• Journal Of Clinical Oncology 2023, 41: 7573-7573. (yale.edu)
  • The Biliary Tract Cancers Pipeline Insight 2023 report by DelveInsight offers a thorough global overview of Biliary Tract Cancers treatments, including those already in the market, as well as those in different phases of clinical development. (nainitalnewsflash.in)
  • On September 2023, AstraZenca announced a study of Phase 3 Clinical Trials for Durvalumab. (nainitalnewsflash.in)
  • On June 2023, InnoPharmax Inc. announced a study of Phase 2 & 3 Clinical Trials for mFOLFOX and D07001-softgel capsules + Xeloda (or TS-1). (nainitalnewsflash.in)
  • On February 2023, Enterome announced a study of Phase 1 & 2 clinical trials for Multiple dose of EO2401. (vascodagamaonlinejournal.in)
  • On February 2023, Laminar Pharmaceuticals announced a study of Phase 2 & 3 clinical trials for LAM561 and TMZ. (vascodagamaonlinejournal.in)
  • On May 2023, Inovio Pharmaceuticals announced a study of Phase 1 & 2 clinical trials for INO-5401 and INO-9012. (vascodagamaonlinejournal.in)
  • On August 2023, Chimeric Therapeutics announced a study of Phase 1 clinical trials for CHM-1101 CAR-T Cells. (vascodagamaonlinejournal.in)
  • The trial, which began enrolling in May 2023 in nine states, is seeking to enroll 394 participants. (medscape.com)
  • The primary goal of this clinical trial is to determine the appropriate dose of ALZN002 for treatment of patients with Alzheimer's in a larger Phase IIB efficacy and safety clinical trial, which Alzamend expects to initiate within three months of receiving data from the initial trial. (businesswire.com)
  • On December 28, 2012, on the basis of data from two Phase IIb trials (i.e., well-controlled trials to evaluate the efficacy and safety of drugs in patients with a disease or condition to be treated, diagnosed, or prevented), the Food and Drug Administration (FDA) approved use of bedaquiline under the provisions of the accelerated approval regulations for "serious or life-threatening illnesses" (21CFR314.500) (Cox EM. (cdc.gov)
  • The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy. (vascodagamaonlinejournal.in)
  • 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)
  • The company reported today the enrollment of the first patient in the second cohort of its global Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte in patients with severe, non-penetrating traumatic brain injury. (seekingalpha.com)
  • Enrollment of participants in the clinical trial is expected to be completed by July 2020. (iavi.org)
  • Joan Perelló, CEO of Sanifit said , "The enrollment of the first patients in this Phase II trial is a significant milestone in the clinical development of SNF472 for calcification disorders. (sanifit.com)
  • Enrollment in this trial will not directly benefit the study subjects, as this study is evaluating a new diagnostic rather than a therapeutic strategy," said Goldberg. (medscape.com)
  • Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax' Phase IIb trial in South Africa and its pivotal Phase III trial in the UK. (ddw-online.com)
  • Participants in the South Africa Phase IIB trial will receive either active vaccine for those who initially received placebo, or a booster dose of active vaccine for those who initially received active vaccine. (ddw-online.com)
  • The grant finances a clinical trial in South Africa and Tanzania of a new and promising tuberculosis (TB) vaccine candidate H56:IC31* developed by SSI. (iavi.org)
  • The ALPHA-STAR Trial is an Astria Therapeutics, Inc., global trial evaluating STAR-0215, an investigational drug, as a potential long-acting treatment for prevention of hereditary angioedema (HAE) attacks in participants with HAE types I and II. (globalgenes.org)
  • Nykode Therapeutics dosed the first patient in its VB-D-01 Phase I/II trial of its T cell focused next-generation SARS-CoV-2 vaccine candidate. (biospace.com)
  • Revive Therapeutics announced its Phase III trial of Bucillamine for mild to moderate COVID-19 has screened about 700 subjects and the Independent Data and Safety Monitoring Board supported continuing the study. (biospace.com)
  • The trials will test CTS-1027 in combination with pegylated interferon (Pegasys) and ribavirin (Copegus), assessing antiviral activity and safety and tolerability after up to 48 weeks of therapy. (pharmaceutical-technology.com)
  • In the recently completed 12 week Phase IIb clinical trial in 494 patients with type 2 diabetes mellitus (T2DM), 'Melogliptin', Glenmark's investigational medicine from a new class of diabetes treatments called dipeptidyl peptidase 4 (DPP-4) inhibitors, improved glycemic control in patients with type 2 diabetes mellitus and exhibited excellent safety and tolerability profile. (science20.com)
  • The trial will evaluate the safety and tolerability of STAR-0215, assess its effect on HAE attacks and quality of life, and study how it works in the body. (globalgenes.org)
  • The randomization phase of the study will be preceded by a dose-escalation phase with the aim of determining PledOx clinical safety, tolerability and pharmacokinetic and pharmacodynamic properties (effects of the body on the drug, and of the drug on the body). (egetis.com)
  • Investigating the impact of demographic disparities on clinical outcomes in cutaneous T-cell lymphoma (CTCL): A multicenter retrospective cohort analysis. (yale.edu)
  • I. To assess the efficacy nivolumab administered in the adjuvant setting in patients with resected stage IIB or stage IIC cutaneous melanoma. (survivornet.com)
  • Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for neurodegenerative disorders such as Alzheimer's disease (AD), reported one-year findings from its Phase II trial assessing the safety and efficacy of daily ALZ-801 treatment for up to two years in people with early AD who have one or two copies of APOE4. (alzheimer-europe.org)
  • LAS VEGAS--( BUSINESS WIRE )-- Ault Alliance, Inc. (NYSE American: AULT), a diversified holding company (" Ault Alliance " or the " Company "), is proud to announce that Alzamend Neuro, Inc. (Nasdaq: ALZN) (" Alzamend ") has initiated its Phase I/IIA clinical trial for its immunotherapeutic vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer's type. (businesswire.com)
  • Ault Alliance plans to continue to champion Alzamend Neuro's efforts, providing strong support and encouragement throughout the clinical trial process, and together, the companies are committed to making a difference in the lives of millions suffering from Alzheimer's disease. (businesswire.com)
  • This SNF472 trial is a prospective interventional study targeting unmet medical need in calciphylaxis and we are excited to understand more about the potential for this drug to benefit dialysis patients afflicted with this grievous condition. (sanifit.com)
  • The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts. (nih.gov)
  • Specifically, connections must be made between basic research, technological development, Clinical Trials (CTs), and the commercialization of products. (scielo.br)
  • Conatus Pharmaceuticals has begun Phase II clinical trials to evaluate a triple-combination drug for patients with the hepatitis C virus (HCV) who have not responded to single treatment. (pharmaceutical-technology.com)
  • As a trial is designed to test hypotheses and rigorously monitor and assess outcomes, it can be seen as an application of the scientific method, specifically the experimental step. (wikipedia.org)
  • The primary outcomes in the phase 2 part of the study include circulating-tumor DNA (ctDNA) clearance or ctDNA recurrence-free survival 6 months after randomization among patients with detectable ctDNA status at randomization. (medscape.com)
  • LGPIN is believed to have different clinical outcomes than does HGPIN. (medscape.com)
  • Bionomics is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. (accesswire.com)
  • San Diego, USA and Palma, Spain, October 20, 2016 - Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, today announced successful initiation of the first clinical trial of its lead candidate, SNF472, for the treatment of the orphan disease calciphylaxis (calcific uraemic arteriolopathy, CUA). (sanifit.com)
  • Clinical study design aims to ensure the scientific validity and reproducibility of the results. (wikipedia.org)
  • In addition to the paucity of reported results, the poor publication record of clinical trials is further evident in the lack of information on these studies in scientific publications. (scielo.br)
  • The Triac Trial I results have been published in The Lancet D&E in 2019. (egetis.com)
  • The NDA requires a small, randomized, placebo-controlled trial with 16 patients, and up to 30 days treatment duration with either Emcitate or placebo, to be conducted to verify the results on thyroid hormone T3 levels seen in previous clinical trials and publications. (egetis.com)
  • Shionogi-ViiV Healthcare LLC today announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1. (news-medical.net)
  • This review analyzes the formulation, methodological design, and results of active clinical trials for merozoite-stage vaccines, regarding their safety profile, immunological response (phase Ia/Ib), and protective efficacy levels (phase II). (urosario.edu.co)
  • Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting. (druglib.com)
  • Symptom and quality of life benefit of afatinib in advanced non-small-cell lung cancer patients previously treated with erlotinib or gefitinib: results of a randomized phase IIb/III trial (LUX-Lung 1). (druglib.com)
  • The Phase IIb results for Melogliptin demonstrate potential for offering class leading improvements in glycemic control and metabolic function. (science20.com)
  • Faraday Pharmaceuticals published results from its Phase II trial of FDY-5301 for reperfusion injury after a ST-elevation myocardial infarction (STEMI) heart attack. (biospace.com)
  • Madrigal Pharmaceuticals announced an expected delay in the topline 52-week results in its MAESTRO-NAFLD-1 Phase III trial. (biospace.com)
  • The latest results from drugs and devices trials will be announced at the meeting. (news-medical.net)
  • The trial is a randomized, double-blind, placebo-controlled, dose-escalation study of Oxycyte. (seekingalpha.com)
  • Methods In this double-blind randomised controlled phase III study, 755 MTX-naïve patients with active RA were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX. (bmj.com)
  • The biotech pharmaceutical company HIPRA has received authorisation from the Spanish Agency of Medicines and Health Products (AEMPS) to initiate a new Phase IIb/III, double-blind, randomised, active-controlled, multicentre, non-inferiority clinical trial to evaluate the safety and immune response of a booster dose of its adapted vaccine against current variants of COVID-19, specifically the XBB.1.16 variant , in adults previously vaccinated against this infection. (hipra.com)
  • Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial. (hipra.com)
  • ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. (druglib.com)
  • A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). (druglib.com)
  • 2013] in a double-blind, randomized, phase IIb/III trial (LUX-Lung 1). (druglib.com)
  • This research study is a randomized, double-blind, sham-controlled, global Phase 3 clinical trial. (globalgenes.org)
  • Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. (wikipedia.org)
  • 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)
  • 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)
  • This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. (nih.gov)
  • CV thrombotic events were assessed across 23 phase IIb to V rofecoxib studies. (qxmd.com)
  • Statistical aspect of translational and correlative studies in clinical trials. (unc.edu)
  • Sanifit has completed Phase Ia studies with healthy volunteers and a Phase Ib/IIa study in haemodialysis patients. (sanifit.com)
  • Created through a Clinical and Translational Science Awards (CTSA) Program initiative, this standardized contract model is designed to reduce negotiation time and contracting delays for industry-sponsored multisite clinical studies, including Phase IIb and Phase III. (nih.gov)
  • Supported by the CTSA Program, ResearchMatch is a free, secure registry, making it easier for the public to volunteer and to become involved in clinical research studies that contribute to improved human health. (nih.gov)
  • This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. (ucsf.edu)
  • This phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC melanoma that can be removed by surgery . (survivornet.com)
  • The sponsor designs the trial in coordination with a panel of expert clinical investigators, including what alternative or existing treatments to compare to the new drug and what type(s) of patients might benefit. (wikipedia.org)
  • 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)
  • It will be recruiting hepatitis B-associated liver cancer patients for twenty clinical sites, include Memorial Sloan Kettering Cancer Center, National Cancer Center of China, Taipei Medical University and Queen Mary Hospital in Hong Kong. (nfcr.org)
  • We are excited about the start of multi-country Phase II clinical trials for YIV-906 and optimistic about its potential to improve the lives of cancer patients, as well as its vanguard role in possibly ushering in a new era of treatment-a convergence of Western and Eastern medicines" said NFCR President and CEO Sujuan Ba, Ph.D. (nfcr.org)
  • The clinical trial tested patients with moderate to severe allergic asthma, and showed that the immune modulator did not achieve a statistically significant reduction of the Asthma Control Questionnaire (ACQ) score at week 12 in comparison to placebo. (clinicalprofessionals.co.uk)
  • Cytos' Chairman and CEO, Dr. Christian Itin, noted: "we are very disappointed with the outcome of the Phase 2b study and would like to thank our patients and investigators for their support of the study. (clinicalprofessionals.co.uk)
  • In October 2021, strong data from long-term treatment in patients with MCT8 deficiency up to 6 years, with Emcitate was published in the Journal of Clinical Endocrinology & Metabolism . (egetis.com)
  • Clinical prognostic model for older patients with advanced non-small cell lung cancer. (unc.edu)
  • The recently initiated Phase II study is the first clinical investigation of SNF472 in patients with newly diagnosed calciphylaxis. (sanifit.com)
  • We anticipate this trial will demonstrate SNF472's potential and build on the strong Phase I data to support its continued clinical advancement and to ultimately benefit patients. (sanifit.com)
  • Dr. Chung is conducting clinical trials to develop less toxic but effective molecularly targeted agents which can potentially benefit this subset of HNC patients. (moffitt.org)
  • A total of nine patients were enrolled in the Phase I portion and dose-limiting toxicity was defined in cycle 1. (medscape.com)
  • Among the six patients who were evaluable for response (with the caveat that all of them were part of the Phase I portion of the study), three patients achieved a partial response and three had stable disease (one at 5 months, two at ≥ 6 months). (medscape.com)
  • A fairly similar Phase I/II study of sorafenib with anastrozole to overcome resistance to the aromatase inhibitors in patients with hormone receptor-positive MBC who had developed resistance to one of the aromatase inhibitors was presented at the 2009 SABCS. (medscape.com)
  • Randomized trial of erlotinib plus whole-brain radiotherapy for NSCLC patients with multiple brain metastases. (druglib.com)
  • To this end patients on this trial will be randomly assigned to one of three arms to receive either Tarceva, Tarceva plus sulindac, or a placebo in the 2 week pre-operative period. (druglib.com)
  • This is a Phase 2, randomized, open-label, parallel-group, multi-center study for patients with documented carcinoid syndrome requiring medical therapy including at least 1 instance of an elevated 5-HIAA level. (globalgenes.org)
  • The estimated enrolment of patients in the randomization phase of the study is 126 (42 in each of the 3 groups). (egetis.com)
  • 6-12 patients will be enrolled in the dose escalation phase. (egetis.com)
  • Hansa Biopharma treated the first patient in its Phase III ConfideS trial of imlifidase in highly sensitized kidney transplant patients. (biospace.com)
  • I. To evaluate and estimate the median duration of overall survival (OS) in stage IIB-IIC melanoma patients. (survivornet.com)
  • The trial has recruited patients from 36 centers across Europe. (news-medical.net)
  • Adult patients with this inherited cancer syndrome are eligible for a National Cancer Institute randomized controlled phase 2b study. (medscape.com)
  • Methods: We conducted a randomized phase II study to compare CHOP with fractionated ifosfamide, carboplatin, etoposide, and dexamethasone (ICED) for patients eligible for ASCT. (bvsalud.org)
  • In this phase 2, open-label study (NCT03677141), 40 patients (52.5% with international prognostic index ≥3) with previously untreated DLBCL initiated 6 cycles of IV mosunetuzumab with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy. (bvsalud.org)
  • TRACON Pharmaceuticals announced the Independent Data Monitoring Committee (IDMC) for the Phase III ENVASARC trial recommended accrual as planned in both cohort A of single agent envafolimab and cohort B of enfavolimab with Yervoy (ipilimumab). (biospace.com)
  • This is a phase 1b study to evaluate the safety of chimeric antigen receptor (CAR) T cells with a chlorotoxin tumor-targeting domain (ie, CHM-1101, the study treatment) to determine the best dose of CHM-1101, and to assess the effectiveness of CHM-1101 in treating MMP2+ glioblastoma that has come back (recurrent) or that is growing, spreading, or getting worse (progressive). (vascodagamaonlinejournal.in)
  • Clinical trials generate data on dosage, safety and efficacy. (wikipedia.org)
  • People over 55 (or a similar cutoff age) are often excluded from trials because their greater health issues and drug use complicate data interpretation, and because they have different physiological capacity than younger people. (wikipedia.org)
  • During the trial, investigators recruit subjects with the predetermined characteristics, administer the treatment(s) and collect data on the subjects' health for a defined time period. (wikipedia.org)
  • The researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests. (wikipedia.org)
  • The protocol is the trial's "operating manual" and ensures all researchers perform the trial in the same way on similar subjects and that the data is comparable across all subjects. (wikipedia.org)
  • As part of the innovation process, clinical research generates valuable data to assess technological solutions in healthcare, linking scientific research and knowledge transfer to provide beneficial innovations for society. (scielo.br)
  • However, the generated clinical data do not appear to be adequately available to the scientific community and society. (scielo.br)
  • The company is also planning a crossover in the PREVENT-19 study, for which the company expects to read out initial clinical data during the second quarter. (ddw-online.com)
  • REDCap is an easy-to-use, free tool for clinical study management and data capture, which provides investigators with the ability to build and manage online surveys and databases. (nih.gov)
  • CanSino Biologics published Phase III data on its Convidecia vaccine against COVID-19. (biospace.com)
  • Ocugen and its partner Bharat Biotech , announced positive data from a Phase II/III trial of its COVID-19 vaccine, Covaxin, in children from the ages of two to 18 years. (biospace.com)
  • BridgeBio Pharma reported topline data from Part A (Month 12) of its Phase III ATTRibute-CM study of acoramidis for symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The drug failed the study arm's 6-minute walking distance (6MWD) test, but otherwise demonstrated biomarkers of efficacy. (biospace.com)
  • A novel oral anti-coagulant outperformed the injected standard therapy on important safety measures for initial and long-term treatment of pulmonary embolism - a blockage of lung blood vessels usually caused by a clot - and showed comparable efficacy, according to data from the EINSTEIN-PE trial presented today at the American College of Cardiology's 61st Annual Scientific Session. (news-medical.net)
  • Note: This record shows only 22 elements of the WHO Trial Registration Data Set. (who.int)
  • Under Novavax' updated clinical trial protocols, all participants in the UK and US Phase III trials will be offered the opportunity to receive an additional round of injections. (ddw-online.com)
  • Participants across all three trials will remain blinded to the courses of treatment to preserve the ability to assess efficacy in each trial, and all will be followed for up to two years to monitor the safety and durability protection of the vaccine. (ddw-online.com)
  • In the clinical trial, 900 participants will be vaccinated with either H56:IC31 or placebo at the end of their TB treatment. (iavi.org)
  • All sites in the clinical trial are now randomizing and vaccinating participants. (iavi.org)
  • This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of durvalumab in combination with investigator's choice of 3 different gemcitabine-based chemotherapy regimens in participants with aBTC with a WHO/ECOG PS of 0 to 2 at enrolment. (nainitalnewsflash.in)
  • The trial, which will involve 300 participants, will be carried out in 5 hospitals in Spain. (hipra.com)
  • In the trial, one group of participants will receive subcutaneous injections of the TriAd5-N803 combination at baseline and at 4, 8, and 52 weeks thereafter. (medscape.com)
  • In the trial, one group of participants will receive usual care (observation) after surgery and chemotherapy. (medscape.com)
  • Cytos Biotechnology yesterday announced that their Phase IIb clinical study of CYT003 failed to meet its primary or secondary endpoints. (clinicalprofessionals.co.uk)
  • The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. (nih.gov)
  • We support a broad range of clinical research tools that facilitate clinical trial design, patient recruitment and regulatory compliance. (nih.gov)
  • The Biliary Tract Cancers pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Biliary Tract Cancers drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Biliary Tract Cancers clinical trial landscape. (nainitalnewsflash.in)
  • The most common histology-high-grade serous epithelial ovarian cancer-is considered as a single clinical entity along with fallopian tube and peritoneal cancers because of shared clinical features. (msdmanuals.com)
  • The Company believes this marks a key milestone in clinical drug discovery and development, and Ault Alliance congratulates Alzamend Neuro on this achievement. (businesswire.com)
  • Salarius Pharmaceuticals announced a dosing milestone in the Phase I/II Sarcoma trial of seclidemstat for Ewing sarcoma and other FET-rearranged sarcomas. (biospace.com)
  • This may include preparation of documents for a Food and Drug Administration (FDA) submission, development of an intellectual property strategy, and/or planning for a clinical trial. (nih.gov)
  • Development and Validation of a Natural Language Processing Tool to Generate the CONSORT Reporting Checklist for Randomized Clinical Trials. (unc.edu)
  • Explore end-to-end solutions throughout development - from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more. (parexel.com)
  • Learn the drug development process, what it's like to participate, how to find a trial, and answers to frequently asked questions. (parexel.com)
  • this stage is important in the development of symptoms and clinical complications. (urosario.edu.co)
  • We support the development of many clinical research tools designed to be shared broadly. (nih.gov)
  • The company has several molecules in various stages of pre-clinical and clinical development primarily focused in the areas of Oncology Respiratory and Dermatology. (business-standard.com)
  • They completed pre-clinical development for initiating Phase I trials for GBR 500 a monoclonal antibody for inflammation. (business-standard.com)
  • The trial will evaluate whether a trivalent adenovirus-5 vaccine (TriAd5) along with the IL-15 superagonist nogapendekin alfa inbakicept (N803) can stave off the development of colorectal neoplasms. (medscape.com)
  • Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. (wikipedia.org)
  • Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. (wikipedia.org)
  • Among Dr. Cheng's most intensively reviewed and extensively published research has been that on YIV-906, the proprietary formulation of four herbs which he has been studying since 1999 that is now under clinical review. (nfcr.org)
  • Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics, retreats, and clinical research sites. (accesswire.com)
  • Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. (accesswire.com)
  • A drug from Brisol-Myers Squibb and Albany Molecular Research showed non-superiority to Cymbalta and Lexapro in Phase II clinical trials. (medicaldaily.com)
  • The present study seeks to analyze the effectiveness of databases of clinical records as a source of relevant information for scientific research. (scielo.br)
  • Take a look at each step in the process, and see how being part of a clinical research study can help others - and yourself. (worldwide.com)
  • Once you're approved as a candidate and if you're happy with the study conditions, your participation in the clinical research study will begin. (worldwide.com)
  • SATVI is regarded as a worldwide leader in TB vaccine research and has conducted 28 Phase I-IV trials of 9 different TB vaccine candidates since 2005. (iavi.org)
  • Sanifit is also collaborating on this trial with Frenova Renal Research, a Fresenius Medical Care North America company, one of the world's largest providers of dialysis services with an extensive renal research network across the United States. (sanifit.com)
  • These resources can further enable and speed research collaboration, particularly for multisite trials. (nih.gov)
  • View a selection of clinical research tools. (nih.gov)
  • Given the high degree of similarity, many experts consider the extensive clinical research performed for AOD9604 to be relevant for frag 176-191. (outlookindia.com)
  • RBDCOV is one of 11 selected projects that support clinical trials of the new vaccine and may reach beyond Europe's borders by creating links with other European initiatives to address the fight against the coronavirus crisis and strengthen existing research infrastructures. (hipra.com)
  • Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. (nih.gov)
  • The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery. (nih.gov)
  • Want to collaborate with us to offer clinical trials at your site? (parexel.com)
  • November 21, 2018 - Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NINDS associated SBIR FOAs NOT-NS-19-024 . (nih.gov)
  • Biotech company Novavax has announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's Covid-19 vaccine candidate. (ddw-online.com)
  • A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United States. (alacrita.com)
  • The current clinical trial is an innovative type of TB vaccine Phase IIb efficacy trial, using the prevention of TB recurrence post-TB treatment as an indicator of the ability of a vaccine to prevent TB disease in the broader healthy population. (iavi.org)
  • This trial was originally designed and powered to compare biomarker modulation in the neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical response to erlotinib in the adjuvant setting. (druglib.com)
  • Since implementing the trial in late 2005, The investigators have encountered significant obstacles to implementing the adjuvant therapy phase of the trial. (druglib.com)
  • Adults with this cancer who have undergone standard surgery and chemotherapy are sought for a randomized, open-label, phase 2/3 trial to determine whether encorafenib plus cetuximab can slow or prevent disease recurrence. (medscape.com)
  • [ 59 ] A Phase I/II trial of letrozole and sorafenib was presented at the 2009 American Society of Clinical Oncology Breast Cancer symposium. (medscape.com)
  • Seamless Phase IIa/IIb and enhanced dose-finding adaptive design. (unc.edu)
  • Most vaccine candidates are in phase I trials and have had an acceptable safety profile. (urosario.edu.co)
  • In addition, the company is planning to expand the trial to include paediatric and adolescent arms, which are also expected to begin in the second quarter. (ddw-online.com)
  • The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). (clinicaltrialsregister.eu)
  • I. To assess and compare clinical, histological, immunological and molecular panels as prognostic and predictive biomarkers . (survivornet.com)
  • We conducted a comparative analysis of 27 correlations of clinical trials between three different technologies and their scientific articles by consulting two information sources. (scielo.br)
  • GCP is an international ethical and scientific quality standard that helps assure the safety, integrity, and quality of clinical trials. (nih.gov)
  • Elsevier, a world-leading provider of scientific, technical and medical information products and services, announced today the publication of an important clinical guide from the European Menopause and Andropause Society (EMAS) in the February issue of Maturitas. (news-medical.net)
  • Some clinical trials involve healthy subjects with no pre-existing medical conditions. (wikipedia.org)
  • The clinical trial will involve 612 volunteers over 18 years of age who are not affected by a serious pathology. (hipra.com)
  • Pilot experiments are conducted to gain insights for design of the clinical trial to follow. (wikipedia.org)
  • Other clinical trials pertain to people with specific health conditions who are willing to try an experimental treatment. (wikipedia.org)
  • Treatment recommendations for the management of early arthritis concluded that the main goal of treatment is clinical remission, in order to prevent structural joint damage and long-term disability. (bmj.com)
  • The trial investigates if vaccination with H56:IC31 added at the end of standard TB treatment is better at preventing recurrent TB than standard drug treatment alone. (iavi.org)
  • Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials. (unc.edu)
  • The findings of two large international randomised trials published in this week's Lancet also indicate that the new "Quad" pill is faster acting, doesn't have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment. (news-medical.net)
  • Bedaquiline should be used with clinical expert consultation as part of combination therapy (minimum four-drug treatment regimen) and administered by direct observation to adults aged ≥18 years with a diagnosis of pulmonary MDR TB (Food and Drug Administration. (cdc.gov)
  • After completion of Screening, subjects will be randomly assigned to 40 mg QD vs. 80 mg QD open-label dose groups for 8 weeks, referred to as the Randomized Treatment Phase. (globalgenes.org)
  • Following the completion of the Randomized Treatment Phase, subjects may be eligible to enter the Open-Label Extension (OLE) Phase of the study in which they will receive paltusotine for 50 weeks. (globalgenes.org)
  • If eligible and enrolled in the trial, the adolescent will remain on a phenylalanine (Phe)-restricted diet and will be randomly assigned to one of two treatment groups. (globalgenes.org)
  • Its lead product had been successfully evaluated in a Phase I dose-escalation study. (alacrita.com)
  • Costs for clinical trials can range into the billions of dollars per approved drug. (wikipedia.org)
  • If, following these and future Phase III trials, the drug is approved by the U.S. Food and Drug Administration (FDA), it would be the country's first authorization for usage of a purely botanical cancer drug and usher in a new paradigm for drug discovery. (nfcr.org)
  • Costs for clinical trials can range into the billions of dollars per approved drug, [3] and they take 11-14 years to complete. (wikipedia.org)
  • As a result of the clinical trial failure for the asthma drug, the condition for the conversion of convertible loan notes has not been achieved. (clinicalprofessionals.co.uk)
  • This report provides provisional CDC guidelines for FDA-approved and unapproved, or off-label, uses of bedaquiline in certain populations, such as children, pregnant women, or persons with extrapulmonary MDR TB who were not included in the clinical trials for the drug. (cdc.gov)
  • Preparations for a Phase IIb trial are currently underway for this separate indication. (sanifit.com)
  • This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. (ucsf.edu)
  • Adults with this diagnosis can join an open-label phase 2 study evaluating a new diagnostic imaging agent, 89 Zr-girentuximab. (medscape.com)
  • Individuals with this rare condition who have undergone colectomy or subtotal colectomy can enroll in an open-label phase 2 trial to see whether REC-4881 reduces the remaining polyps. (medscape.com)
  • New Trials in Colorectal Cancer: Could Your Patient Benefit? (medscape.com)
  • Several clinical trials in colorectal cancer have started recently. (medscape.com)
  • Phase 1/2 trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab (REGN2810), with radiation and chemotherapy, in subjects with newly-diagnosed glioblastoma (GBM). (vascodagamaonlinejournal.in)
  • As part of the BARDA contract, Gritstone bio will launch a Phase IIb vaccine trial enrolling 10,000 subjects. (clinicaltrialsarena.com)
  • The EU Clinical Trials Register currently displays 43715 clinical trials with a EudraCT protocol, of which 7255 are clinical trials conducted with subjects less than 18 years old. (clinicaltrialsregister.eu)
  • In phase IIb/III,the first 40 subjects (20 subjects per arm) will be randomly allocated in a 1:1 ratio in two arms. (nainitalnewsflash.in)
  • The combination was deemed to have a manageable toxicity profile, and the recommended dose for the ongoing Phase II trial is letrozole 2.5 mg daily with sorafenib 400 mg twice daily. (medscape.com)
  • This public website was created by NIH's National Institute of Allergy and Infectious Diseases to help researchers navigate country-specific regulatory information as they plan and implement clinical trials. (nih.gov)
  • Note: There may be more study sites and/or diseases associated with a clinical trial than those listed. (globalgenes.org)
  • Disease-free survival, assessed up to 6 years after randomization, is the primary outcome in phase 3. (medscape.com)