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https://www.readbyqxmd.com/read/28546769/treatment-of-chronic-low-back-pain-new-approaches-on-the-horizon
#1
REVIEW
Nebojsa Nick Knezevic, Shane Mandalia, Jennifer Raasch, Ivana Knezevic, Kenneth D Candido
Back pain is the second leading cause of disability among American adults and is currently treated either with conservative therapy or interventional pain procedures. However, the question that remains is whether we, as physicians, have adequate therapeutic options to offer to the patients who suffer from chronic low back pain but fail both conservative therapy and interventional pain procedures before they consider surgical options such as discectomy, disc arthroplasty, or spinal fusion. The purpose of this article is to review the potential novel therapies that are on the horizon for the treatment of chronic low back pain...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28546463/a-phase-ii-study-of-everolimus-plus-oral-prednisone-in-patients-with-metastatic-renal-cell-cancer
#2
Cristian Lolli, Valentina Gallà, Giuseppe Schepisi, Domenico Barone, Salvatore Luca Burgio, Antonio Maugeri, Bernadette Vertogen, Dino Amadori, Ugo De Giorgi
LESSONS LEARNED: The combination of everolimus and low-dose prednisone administered daily was hypothesized to prevent noninfectious pneumonitis (NIP) and mucositis, two common adverse events related to everolimus. Although mucositis was detected in only one case, all-grade NIP occurred in four of eight cases (50%), and this was considered enough to stop accrual of the study.These data suggest the need for careful monitoring of patients receiving everolimus who are treated with corticosteroids...
May 25, 2017: Oncologist
https://www.readbyqxmd.com/read/28546227/keyboard-a-novel-bayesian-toxicity-probability-interval-design-for-phase-i-clinical-trials
#3
Fangrong Yan, Sumithra J Mandrekar, Ying Yuan
The primary objective of phase I oncology trials is to find the maximum tolerated dose (MTD). The 3+3 design is easy to implement but performs poorly in finding the MTD. A newer design, such as the modified toxicity probability interval (mTPI) design, provides better accuracy to identify the MTD but tends to overdose patients. We propose the keyboard design, an intuitive Bayesian design that conducts dose escalation and de-escalation based on whether the strongest key, defined as the dosing interval that most likely contains the current dose, is below or above the target dosing interval...
May 25, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28546065/external-beam-radiotherapy-affects-serum-testosterone-in-patients-with-localized-prostate-cancer
#4
Raisa S Pompe, Pierre I Karakiewicz, Emanuele Zaffuto, Ariane Smith, Marco Bandini, Michele Marchioni, Zhe Tian, Sami-Ramzi Leyh-Bannurah, Jonas Schiffmann, Guila Delouya, Carole Lambert, Jean-Paul Bahary, Marie Claude Beauchemin, Maroie Barkati, Cynthia Ménard, Markus Graefen, Fred Saad, Derya Tilki, Daniel Taussky
BACKGROUND: Previous studies have examined testosterone levels after external beam radiation (EBRT) monotherapy, but since 2002 only sparse contemporary data have been reported. AIM: To examine testosterone kinetics in a large series of contemporary patients after EBRT. METHODS: The study was conducted in 425 patients who underwent definitive EBRT for localized prostate cancer from 2002 through 2014. Patients were enrolled in several phase II and III trials...
May 22, 2017: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/28545837/emerging-technologies-for-prediction-of-drug-candidate-efficacy-in-the-preclinical-pipeline
#5
Denis Menshykau
The pharmaceutical industry is tackling increasingly complex multifactorial diseases, resulting in increases in research & development (R&D) costs and reductions in the success rates for drug candidates during Phase 2 and 3 clinical trials, with a lack of efficacy being the primary reason for drug candidate failure. This implies that the predictive power of current preclinical assays for drug candidate efficacy is suboptimal and, therefore, that alternatives should be developed. Here, I review emerging in vitro, imaging, and in silico technologies and discuss their potential contribution to drug efficacy assessment...
May 22, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28544662/tracheal-replacement-therapy-with-a-stem-cell-seeded-graft-lessons-from-compassionate-use-application-of-a-gmp-compliant-tissue-engineered-medicine
#6
Martin J Elliott, Colin R Butler, Aikaterini Varanou-Jenkins, Leanne Partington, Carla Carvalho, Edward Samuel, Claire Crowley, Peggy Lange, Nicholas J Hamilton, Robert E Hynds, Tahera Ansari, Paul Sibbons, Anja Fierens, Claire McLaren, Derek Roebuck, Colin Wallis, Nagarajan Muthialu, Richard Hewitt, David Crabbe, Sam M Janes, Paolo De Coppi, Mark W Lowdell, Martin A Birchall
Tracheal replacement for the treatment of end-stage airway disease remains an elusive goal. The use of tissue-engineered tracheae in compassionate use cases suggests that such an approach is a viable option. Here, a stem cell-seeded, decellularized tissue-engineered tracheal graft was used on a compassionate basis for a girl with critical tracheal stenosis after conventional reconstructive techniques failed. The graft represents the first cell-seeded tracheal graft manufactured to full good manufacturing practice (GMP) standards...
June 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28543263/randomised-clinical-trial-mesalazine-versus-placebo-in-the-prevention-of-diverticulitis-recurrence
#7
W Kruis, V Kardalinos, T Eisenbach, M Lukas, T Vich, I Bunganic, J Pokrotnieks, J Derova, J Kondrackiene, R Safadi, D Tuculanu, Z Tulassay, J Banai, A Curtin, A E Dorofeyev, S F Zakko, N Ferreira, S Björck, M M Diez Alonso, J Mäkelä, N J Talley, K Dilger, R Greinwald, R Mohrbacher, R Spiller
BACKGROUND: Previous studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis. AIM: To investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis. METHODS: Two phase 3, randomised, placebo-controlled, double-blind multicentre trials (SAG-37 and SAG-51) investigated mesalazine granules in patients with prior episodes (<6 months) of uncomplicated left-sided diverticulitis...
May 23, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28541500/prophylactic-efficacy-of-hyperimmune-bovine-colostral-antiadhesin-antibodies-against-enterotoxigenic-escherichia-coli-diarrhea-a-randomized-double-blind-placebo-controlled-phase-1-trial
#8
Stephen J Savarino, Robin McKenzie, David R Tribble, Chad K Porter, Aisling O'Dowd, Joyce A Cantrell, Stephanie A Sincock, Steven T Poole, Barbara DeNearing, Colleen M Woods, Hye Kim, Shannon L Grahek, Carl Brinkley, Joseph H Crabb, A Louis Bourgeois
Background.: Tip-localized adhesive proteins of bacterial fimbriae from diverse pathogens confer protection in animal models, but efficacy in humans has not been reported. Enterotoxigenic Escherichia coli (ETEC) commonly elaborate colonization factors comprising a minor tip adhesin and major stalk-forming subunit. We assessed the efficacy of antiadhesin bovine colostral IgG (bIgG) antibodies against ETEC challenge in volunteers. Methods.: Adults were randomly assigned (1:1:1) to take oral hyperimmune bIgG raised against CFA/I minor pilin subunit (CfaE) tip adhesin or colonization factor I (CFA/I) fimbraie (positive control) or placebo...
May 24, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28540737/investigational-drugs-in-phase-i-and-phase-ii-clinical-trials-for-thalassemia
#9
Irene Motta, Natalia Scaramellini, Maria Domenica Cappellini
Regular transfusion and iron chelation are the current treatment of severe forms of thalassemia. As a result of this demanding supportive treatment, there are several unmet therapeutic needs. Due to a deeper understanding in the pathophysiology of thalassemia, new therapeutic strategies have been developed that are now in pre-clinical and clinical trials. Areas covered: Activin receptor ligand traps (luspatercept and sotatercept), drugs targeting ineffective erythropoiesis, showed encouraging results in Phase I and II clinical trials...
May 25, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28540640/a-population-pharmacokinetic-and-pharmacodynamic-analysis-of-abemaciclib-in-a-phase-i-clinical-trial-in-cancer-patients
#10
Sonya C Tate, Amanda K Sykes, Palaniappan Kulanthaivel, Edward M Chan, P Kellie Turner, Damien M Cronier
BACKGROUND AND OBJECTIVES: Abemaciclib, a dual inhibitor of cyclin-dependent kinases 4 and 6, has demonstrated clinical activity in a number of different cancer types. The objectives of this study were to characterize the pharmacokinetics of abemaciclib in cancer patients using population pharmacokinetic (popPK) modeling, and to evaluate target engagement at clinically relevant dose levels. METHODS: A phase I study was conducted in cancer patients which incorporated intensive pharmacokinetic sampling after single and multiple oral doses of abemaciclib...
May 24, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28540536/effects-of-robot-assisted-upper-limb-rehabilitation-in-stroke-patients-a-systematic-review-with-meta-analysis
#11
Rachele Bertani, Corrado Melegari, Maria C De Cola, Alessia Bramanti, Placido Bramanti, Rocco Salvatore Calabrò
Technology-supported training is emerging as a solution to support therapists in their efforts providing high-intensity, repetitive, and task-specific treatment, in order to enhance the recovery process. The aim of this review is to assess the effectiveness of different robotic devices (end-effector and exoskeleton robots) in comparison with any other type of intervention. Furthermore, we aim to assess whether or not better improvements are obtained in the sub-acute phase after stroke onset than in the chronic phase...
May 24, 2017: Neurological Sciences
https://www.readbyqxmd.com/read/28539888/safety-and-immunogenicity-of-a-human-epidermal-growth-factor-receptor-1-her1-based-vaccine-in-prostate-castration-resistant-carcinoma-patients-a-dose-escalation-phase-i-study-trial
#12
Iraida Caballero, Lazaro E Aira, Anabel Lavastida, Xitlally Popa, Javier Rivero, Joaquín González, Mónica Mesa, Narjara González, Kelly Coba, Patricia Lorenzo-Luaces, Barbara Wilkinson, Yuliannis Santiesteban, Yanela Santiesteban, Mayelin Troche, Eduardo Suarez, Tania Crombet, Belinda Sánchez, Angel Casacó, Amparo Macías, Zaima Mazorra
Metastatic castration-resistant prostate cancer (CRPC) remains incurable due to the lack of effective therapies. Activation of the human epidermal growth factor receptor 1 (HER1) in prostate cancer contributes to metastatic progression as well as to disease relapse. Here, we determined the toxicity and immunogenicity of a HER1-based cancer vaccine in CRPC patients included in a phase I clinical trial. CRPC patients (n = 24) were intramuscularly vaccinated with HER1 vaccine consisting of the extracellular domain of HER1 molecule (ECD) and very small size proteoliposome from Neisseria meningitidis (VSSP) and Montanide ISA-51 VG as adjuvants...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28539464/phase-ib-pilot-study-to-evaluate-reparixin-in-combination-with-weekly-paclitaxel-in-patients-with-her-2-negative-metastatic-breast-cancer-mbc
#13
Anne F Schott, Lori Goldstein, Massimo Cristofanilli, Pier Adelchi Ruffini, Susan McCanna, James M Reuben, Raymond Perez, Giraldo Kato, Max S Wicha
CXCR1 is recognized as an actionable receptor selectively expressed by breast cancer stem cells (BCSC). Reparixin is an investigational allosteric inhibitor of chemokine receptors 1 and 2 (CXCR1/2), and demonstrates activity against BCSC in human breast cancer xenografts. This Phase Ib clinical trial examined dose, safety, and pharmacokinetics of paclitaxel plus reparixin therapy, and explored effects of reparixin on BCSCs in metastatic breast cancer (MBC) patients (Trial registration ID: NCT02001974). <p>Experimental Design: Eligible patients had MBC and were candidates for paclitaxel therapy...
May 24, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28538831/effects-of-laryngeal-manual-therapy-lmt-and-transcutaneous-electrical-nerve-stimulation-tens-in-vocal-folds-diadochokinesis-of-dysphonic-women-a-randomized-clinical-trial
#14
Larissa Thaís Donalonso Siqueira, Kelly Cristina Alves Silverio, Alcione Ghedini Brasolotto, Rinaldo Roberto de Jesus Guirro, Christiano Giácomo Carneiro, Mara Behlau
Purpose: To verify and compare the effect of transcutaneous electrical nerve stimulation (TENS) and laryngeal manual therapy (LMT) on laryngeal diadochokinesis (DDK) of dysphonic women. Methods: Twenty women with bilateral vocal nodules participated and were equally divided into: LMT Group - LMT application; TENS Group - TENS application; both groups received 12 sessions of treatment, twice a week, with a duration of 20 minutes each, applied by the same therapist...
May 15, 2017: CoDAS
https://www.readbyqxmd.com/read/28538644/validation-of-a-clinical-trial-composite-endpoint-for-patients-with-necrotizing-soft-tissue-infections
#15
Eileen M Bulger, Addison May, Wayne Dankner, Greg Maislin, Bryce Robinson, Anat Shirvan
OBJECTIVE: Our objective was to develop and validate a composite endpoint for patients with necrotizing soft tissue infections (NSTI) that incorporates: local tissue injury, systemic organ dysfunction, and mortality. METHODS: The Necrotizing Infection Clinical Composite Endpoint (NICCE) was defined as follows:(i) Alive at day 28 (ii) ≤3 debridements prior to day 14 (iii) No amputation beyond first debridement (iv) Modified SOFA score (mSOFA) at day 14 ≤1. To be considered a success, all individual criteria must be met...
May 22, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28537998/lactate-and-microcirculation-as-suitable-targets-for-hemodynamic-optimization-in-resuscitation-of-circulatory-shock
#16
Michael E Kiyatkin, Jan Bakker
PURPOSE OF REVIEW: A discussion of recent research exploring the feasibility of perfusion-guided resuscitation of acute circulatory failure with a focus on lactate and microcirculation. RECENT FINDINGS: Upon diagnosis of shock, hyperlactemia is associated with poor outcome and, under appropriate clinical circumstances, may reflect inadequate tissue perfusion. Persistent hyperlactemia despite resuscitation is even more strongly correlated with morbidity and mortality...
May 22, 2017: Current Opinion in Critical Care
https://www.readbyqxmd.com/read/28537354/the-use-of-transcutaneous-electrical-nerve-stimulation-after-total-knee-arthroplasty-a-prospective-randomized-controlled-trial
#17
Deepak Ramanathan, Anas Saleh, Alison K Klika, Carlos A Higuera, Wael K Barsoum
INTRODUCTION: Multimodal pain management is used after total knee arthroplasty (TKA) to reduce opioid intake. Transcutaneous electrical nerve stimulation (TENS) has generated much interest as a non-pharmacologic, patient-controlled therapy. The aims of this study were to evaluate the efficacy of TENS in reducing opioid intake and improving recovery after TKA. MATERIALS AND METHODS: This was a prospective, parallel-group, double-blinded, randomized trial of patients receiving femoral nerve catheter block with allocation to either active or placebo TENS device groups...
May 24, 2017: Surgical Technology International
https://www.readbyqxmd.com/read/28536387/emerging-therapeutic-potential-of-nanoparticles-in-pancreatic-cancer-a-systematic-review-of-clinical-trials
#18
REVIEW
Minnie Au, Theophilus I Emeto, Jacinta Power, Venkat N Vangaveti, Hock C Lai
Pancreatic cancer is an aggressive disease with a five year survival rate of less than 5%, which is associated with late presentation. In recent years, research into nanomedicine and the use of nanoparticles as therapeutic agents for cancers has increased. This article describes the latest developments in the use of nanoparticles, and evaluates the risks and benefits of nanoparticles as an emerging therapy for pancreatic cancer. The Preferred Reporting Items of Systematic Reviews and Meta-Analyses checklist was used...
August 19, 2016: Biomedicines
https://www.readbyqxmd.com/read/28536308/immune-correlates-of-gm-csf-and-melanoma-peptide-vaccination-in-a-randomized-trial-for-the-adjuvant-therapy-of-resected-high-risk-melanoma-e4697
#19
Lisa H Butterfield, Fengmin Zhao, Sandra Lee, Ahmad A Tarhini, Kim A Margolin, Richard L White, Michael Atkins, Gary I Cohen, Theresa L Whiteside, John M Kirkwood, David H Lawson
Purpose: E4697 was a multi-center intergroup randomized placebo-controlled Phase III trial of adjuvant GM-CSF and/or a multi-epitope melanoma peptide vaccine for patients with completely resected, high-risk stage III/IV melanoma. <p>Experimental Design: 815 patients were enrolled from 12/99 to 10/06 into this 6-arm study. GM-CSF was chosen to promote the numbers and functions of dendritic cells (DC). The melanoma antigen peptide vaccine (Tyrosinase368-376 (370D), gp100209-217 (210M), MART-127-35) in Montanide was designed to promote melanoma specific CD8(+) T cell responses...
May 23, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28536084/long-term-treatment-with-onabotulinumtoxina-results-in-consistent-durable-improvements-in-health-related-quality-of-life-in-patients-with-overactive-bladder
#20
David A Ginsberg, Marcus J Drake, Albert Kaufmann, Sidney Radomski, Angelo Gousse, Christopher J Chermansky, Andrew Magyar, Jean Paul Nicandro, Victor W Nitti
PURPOSE: To present the long-term effects of repeat onabotulinumtoxinA 100U treatment on health-related quality of life in overactive bladder patients with urinary incontinence who had an inadequate response to/were intolerant of an anticholinergic. MATERIALS AND METHODS: Patients completing either of two 24-week, phase III trials could enter a 3-year extension study and request multiple onabotulinumtoxinA 100U treatments as needed. Results for the I-QOL (Incontinence-Quality of Life) and KHQ (King's Health Questionnaire) are reported for upto 6 treatments...
May 20, 2017: Journal of Urology
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