10,737 results match your criteria Clinical Safety in Neurology


Barriers and facilitators for the usage of a personal health record for medication reconciliation: a qualitative study among patients.

Br J Clin Pharmacol 2022 May 18. Epub 2022 May 18.

Department of Pharmacy, Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre, Nijmegen, the Netherlands.

Aim: Personal health records (PHRs) are more often used for medication reconciliation (MR). However, patients' adoption rate is low. We aimed to provide insight into patients' barriers and facilitators for the usage of a PHR for MR prior to an in- or outpatient visit. Read More

View Article and Full-Text PDF

Efficacy and Safety of Neoadjuvant Chemoradiation Therapy Administered for 5 Versus 2 Weeks for Resectable and Borderline Resectable Pancreatic Cancer.

Pancreas 2022 Mar;51(3):269-277

From the Departments of Gastroenterological Surgery.

Objectives: Indications of preoperative treatment for resectable (R-) or borderline resectable (BR-) pancreatic ductal adenocarcinoma (PDAC) are unclear, and the protocol remains to be standardized.

Methods: Included 65 patients with R- and BR-PDAC with venous involvement (V-) received neoadjuvant chemoradiotherapy with S-1 and 50 Gy of radiation as the 5-week regimen. The outcomes of this group were compared with those of 52 patients who underwent S-1 and 30 Gy of radiation as the 2-week regimen, previously collected as our prospective phase II study. Read More

View Article and Full-Text PDF

Serum neurofilament light in professional soccer players: goal on safety.

Neurol Sci 2022 May 18. Epub 2022 May 18.

Neurology, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Background: Sports-related concussion (SRC) is a subset of mild traumatic brain injuries occurring in contact sports. Most people recover spontaneously, but in retired professional players, the risk for neurodegenerative diseases is increased. A biomarker, such as neurofilament light chains (NfL), would help to address this issue and demonstrate sports' safety. Read More

View Article and Full-Text PDF

Ambroxol for neuropathic pain: hiding in plain sight?

Pain 2022 May 17. Epub 2022 May 17.

Genesis Research Services, Broadmeadow, NSW, Australia.

Abstract: Ambroxol is a multifaceted drug with primarily mucoactive and secretolytic actions, along with anti-inflammatory, antioxidant, and local anaesthetic properties. It has a long history of use in the treatment of respiratory tract diseases and has shown to be efficacious in relieving sore throat. In more recent years, ambroxol has gained interest for its potential usefulness in treating neuropathic pain. Read More

View Article and Full-Text PDF

Opportunities and challenges: mesenchymal stem cells in the treatment of multiple sclerosis.

Int J Neurosci 2022 May 17:1-14. Epub 2022 May 17.

Department of Neurology, China-Japan Union hospital of Jilin University, Changchun city, Jilin, P.R. China.

Multiple sclerosis (MS) was once considered an untreatable disease. Through years of research, many drugs have been discovered and are widely used for the treatment of MS. However, the current treatment can only alleviate the clinical symptoms of MS and has serious side effects. Read More

View Article and Full-Text PDF

Tranilast for advanced heart failure in patients with muscular dystrophy: a single-arm, open-label, multicenter study.

Orphanet J Rare Dis 2022 May 16;17(1):201. Epub 2022 May 16.

Department of Cardiac Physiology, National Cerebral and Cardiovascular Center Research Institute, 6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan.

Background: The transient receptor potential cation channel subfamily V member 2 (TRPV2) is a stretch-sensitive calcium channel. TRPV2 overexpression in the sarcolemma of skeletal and cardiac myocytes causes calcium influx into the cytoplasm, which triggers myocyte degeneration. In animal models of cardiomyopathy and muscular dystrophy (MD), TRPV2 inhibition was effective against heart failure and motor function. Read More

View Article and Full-Text PDF

Effect of sodium phenylbutyrate/taurursodiol on tracheostomy/ventilation-free survival and hospitalisation in amyotrophic lateral sclerosis: long-term results from the CENTAUR trial.

J Neurol Neurosurg Psychiatry 2022 May 16. Epub 2022 May 16.

Neurology Associates, Lincoln, Nebraska, USA.

Background: Coformulated sodium phenylbutyrate/taurursodiol (PB/TURSO) was shown to prolong survival and slow functional decline in amyotrophic lateral sclerosis (ALS).

Objective: Determine whether PB/TURSO prolonged tracheostomy/ventilation-free survival and/or reduced first hospitalisation in participants with ALS in the CENTAUR trial.

Methods: Adults with El Escorial Definite ALS ≤18 months from symptom onset were randomised to PB/ TURSO or placebo for 6 months. Read More

View Article and Full-Text PDF

Disease modifying therapy management of multiple sclerosis after stem cell therapies: A retrospective case series.

Mult Scler Relat Disord 2022 May 10;63:103861. Epub 2022 May 10.

Department of Neurology, Division of Neuroimmunology and Neuroinfectious Diseases, Massachusetts General Hospital, 15 Parkman Street, Wang 8-835, Boston, MA 02114, United States; Harvard Medical School, Boston, MA, United States.

Background: Stem cell therapies (SCT) have not received formal regulatory approval for the treatment of people with multiple sclerosis (PwMS), but PwMS may seek various options on their own accord. The current literature largely focuses on the efficacy and safety of SCT in PwMS in clinical trials, in particular autologous hematopoietic stem cell transplantation (aHSCT), in carefully selected participants. There is little reported on the MS disease modifying therapy (DMT) management of PwMS who choose to undergo SCT outside of these trials. Read More

View Article and Full-Text PDF

Ultrashort Door-to-Needle Time for Intravenous Thrombolysis Is Safer and Improves Outcome in the Czech Republic: Nationwide Study 2004 to 2019.

J Am Heart Assoc 2022 May 16;11(10):e023524. Epub 2022 May 16.

Department of Neurology and AGEL Research and Training Institute Ostrava Vítkovice Hospital Ostrava Czech Republic.

Background The benefit of intravenous thrombolysis is time dependent. It remains unclear, however, whether dramatic shortening of door-to-needle time (DNT) among different types of hospitals nationwide does not compromise safety and still improves outcome. Methods and Results Multifaceted intervention to shorten DNT was introduced at a national level, and prospectively collected data from a registry between 2004 and 2019 were analyzed. Read More

View Article and Full-Text PDF

A phase 1b open-label study of sodium selenate as a disease-modifying treatment for possible behavioral variant frontotemporal dementia.

Alzheimers Dement (N Y) 2022 5;8(1):e12299. Epub 2022 May 5.

Department of Neurosciences Central Clinical School Monash University Melbourne Australia.

Introduction: Sodium selenate increases tau dephosphorylation through protein phosphatase 2 activation. Here we report an open-label Phase 1b study of sodium selenate as a disease-modifying treatment for behavioral variant frontotemporal dementia (bvFTD).

Methods: Twelve participants with bvFTD received sodium selenate (15 mg, three times a day) for 52 weeks. Read More

View Article and Full-Text PDF

The power of public-private partnership in medical technology innovation: Lessons from the development of FDA-cleared medical devices for assessment of concussion.

J Clin Transl Sci 2022 10;6(1):e42. Epub 2022 Mar 10.

Acute Care Neurology, Johns Hopkins University, Baltimore, MD, USA.

Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public-private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. Read More

View Article and Full-Text PDF

Evaluation of Humoral and Cellular Immune Responses to the SARS-CoV-2 Vaccine in Patients With Common Variable Immunodeficiency Phenotype and Patient Receiving B-Cell Depletion Therapy.

Front Immunol 2022 29;13:895209. Epub 2022 Apr 29.

Department of Internal Medicine, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.

Introduction: SARS-CoV-2 vaccines' effectiveness is not yet clearly known in immunocompromised patients. This study aims to assess the humoral and cellular specific immune response to SARS-CoV-2 vaccines and the predictors of poor response in patients with common variable immunodeficiency (CVID) phenotype and in patients treated with B-cell depletion therapies (BCDT), as well as the safety of these vaccines.

Methods: From March to September 2021, we performed a prospective study of all adult patients who would receive the SARS-CoV-2 vaccination and were previously diagnosed with (i) a CVID syndrome (CVID phenotype group; n=28) or (ii) multiple sclerosis (MS) treated with B-cell depleting therapies three to six months before vaccination (BCD group; n=24). Read More

View Article and Full-Text PDF

Preliminary Report of the Safety and Tolerability of 1 Hz Repetitive Transcranial Magnetic Stimulation in Temporal Lobe Epilepsy.

J Cent Nerv Syst Dis 2022 9;14:11795735221088522. Epub 2022 May 9.

Neuromodulation Program, Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.

Background: Low frequency (≤1 Hz) repetitive transcranial magnetic stimulation (rTMS) has been shown to suppress cortical excitability and is beginning to be trialed for the treatment of refractory epilepsy.

Purpose: As a step toward a larger trial, the current pilot study was aimed to test the tolerability and safety of temporal lobe rTMS using H-coil for the treatment of temporal lobe epilepsy (TLE).

Research Design: 1800 pulses of active or sham rTMS were applied 5  days a week for 2 weeks over the temporal lobe of the affected hemisphere. Read More

View Article and Full-Text PDF

Efficacy and safety of intensified antithrombotic therapy followed by stenting in treatment of highly severe stenosis accompanied by thrombosis in carotid atherosclerosis.

Clin Neurol Neurosurg 2022 Apr 30;218:107274. Epub 2022 Apr 30.

Department of Vascular Surgery, 2nd Affiliated Hospital of Fujian Medical University, Quanzhou 362000, China. Electronic address:

Objective: This study explored the efficacy and safety of intensified antithrombotic therapy followed by stenting in treatment of highly severe stenosis accompanied by thrombosis in patients with carotid atherosclerosis (CAS).

Methods: This study recruited a total of 24 CAS patients between June 2016 and November 2020 in the research group, who had highly severe stenosis accompanied by in situ thrombosis and were treated with intensified antithrombotic treatment followed by stenting. The control group included 17 patients treated with stent angioplasty immediately after diagnosis with stenosis and thrombosis between January 2012 and May 2016. Read More

View Article and Full-Text PDF

Feasibility and safety of intranasally administered mesenchymal stromal cells after perinatal arterial ischaemic stroke in the Netherlands (PASSIoN): a first-in-human, open-label intervention study.

Lancet Neurol 2022 Jun;21(6):528-536

Department of Neonatology, University Medical Center, Utrecht Brain Center and Wilhelmina Children's Hospital, Utrecht University, Utrecht, Netherlands. Electronic address:

Background: Perinatal arterial ischaemic stroke (PAIS) is an important cause of neurodevelopmental disabilities. In this first-in-human study, we aimed to assess the feasibility and safety of intranasally delivered bone marrow-derived allogeneic mesenchymal stromal cells (MSCs) to treat PAIS in neonates.

Methods: In this open-label intervention study in collaboration with all neonatal intensive care units in the Netherlands, we included neonates born at full term (≥36 weeks of gestation) with MRI-confirmed PAIS in the middle cerebral artery region. Read More

View Article and Full-Text PDF

Targeting the CCL2-CCR2 axis for atheroprotection.

Eur Heart J 2022 May;43(19):1799-1808

Institute for Stroke and Dementia Research (ISD), University Hospital, LMU Munich, D-81377 Munich, Germany.

Decades of research have established atherosclerosis as an inflammatory disease. Only recently though, clinical trials provided proof-of-concept evidence for the efficacy of anti-inflammatory strategies with respect to cardiovascular events, thus offering a new paradigm for lowering residual vascular risk. Efforts to target the inflammasome-interleukin-1β-interleukin-6 pathway have been highly successful, but inter-individual variations in drug response, a lack of reduction in all-cause mortality, and a higher rate of infections also highlight the need for a second generation of anti-inflammatory agents targeting atherosclerosis-specific immune mechanisms while minimizing systemic side effects. Read More

View Article and Full-Text PDF

An expanded access program of risdiplam for patients with Type 1 or 2 spinal muscular atrophy.

Ann Clin Transl Neurol 2022 May 14. Epub 2022 May 14.

Division of Neurology, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.

Objective: The US risdiplam expanded access program (EAP; NCT04256265) was opened to provide individuals with Type 1 or 2 spinal muscular atrophy (SMA) who had no satisfactory treatment options access to risdiplam prior to commercial availability. The program was designed to collect safety data during risdiplam treatment.

Methods: Patients were enrolled from 23 non-preselected sites across 17 states and treated with risdiplam orally once daily. Read More

View Article and Full-Text PDF

Robotic Living Donor Right Hepatectomy: A Systematic Review and Meta-Analysis.

J Clin Med 2022 May 5;11(9). Epub 2022 May 5.

Department of Surgery, Duke University, Durham, NC 27705, USA.

The introduction of robotics in living donor liver transplantation has been revolutionary. We aimed to examine the safety of robotic living donor right hepatectomy (RLDRH) compared to open (ODRH) and laparoscopic (LADRH) approaches. A systematic review was carried out in Medline and six additional databases following PRISMA guidelines. Read More

View Article and Full-Text PDF

Long-term efficacy, safety and neurotolerability of MATRix regimen followed by autologous transplant in primary CNS lymphoma: 7-year results of the IELSG32 randomized trial.

Leukemia 2022 May 13. Epub 2022 May 13.

Martin-Luther Universität, Halle/Saale, Germany.

219 HIV-negative adults ≤70 years with primary CNS lymphoma (PCNSL) were enrolled in the randomized IELSG32 trial. Enrolled patients were randomly assigned to receive methotrexate-cytarabine (arm A), or methotrexate-cytarabine-rituximab (B), or methotrexate-cytarabine-thiotepa-rituximab (MATRix; arm C). A second randomization allocated patients with responsive/stable disease to whole-brain irradiation (WBRT) or carmustine-thiotepa-conditioned autologous transplantation (ASCT). Read More

View Article and Full-Text PDF

Bedside Monitoring of Hypoxic Ischemic Brain Injury Using Low-Field, Portable Brain Magnetic Resonance Imaging After Cardiac Arrest.

Resuscitation 2022 May 10. Epub 2022 May 10.

Department of Neurology, Yale School of Medicine, New Haven, CT, USA.

Background: Assessment of brain injury severity is critically important after survival from cardiac arrest (CA). Recent advances in low-field MRI technology have permitted the acquisition of clinically useful bedside brain imaging. Our objective was to deploy a novel approach for evaluating brain injury after CA in critically ill patients at high risk for adverse neurological outcome. Read More

View Article and Full-Text PDF

Keap1-Nrf2/ARE signal pathway activated by butylphthalide in the treatment of ischemic stroke.

Am J Transl Res 2022 15;14(4):2637-2646. Epub 2022 Apr 15.

Department of Neurology, Cangzhou Central Hospital Cangzhou 061001, Hebei, China.

Objective: To analyze the clinical efficacy and possible mechanism of butylphthalide in treatment of acute ischemic stroke.

Methods: In this retrospective study, 127 patients with ischemic stroke, hospitalized during Jan. 2019 to Jan. Read More

View Article and Full-Text PDF

Case Report: MRI, Clinical, and Pathological Correlates of Bromethalin Toxicosis in Three Dogs.

Front Vet Sci 2022 26;9:879007. Epub 2022 Apr 26.

Department of Surgical and Radiological Sciences, University of California, Davis, Davis, CA, United States.

Bromethalin toxicosis is an increasingly common clinical presentation in dogs that may be fatal depending on the extent of intoxication. Antemortem diagnosis of bromethalin toxicosis was achieved in three dogs by demonstration of the active metabolite desmethylbromethalin in fat or serum. Magnetic resonance imaging (MRI) findings were consistent with a diffuse leukoencephalopathy with restricted diffusion and prominent involvement of the corticospinal motor tracts on T2-weighted and diffusion-weighted sequences. Read More

View Article and Full-Text PDF

Seroconversion following COVID-19 vaccination: can we optimize protective response in CD20-treated individuals?

Clin Exp Immunol 2022 May;207(3):263-271

Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK.

Although there is an ever-increasing number of disease-modifying treatments for relapsing multiple sclerosis (MS), few appear to influence coronavirus disease 2019 (COVID-19) severity. There is concern about the use of anti-CD20-depleting monoclonal antibodies, due to the apparent increased risk of severe disease following severe acute respiratory syndrome corona virus two (SARS-CoV-2) infection and inhibition of protective anti-COVID-19 vaccine responses. These antibodies are given as maintenance infusions/injections and cause persistent depletion of CD20+ B cells, notably memory B-cell populations that may be instrumental in the control of relapsing MS. Read More

View Article and Full-Text PDF

Potential mechanisms and therapeutic targets of mesenchymal stem cell transplantation for ischemic stroke.

Stem Cell Res Ther 2022 May 12;13(1):195. Epub 2022 May 12.

Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, 1 Youyi Road, Yuzhong District, Chongqing, 400016, China.

Ischemic stroke is one of the major causes of death and disability in the world. Currently, most patients cannot choose intravenous thrombolysis or intravascular mechanical thrombectomy because of narrow therapeutic windows and severe complications. Stem cell transplantation is an emerging treatment and has been studied in various central nervous system diseases. Read More

View Article and Full-Text PDF

Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility.

Sleep Breath 2022 May 13. Epub 2022 May 13.

Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Purpose: Preliminary studies have shown a significant decrease in severity of obstructive sleep apnea (OSA) with the use of a combination of atomoxetine and oxybutynin, with patients having moderate pharyngeal collapsibility during sleep more likely to respond. This study evaluated the efficacy and safety of AD036 (atomoxetine 80 mg and oxybutynin 5 mg) in the treatment of OSA.

Methods: This trial was a phase 2, randomized, placebo-controlled crossover study comparing AD036, atomoxetine 80 mg alone, and placebo during three home sleep studies, each separated by about 1 week. Read More

View Article and Full-Text PDF

Safety and Effectiveness of First-line Endovascular Management of Low-Grade Brain Arteriovenous Malformations : Single Center Experience in 145 Patients.

Clin Neuroradiol 2022 May 13. Epub 2022 May 13.

Department of Neuroradiology, Pitié-Salpêtrière Hospital, APHP, Sorbonne University, 47-83 Boulevard de l'Hôpital, 75013, Paris, France.

Purpose: Spetzler-Martin grade (SMG) I-II (low-grade) brain arteriovenous malformations (BAVMs) are often considered safe for microsurgical resection; however, the role of endovascular treatment (EVT) remains to be clarified in this indication, especially for unruptured BAVMs. The purpose of our study was to assess the safety and effectiveness of endovascular treatment as the first-line treatment for low-grade BAVMs.

Methods: From our local database, we retrospectively retrieved patients with low-grade BAVMs, either ruptured or unruptured, treated by embolization as first-line treatment in our department between January 2005 and January 2020. Read More

View Article and Full-Text PDF

Human Umbilical Cord Mesenchymal Stem Cells to Treat Neuromyelitis Optica Spectrum Disorder (hUC-MSC-NMOSD): A Study Protocol for a Prospective, Multicenter, Randomized, Placebo-Controlled Clinical Trial.

Front Neurol 2022 25;13:860083. Epub 2022 Apr 25.

Department of Neurology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

Background: Neuromyelitis Optica spectrum disorder (NMOSD) is severe relapsing and disabling autoimmune disease of the central nervous system. Its optimal first-line treatment to reduce relapse rate and ameliorate neurological disability remains unclear. We will conduct a prospective, multicenter, randomized, placebo-controlled clinical trial to study the safety and effectiveness of human umbilical cord mesenchymal stem cells (hUC-MSCs) in treating NMOSD. Read More

View Article and Full-Text PDF

Randomized Phase 2 Study of ACE-083 in Patients With Charcot-Marie-Tooth Disease.

Neurology 2022 May 11. Epub 2022 May 11.

Acceleron Pharma, Cambridge, MA.

Objective: To determine whether locally acting ACE-083 is safe, well tolerated, and increases muscle volume, motor function, and quality of life (QoL) in adults with Charcot-Marie-Tooth disease (CMT) type 1.

Methods: This phase 2 study enrolled adults with CMT1 or CMTX (N=63). Part 1 was open-label and evaluated safety and tolerability of different dose levels of ACE-083 for use in Part 2. Read More

View Article and Full-Text PDF

A Polymorphism Cluster at the 2q12 locus May Predict Response to Piromelatine in Patients with Mild Alzheimer's Disease.

J Prev Alzheimers Dis 2022 ;9(2):247-254

Lon S. Schneider, Department of Psychiatry and the Behavioral Sciences, and Department of Neurology, Keck School of Medicine, and Leonard Davis School of Gerontology of the University of Southern California, Los Angeles, CA, USA,

Background: Piromelatine is a novel melatonin MT1/2/3 and serotonin 5-HT-1A/1D receptors agonist developed for mild Alzheimer's disease (AD). In a randomized, placebo-controlled, dose-ranging study (ReCognition) of piromelatine (5, 20, and 50 mg daily for 6 months) in participants with mild dementia due to AD (n=371, age 60-85 years), no statistically significant differences were found between the piromelatine and placebo-treated groups on the primary (i.e. Read More

View Article and Full-Text PDF