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Flex Pharma Begins Phase Trial PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Flex Pharma Begins Phase Trial articles that have been published worldwide.
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A flexible 19-gauge (Flex 19G) needle has been developed for endobronchial ultrasonography.
The traditional Flex Robotic System, utilized for head and neck surgery, is not a sealed system, and cannot maintain insufflation [1-3]. The Flex Colorectal Drive Robotic System has been adapted to maintain insufflation for transanal visualization and access to the mid and upper rectum using articulating instruments with tactile feedback. This is the first video of the new transanal Flex Robotic System in a human. The robot takes a non-linear path to the target lesion, throughout which it is able to deploy ...
The increasing complexity of modern neurointerventions has necessitated a shift in intracranial access techniques towards more robust distal support platforms. Here we present our experience with the Syphontrak Support Catheter (Codman Neuro, Raynham, MA, USA) in the triaxial platform for the implantation of the second-generation Pipeline Flex embolization device (PED Flex; Medtronic Neurovascular, Irvine, CA, USA).
When Phase III treatment effect is diluted from what was observed from Phase II results, we propose to determine the Bayesian sample size for a Phase III clinical trial based on the normal, uniform, and truncated normal prior distributions of the treatment effects on an interval, which starts from an acceptable treatment effect to the observed treatment effect from Phase II. After incorporating the prior information of the treatment effects, the Bayesian sample size is the number of patients of the Phase II...
In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescarta of KITE Pharma, the first CAR T cell therapy products have been approved. Promising clinical outcomes have yet been tempered by the fact that many therapies may be prohibitively expensive to manufacture. The process is not yet defined, far from being standardised and often requires extensive manual handling ...
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...
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.
To describe a novel use of the flexible nitinol loop membrane scraper (FINESSE Flex loop; Alcon, Fort Worth, TX) for rescue and refixation of a dislocated intraocular lens (IOL).
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...
There is perhaps no more important time in the history of placebos to consider their role in clinical trials and in medicine. Increasingly well-designed pharmaceutical and academic clinical trials testing promising and established drug and surgical interventions have failed to "beat" the placebo response. The collateral damage resulting from these failures is staggering; novel treatments, many with compelling mechanisms of action and promising Phase 2 trial results, never reach the patient, adversely affect...
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 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).
We study the phase diagram of symmetric electron-hole bilayer at zero temperature and zero magnetic field within quantum Monte Carlo approach. Particularly, we conduct variational Monte Carlo simulation for various phases viz. paramagnetic fluid phase, ferromagnetic fluid phase, anti-ferromagnetic Wigner crystal phase, ferromagnetic Wigner crystal phase and excitonic phase to estimate the ground-state energy at different values of inlayer density and inter-layer spacing. The Slater-Jastrow style trial ...
The German rectal cancer trial CAO/ARO/AIO-04 has shown a significant benefit in 3-year disease-free survival (DFS) of adding oxaliplatin to a standard preoperative 5-fluorouracil-based chemoradiotherapy (CRT) and adjuvant chemotherapy in patients with locally advanced rectal cancer. The use of oxaliplatin as adjuvant treatment in elderly patients with colon cancer is controversial . We therefore investigated the impact of age on clinical outcome in the CAO/ARO/AIO-04 phase 3 trial.
Polyethylene glycol (PEG) bowel preparations are widely used for precolonoscopy bowel cleansing. This phase 3 trial assessed the efficacy, safety, and tolerability of the novel 1 L PEG-based NER1006 vs. sodium picosulfate plus magnesium citrate (SP + MC) in day-before dosing.
Preclinical randomized controlled trial of bilateral discectomy versus bilateral discopexy in Black Merino sheep temporomandibular joint: TEMPOJIMS - Phase 1- histologic, imaging and body weight results.
The role of temporomandibular joint (TMJ) surgery is not well defined due to a lack of quality randomized controlled clinical trials, comparing different TMJ surgical treatments with medical and placebo interventions. The temporomandibular joint interposal study (TEMPOJIMS) is a rigorous preclinical trial divided in 2 phases. In phase 1 the authors investigated the role of the TMJ disc and in phase 2 the authors evaluated 3 different interposal materials. The present work of TEMPOJIMS - phase 1, aims to eva...
Cryptococcal meningitis (CM) causes 10-20% of HIV-related deaths in Africa. We performed a phase-II non-inferiority trial examining the Early Fungicidal Activity (EFA) of three short-course, high-dose liposomal amphotericin B (L-AmB) regimens for CM in Tanzania and Botswana.
Fosaprepitant improved prevention of chemotherapy-induced nausea and vomiting (CINV) in a randomized, double-blind phase III trial (PN031). This post hoc analysis explored factors that may have influenced response.
Early development of the Adriatic sturgeon Acipenser naccarii from its free embryo after hatching (stage 36), until late embryo stage, when the transition to exogenous feeding starts (stage 45) is described. Special emphasis is given to morphological development and description of the different structures that are formed at each life stage. After hatching, free embryos still present embryonic characteristics, little pigmentation and an ovoid yolk sac. The mouth begins to open on the 2nd day post hatch (dph)...
This phase III clinical trial compared the immunogenicity and safety of a purified chick-embryo cell rabies vaccine (PCECV) administered according to a shortened post-exposure prophylaxis (PEP) 4-site/1-week intradermal regimen, compared with the currently recommended 2-site/Thai Red Cross (TRC).