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Clinical Trials and Neurology

Áine Maguire, April Hargreaves, Michael Gill
OBJECTIVE: Mitochondrial dysfunction has been implicated in the pathophysiology of schizophrenia and other neuropsychiatric disorders. Though the exact mechanisms and clinical implications for this dysfunction are not fully determined, there is a hypothesis that deficiency in coenzyme Q10 (CoQ10) may contribute to mitochondrial impairments and be reflected in cognitive, affective, and energy disturbances in the disorders. CoQ10 is a critical component of the mitochondrial respiratory chain and an essential free radical scavenger, necessary for mitochondrial function...
December 12, 2018: Nutritional Neuroscience
Jitka Vanderpol, Leon Jonker
OBJECTIVE: Greater occipital nerve (GON) block is a treatment option applied for a variety of primary headache disorders. Although a patient's body position is known to have an impact on the effect of local anaesthetics, this has not before been investigated for patients undergoing GON block. Therefore, the clinical effectiveness of either a sitting or supine position was assessed. PATIENTS AND METHODS: This evaluative prospective study took place in a single neurology department in the UK...
December 3, 2018: Clinical Neurology and Neurosurgery
Danyang Li, Xueyang Li, Wei Cui, Huahao Shen, Hong Zhu, Yi Xia
BACKGROUND: Sepsis and septic shock are potentially life-threatening complications of infection that are associated with high morbidity and mortality in adults and children. Fluid therapy is regarded as a crucial intervention during initial treatment of sepsis. Whether conservative or liberal fluid therapy can improve clinical outcomes in patients with sepsis and septic shock remains unclear. OBJECTIVES: To determine whether liberal versus conservative fluid therapy improves clinical outcomes in adults and children with initial sepsis and septic shock...
December 10, 2018: Cochrane Database of Systematic Reviews
Rosanna Vaschetto, Federico Longhini, Paolo Persona, Carlo Ori, Giulia Stefani, Songqiao Liu, Yang Yi, Weihua Lu, Tao Yu, Xiaoming Luo, Rui Tang, Maoqin Li, Jiaqiong Li, Gianmaria Cammarota, Andrea Bruni, Eugenio Garofalo, Zhaochen Jin, Jun Yan, Ruiqiang Zheng, Jingjing Yin, Stefania Guido, Francesco Della Corte, Tiziano Fontana, Cesare Gregoretti, Andrea Cortegiani, Antonino Giarratano, Claudia Montagnini, Silvio Cavuto, Haibo Qiu, Paolo Navalesi
PURPOSE: Noninvasive ventilation (NIV) may facilitate withdrawal of invasive mechanical ventilation (i-MV) and shorten intensive care unit (ICU) length of stay (LOS) in hypercapnic patients, while data are lacking on hypoxemic patients. We aim to determine whether NIV after early extubation reduces the duration of i-MV and ICU LOS in patients recovering from hypoxemic acute respiratory failure. METHODS: Highly selected non-hypercapnic hypoxemic patients were randomly assigned to receive NIV after early or standard extubation...
December 10, 2018: Intensive Care Medicine
Jian Sun, Fa Liang, Youxuan Wu, Yan Zhao, Zhongrong Miao, Li Zhang, Adrian W Gelb, Matthew T V Chan, Yuming Peng, Ruquan Han
BACKGROUND: The effect of choice of anesthesia on clinical outcome for endovascular treatment (EVT) in patients with acute ischemic stroke (AIS) remains unclear. METHODS: We conducted a pilot trial of 43 patients with acute anterior circulation ischemic stroke having EVT. Patients were randomly allocated to receive general anesthesia or conscious sedation. We documented the rate of recruitment and rate of conversion from conscious sedation to general anesthesia...
December 7, 2018: Journal of Neurosurgical Anesthesiology
Ai-Jia Shang, Chang-Hao Yang, Cheng Cheng, Ben-Zhang Tao, Yuan-Zheng Zhang, Hai-Hao Gao, Shao-Cong Bai
Tethered cord syndrome is a progressive disease with a typically insidious onset in infants and children, and which can lead to persistent progress of neurological deficits and a high rate of disability without timely intervention. The purpose of this study was to investigate the curative effect of microsurgery in children with different types of tethered cord syndrome. In this study, we analyzed 326 patients with tethered cord syndrome, aged from 2 months to 14 years old, who were followed for 3-36 months after microscopic surgery...
January 2019: Neural Regeneration Research
Y Kanjanapan, D Day, M O Butler, L Wang, A M Joshua, D Hogg, N B Leighl, A R Abdul Razak, A R Hansen, S Boujos, M Chappell, K Chow, B Sherwin, L-A Stayner, L Soultani, A Zambrana, L L Siu, P L Bedard, A Spreafico
BACKGROUND: Immunotherapy (IO) agents can cause late-onset immune-related adverse events (irAEs). In phase I trials, observation for dose-limiting toxicities (DLTs) is typically limited to the first cycle. The incidence of delayed-onset DLTs and their potential impact on dose determination have not been fully elucidated. PATIENTS AND METHODS: Consecutive patients enrolled in early phase IO trials at Princess Margaret Cancer Centre between August 2012 and September 2016 were retrospectively reviewed, applying trial-specific definitions for DLTs...
December 6, 2018: European Journal of Cancer
Talita Glaser, Vanessa Fernandes Arnaud Sampaio, Claudiana Lameu, Henning Ulrich
Calcium is the ubiquitous second messenger used by any living cell. The fine-tuning of intracellular free calcium [(Ca2+ )i ] homeostasis and signalling pathways is crucial for the maintenance of the healthy organism. Many alterations in the homeostasis can be compensated by robust mechanisms; however, cells that already present some debility in those mechanisms, or that are over stimulated cannot compensate the stress and die. Many neurological diseases show Ca2+ disbalance as trigger of apoptotic response resulting in massive neuronal loss and the neurodegeneration...
December 5, 2018: Seminars in Cell & Developmental Biology
(no author information available yet)
BACKGROUND: Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects. METHODS: FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits...
December 4, 2018: Lancet
Mohammad-Hadi Farahzadi, Ehsan Moazen-Zadeh, Emran Razaghi, Mohammad-Reza Zarrindast, Reza Bidaki, Shahin Akhondzadeh
BACKGROUND: Riluzole is a glutamate regulator and effective in treatment of neuropsychiatric conditions. AIMS: We assessed riluzole for treatment of methamphetamine dependence. METHODS: In this randomized, double-blind, placebo-controlled clinical trial, male outpatients with methamphetamine dependence who were 18-65 years old received either 50 mg riluzole ( n=34) or placebo ( n=54) twice daily for 12 weeks. Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole...
December 11, 2018: Journal of Psychopharmacology
Takeo Mukai, Arinobu Tojo, Tokiko Nagamura-Inoue
Several studies have reported that mesenchymal stromal/stem cells (MSCs) restore neurological damage through their secretion of paracrine factors or their differentiation to neuronal cells. Based on these studies, many clinical trials have been conducted using MSCs for neurological disorders, and their safety and efficacy have been reported. In this review, we provide a brief introduction to MSCs, especially umbilical cord derived-MSCs (UC-MSCs), in terms of characteristics, isolation, and cryopreservation, and discuss the recent progress in regenerative therapies using MSCs for various neurological disorders...
December 2018: Regenerative Therapy
Junying Yuan, Juan Song, Dengna Zhu, Erliang Sun, Lei Xia, Xiaoli Zhang, Chao Gao, Galila Agam, Xiaoyang Wang, Klas Blomgren, Changlian Zhu
Lithium is a widely used and effective treatment for individuals with psycho-neurological disorders, and it exhibits protective and regenerative properties in multiple brain injury animal models, but the clinical experience in young children is limited due to potential toxicity. As an interim analysis, this paper reports the safety/tolerability profiles of low-dose lithium treatment in children with intellectual disability (ID) and its possible beneficial effects. In a randomized, single-center clinical trial, 124 children with ID were given either oral lithium carbonate 6 mg/kg twice per day or the same dose of calcium carbonate as a placebo ( n = 62/group) for 3 months...
2018: Frontiers in Molecular Neuroscience
Leonid Churilov, Henry Ma, Bruce Cv Campbell, Stephen M Davis, Geoffrey A Donnan
BACKGROUND: EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients. OBJECTIVE: To formulate the detailed statistical analysis plan for the EXTEND trial prior to database lock. This statistical analysis plan is based on the published and registered EXTEND trial protocol and is developed by the blinded steering committee and management team...
December 7, 2018: International Journal of Stroke: Official Journal of the International Stroke Society
Peter A Schneider, Elad Levy, J Michael Bacharach, D Christopher Metzger, Bryan Randall, Andrew Garcia, Adnan Siddiqui, Claudio Schonholz, William Gray
OBJECTIVES: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days. BACKGROUND: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates...
December 10, 2018: JACC. Cardiovascular Interventions
Ian A Harris, Adrian Traeger, Ralph Stanford, Christopher G Maher, Rachelle Buchbinder
Lumbar spine fusion is a common procedure associated with a high cost burden and risk of serious complications. We aimed to summarise systematic reviews on the effectiveness of lumbar spine fusion for most diagnoses. We found no high-quality systematic reviews and the risk of bias of the randomised controlled trials in the reviews was generally high. The available evidence does not support a benefit from spine fusion compared to non-operative alternatives for back pain associated with degeneration. The available evidence does not support a clinical benefit from spine fusion compared to non-operative treatment or stabilisation without fusion for thoracolumbar burst fractures...
December 2018: Internal Medicine Journal
Susanne Muehlschlegel
PURPOSE OF REVIEW: This article reviews the epidemiology, clinical presentation, diagnosis, and management of patients with aneurysmal subarachnoid hemorrhage (SAH). SAH is a type of hemorrhagic stroke and is a neurologic emergency with substantial morbidity and mortality. This article reviews the most common and potentially life-threatening neurologic and medical complications to promote their early recognition and prevent secondary brain injury. RECENT FINDINGS: Over the past 30 years, the incidence of SAH has remained stable; yet, likely because of improved care in specialized neurocritical care units, discharge mortality has considerably decreased...
December 2018: Continuum: Lifelong Learning in Neurology
Bonnie M Kaas, Casey Jo Humbyrd, Alexander Pantelyat
Background: Functional movement disorders are common and disabling neurologic conditions. Patients with functional neurologic disorders represent a large proportion of neurology clinic referrals, and limited availability of subspecialty care creates a considerable burden for the healthcare system. These conditions are currently treated with a combination of physical therapy and cognitive behavioral therapy, with variable success. Methods: We searched the Medline database for studies on the epidemiology and physiology of functional movement disorders, as well as those on the placebo effect in movement disorders...
September 2018: Movement Disorders Clinical Practice
Hae-Ryeon Choi, Jinmin Kim, Hyojung Lim, Yoo Kyoung Park
The ketogenic diet has long been recommended in patients with neurological disorders, and its protective effects on the cardiovascular system are of growing research interest. This study aimed to investigate the effects of two-week of low-calorie ketogenic nutrition drinks in obese adults. Subjects were randomized to consume drinks either a ketone-to-non-ketone ratio of 4:1 (KD 4:1), a drink partially complemented with protein at 1.7:1 (KD 1.7:1), or a balanced nutrition drink (BD). Changes in body weight, body composition, blood lipid profile, and blood ketone bodies were investigated...
December 3, 2018: Nutrients
Sonia L Ramírez-Garza, Emily P Laveriano-Santos, María Marhuenda-Muñoz, Carolina E Storniolo, Anna Tresserra-Rimbau, Anna Vallverdú-Queralt, Rosa M Lamuela-Raventós
The effect of resveratrol (RV) intake has been reviewed in several studies performed in humans with different health status. The purpose of this review is to summarize the results of clinical trials of the last decade, in which RV was determined in biological samples such as human plasma, urine, and feces. The topics covered include RV bioavailability, pharmacokinetics, effects on cardiovascular diseases, cognitive diseases, cancer, type 2 diabetes (T2D), oxidative stress, and inflammation states. The overview of the recent research reveals a clear tendency to identify RV in plasma, showing that its supplementation is safe...
December 3, 2018: Nutrients
Ying Zhou, Jinhua Wen, Bei Hu, Hongyun Wang, Ji Jiang
HR7056 is a new benzodiazepine, showing more faster acting onset and recovery than currently available short-acting sedatives. To avoid inadequate anesthesia and predict return of cognition, allowing for immediate neurological evaluation, HR7056 pharmacokinetics and pharmacodynamics were characterized in Chinese healthy subjects. We report on modeling of the data and simulations of dosage regimens for future study. Up to 63 subjects were evaluated, using Bispectral Index (BIS) and Modified Observer's Assessment of Alertness/Sedation (MOAA/S) as pharmacodynamics endpoints...
2018: Frontiers in Pharmacology
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