84,827 results match your criteria phase iii


Prognostic value of testosterone castration levels following androgen deprivation and high-dose radiotherapy in localized prostate cancer: results from a phase iii trial.

Radiother Oncol 2021 May 5. Epub 2021 May 5.

Hospital General Universitario Gregorio Marañón, Madrid, Spain.

Background/objective: The optimal prognostic value of testosterone following androgen deprivation therapy (ADT) is controversial. We studied the effect of serum testosterone levels on clinical outcome in localized prostate cancer (PCa) treated with ADT and high-dose radiotherapy (HRT).

Patients And Methods: The DART01/05 trial randomized 355 men with intermediate and high-risk PCa to 4 months of ADT plus HRT (STADT, N=178) or the same treatment followed by 24 months of ADT (LTADT, N=177). Read More

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A Pharmacological and Clinical Overview of Oral Semaglutide for the Treatment of Type 2 Diabetes.

Drugs 2021 May 8. Epub 2021 May 8.

Steno Diabetes Center Copenhagen, Gentofte Hospital, University of Copenhagen, 2900, Gentofte, Denmark.

Oral semaglutide (Rybelsus) is a glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1RA) with 94% homology to human GLP-1. It is the first GLP-1RA developed for oral administration, and it comprises a co-formulation of the peptide semaglutide with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate, which overcomes the challenges of peptide absorption in the acidic conditions of the stomach. Oral semaglutide is indicated for use as an add-on combination therapy (with other glucose-lowering agents, including insulin) or as a monotherapy (in patients who are intolerant to metformin) for type 2 diabetes when diet and exercise do not provide adequate glycemic control. Read More

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Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis.

Clin Transl Sci 2021 May 7. Epub 2021 May 7.

Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Illinois, USA.

Elagolix is a novel, oral gonadotropin-releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. Consistent with its mechanism of action, elagolix exhibited dose-dependent suppression of estradiol (E2) in clinical studies. A dose-response model that describes the relationship between elagolix dosages and average E2 levels was combined with a previously published quantitative systems pharmacology (QSP) model of calcium homeostasis to predict bone mineral density (BMD) changes during and following elagolix treatment. Read More

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A phase I/II study of bevacizumab, irinotecan and erlotinib in children with progressive diffuse intrinsic pontine glioma.

J Neurooncol 2021 May 7. Epub 2021 May 7.

Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Pediatric Oncology, Amsterdam, The Netherlands.

Introduction: This study investigates the safety, tolerability, and preliminary efficacy of combined treatment with VEGF inhibitor bevacizumab, topoisomerase I inhibitor irinotecan, and EGFR inhibitor erlotinib in children with progressive diffuse intrinsic pontine glioma (DIPG).

Methods: Biweekly bevacizumab (10 mg/kg) and irinotecan (125 mg/m) were combined with daily erlotinib. Two cohorts received increasing doses of erlotinib (65 and 85 mg/m) following a 3 + 3 dose-escalation schedule, until disease progression with a maximum of one year. Read More

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Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study.

BMC Cancer 2021 May 7;21(1):511. Epub 2021 May 7.

Department of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China.

Background: Concurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-small-cell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients. Read More

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"Why would you not listen? It is like being given the winning lottery numbers and deciding not to take them": semi-structured interviews with post-acute myocardial infarction patients and their significant others exploring factors that influence participation in cardiac rehabilitation and long-term exercise training.

Disabil Rehabil 2021 May 7:1-11. Epub 2021 May 7.

Institute of Nursing and Health Research, Ulster University, Newtownabbey, UK.

Purpose: Despite the clinical benefits, coronary artery disease patient participation rates in cardiac rehabilitation (CR) and long-term exercise are poor. This study explored the factors related to participation in these interventions from the perspectives of post-acute myocardial infarction (AMI) patients and their significant others.

Methods: Semi-structured interviews were performed with post-AMI patients (number () = 10) and their significant others ( = 10) following phase-III and phase-IV CR. Read More

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Efficacy and safety of ceftobiprole in patients aged 65 years or older: a  analysis of three Phase III studies.

Future Microbiol 2021 May 7. Epub 2021 May 7.

Basilea Pharmaceutica International Ltd., Basel, Switzerland.

To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. We conducted a analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16. Read More

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Therapeutic strategies to fight COVID-19: Which is the status artis?

Br J Pharmacol 2021 May 7. Epub 2021 May 7.

Department of Experimental Medicine, Università degli studi della Campania 'Luigi Vanvitelli', Naples, Italy.

COVID-19 is a complex disease, and many difficulties are faced today especially in the proper choice of pharmacological treatments. The role of antiviral agents for COVID-19 is still being investigated and evidence for immunomodulatory and anti-inflammatory drugs is quite conflicting, whereas the use of corticosteroids is supported by robust evidence. The use of heparins in hospitalized critically ill patients is preferred over other anticoagulants. Read More

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Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study.

Ther Adv Musculoskelet Dis 2021 20;13:1759720X211006964. Epub 2021 Apr 20.

Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People's Hospital, Xicheng District, Beijing, P.R. China.

Introduction: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).

Methods: This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients ( = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. Read More

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Efficacy and safety of trifluridine/tipiracil plus bevacizumab and trifluridine/tipiracil or regorafenib monotherapy for chemorefractory metastatic colorectal cancer: a retrospective study.

Ther Adv Med Oncol 2021 20;13:17588359211009143. Epub 2021 Apr 20.

Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Background: The C-TASK-FORCE phase I/II and Danish randomized phase II trials reported the promising efficacy of trifluridine/tipiracil (TAS102) plus bevacizumab (BEV) in patients with chemorefractory metastatic colorectal cancer (mCRC). However, there had been no direct comparative phase III trial to compare the efficacy between TAS102 plus BEV and standard therapy with either TAS102 or regorafenib monotherapy.

Methods: We retrospectively reviewed the medical records of patients with mCRC who received TAS102 plus BEV, TAS102 monotherapy, or regorafenib monotherapy after standard chemotherapies during 2013-2019. Read More

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Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic .

Front Pharmacol 2021 20;12:632818. Epub 2021 Apr 20.

Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China.

The PARP inhibitor olaparib has been shown to have clinical efficacy in patients with a germline BRCA mutation and ovarian or breast cancer. However, the high treatment cost associated with this drug limits its viability as a clinical treatment option. This work aims to evaluate the cost-effectiveness of olaparib as a maintenance treatment for metastatic pancreatic cancer from the perspective of the United States and China healthcare systems and provides valuable suggestions for clinical decision making. Read More

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Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y).

Ann Rheum Dis 2021 May 6. Epub 2021 May 6.

Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.

Objectives: The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission.

Methods: COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Read More

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The effects of topical erythropoietin on non-surgical treatment of periodontitis: a preliminary study.

BMC Oral Health 2021 May 6;21(1):240. Epub 2021 May 6.

Department of Periodontics, School of Dentistry, Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street, Tehran, Iran.

Background: The purpose of periodontal treatments is to reduce inflammation, restore gingival health and clinical attachment level gain by controlling microbial plaque formation and other etiological factors. One of the drugs that has been tested in many areas and shown good anti-inflammatory properties is erythropoietin (EPO). We evaluated the effect of this drug on the improvement of periodontitis after the phase I treatment. Read More

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Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult and elderly participants in India - A phase III, active-controlled, randomized clinical study.

Hum Vaccin Immunother 2021 May 6:1-10. Epub 2021 May 6.

Established Pharmaceuticals Division, Abbott Healthcare Products B.V, Weesp, The Netherlands.

: This study was conducted to compare the immunogenicity and safety profile of two quadrivalent influenza vaccines (QIVs) in healthy adults (18-60 years) and elderly (>61 years) participants.: This phase III study was conducted from March 2018 to April 2018 across 12 sites in India. In this randomized, observer-blind, active-controlled study, 480 participants were randomized to receive a single dose of test vaccine (subunit, inactivated influenza vaccine; Influvac® Tetra, Abbott) (n = 240) or reference vaccine (split virion, inactivated influenza vaccine; VaxiFlu-4, Zydus Cadilla Healthcare) (n = 240). Read More

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First-line liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) in pancreatic ductal adenocarcinoma: A phase I/II study.

Eur J Cancer 2021 May 3;151:14-24. Epub 2021 May 3.

St John of God Subiaco Hospital, Subiaco, WA, Australia.

Background: This open-label, phase I/II study evaluated safety and efficacy for first-line liposomal irinotecan + oxaliplatin + 5-fluorouracil + leucovorin (NALIRIFOX).

Methods: Patients (aged ≥18 years) had locally advanced/metastatic pancreatic ductal adenocarcinoma (mPDAC), with an Eastern Cooperative Oncology Group performance status score of 0/1 and adequate organ function. Primary objectives were to determine the maximum tolerated dose (MTD) and to evaluate safety and tolerability. Read More

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Efficacy and Safety of Biosimilar FYB201 Compared With Ranibizumab in Neovascular Age-Related Macular Degeneration.

Ophthalmology 2021 May 3. Epub 2021 May 3.

Department of Ophthalmology, University of Bonn, Bonn, Germany;; Department of Ophthalmology & Visual Sciences, University of Utah, Salt Lake City, UT, USA.

Purpose: This trial was conducted to investigate the clinical equivalence of the proposed biosimilar FYB201 and reference ranibizumab in patients with treatment-naive, subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration (nAMD).

Design: This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study.

Participants: A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239). Read More

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Collective vibrational strong coupling effects on molecular vibrational relaxation and energy transfer: Numerical insights via cavity molecular dynamics simulations.

Angew Chem Int Ed Engl 2021 May 6. Epub 2021 May 6.

University of Pennsylvania, Chemistry, 231 S. 34 Street, 19104, Philadelphia, UNITED STATES.

For a small fraction of hot CO2 molecules immersed in a liquid-phase CO2 thermal bath, classical cavity molecular dynamics simulations show that forming collective vibrational strong coupling (VSC) between the C=O asymmetric stretch of CO2 molecules and a cavity mode accelerates hot-molecule relaxation. This acceleration stems from the fact that polaritons can be transiently excited during the nonequilibrium process, which facilitates intermolecular vibrational energy transfer. The VSC effects on these rates (i) resonantly depend on the cavity mode detuning, (ii) cooperatively depend on Rabi splitting, and (iii) collectively scale with the number of hot molecules. Read More

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The learning curve for uniportal video-assisted thoracoscopic anatomical segmentectomy.

J Surg Oncol 2021 May 6. Epub 2021 May 6.

Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China.

Objectives: The aim of this study is to evaluate the time course and caseload required to achieve proficiency by plotting the learning curve of uniportal thoracoscopic segmentectomy.

Methods: We retrospectively analyzed the first 238 and 159 cases of uniportal thoracoscopic segmentectomy performed by two surgeons (A and B). The learning curves were assessed using cumulative sum analysis. Read More

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Enzalutamide with androgen deprivation therapy in Japanese men with metastatic hormone-sensitive prostate cancer: A subgroup analysis of the phase III ARCHES study.

Int J Urol 2021 May 6. Epub 2021 May 6.

Eberhard Karls University of Tübingen, Tübingen, Germany.

Objective: To evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy in Japanese men with metastatic hormone-sensitive prostate cancer.

Methods: A post-hoc analysis of the Japanese subgroup in the phase III, randomized, multinational ARCHES study (NCT02677896) was carried out. Patients with metastatic hormone-sensitive prostate cancer were randomized to receive enzalutamide or a placebo, plus androgen deprivation therapy, stratified by disease volume and prior docetaxel therapy. Read More

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Transfusion management of severe anaemia in African children: a consensus algorithm.

Br J Haematol 2021 May 6. Epub 2021 May 6.

Medical Research Council Clinical Trials Unit (MRC CTU), University College London, London, UK.

The phase III Transfusion and Treatment of severe anaemia in African Children Trial (TRACT) found that conservative management of uncomplicated severe anaemia [haemoglobin (Hb) 40-60 g/l] was safe, and that transfusion volume (20 vs. 30 ml/kg whole blood equivalent) for children with severe anaemia (Hb <60 g/l) had strong but opposing effects on mortality, depending on fever status (>37·5°C). In 2020 a stakeholder meeting of paediatric and blood transfusion groups from Africa reviewed the results and additional analyses. Read More

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Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig [octanorm]).

Immunotherapy 2021 May 6. Epub 2021 May 6.

Division of Basic and Clinical Immunology, University of California, Irvine, CA 92697, USA.

Subcutaneous human immunoglobulin (16.5%; octanorm/cutaquig) was efficacious and well tolerated in patients with primary immunodeficiencies in a Phase III study. A subanalysis of pediatric data is presented here. Read More

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Sequential induction chemotherapy plus intensity-modulated radiotherapy versus concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: the three-year report of a phase II, single center, randomized, non-inferiority trial.

Cancer Med 2021 May 6. Epub 2021 May 6.

Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, China.

To compare the efficacy and safety of induction chemotherapy (IC) followed by intensity-modulated radiotherapy (IMRT) alone versus concurrent CCRT in locoregionally advanced nasopharyngeal carcinoma (LA-NPC). Patients with newly diagnosed stage III to IVB nasopharyngeal carcinoma (NPC) were randomized to receive IC plus IMRT (IC+RT arm), or concurrent chemotherapy plus IMRT (CCRT arm), using a random number table. Both treatment arms received the same chemotherapy regimen. Read More

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Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes.

Am J Clin Dermatol 2021 May 5. Epub 2021 May 5.

Pfizer Inc., New York, NY, USA.

Background: Atopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life.

Objective: This analysis evaluated changes in patient-reported outcomes of disease-specific signs/symptoms and health-related quality of life in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with once-daily oral abrocitinib 200-mg or 100-mg monotherapy.

Methods: Pooled data from one phase IIb (NCT02780167) and two phase III (NCT03349060, JADE MONO-1; NCT03575871, JADE MONO-2) monotherapy trials in adult and adolescent patients with moderate-to-severe atopic dermatitis were analyzed. Read More

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Genetic Analysis and Targeted Therapy Using Buparlisib and MK2206 in a Patient with Triple Metachronous Cancers of the Kidney, Prostate, and Squamous Cell Carcinoma of the Lung: A Case Report.

Onco Targets Ther 2021 28;14:2839-2845. Epub 2021 Apr 28.

The Institute for Translational Medicine, The Affiliated Zhongshan Hospital of Dalian University, Dalian, People's Republic of China.

Multiple primary cancers (MPC) occurring in the same individual is considered rare but being increasingly recognized owing to the longer cancer survival nowadays. Despite of accumulating experience in diagnosis, effective treatment remains to be problematic in many scenarios. Genetic testing-based targeted therapy could be an invaluable option for both diagnosis and treatment of such patients. Read More

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Anticancer drugs repurposed for Alzheimer's disease: a systematic review.

Alzheimers Res Ther 2021 May 5;13(1):96. Epub 2021 May 5.

National Center for Disease Prevention and Health Promotion, Italian National Institute of Health, Via Giano della Bella 34, 00162, Rome, Italy.

Background: The relationship between cancer and dementia is triggering growing research interest. Several preclinical studies have provided the biological rationale for the repurposing of specific anticancer agents in Alzheimer's disease (AD), and a growing number of research protocols are testing their efficacy and safety/tolerability in patients with AD.

Methods: The aim of the present systematic review was to provide an overview on the repurposing of approved anticancer drugs in clinical trials for AD by considering both ongoing and completed research protocols in all phases. Read More

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Current management of metastatic castration-sensitive prostate cancer.

Cancer Treat Res Commun 2021 Apr 24;28:100384. Epub 2021 Apr 24.

Division of Medical Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, United States. Electronic address:

Prostate cancer affects one in nine men and once metastatic is incurable. The treatment for metastatic castration-sensitive prostate cancer (mCSPC) has evolved rapidly over the last decade with the addition of upfront intensification with novel hormonal therapies (abiraterone, enzalutamide, apalutamide) or docetaxel in addition to androgen deprivation therapy. In this review, we discuss the phase III studies that lead to the approval of these upfront intensification therapies. Read More

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Early phase studies of JAK1 selective inhibitors in rheumatoid arthritis.

Rheumatology (Oxford) 2021 May;60(Supplement_2):ii11-ii16

Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.

The first approved Janus kinase (JAK) inhibitors for treatment of RA targeted more than one JAK molecule. Although this brings an advantage of simultaneous blocking of more cytokines involved in RA, it may also carry an increased risk of toxicity. Subsequently, more selective JAK inhibitors were developed with the aim of improving the safety-efficacy profile and to further increase drug maintenance. Read More

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Phase III trials of JAK1 selective inhibitors in rheumatoid arthritis.

Rheumatology (Oxford) 2021 May;60(Supplement_2):ii17-ii23

Department of Rheumatology, OMI (Medical Research Organization), Uruguay, Buenos Aires, Argentina.

Upadacitinib and filgotinib, two JAK1 selective drugs have undergone extensive phase III clinical trials in RA and have demonstrated rapid improvements in disease activity, function and patient reported outcomes. Six global phase III randomized controlled clinical trials (SELECT phase III program) evaluated the efficacy and safety of upadacitinib and four clinical phase III trials (the FINCH program) evaluated the efficacy and safety of filgotinib. This article is a critical review of all these studies with focus on the therapeutic efficacy in RA. Read More

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Microcirculatory Changes in Pediatric Patients During Congenital Heart Defect Corrective Surgery.

J Cardiovasc Transl Res 2021 May 4. Epub 2021 May 4.

Paediatric Intensive Care Unit, Gregorio Marañón General University Hospital, Calle Dr. Castelo 47, 28007, Madrid, Spain.

A prospective, observational single-center study was carried out. Pediatric patients undergoing congenital heart defect surgery were evaluated before, during, and after surgery. At each time point, sublingual microcirculation and clinical parameters were assessed, along with analytical variables. Read More

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Similar kinematic patterns between revision total stabilized (TS) and primary posterior stabilized (PS) knee prostheses: a prospective case-controlled study with gait assessment.

Knee Surg Sports Traumatol Arthrosc 2021 May 4. Epub 2021 May 4.

Orthopaedic Department, Lyon North University Hospital, Hôpital de La Croix Rousse, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France.

Purpose: There are increased surgical considerations when revising total knee arthroplasty (TKA) in active patients. Few studies have assessed if a semi-constrained [Total Stabilized (TS)] prostheses has similar knee biomechanics to a primary posterior stabilized (PS) prosthesis. The aim was to compare the gait parameters in patients with PS or TS TKA and normal controls. Read More

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