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https://www.readbyqxmd.com/read/27911344/patient-perspectives-on-deep-brain-stimulation-clinical-research-in-early-stage-parkinson-s-disease
#1
Lauren Heusinkveld, Mallory Hacker, Maxim Turchan, Madelyn Bollig, Christina Tamargo, William Fisher, Lauren McLaughlin, Adria Martig, David Charles
The FDA approved a multicenter, double-blind, Phase III, pivotal trial testing deep brain stimulation in 280 people with very early stage Parkinson's disease (PD; IDE#G050016). In partnership with The Michael J. Fox Foundation for Parkinson's Research, we conducted a survey to investigate motivating factors, barriers, and gender differences for participation in a trial testing DBS in early PD. The majority of survey respondents (72%) indicated they would consider learning more about participating. Men and women with early PD are likely to consider enrolling in trials of invasive therapies that may slow symptom progression and help future patients...
November 30, 2016: Journal of Parkinson's Disease
https://www.readbyqxmd.com/read/27910962/baricitinib-jak-inhibition-for-rheumatoid-arthritis
#2
J Gras
Rheumatoid arthritis (RA), a chronic autoimmune inflammatory disease characterized by inflammation and joint destruction, is associated with pain, progressive disability, systemic comorbidities and early death. Conventional disease-modifying antirheumatic drugs (DMARDs) and biological DMARDs (bDMARDs) have been able to achieve remission or a very low disease activity status for RA. Nevertheless, since many patients do not reach a sufficient response with DMARDs or present with unacceptable side effects, new therapies are needed...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910704/the-safety-of-nivolumab-for-the-treatment-of-advanced-non-small-cell-lung-cancer
#3
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/27910150/randomised-clinical-trial-exploratory-phase-2-study-of-ono-2952-in-diarrhoea-predominant-irritable-bowel-syndrome
#4
W E Whitehead, K Duffy, J Sharpe, T Nabata, M Bruce
BACKGROUND: ONO-2952 is a novel and selective inhibitor of translocator protein 18 kDa that reduces stress-induced defecation and visceral hyperalgesia in rat models. AIM: To evaluate the efficacy and safety of ONO-2952 in females with irritable bowel syndrome with diarrhoea in an exploratory proof-of-concept study. METHODS: A randomised, double-blind, placebo-controlled study was conducted at 49 US centres. Two hundred subjects with irritable bowel syndrome with diarrhoea (Rome III criteria) were randomised to ONO-2952 20 mg, or 60 mg, or placebo...
January 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27909995/solithromycin-a-novel-fluoroketolide-for-the-treatment-of-community-acquired-bacterial-pneumonia
#5
REVIEW
George G Zhanel, Erika Hartel, Heather Adam, Sheryl Zelenitsky, Michael A Zhanel, Alyssa Golden, Frank Schweizer, Bala Gorityala, Philippe R S Lagacé-Wiens, Andrew J Walkty, Alfred S Gin, Daryl J Hoban, Joseph P Lynch, James A Karlowsky
Solithromycin is a novel fluoroketolide developed in both oral and intravenous formulations to address increasing macrolide resistance in pathogens causing community-acquired bacterial pneumonia (CABP). When compared with its macrolide and ketolide predecessors, solithromycin has several structural modifications which increase its ribosomal binding and reduce its propensity to known macrolide resistance mechanisms. Solithromycin, like telithromycin, affects 50S ribosomal subunit formation and function, as well as causing frame-shift errors during translation...
December 1, 2016: Drugs
https://www.readbyqxmd.com/read/27909987/orexin-ox2-receptor-antagonists-as-sleep-aids
#6
Laura H Jacobson, Sui Chen, Sanjida Mir, Daniel Hoyer
The discovery of the orexin system represents the single major progress in the sleep field of the last three to four decades. The two orexin peptides and their two receptors play a major role in arousal and sleep/wake cycles. Defects in the orexin system lead to narcolepsy with cataplexy in humans and dogs and can be experimentally reproduced in rodents. At least six orexin receptor antagonists have reached Phase II or Phase III clinical trials in insomnia, five of which are dual orexin receptor antagonists (DORAs) that target both OX1 and OX2 receptors (OX2Rs)...
December 2, 2016: Current Topics in Behavioral Neurosciences
https://www.readbyqxmd.com/read/27906472/long-term-clinical-impact-and-cost-effectiveness-of-obeticholic-acid-for-the-treatment-of-primary-biliary-cholangitis
#7
Sumeyye Samur, Matthew Klebanoff, Reiner Banken, Daniel S Pratt, Rick Chapman, Daniel A Ollendorf, Anne M Loos, Kathleen Corey, Chin Hur, Jagpreet Chhatwal
: Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune liver disease that mainly affects middle-aged women. Obeticholic acid (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demonstrated positive effects on biochemical markers of liver function. Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA...
November 7, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27904904/clinical-evaluation-of-glycopegylated-recombinant-fviii-efficacy-and-safety-in-severe-haemophilia-a
#8
Paul Giangrande, Tatiana Andreeva, Pratima Chowdary, Silke Ehrenforth, Hideji Hanabusa, Frank W G Leebeek, Steven R Lentz, Laszlo Nemes, Lone Hvitfeldt Poulsen, Elena Santagostino, Chur Woo You, Wan Hui Ong Clausen, Peter G Jönsson, Johannes Oldenburg
Turoctocog alfa pegol (N8-GP) is a novel glycoPEGylated extended half-life recombinant factor VIII (FVIII) product developed for prophylaxis and treatment of bleeds in patients with haemophilia A, to enable higher activity levels with less frequent injections compared with standard FVIII products. This phase III (NCT01480180), multinational, open-label, non-randomised trial evaluated the safety and clinical efficacy of N8-GP when administered for treatment of bleeds and for prophylaxis, in previously treated patients aged ≥12 years with severe haemophilia A...
December 1, 2016: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/27902600/efficacy-and-safety-of-canagliflozin-in-patients-with-type-2-diabetes-a-meta-analysis-of-randomized-controlled-trials
#9
Wei Xiong, Ming Yue Xiao, Mei Zhang, Fei Chang
BACKGROUND: Canagliflozin is a new SGLT2 inhibitor which has been approved as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes (T2D) mellitus in more than 30 countries. To evaluate the efficacy and safety of canagliflozin in patients with T2D, we carried out a meta-analysis of phase III clinical trials to offer an additional evidence of the efficacy and safety of canagliflozin for evidence-based clinical practice, strictly restricting the treatment durations to 26 weeks (core period) and 52 weeks (extension period)...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27902583/adverse-events-risk-associated-with-anti-vegfr-agents-in-the-treatment-of-advanced-nonsmall-cell-lung-cancer-a-meta-analysis
#10
Biao Gu, WenChuang Gao, HongJun Chu, Jian Gao, Zhi Fu, Hui Ding, JunJie Lv, QingQuan Wu
To perform this meta-analysis, we investigated the risk of the most clinically relevant adverse events related to antivascular endothelial growth factor receptor (VEGFR) agents in advanced nonsmall-cell lung cancer (NSCLC).A comprehensive literature search for studies published up to October 2015 was performed. Prospective randomized controlled phase II/III clinical trials that comparing therapy with or without anti-VEGFR agents for advanced NSCLC were included for analysis. Summary relative risk (RR) and 95% confidence intervals (CIs) were calculated using random effects or fixed effects according to the heterogeneity among included trials...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27902493/intravenous-amisulpride-for-the-prevention-of-postoperative-nausea-and-vomiting-two-concurrent-randomized-double-blind-placebo-controlled-trials
#11
Tong J Gan, Peter Kranke, Harold S Minkowitz, Sergio D Bergese, Johann Motsch, Leopold Eberhart, David G Leiman, Timothy I Melson, Dominique Chassard, Anthony L Kovac, Keith A Candiotti, Gabriel Fox, Pierre Diemunsch
BACKGROUND: Two essentially identical, randomized, double-blind, placebo-controlled, parallel-group phase III studies evaluated the efficacy of intravenous amisulpride, a dopamine D2/D3 antagonist, in the prevention of postoperative nausea and vomiting in adult surgical patients. METHODS: Adult inpatients undergoing elective surgery during general anesthesia and having at least two of the four Apfel risk factors for postoperative nausea and vomiting were enrolled at 9 U...
November 30, 2016: Anesthesiology
https://www.readbyqxmd.com/read/27900868/-rivaroxaban-use-in-prevention-of-stroke-in-patients-with-non-valvular-atrial-fibrillation-in-clinical-practice-results-of-observational-studies-and-our-experience
#12
Filip Málek
Rivaroxaban is direct oral factor Xa inhibitor indicated for tromboembolic event rate reduction in patients with non-valvular atrial fibrillation. Knowledge of rivaroxaban efficacy and safety comes from a phase III randomized clinical trial ROCKET AF. In the present, we have more evidence of rivaroxaban efficacy from real-life clinical studies. XANTUS study was first international prospective observational real-life study documenting use of rivaroxaban in stroke prevention in a broad population of patients with non-valvular atrial fibrillation...
2016: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27900428/relationship-between-baseline-characteristics-and-response-to-risedronate-treatment-for-osteoporosis-data-from-three-japanese-phase-iii-trials
#13
T Mawatari, R Muraoka, Y Iwamoto
: We evaluated the influence of baseline age, bone mineral density (BMD), and serum levels of vitamin D on the response to risedronate treatment. Risedronate consistently increased BMD, but our results suggest vitamin D supplementation may be necessary to achieve optimal treatment effect. Furthermore, early intervention may help prevent bone fractures. INTRODUCTION: We aimed to investigate the influence of baseline age, BMD, and vitamin D insufficiency on the response to risedronate treatment...
November 30, 2016: Osteoporosis International
https://www.readbyqxmd.com/read/27899400/study-protocol-a-phase-iii-randomised-double-blind-parallel-arm-stratified-block-randomised-placebo-controlled-trial-investigating-the-clinical-effect-and-cost-effectiveness-of-sertraline-for-the-palliative-relief-of-breathlessness-in-people-with-chronic-breathlessness
#14
Gareth J Watts, Katherine Clark, Meera Agar, Patricia M Davidson, Christine McDonald, Lawrence T Lam, Dimitar Sajkov, Nicola McCaffrey, Matthew Doogue, Amy P Abernethy, David C Currow
INTRODUCTION: Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness...
November 29, 2016: BMJ Open
https://www.readbyqxmd.com/read/27899357/a-phase-iii-randomized-trial-comparing-inolimomab-vs-usual-care-in-steroid-resistant-acute-gvhd
#15
Gérard Socié, Stéphane Vigouroux, Ibrahim Yakoub-Agha, Jacques-Olivier Bay, Sabine Fürst, Karin Bilger, Felipe Suarez, Mauricette Michallet, Dominique Bron, Philippe Gard, Zakaria Medeghri, Philippe Lehert, Chinglin Lai, Tim Corn, Jean-Paul Vernant
Treatment of steroid resistant (SR) aGVHD remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase II trials. This phase III randomized, open-label, multicenter compared Inolimomab vs. usual care in adult patients with steroid-refractory aGvHD. Patients were randomized to treatment with Inolimomab or usual care [control group were all treated with Anti Thymocyte Globulin (ATG)]. The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy...
November 29, 2016: Blood
https://www.readbyqxmd.com/read/27898364/liquid-chromatography-tandem-mass-spectrometry-assay-for-the-quantification-of-niraparib-and-its-metabolite-m1-in-human-plasma-and-urine
#16
L van Andel, Z Zhang, S Lu, V Kansra, S Agarwal, L Hughes, M M Tibben, A Gebretensae, H Rosing, J H M Schellens, J H Beijnen
Niraparib (MK-4827) is a novel poly(ADP-Ribose) polymerase (PARP) inhibitor currently investigated in phase III clinical trials to treat cancers. The development of a new drug includes the characterisation of absorption, metabolism and excretion (AME) of the compound. AME studies are a requirement of regulatory agencies and for this purpose bioanalytical assays are essential. This article describes the development and validation of a bioanalytical assay for niraparib and its carboxylic acid metabolite M1 in human plasma and urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS)...
November 19, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27896440/a-phase-iii-open-label-randomized-multicenter-controlled-trial-of-oral-versus-intravenous-treosulfan-in-heavily-pretreated-recurrent-ovarian-cancer-a-study-of-the-north-eastern-german-society-of-gynecological-oncology-noggo
#17
Jalid Sehouli, Oliver Tomè, Desislava Dimitrova, Oumar Camara, Ingo Bernhard Runnebaum, Hans Werner Tessen, Beate Rautenberg, Radoslav Chekerov, Mustafa Zelal Muallem, Michael Patrick Lux, Tanja Trarbach, Gerald Gitsch
OBJECTIVE: In recurrent ovarian cancer (ROC), there is a high demand on effective therapies with a mild toxicity profile. Treosulfan is an alkylating agent approved as oral (p.o.) and intravenous (i.v.) formulation for the treatment of recurrent ovarian cancer. Data on safety and efficacy for either formulation are rare. For the first time we conducted a randomized phase III study comparing both formulations in women with ROC. METHODS: Patients having received at least two previous lines of chemotherapy were randomly assigned to one of two treatment arms: treosulfan i...
November 28, 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/27895504/deferred-radiotherapy-and-upfront-procarbazine-acnu-vincristine-administration-for-1p19q-codeleted-oligodendroglial-tumors-are-associated-with-favorable-outcome-without-compromising-patient-performance-regardless-of-who-grade
#18
Nobuhiro Hata, Koji Yoshimoto, Ryusuke Hatae, Daisuke Kuga, Yojiro Akagi, Satoshi O Suzuki, Toru Iwaki, Tadahisa Shono, Masahiro Mizoguchi, Koji Iihara
Recently updated phase III trials revealed the favorable effect of add-on procarbazine-lomustine-vincristine chemotherapy (CT) to radiotherapy (RT) in treating anaplastic oligodendrogliomas with 1p19q codeletion (codel). However, the underlying rationality of deferring RT and upfront CT administration for these tumors is yet to be elucidated. Here, we retrospectively analyzed the long-term outcome of our case series with oligodendroglial tumors treated with deferred RT and upfront procarbazine+nimustine+vincristine (PAV) in the introduction administration...
2016: OncoTargets and Therapy
https://www.readbyqxmd.com/read/27895464/selexipag-in-the-treatment-of-pulmonary-arterial-hypertension-design-development-and-therapy
#19
REVIEW
Elizabeth Ashley Hardin, Kelly M Chin
Pulmonary arterial hypertension is characterized by abnormalities in the small pulmonary arteries including increased vasoconstriction, vascular remodeling, proliferation of smooth muscle cells, and in situ thrombosis. Selexipag, a novel, oral prostacyclin receptor agonist, has been shown to improve hemodynamics in a phase II clinical trial and reduce clinical worsening in a large phase III clinical trial involving patients with pulmonary arterial hypertension. In this paper, we describe the prostacyclin signaling pathway, currently available oral prostanoid medications, and the development and clinical use of selexipag...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27895236/a-review-of-single-tablet-regimens-for-the-treatment-of-hiv-1-infection
#20
REVIEW
Jamielynn C Sebaaly, Denise Kelley
OBJECTIVE: To review the pharmacokinetics, safety, drug-drug interactions, and advantages and disadvantages of currently available single-tablet regimens (STRs) for HIV-1 infection. DATA SOURCES: A search using PubMed was conducted (up to September 2016) using the following keywords: single tablet regimen AND HIV Additionally, a PubMed search was conducted for each individual STR using the generic names of the agents. Articles were evaluated for content, and additional references were identified from a review of literature citations...
November 27, 2016: Annals of Pharmacotherapy
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