9,054 results match your criteria Clinical Safety in Neurology


EXPRESS: Stent Retriever Alone vs. Aspiration and Stent-Retriever Combination in Large Vessel Occlusion Stroke: A Matched Analysis.

Int J Stroke 2021 May 14:17474930211019204. Epub 2021 May 14.

Emory University School of Medicine, Atlanta, Georgia, United States.

Background Three randomized clinical trials have reported similar safety and efficacy for contact aspiration (CA) and Stent-retriever (SR) thrombectomy. AimWe aimed to determine whether the Combined Technique (SR+CA) was superior to SR alone as first-line thrombectomy strategy in a patient cohort where balloon-guide catheter was universally used. MethodsA prospectively maintained mechanical thrombectomy database from January 2018-December 2019 was reviewed. Read More

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Assessing the Effect of Zinc Supplementation on the Frequency of Migraine Attack, Duration, Severity, Lipid Profile and hs-CRP in Adult Women.

Clin Nutr Res 2021 Apr 27;10(2):127-139. Epub 2021 Apr 27.

Food and Beverages Safety Research Center, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences, Urmia 32770-397, Iran.

Migraine is a widespread incapacitating neurologic disorder with debilitating headaches which are usually throbbing due to inefficacy and several side effects, complementary therapies recommended as possible alternatives. The current randomized controlled trial was carried out to evaluate the effect of zinc gluconate supplementation on migraine-related symptoms, serum level of high sensitivity C-reactive protein (hs-CRP) and lipid profile in migraineurs. Present study was designed as randomized double-blind, placebo-controlled trial. Read More

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CAR T-Cells for Glioblastoma: Current Concepts, Challenges and Future Perspectives.

Neurology 2021 May 13. Epub 2021 May 13.

Department of Neurosurgery, Ludwig-Maximilians-University School of Medicine, Munich, Germany

Glioblastoma is the most common malignant primary brain tumor and associated with a poor prognosis even after multimodal therapy. Chimeric antigen receptor (CAR) T-cells have emerged as a promising therapeutic avenue in glioblastoma. CARs incorporate antigen-recognition moieties that endow autologous T-cells with specificity against antigens expressed on glioblastoma (e. Read More

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BeatWalk: Personalized Music-Based Gait Rehabilitation in Parkinson's Disease.

Front Psychol 2021 26;12:655121. Epub 2021 Apr 26.

EuroMov Digital Health in Motion, University of Montpellier, IMT Mines Alès, Montpellier, France.

Taking regular walks when living with Parkinson's disease (PD) has beneficial effects on movement and quality of life. Yet, patients usually show reduced physical activity compared to healthy older adults. Using auditory stimulation such as music can facilitate walking but patients vary significantly in their response. Read More

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Differential response to scrambler therapy by neuropathic pain phenotypes.

Sci Rep 2021 May 12;11(1):10148. Epub 2021 May 12.

Department of Neurology, Seoul National University College of Medicine, Seoul, South Korea.

Scrambler therapy is a noninvasive electroanalgesia technique designed to remodulate the pain system. Despite growing evidence of its efficacy in patients with neuropathic pain, little is known about the clinical factors associated with treatment outcome. We conducted a prospective, open-label, single-arm trial to assess the efficacy and safety of scrambler therapy in patients with chronic neuropathic pain of various etiologies. Read More

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Opicapone for the Treatment of Parkinson's Disease: a review.

Int J Neurosci 2021 May 12:1-19. Epub 2021 May 12.

Department of Neurology, University of Miami Miller School of Medicine, Miami, Florida, USA.

Levodopa formulations are the workhorses of the labor against motor symptoms management in Parkinson's disease (PD). Progression of PD on levodopa inevitably leads to motor fluctuations. It is important to understand the safety and efficacy of opicapone, the most recent addition to the clinician's armamentarium against these fluctuations. Read More

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Oral Anticoagulation and Adverse Outcomes after Ischemic Stroke in Heart Failure Patients without Atrial Fibrillation.

J Card Fail 2021 May 4. Epub 2021 May 4.

Division of Cardiology, University of California, Los Angeles, Los Angeles, CA.

Background: The safety and effectiveness of oral anticoagulation (OAC) after an ischemic stroke in older patients with heart failure (HF) without atrial fibrillation remains uncertain.

Methods: Utilizing Get With The Guidelines Stroke national clinical registry data linked to Medicare claims from 2009-2014, we assessed the outcomes of eligible patients with a history of HF who were initiated on OAC during a hospitalization for an acute ischemic stroke. The cumulative incidences of adverse events were calculated using Kaplan-Meier curves and adjusted Cox proportional hazard ratios were compared between patients discharged on or off OAC. Read More

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Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres.

Mult Scler 2021 May 12:13524585211012227. Epub 2021 May 12.

Department of Neurology and Center for Translational and Behavioral Neurosciences (C-TNBS), University Medicine Essen, Essen, Germany.

Background: Oral cladribine has been approved for the treatment of relapsing multiple sclerosis (MS) yet real-world evidence regarding its effectiveness and safety remains scarce.

Objective: To evaluate efficacy and safety outcomes of MS patients following induction of cladribine.

Methods: We evaluated our prospective cohort of cladribine-treated MS patients from two tertiary centres in Germany. Read More

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Voluntary and magnetically evoked muscle contraction protocol in males with Duchenne muscular dystrophy: safety, feasibility, reliability, and validity.

Muscle Nerve 2021 May 11. Epub 2021 May 11.

Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School-University of Minnesota, Minneapolis, MN.

Introduction: Clinical trials addressing treatments for Duchenne muscular dystrophy (DMD) require reliable and valid measurement of muscle contractile function across all disease severity levels. This work aimed to evaluate a protocol combining voluntary and evoked contractions to measure strength and excitability of wrist extensor muscles, for safety, feasibility, reliability, and discriminant validity between males with DMD and controls.

Methods: Wrist extensor muscle strength and excitability were assessed in males with DMD (N=10; mean 15. Read More

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A Detailed Analysis of Infarct Patterns and Volumes at 24-hour Noncontrast CT and Diffusion-weighted MRI in Acute Ischemic Stroke Due to Large Vessel Occlusion: Results from the ESCAPE-NA1 Trial.

Radiology 2021 May 11:203964. Epub 2021 May 11.

From the Department of Clinical Neurosciences and Diagnostic Imaging, University of Calgary Cumming School of Medicine, 29th St NW, 1079 A, Calgary, AB, Canada T2N 2T9 (J.M.O., B.K.M., W.Q., N.K., A.M., N.S., P.C., M.M., A.M.D., C.Z., M.J., M.A.A., S.B.C., M.D.H., M.G.); Department of Radiology, University Hospital of Basel, Basel, Switzerland (J.M.O.); Department of Radiology, University of Calgary, Calgary, Alberta, Canada (B.K.M., N.K., A.M.D., C.Z., M.J., M.A.A., S.B.C., M.D.H., M.G.); Department of Medical Imaging, St Anne's University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic (P.C.); International Clinical Research Center, St Anne's University Hospital Brno, Czech Republic (P.C.); Department of Neurology, Emory University School of Medicine, Atlanta, Ga (R.G.N., D.H.); Department of Interventional Radiology, Warren Alpert Medical School of Brown University, Providence, RI (R.A.M.); Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada (A.Y.P., D.R., D.I.); Department of Neurology, Warren Alpert Medical School of Brown University, Providence, RI (S.C.); Department of Neuroradiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada (A.R.); and NoNo, Toronto, Ontario, Canada (M.T.).

Background The effect of infarct pattern on functional outcome in acute ischemic stroke is incompletely understood. Purpose To investigate the association of qualitative and quantitative infarct variables at 24-hour follow-up noncontrast CT and diffusion-weighted MRI with 90-day clinical outcome. Materials and Methods The Safety and Efficacy of Nerinetide in Subjects Undergoing Endovascular Thrombectomy for Stroke, or ESCAPE-NA1, randomized controlled trial enrolled patients with large-vessel-occlusion stroke undergoing mechanical thrombectomy from March 1, 2017, to August 12, 2019. Read More

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Autoimmune Processes Involved in Organ System Failure Following Infection with SARS-CoV-2.

Adv Exp Med Biol 2021 ;1318:355-368

Biological Safety and Security, Frederick, MD, USA.

During the COVID-19 pandemic associated with high incidence, transmissibility, and mortality, this chapter focuses on three phases of the disease: initial exposure, initiation of the immune response to the agent, and finally, an inflammatory/autoimmune-like presentation with pulmonary, neurological, and renal failure and disseminated intravascular coagulation which occurs in a small proportion of the patients. The elegant demonstration of the site of interaction between the spike (S) protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is the causative agent of COVID-19, and the ACE (angiotensin-converting enzyme) 2 receptor of cells distributed throughout the body has enabled research efforts to develop pharmacological and immune countermeasures to the viral phase of the disease. This chapter rapidly reviews the molecular and structural organization of SARS-CoV-2 and its interaction with ACE2. Read More

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MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

Nat Med 2021 May 10. Epub 2021 May 10.

Fluence, Woodstock, NY, USA.

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. Read More

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Study protocol for a phase II randomised, double-blind, placebo-controlled trial of perampanel as an antiepileptogenic treatment following acute stroke.

BMJ Open 2021 May 10;11(5):e043488. Epub 2021 May 10.

Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia.

Introduction: Stroke is a common cause of epilepsy that may be mediated via glutamate dysregulation. There is currently no evidence to support the use of antiseizure medications as primary prevention against poststroke epilepsy. Perampanel has a unique antiglutamatergic mechanism of action and may have antiepileptogenic properties. Read More

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Risk of Infection after Deep Brain Stimulation Surgery with Externalization and Local-Field Potential Recordings: Twelve-Year Experience from a Single Institution.

Stereotact Funct Neurosurg 2021 May 10:1-9. Epub 2021 May 10.

Department of Neurology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Introduction: Deep brain stimulation (DBS) has been an established surgical procedure in the field of functional neurosurgery for many years. The experimental electrophysiological method of local field potential (LFP) recordings in postsurgically externalized patients has made substantial contributions to the better understanding of pathophysiologies underlying movement disorders. As interest in LFP recordings for the development of improved stimulation strategies increases, this study's aim was to provide evidence concerning safety of this research method, in a major DBS center. Read More

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Digital Biomarkers of Cognitive Frailty: The Value of Detailed Gait Assessment Beyond Gait Speed.

Gerontology 2021 May 10:1-10. Epub 2021 May 10.

Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.

Background: Cognitive frailty (CF), defined as the simultaneous presence of cognitive impairment and physical frailty, is a clinical symptom in early-stage dementia with promise in assessing the risk of dementia. The purpose of this study was to use wearables to determine the most sensitive digital gait biomarkers to identify CF.

Methods: Of 121 older adults (age = 78. Read More

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Resuscitative Effect of Centhaquine (Lyfaquin) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial.

Adv Ther 2021 May 10. Epub 2021 May 10.

Pharmazz India Private Limited, Greater Noida, India.

Introduction: Centhaquine (Lyfaquin) showed significant efficacy as a resuscitative agent in animal models of haemorrhagic shock. Its safety and tolerability were confirmed in healthy human volunteers. In this study, our primary objective was to determine the safety, and the secondary objective was to assess the efficacy of centhaquine in patients with hypovolemic shock. Read More

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The Role of Cannabidiol in Neurological Disorders.

Perm J 2021 May;25

Department of Neurology, Kaiser Permanente Medical Center, Orange County, CA.

None: Cannabis has been used for both recreational and medicinal purposes for more than 4 millennia. Cannabis has been studied in various medical disorders including neurological disorders. There are well-known risks of long-term use of cannabis, including low motivation, lowered cognitive capabilities, and diminished IQ and brain mass. Read More

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A phase I study assessing the safety, tolerability, immunogenicity, and low-density lipoprotein cholesterol-lowering activity of immunotherapeutics targeting PCSK9.

Eur J Clin Pharmacol 2021 May 10. Epub 2021 May 10.

AFFiRiS AG, Karl Farkas Gasse 22, 1030, Vienna, Austria.

Purpose: AT04A and AT06A are two AFFITOPE® peptide vaccine candidates being developed for the treatment of hypercholesterolemia by inducing proprotein convertase subtilisin/kexin type 9 (PCSK9)-specific antibodies. This study aimed to investigate safety, tolerability, antibody development, and reduction of low-density lipoprotein cholesterol (LDLc) following four subcutaneous immunizations.

Methods: This phase I, single-blind, randomized, placebo-controlled study was conducted in a total of 72 healthy subjects with a mean fasting LDLc level at baseline of 117. Read More

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Case Report: Antibodies to the N-Methyl-D-Aspartate Receptor in a Patient With Multiple Sclerosis.

Front Immunol 2021 23;12:664364. Epub 2021 Apr 23.

Department of Neurology, Xiangya Hospital, Central South University, Changsha, China.

The association between multiple sclerosis and anti-N-Methyl-D-Aspartate receptor encephalitis is limited to merely a few case reports, and the exploration of the pathogenic mechanisms underlying the overlap of these two disease entities is very limited. Therefore, case reports and literature review on N-Methyl-D-aspartate receptor antibody in patients with multiple sclerosis are unusual and noteworthy. A young female had the first episode of paresthesia and motor symptoms with positive anti-N-Methyl-D-Aspartate receptor antibody and recovered after immunotherapy, and at the first relapse, the patient developed disorders of consciousness with positive anti-N-Methyl-D-Aspartate receptor antibody, findings of magnetic resonance imaging showed features of autoimmune encephalitis, which was also controlled by immunotherapy. Read More

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Botulinum Neurotoxin Therapy for Depression: Therapeutic Mechanisms and Future Perspective.

Front Psychiatry 2021 23;12:584416. Epub 2021 Apr 23.

Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.

Depression is one of the most common mental disorders, which causes global burden. Antidepressants and psychotherapies are the mainstay of treatment for depression, which have limited efficacy. Thus, alternative approaches for preventing and treating depression are urgently required. Read More

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Efficacy and Safety of (Xueshuantong) in Patients With Acute Ischemic Stroke (EXPECT) Trial: Rationale and Design.

Front Pharmacol 2021 22;12:648921. Epub 2021 Apr 22.

Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China.

Although revascularization treatment is recommended as the first-line therapy for patients with non-minor acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of (PNS) (Xueshuantong lyophilized powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS therapy for patients with AIS. Read More

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Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal With Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy.

Stroke 2021 May 10:STROKEAHA120030565. Epub 2021 May 10.

Department of Medicine, McMaster University, Hamilton, ON, Canada (E.Z., J.N., L.X., J.W.E., M.C., S.J.C.).

Background And Purpose: Andexanet alfa is a recombinant modified human FXa (factor Xa) developed to reverse FXa inhibition from anticoagulants. Hemostatic efficacy and reversal of anti-FXa activity with andexanet were assessed in patients from the ANNEXA-4 study (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXa Inhibitors) with intracranial hemorrhage (ICrH).

Methods: ANNEXA-4 was a single-arm study evaluating andexanet in patients presenting with major bleeding ≤18 hours after taking an FXa inhibitor. Read More

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Long-term safety, efficacy, and tolerability of levetiracetam in pediatric patients with epilepsy in Uygur, China: A retrospective analysis.

Epilepsy Behav 2021 May 5;120:108010. Epub 2021 May 5.

Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China; Institute of Clinical Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. Electronic address:

Purpose: Levetiracetam is approved as an add-on therapy to treat refractory partial seizures in pediatric patients over four years old. The efficacy and safety in pediatric patients with epilepsy in Uygur, China, is unknown. Therefore, the objective of this study was to investigate the safety, efficacy, and tolerability of levetiracetam in pediatric patients with epilepsy in Uygur, China. Read More

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Mechanical thrombectomy in distal residual occlusions of the middle cerebral artery after large vessel recanalization in acute stroke: 2b or not 2b? A pragmatic approach in real-life scenarios.

World Neurosurg 2021 May 5. Epub 2021 May 5.

Hopital Foch, Department of Diagnostic and Interventional Neuroradiology, Suresnes, Île-de-France, FR.

Background: AND PURPOSE: Recent studies have suggested that a recanalization grade of modified thrombolysis in cerebral infarction (mTICI) ≥2c is strongly related with good clinical outcome rather than the current therapeutic angiography target ≥2b. In order to achieve better recanalization, additional further maneuvers on distal residual vessel occlusion may be required. The aim of this paper was to evaluate the safety and efficacy of rescue treatment in residual vessel occlusions (RVOs) after recanalization of large vessel occlusions in the anterior circulation. Read More

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A phase I/II study of bevacizumab, irinotecan and erlotinib in children with progressive diffuse intrinsic pontine glioma.

J Neurooncol 2021 May 7. Epub 2021 May 7.

Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Pediatric Oncology, Amsterdam, The Netherlands.

Introduction: This study investigates the safety, tolerability, and preliminary efficacy of combined treatment with VEGF inhibitor bevacizumab, topoisomerase I inhibitor irinotecan, and EGFR inhibitor erlotinib in children with progressive diffuse intrinsic pontine glioma (DIPG).

Methods: Biweekly bevacizumab (10 mg/kg) and irinotecan (125 mg/m) were combined with daily erlotinib. Two cohorts received increasing doses of erlotinib (65 and 85 mg/m) following a 3 + 3 dose-escalation schedule, until disease progression with a maximum of one year. Read More

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Smart glasses evaluation during the COVID-19 pandemic: First-use on Neurointerventional procedures.

Clin Neurol Neurosurg 2021 Apr 19;205:106655. Epub 2021 Apr 19.

Interventional Neuroradiology, Clinical Hospital Center "Sisters of Mercy", Zagreb, Croatia.

The COVID-19 pandemic is rapidly transforming the healthcare system, with telemedicine, or virtual health, being one of the key drivers of the change. Smart glasses have recently been introduced to the public and have generated interest with healthcare professionals as demonstrated by their early adoption in clinics and hospitals. Observing procedures is essential for young interventionalist-in-training, but sometimes it is difficult for them to be able to get the volume of exposure to procedures that they need. Read More

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A phase 1b/2a, open-label, multiple ascending dose trial of domagrozumab in FKRP limb-girdle muscular dystrophy.

Muscle Nerve 2021 May 7. Epub 2021 May 7.

Center for Genetic Muscle Disorders, Kennedy Krieger Institute, Baltimore, MD.

Introduction: We report the results of a phase 1b/2a, open-label, multiple ascending dose trial of domagrozumab, a myostatin inhibitor, in patients with FKRP-associated limb-girdle muscular dystrophy.

Methods: Nineteen patients were enrolled and assigned to one of three dosing arms (5 mg/kg, 20mg/kg, or 40mg/kg every 4 weeks). Following 32 weeks of treatment, participants receiving the lowest dose were switched to the highest dose (40mg/kg) for an additional 32 weeks. Read More

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Outcomes in young adults with acute ischemic stroke undergoing endovascular thrombectomy: a real-world multi-center experience.

Eur J Neurol 2021 May 6. Epub 2021 May 6.

Division of Interventional Radiology, Department of Diagnostic Imaging, National University Health System, Singapore, Singapore.

Background: Endovascular thrombectomy (EVT) is standard of care for anterior circulation acute ischemic stroke (AIS) with large vessel occlusion (LVO). Young patients with AIS-LVO have distinctly different underlying stroke mechanisms and etiologies. Much is unknown about the safety and efficacy of EVT in this population of young AIS-LVO patients. Read More

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Intracranial Angioplasty with Enterprise Stent for Intracranial Atherosclerotic Stenosis: A Single-Center Experience and a Systematic Review.

Biomed Res Int 2021 17;2021:6645500. Epub 2021 Apr 17.

Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China.

Background: The high rate of periprocedural complications for the endovascular stent procedure in the Stenting Versus Aggressive Medical Management Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial resulted in it being less recommended than medical therapy to treat intracranial atherosclerotic stenosis (ICAS). Because Enterprise stent use might reduce the incidence of complications in ICAS treatment compared to other frequently used stents, this paper evaluated the safety and effectiveness of the Enterprise stent for the treatment of ICAS.

Methods: We performed a comprehensive literature search for reports on intracranial angioplasty using the Enterprise stent for ICAS treatment from the earliest date available from each database to May 2020 for PubMed, EMBASE, Web of Science, Cochrane, and Clinical Trials databases. Read More

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Patterns of whole-body muscle activations following vertical perturbations during standing and walking.

J Neuroeng Rehabil 2021 May 6;18(1):75. Epub 2021 May 6.

Center of Advanced Technologies in Rehabilitation, Sheba Medical Center, Ramat Gan, Israel.

Background: Falls commonly occur due to losses of balance associated with vertical body movements (e.g. reacting to uneven ground, street curbs). Read More

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