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https://www.readbyqxmd.com/read/28350787/quality-adjusted-survival-with-combination-nal-iri-5-fu-lv-vs-5-fu-lv-alone-in-metastatic-pancreatic-cancer-patients-previously-treated-with-gemcitabine-based-therapy-a-q-twist-analysis
#1
Uwe Pelzer, Jean-Frédéric Blanc, Davide Melisi, Antonio Cubillo, Daniel D Von Hoff, Andrea Wang-Gillam, Li-Tzong Chen, Jens T Siveke, Yin Wan, Caitlyn T Solem, Marc F Botteman, Yoojung Yang, Floris A de Jong, Richard A Hubner
BACKGROUND: In the NAPOLI-1 Phase 3 trial, nal-IRI+5-fluorouracil and leucovorin (5-FU/LV) significantly improved median overall survival (6.1 vs 4.2 months, P=0.012) and progression-free survival (3.1 vs 1.5 months, P=0.0001) vs 5-FU/LV alone in metastatic pancreatic adenocarcinoma patients previously treated with gemcitabine-based therapy. This analysis evaluated between treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST). METHODS: Overall survival was partitioned into time with grade ⩾3 toxicity (TOX), disease progression (REL), and time without disease progression symptoms or grade ⩾3 toxicity (TWiST)...
March 28, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28346484/a-neighborhood-wide-association-study-nwas-example-of-prostate-cancer-aggressiveness
#2
Shannon M Lynch, Nandita Mitra, Michelle Ross, Craig Newcomb, Karl Dailey, Tara Jackson, Charnita M Zeigler-Johnson, Harold Riethman, Charles C Branas, Timothy R Rebbeck
PURPOSE: Cancer results from complex interactions of multiple variables at the biologic, individual, and social levels. Compared to other levels, social effects that occur geospatially in neighborhoods are not as well-studied, and empiric methods to assess these effects are limited. We propose a novel Neighborhood-Wide Association Study(NWAS), analogous to genome-wide association studies(GWAS), that utilizes high-dimensional computing approaches from biology to comprehensively and empirically identify neighborhood factors associated with disease...
2017: PloS One
https://www.readbyqxmd.com/read/28345792/adding-fast-acting-insulin-aspart-to-basal-insulin-significantly-improved-glycaemic-control-in-patients-with-type-2-diabetes-a-randomised-18-week-open-label-phase-3-trial-onset-3
#3
Helena W Rodbard, Devjit Tripathy, Maricela Vidrio Velázquez, Marek Demissie, Søren Can Tamer, Milivoj Piletič
AIM: To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen versus basal-only insulin. MATERIALS AND METHODS: In this open-label, randomised, 18-week trial (51 sites; 6 countries) adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c ] ±SD: 7.9 ± 0.7% [63.1 ± 7.5 mmol/mol) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimisation of prior once-daily basal insulins followed by randomisation 1:1 to a BB regimen with faster aspart (n = 116) or continuation of once-daily basal insulin (n = 120), both with metformin...
March 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28344102/effect-of-visceral-disease-site-on-outcomes-in-patients-with-metastatic-castration-resistant-prostate-cancer-treated-with-enzalutamide-in-the-prevail-trial
#4
Joshi J Alumkal, Simon Chowdhury, Yohann Loriot, Cora N Sternberg, Johann S de Bono, Bertrand Tombal, Joan Carles, Thomas W Flaig, Tanya B Dorff, De Phung, David Forer, Sarah B Noonberg, Hank Mansbach, Tomasz M Beer, Celestia S Higano
BACKGROUND: The Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy (PREVAIL) trial was unique as it included patients with visceral disease. This analysis was designed to describe outcomes for the subgroup of men from PREVAIL with specific sites of visceral disease to help clinicians understand how these patients responded to enzalutamide prior to chemotherapy...
March 3, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28343976/prophylactic-cranial-irradiation-versus-observation-in-patients-with-extensive-disease-small-cell-lung-cancer-a-multicentre-randomised-open-label-phase-3-trial
#5
Toshiaki Takahashi, Takeharu Yamanaka, Takashi Seto, Hideyuki Harada, Hiroshi Nokihara, Hideo Saka, Makoto Nishio, Hiroyasu Kaneda, Koichi Takayama, Osamu Ishimoto, Koji Takeda, Hiroshige Yoshioka, Motoko Tachihara, Hiroshi Sakai, Koichi Goto, Nobuyuki Yamamoto
BACKGROUND: Results from a previous phase 3 study suggested that prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs overall survival compared with no prophylactic cranial irradiation in patients with extensive-disease small-cell lung cancer. However, because of the absence of brain imaging before enrolment and variations in chemotherapeutic regimens and irradiation doses, concerns have been raised about these findings. We did a phase 3 trial to reassess the efficacy of prophylactic cranial irradiation in the treatment of extensive-disease small-cell lung cancer...
March 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28343225/clinical-trial-of-vadadustat-in-patients-with-anemia-secondary-to-stage-3-or-4-chronic-kidney-disease
#6
Edouard R Martin, Mark T Smith, Bradley J Maroni, Qing C Zuraw, Emil M deGoma
BACKGROUND: Therapeutic options for the treatment of anemia secondary to chronic kidney disease (CKD) remain limited. Vadadustat (AKB-6548) is an oral hypoxia-inducible factor prolyl-hydroxylase domain (HIF-PHD) inhibitor that is being investigated for the treatment of anemia secondary to CKD. METHODS: A phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial (NCT01381094) was undertaken in adults with anemia secondary to CKD stage 3 or 4...
March 25, 2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28342534/comparison-of-ixekizumab-with-etanercept-or-placebo-in-moderate-to-severe-psoriasis-subgroup-analysis-of-latin-american-patients-in-the-phase-3-randomized-uncover-3-study
#7
F Valenzuela, C de la Cruz Fernandez, R L Galimberti, S Gürbüz, M McKean-Matthews, L Goncalves, R Romiti
BACKGROUND AND OBJECTIVES: Ixekizumab demonstrated greater efficacy than placebo and etanercept in UNCOVER-3. Subgroup analysis of Latin American patients was performed. We report 12-week and 60-week data. PATIENTS AND METHODS: Analysis included 102 Latin American patients randomized to receive placebo (n=14), etanercept 50mg twice weekly (n=30), or ixekizumab 160-mg starting dose followed by 80mg every 2 weeks (Q2W; n=29) or every 4 weeks (Q4W; n=29). At week 12, patients maintaining efficacy response and adequate overall safety were assigned, at the discretion of the investigator, to long-term extension with ixekizumab Q4W...
March 22, 2017: Actas Dermo-sifiliográficas
https://www.readbyqxmd.com/read/28341108/treatment-rationale-and-design-for-j-axel-a%C3%A2-randomized-phase-3-study-comparing-nab-paclitaxel-with-docetaxel-in-patients-with-previously-treated-advanced-non-small-cell-lung-cancer
#8
Yasuto Yoneshima, Satoshi Morita, Masahiko Ando, Satoru Miura, Hiroshige Yoshioka, Tetsuya Abe, Terufumi Kato, Masashi Kondo, Yukio Hosomi, Katsuyuki Hotta, Nobuyuki Yamamoto, Junji Kishimoto, Yoichi Nakanishi, Isamu Okamoto
BACKGROUND: Nanoparticle albumin-bound (nab) paclitaxel is a promising new therapeutic agent for all histologic types of non-small-cell lung cancer (NSCLC). We recently performed a phase 2 study of weekly nab-paclitaxel in patients with previously treated advanced NSCLC, finding promising activity and acceptable toxicity for this regimen. We have now designed a randomized phase 3 intergroup study (J-AXEL, UMIN000017487) to examine the clinical benefit and safety of nab-paclitaxel compared to docetaxel in patients with previously treated advanced NSCLC...
January 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28340866/epidemiology-of-clinical-trials-of-medicines-in-respiratory-diseases-in-europe-and-italy
#9
Roberta Bodini, Pierachille Santus, Fabiano Di Marco, Stefano Aliberti, Stefano Centanni, Francesco Blasi, Andrea Rizzi, Giuseppe Recchia
BACKGROUND: Clinical trials play a key role in advancing medical knowledge, improving patient care and promoting economic growth in Europe. We have assessed the clinical trial activity in any respiratory diseases in Europe, with a specific focus on Italy. METHODS: Information from public sources (EFPIA, clinicaltrials.gov, clinicaltrialsregister. eu, AIFA) was used to describe clinical trial activity of in respiratory diseases in Europe and by country. RESULTS: In 2015, 3908 clinical trials were reported in Europe, 386 in respiratory diseases (9...
April 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28339993/one-year-efficacy-and-safety-of-the-iron-based-phosphate-binder-sucroferric-oxyhydroxide-in-patients-on-peritoneal-dialysis
#10
Jürgen Floege, Adrian C Covic, Markus Ketteler, Johannes Mann, Anjay Rastogi, Bruce Spinowitz, Viatcheslav Rakov, Laura J Lisk, Stuart M Sprague
Background.: Sucroferric oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of sucroferric oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods.: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing sucroferric oxyhydroxide (1...
February 23, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28339098/quality-of-life-with-cediranib-in-relapsed-ovarian-cancer-the-icon6-phase-3-randomized-clinical-trial
#11
Dan P Stark, Adrian Cook, Julia M Brown, Michael D Brundage, Andrew C Embleton, Richard S Kaplan, Fharat A Raja, Ann Marie W Swart, Galina Velikova, Wendi Qian, Jonathan A Ledermann
BACKGROUND: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment. METHODS: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance...
March 24, 2017: Cancer
https://www.readbyqxmd.com/read/28337324/discovery-of-gbt440-an-orally-bioavailable-r-state-stabilizer-of-sickle-cell-hemoglobin
#12
Brian Metcalf, Chihyuan Chuang, Kobina Dufu, Mira P Patel, Abel Silva-Garcia, Carl Johnson, Qing Lu, James R Partridge, Larysa Patskovska, Yury Patskovsky, Steven C Almo, Matthew P Jacobson, Lan Hua, Qing Xu, Stephen L Gwaltney, Calvin Yee, Jason Harris, Bradley P Morgan, Joyce James, Donghong Xu, Athiwat Hutchaleelaha, Kumar Paulvannan, Donna Oksenberg, Zhe Li
We report the discovery of a new potent allosteric effector of sickle cell hemoglobin, GBT440 (36), that increases the affinity of hemoglobin for oxygen and consequently inhibits its polymerization when subjected to hypoxic conditions. Unlike earlier allosteric activators that bind covalently to hemoglobin in a 2:1 stoichiometry, 36 binds with a 1:1 stoichiometry. Compound 36 is orally bioavailable and partitions highly and favorably into the red blood cell with a RBC/plasma ratio of ∼150. This partitioning onto the target protein is anticipated to allow therapeutic concentrations to be achieved in the red blood cell at low plasma concentrations...
March 9, 2017: ACS Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/28336579/implementation-of-a-modified-who-pediatric-procedural-sedation-safety-checklist-and-its-impact-on-risk-reduction
#13
Lindsay Kahlenberg, Lindsay Harsey, Mary Patterson, Don Wachsberger, Dave Gothard, Michael Holder, Michael Forbes, Urmila Tirodker
BACKGROUND AND OBJECTIVES: Major adverse events (AEs) related to pediatric deep sedation occur at a low frequency but can be of high acuity. The high volume of deep sedations performed by 3 departments at our institution provided an opportunity to reduce variability and increase safety through implementation of a procedural sedation safety checklist. We hypothesized that implementation of a checklist would improve compliance of critical safety elements (CSEs) (primary outcome variable) and reduce the sedation-related AE rate (secondary outcome variable)...
March 23, 2017: Hospital Pediatrics
https://www.readbyqxmd.com/read/28336575/pharmacologic-profile-of-naloxegol-a-peripherally-acting-%C3%A2%C2%B5-opioid-receptor-antagonist-for-the-treatment-of-opioid-induced-constipation
#14
Eike Floettmann, Khanh Bui, Mark Sostek, Kemal Payza, Michael Eldon
Opioid-induced constipation (OIC) is a common side effect of opioid pharmacotherapy for the management of pain because opioid agonists bind to µ-opioid receptors in the enteric nervous system (ENS). Naloxegol, a polyethylene glycol derivative of naloxone and a peripherally acting µ-opioid receptor antagonist, targets the physiologic mechanisms that cause OIC. Pharmacologic measures of opioid activity and pharmacokinetic measures of central nervous system (CNS) penetration were employed to characterize the mechanism of action of naloxegol...
March 23, 2017: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/28336242/pacritinib-versus-best-available-therapy-for-the-treatment-of-myelofibrosis-irrespective-of-baseline-cytopenias-persist-1-an-international-randomised-phase-3-trial
#15
Ruben A Mesa, Alessandro M Vannucchi, Adam Mead, Miklos Egyed, Anita Szoke, Aleksandr Suvorov, Janos Jakucs, Andrew Perkins, Ritam Prasad, Jiri Mayer, Judit Demeter, Peter Ganly, Jack W Singer, Huafeng Zhou, James P Dean, Peter A Te Boekhorst, Jyoti Nangalia, Jean-Jacques Kiladjian, Claire N Harrison
BACKGROUND: Available therapies for myelofibrosis can exacerbate cytopenias and are not indicated for patients with severe thrombocytopenia. Pacritinib, which inhibits both JAK2 and FLT3, induced spleen responses with limited myelosuppression in phase 1/2 trials. We aimed to assess the efficacy and safety of pacritinib versus best available therapy in patients with myelofibrosis irrespective of baseline cytopenias. METHODS: This international, multicentre, randomised, phase 3 trial (PERSIST-1) was done at 67 sites in 12 countries...
March 20, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28334390/seqarray-a-storage-efficient-high-performance-data-format-for-wgs-variant-calls
#16
Xiuwen Zheng, Stephanie M Gogarten, Michael Lawrence, Adrienne Stilp, Matthew P Conomos, Bruce S Weir, Cathy Laurie, David Levine
Motivation: Whole-genome sequencing (WGS) data is being generated at an unprecedented rate. Analysis of WGS data requires a flexible data format to store the different types of DNA variation. Variant call format (VCF) is a general text-based format developed to store variant genotypes and their annotations. However, VCF files are large and data retrieval is relatively slow. Here we introduce a new WGS variant data format implemented in the R/Bioconductor package "SeqArray" for storing variant calls in an arrayoriented manner which provides the same capabilities as VCF, but with multiple high compression options and data access using high-performance parallel computing...
March 16, 2017: Bioinformatics
https://www.readbyqxmd.com/read/28333844/the-impact-of-an-international-network-gynecologic-cancer-intergroup-for-clinical-research-on-global-capacity-for-gynecologic-cancer-clinical-trials
#17
Gavin C E Stuart, Henry C Kitchener, Jan B Vermorken, Michael J Quinn, William Small, Eric Pujade-Lauraine, Hansen Chou, Michelle Wong, Monica Bacon
OBJECTIVE: The objective of this study was to demonstrate that the construction of the Gynecologic Cancer InterGroup (GCIG) has increased collaboration and accrual to high-quality phase 3 trials at a global level. MATERIALS AND METHODS: The GCIG is a collaboration of 29 international cooperative clinical trial groups committed to conduct of high-quality phase 3 trials among women with gynecologic cancer. A complete bibliography of the reported phase 3 trials has been developed and is available on the GCIG Web site http://www...
March 23, 2017: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/28332144/efficacy-and-safety-of-ideglira-in-participants-with-type-2-diabetes-in-india-uncontrolled-on-oral-antidiabetic-drugs-and-basal-insulin-data-from-the-dual-clinical-trial-program
#18
Kamlesh Khunti, Viswanathan Mohan, Sunil M Jain, Trine Welløv Boesgaard, Kamilla Begtrup, Bipin Sethi
INTRODUCTION: The efficacy and safety of insulin degludec/liraglutide (IDegLira) has been evaluated in the Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes (DUAL) phase 3 clinical trial program. In this post hoc analysis, we compared the efficacy and safety of IDegLira in the Indian subpopulation with the results from the global trial population of DUAL trials. The analysis includes participants uncontrolled on oral antidiabetic drugs (OADs) in DUAL I and DUAL IV and participants uncontrolled on basal insulin and OADs in DUAL II...
March 22, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28332096/efficacy-and-safety-of-paricalcitol-in-children-with-stages-3-to-5-chronic-kidney-disease
#19
Nicholas J A Webb, Gary Lerner, Bradley A Warady, Katherine M Dell, Larry A Greenbaum, Gema Ariceta, Bernd Hoppe, Peter Linde, Ho-Jin Lee, Ann Eldred, Matthew B Dufek
BACKGROUND: Elevated intact parathyroid hormone (iPTH) levels can contribute to morbidity and mortality in children with chronic kidney disease (CKD). We evaluated the pharmacokinetics, efficacy, and safety of oral paricalcitol in reducing iPTH levels in children with stages 3-5 CKD. METHODS: Children aged 10-16 years with stages 3-5 CKD were enrolled in two phase 3 studies. The stage 3/4 CKD study characterized paricalcitol pharmacokinetics and compared the efficacy and safety of paricalcitol with placebo followed by an open-label period...
March 22, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28331351/long-term-management-of-type-2-diabetes-with-glucagon-like-peptide-1-receptor-agonists
#20
REVIEW
Hamish Courtney, Rahul Nayar, Chinnadorai Rajeswaran, Ravi Jandhyala
Continuously reducing excess blood glucose is a primary goal for the management of type 2 diabetes (T2D). Most patients with T2D require glucose-lowering medications to achieve and maintain adequate glycemic control; however, treatment failure may occur, limiting treatment options. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are an emerging therapeutic class that can be prescribed for patients instead of basal insulin after the failure of oral therapies. Recent studies have focused on the durability and tolerability of long-term GLP-1RA therapy...
2017: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
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