on safety data reviews using a Bayesian escalation algorithm. Subjects who completed the FIH study were permitted to enter a 1-year open-label extension trial with four additional intravenous infusions of AAB-003 (NCT01369225; registered 10 May 2011). Dose-dependent increases in plasma amyloid β and AAB-003 were observed. No significant changes in cerebral spinal fluid biomarkers were observed. Pharmacokinetics elimination half-life (21–28 days) clearance and volume of distribution values were consistent across dose groups indicating linearity. ARIA-E was the most notable safety finding detected by magnetic resonance imaging (MRI) at 8 mg/kg in two patients. Three cases of microhemorrhage were observed. No new safety findings or MRI abnormalities were observed for the 52 subjects who received AAB-003 in the extension trial. Based on integrated review of laboratory, electrocardiogram, adverse events, and MRI, AAB-003 was safe and well tolerated up to 8 mg/kg for up to 91 weeks (FIH and extension trials) in patients with mild to moderate AD. Asymptomatic and resolvable ARIA-E was observed after the first or second infusion of AAB-003, similar to bapineuzumab. The AAB-003 dose at which ARIA-E was observed was higher compared to bapineuzumab, supporting the hypothesis that reducing Fc-receptor effector function may reduce the ARIA associated with monoclonal antibodies targeting cerebral amyloid.
Comparison of swimming capacity and energetics of migratory European eel (Anguilla anguilla) and New Zealand short-finned eel (A. australis)

The spawning migration of the European eel (Anguilla anguilla) can cover more than 6000 km, while that of the New Zealand short-finned eel (A. australis) is assumed to be approximately 3000 km. Since these species are expected to show adaptive traits to such an important lifetime event, we hypothesized differences in swimming capacity and energetics as a response to this adaptation. In an experimental swimming respirometer set-up, critical swimming speed (Ucrit), optimal swimming speed (Uopt), mass specific oxygen consumption rate (ṀO2), standard metabolic rate (SMR), active metabolic rate at Ucrit (AMRcrit) and at Uopt (AMRopt), the minimum cost of transport at Uopt (COTmin), and the scope for activity, were assessed and compared between the species. With a similar body length and mass, European eels showed ca. 25% higher values for both Ucrit and Uopt, and 23% lower values for COTmin, compared to New Zealand short-finned eels. However, SMR, AMRcrit, AMRopt, and scope for activity did not differ between the species, indicating very similar swimming physiology traits. This study discusses physiological aspects of long distance migration and provides recommendations for (a) swimming respirometry in anguilliform fish, and (b) telemetry research using externally attached pop-up tags.
Abuse liability assessment of atomoxetine in a drug-abusing population.

Atomoxetine is a non-amphetamine medication approved to treat ADHD in children, adolescents, and adults. Previous studies demonstrated low abuse potential for atomoxetine in recreational drug users. This study assessed the abuse potential of atomoxetine in stimulant-preferring drug abusers compared to methylphenidate and phentermine as positive controls and desipramine and placebo as negative controls.



Forty male and female, 32-53 years old stimulant-preferring drug abusers completed this balanced Latin-square designed study. Subjects received acute, double-blind doses of placebo, desipramine (100 and 200 mg), methylphenidate (90 mg), phentermine (60 mg), and atomoxetine (45, 90, and 180 mg). Subjective and physiological effects were collected for 24 h following each drug treatment.



Methylphenidate and phentermine were liked significantly more than placebo, atomoxetine, or desipramine. No atomoxetine dose was liked significantly more than placebo and liking scores for atomoxetine were similar to, or significantly lower than, desipramine, as assessed by the Drug Rating Questionnaire-Subject. While atomoxetine 45 and 180 mg did not significantly change any Addiction Research Center Inventory (ARCI) scores, atomoxetine 90 mg significantly increased A and BG stimulant scores of the ARCI and both methylphenidate and phentermine produced greater A and BG increases than any atomoxetine dose and also increased MBG (euphoria) scores relative to placebo.



Atomoxetine has significantly less abuse liability than methylphenidate or phentermine and no greater abuse liability than desipramine.
Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD.

CERV-PTSD is a randomized controlled trial of two of the most effective treatments for PTSD, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT). Despite solid evidence that both treatments are effective, there is limited evidence about their effectiveness relative to one another. The primary objective is to compare the effectiveness of PE and CPT for reducing PTSD symptom severity in a healthcare system that offers both treatments. The secondary objective is to compare the effectiveness of PE and CPT for reducing the severity of comorbid mental health problems and service utilization as well as improving functioning and quality of life. The tertiary objective is to examine whether discrepancy between patient preferences and treatment assignment reduces the effectiveness of each treatment. Exploratory analyses will examine whether demographic and clinical characteristics predict differential response to PE and CPT. The study is designed to randomize 900 male and female veterans with PTSD due to any traumatic military event to receive PE or CPT. The standard dose of treatment is 12 weekly sessions but veterans who improve more rapidly may finish in fewer sessions and veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms, measured during and after treatment and then 3 and 6 months later. As a large multi-site trial with men and women, CERV-PTSD is designed to advance the delivery of care for PTSD by providing conclusive information about whether one treatment is better than the other, overall, and for different types of patients.
Nitroglycerin infusion after percutaneous coronary intervention does not influence short- and long-term outcome--a prospective NAPI (Nitroglycerin Administration after Percutaneous Intervention) study.

Although the benefit of nitroglycerin infusion in patients after elective coronary angioplasty has not been established, this regimen is routinely used in some centres.



The Nitroglycerin Administration after Percutaneous Intervention (NAPI) study tested the efficacy of routine nitroglycerin infusion on the 1st day after percutaneous coronary intervention (PCI) in a double-blind randomised single-centre clinical trial.



We randomly assigned 200 patients scheduled for elective PCI to treatment with nitroglycerin (100 patients, age 58+/-6 years, infusion up to 100 microg/min) or placebo (100 patients, age 57+/-5 years, p=NS, NaCl 0.9%) for 12 hours after PCI. Patients with acute myocardial infarction, haemodynamic instability during PCI and known intolerance to nitrates were excluded. Patients who were randomised to the placebo group had the possibility to receive nitroglycerin infusion according to the attending physician's decision. Clinical endpoints (cardiac death, myocardial infarction, postprocedural chest pain, unstable angina and repeated PCI) were assessed in hospital and out of hospital with follow-up extended to 24 months.



There were no differences during in-hospital stay between those receiving nitroglycerin and receiving placebo, regarding mortality (0 vs. 0%, NS), myocardial infarction (0 vs. 2%, NS), postprocedural chest pain (10 vs. 8%, NS) or repeated PCI (0 vs. 2%, NS). Similarly, 24-month follow-up also revealed no significant differences between those receiving nitroglycerin and placebo (mortality: 0 vs. 0%, NS; myocardial infarction: 4 vs. 4%, NS; repeated PCI: 10 vs. 8%, NS or CABG: 0 vs. 0%, NS).



Routine use of intravenous nitroglycerin after elective PCI has no influence on in-hospital and long-term outcome, including cardiac death, myocardial infarction, postprocedural chest pain, unstable angina and repeated PCI.
Radiculopathy in degenerative lumbar scoliosis: correlation of stenosis with relief from selective nerve root steroid injections.

The purpose is to define the origin of radiculopathy of patients with degenerative lumbar scoliosis-stenosis and to assess the correlation between percentage of initial radicular leg pain relief with selective nerve root injections and lateral canal dimensions.



Retrospective clinical study.



Thirty-six consecutive patients (average age 72) from Twin Cities Spine Center with degenerative lumbar scoliosis (average major curve 25°) and radicular symptoms were studied.



Patients underwent 46 selective steroid injections of nerve roots concordant with clinical symptomatology.



Radiographic measurements included major and lumbosacral curve Cobb angle. Computerized measurements of magnetic resonance imaging (MRI) included minimum subarticular height and foramen cross-sectional area of the nerve roots that were injected. Initial response from the nerve root injections was also rated.



Twenty-five percent of nerve root symptoms were coming from the major curve, 72.2% from the lumbosacral hemicurve and 2.8% from both (P<0.001). The affected nerve roots were more frequently the L4 (34.8%) and L5 (28.3%) nerve roots. A total of 71.7% of radicular symptoms were originating from the concavity of the curve and 28.7% from the convexity (P<0.001). The relief from injections was more than 50% in 75% of the patients at 15 days postinjection. There was no statistical significant correlation (P>0.05) between the lateral canal dimensions and the initial response to injection of anesthetic plus steroid injection.



In degenerative lumbar scoliotic curves, radicular symptoms are attributed mainly to nerve roots exiting from the concavity of the lumbosacral hemicurve. No evidence was found that the rate of initial relief from selective nerve root injections correlates with the degree of stenosis noted in the MRI.