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Proof of concept clinical trial

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https://www.readbyqxmd.com/read/28738565/zwitterionic-hydrophilic-interaction-liquid-chromatography-tandem-mass-spectrometry-with-hybridspe-precipitation-for-the-determination-of-intact-cisplatin-in-human-plasma
#1
Feifan Xie, Pieter Colin, Jan Van Bocxlaer
Cisplatin is a first-line chemotherapeutic for the treatment of a wide variety of cancers since its discovery in the 1960s. Although various techniques have been reported for the measurement of total platinum in biological matrices, such as inductively coupled plasma-mass spectrometry and derivatization procedures, a specific, sensitive and robust assay for the quantification of intact cisplatin is still lacking. Therefore, we present a rapid, selective, sensitive, and reliable UHPLC-MS/MS based method for the determination of intact cisplatin in human plasma in support of a Phase II clinical trial...
November 1, 2017: Talanta
https://www.readbyqxmd.com/read/28735873/the-therapeutic-potential-of-purinergic-signalling
#2
REVIEW
Geoffrey Burnstock
This review is focused on the pathophysiology and therapeutic potential of purinergic signalling. A wide range of diseases are considered, including those of the central nervous system, skin, kidney, musculoskeletal, liver gut, lower urinary tract, cardiovascular, airways and reproductive systems, the special senses, infection, diabetes and obesity. Several purinergic drugs are already on the market, including P2Y12 receptor antagonists for stroke and thrombosis, P2Y2 receptor agonists for dry eye, A1 receptor agonists for supraventricular tachycardia...
July 20, 2017: Biochemical Pharmacology
https://www.readbyqxmd.com/read/28723914/safety-and-pharmacodynamics-of-dalazatide-a-kv1-3-channel-inhibitor-in-the-treatment-of-plaque-psoriasis-a-randomized-phase-1b-trial
#3
Eric J Tarcha, Chelsea M Olsen, Peter Probst, David Peckham, Ernesto J Muñoz-Elías, James G Kruger, Shawn P Iadonato
BACKGROUND: Dalazatide is a specific inhibitor of the Kv1.3 potassium channel. The expression and function of Kv1.3 channels are required for the function of chronically activated memory T cells, which have been shown to be key mediators of autoimmune diseases, including psoriasis. OBJECTIVE: The primary objective was to evaluate the safety of repeat doses of dalazatide in adult patients with mild-to-moderate plaque psoriasis. Secondary objectives were to evaluate clinical proof of concept and the effects of dalazatide on mediators of inflammation in the blood and on chronically activated memory T cell populations...
2017: PloS One
https://www.readbyqxmd.com/read/28714735/effect-of-yoga-breathing-pranayama-on-exercise-tolerance-in-patients-with-chronic-obstructive-pulmonary-disease-a-randomized-controlled-trial
#4
David A Kaminsky, Kalpalatha K Guntupalli, Joan Lippmann, Stephanie M Burns, Melissa A Brock, Joan Skelly, Michael DeSarno, Heidi Pecott-Grimm, Ali Mohsin, Catherine LaRock-McMahon, Penney Warren, Martha C Whitney, Nicola A Hanania
OBJECTIVE: Pulmonary rehabilitation improves exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). However, many patients do not have access to pulmonary rehabilitation programs. We hypothesized that an alternative to pulmonary rehabilitation to improve exercise tolerance is the practice of pranayama, or yoga breathing, which could be done independently at home. We also sought to determine whether yoga nonprofessionals could adequately teach pranayama to patients...
July 17, 2017: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/28709498/targeting-fyn-kinase-in-alzheimer-s-disease
#5
REVIEW
Haakon B Nygaard
The past decade has brought tremendous progress in unraveling the pathophysiology of Alzheimer's disease (AD). While increasingly sophisticated immunotherapy targeting soluble and aggregated brain amyloid-beta (Aβ) continues to dominate clinical research in AD, a deeper understanding of Aβ physiology has led to the recognition of distinct neuronal signaling pathways linking Aβ to synaptotoxicity and neurodegeneration and to new targets for therapeutic intervention. Identifying specific signaling pathways involving Aβ has allowed for the development of more precise therapeutic interventions targeting the most relevant molecular mechanisms leading to AD...
June 13, 2017: Biological Psychiatry
https://www.readbyqxmd.com/read/28706485/the-combination-of-rituximab-and-bendamustine-as-first-line-treatment-is-highly-effective-in-the-eradicating-minimal-residual-disease-in-follicular-lymphoma-an-italian-retrospective-study
#6
Sara Galimberti, Elena Ciabatti, Giacomo Ercolano, Susanna Grassi, Francesca Guerrini, Nadia Cecconi, Martina Rousseau, Giulia Cervetti, Francesco Mazziotta, Lorenzo Iovino, Franca Falzetti, Flavio Falcinelli, Alberto Bosi, Luigi Rigacci, Sofia Kovalchuk, Daniele Vallisa, Lucia Macchia, Eugenio Ciancia, Mario Petrini
R-Bendamustine is an effective treatment for follicular lymphoma (FL). Previous large trials demonstrated the prognostic role of the molecular minimal residual disease (MRD) during the most frequently adopted chemotherapeutic regimens, but there are not yet conclusive data about the effect of combination of rituximab (R) and bendamustine in terms of MRD clearance. Thus, the aim of this retrospective study was to assess if and in what extent the combination of rituximab and bendamustine would exert a significant reduction of the molecular disease in 48 previously untreated FL patients...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28693439/combatting-pain-after-orthopedic-trauma-surgery-perioperative-oral-extended-release-tapentadol-vs-extended-release-oxycodone-naloxone
#7
Gertrud Haeseler, Dirk Schaefers, Natalie Prison, Jörg Ahrens, Xiaofei Liu, Annika Karch
BACKGROUND: High post-operative pain scores after "minor" orthopedic/trauma surgery are in part attributed to inadequate prescription of opioid analgesics. Novel concepts aiming to achieve sufficient analgesia while minimizing opioid-related side effects by avoiding fluctuating plasma levels are based on perioperative oral administration of extended-release opioids beginning with the first dose pre-operatively. This is the first study to evaluate analgesic efficacy and side effect rates of extended-release tapentadol compared to oxycodone/naloxone following orthopedic/trauma surgery...
July 11, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28675563/neuroinflammatory-targets-and-treatments-for-epilepsy-validated-in-experimental-models
#8
Eleonora Aronica, Sebastian Bauer, Yuri Bozzi, Matteo Caleo, Raymond Dingledine, Jan A Gorter, David C Henshall, Daniela Kaufer, Sookyong Koh, Wolfgang Löscher, Jean-Pierre Louboutin, Michele Mishto, Braxton A Norwood, Eleonora Palma, Michael O Poulter, Gaetano Terrone, Annamaria Vezzani, Rafal M Kaminski
A large body of evidence that has accumulated over the past decade strongly supports the role of inflammation in the pathophysiology of human epilepsy. Specific inflammatory molecules and pathways have been identified that influence various pathologic outcomes in different experimental models of epilepsy. Most importantly, the same inflammatory pathways have also been found in surgically resected brain tissue from patients with treatment-resistant epilepsy. New antiseizure therapies may be derived from these novel potential targets...
July 2017: Epilepsia
https://www.readbyqxmd.com/read/28673279/pharmacogenetic-evaluation-to-assess-breakthrough-psychosis-with-aripiprazole-long-acting-injection-a-case-report
#9
Seenae Eum, Mark E Schneiderhan, Jacob T Brown, Adam M Lee, Jeffrey R Bishop
BACKGROUND: Given the complex nature of symptom presentation and medication regimens, psychiatric clinics may benefit from additional tools to personalize treatments. Utilizing pharmacogenetic information may be helpful in assessing unique responses to therapy. We report herein a case of wearing-off phenomena during treatment with aripiprazole long-acting injectable (LAI) and a proof of concept strategy of how pharmacogenetic information may be used to assess possible genetic factors and also hypothesize potential mechanisms for further study...
July 3, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28667887/feasibility-safety-and-preliminary-efficacy-of-low-amplitude-seizure-therapy-lap-st-a-proof-of-concept-clinical-trial-in-man
#10
Nagy A Youssef, Emad Sidhom
BACKGROUND: Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5-0.6A) minimizes cognitive adverse effects while retaining efficacy. METHODS: Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study...
November 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28667510/a-randomized-controlled-trial-of-ganaxolone-in-posttraumatic-stress-disorder
#11
Ann M Rasmusson, Christine E Marx, Sonia Jain, Gail M Farfel, Julia Tsai, Xiaoying Sun, Thomas D Geracioti, Mark B Hamner, James Lohr, Richard Rosse, Lanier Summerall, Jennifer C Naylor, Cristine Cusin, Ariel J Lang, Rema Raman, Murray B Stein
Preclinical and clinical research supports a role for neuroactive steroids in the pathophysiology of posttraumatic stress disorder (PTSD). We investigated ganaxolone (a synthetic 3β-methylated derivative of allopregnanolone, a GABAergic neuroactive steroid) for treatment of PTSD in a proof-of-concept, multisite, double-blind, placebo-controlled trial. Veteran and non-veteran participants (n = 112) were randomized to ganaxolone or placebo at biweekly escalating doses of 200, 400, and 600 mg twice daily for 6 weeks...
August 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28667207/a-cluster-randomised-controlled-proof-of-concept-study-to-explore-the-feasibility-and-effect-of-a-patient-directed-intervention-on-quality-of-life-in-patients-with-advanced-soft-tissue-sarcoma
#12
Markus Schuler, Stephan Richter, Gerhard Ehninger, Martin Bornhäuser, Leopold Hentschel
INTRODUCTION: Even with evolving and expanding therapeutical options for the treatment of advanced sarcomas over recent years, the balance between efficacy and toxicity still remains a major concern. Moreover, the symptom burden in patients with sarcoma remains high compared with other malignant diseases. It is, therefore, crucial to assess treatment effectiveness not only in terms of disease-related outcomes (eg, overall survival) but also from an individual and patient-centred perspective using the assessment of patient-reported outcomes (PROs)...
June 30, 2017: BMJ Open
https://www.readbyqxmd.com/read/28660121/point-of-care-testing-to-promote-cardiovascular-disease-risk-assessment-a-proof-of-concept-study
#13
Kunal N Karmali, Tiffany Brown, Thomas Sanchez, Timothy Long, Stephen D Persell
Updated cholesterol guidelines emphasize multivariable cardiovascular disease (CVD) risk estimation to guide treatment decision-making in primary prevention. This study tested the preliminary feasibility, acceptability and efficacy of point-of-care testing (POCT) and quantitative CVD risk assessment in high-risk adults to increase guideline-recommended statin use in primary prevention. Participants were aged 40-75 years, without CVD or diabetes mellitus, and potentially-eligible for consideration of statins based on estimated 10-year CVD risk from last-measured risk factor levels in the electronic health record...
September 2017: Preventive Medicine Reports
https://www.readbyqxmd.com/read/28649911/three-dimensional-printed-upper-limb-prostheses-lack-randomised-controlled-trials-a-systematic-review
#14
Laura E Diment, Mark S Thompson, Jeroen Hm Bergmann
BACKGROUND: Three-dimensional printing provides an exciting opportunity to customise upper-limb prostheses. OBJECTIVE: This review summarises the research that assesses the efficacy and effectiveness of three-dimensional printed upper-limb prostheses. STUDY DESIGN: Systematic review. METHODS: PubMed, Web of Science and OVID were systematically searched for studies that reported human trials of three-dimensional printed upper-limb prostheses...
June 1, 2017: Prosthetics and Orthotics International
https://www.readbyqxmd.com/read/28649438/translational-learning-from-clinical-studies-predicts-drug-pharmacokinetics-across-patient-populations
#15
Markus Krauss, Ute Hofmann, Clemens Schafmayer, Svitlana Igel, Jan Schlender, Christian Mueller, Mario Brosch, Witigo von Schoenfels, Wiebke Erhart, Andreas Schuppert, Michael Block, Elke Schaeffeler, Gabriele Boehmer, Linus Goerlitz, Jan Hoecker, Joerg Lippert, Reinhold Kerb, Jochen Hampe, Lars Kuepfer, Matthias Schwab
Early indication of late-stage failure of novel candidate drugs could be facilitated by continuous integration, assessment, and transfer of knowledge acquired along pharmaceutical development programs. We here present a translational systems pharmacology workflow that combines drug cocktail probing in a specifically designed clinical study, physiologically based pharmacokinetic modeling, and Bayesian statistics to identify and transfer (patho-)physiological and drug-specific knowledge across distinct patient populations...
2017: NPJ Systems Biology and Applications
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
#16
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
#17
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
#18
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
#19
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
#20
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, Richard T Stravitz, Jasmohan S Bajaj
BACKGROUND & AIMS: Readmissions are a major burden in cirrhosis. A proportion of readmissions in cirrhosis, especially because of 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
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