• Newswise - There is great interest among glaucoma patients, scientists and doctors alike, in discovering regenerative therapies for the optic nerve and translating them from the laboratory to the clinic - and stem cell therapy is one of several promising approaches being studied. (newswise.com)
  • Although patient-funded research would appear superficially to provide an avenue for patients to obtain therapies under investigation, it is controversial for a number of reasons, both scientific and ethical. (newswise.com)
  • Scientific considerations are deeply concerning: the gold standard for evaluating an experimental treatment is a randomized clinical trial in which participants are randomly allocated to the experimental treatment group or a control group that may not receive any treatment (placebo-controlled study), or may receive standard, approved therapies. (newswise.com)
  • Patritumab deruxtecan was granted Breakthrough Therapy Designation by the US Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies. (insideprecisionmedicine.com)
  • The idea behind the ACTIV trial program is that multiple therapies can be tested within the same trial protocol over time (and dropped if not effective) and compared with the same placebo group without having to restart the trial each time. (clinicalomics.com)
  • ACTIV 2 is looking into therapies such as monoclonal antibodies but focusing on patients with less severe disease who are not hospitalized and assessing if such treatments can reduce severity and duration of symptoms. (clinicalomics.com)
  • ACTIV 3, which the AstraZeneca antibody combination trial forms part of, is testing monoclonal antibodies and other therapies for hospitalized patients with COVID-19. (clinicalomics.com)
  • As the arms of the study are run concurrently, new patients will be randomized to either receive a placebo treatment or one of the three antibody therapies being tested in the different study arms. (clinicalomics.com)
  • ACTIV 5 trials are aiming to assess if therapies approved for other indications or drugs in late-stage development could also be used to treat COVID-19. (clinicalomics.com)
  • The focus of this webinar is on the Lessons Learned from IND/Phase I trials including overcoming the challenges, and addressing the regulatory issues, as stem cell based therapies move towards the clinic. (ca.gov)
  • 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)
  • With respect to the association between the status of the CXCR4 gene and response to specific therapies in WM, there was evidence that patients with disease characterized by mutated CXCR4 were less likely to respond to single-agent ibrutinib, a Bruton tyrosine kinase inhibitor, or ibrutinib/rituximab combination therapy than patients with CXCR4 wild-type disease. (cancertherapyadvisor.com)
  • Dr. Eroglu's research interests are translational and clinical research in targeted therapies and combination immunotherapeutics for melanoma and other skin cancers, along with development of personalized treatment strategies and biomarkers for patients with melanoma. (moffitt.org)
  • Eligible patients were unresponsive to or unable to tolerate standard therapies. (scienceboard.net)
  • Cellular reprogramming of ex vivo cells may offer improvements on first-generation adoptive cell therapies, which have experienced limited clinical success. (scienceboard.net)
  • This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays. (clinicaltrials.gov)
  • The practice of integrative oncology cancer treatment that integrates the best of conventional medicine with the best of alternative therapies backed by science and personalized to each patient. (drstegall.com)
  • Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard-of-care therapies. (biospace.com)
  • 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)
  • Organoid and tissue cultures are applied as (autologous) tumor model systems for in vitro testing of cell products and antibody-based compounds paving the way for early clinical trials (phase I/II) evaluating novel (combination) therapies. (nct-heidelberg.de)
  • We aim for the development and routine application of personalized TCR gene-engineered adoptive T cell therapies (ACT) targeting individual- as well as shared patient-derived neoepitopes. (nct-heidelberg.de)
  • The use of genetic data holds great promise for predicting disease risk or determining optimal therapies, but it must be put to the test through clinical trials like this one to determine how to best use that information," said Gary H. Gibbons, M.D., director of the NHLBI. (nih.gov)
  • Clinical trials test whether new drugs or therapies can improve outcomes for patients. (bmtinfonet.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)
  • All HIV-infected patients undergoing treatment for TB should be evaluated for antiretroviral therapy, because most patients with HIV-related TB are candidates for concurrent administration of antituberculosis and antiretroviral drug therapies. (cdc.gov)
  • He contributed to Track-HD and Track-ON HD, two influential observational studies in HD, and to 26 phase I-III clinical trials, primarily in HD, including a first-in-man intrathecal application of antisense oligonucleotides ASO to silence huntingtin gene expression evaluating the safety, tolerability, and efficacy of intrathecally administered agents as well as non-pharmacological interventions, studying the impact of physical activity and exercise in people with HD. (wikipedia.org)
  • 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)
  • Adicet Bio reported positive interim data from its dose escalation phase I study evaluating the safety and tolerability of ADI-001, Adicet's investigational. (scienceboard.net)
  • SAN DIEGO--( BUSINESS WIRE )--Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that the first patient has been dosed in RADIANT, a Phase 2 clinical trial comparing the safety and tolerability of the novel echinocandin, CD101, to standard-of-care fluconazole for the treatment of acute vulvovaginal candidiasis (VVC). (biospace.com)
  • RADIANT is a Phase 2, multicenter, randomized, open-label, active-controlled, dose-ranging trial designed to evaluate the safety and tolerability of CD101 in women with moderate to severe episodes of VVC. (biospace.com)
  • The primary endpoints of RADIANT will be the safety and tolerability of a single dose of CD101 Ointment and multiple doses of CD101 Gel in patients with acute VVC. (biospace.com)
  • The clinical trials will evaluate the efficacy and safety of Liporaxel as a first-line therapy in patients with relapsed or metastatic breast cancer. (pharmemed.com)
  • The results, published January 11 in the journal Clinical Cancer Research , showed promising antiviral efficacy and safety in a phase II clinical trial of patients who had undergone stem cell transplantation to treat blood diseases including cancer. (scienceboard.net)
  • To evaluate the efficacy and safety of conservative or deresuscitative fluid strategies in adults and children with acute respiratory distress syndrome (ARDS), sepsis or systemic inflammatory response syndrome (SIRS) in the post-resuscitation phase of critical illness. (nih.gov)
  • The objective of the study was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure requiring high flow oxygen or mechanical ventilation, and death. (accesswire.com)
  • In a phase III clinical trial, we evaluate the superiority of a novel agent or regimen on patient outcomes, compared to the standard therapy. (hstalks.com)
  • 2 It has also been identified as a prognostic marker of worse clinical outcomes that may influence patient response to treatment. (cancertherapyadvisor.com)
  • In their concluding remarks, the authors of this systematic review stated that "additional research is needed to further understand the biology of CXCR4 mutations in WM and how to overcome its adverse effect on outcomes of WM patients treated with ibrutinib. (cancertherapyadvisor.com)
  • The results of this trial should provide valuable information regarding a novel approach to improve biological, and potentially clinical, outcomes post CABG. (frontiersin.org)
  • While the magnitude of the observed outcomes differed between these trials, altogether, their findings suggest that a conventional management coupled with inflammation inhibition could maximize vascular benefit and clinical outcomes ( 6 - 8 ). (frontiersin.org)
  • We included randomised trials comparing fluid regimens with differing fluid balances between groups, and observational studies investigating the relationship between fluid balance and clinical outcomes. (nih.gov)
  • The purpose of a prospective clinical trial is to test the effect and the value of a particular intervention in improving patient's outcomes. (bmtinfonet.org)
  • 00:06:54): The goal of interventional clinical trials is to improve transplant outcomes through a scientific rationale. (bmtinfonet.org)
  • 00:17:57): Randomized or blinded trials reduce unconscious bias that can skew outcomes. (bmtinfonet.org)
  • Palliative care interventions in the ED capture high-risk patients at a time of crisis and can dramatically improve patient-centred outcomes. (nyu.edu)
  • Using Centers for Medicare and Medicaid Services (CMS) data, we will assess the primary outcomes in approximately 300 000 patients: ED disposition to an acute care setting, healthcare utilisation in the 6 months following the ED visit and survival following the index ED visit. (nyu.edu)
  • Objectives: We describe the use of the PPTR process and evaluate whether the goals of minimizing bias in efficacy endpoint assessment and attainment of relevant data to determine outcomes for all participants were achieved. (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)
  • In a Jan 19 epidemiological update on polio, the Pan American Health Organization (PAHO) said the genetic testing on the two Canadian samples was conducted by the US Centers for Disease Control and Prevention (CDC). (umn.edu)
  • The RADIANT trial will be conducted at clinical trial centers across the United States. (biospace.com)
  • The 233 treated patients (Intent To Treat, ITT population) were 63 years old on average, 64% of the patients were male, recruited in 37 centers in Europe, the US and Brazil between Q3 2020 and Q1 2022, infected with the main SARS-Cov-2 variants.The trial ended early before reaching the 310 patients originally planned, due to stalled recruitment. (accesswire.com)
  • I am Marcy Friedman and I'm representing the Clinical Outreach and Communication Activity, COCA, with the Emergency Risk Communication Branch at the Centers for Disease Control and Prevention. (cdc.gov)
  • https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png 0 0 BCeditor https://southeastclinicaloncology.org/wp-content/uploads/2018/06/SCOR-Southeast-Clinical-Oncology-Research_Logo.png BCeditor 2021-07-26 10:25:16 2021-08-03 13:38:26 What are Clinical Trial Phases? (southeastclinicaloncology.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)
  • This multi-disciplinary center provides genetic counselling, clinical in- and out-patient services as well as rehabilitation for HD affected families along with basic and translational science. (wikipedia.org)
  • His laboratory is developing novel stem cell approaches for glaucoma, and working steadily towards a translational program to bring discoveries out of the laboratory and into human testing once safety and efficacy in pre-clinical models is established. (newswise.com)
  • We fund ambitious translational clinical research, evaluating novel and repurposed interventions and promoting our understanding of disease or therapeutic mechanisms. (nihr.ac.uk)
  • If these studies are successful, the alliance will select antibody programs for preclinical and clinical development. (beursonline.nl)
  • He served as principal investigator in numerous HD clinical trials and observational studies and is the principal investigator of the CHDI-sponsored Enroll-HD study. (wikipedia.org)
  • NCIC CTG MA.27 had the highest proportion of 'not met' subcategory due to an inclusion criterion requiring participation to two companion studies. (nih.gov)
  • Patient-funded trials are studies in which patients pay to participate. (newswise.com)
  • Experimental studies, called clinical trials. (cancer.net)
  • Experimental studies and clinical trials help researchers learn more about how cancer starts or spreads. (cancer.net)
  • Studies have shown injection site reactions, including erythema, pain at injection site, and vein discoloration occur in approximately one third of NSCLC patients treated with vinorelbine. (lungevity.org)
  • Pre-clinical studies with ANX-530 showed equivalent pharmacokinetic and pharmacodynamic profiles when compared to Navelbine. (lungevity.org)
  • Learn more about the Belmont Report as the foundation for the Institutional Review Board, an overview of the levels of review, and the use of consent waivers for clinical research studies. (ncbionetwork.org)
  • This systematic review included 85 publications, the majority of which were wee divided between preclinical studies, clinical studies, and review articles in approximately equal numbers. (cancertherapyadvisor.com)
  • Of the 17 studies evaluating the prevalence of CXCR4 mutations in WM, the prevalence of CXCR4 alterations was 34% and 5% in patients with disease characterized by MYD88 L265P and wild-type MYD88 , respectively. (cancertherapyadvisor.com)
  • Finally, 2 studies evaluating the prognostic impact of a mutated CXCR4 gene did not find an association between CXCR4 gene status and overall survival in patients with WM. (cancertherapyadvisor.com)
  • We have a mixed portfolio of studies including diagnostic evaluations, phase 2 and 3 clinical trials, adaptive trials, studies using stratification and other novel approaches. (nihr.ac.uk)
  • We also have a portfolio of mechanistic studies, which are funded as 'bolt-ons' to existing late phase clinical trials. (nihr.ac.uk)
  • 2) Methods: A literature search was conducted and included any study that evaluated the effects or mechanisms of antioxidants in the healing process (in vitro, animal models or human studies). (mdpi.com)
  • Lu and colleagues are planning additional studies that could inform treatment plans for burn patients. (sciencedaily.com)
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (clinicaltrials.gov)
  • Clinical trials are research studies which evaluate potential new treatments. (drstegall.com)
  • One of the most common types of experimental studies is the clinical trial . (southeastclinicaloncology.org)
  • 6 However, there are few studies evaluating bright light therapy. (psychiatryadvisor.com)
  • Based on these studies, dosing formulas have been developed that incorporate a person's genetic profile along with the patient's clinical characteristics to try and better predict the proper dose of warfarin - an approach known as pharmacogenetics. (nih.gov)
  • small clinical studies and some observational data have produced conflicting results. (nih.gov)
  • We look forward to further evaluating PTC124 in registration-directed clinical trials in both CF and DMD this year, as well as in studies in additional genetic disorders in the future. (cff.org)
  • HM71224 is a potent and effective BTK inhibitor and has successfully demonstrated proof of mechanism in preclinical studies and a Phase 1 study in Europe,' said Dr. Gwan Sun Lee, president and CEO of Hanmi Pharmaceutical, in a press release. (drugdiscoverynews.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)
  • The review involved 94 studies, most of which assessed patients with OA only in the knee. (medscape.com)
  • 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)
  • Evaluation of the vaccine regimen commenced with Phase I clinical trial at the Oxford Vaccine Group in December 2014 and this has been followed by Phase 1 studies in the United States (US) and Africa (Kenya, Uganda, Tanzania). (who.int)
  • Many studies have been conducted to evaluate the American heart association (AHA) and the American tobacco smoking prevalence, risk factors, complications, Stroke Association (ASA) strongly recommended and prevention efforts in different countries. (who.int)
  • Updated results from a subgroup analysis of a Phase I/II trial of ifinatamab deruxtecan in SCLC were recently presented at the IASLC 2023 World Conference on Lung Cancer. (insideprecisionmedicine.com)
  • Biophytis is nowinitiating key regulatory activities to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023.The strategy to give access to Sarconeos (BIO101) as quickly as possible is to file for Early Access Programs (EAP) in France and Brazil, while filing for conditional Marketing Authorisation (CMA) in Europe and Emergency Use Authorization (EUA) in the USA. (accesswire.com)
  • 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)
  • We will treat patients with relapsed and refractory T cell lymphoma to define the safety and feasibility of this therapy. (lls.org)
  • Researchers conducted a phase I pilot study to assess the feasibility of using potato starch as a dietary intervention to modify the gut microbiome in bone marrow transplant patients. (sciencedaily.com)
  • 00:13:24): Phase two trials evaluate the feasibility, acceptability, and affordability of the intervention for the broader patient population. (bmtinfonet.org)
  • The study is divided into two phases: a pilot phase, to ensure feasibility in two sites, and an implementation and evaluation phase, where we implement the intervention and test the effectiveness in 33 EDs over 2 years. (nyu.edu)
  • A total of 985 patient-trials were evaluated, defined as the experimental unit since one patient could be eligible to more than one trial. (nih.gov)
  • The National Institutes of Health - supported trial is evaluating the experimental bacteriophage cocktail WRAIR-PM-CF1 in cystic fibrosis (CF) patients. (umn.edu)
  • In contrast, patient-funded trials do not have a control group, since it is extremely unlikely that patients would pay when there is a possibility of not receiving the experimental treatment. (newswise.com)
  • As the trial did not exclude other experimental therapeutics, many participants also received Remdesivir and/or corticosteroids including dexamethasone. (biopharma-reporter.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)
  • Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. (cdc.gov)
  • 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)
  • MATERIAL AND METHODS: The Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) study A5349 (S31) is an international, multi-site, randomized, open-label, controlled, non-inferiority phase 3 clinical trial comparing two 4-month regimens to a standard 6 month regimen for treatment of drug-susceptible tuberculosis (TB) among adolescents and adults with a sample size of 2500 participants. (cdc.gov)
  • The most notable changes in these guidelines reflect both the findings of clinical trials that evaluated new drug regimens for treating and preventing TB among HIV-infected persons and recent advances in the use of antiretroviral therapy. (cdc.gov)
  • Adding to CDC's current recommendations for administering isoniazid preventive therapy to HIV-infected persons with positive tuberculin skin tests and to HIV-infected persons who were exposed to patients with infectious TB, this report also describes in detail the use of new short-course (i.e., 2 months) multidrug regimens (e.g., a rifamycin, such as rifampin or rifabutin, combined with pyrazinamide) to prevent TB in persons with HIV infection. (cdc.gov)
  • 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)
  • 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)
  • Study amended with extension to evaluate safety of higher rifapentine doses. (cdc.gov)
  • By addressing patient safety, we believe costs can be reduced and quality improved. (sbir.gov)
  • Non-infectious urethral catheter related complications are one such patient safety problem the US and worldwide health care industry faces. (sbir.gov)
  • 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)
  • Casgevy's safety profile is consistent with the current standard of care for the two diseases namely, myeloablative conditioning with busulfan and haematopoietic stem cell transplant. (pharmaceutical-technology.com)
  • If AZD7442 is given to around 150 participants and shows good safety and efficacy at 5 days after treatment then it will be given to a much larger group of patients. (clinicalomics.com)
  • 2) of the US Food, Drug & Cosmetic Act permits the FDA to approve a new drug application (NDA) in part on the basis of published literature or on a previous finding of safety or effectiveness of a drug. (lungevity.org)
  • Prior to the Phase 3 clinical trial for COVID-19 patients, CD24Fc has been studied for safety in healthy volunteers and in Phase 2 clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia. (biopharma-reporter.com)
  • The SAC-COVID Phase 3 clinical trial (NCT04317040) is a randomized, double blind, placebo-controlled trial designed to evaluate the safety and efficacy of CD24Fc in hospitalized patients with COVID-19 requiring oxygen support, including those requiring supplemental oxygen, high flow oxygen, and mechanical ventilation. (biopharma-reporter.com)
  • The safety and efficacy of pridopidine were tested in the HEALEY ALS Platform Trial where positive effects of pridopidine on overall function (ALSFRS-R), speech, bulbar function, and breathing in people who are fast progressors and earlier in disease course were seen. (massgeneral.org)
  • Additionally, this EAP will provide real world safety, biomarker, and clinical data in two hundred (200) ALS individuals treated with pridopidine for up to two (2) years, thus contributing to our understanding of the effects of pridopidine in a broad population. (massgeneral.org)
  • Data from patients who were already treated in the 500 mg dose group will be analyzed for safety and included in the secondary efficacy analysis, but will not be included in the primary efficacy analysis. (iex.nl)
  • The proportion of patients and time to respiratory failure or early death were studied at 28 days in the primary analysis, corresponding to the maximum treatment period, with follow-up of mortality and safety for at least 90 days. (accesswire.com)
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. (mayo.edu)
  • Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. (mayo.edu)
  • A Phase II Study Evaluating the Safety and Efficacy of an Adenovirus-ΔLMP1-LMP2 Transduced Dendritic Cell Vaccine in Patients with Advanced Metastatic Nasopharyngeal Carcinoma. (texaschildrens.org)
  • Previously, Hanmi was able to demonstrate the compound's safety and efficacy in a clinical trial of lung cancer patients who had developed resistance to conventional anticancer drugs. (drugdiscoverynews.com)
  • In this Phase 2 trial, Hanmi will evaluate HM61713's safety, speed and anti-cancer effects as a potential primary therapy for treating non-small cell lung cancer. (drugdiscoverynews.com)
  • 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)
  • Phase 1 evaluates safety and toxicity in humans. (msdmanuals.com)
  • AVAREF Chair Dr Beno Yakubu said, "Under the platform of AVAREF, this meeting is an indication of the due diligence taken by the pharmaceutical companies and partners to jointly ensure that the clinical trial process is of the highest ethical and scientific standards to ensure the safety of the volunteers and patients who will ultimately receive the vaccine. (who.int)
  • No patient experienced cytokine release syndrome, an acute systemic inflammatory condition. (scienceboard.net)
  • The trial is the first to describe acute anti-inflammatory benefits from taking vitamin D. According to the authors, despite widespread attention given to vitamin D deficiency, "there is a lack of evidence demonstrating that intervention with vitamin D is capable of resolving acute inflammation. (sciencedaily.com)
  • Following an acute coronary syndrome, patients display an elevated inflammatory profile, promoted in part by cellular senescence. (frontiersin.org)
  • The Q-CABG study aims to explore the efficacy of quercetin to reduce inflammation, myocardial injury and senescence in patients undergoing CABG following an acute coronary syndrome. (frontiersin.org)
  • The preventive intake of quercetin supplementation may help limit the vigorous inflammatory response triggered by CABG and subsequent postoperative complications in patients suffering from an acute coronary syndrome. (frontiersin.org)
  • Many patients on potent agents addressing modifiable cardiovascular risk factors, such as hypertension, hyperlipidemia or diabetes, still suffer from cardiovascular complications, including acute coronary syndromes (ACS). (frontiersin.org)
  • High levels of inflammatory markers, such as C-reactive protein, were associated with left ventricular dysfunction ( 2 ), higher cardiovascular event rates ( 3 ) and worse clinical prognosis ( 4 ) following an acute myocardial infarction, independent of traditional risk factors. (frontiersin.org)
  • Secondary endpoints include therapeutic efficacy in acute VVC patients treated with CD101. (biospace.com)
  • Introduction: Emergency departments (ED) care for society's most vulnerable older adults who present with exacerbations of chronic disease at the end of life, yet the clinical paradigm focuses on treatment of acute pathologies. (nyu.edu)
  • Acute- and convalescent-phase serum samples were collected when possible for serologic analysis performed at the Unité des Rickettsies. (cdc.gov)
  • Among the 10 remaining travelers, for whom a serum sample was available, with no clinical evidence of ATBF, 5 were positive for R. africae with only immunoglobulin M (IgM) at a titer of 1:32 in 4 cases and IgG at 1:128 with IgM at 1:32 in 1 case (an acute-phase serum from this patient showed IgG at 1:32 and IgM at 1:32). (cdc.gov)
  • Study investigators compared how much time the patients spent in their ideal therapeutic dosage range during the 28-day monitoring phase. (nih.gov)
  • Among all patients, the clinical and pharmacogenetic groups were virtually identical at 45.4 percent and 45.2 percent time in therapeutic range, respectively. (nih.gov)
  • Among the 255 African-American participants, the pharmacogenetic formula provided only 35.2 percent time in therapeutic range compared to 43.5 percent for the clinical formula. (nih.gov)
  • While there is a resurgence of COVID-19 patients in China and still unacceptable levels of patients dying from COVID-19 in Europe, the USA and Brazil, Sarconeos (BIO101) may offer an effective therapeutic option to reduce further the threat of COVID-19 pandemic. (accesswire.com)
  • This can in part be explained by the relative lack of clinical trials evaluating the multitude of therapeutic options for any given dermatologic condition. (medscape.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)
  • 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)
  • Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for isoniazid in standard intensive phase TB treatment regimen. (cdc.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)
  • Usually, study patients and doctors are both unaware of who receives which treatment and this study design minimizes bias towards a particular treatment. (newswise.com)
  • These include disparity in access to the treatment, and risk of exploitation of vulnerable patients who have exhausted all treatment options and may be willing to undergo an unproven treatment at any cost. (newswise.com)
  • In addition, a reported lack of proper oversight and monitoring for patient-funded trials implies the possibility that these may be thinly-veiled attempts to make money by the treating clinic or physician before proper FDA approval of new treatment methods. (newswise.com)
  • All three of the ADCs in this deal are in various stages of clinical development for the treatment of multiple solid tumors both as monotherapy and/or in combination with other treatments. (insideprecisionmedicine.com)
  • Trial data has shown that the combination treatment reduced mortality risk by 22% versus chemotherapy alone. (pharmaceutical-technology.com)
  • This allows a better assessment of whether the treatment being tested can actually impact recovery and allow patients to return home. (clinicalomics.com)
  • Mutations in CXCR4 are common in patients with Waldenström macroglobulinemia (WM) , and have implications with respect to the clinical presentation of disease and patient response to treatment. (cancertherapyadvisor.com)
  • Because somatic alterations in CXCR4 have also been reported to commonly occur in patients with WM, the aim of this systematic review was to evaluate the mechanisms of action of these alterations and their prevalence in this disease, as well as their potential impact on clinical presentation, treatment response, and prognosis in patients with WM. (cancertherapyadvisor.com)
  • Merck will acquire Oncolmmune for an upfront payment of $425m: pledging to accelerate the development of CD24Fc, a candidate for the treatment of patients with severe and critical COVID-19. (biopharma-reporter.com)
  • Merck's other COVID-19 efforts include a collaboration with Miami-headquartered Ridgeback Biotherapeutics to evaluate molnupiravir (EIDD-2801), an investigational orally available anti-viral candidate, in two Phase 2/3 trials, for the treatment of patients with COVID-19 in both outpatient and inpatient settings. (biopharma-reporter.com)
  • Physicians and researchers work close together to provide innovative treatment options for patients. (moffitt.org)
  • Within six weeks of treatment, 83% of the 12 adenovirus patients responded, as did 100% of the 27 BK virus patients, 96% of the 24 CMV patients, 100% of the two Epstein-Barr virus patients, and 75% of the four human herpes virus 6 patients. (scienceboard.net)
  • The approval of Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease. (medscape.com)
  • POD1UM-201 was an open-label, single-arm, phase 2 study that evaluated the agent in 65 systemic treatment-naive adults with metastatic or recurrent locally advanced MCC. (medscape.com)
  • 11% of patients discontinued treatment because of serious adverse events. (medscape.com)
  • So when we look at any treatment which qualifies for a clinical trial, we know that it must do a few things. (drstegall.com)
  • Phase two is a larger study to better define optimal dosing, while also seeing if the treatment actually works. (drstegall.com)
  • Soterix Medical announced the launch of a Phase-2 clinical trial that will evaluate the combination of REMOTE-tDCS and a brain training program for the treatment of long COVID.The trial will be administered through NYU Langone Health's home-based remotely supervised (RS) tDCS program, which includes a clinical service that is available to patients across the United States. (medicaldesigndevelopment.com)
  • If a new treatment is successful in one phase, it will proceed to further testing in the next phase. (southeastclinicaloncology.org)
  • Each phase of a clinical trial provides different answers about the new treatment. (southeastclinicaloncology.org)
  • In a clinical trial, volunteers are usually selected by chance to either be in the treatment or control group. (southeastclinicaloncology.org)
  • In this type of trial, the volunteers do not know whether they belong to a treatment or control group. (southeastclinicaloncology.org)
  • The study will enroll up to 125 patients who will be randomized into three treatment cohorts. (biospace.com)
  • The first cohort will involve the treatment of 50 patients with CD101 Ointment while a second cohort of 50 patients will receive CD101 Gel. (biospace.com)
  • Treatment evaluations and assessments will occur on trial days 7, 14 and 28. (biospace.com)
  • 5 The most recent available Cochrane review on the topic of light therapy for nonseasonal depression, published in 2004, concluded that it offers "modest though promising antidepressive efficacy, especially when administered during the first week of treatment, in the morning, and as an adjunctive treatment to sleep deprivation responders. (psychiatryadvisor.com)
  • 13 Moreover, antidepressant treatment failure and medication nonadherence are more common in older patients with depression compared with younger age groups. (psychiatryadvisor.com)
  • This is an exciting potential new treatment for patients afflicted with nonsense-mutation-mediated CF. We look forward to the next stage of clinical development to demonstrate the benefits of this promising new investigational drug. (cff.org)
  • PTC124 is an orally delivered investigational new drug in Phase 2 clinical development for the treatment of genetic disorders due to nonsense mutations. (cff.org)
  • In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. (mayo.edu)
  • We are very pleased to be collaborating with Lilly on HM71224, and through this agreement and R&D collaborations, we are excited to drive the joint project forward with the ultimate aim to offer new medical treatment options to patients with autoimmune disorders and related conditions. (drugdiscoverynews.com)
  • WHO issued a guidance document on the "Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease: Empirical treatment during outbreaks" to guide countries on the safe collection and use of blood. (who.int)
  • Eight patients received doxycycline (200 mg per day) for a mean of 10.8 ± 5.9 days (range 5-20), 1 patient received pristinamycin for 8 days, and 1 patient received no treatment. (cdc.gov)
  • Adverse Effects Obviously, a drug (or any medical treatment) should be used only when it will benefit a patient. (msdmanuals.com)
  • SELECTION CRITERIA: We included randomized controlled trials which compared the treatment drug with placebo. (who.int)
  • We excluded trials which did not report a minimum follow-up period of six months from start of treatment. (who.int)
  • Early diagnosis and effective treatment of TB among HIV-infected patients are critical for curing TB, minimizing the negative effects of TB on the course of HIV, and interrupting the transmission of Mycobacterium tuberculosis to other persons in the community. (cdc.gov)
  • Ideally, the management of TB among HIV-infected patients taking antiretroviral drugs requires a) directly observed therapy, b) availability of experienced and coordinated TB/HIV care givers, and in most situations, c) use of a TB treatment regimen that includes rifabutin instead of rifampin. (cdc.gov)
  • Because alternatives to the use of rifampin for antituberculosis treatment are now available, the previously recommended practice of stopping protease inhibitor therapy to allow the use of rifampin for TB treatment is no longer recommended for patients with HIV-related TB. (cdc.gov)
  • Physicians and patients also should be aware that paradoxical reactions might occur during the course of TB treatment when antiretroviral therapy restores immune function. (cdc.gov)
  • 1 2 3 Motivated by the amyloid cascade hypothesis, a primary aim of many new treatments for the prevention or management of Alzheimer's disease has been to reduce amyloid β levels in the brain. (bmj.com)
  • Clinical trials to test new cancer treatments involve a series of steps, called phases. (southeastclinicaloncology.org)
  • Clinical trials for stem cell and bone marrow transplant patients are an important tool for identifying new and more effective treatments for many diseases. (bmtinfonet.org)
  • 00:34:56): Patients also should understand the different treatments and obligations (like the number of clinic visits) in each arm of a trial. (bmtinfonet.org)
  • This is tremendous news for patients worldwide, especially for the elderly with co-morbidities, who are at high risk of developing severe COVID-19, despite the great progress made in vaccination and anti-viral treatments now available. (accesswire.com)
  • Significant unmet medical need exists in many prevalent autoimmune diseases where individual patient needs are not adequately being met with available treatments,' Dr. Thomas Bumol, senior vice president of biotechnology and immunology research at Lilly, commented in a statement. (drugdiscoverynews.com)
  • This off-label use includes treatments for disorders not formally reviewed by the FDA, dosages or delivery mechanisms not approved by the agency, or use of the agents in patient populations not tested in FDA approved clinical trials. (medscape.com)
  • This phase also compares the drug with existing treatments, a placebo, or both. (msdmanuals.com)
  • Each phase of a clinical trial gives different answers about the intervention being tested. (cancer.net)
  • In a phase 3 clinical trial, people in the study are usually randomly placed in either the intervention group or control group. (cancer.net)
  • For patients requiring a coronary artery bypass (CABG) surgery, exposure to the surgical intervention and cardiopulmonary bypass further exacerbate their residual inflammation. (frontiersin.org)
  • The aim of this paper is to describe the development of a complex intervention of peer support in type 2 diabetes for a randomised control trial in a primary care setting. (biomedcentral.com)
  • The Medical Research Council (MRC) framework for the development and evaluation of complex interventions for randomised control trials (RCT) was used as a theoretical guide to designing the intervention. (biomedcentral.com)
  • In Phase 1 the theoretical background and qualitative data from 4 focus groups were combined to define the main components of the intervention. (biomedcentral.com)
  • The preliminary intervention was conducted in Phase 2. (biomedcentral.com)
  • The four components of the intervention were identified from the Preclinical Phase and Phase 1. (biomedcentral.com)
  • Findings from this phase allowed further modeling of the intervention, to produce the definitive intervention. (biomedcentral.com)
  • The MRC framework was instrumental in the development of a robust intervention of peer support of type 2 diabetes in primary care. (biomedcentral.com)
  • It's exciting that this is the first demonstration that a simple, safe dietary intervention has an effect on the gut microbiome and metabolites in these patients," Reddy said. (sciencedaily.com)
  • In Phase 3 trials, patients are randomized to receive either the current standard of care or the new intervention being studied. (bmtinfonet.org)
  • 00:16:20): Phase three trials are randomized comparisons of an intervention group and a control group. (bmtinfonet.org)
  • 00:30:19): Highly successful trials may be terminated early so all patients can receive the newly successful intervention. (bmtinfonet.org)
  • RESULTS: Central monitoring utilized primary study data in a five-tiered approach, including (1) real-time data checks & topic-specific intervention reports, (2) missing forms reports, (3) quality assurance metrics, (4) critical data reports and (5) protocol deviation identification, aimed to detect and resolve quality challenges. (cdc.gov)
  • 00:02:40): So, just as an overview, I'm going to provide some information about what is an observational trial versus an interventional trial. (bmtinfonet.org)
  • We searched Medline, EMBASE and the Cochrane central register of controlled trials from 1980 to June 2016, and manually reviewed relevant conference proceedings from 2009 to the present. (nih.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)
  • Patients with blood cancers may be treated with allogeneic stem cell transplantation (allo-SCT), a procedure in which the patient's stem cells are replaced with donor stem cells. (scienceboard.net)
  • Researchers at Texas Children's Cancer Center are undertaking a ground breaking clinical trial to train patient's own immune system to kill nasopharyngeal cancer cells. (texaschildrens.org)
  • Today we'll go over the objective of phase II trials, the clinical trial endpoints for the trials, as well as different phase II trial designs, including single-arm phase II trials, randomized phase II trials, phase II/III or phase I/II trials, as well as enrichment designs. (hstalks.com)
  • Some research is very preliminary or "early", which means it will be a long time before the results affect patient care. (cancer.net)
  • See how clinical trials of a research drug or medical device are conducted and managed. (ncbionetwork.org)
  • 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)
  • This series of activities explores the processes, research trials, and other considerations for developing and delivering a new drug product to the market. (ncbionetwork.org)
  • Such EAPs run in parallel to late phase randomized controlled clinical trials and contribute research data to supplement clinical development programs of investigational products in ALS. (massgeneral.org)
  • Doctors and researchers conduct clinical research in segments called phases. (southeastclinicaloncology.org)
  • We will first translate our preliminary results - that were obtained in the research laboratory - into a clinical-grade immunotherapy CART product. (lls.org)
  • LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care. (lls.org)
  • Recent research has suggested that variants of two genes, CYP2C9 and VKORC1, may be important in selecting the dose of warfarin needed for individual patients. (nih.gov)
  • Dr. Marcie Riches, Associate professor of Medicine, Director of Clinical Research and Data Quality in BMT and the Clinical Medical Director for the BMT clinic at the University of North Carolina Hospitals. (bmtinfonet.org)
  • Lilly is committed to changing patient expectations in some of the world's most debilitating disease areas, and we're building a portfolio of potential advances in immunology through our own research and key collaborations such as with Hanmi. (drugdiscoverynews.com)
  • The Ebola vaccine regimen in development at the Janssen Pharmaceutical Companies of Johnson & Johnson, which was discovered in a collaborative research program with the National Institutes of Health, uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic. (who.int)
  • 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 2000 he was appointed full Professor of Neurology, 'Clinical Neurobiology,' at the University of Ulm and was given the opportunity to organize (together with Albert Ludolph, the chairperson of the Department of Neurology at the University of Ulm, who initiated the work) the first large (>500 participants), long-term (3-year randomized clinical trial, followed by a blinded extension) multicenter European phase III HD trial. (wikipedia.org)
  • This is to make sure the study's participants have specific things in common so the results are helpful for similar patients in the future. (cancer.net)
  • Data from 203 participants (75% of planned enrolment) also indicated that patients treated with a single dose of CD24Fc showed a 60% higher probability of improvement in clinical status (as defined by the protocol) compared to placebo. (biopharma-reporter.com)
  • Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. (clinicaltrials.gov)
  • Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. (clinicaltrials.gov)
  • During the first five days of therapy, the participants would have their dosages determined and adjusted by a clinical formula or a pharmacogenetic formula. (nih.gov)
  • The nine trials covered 7267 participants, 4744 of whom used varenicline. (who.int)
  • The one cytisine trial included in this review found that more participants taking cytisine stopped smoking compared with placebo at two-year follow up, with an RR of 1.61 (95% CI 1.24 to 2.08). (who.int)
  • Also, at the end of today's session, participants will be able to apply CDC Zika laboratory testing algorithms when determining which patients with relevant travel history, possible Zika virus exposure, or Zika symptoms, should receive testing. (cdc.gov)
  • The programme and list of participants are included as Annexes 1 and 2, respectively. (who.int)
  • METHODS: The MSWS-12 was translated in a process modified from guidelines for the cross-cultural adaption of PROMs, and a pre-test was applied in a small sample of 20 pwMS to evaluate comprehensibility and acceptance. (bvsalud.org)
  • Methods and analysis: This is the protocol for a pragmatic, cluster-randomised stepped wedge trial to test the effectiveness of PRIM-ER in 35 EDs across the USA. (nyu.edu)
  • The prevalence of somatic alterations in the MYD88 gene has been estimated at more than 90% in bone marrow specimens of patients with WM, a low-grade B-cell lymphoma characterized by an accumulation of lymphoplasmacytic cells that infiltrate the bone marrow and secrete a monoclonal IgM immunoglobulin. (cancertherapyadvisor.com)
  • Prevalence of diabetes amongst people over 40 years of age attending 41 general practices in the Republic of Ireland reported a prevalence of type 2 diabetes of 9.2% indicating similar prevalence figures to other European countries [ 6 ]. (biomedcentral.com)
  • 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)
  • however, the of which 600 000 individuals die from the effects of increasing prevalence of tobacco use among Egyptians second-hand smoke ( 2 ). (who.int)
  • Pregnancy outcome data were available from 79% of infected patients. (umn.edu)
  • The MHRA approval was based on two open-label Phase I/II/III clinical trial data evaluating Casgevy in patients with severe sickle cell disease (NCT03745287) and transfusion-dependent beta-thalassemia (NCT03655678). (pharmaceutical-technology.com)
  • The approval for the new indication is based on interim data from Part 1 of the Phase III RUBY clinical trial. (pharmaceutical-technology.com)
  • Most researchers feel this type of clinical trial produces the best study data. (cancer.net)
  • Two reviewers independently assessed search results for inclusion and undertook data extraction and quality appraisal. (nih.gov)
  • Previous pre-clinical data from the Reddy lab demonstrated that butyrate, a compound produced by healthy intestinal bacteria when they digest resistant potato starch, a form of starch that people cannot digest, was significantly decreased in the gut of mice experiencing GVHD. (sciencedaily.com)
  • Combining genetic data with clinical information to determine the initial dosage of the blood thinner warfarin, used to prevent blood clots in the circulatory system, was no more effective in achieving stable anticoagulation than using only clinical information, according to a National Institutes of Health-funded clinical trial. (nih.gov)
  • The preclinical and clinical data on PTC124 support our hope that this drug will be an important disease-modifying therapy for cystic fibrosis," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. (cff.org)
  • Biophytis announces today final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022. (accesswire.com)
  • MS specific clinical data, e.g., disease course, duration, disability and MS-specific QoL were collected from the clinical database. (bvsalud.org)
  • Ethics and dissemination: Institutional Review Board approval was obtained at New York University School of Medicine to evaluate the CMS data. (nyu.edu)
  • The STAC-EE reviewed clinical trial protocols and data for blood products and medicines. (who.int)
  • After informed consent was obtained, the tourists completed a questionnaire for epidemiologic and clinical data. (cdc.gov)
  • In our study, epidemiologic and clinical data for the 10 symptomatic patients were obtained in accordance with current knowledge of ATBF ( 2 ). (cdc.gov)
  • INTRODUCTION: With the growing use of online study management systems and rapid availability of data, timely data review and quality assessments are necessary to ensure proper clinical trial implementation. (cdc.gov)
  • In this report we describe central monitoring used to ensure protocol compliance and accurate data reporting, implemented during a large phase 3 clinical trial. (cdc.gov)
  • Data currently do not support outcome differences based on translocation exon combination when patients are prospectively evaluated. (medscape.com)
  • Note: This record shows only 22 elements of the WHO Trial Registration Data Set. (who.int)
  • 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)
  • 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)
  • The researchers at the Healey & AMG Center for ALS and Prilenia are hopeful that this study will continue to pave the way for patient-centric and scientifically relevant EAPs to be conducted across the US. (massgeneral.org)
  • Researchers can prevent bias in a clinical trial by keeping volunteers and/or themselves from knowing how the volunteers are grouped. (southeastclinicaloncology.org)
  • These findings led the researchers to investigate whether increasing intestinal butyrate-producing bacteria and intestinal butyrate levels in bone marrow transplant patients would reduce or prevent the progression of GVHD. (sciencedaily.com)
  • Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. (mayo.edu)
  • While patients, physicians not employed by pharmaceutical companies, insurers and government researchers are free to discuss whatever they want about off-label uses, the pharmaceutical company is prohibited from entering the discussion. (medscape.com)
  • Q-CABG is a phase II, prospectively registered, randomized, double-blind and placebo-controlled clinical trial. (frontiersin.org)
  • 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)
  • The study is the first part of a two-phase ongoing clinical trial evaluating the effect of modifying the microbiome on the incidence of graft-versus-host disease (GVHD), a major complication that develops in up to half the patients who receive a bone marrow transplant and can lead to injury and death. (sciencedaily.com)
  • This EAP will evaluate the benefits of the investigational drug pridopidine in individuals with ALS and will be led by Healey & AMG Center faculty, Drs. Suma Babu, James Berry, and Sabrina Paganoni. (massgeneral.org)
  • The EAP made possible by this award will allow ALS individuals who are otherwise not eligible for participation in clinical trials of pridopidine to access this investigational drug. (massgeneral.org)
  • The traditional paradigm of drug development moves from phase I, where a new drug is evaluated for the appropriate dose, scheduling of delivery, as well as toxicity, and at the end of the phase I trial, we arrive at the recommended phase II dose, which is sometimes also called the maximum tolerated dose. (hstalks.com)
  • During early development, potentially useful compounds are studied in animals to evaluate desired effects and toxicity. (msdmanuals.com)
  • 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)
  • 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)
  • Our laboratory and a number of other laboratories have made considerable progress on the two main fronts of bringing stem cell therapy to optic nerve restoration for glaucoma. (newswise.com)
  • It is important to highlight that more than 20% of cell and gene therapy focused-clinical trials are currently in phase II. (party.biz)
  • Ardelyx scores another FDA win after Xphyozah was approved last month as an add-on therapy for chronic kidney disease patients. (pharmaceutical-technology.com)
  • A National Institutes of Health Phase III trial of a long-acting antibody combination therapy developed by AstraZeneca for treating severe COVID-19 is now recruiting patients. (clinicalomics.com)
  • ACTIV is split into several sections depending on the type of therapy being tested and patient characteristics. (clinicalomics.com)
  • The other two began in December and are being tested concurrently with the AZD7442 combination therapy. (clinicalomics.com)
  • Recent clinical investigations support the view that CD24Fc may provide benefit beyond standard of care therapy for COVID-19 patients requiring oxygen support, and hence will represent an important addition to the Merck pipeline of investigational medicines and vaccines designed to address the COVID-19 pandemic. (biopharma-reporter.com)
  • Posoleucel, an allogeneic therapy comprising donor T cells, targets six of the most common viruses in patients following allo-SCT: adenovirus, BK virus, cytomegalovirus (CMV), Epstein-Barr virus, human herpes virus 6, and JC virus. (scienceboard.net)
  • The main way we obtain evidence for a given therapy is by a clinical trial. (drstegall.com)
  • It is unknown whether a conservative approach to fluid administration or deresuscitation (active removal of fluid using diuretics or renal replacement therapy) is beneficial following haemodynamic stabilisation of critically ill patients. (nih.gov)
  • Patients undergoing light therapy situate themselves near a light box fitted with fluorescent tubes and a diffusing screen to filter out ultraviolet light. (psychiatryadvisor.com)
  • One leading hypothesis is that light therapy corrects phased-delayed circadian rhythms by activating the suprachiasmatic nucleus, the body's master clock, through an ocular receptor mechanism. (psychiatryadvisor.com)
  • Methodologically valid clinical trials in light therapy have proven challenging because it is difficult to provide a placebo equivalent. (psychiatryadvisor.com)
  • Patients who are aware that light therapy is the modality being investigated may have higher expectations for bright light as opposed to the dim red light typically used as a control. (psychiatryadvisor.com)
  • According to evidence from a recent meta-analysis, light therapy appears to be safe and efficacious in older patients with nonseasonal depression. (psychiatryadvisor.com)
  • COAG enrolled 1,015 patients beginning warfarin therapy and randomly assigned them to one of two dosing strategies. (nih.gov)
  • We also found one open-label trial comparing varenicline with nicotine replacement therapy. (who.int)
  • 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)
  • 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)
  • All HIV-infected persons at risk for infection with M. tuberculosis must be carefully evaluated and, if indicated, administered therapy to prevent the progression of latent infection to active TB disease and avoid the complications associated with HIV-related TB. (cdc.gov)
  • Of the 10 patients in this study, only one developed GVHD, while typically about half of bone marrow transplant patients develop the condition. (sciencedaily.com)
  • Results Pooled results from the 14 randomized controlled trials were more precise than estimates from any single trial. (bmj.com)
  • Raludotatug deruxtecan is being evaluated in a first-in-human Phase 1 clinical trial and updated results in patients with advanced ovarian cancer were presented at the this year's European Society for Medical Oncology ( ESMO ) Congress. (insideprecisionmedicine.com)
  • The promising results from clinical trials of patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan continue to demonstrate the broad applicability of Daiichi Sankyo's DXd ADC technology across multiple targets, with each of these medicines having the potential to change clinical practice as has been already seen with ENHERTU," said Sunao Manabe, representative director, executive chairperson and CEO, Daiichi Sankyo Company, Limited. (insideprecisionmedicine.com)
  • The trial results were recently published in the Journal of Investigative Dermatology . (sciencedaily.com)
  • The results of the Clarification of Optimal Anticoagulation through Genetics (COAG) trial, supported by the NIH's National Heart, Lung, and Blood Institute, were presented today at the American Heart Association (AHA) Scientific Sessions in Dallas. (nih.gov)
  • Collectively, these results indicate that this new approach may ultimately be applicable to a subset of patients across a large number of genetic disorders. (cff.org)
  • An EAP has already been approved in 2022 in Brazil to treat COVID-19 patients at critical stage in Intensice Care Units (ICU) and the request to lift the hold given completion of the study and positive results is pending. (accesswire.com)
  • Results support the relevance of PROMs to capture patient perception of walking ability in addition to performance-based assessments such as maximum walking speed or maximum walking distance. (bvsalud.org)
  • Adoptive Transfer of EBV-Specific T Cells Results in Sustained Clinical Responses in Patients with Locoregional Nasopharyngeal Carcinoma. (texaschildrens.org)
  • Trial results will be submitted for publication in a peer-reviewed journal. (nyu.edu)
  • A case of symptomatic confirmed ATBF was defined as clinical illness and positive serologic results against R. africae , whereas a case of probable ATBF was defined as typical clinical symptoms without definite serologic evidence of R. africae infection. (cdc.gov)
  • This study's principal objective was to determine whether a specific category of eligibility criteria could be identified as a major barrier to patient enrollment. (nih.gov)
  • High doses of vitamin D taken one hour after sunburn significantly reduce skin redness, swelling, and inflammation, according to double-blinded, placebo-controlled clinical trial. (sciencedaily.com)
  • High doses of vitamin D taken one hour after sunburn significantly reduce skin redness, swelling, and inflammation, according to double-blinded, placebo-controlled clinical trial out of Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center. (sciencedaily.com)
  • Recruited patients awaiting CABG surgery at the Montreal Heart Institute (n = 100) will be randomly assigned in a 1:1 ratio to receive either quercetin supplementation (500 mg twice daily) or placebo, starting 2 days before surgery and until the seventh postoperative day. (frontiersin.org)
  • Primary objective: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an improvement in the Maintenance of Wakefulness Test (MWT) score. (mayo.edu)
  • Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the change in total Epworth Sleepiness Scale (ESS) score. (mayo.edu)
  • We found one relapse prevention trial, comparing varenicline with placebo. (who.int)
  • 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)
  • We identified one trial of cytisine (Tabex) for inclusion. (who.int)
  • Following proof of concept in human clinical trials, programs may be partnered for subsequent development, approval and marketing. (beursonline.nl)
  • Human clinical trials require several things. (drstegall.com)
  • Human clinical trials also have to go through an approval process by what is known as an institutional review board or IRB. (drstegall.com)
  • And finally, human clinical trials also require funding. (drstegall.com)
  • Our key focus is the understanding of systemic and local immunological effects in cancer patients. (nct-heidelberg.de)
  • The final analysis demonstrates that COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with positive Post-Hoc analysis released on November 3, 2022. (accesswire.com)
  • 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 Multiple Sclerosis Walking Scale 12 (MSWS-12) is a valid Patient Reported Outcome Measure (PROM) to evaluate walking ability in pwMS. (bvsalud.org)
  • The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. (nih.gov)
  • They also noted that there is a need for the development of standardized testing for CXCR4 mutations in the setting of WM, and encouraged the design and implementation of clinical trials of patients with CXCR4 -mutated disease across hematologic and solid cancers. (cancertherapyadvisor.com)
  • The company is also conducting clinical trials to evaluate two SARS-CoV-2/COVID-19 vaccine candidates: both of which are currently in Phase 1 trials. (biopharma-reporter.com)
  • A pivotal Phase 3 clinical trial (NCT04095858) for prophylaxis of GVHD has been initiated nationwide. (biopharma-reporter.com)
  • We have enrolled more patients in our ongoing phase 2 clinical trial to evaluate the value of potato starch in reducing the incidence of GVHD in transplant patients. (sciencedaily.com)
  • We could potentially be able to use a food substance in patients undergoing a bone marrow transplant, as a simple-to-administer, low-cost and relatively safe approach to prevent GVHD, which is a major limitation to the life-saving capability of a bone-marrow transplant," Riwes said. (sciencedaily.com)
  • Randomized phase III clinical trials evaluating posoleucel are currently underway. (scienceboard.net)
  • It must be safe, or at least tolerable, although there is no way to know this for sure until the trial is underway, or in some cases, until the trial is completed. (drstegall.com)
  • The first trial reports of varenicline were released in 2006, and further trials have now been published or are currently are underway. (who.int)
  • Here, we summarize and discuss the risks and benefits of off-label promotion and how this relates to quality patient care in dermatology. (medscape.com)
  • The phase II trial objective, which is the topic of today, is a signal of drug activity, worthy of moving forward to phase III. (hstalks.com)
  • The number of drugs that are successful through each phase of drug development decreases. (hstalks.com)
  • Substudy to characterize to characterize linezolid pharmacokinetic (PK) and linezolid time over the minimum inhibitory concentration (MIC) in patients with multi-drug resistant (MDR) and extensively-drug resistant (XDR) tuberculosis (TB). (cdc.gov)
  • Also known as exa-cel, Casgevy is currently being evaluated by the US Food and Drug Administration (FDA). (pharmaceutical-technology.com)
  • 2) New Drug Application (NDA) regulatory plan for ANX-530 (vinorelbine emulsion). (lungevity.org)
  • The FDA granted accelerated approval for the drug on the basis of tumor response rate and duration of response from the POD1UM-201 trial. (medscape.com)
  • Phase one is when the drug is tested to determine the optimal safe dose. (drstegall.com)
  • RADIANT will evaluate two topical formulations of CD101, which is Cidara's lead antifungal drug candidate. (biospace.com)
  • In other recent news from Hanmi, the company announced on Tuesday that it had received approval for a Phase 2 clinical trial of HM61713, a targeted anti-cancer drug that selectively suppresses EGFR mutation. (drugdiscoverynews.com)
  • Recent policy changes on the regulatory abilities of the US FDA and legal precedents regarding this topic have led to intense debate on free speech about off-label drug use by physicians and drug manufacturers. (medscape.com)
  • Branding a drug's particular use as "off-label" not only limits the dissemination of information about the drug, but also decreases patient access to the agent. (medscape.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 two trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. (who.int)
  • SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group's specialised register for trials, using the terms ('varenicline' or 'cytisine' or 'Tabex' or 'nicotine receptor partial agonist') and 'smoking' in the title or abstract, or as keywords. (who.int)
  • The NRCP programme considers 2-3 topics per year, which may be referred by NHS England when other standard NIHR routes for commissioning are not suitable. (nihr.ac.uk)
  • Recently, we heard from a glaucoma patient who enrolled in a "patient-funded trial" in which the person paid $20,000 and received "stem cell injections" around one eye. (newswise.com)
  • Q: Dr. Goldberg, how might stem cells be helpful for patients with glaucoma? (newswise.com)
  • A: Stem cells may be helpful for patients with glaucoma in different ways. (newswise.com)
  • There, stem cells may have two positive effects. (newswise.com)
  • Later in the disease when patients have lost considerable numbers of retinal ganglion cells and optic nerve axons, and have thereby lost considerable vision, stem cells may be useful to replace lost ganglion cells and restore the connections from the eye to the brain. (newswise.com)
  • Casgevy has been approved to treat patients with sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia aged 12 years or older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available. (pharmaceutical-technology.com)
  • Several academic and industry efforts are well under owned subsidiary Cyto Therapeutics, it had received way to produce dopaminergic neurons from stem approval by the Australian government to conduct a cells under conditions compliant with use in patients. (lu.se)
  • Clinical trial recruitment can be impeded by eligibility criteria being too numerous or too restrictive. (nih.gov)
  • Proportions of cases with 'not met' eligibility criteria were assessed for each category in each trial. (nih.gov)
  • All other subcategories of eligibility criteria assessed were 'not met' by less than 15% of patients. (nih.gov)
  • Many eligibility criteria were considered 'nonevaluable' because the information evaluated would have required additional procedures not performed as part of the general practice. (nih.gov)
  • The subjects from the study population are not precluded from entry in a trial because of stringent eligibility criteria. (nih.gov)
  • DESCRIPTION (provided by applicant): Bacterial contamination of dental water lines is a major concern in modern dentistry and may cause infection in dental patients with compromised immune systems. (sbir.gov)
  • The meeting aimed to review the scientific and ethical aspects of the proposed vaccine trial in Sierra Leone to evaluate the immune response, identify any side effects and determine its effectiveness. (who.int)
  • More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality," principal author Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, said in a news release . (medscape.com)
  • My name is Patricia Tang, I'm a medical oncologist at the Tom Baker Cancer Centre in Calgary, Alberta, Canada, and I'm a clinical associate professor in the medical school. (hstalks.com)