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https://www.readbyqxmd.com/read/29166256/infection-free-clinical-response-among-patients-with-hidradenitis-suppurativa-who-were-treated-with-adalimumab-results-from-two-phase-3-studies
#1
Evangelos J Giamarellos-Bourboulis, Jeffrey Sobell, Caitriona Ryan, Pierre J Wolkenstein, Ziqian Geng, Gerit D Mulder
OBJECTIVE: The objective of this study is to assess the rates of infection-free achievement of hidradenitis suppurativa clinical response (HiSCR) using integrated data from 2 phase 3, placebo-controlled trials, PIONEER I and II. MATERIALS AND METHODS: Analyses from the first 12 weeks of both studies were examined. Patients were randomized to receive adalimumab (ADA) or placebo, and they then were assessed in the clinic at weeks 0, 2, 4, 8, and 12. All reports of an adverse or serious adverse event and infection were classified as treatment-emergent adverse events (TEAEs)...
November 2017: Wounds: a Compendium of Clinical Research and Practice
https://www.readbyqxmd.com/read/29164973/an-indirect-treatment-comparison-of-the-efficacy-of-insulin-degludec-liraglutide-ideglira-and-insulin-glargine-lixisenatide-iglarlixi-in-patients-with-type-2-diabetes-uncontrolled-on-basal-insulin
#2
Marc Evans, Liana K Billings, Jonas Håkan-Bloch, Ulla Slothuus, Trine J Abrahamsen, Andreas Andersen, Jeroen P Jansen
AIMS: To obtain estimates of the relative treatment effects between insulin degludec/liraglutide (IDegLira) and insulin glargine U100/lixisenatide (iGlarLixi) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin therapy. MATERIALS AND METHODS: Data from phase 3 trials providing evidence for estimating the relative efficacy and safety of IDegLira versus iGlarLixi in patients uncontrolled on basal insulin-only regimens were used in this analysis...
November 22, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/29164088/step-initiation-deficits-in-children-with-faulty-posture-diagnosed-with-neurodevelopmental-disorders-during-infancy
#3
Magdalena Stania, Alina Sarat-Spek, Teresa Blacha, Beata Kazek, Kajetan J Słomka, Ewa Emich-Widera, Grzegorz Juras
Background: Early detection of movement deficits during step initiation will facilitate the selection of the optimal physiotherapy management strategy. The main aim of the study was to assess potential differences in step initiation between 5- and 6-year-old children with faulty posture who had been diagnosed with neurodevelopmental disorders during infancy and healthy children. Methods: The experimental group consisted of 19 children aged 5-6 years with faulty posture, who had been diagnosed with neurodevelopmental disorders during infancy and were given physiotherapy in the first year of their lives...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/29164059/intravesical-gemcitabine-versus-intravesical-bacillus-calmette-gu%C3%A3-rin-for-the-treatment-of-non-muscle-invasive-bladder-cancer-an-evaluation-of-efficacy-and-toxicity
#4
Thiru Prasanna, Paul Craft, Gayathri Balasingam, Hodo Haxhimolla, Ganes Pranavan
Background: Intravesical Bacillus Calmette-Guérin (BCG) remains the standard adjuvant treatment for non-muscle invasive bladder cancer (NMIBC) following transurethral resection; however, BCG failure and related toxicities are common. Objectives: To compare the efficacy and toxicity of intravesical BCG and gemcitabine in the treatment of NMIBC. Methods: Retrospective data were collected in the region of Canberra, Australia from January 2010 to December 2015...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/29160598/a-randomized-8-week-double-blind-placebo-controlled-trial-of-vortioxetine-in-japanese-adults-with-major-depressive-disorder-followed-by-a-52-week-open-label-extension-trial
#5
Takeshi Inoue, Akira Nishimura, Kiyofumi Sasai, Tadayuki Kitagawa
AIM: Safety and efficacy of vortioxetine (5-20 mg/day) in Japanese patients with major depressive disorder were evaluated in two phase 3 studies consisting of a short-term, 8-week, placebo-controlled, double-blind study followed by a long-term, 52-week, open-label extension study. METHODS: The primary endpoint of the short-term study was change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8. The primary objective of the extension study was vortioxetine's long-term safety; efficacy endpoints included change in MADRS total score, clinical global impression scale-severity (CGI-S) score from the long-term study baseline, and clinical global impression scale-improvement (CGI-I) score over 52 weeks...
November 21, 2017: Psychiatry and Clinical Neurosciences
https://www.readbyqxmd.com/read/29160303/the-pnpla3-i148m-variant-is-associated-with-transaminase-elevations-in-type-2-diabetes-patients-treated-with-basal-insulin-peglispro
#6
S Pillai, S Duvvuru, P Bhatnagar, W Foster, M Farmen, S Shankar, C Harris, E Bastyr, B Hoogwerf, A Haupt
Basal insulin peglispro (BIL) is a novel insulin with hepato-preferential action. In phase 3 trials, BIL showed significantly improved glycemic control but higher levels of transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), triglycerides (TGs) and liver fat content (LFC) compared with insulin glargine (GL). As variants in PNPLA3 (I148M) and TM6SF2 (E167K) are associated with nonalcoholic fatty liver disease, we assessed these variants in type 2 diabetes (T2D) patients randomized to receive BIL (n=1822) or GL (n=1270) in three phase 3 trials...
November 21, 2017: Pharmacogenomics Journal
https://www.readbyqxmd.com/read/29158912/a-phase-2-quasi-experimental-trial-evaluating-the-feasibility-acceptability-and-potential-effectiveness-of-complex-nursing-intervention-focused-on-qol-assessment-on-advanced-cancer-patients-with-palliative-care-needs-study-protocol
#7
Gianluca Catania, Annamaria Bagnasco, Alessio Signori, Paola Pilastri, Marta Bottino, Claudia Cervetti, Milko Zanini, Giuseppe Aleo, Loredana Sasso
Background: Palliative care (PC) is an approach that improves the quality of life (QoL) of patients and their families facing the problem associated with incurable terminal disease. A number of QoL assessment tools have been validated in PC and their use described for research purposes, to support clinical practice, and as part of the quality improvement programs. There is a paucity of evidence on the implementation of a nursing intervention focused on QoL assessment in PC practice.The aim of this study is to model and determine the feasibility of a nursing complex intervention focused on QoL assessment in PC practice...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/29158666/tenofovir-alafenamide-in-the-treatment-of-chronic-hepatitis-b-design-development-and-place-in-therapy
#8
REVIEW
Eiichi Ogawa, Norihiro Furusyo, Mindie H Nguyen
Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). In two randomized, double-blind, multinational, Phase 3, non-inferiority trials for hepatitis B e antigen (HBeAg)-positive and -negative patients (primary analysis: 48 weeks), TAF 25 mg orally once-daily was not inferior to TDF 300 mg in achieving an HBV DNA level <29 IU/mL at week 48...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29158281/pharmacokinetics-and-safety-of-omadacycline-in-subjects-with-impaired-renal-function
#9
Jolene K Berg, Evan Tzanis, Lynne Garrity-Ryan, Stephen Bai, Surya Chitra, Amy Manley, Stephen Villano
Many antibiotics require dosing adjustments in patients with renal impairment and/or in those undergoing hemodialysis. Omadacycline, the first aminomethylcycline antibiotic in late-stage clinical development, displays activity against a broad-spectrum of bacterial pathogens, including resistant strains. Data from completed phase 3 acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) studies showed intravenous (IV) to once-daily oral omadacycline to be clinically effective and well tolerated...
November 20, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29158011/extended-adjuvant-intermittent-letrozole-versus-continuous-letrozole-in-postmenopausal-women-with-breast-cancer-sole-a-multicentre-open-label-randomised-phase-3-trial
#10
Marco Colleoni, Weixiu Luo, Per Karlsson, Jacquie Chirgwin, Stefan Aebi, Guy Jerusalem, Patrick Neven, Erika Hitre, Marie-Pascale Graas, Edda Simoncini, Claus Kamby, Alastair Thompson, Sibylle Loibl, Joaquín Gavilá, Katsumasa Kuroi, Christian Marth, Bettina Müller, Seamus O'Reilly, Vincenzo Di Lauro, Andrea Gombos, Thomas Ruhstaller, Harold Burstein, Karin Ribi, Jürg Bernhard, Giuseppe Viale, Rudolf Maibach, Manuela Rabaglio-Poretti, Richard D Gelber, Alan S Coates, Angelo Di Leo, Meredith M Regan, Aron Goldhirsch
BACKGROUND: In animal models of breast cancer, resistance to continuous use of letrozole can be reversed by withdrawal and reintroduction of letrozole. We therefore hypothesised that extended intermittent use of adjuvant letrozole would improve breast cancer outcome compared with continuous use of letrozole in postmenopausal women. METHODS: We did the multicentre, open-label, randomised, parallel, phase 3 SOLE trial in 240 centres (academic, primary, secondary, and tertiary care centres) in 22 countries...
November 17, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29156043/tenofovir-alafenamide-fumarate-a-new-tenofovir-prodrug-for-the-treatment-of-chronic-hepatitis-b-infection
#11
Maria Buti, Mar Riveiro-Barciela, Rafael Esteban
Tenofovir alafenamide fumarate (TAF), a new prodrug of tenofovir and a potential successor of tenofovir disoproxil fumarate (TDF), has been approved in the United States and Europe for treating adolescents and adults with chronic hepatitis B infection. TAF is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. In patients with chronic hepatitis B, TAF appears to be as effective as TDF, with lower bone and renal toxicity...
November 16, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29155352/patient-reported-outcomes-following-treatment-of-chronic-hepatitis-c-virus-infection-with-sofosbuvir-and-velpatasvir-with-or-without-voxilaprevir
#12
Zobair M Younossi, Maria Stepanova, Stuart Gordon, Stefan Zeuzem, Michael P Mann, Ira Jacobson, Marc Bourliere, Curtis Cooper, Steven Flamm, K Rajender Reddy, Kris Kowdley, Issah Younossi, Sharon Hunt
BACKGROUND & AIMS: Chronic infection with hepatitis C virus (HCV) has many hepatic and extrahepatic manifestations, measured by patient-reported outcomes (PROs). We measured changes in PROs during HCV treatment with recently developed pangenotypic regimens and from a sustained virologic response 12 weeks after treatment ended (SVR12). METHODS: We collected PRO data from 2 multi-center, blinded, international phase 3 trials of sofosbuvir, velpatasvir, and voxilaprevir, from 748 patients previously treated with direct-acting antivirals for chronic infection with HCV of any genotype (59% HCV genotype 1, 43% with compensated cirrhosis) (POLARIS-1 and POLARIS-4)...
November 16, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29152847/a-case-study-in-identifying-targeted-patients-population-in-major-depressive-disorder-by-enhanced-enrichment-design
#13
Peter Zhang, Kevin Carroll, Mary Hobart, Carole Augustine, Gary Koch
Despite advances in clinical trial design, failure rates near 80% in phase 2 and 50% in phase 3 have recently been reported. The challenges to successful drug development are particularly acute in central nervous system trials such as for pain, schizophrenia, mania, and depression because high-placebo response rates lessen assay sensitivity, diminish estimated treatment effect sizes, and thereby decrease statistical power. This paper addresses the importance of rigorous patient selection in major depressive disorder trials through an enhanced enrichment paradigm...
November 19, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29152828/efficacy-and-safety-of-12-weeks-of-elbasvir-%C3%A2-grazoprevir-%C3%A2-ribavirin-in-participants-with-hcv-genotype-2-4-5-or-6-infection-the-c-scape-study
#14
A Brown, C Hézode, E Zuckerman, G R Foster, A Zekry, S K Roberts, F Lahser, C Durkan, C Badshah, B Zhang, M Robertson, J Wahl, E Barr, B Haber
People with hepatitis C virus (HCV) infection other than genotype 1 represent a heterogeneous group. The aim of the phase 2 C-SCAPE study was to evaluate elbasvir/grazoprevir (EBR/GZR), with or without ribavirin (RBV), in participants with HCV genotype 2, 4, 5 or 6 infection. This was a part randomized, open-label, parallel-group study (NCT01932762; PN047-03) of treatment-naive, non-cirrhotic participants. Participants with HCV genotype 2 infection received GZR 100 mg+RBV±EBR 50 mg for 12 weeks and those with genotype 4, 5 or 6 infection were randomized to receive EBR/GZR±RBV for 12 weeks...
November 20, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29152781/glecaprevir-pibrentasvir-in-patients-with-hcv-genotype-1-or-4-and-prior-direct-acting-antiviral-treatment-failure
#15
Fred Poordad, Stanislas Pol, Armen Asatryan, Maria Buti, David Shaw, Christophe Hézode, Franco Felizarta, Robert W Reindollar, Stuart C Gordon, Stephen Pianko, Michael W Fried, David E Bernstein, Joel Gallant, Chih-Wei Lin, Yang Lei, Teresa I Ng, Preethi Krishnan, Sarah Kopecky-Bromberg, Jens Kort, Federico Mensa
METHODS: MAGELLAN-1 Part 2 was a randomized, open-label, phase 3 study to evaluate the efficacy and safety of ribavirin (RBV)-free glecaprevir and pibrentasvir (G/P; 300 mg/120 mg) in patients with chronic HCV and prior virologic failure on at least one NS3/4A protease and/or NS5A inhibitor-containing therapy. Patients with compensated liver disease, with or without cirrhosis, and HCV genotype (GT) 1, 4, 5, or 6 were randomized 1:1 to receive 12 or 16 weeks of G/P. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12)...
November 20, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29152674/progress-and-promise-for-the-mdma-drug-development-program
#16
REVIEW
Allison A Feduccia, Julie Holland, Michael C Mithoefer
Pharmacotherapy is often used to target symptoms of posttraumatic stress disorder (PTSD), but does not provide definitive treatment, and side effects of daily medication are often problematic. Trauma-focused psychotherapies are more likely than drug treatment to achieve PTSD remission, but have high dropout rates and ineffective for a large percentage of patients. Therefore, research into drugs that might increase the effectiveness of psychotherapy is a logical avenue of investigation. The most promising drug studied as a catalyst to psychotherapy for PTSD thus far is 3,4-methylenedioxymethamphetamine (MDMA), commonly known as the recreational drug "Ecstasy...
November 20, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/29152128/modulation-of-cabozantinib-efficacy-by-the-prostate-tumor-microenvironment
#17
Manisha Tripathi, Srinivas Nandana, Sandrine Billet, Karen A Cavassani, Rajeev Mishra, Leland W K Chung, Edwin M Posadas, Neil A Bhowmick
The tumor microenvironment (TME) is increasingly recognized as the arbiter of metastatic progression and drug resistance in advanced prostate cancer (PCa). Cabozantinib is a potent tyrosine kinase inhibitor (TKI) with reported biological activity in the PCa epithelia, but failed to provide an overall survival benefit in phase 3 clinical trials. However, the promising biologic efficacy of the drug in early trials warranted a better understanding of the mechanism of action, with the goal of improving patient selection for TKI-based therapy such as cabozantinib...
October 20, 2017: Oncotarget
https://www.readbyqxmd.com/read/29151359/osimertinib-in-untreated-egfr-mutated-advanced-non-small-cell-lung-cancer
#18
Jean-Charles Soria, Yuichiro Ohe, Johan Vansteenkiste, Thanyanan Reungwetwattana, Busyamas Chewaskulyong, Ki Hyeong Lee, Arunee Dechaphunkul, Fumio Imamura, Naoyuki Nogami, Takayasu Kurata, Isamu Okamoto, Caicun Zhou, Byoung Chul Cho, Ying Cheng, Eun Kyung Cho, Pei Jye Voon, David Planchard, Wu-Chou Su, Jhanelle E Gray, Siow-Ming Lee, Rachel Hodge, Marcelo Marotti, Yuri Rukazenkov, Suresh S Ramalingam
Background Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). Methods In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1:1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily)...
November 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29151197/impact-of-the-dapivirine-vaginal-ring-on-sexual-experiences-and-intimate-partnerships-of-women-in-an-hiv-prevention-clinical-trial-managing-ring-detection-and-hot-sex
#19
Nicole D Laborde, Elizabeth Pleasants, Krishnaveni Reddy, Millicent Atujuna, Teopista Nakyanzi, Miria Chitukuta, Sarita Naidoo, Thesla Palanee-Phillips, Jared M Baeten, Elizabeth T Montgomery
Vaginally-inserted HIV prevention methods have been reported to impact the sexual experience for women and their partners, and hence impacts acceptability of and adherence to the method. We analyzed in-depth interviews and focus group discussions about participants' sexual experiences while wearing the ring, collected during the MTN-020/ASPIRE phase 3 safety and effectiveness trial of a dapivirine vaginal ring for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe. Most women reported that partners did not feel the ring during sex, however, women felt they had to manage their partners' interaction with or reaction to the ring...
November 18, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/29151036/combination-therapy-is-superior-to-sequential-monotherapy-for-the-initial-treatment-of-hypertension-a-double-blind-randomized-controlled-trial
#20
Thomas M MacDonald, Bryan Williams, David J Webb, Steve Morant, Mark Caulfield, J Kennedy Cruickshank, Ian Ford, Peter Sever, Isla S Mackenzie, Sandosh Padmanabhan, Gerald P McCann, Jackie Salsbury, Gordon McInnes, Morris J Brown
BACKGROUND: Guidelines for hypertension vary in their preference for initial combination therapy or initial monotherapy, stratified by patient profile; therefore, we compared the efficacy and tolerability of these approaches. METHODS AND RESULTS: We performed a 1-year, double-blind, randomized controlled trial in 605 untreated patients aged 18 to 79 years with systolic blood pressure (BP) ≥150 mm Hg or diastolic BP ≥95 mm Hg. In phase 1 (weeks 0-16), patients were randomly assigned to initial monotherapy (losartan 50-100 mg or hydrochlorothiazide 12...
November 18, 2017: Journal of the American Heart Association
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