Evaluation of the Efficacy and Safety of FFX Facet Cages Compared With Pedicle Screw Fixation in Patients With Lumbar Spinal Stenosis: A Long-Term Study.

Study Design: Hybrid retrospective/prospective study.

Objective: The study evaluated the long-term safety and efficacy of the FFX facet cage versus pedicle screw (PS) fixation in patients with lumbar spinal stenosis (LSS).

Summary Of Background Data: A previous single-arm study reported on the safety, fusion rate, and patient outcomes associated with the use of the FFX facet cage in patients with lumbar spinal stenosis.

Five-year Follow-up of a Prospective Food and Drug Administration Investigational Device Exemption Trial Evaluating a PEEK-on-Ceramic Cervical Disk Replacement.

Study Design: Prospective trial comparing the investigation group to propensity-matched historic control group.

Objective: To evaluate five-year results of single-level PEEK-on-ceramic cervical total disc replacement (TDR) compared with a propensity-matched anterior cervical discectomy and fusion (ACDF) control group.

Summary Of Background Data: Cervical TDR has gained acceptance as a treatment for symptomatic disk degeneration.

Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.

Background: Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone.

Objective: The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States.

Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study.

Background Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited.

Towards a More Simplified Approach for Evaluating Strength of Evidence in Health Technology Assessments.

It is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of a new medical device prior to the widespread adoption of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. Even though dozens of organizations perform HTAs, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA.

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up.

Background: Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core.

SOFIA catheter for direct aspiration of large vessel occlusion stroke: A single-center cohort and meta-analysis.

Background And Purpose: Direct aspiration (DA) using large-bore distal aspiration catheters is an established strategy for the endovascular thrombectomy (EVT) of large-vessel occlusion stroke (LVOS). However, the performance of individual catheters like SOFIA has yet to be examined.

Methods: We present a cohort of 144 consecutive patients treated with first-line DA and SOFIA 6 F Plus catheter for LVOS.

Comparison of PRISMA Data with Model Simulations, Hyperion Reflectance and Field Spectrometer Measurements on 'Piano delle Concazze' (Mt. Etna, Italy).

In this work, we compare first acquisitions from the ASI-PRISMA (Agenzia Spaziale Italiana-PRecursore IperSpettrale della Missione Applicativa) space mission with model simulations, past data acquired by the Hyperion sensor and field spectrometer measurements. The test site is 'Piano delle Concazze' (Mt. Etna, Italy), suitable for calibration purposes due to its homogeneity characteristics.

Stroke Thrombectomy in Patients with COVID-19: Initial Experience in 13 Cases.

We performed a retrospective review in both comprehensive stroke units of a region affected early by the coronavirus disease 2019 (COVID-19) pandemic, between March 1 and April 26, 2020, including patients with COVID-19 who underwent mechanical thrombectomy for ischemic stroke. We identified 13 cases, representing 38.2% of 34 thrombectomies performed during this period.

Long-lasting diagonistic dyspraxia suppressed by rTMS applied to the right motor cortex.

We describe the case of a 58-year-old patient with complete callosal agenesis, who developed after a stroke a long lasting and distressing diagonistic dyspraxia. We found two original treatments to relieve the patient from his left limb conflicting movements. Reinforcing left arm sensory input minimized dyspraxic movements but was difficult to apply daily and was found unsatisfactory by the patient.

Myelopathy after cervical disc arthroplasty due to progression of spondylosis at the index level: case report.

Cervical disc arthroplasty (CDA) has emerged as a popular alternative to anterior cervical discectomy and fusion (ACDF) for the surgical treatment of cervical degenerative disc disease. CDA has been well studied, with efficacy reported to be equivalent to or better than that seen with ACDF, and it is associated with a consistently low incidence of adverse events. The development or progression of myelopathy after CDA is a particularly rare occurrence.

Natural molecules for the therapy of hyperandrogenism and metabolic disorders in PCOS.

Objective: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of women of reproductive age and a complex endocrine condition, due to its heterogeneity and uncertainty about its etiology. However, PCOS is also associated with other metabolic abnormalities such as insulin resistance, impaired glucose tolerance, and diabetes. There are few medications that are approved for the most common symptoms of PCOS, leading to the off-label use of medications that were approved for other indications.

Genetic, hormonal and metabolic aspects of PCOS: an update.

Polycystic ovary syndrome (PCOS) is a complex endocrine disorder affecting 5-10 % of women of reproductive age. It generally manifests with oligo/anovulatory cycles, hirsutism and polycystic ovaries, together with a considerable prevalence of insulin resistance. Although the aetiology of the syndrome is not completely understood yet, PCOS is considered a multifactorial disorder with various genetic, endocrine and environmental abnormalities.

Hormonal contraceptives: pharmacology tailored to women's health.

Background: In recent years, several new oral contraceptives have become available. In some ways, they represent an evolution in terms of individualization and compliance on the part of women. The new formulations make it increasingly possible to prescribe a specific hormonal contraceptive on an individual basis.

Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis.

Background: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations.

Objective: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level.

Methods: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States.

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial.

Introduction: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression.

Results of a phase II study of Short-course Accelerated Radiation Therapy (SHARON) for multiple brain metastases.

Objectives: To assess the effectiveness of a SHort-course Accelerated RadiatiON therapy (SHARON) in the treatment of patients with multiple brain metastases.

Materials And Methods: A phase II clinical trial was designed. Eligibility criteria included patients with at least 3 brain metastases or metastatic disease in >3 organ systems, and Eastern Cooperative Oncology Group performance status of ≤3.

Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment.

Background: Approved treatment modalities for the surgical management of lumbar spinal stenosis encompass a variety of direct and indirect methods of decompression, though all have varying degrees of limitations and morbidity which potentially limit the efficacy and durability of the treatment. The coflex(®) interlaminar stabilization implant (Paradigm Spine, New York, NY), examined under a United States Food and Drug Administration (US FDA) Investigational Device Exemption (IDE) clinical trial, is shown to have durable outcomes when compared to posterolateral fusion in the setting of post-decompression stabilization for stenotic patients. Other clinical and radiographic parameters, more indicative of durability, were also evaluated.

Combined use of terrestrial laser scanning and IR thermography applied to a historical building.

The conservation of architectural heritage usually requires a multidisciplinary approach involving a variety of specialist expertise and techniques. Nevertheless, destructive techniques should be avoided, wherever possible, in order to preserve the integrity of the historical buildings, therefore the development of non-destructive and non-contact techniques is extremely important. In this framework, a methodology for combining the terrestrial laser scanning and the infrared thermal images is proposed, in order to obtain a reconnaissance of the conservation state of a historical building.

[Evaluation of a new association between insulin-sensitizers and α-lipoic acid in obese women affected by PCOS].

Aim: Polycystic ovary syndrome (PCOS) is a multifactorial pathology affecting 7-10% of the female population. Usually occurs with oligo/amenorrhea, anovulation, hirsutism, polycystic ovaries. Hyperinsulinemia associated with insulin resistance has been causally linked to all features of the syndrome.

Alterations in thyroid function among the different polycystic ovary syndrome phenotypes.

The study evaluates the prevalence of subclinical thyroid dysfunction in infertile PCOS patients, according to the different PCOS phenotypes and to examine whether insulin sensitizers in insulin resistant (IR) PCOS patients may improve thyroid function. The study population consisted of all PCOS patients, attending the infertility and IVF unit of Department of Pediatrics, Obstetrics and Reproductive Medicine of University of Siena, Italy, and compared them to regularly cycling, healthy, infertile controls. Upon admission, blood was drawn from all patients during the early follicular phase, for complete hormonal and metabolic profiles.