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Pre-clinical studies

Z J Xu, D F Yu, H Xu, G Z Zhou
Objective: To investigate the related risk factors for hemorrhagic transformation (HT) of cerebellar infarction after posterior fossa decompression surgery. Methods: A total of 91 patients with cerebellar infarction were treated by posterior fossa decompression surgery in Department of Neurosurgery of Jinhua Municipal Central Hospital from Jan 2010 to Jan 2018, were selected as study subjects. The HT group included 17 cases, while the Non-HT group included 74 cases. The clinical data of the two groups were analyzed retrospectively, the univariate and non-conditional lgistic regression analysis were performed to detect the relevant risk factors for hemorrhagic transformation of cerebellar infarction after posterior fossa decompression surgery...
January 29, 2019: Zhonghua Yi Xue za Zhi [Chinese medical journal]
Oriana Ciani, Maria Cucciniello, Francesco Petracca, Giovanni Apolone, Giampaolo Merlini, Silvia Novello, Paolo Pedrazzoli, Nicoletta Zilembo, Chiara Broglia, Enrica Capelletto, Marina Garassino, Elena Nicod, Rosanna Tarricone
INTRODUCTION: Mobile health technologies may enhance patient empowerment and data integration along the whole care continuum. However, these interventions pose relatively new regulatory, organisational and technological challenges that limit appropriate evaluation. Lung Cancer App (LuCApp) is a mobile application developed by researchers and clinicians to promote real-time monitoring and management of patients' symptoms. This protocol illustrates a clinical trial designed to evaluate the usability, effectiveness and cost-effectiveness of LuCApp versus standard of care...
February 15, 2019: BMJ Open
Xiujuan Wang, Shuang Ding, Yanli Lu, Zhiqiang Jiao, Lin Zhang, Yan Zhang, Yongfeng Yang, Yujuan Zhang, Wenqiang Li, Luxian Lv
Schizophrenia treatment remains a major challenge, especially the associated cognitive impairments, as these are not consistently alleviated by conventional antipsychotics. Recent animal and clinical studies suggest that the nitric oxide (NO) donor sodium nitroprusside (SNP) reduces the psychiatric symptoms and cognitive deficits of schizophrenia.The present study was designed to investigate the efficacy of SNP against schizophrenia-like behavioral and cognitive deficits in the dizocilpine (MK-801) rat model...
February 14, 2019: Brain Research Bulletin
Ching-Lung Cheung, Kathryn C B Tan, Philip C M Au, Gloria H Y Li, Bernard M Y Cheung
BACKGROUND: Growth differentiation factor 15 (GDF15) is a key regulator of body weight in animals by regulating food intake. Its receptor, glial cell-derived neurotrophic factor receptor alpha-like (GFRAL), was identified recently. Pre-clinical studies showed that it is a promising therapeutic target for cardiometabolic diseases and anorexia/cachexia. Although many pharmaceutical companies are developing drugs targeting GFRAL, whether the findings from animal studies can be extrapolated to man is unknown...
February 13, 2019: EBioMedicine
Kirsten Haas, Stephanie Stangl, Frank Steigerwald, Cordula Matthies, Doreen Gruber, Andrea A Kühn, Joachim K Krauss, Friederike Sixel-Döring, Kajetan von Eckardstein, Günther Deuschl, Joseph Classen, Dirk Winkler, Jürgen Voges, Imke Galazky, Wolfgang Oertel, Andres O Ceballos-Baumann, Max Lange, Alireza Gharabaghi, Daniel T Weiss, Jens Volkmann, Peter U Heuschmann
INTRODUCTION: Deep Brain Stimulation (DBS) is a complex, invasive and cost-intensive therapy that requires a high level of expertise. To date, data on quality of DBS in clinical routine in the German health care system are lacking. METHODS: The development of evidence-based QIs for DBS in PD patients was performed following a standardized process by a multidisciplinary board between 2014 and 2016. The process was initiated by the German Parkinson Society and followed international recommendations for developing QIs including: a systematic literature search; an appraisal of the published evidence; a consensus-based selection of the QI set; and a pilot study to assess the feasibility in implementing the QIs in clinical routine...
February 5, 2019: Parkinsonism & related Disorders
Vincent V G An, Joshua Twiggs, Murilo Leie, Brett A Fritsch
BACKGROUND: Kinematically aligned (KA) total knee arthroplasty (TKA) has emerged as an alternative approach to the intraoperative alignment targets of mechanically aligned (MA) TKA. While the clinical outcomes of the two philosophies have been investigated, further investigation is required to quantify exactly how the two philosophies differ in their approach to correcting the deformities encountered in osteoarthritic knees such as fixed flexion deformities (FFD) and coronal malalignment...
February 13, 2019: Knee
Eric X Jiang, Moneer M Abouljoud, Joshua S Everhart, Alex C DiBartola, Christopher C Kaeding, Robert A Magnussen, David C Flanigan
PURPOSE: To systematically review the literature to determine what clinical factors influence patient outcomes after meniscal root repairs. METHODS: A systematic review of multiple databases was performed. The inclusion criteria included English language, studies evaluating clinical and/or radiographic factors related to meniscal root repair outcomes, medial or lateral posterior root repairs, and human studies. The exclusion criteria included meniscectomy studies, meniscal body studies, technique descriptions, studies reporting only failure rate of meniscal repairs, multiligament repairs, abstracts, controlled laboratory studies, meta-analyses, and systematic reviews...
February 13, 2019: Knee
Manfred Kurz
The assessment of the benefit-risk ratio of investigational medicinal products (IMPs) and the approval of clinical trial applications (CTAs) conducted in the European Union (EU) is a remit of national competent authorities (NCAs) of the 28 member states. The aim of this article is to shed light on clinical studies for oncology drugs carried out in Germany which involve diagnostic radiation tests. The authorisation process surrounding diagnostic radiology accompanying clinical investigations and used for measuring IMP related treatment effects is not well understood...
February 2019: Critical Reviews in Oncology/hematology
Reem Hatamleh, Sanaa Abujilban, Asma'a Shaker AbdelMahdi AbuAbed, Sawsan Abuhammad
OBJECTIVE: This study aimed to examine the effectiveness of a childbirth preparation course on birth outcomes among nulliparous Jordanian women. DESIGN: A randomized control trial pre-test/post-test design was used to assess the effects of a childbirth preparation course conducted in a military hospital in Amman, Jordan from 1 July to 15 September 2016. A total of 133 low-risk nulliparous women were recruited and randomly assigned to either (1) a control group who received standard care in antenatal clinics or (2) an intervention group who received standard care in antenatal clinics as well as a childbirth preparation course specifically designed for the purpose of this study...
February 7, 2019: Midwifery
Zaid A Siddiqui, Gary S Gustafson, Hong Ye, Alvaro A Martinez, Beth Mitchell, Evelyn Sebastian, Amy Limbacher, Daniel J Krauss
PURPOSE: To update outcome and toxicity results of a prospective trial of 19 Gy single-fraction high-dose-rate (HDR) brachytherapy for men with low- and intermediate-risk prostate cancer. MATERIALS AND METHODS: Patients were treated on a prospective study of single-fraction HDR brachytherapy. All patients had low- or intermediate-risk prostate cancer. Patients with prostate volumes > 50 cc, taking alpha-blockers for urinary symptoms, or baseline American Urologic Association (AUA) symptom scores > 12 were ineligible...
February 13, 2019: International Journal of Radiation Oncology, Biology, Physics
Matthieu Blanchet, Vigigah Sinnathamby, Andrew Vaillant, Patrick Labonté
More than 290 million people have chronic HBV infection and are at risk of developing cirrhosis and hepatocellular carcinoma. HBV subviral particles are produced in large excess over virions in infected patients and are the primary source of HBsAg, which is postulated to be important in allowing HBV to chronically persist by interfering with immune function. Nucleic acid polymers (NAPs) have been shown to result in clearance of HBsAg from the blood in pre-clinical and clinical studies. In this study, we show for the first time the recapitulation of NAPs induced inhibition of secretion of HBsAg in vitro using the human HepG2...
February 13, 2019: Antiviral Research
Frank R Halfwerk, Kees Knol, Silvia Mariani, Jan G Grandjean, Gianclaudio Mecozzi
BACKGROUND: Complications related to extracorporeal circulation remain serious. While a Minimal Invasive Extra Corporeal Circulation (MiECC) system was developed to cope with these complications, its effectivity on patient-related outcomes such as blood loss remain uncertain. Therefore, the aim of this study is to compare MiECC to an advanced standard system with respect to blood loss. METHODS: A total of 128 adult patients undergoing elective isolated aortic valve replacement were enrolled in a randomized clinical trial...
February 13, 2019: Annals of Thoracic Surgery
Yusuke Sakuhara, Saori Nishio, Fumihiko Hattanda, Takeshi Soyama, Bunya Takahashi, Daisuke Abo, Hidefumi Mimura
PURPOSE: To assess the safety and effectiveness of transcatheter arterial embolization (TAE) with tris-acryl gelatin microspheres for patients with symptomatic enlarged polycystic liver disease (PCLD). MATERIALS AND METHODS: This prospective study was approved by our hospital's institutional review board and planned for patients with symptoms related to enlarged PCLD, such as distended abdomen, gastrointestinal obstruction and abdominal pain. Hemi-hepatic embolization with tris-acryl gelatin microspheres was performed in the hepatic artery supplying the hepatic lobe that showed the predominant presence of cysts...
February 15, 2019: Clinical and Experimental Nephrology
Adrienne Bingham, Fusun Gundogan, Katherine Rand, Abbot R Laptook
OBJECTIVE: To determine if pre-specified placental abnormalities among newborns with hypoxic-ischemic encephalopathy (HIE) differ compared to newborns admitted to a NICU without encephalopathy. STUDY DESIGN: Retrospective case-control study of newborns with HIE (2006-2014) and controls matched for birth year, gestational age, weight, and gender. One pathologist reviewed archived placental sections using pre-specified criteria. RESULTS: Sixty-seven newborns had HIE, 46 had available placentas and were matched with 92 controls...
February 15, 2019: Journal of Perinatology: Official Journal of the California Perinatal Association
P Hampel, A Köpnick, S Roch
BACKGROUND: This study investigated the long-term effects (12 months post-rehabilitation) of a standard inpatient multidisciplinary rehabilitation program for patients with chronic low back pain (CLBP), in which a control group (CG) received pain competence training and an intervention group (IG) received combined pain competence and depression prevention training. METHODS: In this prospective control group study with cluster-block randomization, a total of n = 583 patients were included into per protocol analyses...
February 15, 2019: BMC Psychology
Xiaolei Guo, Bin Liu, Shiqing Zhang
The evaluation concerns on custom design of implant for bony defect focus on engineered transformation of clinical needs, pre-operation performance verification and clinical validation. These concerns refer to manipulation on imageology information, tissue adhesion and fixation, surgery planning and instruments, design specification and instruction, finite element analysis, bench testing, around market clinical research et al. The evaluation integrates adaptive risk evaluation methods such as biomechanics, mechanobiology, blind crossover reproducility and dynamic design of clinical study et al...
January 30, 2019: Zhongguo Yi Liao Qi Xie za Zhi, Chinese Journal of Medical Instrumentation
Christine Blume, Monika Angerer, Marion Raml, Renata Del Giudice, Nayantara Santhi, Gerald Pichler, Alexander B Kunz, Monika Scarpatetti, Eugen Trinka, Manuel Schabus
INTRODUCTION: Healthy circadian rhythmicity has been suggested to relate to a better state of brain-injured patients and to support the emergence of consciousness in patient groups characterised by a relative instability thereof such as patients with disorders of consciousness (DOC). METHODS: Going beyond earlier studies, we have adopted a systems-level perspective and, using multilevel modelling, assessed the joint predictive value of three indexes of circadian rhythm integrity derived from skin temperature variations, melatoninsulfate (aMT6s) secretion, and physical activity (wrist actigraphy) patterns for DOC patients' (13 unresponsive wakefulness syndrome [UWS]; 7 minimally conscious (exit) state [E/MCS]) behaviourally assessed state (Coma Recovery Scale-Revised [CRS-R] score)...
February 15, 2019: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
Cynthia Bauer, Marie-José Boileau, Cédric Bazert
OBJECTIVE: This systematic review aims to define the recommendations allowing an optimized clinical implementation for orthodontic extraction as a pre-implant soft tissue management procedure. MATERIALS AND METHODS: A digital search was performed in the Cochrane Library, PubMed, Scopus, and DOSS databases; a pre-screening was conducted according to the title and summary of the articles. After a complete reading, only the articles meeting all of our inclusion criteria were selected, and a second search, this time manual, was performed within their references...
February 12, 2019: International Orthodontics
David Ball, G Tao Mai, Shalini Vinod, Scott Babington, Jeremy Ruben, Tomas Kron, Brent Chesson, Alan Herschtal, Marijana Vanevski, Angela Rezo, Christine Elder, Marketa Skala, Andrew Wirth, Greg Wheeler, Adeline Lim, Mark Shaw, Penelope Schofield, Louis Irving, Benjamin Solomon
BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is widely used to treat inoperable stage 1 non-small-cell lung cancer (NSCLC), despite the absence of prospective evidence that this type of treatment improves local control or prolongs overall survival compared with standard radiotherapy. We aimed to compare the two treatment techniques. METHODS: We did this multicentre, phase 3, randomised, controlled trial in 11 hospitals in Australia and three hospitals in New Zealand...
February 12, 2019: Lancet Oncology
Tiantian Zhang, Liangliang Cui, Xingyi Geng, Xiaolin Yu, Ji Zhang
INTRODUCTION: Few studies have reported on the epidemiological characteristics of pediatric primary intussusception in the pre-rotavirus vaccine era of China. It is important to complementary baseline data before rotavirus vaccine introduction in China. This study conduct a retrospective investigation and evaluated the incidence rate, described the epidemiology of pediatric primary intussusception aged ≤24 months. METHODS: We conducted a retrospective investigation in all secondary- and tertiary-hospitals in Jinan...
February 12, 2019: Vaccine
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