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phase 1 trial

Amelia J H Arundale, Jacob J Capin, Ryan Zarzycki, Angela Smith, Lynn Snyder-Mackler
BACKGROUND: The Anterior Cruciate Ligament-Specialized Post-Operative Return to Sports (ACL-SPORTS) randomized controlled trial was designed to address deficits in functional and patient-reported outcomes. The trial examined the effects of a secondary ACL prevention program that included progressive strengthening, agility training, plyometrics (SAP), and other components of current primary prevention protocols, with perturbation training (SAP + PERT group) and without PERT (SAP group)...
June 1, 2018: Sports Health
Takamasa Kayama, Shinya Sato, Kaori Sakurada, Junki Mizusawa, Ryo Nishikawa, Yoshitaka Narita, Minako Sumi, Yasuji Miyakita, Toshihiro Kumabe, Yukihiko Sonoda, Yoshiki Arakawa, Susumu Miyamoto, Takaaki Beppu, Kazuhiko Sugiyama, Hirohiko Nakamura, Motoo Nagane, Yoko Nakasu, Naoya Hashimoto, Mizuhiko Terasaki, Akira Matsumura, Eiichi Ishikawa, Toshihiko Wakabayashi, Yasuo Iwadate, Shiro Ohue, Hiroyuki Kobayashi, Manabu Kinoshita, Kenichiro Asano, Akitake Mukasa, Katsuyuki Tanaka, Akio Asai, Hideo Nakamura, Tatsuya Abe, Yoshihiro Muragaki, Koichi Iwasaki, Tomokazu Aoki, Takao Watanabe, Hikaru Sasaki, Shuichi Izumoto, Masahiro Mizoguchi, Takayuki Matsuo, Hideo Takeshima, Motohiro Hayashi, Hidefumi Jokura, Takashi Mizowaki, Eiji Shimizu, Hiroki Shirato, Masao Tago, Hiroshi Katayama, Haruhiko Fukuda, Soichiro Shibui
Purpose Whereas whole-brain radiotherapy (WBRT) has been the standard treatment of brain metastases (BMs), stereotactic radiosurgery (SRS) is increasingly preferred to avoid cognitive dysfunction; however, it has not been clearly determined whether treatment with SRS is as effective as that with WBRT or WBRT plus SRS. We thus assessed the noninferiority of salvage SRS to WBRT in patients with BMs. Patients and Methods Patients age 20 to 79 years old with performance status scores of 0 to 2-and 3 if caused only by neurologic deficits-and with four or fewer surgically resected BMs with only one lesion > 3 cm in diameter were eligible...
June 20, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Emma A Amissah, Julie Brown, Jane E Harding
BACKGROUND: As preterm infants do not experience the nutrient accretion and rapid growth phase of the third trimester of pregnancy, they are vulnerable to postnatal nutritional deficits, including of fat. Consequently, they require higher fat intakes compared to their full term counterparts to achieve adequate growth and development. Human milk fat provides the major energy needs of the preterm infant and also contributes to several metabolic and physiological functions. Although human milk has many benefits for this population, its fat content is highly variable and may be inadequate for their optimum growth and development...
June 19, 2018: Cochrane Database of Systematic Reviews
Nikita Devnarain, Mahmoud E S Soliman
The global threat of the Zika virus to humanity is real. Innovative and potent anti-Zika virus drugs are still at large, due to the lack of anti-Zika virus drugs that have passed phase 1 trials. Experimental research has revealed novel inhibitors of Zika virus NS5 methyltransferase enzyme. This study has taken a step further to provide insight into the molecular dynamics of Zika virus and inhibitor binding, which have not been established experimentally. Movements of the methyltransferase binding site loops have a large role to play in the methylation of the viral mRNA cap, which is essential for Zika virus replication...
June 20, 2018: Chemical Biology & Drug Design
Allan Lipton, Kim Leitzel, Suhail M Ali, Hyma V Polimera, Vinod Nagabhairu, Eric Marks, Angelique E Richardson, Laura Krecko, Ayesha Ali, Wolfgang Koestler, Francisco J Esteva, Diana J Leeming, Morten A Karsdal, Nicholas Willumsen
Increased extracellular matrix (ECM) formation and matrix metalloprotease (MMP)-mediated ECM degradation are parts of tumorgenesis and generates specific collagen fragments that are released into circulation. We evaluated the association of specific collagen fragments measured in serum with outcomes in two independent metastatic breast cancer (MBC) cohorts. ELISAs were used to measure C1M (MMP-generated type I collagen fragment), C3M (MMP-generated type III collagen fragment), C4M (MMP-generated type IV collagen fragment), and PRO-C3 (pro-peptide of type III collagen) in pre-treatment serum from a phase 3 randomized clinical trial of 2nd -line hormone therapy (HR+, n= 148), and a 1st -line trastuzumab-treated cohort (HER2+, n=55)...
June 20, 2018: International Journal of Cancer. Journal International du Cancer
Sreehari Uragayala, Raghavendra Kamaraju, Satyanarayan Tiwari, Susanta Kumar Ghosh, Neena Valecha
Background & objectives: Different formulations of Bacillus thuringiensis var. israelensis (Bti) have been tested against different mosquito vectors and other insects for their residual activity. In the present study, the efficacy and residual activity of a new formulation of Bti (Bactivec Suspension Concentrate) were evaluated against immature stages of Anopheles stephensi Liston (Diptera: Culicidae), Aedes aegypti Linnaeus (Diptera: Culicidae) and Culex quinquefasciatus Say (Diptera: Culicidae), in natural habitats in Phase II and Phase III in Bengaluru, India...
March 2018: Indian Journal of Medical Research
Danny H Sugimoto, Terry Dex, William Stager, Vanita R Aroda
The Healthcare Effectiveness Data and Information Set (HEDIS) measures assess glycaemic goal attainment in patients with type 2 diabetes, incorporating factors including age and health status. Healthier patients are assigned a glycated haemoglobin (HbA1c) goal of < 7% (classified as low-risk [LR]); individuals aged > 65 years or with comorbidities are assigned a goal of < 8% (high-risk [HR]). This post-hoc analysis assessed the safety and efficacy of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, in 1,898 patients from the phase 3 LixiLan-L and LixiLan-O clinical trials, retrospectively classified as LR (n = 1,181) or HR (n = 717)...
June 19, 2018: Diabetes, Obesity & Metabolism
Jennifer M Trujillo, Michelle Roberts, Terry Dex, Jason Chao, Pa-C John White, James LaSalle
This post hoc analysis of gastrointestinal (GI) adverse events (AEs) from the phase 3 LixiLan-L (NCT02058160) and LixiLan-O (NCT02058147) trials aimed to determine the frequency and timing of nausea, vomiting, and diarrhea for iGlarLixi, a titratable, fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, vs iGlar alone or iGlar and lixisenatide alone, in patients with type 2 diabetes uncontrolled with oral antidiabetes drugs (OADs) or basal insulin ± OADs. In iGlarLixi-treated patients, the rate of GI AEs during initial weeks of treatment was lower vs patients treated with lixisenatide alone (9...
June 19, 2018: Diabetes, Obesity & Metabolism
Fredrik Salvesen Haukaas, Audun Ohna, Tania Krivasi
AIMS: To evaluate the cost-effectiveness of obinutuzumab in combination with bendamustine followed by obinituzumab maintenance (Obin-Benda) compared to bendamustine alone (Benda) in patients with refractory follicular lymphoma (FL) in a Norwegian setting. METHODS: A three-state area-under-the-curve (AUC) model was developed. The states included were progression-free-survival (PFS), progressed disease (PD), and death. Each state had costs and utilities assigned to it...
June 19, 2018: Applied Health Economics and Health Policy
Patricia A Walicke, Franz Hefti, Roxanne Bales, Shiao-Ping Lu, Jon L Ruckle, Mark T Brown, Christine R West, David L Shelton
Introduction: The neurotrophin nerve growth factor has a demonstrated role in pain transduction and pathophysiology. Objectives: Two randomized, double-blind, placebo-controlled, phase 1 studies were conducted to evaluate safety, tolerability, and analgesic efficacy of single doses of tanezumab, a humanized anti-nerve growth factor monoclonal antibody, in chronic or acute pain. Methods: In the first study (CL001), patients with moderate to severe pain from osteoarthritis (OA) of the knee received a single intravenous infusion of tanezumab (3-1000 μg/kg) or placebo in a dose-escalation (part 1; N = 42) or parallel-arm (part 2; N = 79) study design...
May 2018: Pain Reports (Baltimore, Md.)
Heather Burke, Agnieszka Boron, Jung-Hyun Lee, Kudrit Riana Kahlon
Transcatheter aortic valve replacement (TAVR) is a newer alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. Clinical trials have investigated TAVR's safety and effectiveness. Cerebral embolization is a common complication leading to stroke after TAVR and SAVR; different cerebral protection methods have been studied to prevent this. This paper evaluates the rate of post-procedural stroke rates between TAVR and SAVR and investigates the effect of cerebral protective methods on the stroke risk post-TAVR...
April 17, 2018: Curēus
Thomas P Lillicrap, Christopher R Levi, Elizabeth Holliday, Mark William Parsons, Andrew Bivard
Background: The phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whether reducing fatigue resulted in improved quality of life. In addition, we followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy...
2018: Frontiers in Neurology
Wenfei Xue, Guochen Duan, Xiaopeng Zhang, Hua Zhang, Qintao Zhao, Zhifei Xin
Background: Although limited resection was once considered the surgical treatment for patients with Phase IA non-small-cell lung cancer (NSCLC), there has been an ongoing controversial surgical indication for wedge resection and segmentectomy in recent years. The objective of this study was to compare overall survival (OS) and disease-free survival (DFS) of segmentectomy and wedge resection for early stage NSCLC, using a meta-analysis. Methods: Systematic research was conducted using four online databases to search for studies published before 2017...
2018: OncoTargets and Therapy
Claire Gallois, Julien Taieb, Delphine Le Corre, Karine Le Malicot, Josep Tabernero, Claire Mulot, Jean-Francois Seitz, Thomas Aparicio, Gunnar Folprecht, Côme Lepage, Enrico Mini, Jean-Luc Van Laethem, Jean-Francois Emile, Pierre Laurent-Puig
PURPOSE: There are conflicting results concerning the prognostic value of the CpG island methylator phenotype (CIMP) in non-metastatic colon cancer (CC) patients. We studied this phenotype in stage III CC characterized for mismatch repair (MMR), RAS and BRAF status and treated with adjuvant FOLFOX-based regimen. EXPERIMENTAL DESIGN: Tumor samples of 1907 patients enrolled in the PETACC-8 adjuvant phase 3 trial were analyzed. The method used was methylation-specific PCR where CIMP+ status was defined by methylation of at least three of the five following genes: IGF2, CACNA1G, NEUROG1, SOCS1, and RUNX3...
June 19, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Jan Bogaert, Ana Casado Plasencia, Inmaculada Gilaberte, Ann Belmans, María Eugenia Fernández-Santos, Dominique Charron, Miguel Mulet, Raquel Yotti, Itziar Palacios, Manuel Luque, Rafael Sádaba, J A San Roman, Mariano Larman, Pedro L Sánchez, Juan Sanchis, Manuel F Jimenez-Navarro, Piet Claus, Reem Al-Daccak, Eleuterio Lombardo, José Luis Abad, Olga Delarosa, Lucia Corcostegui, Javier Bermejo, Stefan Janssens
<u>Rationale:</u> Allogeneic cardiac stem cells (AlloCSC-01) have shown protective, immunoregulatory and regenerative properties with a robust safety profile in large animal models of heart disease. <u>Objective:</u> To investigate the safety and feasibility of early administration of AlloCSC-01 in patients with ST-segment elevation myocardial infarction (STEMI). <u>Methods and Results:</u> CAREMI was a phase I/II multicenter, randomized, double-blind, placebo-controlled trial in patients with STEMI, LVEF ≤ 45% and infarct size ≥ 25% of left ventricular (LV) mass by cardiac magnetic resonance (MR), who were randomized (2:1) to receive AlloCSC-01 or placebo through the intracoronary route at day 5-7...
June 19, 2018: Circulation Research
Gil Chernin, Iris Szwarcfiter, Dierk Scheinert, Erwin Blessing, Nicolas Diehm, Jo Dens, Antony Walton, Stefan Verheye, Sharad Shetty, Michael Jonas
PURPOSE: To report results of renal denervation (RDN) with the first catheter-based, non-balloon occlusion ultrasonic system in patients with resistant hypertension. MATERIALS AND METHODS: In a multicenter, single-arm trial, 39 patients with resistant hypertension (defined as uncontrolled hypertension while taking ≥ 3 antihypertensive medications) were treated. The cohort consisted of 4 groups: severe resistant hypertension (office systolic blood pressure [OSBP] ≥ 160 mm Hg) treated with a unidirectional catheter (group 1; n = 14); severe resistant hypertension treated with a multidirectional catheter (group 2; n = 18); moderate resistant hypertension (OSBP 140-159 mm Hg) treated with a multidirectional catheter (group 3; n = 5); and recurrent severe resistant hypertension, after an initial response to RF RDN (group 4; n = 2)...
June 16, 2018: Journal of Vascular and Interventional Radiology: JVIR
Brittney A Luc-Harkey, Jason R Franz, J Troy Blackburn, Darin A Padua, Anthony C Hackney, Brian Pietrosimone
Individuals with anterior cruciate ligament reconstruction (ACLR) often exhibit a "stiffened knee strategy" or an excessively extended knee during gait, characterized by lesser knee flexion excursion and peak internal knee extension moment (KEM). The purpose of this study was to determine the effect of real-time biofeedback (RTBF) cuing an acute change in peak vertical ground reaction force (vGRF) during the first 50% of the stance phase of walking gait on: (1) root mean square error (RMSE) between actual vGRF and RTBF target vGRF; (2) perceived difficulty; and (3) knee biomechanics...
June 15, 2018: Journal of Biomechanics
Tao Wang, Yasu Ueda, Zhongxing Zhang, Zhiwei Yin, John Matiskella, Bradley C Pearce, Zheng Yang, Ming Zheng, Dawn Parker, Gregory Yamanaka, Yi-Fei Gong, Hsu-Tso Ho, Richard Colonno, David R Langley, Pin-Fang Lin, Nicholas A Meanwell, John F Kadow
The optimization of the 4-methoxy-6-azaindole series of HIV-1 attachment inhibitors (AIs) that originated with 1 to deliver temsavir (3, BMS-626529) is described. The most beneficial increases in potency and pharmacokinetic (PK) properties were attained by incorporating N-linked, sp2-hybridized heteroaryl rings at the 7-position of the heterocyclic nucleus. Compounds that adhered to a coplanarity model afforded targeted antiviral potency, leading to the identification of 3 with characteristics that provided for targeted exposure and PK properties in three preclinical species...
June 19, 2018: Journal of Medicinal Chemistry
Lanlin Zhang, Yuan Qi, Kailin Xing, Song Qian, Ping Zhang, Xianghua Wu
The discovery of epidermal growth factor receptor (EGFR)‑sensitive mutations in non‑small cell lung cancer (NSCLC) and the successful clinical application of EGFR tyrosine kinase inhibitors (TKIs) have changed the regimen of lung cancer therapy from traditional cytotoxic chemotherapy to molecular‑targeted cancer therapy. However, the main limitation of EGFR‑TKI therapy is the heterogeneity of lung cancer harboring EGFR‑sensitive mutations. In addition, the synergistic effect of the administration of chemotherapy and EGFR‑TKIs, combined with tumor heterogeneity, on NSCLC remains unclear...
June 18, 2018: Oncology Reports
Simon Bissonnette, Nathalie Saint-Pierre, Valerie Lamantia, Catherine Leroux, Viviane Provost, Yannick Cyr, Remi Rabasa-Lhoret, May Faraj
Background: To optimize the prevention of type 2 diabetes (T2D), high-risk obese subjects with the best metabolic recovery after a hypocaloric diet should be targeted. Apolipoprotein B lipoproteins (apoB lipoproteins) induce white adipose tissue (WAT) dysfunction, which in turn promotes postprandial hypertriglyceridemia, insulin resistance (IR), and hyperinsulinemia. Objective: The aim of this study was to explore whether high plasma apoB, or number of plasma apoB lipoproteins, identifies subjects who best ameliorate WAT dysfunction and related risk factors after a hypocaloric diet...
June 18, 2018: American Journal of Clinical Nutrition
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