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clinical trial phase III

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https://www.readbyqxmd.com/read/29329598/treatment-outcome-of-anti-angiogenesis-through-vegf-pathway-in-the-management-of-gastric-cancer-a-systematic-review-of-phase-ii-and-iii-clinical-trials
#1
Brian Mawalla, Xianglin Yuan, Xiaoxiao Luo, Phillip L Chalya
OBJECTIVES: Advanced gastric cancer poses a therapeutic challenge worldwide. In randomised clinical trials, anti-VEGF has been reported as an essential agent for the treatment of advanced gastric cancer. This review aims at assessing the treatment outcome of anti-angiogenesis therapy through the VEGF pathway in the management of patients with advanced gastric cancer. RESULTS: During this review, 38 clinical trials were identified. Of these, 30 clinical trials were excluded, leaving eight trials of phase II and III...
January 12, 2018: BMC Research Notes
https://www.readbyqxmd.com/read/29328860/quality-of-life-from-canadian-cancer-trials-group-ma-17r-a-randomized-trial-of-extending-adjuvant-letrozole-to-10-years
#2
Julie Lemieux, Michael D Brundage, Wendy R Parulekar, Paul E Goss, James N Ingle, Kathleen I Pritchard, Paul Celano, Hyman Muss, Julie Gralow, Kathrin Strasser-Weippl, Kate Whelan, Dongsheng Tu, Timothy J Whelan
Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months...
January 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29327075/phase-ii-study-of-sorafenib-combined-with-concurrent-hepatic-arterial-infusion-of-oxaliplatin-5-fluorouracil-and-leucovorin-for-unresectable-hepatocellular-carcinoma-with-major-portal-vein-thrombosis
#3
Min-Ke He, Ru-Hai Zou, Qi-Jiong Li, Zhong-Guo Zhou, Jing-Xian Shen, Yong-Fa Zhang, Zi-Shan Yu, Li Xu, Ming Shi
BACKGROUND: Sorafenib is recommended for the first-line treatment of advanced hepatocellular carcinoma (HCC). However, the median progression-free survival (PFS) of patients with HCC and major portal vein tumor thrombosis treated with sorafenib monotherapy is no more than 3 months. A prospective single-arm phase II study was conducted to determine whether adding hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin to sorafenib could improve on these results...
January 11, 2018: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/29326191/establishing-anchor-based-minimally-important-differences-mid-with-the-eortc-quality-of-life-measures-a-meta-analysis-protocol
#4
Zebedee Jammbe Musoro, Jean-Francois Hamel, Divine Ewane Ediebah, Kim Cocks, Madeleine T King, Mogens Groenvold, Mirjam A G Sprangers, Yvonne Brandberg, Galina Velikova, John Maringwa, Hans-Henning Flechtner, Andrew Bottomley, Corneel Coens
INTRODUCTION: As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30)...
January 10, 2018: BMJ Open
https://www.readbyqxmd.com/read/29325469/current-update-of-a-thermosensitive-liposomes-composed-of-dppc-and-brij78
#5
Laurence Ho, Mehrdad Bokharaei, Shyh-Dar Li
Thermosensitive liposomes (TSLs) have been a prominent area of study in the discipline of tumor-targeted chemotherapeutics. The representative product of TSLs is ThermoDox® (DPPC/lyso-PC/PEG-lipid), which has advanced to Phase III clinical trials. Various groups have sought to develop a new TSL to improve upon the LTSL (lyso-lipid temperature sensitive liposomes) formulation that is used to prepare ThermoDOX®. This review focuses on the development and recent update of an innovative TSL formulation, HaT-liposomes composed of DPPC and Brij78...
January 11, 2018: Journal of Drug Targeting
https://www.readbyqxmd.com/read/29318022/clinical-trial-experience-with-ca4p-anticancer-therapy-focus-on-efficacy-cardiovascular-adverse-events-and-hypertension-management
#6
REVIEW
Rachel Grisham, Bonnie Ky, Krishnansu S Tewari, David J Chaplin, Joan Walker
Combretastatin A4-phosphate (CA4P) is a vascular-disrupting agent (VDA) in clinical development for the treatment of ovarian and other cancers. In contrast to antiangiogenic agents, such as bevacizumab, which suppress the development of new tumor vasculature, VDAs target established tumor vasculature. These differing but complementary mechanisms of action are currently being explored in clinical trials combining CA4P and bevacizumab. Clinical experience to date has highlighted an important need to better understand the cardiovascular adverse events of CA4P, both alone and in combination with antiangiogenic agents, which can also be associated with cardiovascular adverse events...
2018: Gynecologic Oncology Research and Practice
https://www.readbyqxmd.com/read/29317823/european-perspective-on-the-management-of-rheumatoid-arthritis-clinical-utility-of-tofacitinib
#7
REVIEW
Paweł Kawalec, Katarzyna Śladowska, Iwona Malinowska-Lipień, Tomasz Brzostek, Maria Kózka
Xeljanz® (tofacitinib) is an oral small-molecule inhibitor that reversibly inhibits Janus-activated kinase (JAK)-dependent cytokine signaling, thus reducing inflammation. As a result of these mechanisms, effects on the immune system such as a moderate decrease in the total lymphocyte count, a dose-dependent decrease in natural killer (NK) cell count, and an increase in B-cell count have been observed. Therefore, tofacitinib provides an innovative approach to modulating the immune and inflammatory responses in patients with rheumatoid arthritis (RA), which is especially important in individuals who do not respond to tumor necrosis factor inhibitors or show a loss of response over time...
2018: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/29317553/safety-profile-of-biosimilar-filgrastim-zarzio-zarxio-a-combined-analysis-of-phase-iii-studies
#8
Nadia Harbeck, Pere Gascón, Andriy Krendyukov, Nadja Hoebel, Sreekanth Gattu, Kimberly Blackwell
BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006...
January 9, 2018: Oncologist
https://www.readbyqxmd.com/read/29317395/the-role-of-elotuzumab-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma
#9
REVIEW
Jill M Comeau, Katherine Kelly, Gary W Jean
PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy and safety, cost, and place in therapy of elotuzumab for treatment of relapsed or refractory multiple myeloma (MM) are reviewed. SUMMARY: Elotuzumab is a humanized monoclonal antibody that targets the signaling lymphocytic activation molecule (SLAM) protein SLAMF7 and facilitates an antibody-dependent cellular cytotoxicity interaction between myeloma cells and natural killer cells. Elotuzumab has U.S...
January 15, 2018: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/29317015/randomized-trial-to-assess-the-efficacy-and-safety-of-beclomethasone-dipropionate-breath-actuated-inhaler-in-patients-with-asthma
#10
(no author information available yet)
BACKGROUND: Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standardmetered-dose inhalers (MDI). OBJECTIVE: To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI. METHODS: This 6-week, phase III, double-blind study included patients aged greater than or equal to 12 years with persistent asthma. During the single-blind run-in, patients discontinued asthma medications and received twice-daily placebo BAI or MDI...
January 9, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29316962/hopon-hyperbaric-oxygen-for-the-prevention-of-osteoradionecrosis-a-randomised-controlled-trial-of-hyperbaric-oxygen-to-prevent-osteoradionecrosis-of-the-irradiated-mandible-study-protocol-for-a-randomised-controlled-trial
#11
Richard Shaw, Christopher Butterworth, Binyam Tesfaye, Matthew Bickerstaff, Susanna Dodd, Gary Smerdon, Seema Chauhan, Peter Brennan, Keith Webster, James McCaul, Peter Nixon, Anastasios Kanatas, Paul Silcocks
BACKGROUND: Osteoradionecrosis of the mandible is the most common serious complication of radiotherapy for head and neck malignancy. For decades, hyperbaric oxygen has been employed in efforts to prevent those cases of osteoradionecrosis that are precipitated by dental extractions or implant placement. The evidence for using hyperbaric oxygen remains poor and current clinical practice varies greatly. We describe a protocol for a clinical trial to assess the benefit of hyperbaric oxygen in the prevention of osteoradionecrosis during surgery on the irradiated mandible...
January 10, 2018: Trials
https://www.readbyqxmd.com/read/29316837/ruxolitinib-for-the-treatment-of-patients-with-steroid-refractory-gvhd-an-introduction-to-the-reach-trials
#12
Madan Jagasia, Robert Zeiser, Michael Arbushites, Patricia Delaite, Brian Gadbaw, Nikolas von Bubnoff
For patients with hematologic malignancies and disorders, allogeneic hematopoietic stem cell transplantation offers a potentially curative treatment option. Many patients develop graft-versus-host disease (GVHD), a serious complication and leading cause of nonrelapse mortality. Corticosteroids are the standard first-line treatment for GVHD; however, patients often become steroid-refractory or remain corticosteroid-dependent. New second-line treatment options are needed to improve patient outcomes. Here we review the role of JAK1 and JAK2 in acute and chronic GVHD...
January 10, 2018: Immunotherapy
https://www.readbyqxmd.com/read/29316335/exposure-response-model-of-subcutaneous-c1-inhibitor-concentrate-to-estimate-the-risk-of-attacks-in-patients-with-hereditary-angioedema
#13
Ying Zhang, Michael A Tortorici, Dipti Pawaskar, Ingo Pragst, Thomas Machnig, Matthew Hutmacher, Bruce Zuraw, Marco Cicardi, Timothy Craig, Hilary Longhurst, Jagdev Sidhu
Subcutaneous C1-inhibitor (HAEGARDA, CSL Behring), is a US Food and Drug Administration (FDA)-approved, highly concentrated formulation of a plasma-derived C1-esterase inhibitor (C1-INH), which, in the phase III Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy (COMPACT) trial, reduced the incidence of hereditary angioedema (HAE) attacks when given prophylactically. Data from the COMPACT trial were used to develop a repeated time-to-event model to characterize the timing and frequency of HAE attacks as a function of C1-INH activity, and then develop an exposure-response model to assess the relationship between C1-INH functional activity levels (C1-INH(f)) and the risk of an attack...
January 9, 2018: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29315999/long-term-safety-and-efficacy-of-acotiamide-in-functional-dyspepsia-postprandial-distress-syndrome-results-from-the-european-phase-3-open-label-safety-trial
#14
J Tack, J Pokrotnieks, G Urbonas, C Banciu, V Yakusevich, I Bunganic, H Törnblom, Y Kleban, P Eavis, M Tsuchikawa, T Miyagawa
BACKGROUNDS: Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). This European phase 3 open-label safety trial has been conducted to evaluate the long-term safety of acotiamide and explore the efficacy of acotiamide on PDS symptoms using the validated LPDS, quality of life using SF-36 and SF-NDI, and work productivity using WPAI. METHODS: FD-PDS patients (defined by ROME III criteria) aged ≥18 years with active PDS symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100 mg acotiamide three times daily for 1 year...
January 8, 2018: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
https://www.readbyqxmd.com/read/29315376/autologous-cd34-cell-therapy-improves-exercise-capacity-angina-frequency-and-reduces-mortality-in-no-option-refractory-angina-a-patient-level-pooled-analysis-of-randomized-double-blinded-trials
#15
Timothy D Henry, Douglas W Losordo, Jay H Traverse, Richard A Schatz, E Marc Jolicoeur, Gary L Schaer, Robert Clare, Karen Chiswell, Christopher J White, F David Fortuin, Dean J Kereiakes, Andreas M Zeiher, Warren Sherman, Andrea S Hunt, Thomas J Povsic
Aims: Autologous CD34+ (auto-CD34+) cells represent an attractive option for the treatment of refractory angina. Three double-blinded randomized trials (n = 304) compared intramyocardial (IM) auto-CD34+ cells with IM placebo injections to affect total exercise time (TET), angina frequency (AF), and major adverse cardiac events (MACE). Patient-level data were pooled from the Phase I, Phase II ACT-34, ACT-34 extension, and Phase III RENEW trials to determine the efficacy and safety of auto-CD34+ cells...
January 5, 2018: European Heart Journal
https://www.readbyqxmd.com/read/29314655/randomised-controlled-trial-of-standard-closure-of-stoma-site-versus-biologic-mesh-reinforcement-study-protocol-of-the-rocss-trial
#16
(no author information available yet)
BACKGROUND: Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernias. Hernia formation at closed stoma sites occurs in up to 30% of patients. Use of biological meshes in these situations may provide a safe method of reducing these complications, especially long-term incisional hernias. METHOD: The Reinforcement of Closure of Stoma Site (ROCSS) study is a phase III multicentre randomised controlled trial (RCT), with an internal feasibility study...
January 3, 2018: Colorectal Disease: the Official Journal of the Association of Coloproctology of Great Britain and Ireland
https://www.readbyqxmd.com/read/29313802/augmenting-cognitive-training-in-older-adults-the-act-study-design-and-methods-of-a-phase-iii-tdcs-and-cognitive-training-trial
#17
Adam J Woods, Ronald Cohen, Michael Marsiske, Gene E Alexander, Sara J Czaja, Samuel Wu
BACKGROUND: Adults over age 65 represent the fastest growing population in the US. Decline in cognitive abilities is a hallmark of advanced age and is associated with loss of independence and dementia risk. There is a pressing need to develop effective interventions for slowing or reversing the cognitive aging process. While certain forms of cognitive training have shown promise in this area, effects only sometimes transfer to neuropsychological tests within or outside the trained domain...
December 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29313577/a-randomized-controlled-phase-iii-clinical-trial-to-evaluate-the-efficacy-and-tolerability-of-risorine-with-conventional-rifampicin-in-the-treatment-of-newly-diagnosed-pulmonary-tuberculosis-patients
#18
Naresh Patel, K Jagannath, Agam Vora, Mukesh Patel, Anand Patel
Background: The overall goals for treatment of Tuberculosis (TB) are to cure individual patient and to minimize the transmission of Mycobacterium tuberculosis. At the time of study conduction, the standard treatment for newly diagnosed tuberculosis patients consisted of an intensive phase for two months with four drugs (HRZE), followed by continuation phase for four months with two drugs (HR). Rifampicin, which is very effective against Mycobacterium tuberculosis, in both the phases of treatment, has certain concerns, which includes, decreased bioavailability with chronic use and hepatotoxicity...
September 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/29313492/rufinamide-for-the-treatment-of-lennox-gastaut-syndrome-evidence-from-clinical-trials-and-clinical-practice
#19
Pasquale Striano, Rob McMurray, Estevo Santamarina, Mercè Falip
Rufinamide was granted orphan drug status in 2004 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years, and was subsequently approved for this indication in several countries, including Europe and the United States. Structurally unrelated to other antiepileptic drugs, rufinamide is thought to act primarily by prolonging the inactivation phase of voltage-gated sodium channels. Rufinamide was approved on the basis of an international, randomised, placebo-controlled Phase III trial, conducted in 138 patients with Lennox-Gastaut syndrome, which demonstrated its favourable tolerability profile and efficacy in significantly reducing the frequency of drop attacks and total seizures, compared with placebo...
January 9, 2018: Epileptic Disorders: International Epilepsy Journal with Videotape
https://www.readbyqxmd.com/read/29313486/phase-iii-clinical-trial-to-evaluate-ivermectin-in-the-reduction-of-mansonella-ozzardi-infection-in-the-brazilian-amazon
#20
Sergio de Almeida Basano, Juliana Souza de Almeida Aranha Camargo, Gilberto Fontes, Antonieta Relvas Pereira, Jansen Fernandes Medeiros, Mayara Costa de Oliveira Laudisse, Ricardo de Godoi Mattos Ferreira, Luís Marcelo Aranha Camargo
The treatment of mansonelliasis is still a challenge because there are few clinical trials for the treatment of the disease. This double-blind, randomized, placebo-controlled study (phase III clinical trial) was conducted to evaluate the effectiveness of a single oral dose of ivermectin (0.15 mg/kg) in the reduction of the Mansonella ozzardi microfilaraemia and the occurrence of adverse effects in infected people compared with the control group treated with placebo. A total of 49 microfilaraemic patients were randomly selected from the municipality of Lábrea, State of Amazonas, in the Brazilian Amazon...
January 8, 2018: American Journal of Tropical Medicine and Hygiene
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