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Phase 1 clinical trial

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https://www.readbyqxmd.com/read/27915024/extracellular-matrix-hydrogels-from-decellularized-tissues-structure-and-function
#1
REVIEW
Lindsey T Saldin, Madeline C Cramer, Sachin S Velankar, Lisa J White, Stephen F Badylak
: Extracellular matrix (ECM) bioscaffolds prepared from decellularized tissues have been used to facilitate constructive and functional tissue remodeling in a variety of clinical applications. The discovery that these ECM materials could be solubilized and subsequently manipulated to form hydrogels expanded their potential in vitro and in vivo utility; i.e. as culture substrates comparable to collagen or Matrigel, and as injectable materials that fill irregularly-shaped defects. The mechanisms by which ECM hydrogels direct cell behavior and influence remodeling outcomes are only partially understood, but likely include structural and biological signals retained from the native source tissue...
November 30, 2016: Acta Biomaterialia
https://www.readbyqxmd.com/read/27914971/once-weekly-ofatumumab-in-untreated-or-relapsed-waldenstr%C3%A3-m-s-macroglobulinaemia-an-open-label-single-arm-phase-2-study
#2
Richard R Furman, Herbert A Eradat, Christine G DiRienzo, Craig C Hofmeister, Suzanne R Hayman, John P Leonard, Morton Coleman, Ranjana Advani, Asher Chanan-Khan, Julie Switzky, Qiming M Liao, Damini Shah, Roxanne C Jewell, Steen Lisby, Thomas S Lin
BACKGROUND: The development of more effective and safer treatments, especially non-chemotherapeutics, is needed for patients with Waldenström's macroglobulinaemia. The aim of the study was to assess the safety and clinical activity of intravenous ofatumumab monotherapy for untreated and relapsed Waldenström's macroglobulinaemia. METHODS: We did a phase 2, open-label, single-arm study at six centres (hospitals and cancer clinics) in the USA. Patients aged at least 18 years who were diagnosed with untreated or relapsed Waldenström's macroglobulinaemia and required treatment, received up to three cycles of weekly ofatumumab for 5 weeks...
November 30, 2016: Lancet Haematology
https://www.readbyqxmd.com/read/27914656/chronic-oral-study-of-myosin-activation-to-increase-contractility-in-heart-failure-cosmic-hf-a-phase-2-pharmacokinetic-randomised-placebo-controlled-trial
#3
John R Teerlink, G Michael Felker, John J V McMurray, Scott D Solomon, Kirkwood F Adams, John G F Cleland, Justin A Ezekowitz, Assen Goudev, Peter Macdonald, Marco Metra, Veselin Mitrovic, Piotr Ponikowski, Pranas Serpytis, Jindrich Spinar, János Tomcsányi, Hans J Vandekerckhove, Adriaan A Voors, Maria Laura Monsalvo, James Johnston, Fady I Malik, Narimon Honarpour
BACKGROUND: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil. METHODS: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks...
November 30, 2016: Lancet
https://www.readbyqxmd.com/read/27914501/levosimendan-in-patients-with-left-ventricular-systolic-dysfunction-undergoing-cardiac-surgery-on-cardiopulmonary-bypass-rationale-and-study-design-of-the-levosimendan-in-patients-with-left-ventricular-systolic-dysfunction-undergoing-cardiac-surgery-requiring
#4
Rajendra H Mehta, Sean Van Diepen, James Meza, Paula Bokesch, Jeffrey D Leimberger, Sandra Tourt-Uhlig, Merri Swartz, Jodi Parrotta, Rachael Jankowich, Douglas Hay, Robert W Harrison, Stephen Fremes, Shaun G Goodman, John Luber, Wolfgang Toller, Matthias Heringlake, Kevin J Anstrom, Jerrold H Levy, Robert A Harrington, John H Alexander
BACKGROUND: Low cardiac output syndrome is associated with increased mortality and occurs in 3% to 14% of patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). Levosimendan, a novel calcium sensitizer and KATP channel activator with inotropic, vasodilatory, and cardioprotective properties, has shown significant promise in reducing the incidence of low cardiac output syndrome and related adverse outcomes in patients undergoing cardiac surgery on CPB. METHODS: LEVO-CTS is a phase 3 randomized, controlled, multicenter study evaluating the efficacy, safety, and cost-effectiveness of levosimendan in reducing morbidity and mortality in high-risk patients with reduced left ventricular ejection fraction (≤35%) undergoing cardiac surgery on CPB...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27913881/phase-ii-trial-of-s-1-plus-leucovorin-in-patients-with-advanced-gastric-cancer-and-clinical-prediction-by-s-1-pharmacogenetic-pathway
#5
Ming-Ming He, Dong-Sheng Zhang, Feng Wang, Zi-Xian Wang, Shu-Qiang Yuan, Zhi-Qiang Wang, Hui-Yan Luo, Chao Ren, Miao-Zhen Qiu, Ying Jin, De-Shen Wang, Dong-Liang Chen, Zhao-Lei Zeng, Yu-Hong Li, Yang-Yang He, Yuan-Tao Hao, Pi Guo, Feng-Hua Wang, Yi-Xin Zeng, Rui-Hua Xu
BACKGROUND: The first one-arm phase II trial aimed to evaluate and predict efficacy and safety of S-1 plus oral leucovorin (S-1/LV) as first-line chemotherapy for patients with advanced gastric cancer (AGC), using S-1 pharmacogenetic pathway approach. PATIENTS AND METHODS: A total of 39 patients orally took S-1 at conventional dose and LV simultaneously at a dose of 25 mg twice daily for a week, within a 2-week cycle. The primary endpoint was overall response rate (ORR), while the secondary endpoints were progression-free survival (PFS), time to failure (TTF), overall survival (OS), disease control rate (DCR), and adverse events (AEs)...
December 2, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27913796/a-randomized-controlled-trial-of-assisted-intention-monitoring-for-the-rehabilitation-of-executive-impairments-following-acquired-brain-injury
#6
Fergus Gracey, Jessica E Fish, Eve Greenfield, Andrew Bateman, Donna Malley, Gemma Hardy, Jessica Ingham, Jonathan J Evans, Tom Manly
BACKGROUND: Acquired brain injury (ABI) can impair executive function, impeding planning and attainment of intentions. Research shows promise for some goal-management rehabilitation interventions. However, evidence that alerts assist monitoring and completion of day-to-day intentions is limited. OBJECTIVE: To examine the efficacy of brief goal-directed rehabilitation paired with periodic SMS text messages designed to enhance executive monitoring of intentions (assisted intention monitoring [AIM])...
December 2, 2016: Neurorehabilitation and Neural Repair
https://www.readbyqxmd.com/read/27913228/pd-l1-immunohistochemistry-assays-for-lung-cancer-results-from-phase-1-of-the-blueprint-pd-l1-ihc-assay-comparison-project
#7
Fred R Hirsch, Abigail McElhinny, Dave Stanforth, James Ranger-Moore, Malinka Jansson, Karina Kulangara, William Richardson, Penny Towne, Debra Hanks, Bharathi Vennapusa, Amita Mistry, Rasika Kalamegham, Steve Averbuch, James Novotny, Eric Rubin, Kenneth Emancipator, Ian McCaffery, J Andrew Williams, Jill Walker, John Longshore, Ming S Tsao, Keith M Kerr
BACKGROUND: The "Blueprint PD-L1 IHC Assay Comparison Project" is an industrial-academic collaborative partnership to provide information on the analytical and clinical comparability of four PD-L1 IHC assays used in clinical trials. METHODS: 39 NSCLC tumors were stained with four PD-L1 IHC assays (22C3, 28-8, SP 142 and SP 263) as used in the clinical trials. Three experts in interpreting their respective assays independently evaluated the percentages of tumor and immune cells staining positive at any intensity...
November 29, 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27912933/efficacy-of-healing-meditation-in-reducing-anxiety-of-individuals-at-the-phase-of-weight-loss-maintenance-a-randomized-blinded-clinical-trial
#8
Cynthia Vieira Sanches Sampaio, Manuela Garcia Lima, Ana Marice Ladeia
OBJECTIVE: To verify the efficacy of Healing Meditation in reducing anxiety levels in individuals on a weight loss maintenance program. DESIGN: A randomized, controlled, evaluator-blinded clinical trial, conducted between January and October 2014, with a follow-up of 12 weeks. SETTING: A weight loss secondary care facility in Salvador, Brazil., of 41 patients at the weight maintenance phase (Mean initial BMI 33.6±4.7kg/m(2), who had attained a mean BMI of 24...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912901/individualized-versus-conventional-ovarian-stimulation-for-in%C3%A2-vitro-fertilization-a-multicenter-randomized-controlled-assessor-blinded-phase-3-noninferiority-trial
#9
Anders Nyboe Andersen, Scott M Nelson, Bart C J M Fauser, Juan Antonio García-Velasco, Bjarke M Klein, Joan-Carles Arce
OBJECTIVE: To compare the efficacy and safety of follitropin delta, a new human recombinant FSH with individualized dosing based on serum antimüllerian hormone (AMH) and body weight, with conventional follitropin alfa dosing for ovarian stimulation in women undergoing IVF. DESIGN: Randomized, multicenter, assessor-blinded, noninferiority trial (ESTHER-1). SETTING: Reproductive medicine clinics. PATIENT(S): A total of 1,329 women (aged 18-40 years)...
November 22, 2016: Fertility and Sterility
https://www.readbyqxmd.com/read/27912875/long-term-chamomile-matricaria-chamomilla-l-treatment-for-generalized-anxiety-disorder-a-randomized-clinical-trial
#10
Jun J Mao, Sharon X Xie, John R Keefe, Irene Soeller, Qing S Li, Jay D Amsterdam
BACKGROUND: Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects. PURPOSE: To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse. METHODS: Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center...
December 15, 2016: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
https://www.readbyqxmd.com/read/27912871/short-term-open-label-chamomile-matricaria-chamomilla-l-therapy-of-moderate-to-severe-generalized-anxiety-disorder
#11
John R Keefe, Jun J Mao, Irene Soeller, Qing S Li, Jay D Amsterdam
BACKGROUND: Conventional drug treatments for Generalized Anxiety Disorder (GAD) are often accompanied by substantial side effects, dependence, and/or withdrawal syndrome. A prior controlled study of oral chamomile (Matricaria chamomilla L.) extract showed significant efficacy versus placebo, and suggested that chamomile may have anxiolytic activity for individuals with GAD. HYPOTHESIS: We hypothesized that treatment with chamomile extract would result in a significant reduction in GAD severity ratings, and would be associated with a favorable adverse event and tolerability profile...
December 15, 2016: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
https://www.readbyqxmd.com/read/27911295/efficacy-and-safety-of-plasma-exchange-with-5-albumin-to-modify-cerebrospinal-fluid-and-plasma-amyloid-%C3%AE-concentrations-and-cognition-outcomes-in%C3%A2-alzheimer-s-disease-patients-a%C3%A2-multicenter-randomized-controlled-clinical-trial
#12
Mercè Boada, Fernando Anaya, Pilar Ortiz, Javier Olazarán, Joshua R Shua-Haim, Thomas O Obisesan, Isabel Hernández, Joan Muñoz, Mar Buendia, Montserrat Alegret, Asunción Lafuente, Lluís Tárraga, Laura Núñez, Mireia Torres, Joan Ramon Grifols, Isidre Ferrer, Oscar L Lopez, Antonio Páez
BACKGROUND: Studies conducted in animal models and humans suggest the presence of a dynamic equilibrium of amyloid-β (Aβ) peptide between cerebrospinal fluid (CSF) and plasma compartments. OBJECTIVE: To determine whether plasma exchange (PE) with albumin replacement was able to modify Aβ concentrations in CSF and plasma as well as to improve cognition in patients with mild-moderate Alzheimer's disease (AD). METHODS: In a multicenter, randomized, patient- and rater-blind, controlled, parallel-group, phase II study, 42 AD patients were assigned (1 : 1) to PE treatment or control (sham) groups...
November 28, 2016: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/27911128/s-1-in-combination-with-docetaxel-and-oxaliplatin-in-patients-with-advanced-gastro-esophageal-adenocarcinoma-two-parallel-phase-1-2a-studies
#13
Per Pfeiffer, Camilla Qvortrup, Merete Krogh, Katrine Schoennemann, Lene W Vestermark, Helle A Jensen, Jon K Bjerregaard
BACKGROUND: Docetaxel in combination with cisplatin and 5-fluorouracil (5-FU) is one of several standard chemotherapy regimens for patients with advanced gastro-esophageal adenocarcinoma (aGEA) in Europe. To enable outpatient treatment, we evaluated the maximum tolerated dose (MTD), recommended dose (RD), dose limiting toxicity (DLT) and safety of docetaxel in combination with oxaliplatin (O) and S-1 (DOS) in Caucasian patients with aGEA. METHODS: We present final results of two parallel phase 1/2a studies (3 + 3 design)...
December 2, 2016: Acta Oncologica
https://www.readbyqxmd.com/read/27910805/ebola-virus-vaccines-where-do-we-stand
#14
REVIEW
Vincent Pavot
The recent outbreak of Ebola virus disease in West Africa has led to more than 11,000 deaths, with a peak in mortality from August through December of 2014. A meeting convened by the World Health Organization (WHO) in September 2014, concluded that an urgent unmet need exists for efficacy and safety testing of the Ebola virus vaccine candidates and that clinical trials should be expedited. These vaccines could be used both in an outbreak setting and to provide long-term protection in populations at risk of sporadic outbreaks...
October 28, 2016: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/27910711/endometrial-injury-for-rif-patients-undergoing-ivf-icsi-a-prospective-nonrandomized-controlled-trial
#15
Charalampos Siristatidis, Maria Kreatsa, Nikoleta Koutlaki, George Galazios, Vasileios Pergialiotis, Nikolaos Papantoniou
To evaluate the effect of endometrial injury on clinical outcomes in subfertile women with repeated implantation failures (RIF) undergoing assisted reproduction. In this prospective nonrandomized controlled trial, 103 subfertile women with RIF were included. Fifty-one underwent endometrial injury through hysteroscopy in the early follicular phase of the previous cycle and 52 underwent the standard protocol without any intervention. Live birth and miscarriage were the primary outcomes. Clinical and in vitro fertilization (IVF) cycle characteristics, were also compared between groups...
December 2, 2016: Gynecological Endocrinology
https://www.readbyqxmd.com/read/27910704/the-safety-of-nivolumab-for-the-treatment-of-advanced-non-small-cell-lung-cancer
#16
Giulio Metro, Biagio Ricciuti, Marta Brambilla, Sara Baglivo, Irene Soli, Elisa Minenza, Giulia Costanza Leonardi, Alessandro D'Arpino, Daniela Colabrese, Marco Tazza, Daniela Zicari, Vincenzo Minotti, Rita Chiari
Immune checkpoint blockaders (ICBs) act by unbalancing the immune system, thus favoring the development of an immune-mediated antitumor effect. ICBs targeting the programmed cell death receptor-1 (PD-1) have recently been investigated in a number of advanced tumors, including non-small cell lung cancer (NSCLC). Nivolumab, a fully human IgG4 kappa directed against PD-1, has been the first ICB to be approved for second-line treatment of advanced NSCLC. Areas covered: In this review we focus on the clinical development of nivolumab for the treatment of advanced NSCLC, with an emphasis on its safety profile...
December 2, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27910703/co-calibration-of-two-self-reported-measures-of-adherence-to-antiretroviral-therapy
#17
Robin M Nance, J A Chris Delaney, Carol E Golin, Wendee M Wechsberg, Chinazo Cunningham, Frederick Altice, Katerina Christopoulos, Kevin Knight, Vu Quan, Michael S Gordon, Sandra Springer, Jeremy Young, Paul K Crane, Kenneth H Mayer, Michael J Mugavero, Carlos Del Rio, Richard A Kronmal, Heidi M Crane
Adherence to antiretroviral therapy (ART) is an important determinant of clinical success assessed in many HIV studies. Harmonizing adherence data from studies that use different measures is difficult without a co-calibration equation to convert between validated instruments. Our purpose was to co-calibrate two commonly used adherence measures: the AIDS Clinical Trials Group (ACTG) questionnaire and the Visual Analog Scale (VAS). We used robust linear regression to develop a co-calibration equation in a clinical care cohort...
December 2, 2016: AIDS Care
https://www.readbyqxmd.com/read/27910174/combined-application-of-uhplc-qtof-ms-hplc-elsd-and-1-h-nmr-spectroscopy-for-quality-assessment-of-da-9801-a-standardised-dioscorea-extract
#18
Kyo Bin Kang, Jayoung Ryu, Youngwoong Cho, Sang-Zin Choi, Miwon Son, Sang Hyun Sung
INTRODUCTION: DA-9801, a standardised 50% aqueous ethanolic extract of a mixture of Dioscorea japonica and D. nipponica, is a botanical drug candidate for the treatment of diabetic neuropathy, which finished its US phase II clinical trials recently. An advanced quality control method is needed for further development of DA-9801, considering its high contents of both primary and secondary metabolites. OBJECTIVE: Development of a quality assessment strategy for DA-9801, based on the combination of UHPLC-QTOF/MS, HPLC-ELSD, and (1) H-NMR spectroscopy...
December 1, 2016: Phytochemical Analysis: PCA
https://www.readbyqxmd.com/read/27910052/a-needleless-liquid-jet-injection-delivery-approach-for-cardiac-gene-therapy
#19
Anthony S Fargnoli, Michael G Katz, Charles R Bridges
Fundamentally, cardiac gene therapy clinical trials have demonstrated that route efficiency is paramount in achieving maximum myocardial expression within safety limits. Gene transfer phenomena are largely influenced by physical transport principles (i.e., pressure, residence time, dispersion trafficking, mechanical resistance) that are independent of therapeutic characteristics. An alternative to intracoronary infusion methods, in an effort to improve efficiency in terms of cardiac specificity, is direct myocardial delivery via surgical injection...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/27909071/does-task-specific-training-improve-upper-limb-performance-in-daily-life-poststroke
#20
Kimberly J Waddell, Michael J Strube, Ryan R Bailey, Joseph W Klaesner, Rebecca L Birkenmeier, Alexander W Dromerick, Catherine E Lang
Background A common assumption is that changes in upper limb (UL) capacity, or what an individual is capable of doing, translates to improved UL performance in daily life, or what an individual actually does. This assumption should be explicitly tested for individuals with UL paresis poststroke. Objective To examine changes in UL performance after an intensive, individualized, progressive, task-specific UL intervention for individuals at least 6 months poststroke. Methods Secondary analysis on 78 individuals with UL paresis who participated in a phase II, single-blind, randomized parallel dose-response trial...
December 1, 2016: Neurorehabilitation and Neural Repair
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