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Proof of concept clinical trial

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https://www.readbyqxmd.com/read/28645969/protocol-for-the-residents-in-action-pilot-cluster-randomised-controlled-trial-riat-evaluating-a-behaviour-change-intervention-to-promote-walking-reduce-sitting-and-improve-mental-health-in-physically-inactive-older-adults-in-retirement-villages
#1
Cecilie Thøgersen-Ntoumani, Ashlene Wright, Eleanor Quested, Elissa Burton, Keith D Hill, Ester Cerin, Stuart J H Biddle, Nikos Ntoumanis
INTRODUCTION: Ageing is accompanied by increased risks of chronic disease, declined functioning and increased dependency. Physical activity is critical to retaining health and independence, but the majority of older people are insufficiently physically active to achieve these benefits and have high levels of sedentary (sitting) time. Activity programmes are often offered in retirement villages; however, their uptake is limited. Furthermore, although the physical environment in and around these villages can play an important role in decisions to be physically active, its role is often overlooked by research in these settings...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28642286/brain-regions-important-for-recovery-after-severe-post-stroke-upper-limb-paresis
#2
Jane M Rondina, Chang-Hyun Park, Nick S Ward
Background The ability to predict outcome after stroke is clinically important for planning treatment and for stratification in restorative clinical trials. In relation to the upper limbs, the main predictor of outcome is initial severity, with patients who present with mild to moderate impairment regaining about 70% of their initial impairment by 3 months post-stroke. However, in those with severe presentations, this proportional recovery applies in only about half, with the other half experiencing poor recovery...
June 22, 2017: Journal of Neurology, Neurosurgery, and Psychiatry
https://www.readbyqxmd.com/read/28625625/economic-burden-of-clinical-trials-in-lung-cancer-in-a-german-comprehensive-cancer-center
#3
F Kron, A Kostenko, M Scheffler, D Müller, J-P Glossmann, R Fischer, S Michels, L Nogova, M Hallek, T Zander, J Wolf
OBJECTIVES: The recent success of individualized lung cancer therapy has triggered fundamental changes in clinical research strategies. To date there is a strong focus on early proof of concept trials in genetically preselected small patient subgroups. This analysis focuses on the economic burden caused by such trials for advanced lung cancer patients in a German Comprehensive Cancer Center (CCC). METHODS: The profit margins between recruiting groups with ≤3 and >3 patients were compared...
June 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28622558/photodynamic-therapy-treatment-of-onychomycosis-with-aluminium-phthalocyanine-chloride-nanoemulsions-a-proof-of-concept-clinical-trial
#4
Luciano Ferreira Morgado, Ana Regina Franchi Trávolo, Luís Alexandre Muehlmann, Paulo Souza Narcizo, Rodrigo Barbosa Nunes, Pedro Alencar Gomes Pereira, Karen Rapp Py-Daniel, Cheng-Shi Jiang, Jinsong Gu, Ricardo Bentes Azevedo, João Paulo Figueiró Longo
The conventional treatment of onychomycosis, a common fungal infection, consists in the use of local and systemic drugs for 4-6 months. This long protocol is often ineffective due to patient compliance, and usually promotes important collateral effects such as liver and kidney failure. As the alternative, Photodynamic Therapy (PDT) has been used as a noninvasive alternative local treatment for onychomycosis due to the reduction of systemic side effects, fact indicates their use for patients undergoing other systemic treatments...
June 8, 2017: Journal of Photochemistry and Photobiology. B, Biology
https://www.readbyqxmd.com/read/28618192/the-patient-buddy-app-can-potentially-prevent-hepatic-encephalopathy-related-readmissions
#5
Dinesh Ganapathy, Chathur Acharya, Jatinder Lachar, Kavish Patidar, Richard K Sterling, Melanie B White, Catherine Ignudo, Swamy Bommidi, John DeSoto, Leroy R Thacker, Scott Matherly, Jawaid Shaw, Mohammad S Siddiqui, Puneet Puri, Arun J Sanyal, Velimir Luketic, Hannah Lee, R Todd Stravitz, Jasmohan S Bajaj
BACKGROUND AND AIM: Readmissions are a major burden in cirrhosis. A proportion of readmissions in cirrhosis, especially due to hepatic encephalopathy (HE) could be avoided through patient and caregiver engagement. We aimed to define the feasibility of using the Patient Buddy App and its impact on 30-day readmissions by engaging and educating cirrhotic inpatients and caregivers in a pilot study. METHODS: Cirrhotic inpatients with caregivers were enrolled and followed for 30 days post-discharge...
June 15, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28613086/exploiting-natural-killer-group-2d-receptors-for-car-t-cell-therapy
#6
Benjamin Demoulin, W James Cook, Joana Murad, David J Graber, Marie-Louise Sentman, Caroline Lonez, David E Gilham, Charles L Sentman, Sophie Agaugue
Chimeric antigen receptors (CARs) are genetically engineered proteins that combine an extracellular antigen-specific recognition domain with one or several intracellular T-cell signaling domains. When expressed in T cells, these CARs specifically trigger T-cell activation upon antigen recognition. While the clinical proof of principle of CAR T-cell therapy has been established in hematological cancers, CAR T cells are only at the early stages of being explored to tackle solid cancers. This special report discusses the concept of exploiting natural killer cell receptors as an approach that could broaden the specificity of CAR T cells and potentially enhance the efficacy of this therapy against solid tumors...
June 14, 2017: Future Oncology
https://www.readbyqxmd.com/read/28597211/characterization-and-use-of-equine-bone-marrow-mesenchymal-stem-cells-in-equine-cartilage-engineering-study-of-their-hyaline-cartilage-forming-potential-when-cultured-under-hypoxia-within-a-biomaterial-in-the-presence-of-bmp-2-and-tgf-%C3%A3-1
#7
Thomas Branly, Lélia Bertoni, Romain Contentin, Rodolphe Rakic, Tangni Gomez-Leduc, Mélanie Desancé, Magalie Hervieu, Florence Legendre, Sandrine Jacquet, Fabrice Audigié, Jean-Marie Denoix, Magali Demoor, Philippe Galéra
Articular cartilage presents a poor capacity for self-repair. Its structure-function are frequently disrupted or damaged upon physical trauma or osteoarthritis in humans. Similar musculoskeletal disorders also affect horses and are the leading cause of poor performance or early retirement of sport- and racehorses. To develop a therapeutic solution for horses, we tested the autologous chondrocyte implantation technique developed on human bone marrow (BM) mesenchymal stem cells (MSCs) on horse BM-MSCs. This technique involves BM-MSC chondrogenesis using a combinatory approach based on the association of 3D-culture in collagen sponges, under hypoxia in the presence of chondrogenic factors (BMP-2 + TGF-β1) and siRNA to knockdown collagen I and HtrA1...
June 9, 2017: Stem Cell Reviews
https://www.readbyqxmd.com/read/28593103/natural-history-of-rod-mediated-dark-adaptation-over-2-years-in-intermediate-age-related-macular-degeneration
#8
Cynthia Owsley, Mark E Clark, Gerald McGwin
PURPOSE: To characterize the natural history of rod-mediated dark adaptation (RMDA) over 2 years in eyes with intermediate age-related macular degeneration (AMD). This information will be useful in understanding the potential of RMDA to serve as a functional endpoint in proof-of-concept studies and clinical trials on intermediate AMD. METHODS: RMDA was measured in eyes with intermediate AMD at baseline and follow-up visits over 2 years at 6, 12, 18, and 24 months...
June 2017: Translational Vision Science & Technology
https://www.readbyqxmd.com/read/28590833/evaluation-of-a-decision-aid-for-women-with-epilepsy-who-are-considering-pregnancy-a-randomized-controlled-trial
#9
Amanda McGrath, Louise Sharpe, Suncica Lah, Kaitlyn Parratt
BACKGROUND: For many women with epilepsy (WWE), decision making about pregnancy is complicated by considerations such as the potential teratogenicity of antiepileptic drugs, offspring risk of epilepsy, seizure occurrence during pregnancy, and the challenges of parenting amidst poorly controlled seizures. OBJECTIVE: This proof-of-concept, randomized controlled trial aimed to evaluate a decision aid (DA) developed to help WWE decide if they should start or enlarge their families...
July 2017: Medical Decision Making: An International Journal of the Society for Medical Decision Making
https://www.readbyqxmd.com/read/28589078/recent-clinical-trials-of-cancer-immunogene-therapy-in-companion-animals
#10
REVIEW
Liliana M E Finocchiaro, Gerardo C Glikin
This mini-review presents the results of veterinary clinical trials on immunogene therapy published from 2014 to 2016. A variety of tumors, among them melanoma (canine and equine), mastocytoma (canine), mammary adenocarcinoma (canine) and fibrosarcoma (feline) were treated by using diverse strategies. Non-viral vectors were usually employed to transfer genes of cytokines, suicide enzymes and/or tumor associated antigens. In general terms, minor or no adverse collateral effects were related to these procedures, and treated patients frequently improved their conditions (better quality of life, delayed or suppressed recurrence or metastatic spread, increased survival)...
May 20, 2017: World Journal of Experimental Medicine
https://www.readbyqxmd.com/read/28582570/phase-ii-proof-of-concept-trial-of-the-orexin-receptor-antagonist-filorexant-mk-6096-in-patients-with-major-depressive-disorder
#11
Kathryn M Connor, Paulette Ceesay, Jill Hutzlemann, Duane Snavely, Andrew D Krystal, Madhukar H Trivedi, Michael Thase, Christopher Lines, W Joseph Herring, David Michelson
Background: We evaluated the orexin receptor antagonist filorexant (MK-6096) for treatment augmentation in patients with major depressive disorder (MDD). Methods: Six-week, double-blind, placebo-controlled, parallel-group, Phase II, proof-of-concept study. Patients with MDD (partial responders to ongoing antidepressant therapy) were randomized 1:1 to once-daily oral filorexant 10mg or matching placebo. Results: Due to enrollment challenges the study was terminated early, resulting in insufficient statistical power to detect a pre-specified treatment difference; of 326 patients planned, 129 (40%) were randomized and 128 took treatment...
June 3, 2017: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28578592/adjunctive-minocycline-treatment-for-major-depressive-disorder-a-proof-of-concept-trial
#12
Olivia M Dean, Buranee Kanchanatawan, Melanie Ashton, Mohammadreza Mohebbi, Chee Hong Ng, Michael Maes, Lesley Berk, Atapol Sughondhabirom, Sookjaroen Tangwongchai, Ajeet B Singh, Helen McKenzie, Deidre J Smith, Gin S Malhi, Nathan Dowling, Michael Berk
OBJECTIVE: Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder...
June 1, 2017: Australian and New Zealand Journal of Psychiatry
https://www.readbyqxmd.com/read/28577295/response-assessment-with-the-cxcr4-directed-positron-emission-tomography-tracer-68-ga-pentixafor-in-a-patient-with-extranodal-marginal-zone-lymphoma-of-the-orbital-cavities
#13
Peter Herhaus, Stefan Habringer, Tibor Vag, Katja Steiger, Julia Slotta-Huspenina, Carlos Gerngroß, Benedikt Wiestler, Hans-Jürgen Wester, Markus Schwaiger, Ulrich Keller
CXCR4 belongs to the family of chemokine receptors. Together with its sole known ligand CXCL12 (SDF-1alpha), it has a pivotal role during organogenesis and for homing of hematopoietic stem cells. CXCR4 is overexpressed in various malignancies, and this is often associated with poor prognosis. Therefore, molecular imaging of CXCR4 bears a great potential for diagnostics and selecting patients for CXCR4-directed therapies. The CXCR4-directed positron emission tomography (PET) tracer [(68)Ga]Pentixafor has been shown to visualize CXCR4 expression in various malignancies in vivo...
December 2017: EJNMMI Research
https://www.readbyqxmd.com/read/28574934/pfo-closure-for-cryptogenic-stroke-a-review-and-clinical-treatment-algorithm
#14
Harsimran S Singh, Farhan Katchi, Srihari S Naidu
With a high prevalence in the general population of approximately 25%, and a prevalence in the cryptogenic stroke population approaching 40%, the propensity of a patent foramen ovale (PFO) to precipitate or enable stroke, especially in young, otherwise healthy individuals, has been the subject of much debate. With proof of concept achieved via imaging modalities documenting thrombus-in-transit, and the development of minimally-invasive percutaneous approaches to closure, multiple observational studies and, more recently, several completed randomized controlled trials have sought to answer the question of when and in whom PFO closure should occur...
July 2017: Cardiology in Review
https://www.readbyqxmd.com/read/28574177/review-of-basal-plus-insulin-regimen-options-for-simpler-insulin-intensification-in-people-with-type-2-diabetes-mellitus
#15
REVIEW
D Raccah, D Huet, A Dib, F Joseph, B Landers, J Escalada, H Schmitt
AIMS: To identify simple insulin regimens for people with Type 2 diabetes mellitus that can be accepted and implemented earlier in primary and specialist care, taking into consideration each individual's needs and capabilities. METHODS: Using randomized clinical trials identified by a search of the PubMed database, as well as systematic reviews, meta-analyses and proof-of-concept studies, this review addresses topics of interest related to the progressive intensification of a basal insulin regimen to a basal-plus regimen (one basal insulin injection plus stepwise addition of one to three preprandial short-acting insulin injections/day) vs a basal-bolus regimen (basal insulin plus three short-acting insulin injections per day) in people with Type 2 diabetes...
June 2, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28569122/rationale-and-design-of-combination-of-an-immune-modulator-fingolimod-with-alteplase-bridging-with-mechanical-thrombectomy-in-acute-ischemic-stroke-famtais-trial
#16
Sheng Zhang, Ying Zhou, Ruiting Zhang, Meixia Zhang, Bruce Campbell, Longting Lin, Fu-Dong Shi, Min Lou
Rationale In acute ischemic stroke patients with large vessel occlusion, although reperfusion within 6 h after stroke onset using combined intravenous alteplase and mechanical thrombectomy (bridging therapy) can improve functional outcome, still approximately 50% patients suffer disability which may result from reperfusion injury. Proof-of-concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in acute ischemic stroke patients as a single therapy beyond 4...
January 1, 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28566226/optimization-of-retinal-gene-therapy-for-x-linked-retinitis-pigmentosa-due-to-rpgr-mutations
#17
William A Beltran, Artur V Cideciyan, Shannon E Boye, Guo-Jie Ye, Simone Iwabe, Valerie L Dufour, Luis Felipe Marinho, Malgorzata Swider, Mychajlo S Kosyk, Jin Sha, Sanford L Boye, James J Peterson, C Douglas Witherspoon, John J Alexander, Gui-Shuang Ying, Mark S Shearman, Jeffrey D Chulay, William W Hauswirth, Paul D Gamlin, Samuel G Jacobson, Gustavo D Aguirre
X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene is an early onset and severe cause of blindness. Successful proof-of-concept studies in a canine model have recently shown that development of a corrective gene therapy for RPGR-XLRP may now be an attainable goal. In preparation for a future clinical trial, we have here optimized the therapeutic AAV vector construct by showing that GRK1 (rather than IRBP) is a more efficient promoter for targeting gene expression to both rods and cones in non-human primates...
May 26, 2017: Molecular Therapy: the Journal of the American Society of Gene Therapy
https://www.readbyqxmd.com/read/28560150/amyloid-positron-emission-tomography-in-sporadic-cerebral-amyloid-angiopathy-a-systematic-critical-update
#18
REVIEW
Karim Farid, Andreas Charidimou, Jean-Claude Baron
Sporadic cerebral amyloid angiopathy (CAA) is a very common small vessel disease of the brain, showing preferential and progressive amyloid-βdeposition in the wall of small arterioles and capillaries of the leptomeninges and cerebral cortex. CAA now encompasses not only a specific cerebrovascular pathological trait, but also different clinical syndromes - including spontaneous lobar intracerebral haemorrhage (ICH), dementia and 'amyloid spells' - an expanding spectrum of brain parenchymal MRI lesions and a set of diagnostic criteria - the Boston criteria, which have resulted in increasingly detecting CAA during life...
2017: NeuroImage: Clinical
https://www.readbyqxmd.com/read/28541760/inhibition-of-proteases-activity-in-intestine-needs-a-sustainable-acidic-environment-rather-than-a-transient
#19
Chang Xing, Jin-Feng Xing, Zhi-Qiang Ge
α-Chymotrypsin (α-CT) and trypsin are important components of the enzymatic barrier. They could degrade the therapeutic proteins and peptides, inhibit their activity consequently, and thereby reduce their oral bioavailability. Acidic agents, as one type of indirect protease inhibitors, have shown proof of concept in clinical trials. We report here the inactivated proteases due to acid influence can be reactivated immediately by environmental pH recovery regardless of how long the inactivation last. To keep the inactivation time of proteases for 4-5 h, we designed and prepared a sustained-release tablet containing citric acid (CA) which can effectively reduce the pH below 5...
June 8, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28535453/inhibition-of-neddylation-modification-sensitizes-pancreatic-cancer-cells-to-gemcitabine
#20
Hua Li, Weihua Zhou, Lihui Li, Jianfu Wu, Xiaoli Liu, Lili Zhao, Lijun Jia, Yi Sun
Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer death in the USA with a 5-year survival rate less than 3% to 5%. Gemcitabine remains as a standard care for PDAC patients. Although protein neddylation is abnormally activated in many human cancers, whether neddylation dysregulation is involved in PDAC and whether targeting neddylation would sensitize pancreatic cancer cells to gemcitabine remain elusive. Here we report that high expression of neddylation components, NEDD8 and NAE1, are associated with poor survival of PDAC patients...
June 2017: Neoplasia: An International Journal for Oncology Research
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