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Proof of concept phase I

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https://www.readbyqxmd.com/read/29773528/a-digital-app-to-aid-detection-monitoring-and-management-of-dyslexia-in-young-children-dimmand-protocol-for-a-digital-health-and-education-solution
#1
Mariam R Sood, Annet Toornstra, Martin I Sereno, Mark Boland, Daniele Filaretti, Anuj Sood
BACKGROUND: Dyslexia, a specific learning difficulty and a disability as defined in the Equality Act 2010, is a lifelong condition that affects a child from the start of education. Dyslexia is characterized by difficulties in language processing (reading, spelling, and writing) which do not correspond with the child's general intellectual abilities. Although dyslexia cannot be cured, there is a consensus that interventions are more effective and have greater impact the earlier they are administered...
May 17, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29772028/randomized-phase-i-trial-hiv-core-003-depletion-of-serum-amyloid-p-component-and-immunogenicity-of-dna-vaccination-against-hiv-1
#2
Nicola J Borthwick, Thirusha Lane, Nathifa Moyo, Alison Crook, Jung Min Shim, Ian Baines, Edmund G Wee, Philip N Hawkins, Julian D Gillmore, Tomáš Hanke, Mark B Pepys
BACKGROUND: The failure of DNA vaccination in humans, in contrast to its efficacy in some species, is unexplained. Observational and interventional experimental evidence suggests that DNA immunogenicity may be prevented by binding of human serum amyloid P component (SAP). SAP is the single normal DNA binding protein in human plasma. The drug (R)-1-[6-[(R)-2-carboxypyrrolidin-1-yl]-6-oxo-hexanoyl]pyrrolidine-2-carboxylic acid (CPHPC, miridesap), developed for treatment of systemic amyloidosis and Alzheimer's disease, depletes circulating SAP by 95-99%...
2018: PloS One
https://www.readbyqxmd.com/read/29768707/albumin-apheresis-for-artificial-liver-support-in-vitro-testing-of-a-novel-filter
#3
Tomasz Piatek, Joanna Giebultowicz, Marieke Rüth, Horst-Dieter Lemke, Florian Bonn, Piotr Wroczynski, Piotr Malkowski, Jacek Rozga
Currently there is no direct therapy for liver failure. We have previously described selective plasma exchange therapy using a hemofilter permeable to substances that have a molecular mass of up to 100 kDa. The proof-of-concept studies and a Phase I study in patients with decompensated cirrhosis demonstrated that hemofiltration using an albumin-leaking membrane is safe and effective in removing target molecules, alleviating severe encephalopathy and improving blood chemistry. In this study a novel large-pore filter for similar clinical application is described...
May 16, 2018: Therapeutic Apheresis and Dialysis
https://www.readbyqxmd.com/read/29744448/biodegradation-of-mg-14li-alloy-in-simulated-body-fluid-a-proof-of-concept-study
#4
Xiao-Bo Chen, Chuanqiang Li, Daokui Xu
High corrosion kinetics and localised corrosion progress are the primary concerns arising from the clinical implementation of magnesium (Mg) based implantable devices. In this study, a binary Mg-lithium (Li) alloy consisting a record high Li content of 14% (in weight) was employed as model material aiming to yield homogenous and slow corrosion behaviour in a simulated body fluid, i.e. minimum essential medium (MEM), in comparison to that of generic Mg alloy AZ31 and biocompatible Mg-0.5Zn-0.5Ca counterparts...
March 2018: Bioactive Materials
https://www.readbyqxmd.com/read/29739754/dexpramipexole-as-an-oral-steroid-sparing-agent-in-hypereosinophilic-syndromes
#5
Sandhya R Panch, Michael E Bozik, Thomas Brown, Michelle Makiya, Calman Prussin, Donald G Archibald, Gregory T Hebrank, Mary Sullivan, Xiaoping Sun, Lauren Wetzler, JeanAnne Ware, Michael P Fay, Cynthia E Dunbar, Steven I Dworetzky, Paneez Khoury, Irina Maric, Amy D Klion
Hypereosinophilic syndromes (HES) are a heterogeneous group of disorders characterized by peripheral eosinophilia and eosinophil-related end organ damage. Whereas most patients respond to glucocorticoid (GC) therapy, high doses are often necessary and side effects are common. Dexpramipexole (KNS 760704), an orally bioavailable synthetic amino-benzothiazole, showed an excellent safety profile and was coincidentally noted to significantly decrease absolute eosinophil counts (AEC) in a phase 3 trial for amyotrophic lateral sclerosis...
May 8, 2018: Blood
https://www.readbyqxmd.com/read/29735994/therapeutic-activity-of-retroviral-replicating-vector-mediated-prodrug-activator-gene-therapy-for-pancreatic-cancer
#6
Kazuho Inoko, Kei Hiraoka, Akihito Inagaki, Mizuna Takahashi, Toshihiro Kushibiki, Koji Hontani, Hironobu Takano, Shoki Sato, Shintaro Takeuchi, Toru Nakamura, Takahiro Tsuchikawa, Toshiaki Shichinohe, Harry E Gruber, Douglas J Jolly, Noriyuki Kasahara, Satoshi Hirano
Toca 511, a retroviral replicating vector (RRV) encoding the yeast cytosine deaminase (yCD) prodrug activator gene, which mediates conversion of the prodrug 5-fluorocytosine (5-FC) to the anticancer drug 5-fluorouracil (5-FU), is currently being evaluated in Phase II/III clinical trials for glioma, and showing highly promising evidence of therapeutic activity. Here we evaluated RRV-mediated prodrug activator gene therapy as a new therapeutic approach for pancreatic ductal adenocarcinoma (PDAC). RRV spread rapidly and conferred significant cytotoxicity with prodrug in a panel of PDAC cells...
May 8, 2018: Cancer Gene Therapy
https://www.readbyqxmd.com/read/29715916/photonic-generation-of-linearly-chirped-microwave-waveforms-using-a-monolithic-integrated-three-section-laser
#7
Jin Li, Tao Pu, Jilin Zheng, Yunshan Zhang, Yuechun Shi, Huatao Zhu, Yuandong Li, Xin Zhang, Guowang Zhao, Yuke Zhou, Xiangfei Chen
Photonic generation of linearly chirped microwave waveforms (LCMWs) using a monolithic integrated three-section laser is experimentally demonstrated in this work. All three sections of the laser cavity, including the front DFB section, phase section and rear DFB section, have the same active layer, which can avoid the butt-joint re-growth process. The gratings in both DFB sections are fabricated by the Reconstruction Equivalent Chirp technique, which can significantly decrease the difficulties in realizing precise grating structure...
April 16, 2018: Optics Express
https://www.readbyqxmd.com/read/29670758/remote-biomonitoring-of-temperatures-in-mothers-and-newborns-design-development-and-testing-of-a-wearable-sensor-device-in-a-tertiary-care-hospital-in-southern-india
#8
Prem K Mony, Prashanth Thankachan, Swarnarekha Bhat, Suman Rao, Maryann Washington, Sumi Antony, Annamma Thomas, Sheela C Nagarajarao, Hiteshwar Rao, Bharadwaj Amrutur
Objective: Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India. Methods: Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of 'social innovation' design...
April 2018: BMJ Innovations
https://www.readbyqxmd.com/read/29627231/status-of-vaccine-research-and-development-for-helicobacter-pylori
#9
Philip Sutton, Joanne M Boag
Gastric adenocarcinoma is globally the third leading cause of death due to malignancy, with the bulk of this disease burden being suffered by low and middle income countries (LMIC), especially in Asia. The majority of these cancers develop as a result of a chronic gastritis that arises in response to infection with the stomach-dwelling bacterium, Helicobacter pylori. A vaccine against this pathogen would therefore be a powerful tool for preventing gastric adenocarcinoma. However, notwithstanding a proof-of-concept that vaccination can protect children from acquisition of H...
April 4, 2018: Vaccine
https://www.readbyqxmd.com/read/29587457/an-experimental-study-of-a-micro-projection-enabled-optical-terminal-for-short-range-bidirectional-multi-wavelength-visible-light-communications
#10
Hsi-Hsir Chou, Cheng-Yu Tsai, Jhih-Shan Jiang
A micro-projection enabled short-range communication (SRC) approach using red-, green- and blue-based light-emitting diodes (RGB-LEDs) has experimentally demonstrated recently that micro-projection and high-speed data transmission can be performed simultaneously. In this research, a reconfigurable design of a polarization modulated image system based on the use of a Liquid Crystal on Silicon based Spatial Light Modulator (LCoS-based SLM) serving as a portable optical terminal capable of micro-projection and bidirectional multi-wavelength communications is proposed and experimentally demonstrated...
March 26, 2018: Sensors
https://www.readbyqxmd.com/read/29584724/developing-a-buruli-ulcer-community-of-practice-in-bankim-cameroon-a-model-for-buruli-ulcer-outreach-in-africa
#11
Paschal Kum Awah, Alphonse Um Boock, Ferdinand Mou, Joseph Tohnain Koin, Evaristus Mbah Anye, Djeunga Noumen, Mark Nichter
BACKGROUND: In the Cameroon, previous efforts to identify Buruli ulcer (BU) through the mobilization of community health workers (CHWs) yielded poor results. In this paper, we describe the successful creation of a BU community of practice (BUCOP) in Bankim, Cameroon composed of hospital staff, former patients, CHWs, and traditional healers. METHODS AND PRINCIPLE FINDINGS: All seven stages of a well-defined formative research process were conducted during three phases of research carried out by a team of social scientists working closely with Bankim hospital staff...
March 2018: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29528347/molecular-shape-as-a-means-to-control-the-incidence-of-the-nanostructured-twist-bend-phase
#12
Emily E Pocock, Richard J Mandle, John W Goodby
Liquid crystalline phases with a spontaneous twist-bend modulation are most commonly observed for dimers and bimesogens with nonamethylene spacers. In order to redress this balance we devised a simple chemical intermediate that can be used to prepare unsymmetrical bimesogens; as a proof of concept we prepared and studied eleven novel materials with all found to exhibit the twist-bend phase and exhibit a linear relationship between TN-I and TTB-N. A computational study of the conformational landscape reveals the octamethyleneoxy spacer to have a broader distribution of bend-angles than the nonamethylene equivalent, leading to reductions in the thermal stability of the TB phase...
March 28, 2018: Soft Matter
https://www.readbyqxmd.com/read/29527504/combining-viscoelasticity-diffusivity-and-volume-of-the-hippocampus-for-the-diagnosis-of-alzheimer-s-disease-based-on-magnetic-resonance-imaging
#13
Lea M Gerischer, Andreas Fehlner, Theresa Köbe, Kristin Prehn, Daria Antonenko, Ulrike Grittner, Jürgen Braun, Ingolf Sack, Agnes Flöel
Dementia due to Alzheimer's Disease (AD) is a neurodegenerative disease for which treatment strategies at an early stage are of great clinical importance. So far, there is still a lack of non-invasive diagnostic tools to sensitively detect AD in early stages and to predict individual disease progression. Magnetic resonance elastography (MRE) of the brain may be a promising novel tool. In this proof-of-concept study, we investigated whether multifrequency-MRE (MMRE) can detect differences in hippocampal stiffness between patients with clinical diagnosis of dementia due to AD and healthy controls (HC)...
2018: NeuroImage: Clinical
https://www.readbyqxmd.com/read/29524118/bipedal-gait-model-for-precise-gait-recognition-and-optimal-triggering-in-foot-drop-stimulator-a-proof-of-concept
#14
Muhammad Faraz Shaikh, Zoran Salcic, Kevin I-Kai Wang, Aiguo Patrick Hu
Electrical stimulators are often prescribed to correct foot drop walking. However, commercial foot drop stimulators trigger inappropriately under certain non-gait scenarios. Past researches addressed this limitation by defining stimulation control based on automaton of a gait cycle executed by foot drop of affected limb/foot only. Since gait is a collaborative activity of both feet, this research highlights the role of normal foot for robust gait detection and stimulation triggering. A novel bipedal gait model is proposed where gait cycle is realized as an automaton based on concurrent gait sub-phases (states) from each foot...
March 10, 2018: Medical & Biological Engineering & Computing
https://www.readbyqxmd.com/read/29449609/kinesthetic-stimulation-for-obstructive-sleep-apnea-syndrome-an-on-off-proof-of-concept-trial
#15
Alfredo I Hernández, Diego Pérez, Delphine Feuerstein, Corinne Loiodice, Laurence Graindorge, Gustavo Guerrero, Nadège Limousin, Frédéric Gagnadoux, Yves Dauvilliers, Renaud Tamisier, Arnaud Prigent, Philippe Mabo, Amel Amblard, Lotfi Senhadji, Jean-Louis Pépin
Obstructive sleep apnea (OSA) occurs when the upper airway narrows or collapses due to the loss of upper airway muscle activation at sleep onset. This study investigated the effectiveness of triggered kinesthetic stimulation in patients with OSA. This proof-of-concept, open-label, multicenter prospective study was conducted on 24 patients with severe OSA. During a one night evaluation, kinesthetic stimulation was intermittently delivered in 30 minute periods. The duration of apneas and hypopneas during Stim on and Stim off periods were compared...
February 15, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29361470/prexasertib-a-cell-cycle-checkpoint-kinase-1-and-2-inhibitor-in-brca-wild-type-recurrent-high-grade-serous-ovarian-cancer-a-first-in-class-proof-of-concept-phase-2-study
#16
Jung-Min Lee, Jayakumar Nair, Alexandra Zimmer, Stanley Lipkowitz, Christina M Annunziata, Maria J Merino, Elizabeth M Swisher, Maria I Harrell, Jane B Trepel, Min-Jung Lee, Mohammad H Bagheri, Dana-Adriana Botesteanu, Seth M Steinberg, Lori Minasian, Irene Ekwede, Elise C Kohn
BACKGROUND: High-grade serous ovarian carcinoma is characterised by TP53 mutations, DNA repair defects, and genomic instability. We hypothesised that prexasertib (LY2606368), a cell cycle checkpoint kinase 1 and 2 inhibitor, would be active in BRCA wild-type disease. METHODS: In an open-label, single-centre, two-stage, proof-of-concept phase 2 study, we enrolled women aged 18 years or older with measurable, recurrent high-grade serous or high-grade endometrioid ovarian carcinoma...
February 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29361468/neoadjuvant-plus-adjuvant-dabrafenib-and-trametinib-versus-standard-of-care-in-patients-with-high-risk-surgically-resectable-melanoma-a-single-centre-open-label-randomised-phase-2-trial
#17
Rodabe N Amaria, Peter A Prieto, Michael T Tetzlaff, Alexandre Reuben, Miles C Andrews, Merrick I Ross, Isabella C Glitza, Janice Cormier, Wen-Jen Hwu, Hussein A Tawbi, Sapna P Patel, Jeffrey E Lee, Jeffrey E Gershenwald, Christine N Spencer, Vancheswaran Gopalakrishnan, Roland Bassett, Lauren Simpson, Rosalind Mouton, Courtney W Hudgens, Li Zhao, Haifeng Zhu, Zachary A Cooper, Khalida Wani, Alexander Lazar, Patrick Hwu, Adi Diab, Michael K Wong, Jennifer L McQuade, Richard Royal, Anthony Lucci, Elizabeth M Burton, Sangeetha Reddy, Padmanee Sharma, James Allison, Phillip A Futreal, Scott E Woodman, Michael A Davies, Jennifer A Wargo
BACKGROUND: Dual BRAF and MEK inhibition produces a response in a large number of patients with stage IV BRAF-mutant melanoma. The existing standard of care for patients with clinical stage III melanoma is upfront surgery and consideration for adjuvant therapy, which is insufficient to cure most patients. Neoadjuvant targeted therapy with BRAF and MEK inhibitors (such as dabrafenib and trametinib) might provide clinical benefit in this high-risk p opulation. METHODS: We undertook this single-centre, open-label, randomised phase 2 trial at the University of Texas MD Anderson Cancer Center (Houston, TX, USA)...
February 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29359186/recombinant-zika-virus-subunits-are-immunogenic-and-efficacious-in-mice
#18
Albert To, Liana O Medina, Kenji O Mfuh, Michael M Lieberman, Teri Ann S Wong, Madhuri Namekar, Eileen Nakano, Chih-Yun Lai, Mukesh Kumar, Vivek R Nerurkar, Axel T Lehrer
Following the 2015 Zika virus (ZIKV) outbreaks in the South Pacific, Caribbean, and Americas, ZIKV has emerged as a serious threat due to its association with infantile microcephaly and other neurologic disorders. Despite an international effort to develop a safe and effective vaccine to combat congenital Zika syndrome and ZIKV infection, only DNA and mRNA vaccines encoding the precursor membrane (prM) and envelope (E) proteins, an inactivated-ZIKV vaccine, and a measles virus-based ZIKV vaccine are currently in phase I or II (prM/E DNA) clinical trials...
January 2018: MSphere
https://www.readbyqxmd.com/read/29277841/using-radio-astronomical-receivers-for-molecular-spectroscopic-characterization-in-astrochemical-laboratory-simulations-a-proof-of-concept
#19
I Tanarro, B Alemán, P de Vicente, J D Gallego, J R Pardo, G Santoro, K Lauwaet, F Tercero, A Díaz-Pulido, E Moreno, M Agúndez, J R Goicoechea, J M Sobrado, J A López, L Martínez, J L Doménech, V J Herrero, J M Hernández, R J Peláez, J A López-Pérez, J Gómez-González, J L Alonso, E Jiménez, D Teyssier, K Makasheva, M Castellanos, C Joblin, J A Martín-Gago, J Cernicharo
We present a proof of concept on the coupling of radio astronomical receivers and spectrometers with chemical reactors and the performances of the resulting setup for spectroscopy and chemical simulations in laboratory astrophysics. Several experiments including cold plasma generation and UV photochemistry were performed in a 40 cm long gas cell placed in the beam path of the Aries 40 m radio telescope receivers operating in the 41-49 GHz frequency range interfaced with fast Fourier transform spectrometers providing 2 GHz bandwidth and 38 kHz resolution...
January 2018: Astronomy and Astrophysics
https://www.readbyqxmd.com/read/29211470/a-dipolar-cycloaddition-reaction-to-access-6-methyl-4-5-6-7-tetrahydro-1h-1-2-3-triazolo-4-5-c-pyridines-enables-the-discovery-synthesis-and-preclinical-profiling-of-a-p2x7-antagonist-clinical-candidate
#20
Christa C Chrovian, Akinola Soyode-Johnson, Alexander A Peterson, Christine F Gelin, Xiaohu Deng, Curt A Dvorak, Nicholas I Carruthers, Brian Lord, Ian Fraser, Leah Aluisio, Kevin J Coe, Brian Scott, Tatiana Koudriakova, Freddy Schoetens, Kia Sepassi, David J Gallacher, Anindya Bhattacharya, Michael A Letavic
A single pot dipolar cycloaddition reaction/Cope elimination sequence was developed to access novel 1,4,6,7-tetrahydro-5H-[1,2,3]triazolo[4,5-c]pyridine P2X7 antagonists that contain a synthetically challenging chiral center. The structure-activity relationships of the new compounds are described. Two of these compounds, (S)-(2-fluoro-3-(trifluoromethyl)phenyl)(1-(5-fluoropyrimidin-2-yl)-6-methyl-1,4,6,7-tetrahydro-5H-[1,2,3]triazolo[4,5-c]pyridin-5-yl)methanone (compound 29) and (S)-(3-fluoro-2-(trifluoromethyl)pyridin-4-yl)(1-(5-fluoropyrimidin-2-yl)-6-methyl-1,4,6,7-tetrahydro-5H-[1,2,3]triazolo[4,5-c]pyridin-5-yl)methanone (compound 35), were found to have robust P2X7 receptor occupancy at low doses in rat with ED50 values of 0...
January 11, 2018: Journal of Medicinal Chemistry
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