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https://www.readbyqxmd.com/read/29150198/comparative-effectiveness-of-extended-release-naltrexone-versus-buprenorphine-naloxone-for-opioid-relapse-prevention-x-bot-a-multicentre-open-label-randomised-controlled-trial
#1
Joshua D Lee, Edward V Nunes, Patricia Novo, Ken Bachrach, Genie L Bailey, Snehal Bhatt, Sarah Farkas, Marc Fishman, Phoebe Gauthier, Candace C Hodgkins, Jacquie King, Robert Lindblad, David Liu, Abigail G Matthews, Jeanine May, K Michelle Peavy, Stephen Ross, Dagmar Salazar, Paul Schkolnik, Dikla Shmueli-Blumberg, Don Stablein, Geetha Subramaniam, John Rotrosen
BACKGROUND: Extended-release naltrexone (XR-NTX), an opioid antagonist, and sublingual buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct interventions to prevent opioid relapse. We aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX. METHODS: We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial at eight US community-based inpatient services and followed up participants as outpatients...
November 14, 2017: Lancet
https://www.readbyqxmd.com/read/29141461/development-of-magnetic-anionic-liposome-atelocollagen-complexes-for-efficient-magnetic-drug-targeting
#2
Yusuke Kono, Taketo Nakai, Hitomi Taguchi, Takuya Fujita
Magnetic nanoparticle-incorporated liposomes (magnetic liposomes) are considered a promising site-specific drug delivery carrier vehicle. With regard to their surface charge, magnetic anionic liposomes (Mag-AL) demonstrate little toxicity in comparison with magnetic cationic liposomes (Mag-CL), whereas their cellular association and uptake efficiency are low. In the current study, we constructed complexes of Mag-AL and atelocollagen (ATCOL), which is a biocompatible and minimally immunogenic biomaterial, to improve the cellular uptake properties of Mag-AL in vitro and in vivo...
November 2017: Drug Delivery
https://www.readbyqxmd.com/read/29136037/safety-pharmacokinetics-and-immunological-activities-of-multiple-intravenous-or-subcutaneous-doses-of-an-anti-hiv-monoclonal-antibody-vrc01-administered-to-hiv-uninfected-adults-results-of-a-phase-1-randomized-trial
#3
Kenneth H Mayer, Kelly E Seaton, Yunda Huang, Nicole Grunenberg, Abby Isaacs, Mary Allen, Julie E Ledgerwood, Ian Frank, Magdalena E Sobieszczyk, Lindsey R Baden, Benigno Rodriguez, Hong Van Tieu, Georgia D Tomaras, Aaron Deal, Derrick Goodman, Robert T Bailer, Guido Ferrari, Ryan Jensen, John Hural, Barney S Graham, John R Mascola, Lawrence Corey, David C Montefiori
BACKGROUND: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed. METHODS AND FINDINGS: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29132988/safety-and-immunogenicity-of-a-novel-multiple-antigen-pneumococcal-vaccine-in-adults-a-phase-1-randomised-clinical-trial
#4
Claire Entwisle, Sue Hill, Yin Pang, Michael Joachim, Ann McIlgorm, Camilo Colaco, David Goldblatt, Polly De Gorguette D'Argoeuves, Chris Bailey
BACKGROUND: Pneumococcal vaccines, combining multiple protein antigens, provide an alternative approach to currently marketed vaccines and may provide broader protection against pneumococcal disease. This trial evaluated the safety and immunogenicity of a novel vaccine candidate PnuBioVax in healthy young adults. METHODS: In a Phase 1 double-blind study, 36 subjects (18-40 years) were randomised to receive 3 doses of PnuBioVax, 28 days apart, at one of three dose levels (50, 200, 500 µg) or placebo...
November 10, 2017: Vaccine
https://www.readbyqxmd.com/read/29112001/a-phase-ii-study-to-evaluate-the-pharmacokinetics-safety-and-tolerability-of-risperidone-ism-multiple-intramuscular-injections-once-every-4-weeks-in-patients-with-schizophrenia
#5
Lourdes A Carabias, Jordi Llaudó, Ignacio Ayani, Javier Martínez, Robert E Litman, Ibón Gutierro
This study characterized the pharmacokinetics, safety, and tolerability of Risperidone ISM, a new long-acting intramuscular formulation, for monthly administration without oral supplementation. Patients with schizophrenia received multiple intramuscular injections of 75 mg in the gluteal or deltoid muscle at 28-day intervals. Of the 70 randomized patients, 67 received at least one dose of study medication. The mean Cmax of the active moiety was achieved 24-48 h (tmax) after each administration, regardless of injection site...
November 3, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/29108392/cauterization-of-ozurdex-wound-for-the-prevention-of-scleral-leakage-in-vitrectomized-eyes
#6
Claudio Furino, Nicola Recchimurzo, Francesco Boscia, Giovanni Alessio
PURPOSE: To study if cauterization of the scleroconjuctival wound secondary to intravitreal dexamethasone implant in vitrectomized eyes is effective to avoid scleral leakage and hypotony. METHODS: A total of 35 vitrectomized eyes of 35 consecutive patients with macular edema who underwent a single intravitreal dexamethasone implant injection in the operating room at the Eye Clinic of the University of Bari, Italy, from 2013 to 2017 were retrospectively reviewed...
October 31, 2017: European Journal of Ophthalmology
https://www.readbyqxmd.com/read/29103774/a-single-arm-open-label-clinical-trial-of-autologous-epidermal-cell-transplantation-for-stable-vitiligo-a-30-month-follow-up
#7
Zahra Orouji, Amir Bajouri, Mahshid Ghasemi, Parvaneh Mohammadi, Nasrin Fallah, Atefeh Shahbazi, Mohammad Rezvani, Fatemeh Vaezirad, Zahra Khalajasadi, Ahad Alizadeh, Ehsan Taghiabadi, Sara Dashtbozorgi, Raheleh Aghdami, Seyedeh Esmat Hosseini, Hossein Bahahrvand, Saeed Shafieyan, Nasser Aghdami
BACKGROUND: Recently, we introduced intralesional injection of autologous epidermal cells as a safe and feasible approach for transplantation in patients with stable vitiligo. This approach resulted in less pain during and after the procedure, no scarring or cobblestone formation at the recipient site, and was more feasible to perform on curved surfaces such as joints, lips, eyelids, ears, and face. OBJECTIVE: In this study, we aimed to investigate the long-term efficacy and safety of this transplantation technique...
October 18, 2017: Journal of Dermatological Science
https://www.readbyqxmd.com/read/29101560/feasibility-and-outcomes-of-underwater-endoscopic-mucosal-resection-for-%C3%A2-%C3%A2-10%C3%A2-mm-colorectal-polyps
#8
Keith Siau, Sauid Ishaq, Sergio Cadoni, Toshio Kuwai, Abdulkani Yusuf, Noriko Suzuki
BACKGROUND: Underwater endoscopic mucosal resection (UEMR) is an emerging strategy for the management of colorectal polyps. We aimed to evaluate the efficacy and safety of UEMR for clinically significant (≥ 10 mm) colorectal polyps. METHODS: We performed a prospective dual-centre study of polyps ≥ 10 mm undergoing UEMR between June 2014 and March 2017. Outcomes measured comprised: (1) completeness of resection at index UEMR, (2) intraprocedural and 30-day complications, (3) rates and predictors of submucosal lift, en bloc resection, polyp/adenoma recurrence and (4) pain score...
November 3, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/29074201/safety-acceptability-and-tolerability-of-uncoated-and-excipient-coated-high-density-silicon-micro-projection-array-patches-in-human-subjects
#9
Paul Griffin, Suzanne Elliott, Kenia Krauer, Cristyn Davies, S Rachel Skinner, Christopher D Anderson, Angus Forster
Most vaccinations are performed by intramuscular injection with a needle and syringe. However, this method is not ideal due to limitations, such as the risk of needle-stick injury, the requirement for trained personnel to give injections and the need to reconstitute lyophilized vaccines. Therefore, we tested an alternative delivery technology that overcomes the problems with needle and syringe. The Nanopatch™ is an array of 10,000 silicon micro-projections per cm(2) that can be dry-coated with vaccine for skin delivery...
October 23, 2017: Vaccine
https://www.readbyqxmd.com/read/29067332/ub-311-a-novel-ubith-%C3%A2-amyloid-%C3%AE-peptide-vaccine-for-mild%C3%A2-alzheimer-s%C3%A2-disease
#10
Chang Yi Wang, Pei-Ning Wang, Ming-Jang Chiu, Connie L Finstad, Feng Lin, Shugene Lynn, Yuan-Hung Tai, Xin De Fang, Kesheng Zhao, Chung-Ho Hung, Yiting Tseng, Wen-Jiun Peng, Jason Wang, Chih-Chieh Yu, Be-Sheng Kuo, Paul A Frohna
INTRODUCTION: A novel amyloid β (Aβ) synthetic peptide vaccine (UB-311) has been evaluated in a first-in-human trial with patients of mild-to-moderate Alzheimer's disease. We describe translational research covering vaccine design, preclinical characterization, and phase-I clinical trial with supportive outcome that advances UB-311 into an ongoing phase-II trial. METHODS: UB-311 is constructed with two synthetic Aβ1-14-targeting peptides (B-cell epitope), each linked to different helper T-cell peptide epitopes (UBITh(®)) and formulated in a Th2-biased delivery system...
June 2017: Alzheimer's & Dementia: Translational Research & Clinical Interventions
https://www.readbyqxmd.com/read/29062633/comparative-effectiveness-of-needle-aponeurotomy-and-collagenase-injection-for-dupuytren-s-contracture-a-multicenter-study
#11
Chao Zhou, Steven E R Hovius, Adriana J Pieters, Harm P Slijper, Reinier Feitz, Ruud W Selles
BACKGROUND: Although the efficacy of collagenase clostridium histolyticum (CCH) injections has been demonstrated by randomized clinical trials, the relative effectiveness of CCH remains uncertain. Our aim was to compare the outcomes of CCH with those of percutaneous needle aponeurotomy (PNA) in daily clinical practice. METHODS: We analyzed data from patients undergoing PNA or CCH between 2011 and 2014 at 7 practice sites in the Netherlands. We examined the degree of improvement in contracture and adverse effects at 6-12 weeks after surgery or the last injection...
September 2017: Plastic and Reconstructive Surgery. Global Open
https://www.readbyqxmd.com/read/29054133/effects-of-intrathecal-injection-of-the-conditioned-medium-of-bone-marrow-stromal-cells-on-spinal-cord-injury-of-rats
#12
Kenji Kanekiyo, Tamami Wakabayashi, Norihiko Nakano, Yoshihiro Yamada, Masahiro Tamachi, Yoshihisa Suzuki, Masanori Fukushima, Fukuki Saito, Seiya Abe, Chihiro Tsukagoshi, Chimi Miyamoto, Chizuka Ide
Bone marrow stromal cells (BMSCs) have been studied for the treatment of spinal cord injury (SCI). In previous studies, we showed that the transplantation of BMSCs, even though they disappeared from the host spinal cord within 1-3 weeks after transplantation, improved locomotor behaviors and promoted axonal regeneration. This result led to the hypothesis that BMSCs might release some neurotrophic factors effective for the treatment of SCI. The present study examined this by injecting the conditioned medium (CM) of BMSCs to treat SCI in rats...
October 20, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/29042238/novel-strategy-for-immunomodulation-dissolving-microneedle-array-encapsulating-thymopentin-fabricated-by-modified-two-step-molding-technology
#13
Shiqi Lin, Bingzhen Cai, Guilan Quan, Tingting Peng, Gangtao Yao, Chune Zhu, Qiaoli Wu, Hao Ran, Xin Pan, Chuanbin Wu
Thymopentin (TP5) is commonly used in the treatment for autoimmune diseases, with a short plasma half-life (30 s) and a long treatment period (7 days to 6 months). It is usually administrated by syringe injection, resulting in compromised patient compliance. Dissolving microneedle array (DMNA) offers a superior approach for transdermal delivery of biological macromolecules, as it allows painless penetration through the stratum corneum and generates minimal biohazardous waste after dissolving in the skin. Despite recent advances in DMNA as a novel approach for transdermal drug delivery, problem of insufficient mechanical strength remains to be solved...
October 14, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29040377/safest-practices-for-autologous-buttock-augmentation-with-fat-grafting-using-a-roller-pump-injection-technique
#14
Marc Everett, Rolando Morales, German Newall, Paul F Fortes, Kristi L Hustak, Christopher K Patronella, Henry A Mentz
Background: Autologous buttock augmentation with fat grafting has emerged as one of the preeminent modalities for body contouring employed by plastic surgeons today. Since 2009, we have used the roller pump injection technique. Objectives: This procedure can be performed safely without specialized equipment and eliminates the tasks of manual graft preparation and injection. We describe our technique and standard safety measures. The anatomy of and complications associated with liposuction and fat grafting were recorded and reviewed...
June 23, 2017: Aesthetic Surgery Journal
https://www.readbyqxmd.com/read/29034314/targeting-an-oncolytic-influenza-a-virus-to-tumor-tissue-by-elastase
#15
Irina Kuznetsova, Tobias Arnold, Thomas Aschacher, Cornelia Schwager, Balazs Hegedus, Tamas Garay, Marina Stukova, Maria Pisareva, Stephan Pleschka, Michael Bergmann, Andrej Egorov
Oncolytic viruses are currently established as a novel type of immunotherapy. The challenge is to safely target oncolytic viruses to tumors. Previously, we have generated influenza A viruses (IAVs) containing deletions in the viral interferon antagonist. Those deletions have attenuated the virus in normal tissue but allowed replication in tumor cells. IAV entry is mediated by hemagglutinin (HA), which needs to be activated by a serine protease, for example, through trypsin. To further target the IAV to tumors, we have changed the trypsin cleavage site to an elastase cleavage site...
December 15, 2017: Molecular Therapy Oncolytics
https://www.readbyqxmd.com/read/29027640/the-utility-of-botulinum-toxin-a-in-the-repair-of-distal-biceps-tendon-ruptures
#16
L S Khalil, R A Keller, N Mehran, N E Marshall, K Okoroha, N B Frisch, S P DeSilva
PURPOSE: The purpose of our study is to report the outcomes and complications in patients who underwent distal biceps tendon repair with the use of Botulinum toxin A (BoNT-A) as an adjunct to surgery. METHODS: A retrospective review of 14 patients who underwent 15 distal biceps tendon repairs was performed. All repaired tendons had their correlating muscle bellies injected intraoperatively with a mixture of 100U of BoNT-A and 10 ml of normal saline. Each patient was evaluated for surgical and post-operative complications and followed with Disabilities of the Arm, Shoulder and Hand (DASH) Disability Scores...
October 13, 2017: Musculoskeletal Surgery
https://www.readbyqxmd.com/read/29020321/comparison-of-a-novel-human-rabies-monoclonal-antibody-to-human-rabies-immunoglobulin-for-post-exposure-prophylaxis-a-phase-2-3-randomized-single-blind-non-inferiority-controlled-study
#17
Nithya J Gogtay, Renuka Munshi, D H Ashwathnarayan, B J Mahendra, Vikas Kshirsagar, Bhagwat Gunale, Susan Moore, Peter Cheslock, Saket Thaker, Siddharth Deshpande, Sunil Karande, Dipti Kumbhar, Ravish H S, B R Harish, Sambhaji S Pisal, Rajeev Dhere, Varsha Parulekar, William C Blackwelder, Deborah C Molrine, Prasad S Kulkarni
Background: Lack of access to rabies immunoglobulin (RIG) contributes to the high rabies mortality. A recombinant human monoclonal antibody (SII RMAb) was tested in a post-exposure prophylaxis (PEP) regimen in comparison to a human RIG (HRIG)-containing PEP regimen. Methods: This was a Phase 2/3 randomized, single blind, non-inferiority study conducted in 200 participants with WHO category III suspected rabies exposures. On Day 0, participants received either SII RMAb or HRIG (1:1 ratio) into wounds and if required, intramuscularly (IM) along with five doses of rabies vaccine IM on Days 0, 3, 7, 14 and 28...
September 15, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28991571/wrist-arthroscopy-under-portal-site-local-anesthesia-without-tourniquet-and-sedation
#18
REVIEW
Siu-Cheong Jeffrey Justin Koo, Pak-Cheong Ho
We had developed the technique of portal site local anaesthesia (PSLA) for wrist arthroscopy. Two percent lidocaine with 1:200,000 epinephrine is injected through a 25G needle to various portal sites. The radiocarpal joint is then distended with saline injection and portal is created with transverse superficial skin incision followed by dilation with curved hemostat. The patient is neither sedated, nor under general or regional anaesthesia. Tourniquet is not routinely used. PSLA can achieve satisfactory comfort level in 88% of our 111 patients without any complication...
November 2017: Hand Clinics
https://www.readbyqxmd.com/read/28986092/population-based-hpv-vaccination-programmes-are-safe-and-effective-2017-update-and-the-impetus-for-achieving-better-global-coverage
#19
REVIEW
Julia M L Brotherton, Paul N Bloem
Persistent oncogenic human papillomavirus (HPV) is the cause of cervical cancer, as well as cancers of the anus, penis, vulva, vagina and oropharynx. There is good evidence that prophylactic HPV vaccines are immunogenic and effective against targeted-type HPV infections and type-specific genital lesions, including high-grade cervical intraepithelial neoplasia (CIN), when administered prior to HPV infection. There is good evidence that HPV vaccines are safe in population usage, with the most frequent adverse event being injection-site reactions...
September 6, 2017: Best Practice & Research. Clinical Obstetrics & Gynaecology
https://www.readbyqxmd.com/read/28983894/consecutive-case-series-of-244-age-related-macular-degeneration-patients-undergoing-implantation-with-an-extended-macular-vision-iol
#20
Muhammad A Qureshi, Scott J Robbie, Fritz H Hengerer, Gerd U Auffarth, Ina Conrad-Hengerer, Pablo Artal
PURPOSE: To determine safety and visual outcomes in eyes with age-related macular degeneration (AMD) implanted with a novel intraocular lens (IOL) that delivers an optimized retinal image to all macular areas within 10 degrees of retinal eccentricity. METHODS: This was a consecutive case series of 244 eyes with dry/stable wet AMD and logMAR visual acuity ≥0.3 implanted with iolAMD Eyemax monoTM (London Eye Hospital Pharma), a single-piece, injectable, hydrophobic acrylic IOL sited in the capsular bag...
October 5, 2017: European Journal of Ophthalmology
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