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Proof of concept trials

Behjat Javadi, Amirhossein Sahebkar, Seyed Ahmad Emami
OBJECTIVE: To search major Traditional Persian Medicine (TPM) textbooks for medicinal plants used to treat asthma. The conformity of the TPM findings on the anti-asthmatic efficacy of plants with the findings of pharmacological studies was also explored. METHODS: Major TPM textbooks were hand searched to find medicinal plants used for the treatment of asthma. Scientific names of TPM-suggested plants were determined using botanical databases and were used for a multi-database electronic search in PubMed, Scopus, ScienceDirect and Google Scholar databases...
October 21, 2016: Current Pharmaceutical Design
Preeti Raghavan, Daniel Geller, Nina Guerrero, Viswanath Aluru, Joseph P Eimicke, Jeanne A Teresi, Gbenga Ogedegbe, Anna Palumbo, Alan Turry
: Stroke is a leading cause of disability worldwide. It leads to a sudden and overwhelming disruption in one's physical body, and alters the stroke survivors' sense of self. Long-term recovery requires that bodily perception, social participation and sense of self are restored; this is challenging to achieve, particularly with a single intervention. However, rhythmic synchronization of movement to external stimuli facilitates sensorimotor coupling for movement recovery, enhances emotional engagement and has positive effects on interpersonal relationships...
2016: Frontiers in Human Neuroscience
Yinghe Huo, Renske D Veldhuizen, Desiree M van der Heijde, Nick J Besselink, Johannes W G Jacobs, Jacob M van Laar, Max A Viergever, Koen L Vincken, Floris P Lafeber, Maria J H de Hair
OBJECTIVES: To compare as proof of concept the sensitivity to change of automated quantification of radiographic wrist and hand joint space width (JSW) with scoring JSW according to the Sharp/van der Heijde scoring method (SHS) in two strategy groups of a treat-to-target and tight-control early rheumatoid arthritis (RA) study. METHODS: Digital radiographs were assessed for JSW changes of 134 patients of the 236 patients participating in the second Computer Assisted Management in Early Rheumatoid Arthritis trial, of whom both baseline and year 2 radiographs were available (year 1 radiographs n=125)...
September 2016: Clinical and Experimental Rheumatology
Teresa Liu-Ambrose, John R Best, Jennifer C Davis, Janice J Eng, Philip E Lee, Claudia Jacova, Lara A Boyd, Penelope M Brasher, Michelle Munkacsy, Winnie Cheung, Ging-Yuek R Hsiung
OBJECTIVE: To assess the efficacy of a progressive aerobic exercise training program on cognitive and everyday function among adults with mild subcortical ischemic vascular cognitive impairment (SIVCI). METHODS: This was a proof-of-concept single-blind randomized controlled trial comparing a 6-month, thrice-weekly, progressive aerobic exercise training program (AT) with usual care plus education on cognitive and everyday function with a follow-up assessment 6 months after the formal cessation of aerobic exercise training...
October 19, 2016: Neurology
Jason J Howard, Julien Abinahed, Nikhil Navkar, Jean-Marc Peyrat, Abdulla Al-Ansari, David L Sigalet, Abdalla E Zarroug
BACKGROUND: Open posterior spinal procedures involve extensive soft tissue disruption, increased hospital length of stay, and disfiguring scars. Our aim was to demonstrate the feasibility of using robotic-assistance for minimally invasive exposure of the posterolateral spine with and without carbon dioxide (CO2 ) insufflation. METHODS: Sheep specimens underwent minimally invasive subperiosteal dissection of the spine during three trials. The da Vinci S Surgical system was used for access with and without working space support via CO2 insufflation...
October 19, 2016: International Journal of Medical Robotics + Computer Assisted Surgery: MRCAS
Perparim Limani, Michael Linecker, Philipp Kron, Panagiotis Samaras, Bernhard Pestalozzi, Roger Stupp, Alexander Jetter, Philipp Dutkowski, Beat Müllhaupt, Andrea Schlegel, Claude Nicolau, Jean-Marie Lehn, Henrik Petrowsky, Bostjan Humar, Rolf Graf, Pierre-Alain Clavien
BACKGROUND: Solid tumors, such as hepato-pancreato-biliary cancer, develop tumor hypoxia with tumor growth. Despite advances in surgery, a majority of these patients are in an unresectable condition. At this stage standard cytotoxic chemotherapy regimens are applied with limited success. Novel biological treatment options based on an antiangiogenic mechanism of action neglect other hypoxia mediated mechanisms (e.g. epithelial-mesenchymal transition, Warburg effect, and immunological response) leading to an increased invasiveness with a poor outcome...
October 19, 2016: BMC Cancer
George Bakris
Renal denervation started out as a very promising approach to treat resistant hypertension with a very strong conceptual and basic science frame work from Gerald DiBona's lab and extending into the early non shame clinical studies demonstrating proof of concept in SYMPLICITY HTN-1 and 2. SYMPLICITY-HTN 3 a properly done, sham control trial failed to show a benefit on further reduction of BP compared to the sham group. The conclusion the procedure doesn't work. How could this be-it was clearly effective in animal models but why not in man...
September 2016: Journal of Hypertension
Seong-Choon Choe
There are several classes of anti-hypertensive agents in the world, the most recently developed agent is angiotensin receptor blocker (ARB). There are already 8 ARBs in the market, but still medical unmet need for treatment of hypertension is existed. The 'ideal' anti-hypertensive agent would have a number of characteristics: (1) effective in lowering blood pressure to recommend goals; (2) high efficacy as monotherapy; (3) rapid onset of effect; (4) convenient once-daily administration to maximize compliance; (5) sustained efficacy over 24 hours; (6) response increases with higher doses (clear dose-response effect); and (7) optimum tolerability profile...
September 2016: Journal of Hypertension
Mahesh Kudrimoti, Amarintha Curtis, Samar Azawi, Francis Worden, Sanford Katz, Douglas Adkins, Marcelo Bonomi, Jenna Elder, Stephen T Sonis, Richard Straube, Oreola Donini
Dusquetide, a novel Innate Defense Regulator, modulates the innate immune system at a key convergence point in intracellular signaling pathways and has demonstrated activity in both reducing inflammation and increasing clearance of bacterial infection. Innate immunity has also been implicated in the pathogenesis of oral mucositis (OM), a universal toxicity of chemoradiation therapy (CRT). Testing the hypothesis that dusquetide can mitigate the development and duration of OM, preclinical studies have been completed and correlated with interim results from a Phase 2 clinical study in patients undergoing CRT for head and neck cancer...
October 13, 2016: Journal of Biotechnology
Verónica V Olavarría, Hisatomi Arima, Craig S Anderson, Alejandro Brunser, Paula Muñoz-Venturelli, Laurent Billot, Pablo M Lavados
BACKGROUND: The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h...
October 14, 2016: International Journal of Stroke: Official Journal of the International Stroke Society
Matthew J Scheffel, Gina Scurti, Patricia Simms, Elizabeth Garrett-Mayer, Shikhar Mehrotra, Michael I Nishimura, Christina Voelkel-Johnson
Although adoptive transfer of autologous tumor antigen-specific T-cell immunotherapy can produce remarkable clinical efficacy, most patients do not achieve durable complete responses. We hypothesized that reducing susceptibility of T cells to activation-induced cell death (AICD), which increases during the rapid in vitro expansion of therapeutic T cells before their infusion, might improve the persistence of adoptively transferred cells. Our investigations revealed that repetitive stimulation of the T-cell receptor (TCR) induced AICD, as a result of activating the DNA damage response pathway through ATM-mediated Ser15 phosphorylation of p53...
October 15, 2016: Cancer Research
M R Grootendorst, M Cariati, A Kothari, D S Tuch, A Purushotham
Cerenkov luminescence imaging (CLI) is a novel molecular optical imaging technique based on the detection of optical Cerenkov photons emitted by positron emission tomography (PET) imaging agents. The ability to use clinically approved tumour-targeted tracers in combination with small-sized imaging equipment makes CLI a particularly interesting technique for image-guided cancer surgery. The past few years have witnessed a rapid increase in proof-of-concept preclinical studies in this field, and several clinical trials are currently underway...
2016: Clinical and Translational Imaging: Reviews in Nuclear Medicine and Molecular Imaging
David Mischoulon, Lindsay Hylek, Albert S Yeung, Alisabet J Clain, Lee Baer, Cristina Cusin, Dawn Flosnik Ionescu, Jonathan E Alpert, David P Soskin, Maurizio Fava
BACKGROUND: Given the proposed dopaminergic mechanism of low-dose naltrexone (LDN), we examined its efficacy as augmentation for depressive breakthrough on pro-dopaminergic antidepressant regimens. METHODS: 12 adults (67% female, mean age = 45±12) with recurrent DSM-IV major depressive disorder (MDD) on dopaminergic antidepressant regimens (stimulants, dopamine agonists, bupropion [≥300mg/day], aripiprazole [≤2.5mg/day], or sertraline [≥150mg/day]) were randomized to naltrexone 1mg b...
October 1, 2016: Journal of Affective Disorders
Jean-Yves Paul, Harjeet Khanna, Jennifer Kleidon, Phuong Hoang, Jason Geijskes, Jeff Daniells, Ella Zaplin, Yvonne Rosenberg, Anthony James, Bulukani Mlalazi, Pradeep Deo, Geofrey Arinaitwe, Priver Namanya, Douglas Becker, James Tindamanyire, Wilberforce Tushemereirwe, Robert Harding, James Dale
Vitamin A deficiency remains one of the world's major public health problems despite food fortification and supplements strategies. Biofortification of staple crops with enhanced levels of pro-vitamin A (PVA) offers a sustainable alternative strategy to both food fortification and supplementation. As a proof of concept, PVA-biofortified transgenic Cavendish bananas were generated and field trialed in Australia with the aim of achieving a target level of 20 μg/g of dry weight (dw) β-carotene equivalent (β-CE) in the fruit...
October 13, 2016: Plant Biotechnology Journal
Karin S Coyne, Ahmed M Soliman, Mary Kay Margolis, Christine L Thompson, Kristof Chwalisz
OBJECTIVE: To assess the psychometric performance of the 4-week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire (UFS-QoL), a patient measure of the severity of uterine fibroid (UF) symptoms and their impact on health-related quality of life (HRQL). METHODS: This was a retrospective analysis of Phase 2a data from pre-menopausal women with heavy menstrual bleeding associated with UF. Participants completed the UFS-QoL at Baseline, Treatment Month 3, and Follow-up Month 3 and a daily diary with a Menstrual Bleeding Scale and the UF Daily Symptom Scale throughout the study duration...
October 13, 2016: Current Medical Research and Opinion
Yoann Duffier, Audrey Lorthiois, Pau Cisteró, Florian Dupuy, Grégory Jouvion, Laurence Fiette, Dominique Mazier, Alfredo Mayor, Catherine Lavazec, Alicia Moreno Sabater
The development of new drugs to disrupt malaria transmission requires the establishment of an in vivo model to address the biology of Plasmodium falciparum sexual stages (gametocytes). Herein we show that chemically immune-modulated NSG mice grafted with human erythrocytes support complete sexual development of P. falciparum parasites and generate high gametocytemia. Immunohistochemistry and RT-qPCR analyses indicate an enrichment of immature gametocytes in the bone marrow and the spleen, suggesting a sequestration mechanism reminiscent to that observed in humans...
October 12, 2016: Scientific Reports
Samir Jaber, Marion Monnin, Mehdi Girard, Matthieu Conseil, Moussa Cisse, Julie Carr, Martin Mahul, Jean Marc Delay, Fouad Belafia, Gérald Chanques, Nicolas Molinari, Audrey De Jong
PURPOSE: High-flow nasal cannula oxygen (HFNC) has the potential to provide apnoeic oxygenation. We decided to assess in a proof-of-concept study whether the addition of HFNC to non-invasive ventilation (NIV) could reduce oxygen desaturation during intubation, compared with NIV alone for preoxygenation, in severely hypoxaemic intensive care unit (ICU) patients with respiratory failure. METHODS: We conducted a randomised, controlled, single-centre trial with assessor-blinded outcome assessment in patients admitted to the ICU...
October 11, 2016: Intensive Care Medicine
Sandeep S Sidhu, Omesh Goyal, Harsh Kishore
No abstract text is available yet for this article.
January 2016: Journal of the Association of Physicians of India
Debra Singh, Joel Negin, Christopher Garimoi Orach, Robert Cumming
BACKGROUND: Community Health Volunteers (CHVs) can be effective in improving pregnancy and newborn outcomes through community education. Inadequate supervision of CHVs, whether due to poor planning, irregular visits, or ineffective supervisory methods, is, however, recognized as a weakness in many programs. There has been little research on best practice supervisory or accompaniment models. METHODS: From March 2014 to February 2015 a proof of concept study was conducted to compare training alone versus training and supportive supervision by paid CHWs (n = 4) on the effectiveness of CHVs (n = 82) to deliver education about pregnancy, newborn care, family planning and hygiene...
October 3, 2016: Reproductive Health
Karen L Sweazea, Carol S Johnston, Jessica Knurick, Courtney D Bliss
Oxidative stress resulting from dietary, lifestyle and environmental factors is strongly associated with tissue damage and aging. It occurs when there is either an overproduction of reactive oxygen species (i.e., oxidants) or decreased bioavailability of antioxidants that can scavenge them. The objective of this 12-week double-blind placebo-controlled study was to assess the efficacy of a nutraceutical at augmenting antioxidant status. Healthy adults (25-45 y) were randomized to either a treatment group (Product B, n = 23) or a placebo group (control, n = 20)...
August 15, 2016: Journal of Dietary Supplements
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