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Rebiotix Starts Enrolment Phase Trial RBX2660 Diff Infection PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Rebiotix Starts Enrolment Phase Trial RBX2660 Diff Infection articles that have been published worldwide.
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Cow milk products enriched with Clostridium difficile (C. diff.) specific IgA are possible alternative therapeutics against C. diff. associated diarrhea. A persistently high level of C. diff. specific IgA in mature milk triggered by continuous immunizations of dairy cows against C. diff. was hypothesized. Nine Brown Swiss cows were repeatedly vaccinated against C. diff. and divided into low responder (LR) and high responder (HR) cows, as measured by their production of anti-C. diff. specific IgA in milk (th...
Despite advancements, recurrent Clostridium difficile infections (CDI) remain an urgent public health threat with insufficient response rates to currently-approved antibiotic therapies. Microbiota-based treatments appear effective, but rigorous clinical trials are required to optimize dosing strategies and substantiate long-term safety.
The efficacy of therapeutic vaccines against HIV-1 infection has been modest. New inerts to redirect responses to vulnerable sites are urgently needed to improve these results.
The IPERGAY ANRS trial showed that on-demand pre-exposure prophylaxis (PrEP) with tenofovir (TDF) and emtricitabine (FTC) was highly effective in preventing HIV infection among highly exposed men who have sex with men. Here we analyzed drug resistance-associated mutations (RAMs) among all participants who acquired HIV infection during this trial.
New options for first-line treatment of HIV-2 infection are needed. We evaluated an integrase inhibitor (raltegravir)-containing regimen.
Anlotinib is a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling. A phase 2 trial showed anlotinib to improve progression-free survival with a potential benefit of overall survival, leading to the phase 3 trial to confirm the drug's efficacy in advanced non-small cell lung cancer (NSCLC).
One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error rates, which is limited by assessing the strength of efficacy evidence in a small isolated trial. In this article, we propose a quantitative Bayesian/frequentist decision framework for Go/No-Go criteria and sample size evaluation in Phase II randomized studies with a time-to-even...
Although acquisition techniques have improved tremendously, the neuroscientific understanding of complex cognitive phenomena is still incomplete. One of the reasons for this shortcoming may be the lack of sophisticated signal processing methods. Complex cognitive phenomena usually involve various mental subprocesses whose temporal occurrence varies from trial to trial. Mostly, these mental subprocesses require large-scale integration processes between multiple brain areas that are most likely mediated by co...
This study targeted the assessment of a potential African swine fever virus (ASFV) carrier state of 30 pigs in total which were allowed to recover from infection with ASFV "Netherlands'86" prior exposure to six healthy sentinel pigs for more than 2 months. Throughout the whole trial, blood and swab samples were subjected to routine virological and serological investigations. At the end of the trial, necropsy of all animals was performed and viral persistence and distribution were assessed. Upon infection, ...
In 2003, Ontario introduced a patient enrolment system as part of health care reforms, aimed at enhancing primary health care services, but it is unclear whether immigrants have benefited from this health care reform. Therefore, we studied whether this reform changed the extent of immigrants' enrolment in primary care services in Ontario between 2003 and 2012.
A randomised phase II trial of capecitabine plus cisplatin versus S-1 plus cisplatin as a first-line treatment for advanced gastric cancer: Capecitabine plus cisplatin ascertainment versus S-1 plus cisplatin randomised PII trial (XParTS II).
Capecitabine plus cisplatin (XP) is a standard global regimen, while S-1 plus cisplatin (SP) is a Japanese standard for first-line treatment of advanced gastric cancer (AGC). We conducted a phase II trial comparing XP with SP for patients with AGC to confirm whether these regimens can be used as controls in a phase III study and to explore whether histological subtypes favour XP or SP.
We have previously conducted the Sirolimus and Autophagy Inhibition in LAM (SAIL) trial, a phase I dose escalation study of the combination of sirolimus and hydroxychloroquine in patients with lymphangioeliomyomatosis (LAM). The goal of the present study was to analyze sera from the SAIL trial to identify novel biomarkers that could shed light into disease pathogenesis and response to therapy.
The aims of these phase I trials were to evaluate the pharmacokinetic interaction between elbasvir (EBR) or grazoprevir (GZR) and buprenorphine/naloxone (BUP/NAL). Trial 1 was a single-dose trial in healthy participants. Trial 2 was a multiple-dose trial in participants on BUP/NAL maintenance therapy. Coadministration of EBR or GZR with BUP/NAL had minimal effect on the pharmacokinetics of BUP/NAL, EBR, and GZR. The geometric mean ratios (GMRs (90% CI)) for BUP, norbuprenorphine, and NAL AUC were 0.98 (0.89...
Adenovirus (Ad) DNA undergoes dynamic changes in protein association as the virus progresses through its replicative cycle. Within the virion, the Ad DNA associates primarily with the virus-encoded, protamine-like protein VII. During the early phase of infection (~6 h), the viral DNA showed declining association with VII, suggesting that VII was removed from at least some regions of the viral DNA. Within 6 h, the viral DNA was wrapped into a repeating nucleosome-like array containing the histone variant H3....
Out of several phases of HBV infection, the least understood phase is occult hepatitis virus infection. The paucity of data due to non-availability of biological tissues and the prerequisite of ultra-sensitive assays for the detection of occult hepatitis virus infection prompted us to utilize mathematical modeling in determining mechanisms that lead to occult hepatitis virus infection and characteristics of HBV infection during occult hepatitis virus infection.
Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial.
This phase III, double-blind, randomised, placebo-controlled trial (and extension phase) was designed to assess the efficacy and safety of velmanase alfa (VA) in alpha-mannosidosis (AM) patients.
To report the final results of a phase 2 high-dose gene therapy clinical trial in choroideremia.
Our previous trial with a docetaxel, cisplatin, and 5-fluorouracil (DCF) regimen showed high response rates in metastatic squamous cell carcinoma of the esophagus (SCCE). The observed increased toxicity of the DCF regimen, however, was clinically harmful. S-1, an oral anticancer drug, has been approved as a combination therapy for SCCE, and alternate-day regimen with S-1 has shown lower levels of toxicity. This prospective single-center phase I/II trial examines the efficacy and toxicity of a combination of...
The present study examined corticospinal excitability of the contralateral and ipsilateral hemispheres during actual (ACT) and imaginary (IMG) unilateral hand force-matching tasks of different difficulty.Seventeen young male adults (21.2 ± 2.2 yrs) actually and imaginarily matched their left index finger abduction force to a displayed target force. Task difficulty was manipulated by varying the acceptable force range about each mean target force (5 and 15% MVC for ACT, 15% MVC for IMG). Specifically, easy ...
It is unclear whether γδ T cells are involved in humoral immunity against Plasmodium infection. Here, we show that B cell-immunodeficient mice and γδ T cell-deficient mice were incapable of protecting against Plasmodium berghei XAT parasites. γδ T cell-deficient mice developed reduced levels of antigen-specific antibodies during the late phase of infection. The numbers of follicular helper T cells and germinal centre B cells in γδ T cell-deficient mice were lower than in wild-type mice during the la...
Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the re...
Oral dydrogesterone has been used for luteal phase support on an empirical basis since the early days of in vitro fertilization (IVF) treatment. Systematic comparisons of oral dydrogesterone with vaginal progesterone, so far considered to be the standard of care, started to appear in the middle 2000s. Recently, a large, randomized, double-blind, double-dummy phase III trial on the use of daily 30 mg oral dydrogesterone versus daily 600 mg micronized vaginal progesterone for LPS in IVF was published. This...
The adsorption of O on Ag(111) between 300 and 500 K has been studied with temperature-programmed desorption (TPD) and scanning tunneling microscopy (STM). At the first stage of adsorption, the disordered local oxide phase (commonly looking in STM as an array of black spots) is formed on the surface irrespective of the substrate temperature. The maximum concentration of black spots was found to be ≈0.11 ML, which corresponds to an oxygen coverage of ≈0.66 ML. Taking into account that the nucleation of t...
Nervous necrosis virus (NNV) is a ubiquitous pathogen in the aquaculture worldwide. Little is known about the relationship between NNV virus and host cells. Our studies showed that RGNNV infection could induce cell cycle arrest via activation of p53 signaling in cultured host cells. Infection of RGNNV redistributed NPM1, stabilized p53 and inhibited cell proliferation by inducing G1 arrest. RGNNV infection also led to phosphorylation and accumulation of p53 in a time-dependent manner. Furthermore, RGNNV inf...
The primary objective of this single-institution Phase I clinical trial was to establish the maximum tolerated dose (MTD) of gemcitabine added to cisplatin delivered as heated intraoperative chemotherapy (HIOC) following resection of malignant pleural mesothelioma (MPM).