• Overall, bevacizumab is expected to remain a key agent in cancer therapy, both due to its established efficacy in approved indications and its promise as a partner in novel targeted combination treatments. (nih.gov)
  • Prospective, Randomized, Blinded Phase 2 Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination with Optimized Background Regimen (OBR) for the treatment of MDR-TB. (cdc.gov)
  • Pharmacokinetic and pharmacodynamic studies of efficacy, tolerability and safety of higher dosage rifapentine for treatment of tuberculosis. (cdc.gov)
  • In early-stage Phase I/II trials in liver, pancreatic and colorectal cancers, YIV-906 has demonstrated safety and promising efficacy, with the potential to improve survival and quality of life for patients. (nfcr.org)
  • Researchers will prepare for clinical trials to validate the efficacy of the drug in humans and undertake all the necessary regulatory and commercialisation activities for its rapid clinical translation. (europa.eu)
  • We aim to provide a short summary of the current knowledge of the antiviral efficacy of favipiravir with respect to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected elderly patients. (springer.com)
  • Its clinical efficacy is under evaluation in clinical trials. (clsi.org)
  • Towards the end of last year ​, GSK announced that two Phase III trials examining another antibiotic for urinary tract infections had been stopped early for efficacy. (outsourcing-pharma.com)
  • Through his research, Dr. Frank Fossella works to improve the efficacy and safety of lung cancer treatment. (mesothelioma.app)
  • The present project seeks to translate this discovery into a first-in-human clinical trial to evaluate the feasibility, toxicity, and efficacy of CD5-deleted anti-CD5 chimeric antigen receptor CART for T-cell lymphoma. (lls.org)
  • After bringing the first FDA-approved RET inhibitor to patients earlier this year, we are pleased to follow up with detailed safety and efficacy findings from the largest clinical trial in patients with RET -driven cancers," said Anne White , president of Lilly Oncology. (prnewswire.com)
  • GC012F is currently being studied in multiple investigator-initiated trials (IIT) evaluating its safety and efficacy in RRMM, newly-diagnosed multiple myeloma, and B-cell non-Hodgkin's lymphoma (B-NHL). (biospace.com)
  • Rationale: We developed a standardized method, possible poor treatment response (PPTR), to help ascertain efficacy endpoints in Study S31/A5349 (NCT02410772), an open-label trial comparing two 4-month rifapentine-based regimens with a standard 6-month regimen for the treatment of pulmonary tuberculosis (TB). (cdc.gov)
  • Conclusions: Standardized methodologies, such as our PPTR approach, could facilitate unbiased efficacy outcome determinations, improve discrimination between outcomes that are related and unrelated to regimen efficacy, and enhance the ability to conduct pooled analyses of contemporary trials. (cdc.gov)
  • During the first meeting, ethicists and scientific experts concluded that it would be acceptable to offer to EVD patients as potential treatments unregistered interventions that have shown promising results in the laboratory and in animal models, but have not yet been evaluated for safety and efficacy in humans. (who.int)
  • In late September, at a WHO consultation on Ebola vaccines, participants agreed to a clinical regulatory pathway for the rapid evaluation of vaccines for safety, immunogenicity, and efficacy. (who.int)
  • The purpose is to verify efficacy and detect effects-good and bad-that may not have been observed during phases 1 and 2. (msdmanuals.com)
  • On September 26, 2023, bosutinib (Bosulif) was approved for pediatric patients aged 1 year and older with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (CML) that is newly diagnosed or resistant or intolerant to prior therapy.1 New capsule dosage form strengths of 50 mg. (ascopost.com)
  • Gracell plans to initiate a Phase 1/2, single-arm, open-label, multi-center trial in China in the third quarter of 2023 to further evaluate GC012F in RRMM patients. (biospace.com)
  • Following the U.S. FDA's clearance of Gracell's IND application announced on Feb. 3 , Gracell also plans to initiate a Phase 1b /2 clinical trial in the U.S. in the second quarter of 2023. (biospace.com)
  • This article covers current concepts and recent advances in TB drug discovery and development, including an update of ongoing TB treatment trials, newer clinical trial designs, TB biomarkers and adjunct host-directed therapies. (nih.gov)
  • When the VEGF-A-targeting monoclonal antibody bevacizumab (Avastin®) entered clinical practice more than 15 years ago, it was one of the first targeted therapies and the first approved angiogenesis inhibitor. (nih.gov)
  • This review provides an overview of the clinical experience and lessons learned since bevacizumab's initial approval, and highlights how this knowledge has led to the investigation of novel combination therapies. (nih.gov)
  • Successful clinical trials have led to the approval of a small number of gene therapies, including therapies to treat inherited disorders like spinal muscular atrophy and Leber congenital amaurosis . (medlineplus.gov)
  • In a European phase II trial (EMN12/HOVON-129) reported in The Lancet Oncology, van de Donk et al found that the incorporation of carfilzomib and lenalidomide into induction, consolidation, and maintenance therapies was associated with good outcomes in both younger and older patients with primary. (ascopost.com)
  • This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. (nih.gov)
  • The group also called for further research on such treatments as neuromodulation and for more evidence on sound therapy, methods for assessing tinnitus in primary care, and the clinical- and cost-effectiveness of psychological therapies for children and young adults. (medscape.com)
  • Selinexor, a novel, oral selective inhibitor of XPO1, was approved by the FDA for DLBCL after 2 prior therapies based on an overall response rate (ORR) of 29% including a 13% complete response (CR) rate. (confex.com)
  • Whether brain imaging can identify patients who are most likely to benefit from therapies for acute ischemic stroke and whether endovascular thrombectomy improves clinical outcomes in such patients remains unclear. (qxmd.com)
  • In November 2008, MorphoSys AG and Galapagos NV announced the launch of a long-term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, for the treatment of rheumatoid arthritis, osteoporosis and osteoarthritis. (beursonline.nl)
  • This project is highly relevant to those parts of the LLS's mission that pertain to the development of personalized and novel therapies for cancer treatment. (lls.org)
  • The proposed research is highly relevant to public health because patients with r/r T-NHL have no available cures and addresses those parts of the LLS's mission that pertain to the development of personalized and novel therapies for cancer treatment. (lls.org)
  • Patients living with RET fusion-driven NSCLC represent an underserved population in need of tailored therapies that work against this targetable alteration," said Alexander Drilon , M.D. 2 , chief of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and lead investigator for LIBRETTO-001. (prnewswire.com)
  • Gracell is committed to developing innovative cell therapies to transform patients' lives, and we look forward to launching the Phase 1/2 IND trial in China to further study GC012F. (biospace.com)
  • Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. (biospace.com)
  • Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CART TM technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. (biospace.com)
  • Join the Global Registry for Inherited Neuropathies (GRIN) and help develop drugs, gene therapies, and clinical trials for CMT and other Inherited Neuropathies! (hnf-cure.org)
  • Stem cell-based therapies for Parkinson's dis- ogy company International Stem Cell Corporation ease (PD) are rapidly moving towards clinical trials. (lu.se)
  • Comedogenesis: some new aetiological, clinical, and therapeutic strategies. (bmj.com)
  • The alliance spans all activities from target discovery through to completion of proof-of-concept clinical trials for novel therapeutic antibodies. (beursonline.nl)
  • Its chapters, contributed by internationally renowned methodologists experienced in clinical trials, address topics that include Bayesian methods for phase I clinical trials, adaptive two-stage clinical trials, and the design and analysis of cluster randomization trials, trials with multiple endpoints, and therapeutic equivalence trials. (freepdfbook.com)
  • With this background information as a foundation, we then discuss each of the key questions in relation to the upcoming therapeutic trial and critically assess if the time is ripe for clinical translation of parthenogenetic stem cell technology in Parkinson's disease. (lu.se)
  • however, medical researchers, institutions, and regulatory agencies are working to ensure that gene therapy research, clinical trials, and approved treatments are as safe as possible. (medlineplus.gov)
  • Researchers who wish to test an approach in a clinical trial must first obtain permission from the FDA. (medlineplus.gov)
  • Physicians and researchers work close together to provide innovative treatment options for patients. (moffitt.org)
  • Researchers developed a minuscule device, akin to a grain of rice in size, that can simultaneously test numerous treatments for challenging brain cancers like gliomas. (neurosciencenews.com)
  • Researchers identified two genes - NEK2 and INHBA - responsible for causing chemotherapy resistance in head and neck cancer patients. (neurosciencenews.com)
  • Researchers were encouraged by the results of the small study and plan to use brain imaging to pinpoint personalized targeted areas for treatment in a phase 2 trial. (medscape.com)
  • Experimental studies and clinical trials help researchers learn more about how cancer starts or spreads. (cancer.net)
  • Researchers do clinical trials in segments called phases. (cancer.net)
  • Researchers can prevent bias in a clinical trial by keeping those people and themselves, or just those people, from knowing who is in each group. (cancer.net)
  • Most researchers feel this type of clinical trial produces the best study data. (cancer.net)
  • In the study, published late last week in The Lancet Regional Health , Medical University of Vienna researchers examined fetal and placental development in 38 pregnant women who tested positive for SARS-CoV-2 and 38 matched, uninfected pregnant women from July 2020 to July 2022. (umn.edu)
  • Some medical researchers and commentators on tests of medical treatments recognised more than two centuries ago that conclusions about the effects of treatments should be based on adequate numbers of people ( Tröhler 2010 ). (jameslindlibrary.org)
  • After six cycles of therapy, and based on RECIST measures, researchers observed a significant response rate among patients dosed with the obatoclax-chemotherapy combination - a confirmed Objective Response, defined as either a Partial Response or a Complete Response, was seen in 100% of patients, including two patients with Complete Responses. (lungevity.org)
  • Use of the drug verapamil to treat Type 1 diabetes continues to show benefits lasting at least two years, researchers report. (sciencedaily.com)
  • To examine changes in circulating proteins in response to verapamil treatment, the researchers used liquid chromatography-tandem mass spectrometry of blood serum samples from subjects diagnosed with Type 1 diabetes within three months of diagnosis and at one year of follow-up. (sciencedaily.com)
  • Our groups is multidisciplinary including clinical PhD students and clinical researchers along with a biostatistician, molecular biologist and technical personnel. (lu.se)
  • To support this important aspect of research, LLS created the Academic Clinical Trials Program (ACT) in 2022-23, and now presents a second request for applications. (lls.org)
  • At the European Hematology Association 2022 Hybrid Congress, Gracell presented longer-term follow-up clinical data of GC012F in RRMM that showed a 100% minimal residual disease (MRD) negativity rate in all patients treated. (biospace.com)
  • If these studies are successful, the alliance will select antibody programs for preclinical and clinical development. (beursonline.nl)
  • CDC developed this interim guidance, based on evidence from Study 31/A5349, preclinical and animal evidence, previous clinical trial findings, pharmacokinetic and pharmacodynamic modeling ( 1 , 3 - 6 ), and CDC expert opinion regarding considerations for implementation of the new 4-month daily treatment regimen in the United States. (cdc.gov)
  • In 2006, more than 130 nanotech nologybased drugs and delivery systems had entered preclinical, clinical, or commercial development. (cdc.gov)
  • There are several stages that precede the clinical trial phase of nanomedicine research, including the production of the raw nanomaterial s, synthesis of the pharmaceutical in a lab or manufacturing setting, and preclinical drug studies in animals and in vitro. (cdc.gov)
  • Based on positive findings in this PoC, we plan to pursue Phase II clinical trials. (europa.eu)
  • Clinical trial findings for new survodutide and semaglutide treatments and promising phase 2 retatrutide results. (diabetesvoice.org)
  • On the basis of these findings, CDC recommends the 4-month regimen as a treatment option for U.S. patients aged ≥12 years with drug-susceptible pulmonary TB and provides implementation considerations for this treatment regimen. (cdc.gov)
  • Their most recent findings represent the culmination of nearly two decades of research and clinical trials intended to find new ways to treat some of the world's most difficult-to-treat mental illnesses and disorders. (psychedelics.com)
  • Subsequent to committee findings and discussions, WHO actively engaged with partners, industry and regulatory authorities to expedite clinical trials and regulatory approval pathways for the potential deployment of proven medical products in the affected countries. (who.int)
  • In a German phase II trial (INITIAL-1) reported in the Journal of Clinical Oncology, Matthias Stelljes, MD, and colleagues found that inotuzumab ozogamicin-based induction therapy followed by age-adapted chemotherapy was associated with promising outcomes in newly diagnosed patients older than age. (ascopost.com)
  • In a retrospective study reported in the Journal of Clinical Oncology, Hodder et al found that blinatumomab was effective as a toxicity-sparing alternative to first-line intensive chemotherapy in children and young persons with B-cell acute lymphoblastic leukemia (ALL) who were. (ascopost.com)
  • In an analysis from the phase III ECOG/ACRIN E1912 trial in chronic lymphocytic leukemia (CLL) published in the Journal of Clinical Oncology, O'Connell et al found that grade 1 and 2 adverse events were significant contributors to patient-reported side-effects bother, with grade 2 events being. (ascopost.com)
  • As reported in the Journal of Clinical Oncology by Teachey et al, the phase III Children's Oncology Group AALL1231 trial has shown that the addition of bortezomib to a modified augmented Berlin-Frankfurt-Münster (BFM) backbone improved survival outcomes in patients with newly diagnosed T-cell. (ascopost.com)
  • Journal of Clinical Oncology. (lu.se)
  • Randomized, placebo-controlled, double-blind Phase I/II clinical trial assessing the safety and microbiological activity of Linezolid added to Optimized Background Therapy (OBT) for MDR TB or XDR TB. (cdc.gov)
  • ROCKVILLE, MD - The first patients have been dosed in a multi-regional Phase IIB randomized, placebo-controlled clinical trial for the treatment of hepatitis B-associated liver cancer. (nfcr.org)
  • Learning Outcomes Upon completion of the course, students will learn about (i) the concept of the Bayesian statistical methods, (ii) formulation and derivation of prior and posterior distributions, (iii) estimation of the model using di erent MCMC methods, and (iv) application of the Bayesian methods to analyze data and interpret and compare results with the frequentist approach. (ac.bd)
  • Learning Outcomes At the end of the course, students are expected (i) to understand the theoretical basis of di erent methods related to analysing correlated time-to-event data and competing risks model (ii) to use a statistical software (e.g. related R packages) to analyse data using such models (iii) to interpret the results and write scienti c publication. (ac.bd)
  • A Structured Clinical Abstract at the LOI stage will provide succinct information about the objectives, expected outcomes, and clinical significance of the proposed study. (lls.org)
  • September 27, 2007 - Genmab A/S (OMX: GEN) announced today it has amended the design of an ongoing pivotal study of ofatumumab (HuMax-CD20®) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL) to a single arm trial that will now include approximately 81 patients. (iex.nl)
  • Such regimens are likely to utilize both repurposed drugs and new chemical entities, and several of these regimens are now progressing through clinical trials. (nih.gov)
  • Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. (cdc.gov)
  • COVID-19 (coronavirus disease 2019) is the disease resulting from infection by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus. (bvsalud.org)
  • For the 2021 Leukemia Lymphoma Society Translational Research Program, we assembled a group of investigators from different but complementary disciplines, including the Principal Investigator (Dr. Ruella - CART translational research) and clinical lead (Dr. Barta, lymphoma clinical trials) and collaborators (Drs. Lim, Hwang, Siegel, and June) to tackle the issue of the treatment of relapsed or refractory T cell lymphoma. (lls.org)
  • In November 2021 , the FDA granted GC012F Orphan Drug Designation for the treatment of multiple myeloma. (biospace.com)
  • On May 5, 2021, CDC's Tuberculosis Trials Consortium and the National Institutes of Health (NIH)-sponsored AIDS Clinical Trials Group (ACTG) published results from a randomized controlled trial indicating that a 4-month regimen containing rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) was as effective as the standard 6-month regimen for tuberculosis (TB) treatment ( 1 ). (cdc.gov)
  • Substudy to evaluates 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin and other TB drugs among patients with tuberculosis being treated with multidrug therapy, as well as genetic factors related to pharmacokinetic parameters and associations with markers of tuberculosis disease severity. (cdc.gov)
  • Optimal treatment for A. baumannii depends on susceptibility, pharmacokinetic principles, and site of infection. (cdc.gov)
  • This is an open-label phase 1b study to determine the safety, tolerability, recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of selinexor in combination with R-CHOP in pts with NHL. (confex.com)
  • It is our hope that obatoclax's differentiated mechanism will lead to substantial improvements in response to treatment, tolerability and survival for these patients. (lungevity.org)
  • This close relationship implies that we have a strong interest in biobanks of diseases of interest, use routine collected (clinical, pharmacy, claims) data and are involved in many clinical trials (preferably with a laboratory component). (erasmusmc.nl)
  • Data regarding patients 65 years or older is not sufficient to support or reject the usage of favipiravir for COVD-19 treatment. (springer.com)
  • More than 40,000 Americans per year participate in a clinical trial , and these trials, usually run by large pharmaceutical companies, produce troves of patient data. (medscape.com)
  • While this is a fraction of the overall population of patients with cancer, these datasets have immense depth, often consisting of clinical, demographic, and genetic and molecular data from blood samples. (medscape.com)
  • Cancer registries also collect massive amounts of patient data in order to understand diseases and their treatment outside of clinical trials. (medscape.com)
  • Even though patients do not have routine access to these data, at least with clinical trials and registries the argument can be made that most of the data are used for research. (medscape.com)
  • Yet, the advent of the electronic health record has released patient data from these registries and clinical trial repositories - and such data are increasingly at a premium for more than research. (medscape.com)
  • Clinical trials and registries simply cannot match the speed and scale with which these companies can generate data. (medscape.com)
  • The trial aims to determine whether the treatment is safe and if it reduces the amount of bacteria in trial volunteers, with investigators gathering data on safety and microbiologic activity, how the phages function in the body, how the therapy affects patients' lung function, and it s impact on overall quality of life. (umn.edu)
  • These data were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. (lungevity.org)
  • We are very pleased to be presenting this Phase 1b data at ASCO, as they reinforce the safety of obatoclax and directly support the design of our ongoing Phase 2 study of obatoclax in patients receiving first line therapy for extensive stage, small cell lung cancer. (lungevity.org)
  • There are less common mutations that still have potential targeted drugs, but the data is less definitive in terms of phase III or larger phase II studies. (lcfamerica.org)
  • The STAC-EE reviewed clinical trial protocols and data for blood products and medicines. (who.int)
  • MS specific clinical data, e.g., disease course, duration, disability and MS-specific QoL were collected from the clinical database. (bvsalud.org)
  • In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health (NIH) data base, www.clinicaltrials.gov . (cdc.gov)
  • The prediction models integrate patient´s, clinical and tumour related data to achieve high accuracy. (lu.se)
  • LONDON, UK - Data from two new studies presented last week at the European Society of Cardiology (ESC) 2015 Congress provide some evidence the everolimus -eluting stent with a bioabsorbable vascular scaffold ( Absorb , Abbot Vascular) is as good as the current standard of care [ 1 ] . (medscape.com)
  • During the same ESC session, Dr Patrick Serruys (Imperial College London, UK) presented data from the ABSORB TROFI II study, an imaging study in 191 patients with STEMI [ 2 ] . (medscape.com)
  • Note: This record shows only 22 elements of the WHO Trial Registration Data Set. (who.int)
  • Our research includes clinical, epidemiological, cost-effectiveness, qualitative and translational research to detect conditions at early stages, improve treatment and prognosis, and change public health policies. (erasmusmc.nl)
  • The research methodologies best development in the department are epidemiology (in the broadest sense), clinical research and translational research, especially in immunology and oncology. (erasmusmc.nl)
  • The BTK inhibitor nemtabrutinib may offer a new treatment option for patients with relapsed hematologic malignancies such as chronic lymphocytic leukemia and non-Hodgkin lymphoma, according to a recent study published by Woyach et al in Cancer Discovery. (ascopost.com)
  • In a Chinese single-center phase II study reported in The Lancet Oncology, Pan et al found that sequential CD19- and CD22-directed chimeric antigen receptor (CAR) T-cell therapy was active in pediatric patients with refractory or relapsed B-cell acute lymphocytic leukemia (ALL). (ascopost.com)
  • Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests ( www.ninds.nih.gov/funding/areas/index.htm ). (nih.gov)
  • The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. (nih.gov)
  • Company reports positive topline results from phase 2 study. (snacksafely.com)
  • The company announced topline results from their EPIPHAST II study. (snacksafely.com)
  • Phase 2 study continues to show AQST-109 is safe and well tolerated. (snacksafely.com)
  • Results from a Phase II study, run by Rush University Medical Center and U.S. biotech Tetra Therapeutics, show promising results for an experimental drug designed to treat cognitive symptoms in patients with Fragile X syndrome. (clinicalomics.com)
  • In this study, led by Elizabeth Berry-Kravis, M.D., P.D., a physician and researcher at Rush University and Mark Gurney, Ph.D., Founder and CEO of Tetra, 30 adult (aged 18-41 years), male, fragile X patients received two doses of BPN14770 a day or placebo for 12 weeks. (clinicalomics.com)
  • To allow all the participants to benefit, the groups switched at 12 weeks to the other treatment group and the study continued. (clinicalomics.com)
  • These sounds can affect daily living, but a new open-label study has identified a potential treatment . (medscape.com)
  • of heart Failure Treatment study. (qxmd.com)
  • The Phase 1 part of the study is a dose escalation of STP938 as monotherapy. (clinicaltrials.gov)
  • The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas. (clinicaltrials.gov)
  • In a phase 3 clinical trial, people in the study are usually randomly placed in either the intervention group or control group. (cancer.net)
  • The study enrolled both treatment-naive patients and heavily pretreated patients with a variety of advanced solid tumors including RET fusion-positive NSCLC, RET -mutant MTC, RET fusion-positive thyroid cancer, and certain other advanced solid tumors with RET alterations. (prnewswire.com)
  • The clinically meaningful responses observed in this study demonstrate that selpercatinib can help fill this need, offering a valuable treatment option to these patients. (prnewswire.com)
  • This Phase 1b dose-escalation study is instrumental in establishing safety and identifying an optimal dose for obatoclax, when administered in combination with standard doses of the chemotherapy agents carboplatin and etoposide, as both front-line and second-line therapy. (lungevity.org)
  • The Phase 1b study (total patients = 25) was designed to assess safety and select a dose from two dose schedules of obatoclax in combination with carboplatin and etoposide for a randomized Phase 2 clinical trial. (lungevity.org)
  • This Phase 1b study was conducted as the first portion of an ongoing multi-center, randomized, open-label Phase 2 study that was initiated in March 2009. (lungevity.org)
  • The primary endpoint of the Phase 2 portion of the study, expected to enroll approximately 150 patients with SCLC, is comparison of overall response rate (ORR) for the obatoclax-containing arm versus the control arm. (lungevity.org)
  • Sponsored by CDC and conducted in collaboration with the NIH-sponsored ACTG, Study 31/A5349 ( https://clinicaltrials.gov/ct2/show/NCT02410772 external icon ) was an international, open label, phase 3 noninferiority clinical trial that randomized 2,516 participants at 34 clinical sites in 13 countries. (cdc.gov)
  • In the two-year study, subjects who stopped daily doses of verapamil at one year saw their disease at two years worsen at rates similar to those of the control group of diabetes patients who did not use verapamil at all. (sciencedaily.com)
  • In 2018, Shalev and colleagues reported the benefits of verapamil in a one-year clinical study of Type 1 diabetes patients, finding that regular oral administration of verapamil enabled patients to produce higher levels of their own insulin, thus limiting their need for injected insulin to regulate blood sugar levels. (sciencedaily.com)
  • The current study extends on that finding and provides crucial mechanistic and clinical insights into the beneficial effects of verapamil in Type 1 diabetes, using proteomics analysis and RNA sequencing. (sciencedaily.com)
  • Including the study of BNC210, CCR is currently contracted for nine clinical trials and is evaluating a robust pipeline of additional research studies. (accesswire.com)
  • A protocol describing the clinical study must be approved by an appropriate institutional review board (IRB) and the US Food and Drug Administration (FDA), which then issues an investigational new drug (IND) exemption permit. (msdmanuals.com)
  • The study, which was designed as a noninferiority trial, met its primary end point, report investigators. (medscape.com)
  • The study also had a large noninferiority margin for the primary clinical end point and an event rate lower than expected. (medscape.com)
  • Clinical practice guidelines for treatment of drug-susceptible TB in the United States were published in 2016 ( 2 ). (cdc.gov)
  • A second press release [2] has indicated stem cell source, resulting in widespread excitement that the program is planning to move forward very rapidly, with all of the patients being enrolled in the Correspondence to: Roger A. Barker, John van Geest Centre first quarter of 2016 and interim results being shared for Brain Repair, Department of Clinical Neurosciences, Univer- in October 2016. (lu.se)
  • Initially approved for treatment of metastatic colorectal cancer in combination with chemotherapy, its indications now include metastatic breast cancer, non-small-cell lung cancer, glioblastoma, renal cell carcinoma, ovarian cancer and cervical cancer. (nih.gov)
  • A phase 2 clinical trial of pembrolizumab has shown promising results, with 42% of patients with metastatic brain cancer benefiting from the treatment. (neurosciencenews.com)
  • The publication highlights the first 105 consecutively enrolled RET fusion-positive metastatic NSCLC patients treated with at least prior platinum-based chemotherapy as well as 39 systemic treatment naïve patients. (prnewswire.com)
  • Surgical resection remains the only known curative treatment for localized renal cell carcinoma, and it is also used improve outcome or for palliation in metastatic disease. (medscape.com)
  • In recent years, multiple agents have been developed for systemic treatment of metastatic disease. (medscape.com)
  • Our aim is to improve prediction models for regional and distant metastatic spread in breast cancer in order to individualise treatment selection for the individual patients. (lu.se)
  • Dr. Sallman studies the genetic drivers of myeloid diseases in order to improve prognostication for patients and also to allow for more personalized treatment. (moffitt.org)
  • A candidate dengue vaccine developed by scientists at the National Institutes of Health has been found to be safe and to stimulate a strong immune response in most vaccine recipients, according to results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. (nih.gov)
  • The trial results appeared in the January 17 issue of the Journal of Infectious Diseases. (nih.gov)
  • Main outcome measures Analyses included trials for which information could be obtained on both change in brain amyloid levels measured with amyloid positron emission tomography and change in at least one cognitive test score reported for each randomization arm. (bmj.com)
  • The FDA reviews the results of the clinical trial. (medlineplus.gov)
  • Overexpression of XPO1 results in increased nuclear export of tumor suppressor proteins (TSPs) leading to their functional inactivation, and enhanced expression of Bcl-2 family members and c-Myc. (confex.com)
  • Results Pooled results from the 14 randomized controlled trials were more precise than estimates from any single trial. (bmj.com)
  • Numerous investigative clinical trials and bioequivalence studies are ongoing and a few have been completed, and the results were published. (springer.com)
  • Other vaccines in development require two or three injections at higher doses to achieve similar results. (nih.gov)
  • We will first translate our preliminary results - that were obtained in the research laboratory - into a clinical-grade immunotherapy CART product. (lls.org)
  • The next-generation inhibitor of Bruton's tyrosine kinase (BTK) may be effective in mantle cell lymphoma for patients previously treated with an older BTK inhibitor, according to results from the phase I/II BRUIN trial. (ascopost.com)
  • Exciting new research from the Multidisciplinary Association for Psychedelic Studies (MAPS) has yielded intriguing results regarding methyl​enedioxy​methamphetamine's (MDMA's) potential as a treatment for post-traumatic stress disorder (PTSD). (psychedelics.com)
  • A 2-g dose of cefepime given intravenously results in peak serum levels of ≈163 μg/mL with a relatively low volume of distribution (0.29 L/kg), which would not be expected to eradicate A. baumannii in respiratory secretions. (cdc.gov)
  • Archival tumour tissue from primary tumours and metastasis from patients included in clinical trials is characterised on protein and genomic level and the results linked to clinical outcome. (lu.se)
  • Kimura, who presented the results to the media, said the ABSORB trial was designed to support regulatory approval of the Absorb stent in Japan, and because of that the trial has limitations, one of the most notable being the inclusion of highly selected coronary artery disease patients typical of stent trials designed for regulatory approval. (medscape.com)
  • Experimental studies, called clinical trials. (cancer.net)
  • The National Institutes of Health - supported trial is evaluating the experimental bacteriophage cocktail WRAIR-PM-CF1 in cystic fibrosis (CF) patients. (umn.edu)
  • Experimental treatment approaches include vaccines and nonmyeloablative allogeneic peripheral blood stem cell transplantation. (medscape.com)
  • In the wake of the two ies in experimental animals in several independent press releases from ISCO it can be considered timely laboratories, many groups performed open label clin- to discuss how one should evaluate the opportunities ical trials in PD during the late 1980s and 1990s. (lu.se)
  • The 4-month RPT-MOX regimen is a treatment option for patients aged ≥12 years with drug-susceptible pulmonary tuberculosis. (cdc.gov)
  • A year ago, ASCO released a clinical practice guideline on systemic therapy for patients with stage IV non-small cell lung cancer (NSCLC) without driver alterations. (lcfamerica.org)
  • 1 Center for Clinical Microbiology, Division of Infection and Immunity, University College London Royal Free Campus, Rowland Hill Street, London NW3 2PF, UK. (nih.gov)
  • Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active cases, using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month daily therapy with isoniazid. (cdc.gov)
  • We found that it is rather controversial whether favipiravir is effective against SARS-CoV-2 infection. (springer.com)
  • Studies that enrolled ≥ 65-year-old patients who had symptomatic SARS-CoV-2 infection and were treated with favipiravir are discussed here. (springer.com)
  • Other discussions explore Bayesian reporting, methods incorporating compliance in treatment evaluation, and statistical issues emerging from clinical trials in HIV infection. (freepdfbook.com)
  • There was really nothing at all looking at what happens to people at 2 years after the infection. (mdedge.com)
  • Introduction: Hospitalised patients with coronavirus disease 2019 (COVID-19) as a result of SARS-CoV-2 infection have a high mortality rate and frequently require noninvasive respiratory support or invasive ventilation. (bvsalud.org)
  • Adaptive Phage Therapeutics (APT) recently announced that the first patient in an early-stage clinical trial for its investigative bacteriophage therapy has been dosed. (umn.edu)
  • The program includes courses on advanced topics in statistics and computing with special em- phasis on applying advanced statistical techniques to real-life situations. (ac.bd)
  • In 1854, Thomas Graham Balfour (who later became President of the Royal Statistical Society) was careful not to draw any conclusions about the effects of belladonna in preventing scarlet fever when only two children out of 76 given belladonna and two out of 75 in an untreated comparison group developed the disease. (jameslindlibrary.org)
  • The Phase I clinical trial , launched in July 2010 and led by principal investigator Anna Durbin, M.D., at Johns Hopkins Bloomberg School of Public Health in Baltimore, tested a single dose of each of four versions of the investigational dengue vaccine TetraVax-DV. (nih.gov)
  • We look forward to investigating BNC210 as a potential treatment for PTSD, a condition that is in need of new treatment options," said Dr. Reid Robison, Chief Medical Officer of Novamind and Principal Investigator at CCR. (accesswire.com)
  • Purpose This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. (sbir.gov)
  • As an example, Dr. Sallman has focused research and clinical trial efforts on patients who have TP53 mutation (often associated with complex genes/cytogenetics) given their high risk of transformation to acute leukemia and poor survival. (moffitt.org)
  • A recent clinical trial identified a daily 4-month regimen that is as effective as the standard daily 6-month regimen in curing drug-susceptible tuberculosis. (cdc.gov)
  • He has discovered or developed four approved small molecule drugs for the treatment of hepatitis B, cytomegalovirus and AIDS. (nfcr.org)
  • Acne vulgaris: establishing effectiveness of drugs intended for treatment. (bmj.com)
  • Objective To evaluate trials of drugs that target amyloid to determine whether reductions in amyloid levels are likely to improve cognition. (bmj.com)
  • Setting 14 randomized controlled trials of drugs for the prevention or treatment of Alzheimer's disease that targeted an amyloid mechanism, identified from ClinicalTrials.gov. (bmj.com)
  • Population Adults enrolled in randomized controlled trials of amyloid targeting drugs. (bmj.com)
  • It can take years before these drugs are available on commercial antimicrobial susceptibility testing systems used in clinical laboratories. (clsi.org)
  • The potential treatment reverses resistance and potentiates the activity of two anti-tuberculosis drugs, ethionamide and prothionamide. (outsourcing-pharma.com)
  • Treatment of patients with ALK alterations has become quite complex, with multiple new drugs and not enough comparative trials in a unique population. (lcfamerica.org)
  • In a reversal of the anti-science trends of the War on Drugs, psychedelics, and psychedelic-assisted therapy are becoming more commonly studied as potential treatments for various mental health conditions, including PTSD. (psychedelics.com)
  • We support the concepts that break points are artificial and that pharmacodynamic optimization may enable treatment for some organisms that are not susceptible to certain antimicrobial drugs. (cdc.gov)
  • Some drugs approved by the FDA after phase 3 have been withdrawn from the market after newly recognized and serious adverse effects have occurred in phase 4. (msdmanuals.com)
  • In order to establish that ofatumumab is efficacious in this refractory setting, reducing the number of patients in the trial will help to expedite a result. (iex.nl)
  • Pembrolizumab monotherapy is an established treatment strategy for relapsed or refractory classical Hodgkin lymphoma. (ascopost.com)
  • Comprehensive federal laws, regulations, and guidelines help protect people who participate in research studies (called clinical trials). (medlineplus.gov)
  • Phase I studies determine if a treatment is safe for people and identify its side effects. (medlineplus.gov)
  • Phase II studies determine if the treatment is effective, meaning whether it works. (medlineplus.gov)
  • Phase III studies compare the new treatment to the current treatments available. (medlineplus.gov)
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (clinicaltrials.gov)
  • Finally, there are some studies that use a specific selection process to make decisions about treatment. (cancer.net)
  • GC012F is a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma and B-cell non-Hodgkin's lymphoma. (biospace.com)
  • This is largely related to the lack of randomized clinical trials , or even larger phase II studies in these unique population subsets. (lcfamerica.org)
  • The regimen is intended for administration in settings where mycobacterial cultures, molecular and phenotypic drug susceptibility testing (DST), radiographic studies and other diagnostic tools, infrastructure for adverse event monitoring, patient-centered clinical care, and coordination with public health for case management are available. (cdc.gov)
  • CCR is experienced in hosting pediatric and adult phase I-IV clinical trials and investigator-led studies across a wide range of mental health conditions. (accesswire.com)
  • In addition, two candidate vaccines - the cAd3-ZEBOV vaccine, developed by GlaxoSmithKline in collaboration with the United States National Institutes for Health, and the rVSV-ZEBOV vaccine, developed by NewLink Genetics (and later licenced to Merck Vaccines USA), in collaboration with Health Canada - were identified for further clinical studies. (who.int)
  • Phase 4 typically involves larger populations and longer time periods than phases 1 to 3, which helps detect uncommon or slowly developing adverse effects that are unlikely to be recognized in shorter, smaller studies. (msdmanuals.com)
  • Cerebrospinal fluid, our brain's protective liquid, may be making brain cancers like glioblastoma more resistant to treatments. (neurosciencenews.com)
  • He treats patients with lung cancers, and he has actively conducted clinical research for over 30 years. (mesothelioma.app)
  • Most of these trials aimed to uncover a more effective treatment for patients diagnosed with lung cancers. (mesothelioma.app)
  • Increasingly, renal cell cancers are diagnosed at an earlier stage, and nephron-sparing surgery, thermal ablation, and surveillance are gaining acceptance as a treatment of choice for smaller tumors. (medscape.com)
  • Patients will be assigned to a dose level of STP938 (Phase 1) or an expansion cohort (Phase 2) at the time of their enrollment. (clinicaltrials.gov)
  • Conclusion: This clinical cohort of pwMS shows a high prevalence of critical health behaviors and comorbidities and emphasizes the need for monitoring, education and assistance for behavior change in this population. (bvsalud.org)
  • Over the past two decades and with NFCR support, Dr. Cheng has transitioned his focus from small molecule to botanical drug discovery. (nfcr.org)
  • The biotech is working on the small molecule treatment alongside GSK. (outsourcing-pharma.com)
  • Obatoclax is a small-molecule inhibitor of the Bcl-2 family of proteins, including the key protein Mcl-1. (lungevity.org)
  • Obatoclax, Gemin X's potential first-in-class small molecule antagonist of Bcl-2, is specifically designed to inhibit all relevant members of the Bcl-2 family of proteins, including the dominant member, Mcl-1. (lungevity.org)
  • NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. (sbir.gov)
  • A. Overview Recent advances in biology offer unprecedented opportunities to discover new treatments for nervous system disorders. (sbir.gov)
  • NIH provides guidelines for investigators and institutions (such as universities and hospitals) to follow when conducting clinical trials with gene therapy. (medlineplus.gov)
  • The Leukemia and Lymphoma Society (LLS) recognizes the scientific and clinical merit of research developed and conducted by independent investigators affiliated with academic institutions. (lls.org)
  • Investigators conducting existing trials and expansion of existing trials are welcome to apply. (lls.org)
  • The topics of his research include non-small cell lung cancer, small cell lung cancer, and multiple kinds of chemotherapy and radiation therapy. (mesothelioma.app)
  • After their planned six cycles of chemotherapy, patients achieving a response are eligible to receive single agent obatoclax as maintenance therapy - this portion of the clinical trial is ongoing. (lungevity.org)
  • As reported in The New England Journal of Medicine by Frederick L. Locke, MD, and colleagues, the phase III ZUMA-7 trial of patients with large B-cell lymphoma has shown improved event-free survival with second-line axicabtagene ciloleucel vs chemoimmunotherapy with high-dose chemotherapy and. (ascopost.com)
  • This disease is characterized by a lack of early warning signs, diverse clinical manifestations (see Presentation ), and resistance to radiation and chemotherapy. (medscape.com)
  • A standard 3 + 3 dose escalation design in which pts received 6 cycles of R-CHOP (rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 IV, vincristine 0.5 mg/kg on day 1, prednisone 100 mg po on days 1-5 in a 21 day cycle) and 60 mg or 80 mg selinexor on days 1, 8, and 15 of each cycle was used. (confex.com)
  • Low-dose naltrexone is a major topic of discussion on public long COVID patient groups on Facebook. (mdedge.com)
  • The trial confirmed that a 4-month daily treatment regimen containing high-dose RPT and MOX, as well as INH and PZA, is as effective as (noninferior to) the standard daily 6-month regimen in curing drug-susceptible TB ( 1 ). (cdc.gov)
  • High-dose intravenous tigecycline (initial dose of 200 mg followed by 100 mg daily) has been used to treat A. baumannii , achieving peak concentrations of ≈3 μg/mL, which exceed the isolate's MIC of 2 μg/mL, and a high volume of distribution (8 L/kg), which would be expected to eradicate A. baumanii in respiratory secretions. (cdc.gov)
  • Finally, high-dose interleukin-2 (IL-2) and axitinib can be used in selected patients. (medscape.com)
  • The panel makes a conditional recommendation for interleukin (IL)-6 receptor antagonist monoclonal antibody treatment and high-flow nasal oxygen or continuous positive airway pressure in patients with hypoxaemic respiratory failure. (bvsalud.org)
  • The FDA has the authority to reject or suspend clinical trials that are suspected of being unsafe for participants. (medlineplus.gov)
  • Also, serum CHGA levels in healthy, non-diabetic volunteers were about twofold lower compared to subjects with Type 1 diabetes, and after one year of verapamil treatment, verapamil-treated Type 1 diabetes subjects had similar CHGA levels compared with healthy individuals. (sciencedaily.com)
  • Company Completes Enrollment for Phase 2 Trial of "Immune Resetting" Peptide. (snacksafely.com)
  • Enrollment for the trial is expected to be completed by the end of the third quarter of this year. (lungevity.org)
  • Each phase of a clinical trial gives different answers about the intervention being tested. (cancer.net)
  • Dr Steen Kristensen (Aarhus University Hospital, Denmark), the discussant following the late-breaking clinical-trials presentation, who wrote an editorial accompanying the study's publication in European Heart Journal [ 3 ] , said the new stents have the benefit of delivering the drug and then disappearing, changing a "coronary intervention from treatment with a permanent metallic stent to a resorbable cure. (medscape.com)
  • The elimination half-lives of investigational orexin receptor antagonists are 2 to 3 hours for seltorexant and about 1.5 to 3 hours for vornorexant. (wikipedia.org)
  • Given that patients living with RET fusion-positive NSCLC face a high lifetime risk of disease progression to the brain, intracranial effectiveness is a significant consideration in the treatment journey," added Vivek Subbiah , M.D., associate professor of Investigational Cancer Therapeutics and medical director of the Clinical Center for Targeted Therapy at The University of Texas MD Anderson Cancer Center and co-investigator for LIBRETTO-001. (prnewswire.com)
  • We aim to improve the diagnosis, treatment and outcome of patients with dermatological conditions. (erasmusmc.nl)
  • Trending Clinical Topic: Tinnitus - Medscape - Oct 04, 2019. (medscape.com)
  • Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin in standard intensive phase TB treatment regimen. (cdc.gov)
  • 1 Providing antimicrobial susceptibility testing of an isolate to aztreonam, ceftazidime-avibactam, 2 and aztreonam-avibactam 3 can provide useful information to guide patient treatment. (clsi.org)
  • Most clinical laboratories find it difficult to test some of the newer antimicrobial agents that might warrant consideration for treatment of highly resistant organisms. (clsi.org)
  • Favipiravir for the treatment of COVID-19 in elderly patients-what do we know after 2 years of COVID-19? (springer.com)
  • Favipiravir (Avigan™, T-705, 6-fluoro-3-hydroxy-2-pyrazinecarboxamide) was approved in Japan in 2014 against emerging influenza viruses. (springer.com)
  • investigated the in vitro antiviral activity of favipiravir against SARS-CoV-2 in the Vero E6 cell line. (springer.com)
  • Presumably, favipiravir is inserted into the newly synthesized SARS-CoV-2 RNA chain, which caused a detrimental effect on the viral replication. (springer.com)
  • These mutations following favipiravir treatment have been observed in other viruses as well [ 1 ]. (springer.com)
  • Favipiravir has been approved at a fast pace for the treatment of mild to moderate COVID-19 for instance in China, Russia, India, Hungary, and Thailand. (springer.com)
  • Only two of these - favipiravir and brincidofovir - demonstrated sufficient activity in non-human primates infected with EV to warrant further investigation. (who.int)
  • Favipiravir entered clinical trials in early December in Guinea. (who.int)
  • The reactivation of a dormant retrovirus, HML-2, may contribute to the aggressiveness of glioblastoma, a type of brain tumor. (neurosciencenews.com)
  • A Patient Involvement Plan (up to 2 pages) is expected in the Full Application . (lls.org)
  • Patient engagement activities help assure that patients' needs (both unmet medical needs and first-hand experiences) are reflected in the design of the clinical trial. (lls.org)
  • Shorter, effective TB treatments could enable more rapid cure and improve patient quality of life. (cdc.gov)
  • Helpful patient care resources for the treatment & management of CMT. (hnf-cure.org)
  • Adverse Effects Obviously, a drug (or any medical treatment) should be used only when it will benefit a patient. (msdmanuals.com)
  • Recent news of an impending clinical cell transplantation trial in Parkinson's disease using parthenogenetic stem cells as a source of donor tissue have raised hopes in the patient community and sparked discussion in the research community. (lu.se)
  • In this article, we first provide a short history of cell therapy in Parkinson's disease and briefly describe the current state-of-art regarding human stem cell-derived dopamine neurons for use in any patient trial. (lu.se)
  • Blood samples were obtained on days 0, 3, 5, 8 and 15 for RNA isolation followed by RT-PCR to evaluate the expression of targets or downstream effectors including XPO1, AABCG2, AKT, Bcl-2, Bax and ERK. (confex.com)
  • Despite the introduction 40 years ago of the inexpensive and effective four-drug (isoniazid, rifampicin, pyrazinamide and ethambutol) treatment regimen, tuberculosis (TB) continues to cause considerable morbidity and mortality worldwide. (nih.gov)
  • The first gene therapy trial was run more than thirty years ago. (medlineplus.gov)
  • As the original drug was already successfully commercialized by our institute, we can build on this experience and have the treatment available in approximately 5-6 years. (europa.eu)
  • Inclusion criteria for trials vary, but typically include adults aged 50 years or older with a diagnosis of mild cognitive impairment or Alzheimer's disease, and amyloid positivity at baseline. (bmj.com)
  • These awards will fund clinical trials, up to $1M USD over a period of up to three years. (lls.org)
  • Gepotidacin has the potential to be the first new oral antibiotic treatment in 20 years, should it be approved. (outsourcing-pharma.com)
  • Furthermore, specimens from these trials are often used for years after the trial is over. (medscape.com)
  • We hope that over the coming years there will be additional clinical trials that more definitively answer these questions to confirm (or refute) our recommendations. (lcfamerica.org)
  • Patients taking the oral blood pressure medication not only required less daily insulin two years after first diagnosis of the disease, but also showed evidence of surprising immunomodulatory benefits. (sciencedaily.com)
  • Being tested in the first line setting is a first-in-class botanical drug candidate, YIV-906 (also known as PHY906 and KD018), whose development has been supported by the National Foundation for Cancer Research (NFCR) for two decades. (nfcr.org)
  • Project Summary Glaucoma is the leading cause of irreversible blindness worldwide and is expected to affect more than 110 million people worldwide within the next two decades. (sbir.gov)
  • This finding stemmed from more than two decades of her basic research into a gene in pancreatic islets called TXNIP. (sciencedaily.com)
  • We view this unique Bcl-2 inhibitor - an antagonist of all of the relevant Bcl-2 prosurvival proteins - as having important and broad applicability in cancer treatment," said Jean Viallet, M.D., Chief Medical Officer at Gemin X. "We are very encouraged by the 100% response rate seen in these previously untreated SCLC patients who enrolled in this Phase 1b trial. (lungevity.org)
  • On December 1, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca) for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine. (ascopost.com)
  • 2 pts had follicular lymphoma. (confex.com)
  • These immunomodulatory properties of bevacizumab have opened up new perspectives for combination therapy approaches, which are being investigated in clinical trials. (nih.gov)
  • Also, suvorexant is in a phase 4 trial for use as an adjunct to antidepressant therapy in people with major depressive disorder and residual insomnia. (wikipedia.org)
  • An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. (medlineplus.gov)
  • If it determines that the benefits of the new treatment outweigh the side effects, it approves the therapy, and doctors can use it to treat a disorder. (medlineplus.gov)
  • There is no cure for the condition and treatments have mostly involved management of symptoms with therapy, educational assistance and medications such as selective serotonin reuptake inhibitors to treat variable moods and stimulants to treat ADHD-type symptoms. (clinicalomics.com)
  • In this Phase 2 trial the clinical effect of a combination of carboplatin, etoposide and obatoclax (the "CEO" regimen) is being compared to the standard chemotherapeutic therapy alone (carboplatin and etoposide - the control arm) in patients with SCLC. (lungevity.org)
  • In fact, there is an NCI clinical trial that attempts to address sequencing of therapy for patients with advanced non-small cell lung cancer with ALK alterations: "NRG LU-003: Biomarker driven protocol for previously treated ALK positive non-squamous non-small cell lung cancer patients. (lcfamerica.org)
  • Although the optimal treatment strategy continues to evolve, three agents that target angiogenesis (sunitinib, bevacizumab/interferon, and pazopanib) and a mammalian target of rapamycin (mTOR)-targeted therapy (temsirolimus) are approved as front-line agents. (medscape.com)
  • For selected patients, cabozantinib or combination therapy with nivolumab plus ipilimumab are also used as first-line treatments. (medscape.com)
  • A number of agents are available to be used in second and subsequent lines of therapy, these include anti-angiogenic therapy (if not already used in first-line treatment), nivolumab, cabozantinib, and mTOR inhibitors. (medscape.com)
  • Based on discussions held by a global collaborative initiative on translation of stem cell therapy in Parkinson's disease, we have identified a set of key questions that we believe should be addressed ahead of every clinical stem cell-based transplantation trial in this disorder. (lu.se)
  • 7 To date, no anti-amyloid treatments have progressed sufficiently to receive approval from the Food and Drug Administration (the regulatory agency for pharmaceuticals in the United States). (bmj.com)
  • This milestone marks successful regulatory clearances to commence key clinical trials for Gracell's lead asset, GC012F, in both China and the United States ," said Dr. William (Wei) Cao , founder, Chairman, and CEO of Gracell. (biospace.com)
  • Forum (AVAREF), where regulators and ethicists agreed to conduct joint ethical and regulatory reviews to expedite approval of later phase vaccine clinical trials in African countries. (who.int)
  • On December 15-16, National ethics and regulatory authorities from Cameroon, Ghana, Mali, Nigeria and Senegal met at WHO to expedite approval through a joint review of GSK's phase 2 clinical trial application for the cAd3-ZEBOV vaccine. (who.int)
  • Search for topics. (lls.org)
  • Enter search terms to find related medical topics, multimedia and more. (msdmanuals.com)
  • Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. (who.int)
  • This system has potential application to rescue of patients in acute respiratory failure and treatment of cystic fibrosis. (sbir.gov)
  • This paper provides a description of the types of potential nanomedicine exposures, the existing oversight framework for handling worker and third-party exposures, the deficiencies of that framework in clinical and residential settings, and possible new approaches to oversight. (cdc.gov)