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https://www.readbyqxmd.com/read/29332597/synthesis-of-a-novel-class-of-1-3-oxathiolane-nucleoside-derivatives-of-t-705-and-evaluation-of-their-anti-influenza-a-virus-and-anti-hiv-activity
#1
Mingming Han, Xu Zhao, Xuedong Wu, Wei Huang, Xingzhou Li, Fang Yu
Backgroud: T-705 (Favipiravir) is a broad spectrum antiviral agent approved for stockpiling in Japan and currently in Phase 3 testing in the United States. Against influenza acts as a prodrug, converted intracellularly to selectively inhibit viral RNA-dependent RNA polymerase or similar enzymes. This is regarded as a novel antiviral mechanism of action, reducing cross-resistance to other existing anti-influenza drugs. OBJECTIVE: To develop new analogs, a class of 1,3-oxathiolane nucleoside derivatives of T-705 were designed and synthesized in this work...
January 11, 2018: Medicinal Chemistry
https://www.readbyqxmd.com/read/29332135/sequential-versus-simultaneous-use-of-chemotherapy-and-gonadotropin-releasing-hormone-agonist-gnrha-among-estrogen-receptor-er-positive-premenopausal-breast-cancer-patients-effects-on-ovarian-function-disease-free-survival-and-overall-survival
#2
Ying Zhang, Yajie Ji, Jianwei Li, Li Lei, Siyu Wu, Wenjia Zuo, Xiaoqing Jia, Yujie Wang, Miao Mo, Na Zhang, Zhenzhou Shen, Jiong Wu, Zhimin Shao, Guangyu Liu
OBJECTIVE: To investigate ovarian function and therapeutic efficacy among estrogen receptor (ER)-positive, premenopausal breast cancer patients treated with gonadotropin-releasing hormone agonist (GnRHa) and chemotherapy simultaneously or sequentially. METHOD: This study was a phase 3, open-label, parallel, randomized controlled trial (NCT01712893). Two hundred sixteen premenopausal patients (under 45 years) diagnosed with invasive ER-positive breast cancer were enrolled from July 2009 to May 2013 and randomized at a 1:1 ratio to receive (neo)adjuvant chemotherapy combined with sequential or simultaneous GnRHa treatment...
January 13, 2018: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29330194/telotristat-ethyl-in-carcinoid-syndrome-safety-and-efficacy-in-the-telecast-phase-3-trial
#3
Marianne E Pavel, David J Gross, Marta Benavent, Petros Perros, Raj Srirajaskanthan, Richard R P Warner, Matthew H Kulke, Lowell Anthony, Pamela Kunz, Dieter Hörsch, Martin O Weickert, Pablo Lapuerta, Wenjun Jiang, Kenneth Kassler-Taub, Suman Wason, Rosanna Fleming, Douglas Fleming, Rocio García-Carbonero
Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the Phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a Phase 3 companion study, assessed safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea, or elevated urinary 5-hydroxyindoleacetic acid [u5-HIAA]) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE)...
January 12, 2018: Endocrine-related Cancer
https://www.readbyqxmd.com/read/29330071/onabotulinumtoxina-for-the-treatment-of-post-stroke-distal-lower-limb-spasticity-a-randomized-trial
#4
Theodore Wein, Alberto Esquenazi, Wolfgang H Jost, Anthony B Ward, Grace Pan, Rozalina Dimitrova
BACKGROUND: Post-stroke distal lower limb spasticity impairs mobility, limiting activities of daily living, requiring additional caregiver time. OBJECTIVE: To evaluate the efficacy, safety, and sustained benefit of onabotulinumtoxinA in adults with post-stroke lower limb spasticity (PSLLS). DESIGN: A multicenter, randomized, double-blind, phase 3, placebo-controlled trial. SETTING: 60 study centers across North America, Europe, Russia the United Kingdom, and South Korea...
January 9, 2018: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/29329763/efficacy-and-safety-of-varenicline-for-smoking-cessation-in-people-living-with-hiv-in-france-anrs-144-inter-activ-a-randomised-controlled-phase-3-clinical-trial
#5
Patrick Mercié, Julie Arsandaux, Christine Katlama, Samuel Ferret, Aurélie Beuscart, Christian Spadone, Claudine Duvivier, Jacques Reynes, Nathalie Wirth, Laetitia Moinot, Antoine Bénard, David Zucman, Xavier Duval, Jean-Michel Molina, Bruno Spire, Catherine Fagard, Geneviève Chêne
BACKGROUND: Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV. METHODS: The ANRS 144 Inter-ACTIV randomised, parallel, double-blind, multicentre, placebo-controlled phase 3 trial was done at 30 clinical hospital sites in France. People living with HIV who had smoked at least ten cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempt were eligible...
January 9, 2018: Lancet HIV
https://www.readbyqxmd.com/read/29329629/estimates-of-repeatability-and-correlations-of-hemoparasites-infection-levels-for-cattle-reared-in-endemic-areas-for-rhipicephalus-microplus
#6
Rodrigo Giglioti, Henrique Nunes de Oliveira, Talita Barban Bilhassi, Amanda Izeli Portilho, Cintia Hiromi Okino, Cintia Righetti Marcondes, Marcia Cristina de Sena Oliveira
Rhipicephalus microplus is a vector of cattle tick fever, a disease caused by the protozoans Babesia bovisand B. bigemina, and also anaplasmosis, produced by the Rickettsiales Anaplasma marginale. These tick-borne pathogens cause considerable losses to Brazilian livestock breeders and represent an obstacle to the expanded use of taurine breeds due to their higher sensitivity to ticks and hemoparasites compared to zebu breeds. Differences in the susceptibility to hemoparasites were also verified within breeds, suggesting that may be possible to select a most resistant phenotype...
January 30, 2018: Veterinary Parasitology
https://www.readbyqxmd.com/read/29328007/-prophylactic-hydration-to-protect-renal-function-from-intravascular-iodinated-contrast-material-in-patients-at-high-risk-of-contrast-induced-nephropathy-amacing-a-prospective-randomised-phase-3-controlled-open-label-non-inferiority-trial
#7
E C Nijssen, R J Rennenberg, P J Nelemans, B A Essers, M M Janssen, M A Vermeeren, V van Ommen, J E Wildberger
BACKGROUND: Intravenous saline is recommended in clinical practice guidelines as the cornerstone for preventing contrast-induced nephropathy in patients with compromised renal function. However, clinical-effectiveness and cost-effectiveness of this prophylactic hydration treatment in protecting renal function has not been adequately studied in the population targeted by the guidelines, against a group receiving no prophylaxis. This was the aim of the AMACING trial. METHODS: AMACING is a prospective, randomised, phase 3, parallel-group, open-label, non-inferiority trial of patients at risk of contrast-induced nephropathy according to current guidelines...
2018: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/29327948/effects-of-lumacaftor-ivacaftor-therapy-on-cftr-function-in-phe508del-homozygous-patients-with-cystic-fibrosis
#8
Simon Y Graeber, Christian Dopfer, Lutz Naehrlich, Lena Gyulumyan, Heike Scheuermann, Stephanie Hirtz, Sabine Wege, Heimo Mairbäurl, Marie Dorda, Rebecca Hyde, Azadeh Bagheri-Hanson, Claudia Rueckes-Nilges, Sebastian Fischer, Marcus A Mall, Burkhard Tümmler
RATIONALE: The combination of the CFTR corrector lumacaftor with the potentiator ivacaftor has been approved for the treatment of patients with cystic fibrosis (CF) homozygous for the Phe508del CFTR mutation. The phase 3 trials examined clinical outcomes, but did not evaluate CFTR function in patients. OBJECTIVES: To examine the effect of lumacaftor-ivacaftor on biomarkers of CFTR function in Phe508del homozygous CF patients aged 12 years and older. METHODS: This prospective observational study assessed clinical outcomes including FEV1 % predicted and BMI, and CFTR biomarkers including sweat chloride concentration, nasal potential difference (NPD) and intestinal current measurement (ICM) before and 8-16 weeks after initiation of lumacaftor-ivacaftor...
January 12, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29327055/comparing-neoadjuvant-nab-paclitaxel-vs-paclitaxel-both-followed-by-anthracycline-regimens-in-women-with-erbb2-her2-negative-breast-cancer-the-evaluating-treatment-with-neoadjuvant-abraxane-etna-trial-a-randomized-phase-3-clinical-trial
#9
Luca Gianni, Mauro Mansutti, Antonio Anton, Lourdes Calvo, Giancarlo Bisagni, Begoña Bermejo, Vladimir Semiglazov, Marc Thill, Jose Ignacio Chacon, Arlene Chan, Serafin Morales, Isabel Alvarez, Arrate Plazaola, Milvia Zambetti, Andrew D Redfern, Christian Dittrich, Rebecca Alexandra Dent, Domenico Magazzù, Raffaella De Fato, Pinuccia Valagussa, Ignacio Tusquets
Importance: Studies of neoadjuvant chemotherapy regimens using anthracyclines followed by taxanes have reported a doubling of pathological complete remission (pCR) rates compared with anthracycline-based regimens alone. A reverse sequence did not reduce activity. Nab-paclitaxel is an albumin-bound nanoparticle of paclitaxel that allows for safe infusion without premedication, and its use led to a significantly higher rate of pCR in the GeparSepto trial. Objective: To determine whether nab-paclitaxel improves the outcomes of early and locally advanced human epidermal growth factor receptor 2 (ERBB2/HER2)-negative breast cancer compared with paclitaxel when delivered in a neoadjuvant setting...
January 11, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29326030/patient-reported-outcomes-following-abiraterone-acetate-plus-prednisone-added-to-androgen-deprivation-therapy-in-patients-with-newly-diagnosed-metastatic-castration-naive-prostate-cancer-latitude-an-international-randomised-phase-3-trial
#10
Kim N Chi, Andrew Protheroe, Alfredo Rodríguez-Antolín, Gaetano Facchini, Henrik Suttman, Nobuaki Matsubara, Zhangqun Ye, Bhumsuk Keam, Ronaldo Damião, Tracy Li, Kelly McQuarrie, Bin Jia, Peter De Porre, Jason Martin, Mary B Todd, Karim Fizazi
BACKGROUND: In the LATITUDE trial, addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) improved overall survival compared with placebos plus ADT in patients with newly diagnosed, high-risk, metastatic castration-naive prostate cancer. Understanding the effects of treatments on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) is important for treatment decisions; therefore we aimed to analyse the effects of ADT plus abiraterone acetate and prednisone versus ADT plus placebos on PROs and HRQOL in patients in the LATITUDE study...
January 8, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29325546/development-and-evaluation-of-a-measure-of-patient-reported-symptoms-of-blepharitis
#11
Kamran Hosseini, Linda B Bourque, Ron D Hays
BACKGROUND: Blepharitis is an ocular surface disease and chronic ophthalmic condition. This paper reports on the development of psychometric evaluation of a patient-reported measure of blepharitis symptoms. METHODS: Self-reports of 13 blepharitis symptoms collected in a Phase 3 multi-site, randomized, double-masked, 4-arm parallel group, clinical trial of 907 individuals with blepharitis (mean age = 62, range: 19-93; 57% female) were analyzed. Symptoms asked about were: eyes that itch; eyes that burn; eyelids feel heavy or puffy; feel like something is in your eye; dry eyes; gritty eyes; irritated eyes; eyes that tear or water; crusty eyes; flaking from your eyelids; eyelids that are stuck together; red eyes or eyelids; and debris like pieces of skin or dandruff in your eyes...
January 11, 2018: Health and Quality of Life Outcomes
https://www.readbyqxmd.com/read/29323627/a-phase-3-multicenter-prospective-open-label-study-to-evaluate-the-safety-of-a-single-dose-of-secnidazole-2%C3%A2-g-for-the-treatment-of-women-and-postmenarchal-adolescent-girls-with-bacterial-vaginosis
#12
Steven E Chavoustie, Janet K Gersten, Milroy J Samuel, Jane R Schwebke
BACKGROUND: A novel formulation of secnidazole is under development in the United States for the treatment of bacterial vaginosis (BV). Efficacy and safety of other formulations of secnidazole have been reported. The objective of this study is to evaluate the safety of a single-dose oral granule formulation of secnidazole in a U.S. population of women with BV. METHODS: In this open-label study, patients were enrolled based on the following criteria: off-white, thin, homogeneous vaginal discharge; vaginal pH ≥4...
January 11, 2018: Journal of Women's Health
https://www.readbyqxmd.com/read/29322849/safety-profile-of-lenalidomide-in-patients-with-lower-risk-myelodysplastic-syndromes-without-del-5q-results-of-a-phase-3-trial
#13
Antonio Almeida, Pierre Fenaux, Guillermo Garcia-Manero, Stuart L Goldberg, Stefanie Gröpper, Anna Jonasova, Norbert Vey, Carmen Castaneda, Jianhua Zhong, C L Beach, Valeria Santini
The safety profile of lenalidomide use in lower-risk myelodysplastic syndromes (MDS) patients with del(5q) is well-established, but less is known in non-del(5q) patients. We provide safety data from a randomized, phase 3 trial evaluating lenalidomide in 239 patients with lower-risk non-del(5q) MDS ineligible/refractory to erythropoiesis-stimulating agents (ESAs). Compared with placebo, lenalidomide was associated with a higher incidence of grade 3-4 treatment-emergent adverse events (TEAEs; 86% vs. 44%), but not risk of infection (p = ...
January 11, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29322610/safety-and-efficacy-of-once-weekly-semaglutide-versus-additional-oral-antidiabetic-drugs-in-japanese-subjects-with-inadequately-controlled-t2d-a-randomised-trial
#14
Kohei Kaku, Yuichiro Yamada, Hirotaka Watada, Atsuko Abiko, Tomoyuki Nishida, Jeppe Zacho, Arihiro Kiyosue
AIMS: Semaglutide is a glucagon-like peptide 1 analogue in development for type 2 diabetes (T2D). Safety and efficacy of once-weekly subcutaneous semaglutide as monotherapy or combined with an oral antidiabetic drug (OAD) vs an additional OAD was evaluated in Japanese subjects with T2D inadequately controlled on diet/exercise or OAD monotherapy. METHODS: In this phase 3, open-label trial, adults with T2D were randomised 2:2:1 to semaglutide 0.5 mg or 1.0 mg, or one additional OAD (dipeptidyl peptidase-4 inhibitor, biguanide, sulphonylurea, glinide, α-glucosidase inhibitor or thiazolidinedione) with different modes of action...
January 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29320594/pivotal-trial-of-the-efficacy-and-safety-of-oxymetazoline-cream-1-0-for-the-treatment-of-persistent-facial-erythema-associated-with-rosacea-findings-from-the-first-reveal-trial
#15
Leon H Kircik, Janet DuBois, Zoe Diana Draelos, Philip Werschler, Kimberly Grande, Fran E Cook-Bolden, Emily Weng, David R Berk, Gurpreet Ahluwalia
An unmet need exists for a safe, tolerable, effective treatment for moderate to severe persistent facial erythema in patients with rosacea. This pivotal phase 3, multicenter, double-blind study evaluated the efficacy and safety of topical oxymetazoline in patients with facial erythema associated with moderate to severe rosacea. Patients were randomly assigned to treatment with oxymetazoline hydrochloride cream 1.0% or vehicle applied once daily for 29 days, and were followed for 28 days posttreatment. The primary efficacy outcome was having at least a 2-grade decrease from baseline on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment for rosacea facial redness (SSA) scales (composite success) at 3, 6, 9, and 12 hours postdose on day 29...
January 1, 2018: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29319191/linaclotide-in-irritable-bowel-syndrome-with-constipation-a-phase-3-randomized-trial-in-china-and-other-regions
#16
Yunsheng Yang, Jingyuan Fang, Xiaozhong Guo, Ning Dai, Xizhong Shen, Youlin Yang, Jing Sun, Bal Raj Bhandari, David S Reasner, Jacquelyn A Cronin, Mark G Currie, Jeffrey M Johnston, Peter Zeng, Niwat Montreewasuwat, George Zhijian Chen, Sam Lim
BACKGROUND AND AIM: Linaclotide is a guanylate cyclase-C agonist approved in multiple countries to treat irritable bowel syndrome with constipation (IBS-C). China has unmet need for well-tolerated therapy that is effective in treating both bowel and abdominal symptoms of IBS-C. This trial evaluated linaclotide's efficacy and safety in IBS-C patients in China and other regions. METHODS: This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania...
January 10, 2018: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29319030/efficacy-of-gefitinib-in-epidermal-growth-factor-receptor-activating-mutation-positive-nonsmall-cell-lung-cancer-does-exon-19-deletion-differ-from-exon-21-mutation
#17
Amit Joshi, Vijay Patil, Vanita Noronha, Anuradha Chougule, Atanu Bhattacharjee, Rajiv Kumar, Supriya Goud, Sucheta More, Anant Ramaswamy, Ashay Karpe, Nikhil Pande, Arun Chandrasekharan, Alok Goel, Vikas Talreja, Abhishek Mahajan, Amit Janu, Nilendu Purandare, Kumar Prabhash
BACKGROUND: This study was designed to evaluate the differential effect of epidermal growth factor receptor (EGFR) mutation status (exon 19 vs. 21) on progression-free survival (PFS) and overall survival (OS) in treatment-naïve advanced EGFR mutation-positive nonsmall cell lung cancer (NSCLC) treated with gefitinib as first-line agent. METHODS: This was a post hoc analysis of EGFR-mutated (exon 19 and 21) advanced-stage (Stage IIIB or IV), chemotherapy-naive NSCLC patients treated with gefitinib as first line in a phase 3 randomized study...
January 2018: Lung India: Official Organ of Indian Chest Society
https://www.readbyqxmd.com/read/29318031/para-aortic-lymphadenectomy-in-advanced-stage-cervical-cancer-a-protocol-for-comparing-safety-feasibility-and-diagnostic-accuracy-of-surgical-staging-versus-pet-ct-paldisc-trial
#18
Casper Tax, Karin Abbink, Maroeska M Rovers, Ruud L M Bekkers, Petra L M Zusterzeel
Background: Currently, a PET-CT is used to assess the need for extended field radiotherapy of para-aortic lymph nodes (PALN) in International Federation of Gynaecology and Obstetrics (FIGO) stage IB2, IIA2-IVA (locally advanced stage) cervical cancer. A small study established a sensitivity and specificity estimate for PALN metastases of 50% (95% CI; 7-93%) and 83% (95% CI; 52-98%), respectively. Surgical staging of PALN may lead to a higher diagnostic accuracy. However, surgical staging of para-aortic lymph nodes in locally advanced stage cervical cancer is not common practice...
2018: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/29317118/safety-and-immunogenicity-of-single-dose-live-oral-cholera-vaccine-strain-cvd-103-hgr-in-healthy-adults-age-18-45
#19
James M McCarty, Michael D Lock, Kristin M Hunt, Jakub K Simon, Marc Gurwith
The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera diarrhea in volunteer challenge studies. We performed a phase 3, placebo controlled, double blind, multi-center study to further assess the safety, immunogenicity, and lot-to-lot consistency of PXVX0200. Adult volunteers 18-45 years of age were randomized 8:1 to receive a single dose of 1 × 109 CFU of PXVX0200 from three production lots or saline placebo...
January 6, 2018: Vaccine
https://www.readbyqxmd.com/read/29316130/efficacy-and-safety-of-fast-acting-insulin-aspart-in-comparison-with-insulin-aspart-in-type-1-diabetes-onset%C3%A2-1-a-52-week-randomized-treat-to-target-phase%C3%A2-3-trial
#20
Chantal Mathieu, Bruce W Bode, Edward Franek, Athena Philis-Tsimikas, Ludger Rose, Tina Graungaard, Anne Birk Østerskov, David Russell-Jones
AIMS: Compare safety and efficacy of fast-acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D). MATERIALS AND METHODS: onset 1 was a randomized, multicentre, treat-to-target, phase 3, 52-week (initial 26 weeks + additional 26 weeks) trial conducted at 165 sites across nine countries. Adults with T1D were randomly allocated to double-blind mealtime faster aspart or IAsp, each with once- or twice-daily insulin detemir...
January 8, 2018: Diabetes, Obesity & Metabolism
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