A diagnostic phase III/IV seamless design to investigate the diagnostic accuracy and clinical effectiveness using the example of HEDOS and HEDOS II.

The development process of medical devices can be streamlined by combining different study phases. Here, for a diagnostic medical device, we present the combination of confirmation of diagnostic accuracy (phase III) and evaluation of clinical effectiveness regarding patient-relevant endpoints (phase IV) using a seamless design. This approach is used in the Thyroid HEmorrhage DetectOr Study (HEDOS & HEDOS II) investigating a post-operative hemorrhage detector named ISAR-M THYRO® in patients after thyroid surgery.

Cerebrovascular Hemodynamics in Cognitive Impairment and Dementia: A Systematic Review and Meta-Analysis of Transcranial Doppler Studies.

Introduction: Transcranial Doppler (TCD) sonography is a noninvasive tool for measuring cerebrovascular hemodynamics. Studies have reported alterations in cerebrovascular hemodynamics in normal aging, mild cognitive impairment (MCI), and dementia, as well as in different etiologies of dementia. This systematic review and meta-analysis was designed to investigate the relationship between cerebral blood velocity (CBv) and pulsatility index (PI) in the middle cerebral artery (MCA) in persons with MCI and dementia.

Multidisciplinary Pain Management: A Tale of Two Outcomes.

Economic implications of pain management. By Loeser JD. Acta Anaesthesiol Scand 1999; 43:957-95.

The effect of cement augmentation on pedicle screw fixation under various load cases : results from a combined experimental, micro-CT, and micro-finite element analysis.

Aims: Anchorage of pedicle screw rod instrumentation in the elderly spine with poor bone quality remains challenging. Our study aims to evaluate how the screw bone anchorage is affected by screw design, bone quality, loading conditions, and cementing techniques.

Methods: Micro-finite element (µFE) models were created from micro-CT (μCT) scans of vertebrae implanted with two types of pedicle screws (L: Ennovate and R: S).

Health and disease as practical concepts: exploring function in context-specific definitions.

Despite the longstanding debate on definitions of health and disease concepts, and the multitude of accounts that have been developed, no consensus has been reached. This is problematic, as the way we define health and disease has far-reaching practical consequences. In recent contributions it is proposed to view health and disease as practical- and plural concepts.

A Prospective, Randomized Study Evaluating Clinical and Radiographic Efficacy of Lumbar Interbody Fusion Performed Using a Truss Technology-Based Interbody Fusion Device With Homologous Bone or Bone Marrow Aspirate.

Background: Our group used vertebral bone marrow aspirate (BMA) with an anterior truss-based interbody implant to promote fusion. This implant has biomechanical characteristics that may enhance bone on-growth and through-growth and allow for the use of BMA clot alone. The primary end point was comparison of the proportion of patients who achieved fusion with the implant packed with either crushed cancellous homologous bone chips (CCB) alone or with BMA clot alone.

miR-19a/b and miR-20a Promote Wound Healing by Regulating the Inflammatory Response of Keratinocytes.

Persistent and impaired inflammation impedes tissue healing and is a characteristic of chronic wounds. A better understanding of the mechanisms controlling wound inflammation is needed. In this study, we show that in human wound-edge keratinocytes, the expressions of microRNA (miR)-17, miR-18a, miR-19a, miR-19b, and miR-20a, which all belong to the miR-17∼92 cluster, are upregulated during wound repair.

MicroRNA-34 Family Enhances Wound Inflammation by Targeting LGR4.

Venous ulcers are the most common type of human chronic nonhealing wounds and are stalled in a constant and excessive inflammatory state. The molecular mechanisms underlying the chronic wound inflammation remain elusive. Moreover, little is known about the role of regulatory RNAs, such as microRNAs, in the pathogenesis of venous ulcers.

Human skin long noncoding RNA WAKMAR1 regulates wound healing by enhancing keratinocyte migration.

An increasing number of studies reveal the importance of long noncoding RNAs (lncRNAs) in gene expression control underlying many physiological and pathological processes. However, their role in skin wound healing remains poorly understood. Our study focused on a skin-specific lncRNA, LOC105372576, whose expression was increased during physiological wound healing.

Kidney Transplantation in Elderly Recipients: A Single-Center Experience.

Unlabelled: In this retrospective single-center study we evaluated the outcome after kidney transplant in recipients older than 65 years in terms of patient and graft survival and causes of death.

Patients And Methods: From 1993 to 2016, 109 consecutive first single kidney transplants in recipients older than 65 years were included. Furthermore, 2 age groups have also been identified (group A, 65-70 years old vs group B, 71-76 years old).

Adherence to optimal heart rate control in heart failure with reduced ejection fraction: insight from a survey of heart rate in heart failure in Sweden (HR-HF study).

Introduction: Despite that heart rate (HR) control is one of the guideline-recommended treatment goals for heart failure (HF) patients, implementation has been painstakingly slow. Therefore, it would be important to identify patients who have not yet achieved their target heart rates and assess possible underlying reasons as to why the target rates are not met.

Materials And Methods: The survey of HR in patients with HF in Sweden (HR-HF survey) is an investigator-initiated, prospective, multicenter, observational longitudinal study designed to investigate the state of the art in the control of HR in HF and to explore potential underlying mechanisms for suboptimal HR control with focus on awareness of and adherence to guidelines for HR control among physicians who focus on the contributing role of beta-blockers (BBs).

A practical approach to low protein diets in Sweden- 45 years of clinical use.

This review provides an overview of the development, implementation and practise of low protein diets (LPD) in Sweden. While the current practice is discussed in general terms emphasizing the interplay between nephrologists and dieticians, the "self-selected" LPD model is explained as a practical approach to facilitated patient's adherence to the nutritional therapy. This model is currently implemented in most clinics of the country and gives considerable flexibility regarding variation in meal planning, food selection, amounts consumed, cooking methods as well as adaptations to day-to-day changes.

Quaking promotes monocyte differentiation into pro-atherogenic macrophages by controlling pre-mRNA splicing and gene expression.

A hallmark of inflammatory diseases is the excessive recruitment and influx of monocytes to sites of tissue damage and their ensuing differentiation into macrophages. Numerous stimuli are known to induce transcriptional changes associated with macrophage phenotype, but posttranscriptional control of human macrophage differentiation is less well understood. Here we show that expression levels of the RNA-binding protein Quaking (QKI) are low in monocytes and early human atherosclerotic lesions, but are abundant in macrophages of advanced plaques.

Hypertrophic Olivary Degeneration: A Neurosurgical Point of View.

Hypertrophic olivary degeneration (HOD) is a rare form of transsynaptic degeneration characterized by hypertrophy of the inferior olivary nucleus situated in the olivary body, part of the medulla oblongata, representing a major source of input to the cerebellum. HOD typically results from focal lesions interrupting connections from the inferior olive within the dentato-rubro-olivary pathway, a region also known as the triangle of Guillain-Mollaret (TGM) (red nucleus, inferior olivary nucleus, and contralateral dentate nucleus). Clinically, HOD presents classically as palatal tremor and can include dentatorubral tremor and/or ocular myoclonus.

Blockade of CCR3 retains the neutrophils, preserving their survival during healing after myocardial infarction.

Background: Chemokines are critical mediators in controlling and monitoring the healing and ventricular remodeling after myocardial infarction (MI). They proved to be valuable targets for therapeutic measures to reduce the scar formation and to preserve heart function in patients suffering MI. In the present study, the role of CCR3 in myocardial ischemia/reperfusion was established.

Palliative Care Medical Education in European Universities: A Descriptive Study and Numerical Scoring System Proposal for Assessing Educational Development.

Context: The lack of palliative medicine (PM) education has been identified as a barrier to the development of the discipline. A number of international institutions have called for its implementation within undergraduate medical curricula.

Objectives: The objectives are to describe the situation of undergraduate PM education in Europe and to propose a scoring system to evaluate its status.

Is a one-night stay in the lab really enough to conclude? First-night effect and night-to-night variability in polysomnographic recordings among different clinical population samples.

While polysomnography remains the current gold standard in sleep investigation, guidelines for single night versus consecutive recordings in a sleep laboratory have been disputed mainly because of two phenomena: the first-night effect and night-to-night variability. One hundred and twenty nine subjects, that underwent two consecutive nights of polysomnographic recording in a general University Hospital's sleep lab, were divided into four groups: sleep-related breathing disorders (SRBD), insomnia, movement and behavioral disorders and a healthy control (HC) group based on their complaints at admission and sleep study results. Sleep parameters of both consecutive two nights were compared and analyzed.

Social psychiatry and public mental health: present situation and future objectives. Time for rethinking and renaissance?

Objective: To describe the social psychiatric challenges of modern psychiatry in European societies in the light of recent psychiatric research evidence and to show how these challenges could be conceptualized.

Method: Reviewing aggregate morbidity and mortality data from the WHO European Health for All Database, and summarizing consultations and fact-finding missions to many European countries during the authors engagement as WHO Regional Advisor for Mental health from 1998 to 2004.

Results: Societal change in Europe is leading to stress and mental ill health for its populations.

Changes in renal tri-iodothyronine and thyroxine handling during fasting.

Objective: Liver handling of thyroid hormones (TH) has been known to alter significantly during fasting. This study investigates whether renal handling of TH is also changed during fasting.

Methods: We measured urinary excretion rates and clearances of free tri-iodothyronine (T(3)) and free thyroxine (T(4)) in healthy subjects prior to and on the third day of fasting.

Pathoanatomical and radiographic findings in spinal breast cancer metastases.

Spine specimens infested with breast cancer metastases, ranging from localized seed of small tumor deposits to massive invasion and vertebral collapse, were frozen in situ, removed, examined with both conventional radiography and high resolution computed tomography (CT), and then studied in great detail by serial cryoplaning. The majority of metastases in the total of 53.5 vertebrae were lytic, and most were in close contact with the vertebral wall or the endplates.

Thrombomodulin and ristocetincofactor in homocystinuria: a study in two siblings.

Homocystinuria due to cystathionine-beta-synthase deficiency (CBS-def-HOCY) initially often presents with vascular disorders, e.g. thromboembolic events.

Findings and outcome in whiplash-type neck distortions.

Study Design: The authors assessed the clinical and imaging findings and late outcome in 50 patients with whiplash-type neck distortions (17 men, 33 women, mean age 33 years).

Summary Of Background Data: Early symptoms are neck pain, stiffness, and sometimes radiating pain; later bizarre symptomatology poses intricate clinical and medicolegal problems. Pathoanatomic studies indicate that soft tissue injuries may be overlooked.

Coagulation factors and markers of activation of coagulation in homocystinuria (HOCY): a study in two siblings.

Homocystinuria due to cystathionine-beta-synthase deficiency (CBS-def-HOCY) initially often present with thromboembolic events. In most cases in which coagulation factors have been analysed, a deficiency of AT-IIIc and factor VIIc has been reported, the cause of which has not been elucidated. Activation of coagulation with consumption of coagulation factors has been postulated as the mechanism.