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Proof of concept trials

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https://www.readbyqxmd.com/read/29146953/achievements-and-obstacles-of-remyelinating-therapies-in-multiple-sclerosis
#1
REVIEW
Martin Stangel, Tanja Kuhlmann, Paul M Matthews, Trevor J Kilpatrick
Remyelination in the CNS is the natural process of damage repair in demyelinating diseases such as multiple sclerosis (MS). However, remyelination becomes inadequate in many people with MS, which results in axonal degeneration and clinical disability. Enhancement of remyelination is a logical therapeutic goal; nevertheless, all currently licensed therapies for MS are immunomodulatory and do not support remyelination directly. Several molecular pathways have been identified as potential therapeutic targets to induce remyelination, and some of these have now been assessed in proof-of-concept clinical trials...
November 17, 2017: Nature Reviews. Neurology
https://www.readbyqxmd.com/read/29143240/dynamic-infrared-thermography-dirt-for-assessment-of-skin-blood-perfusion-in-cranioplasty-a-proof-of-concept-for-qualitative-comparison-with-the-standard-indocyanine-green-video-angiography-icga
#2
P Rathmann, C Chalopin, D Halama, P Giri, J Meixensberger, D Lindner
PURPOSE: Complications in wound healing after neurosurgical operations occur often due to scarred dehiscence with skin blood perfusion disturbance. The standard imaging method for intraoperative skin perfusion assessment is the invasive indocyanine green video angiography (ICGA). The noninvasive dynamic infrared thermography (DIRT) is a promising alternative modality that was evaluated by comparison with ICGA. METHODS: The study was carried out in two parts: (1) investigation of technical conditions for intraoperative use of DIRT for its comparison with ICGA, and (2) visual and quantitative comparison of both modalities in a proof of concept on nine patients...
November 15, 2017: International Journal of Computer Assisted Radiology and Surgery
https://www.readbyqxmd.com/read/29137329/development-of-a-radiolabeled-caninized-anti-egfr-antibody-for-comparative-oncology-trials
#3
Judit Fazekas-Singer, Neydher Berroterán-Infante, Christina Rami-Mark, Monika Dumanic, Miroslawa Matz, Michael Willmann, Fritz Andreae, Josef Singer, Wolfgang Wadsak, Markus Mitterhauser, Erika Jensen-Jarolim
Due to large homology of human and canine EGFR, dogs suffering from spontaneous EGFR+ cancer can be considered as ideal translational models. Thereby, novel immunotherapeutic compounds can be developed for both human and veterinary patients. This study describes the radiolabeling of a canine anti-EGFR IgG antibody (can225IgG) with potential diagnostic and therapeutic value in comparative clinical settings. Can225IgG was functionalized with DTPA for subsequent chelation with the radionuclide (99m)Tc. Successful coupling of 10 DTPA molecules per antibody on average was proven by significant mass increase in MALDI-TOF spectroscopy, gel electrophoresis and immunoblots...
October 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/29134606/intravenous-ferric-carboxymaltose-in-patients-with-type-2-diabetes-mellitus-and-iron-deficiency-clever-trial-study-design-and-protocol
#4
Christoph Schindler, Andreas L Birkenfeld, Markolf Hanefeld, Ulrike Schatz, Carsta Köhler, Martin Grüneberg, Diethelm Tschöpe, Matthias Blüher, Christoph Hasslacher, Stefan R Bornstein
INTRODUCTION: HbA1c is the gold standard for glycemic control in pre-diabetes and diabetes. However, its validity has been questioned, especially in the presence of imbalanced iron homeostasis. The CLEVER trial aims to evaluate the relationship between iron deficiency and HbA1c (a biomarker for the diagnosis and therapeutic monitoring of type 2 diabetes) in a randomized, placebo-controlled, multicenter clinical trial. METHODS: The CLEVER (intravenous ferric CarboxymaLtosE for improVement of mEtabolic parameters in type 2 diabetes patients with iRon deficiency) trial is a randomized, single-blind, proof-of-concept study with two treatment arms...
November 13, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29132229/hyperbaric-oxygen-therapy-in-the-treatment-of-acute-severe-traumatic-brain-injury-a-systematic-review
#5
Samuel Daly, Maxwell Thorpe, Sarah B Rockswold, Molly Hubbard, Thomas A Bergman, Uzma Samadani, Gaylan Rockswold
There has been no major advancement in a quarter of a century for the treatment of acute severe traumatic brain injury (TBI). This review summarizes 40 years of clinical and pre-clinical research on the treatment of acute TBI with hyperbaric oxygen therapy (HBO2) in the context of an impending National Institute of Neurologic Disorders and Stroke (NINDS)-funded, multicenter, randomized, adaptive Phase II clinical trial - the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial. Thirty studies (8 clinical and 22 pre-clinical) that administered HBO2 within 30 days of a TBI were identified from PubMed searches...
November 13, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/29129192/healthcall-delivered-via-smartphone-to-reduce-co-occurring-drug-and-alcohol-use-in-hiv-infected-adults-a-randomized-pilot-trial
#6
Efrat Aharonovich, Malka Stohl, Daniela Cannizzaro, Deborah Hasin
AIMS: Co-occurrence of drug and alcohol use among people living with HIV is linked to poor medication adherence and lack of viral suppression. HealthCall, a technological enhancement of brief Motivational Interviewing (MI), involves brief daily self-monitoring, positive reinforcement, and personalized feedback. This randomized pilot study among people living with HIV investigated the feasibility and efficacy of reducing non-injection drug and alcohol use with MI+HealthCall as adapted for smartphone technology...
December 2017: Journal of Substance Abuse Treatment
https://www.readbyqxmd.com/read/29126848/evaluation-of-external-vibratory-stimulation-as-a-treatment-for-chronic-scrotal-pain-in-adult-men-a-single-center-open-label-pilot-study
#7
Yash S Khandwala, Fernando Serrano, Michael L Eisenberg
BACKGROUND AND AIMS: Chronic scrotal pain is a common yet poorly understood urologic disease. Current treatment paradigms are sub-optimal and include anti-inflammatory drugs and opioids as well as invasive surgical management such as microdenervation of the spermatic cord. In this study, the efficacy of external vibratory stimulation (EVS) was evaluated as an alternative treatment option for idiopathic scrotal pain. MATERIALS AND METHODS: Ten consecutive patients presenting to an academic urology clinic between December 2016 and April 2017 with scrotal pain were prospectively enrolled...
November 7, 2017: Scandinavian Journal of Pain
https://www.readbyqxmd.com/read/29122463/immunogenicity-and-safety-of-one-versus-two-doses-of-tetravalent-dengue-vaccine-in-healthy-children-aged-2-17-years-in-asia-and-latin-america-18-month-interim-data-from-a-phase-2-randomised-placebo-controlled-study
#8
Xavier Sáez-Llorens, Vianney Tricou, Delia Yu, Luis Rivera, José Jimeno, Ana Cecilia Villarreal, Epiphany Dato, Sonia Mazara, Maria Vargas, Manja Brose, Martina Rauscher, Suely Tuboi, Astrid Borkowski, Derek Wallace
BACKGROUND: Development of vaccines that are effective against all four dengue virus serotypes (DENV-1-4) in all age groups is important. Here, we present 18-month interim data from an ongoing study undertaken to assess the immunogenicity and safety of Takeda's tetravalent dengue vaccine (TDV) candidate over 48 months in children living in dengue-endemic countries. METHODS: We undertook a phase 2, multicentre, randomised, double-blind, placebo-controlled study at three sites in the Dominican Republic, Panama, and the Philippines...
November 6, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29118984/clinical-trial-protocol-for-tardox-a-phase-i-study-to-investigate-the-feasibility-of-targeted-release-of-lyso-thermosensitive-liposomal-doxorubicin-thermodox%C3%A2-using-focused-ultrasound-in-patients-with-liver-tumours
#9
Paul C Lyon, Lucy F Griffiths, Jenni Lee, Daniel Chung, Robert Carlisle, Feng Wu, Mark R Middleton, Fergus V Gleeson, Constantin C Coussios
Background: TARDOX is a Phase I single center study of ultrasound triggered targeted drug delivery in adult oncology patients with incurable liver tumours. This proof of concept study is designed to demonstrate the safety and feasibility of targeted drug release and enhanced delivery of doxorubicin from thermally sensitive liposomes (ThermoDox®) triggered by mild hyperthermia induced by focused ultrasound in liver tumours. A key feature of the study is the direct quantification of the doxorubicin concentration before and after ultrasound exposure from tumour biopsies, using high performance liquid chromatography (HPLC)...
2017: Journal of Therapeutic Ultrasound
https://www.readbyqxmd.com/read/29118439/preventing-progression-from-arthralgia-to-arthritis-targeting-the-right-patients
#10
REVIEW
Hanna W van Steenbergen, José A Pereira da Silva, Tom W J Huizinga, Annette H M van der Helm-van Mil
Early treatment is associated with improved outcomes in patients with rheumatoid arthritis (RA), suggesting that a 'window of opportunity', in which the disease is most susceptible to disease-modifying treatment, exists. Autoantibodies and markers of systemic inflammation can be present long before clinical arthritis, and maturation of the immune response seems to coincide with the development of RA. The pre-arthritis phase associated with symptoms such as as joint pain without clinical arthritis (athralgia) is now hypothesized to fall within the aforementioned window of opportunity...
November 9, 2017: Nature Reviews. Rheumatology
https://www.readbyqxmd.com/read/29105592/biologic-annulus-fibrosus-repair-a-review-of-preclinical-in-vivo-investigations
#11
Stephen Rogers Sloan, Marianne Lintz, Ibrahim Hussain, Roger Härtl, Lawrence J Bonassar
Lower back pain, the leading cause of workplace absences and disability, is often attributed to intervertebral disc (IVD) degeneration in which nucleus pulposus (NP) herniates through lesions in the annulus fibrosus (AF) and impinges on the spinal cord and surrounding nerves. Surgeons remove extruded NP via discectomy when indicated by local/radicular pain supported by radiographic evidence, however current interventions do not alter the underlying disease or seal the AF. The reported rates of recurrent herniation or pain following discectomy cases range from 5-25%, which has pushed spine research in recent years towards annular repair and closure strategies...
November 4, 2017: Tissue Engineering. Part B, Reviews
https://www.readbyqxmd.com/read/29102836/efficacy-and-tolerability-of-minocycline-for-depression-a-systematic-review-and-meta-analysis-of-clinical-trials
#12
REVIEW
Joshua D Rosenblat, Roger S McIntyre
BACKGROUND: Minocycline has been identified as a potential novel treatment for depression. The objective of the current review is to determine the overall antidepressant efficacy and tolerability of minocycline. METHODS: Completed and ongoing clinical trials of minocycline for depression (both bipolar and unipolar) published prior to September 12, 2017 were identified through searching relevant databases. Using a random-effects model, data from randomized controlled trials (RCTs) were pooled to determine the antidepressant effect size of minocycline compared to placebo...
October 28, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/29100152/corrigendum-to-randomized-proof-of-concept-trial-of-low-dose-naltrexone-for-patients-with-breakthrough-symptoms-of-major-depressive-disorder-on-antidepressants-j-affect-disord-208-2017-jan-15-6-14-doi-10-1016-j-jad-2016-08-029-epub-2016-oct-1
#13
D Mischoulon, L Hylek, A S Yeung, A J Clain, L Baer, C Cusin, D F Ionescu, J E Alpert, D P Soskin, M Fava
No abstract text is available yet for this article.
October 27, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/29097511/precision-medicine-in-obesity-and-type-2-diabetes-the-relevance-of-early-life-exposures
#14
REVIEW
Angela C Estampador, Paul W Franks
BACKGROUND: Type 2 diabetes is highly prevalent and devastating. Obesity is a diabetogenic factor, driving insulin resistance and a compensatory demand for increased insulin secretion from the pancreatic β cells; a failure to address this demand results in diabetes. Accordingly, primary and secondary prevention of obesity are at the core of diabetes prevention programs. The development of obesity and decline in β-cell function often span many years or decades before diabetes is clinically manifest...
November 2, 2017: Clinical Chemistry
https://www.readbyqxmd.com/read/29093707/add-on-pyridostigmine-enhances-cd4-t-cell-recovery-in-hiv-1-infected-immunological-non-responders-a-proof-of-concept-study
#15
Sergio I Valdés-Ferrer, José C Crispín, Pablo F Belaunzarán-Zamudio, Carlos A Rodríguez-Osorio, Bernardo Cacho-Díaz, Jorge Alcocer-Varela, Carlos Cantú-Brito, Juan Sierra-Madero
Background: In human immunodeficiency virus (HIV)-infection, persistent T-cell activation leads to rapid turnover and increased cell death, leading to immune exhaustion and increased susceptibility to opportunistic infections. Stimulation of the vagus nerve increases acetylcholine (ACh) release and modulates inflammation in chronic inflammatory conditions, a neural mechanism known as the cholinergic anti-inflammatory pathway (CAP). Pyridostigmine (PDG), an ACh-esterase inhibitor, increases the half-life of endogenous ACh, therefore mimicking the CAP...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/29092520/a-brain-controlled-lower-limb-exoskeleton-for-human-gait-training
#16
Dong Liu, Weihai Chen, Zhongcai Pei, Jianhua Wang
Brain-computer interfaces have been a novel approach to translate human intentions into movement commands in robotic systems. This paper describes an electroencephalogram-based brain-controlled lower-limb exoskeleton for gait training, as a proof of concept towards rehabilitation with human-in-the-loop. Instead of using conventional single electroencephalography correlates, e.g., evoked P300 or spontaneous motor imagery, we propose a novel framework integrated two asynchronous signal modalities, i.e., sensorimotor rhythms (SMRs) and movement-related cortical potentials (MRCPs)...
October 2017: Review of Scientific Instruments
https://www.readbyqxmd.com/read/29090661/patent-foramen-ovale-closure-with-gore-helex-or-cardioform-septal-occluder-vs-antiplatelet-therapy-for-reduction-of-recurrent-stroke-or-new-brain-infarct-in-patients-with-prior-cryptogenic-stroke-design-of-the-randomized-gore-reduce-clinical-study
#17
Scott E Kasner, Lars Thomassen, Lars Søndergaard, John F Rhodes, Coby C Larsen, Joth Jacobson
Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone...
December 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/29089466/preclinical-and-clinical-advances-in-transposon-based-gene-therapy
#18
Jaitip Tipanee, Yoke Chin Chai, Thierry VandenDriessche, Marinee K Chuah
Transposons derived from Sleeping Beauty (SB), piggyBac (PB) or Tol2 typically require cotransfection of transposon DNA with a transposase either as an expression plasmid or mRNA. Consequently, this results in genomic integration of the potentially therapeutic gene into chromosomes of the desired target cells and thus conferring stable expression. Nonviral transfection methods are typically preferred to deliver the transposon components in to the target cells. However, these methods do not match the efficacy typically attained with viral vectors and are sometimes associated with cellular toxicity evoked by the DNA itself...
October 31, 2017: Bioscience Reports
https://www.readbyqxmd.com/read/29084144/bipolar-disorder-and-immune-dysfunction-epidemiological-findings-proposed-pathophysiology-and-clinical-implications
#19
REVIEW
Joshua D Rosenblat, Roger S McIntyre
Bipolar disorder (BD) is strongly associated with immune dysfunction. Replicated epidemiological studies have demonstrated that BD has high rates of inflammatory medical comorbidities, including autoimmune disorders, chronic infections, cardiovascular disease and metabolic disorders. Cytokine studies have demonstrated that BD is associated with chronic low-grade inflammation with further increases in pro-inflammatory cytokine levels during mood episodes. Several mechanisms have been identified to explain the bidirectional relationship between BD and immune dysfunction...
October 30, 2017: Brain Sciences
https://www.readbyqxmd.com/read/29080386/the-apex-trial-effects-of-allopurinol-on-exercise-capacity-coronary-and-peripheral-endothelial-function-and-natriuretic-peptides-in-patients-with-cardiac-syndrome-x
#20
Tiong Keng Lim, Awson Noman, AnnaMaria J Choy, Faisel Khan, Allan D Struthers, Chim C Lang
The role of endothelial dysfunction and oxidative stress in the pathogenesis of cardiac syndrome X has recently been recognised. Allopurinol has previously been shown to improve endothelial dysfunction, reduce oxidative stress burden and improve myocardial efficiency. In this 'proof of concept' study, we investigated the effect of allopurinol on exercise capacity, coronary and peripheral endothelial function, and serum B-type natriuretic peptide (BNP: a marker of cardiac function and myocardial ischaemia) in patients with cardiac syndrome X...
October 28, 2017: Cardiovascular Therapeutics
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