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Athenex Announces Phase Clinical Study Results Ointment Treatment PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Athenex Announces Phase Clinical Study Results Ointment Treatment articles that have been published worldwide.
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The purpose of the present two phase 1 studies was to assess the safety, tolerability and pharmacokinetics for topical application of a novel Janus kinase (JAK) inhibitor, JTE-052, in Japanese healthy adult male volunteers and Japanese adult patients with atopic dermatitis (AD). Additionally, exploratory investigation was performed on the efficacy for disease severity and pruritus score in AD patients. In the QBX1-1 study, the cutaneous safety of JTE-052 ointment by a patch test and a photo patch test was a...
There is a high incidence of household knife-related injuries requiring emergency department treatment in the U.S. The Pitch Ointment, a named formula developed by a compounding pharmacist, was used separately by two patients who suffered a knife injury in a finger and a foot. This formula combines Pinene (L-Alpha) 0.5% and Canada Balsam 5% in PracaSil-Plus, special ingredients with applications in scar and wound healing. The patients' level of satisfaction with the Pitch Ointment was very high since all 4 ...
To evaluate the usefulness of Arnica compositum (AC) + Acidum nitricum (AN) + Hekla lava (HL) ointment in Emergency Medicine Department (EMD) as alternative non-pharmacological local treatment of patients with symptomatic calcific periarthritis of the shoulder (CPS) and to compare the effectiveness of this mixture against AC ointment alone.
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...
Mastectomy flap necrosis (MFN) remains a challenging complication in immediate tissue expander breast reconstruction (ITEBR). Nitroglycerin ointment has been shown to reduce the incidence of MFN in a randomized controlled study, using 45g per breast and treating one side only in bilateral cases. This study was conducted to determine the efficacy of 15g of nitroglycerin ointment per breast - therefore permitting application to both breasts in cases of bilateral mastectomy.
Age imposes a disparity in the treatment of and outcomes with gynecologic cancer. Older patients are underrepresented in primary treatment trials, but little is known about their ability to withstand trial-based treatment for recurrent or refractory disease. This study sought to examine treatment-related toxicities and outcomes of older versus younger patients participating in phase 1 clinical trials.
Tivantinib (ARQ 197), a selective, oral MET inhibitor, improved overall survival and progression-free survival compared with placebo in a randomised phase 2 study in patients with high MET expression (MET-high) hepatocellular carcinoma previously treated with sorafenib. The aim of this phase 3 study was to confirm the results of the phase 2 trial.
Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.
The viral load (VL) in patients receiving antiretroviral therapy (ART) is the best predictor of treatment outcome. The anticipated benefits of VL monitoring depend on the actual uptake of VL test results for clinical decisions. The objective of this study was to assess the uptake and utilization of VL test results for clinical decisions on HIV treatment in Cameroon, from 2013 to 2017.
In November 2016, the results of a phase III clinical trial with the protein cell death (PD)-1 inhibitor pembrolizumab for second-line treatment of metastatic urothelial carcinoma were published and showed an overall survival benefit in comparison with conventional chemotherapy with vinflunine, docetaxel, or paclitaxel. In a similar trial the PD-L1 antibody atezolizumab showed no significant benefit in comparison to chemotherapy in the subgroup of PD-L1-positive patients and, thus, missed its primary end...
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...
Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials.
Fentanyl sublingual spray may be a viable alternative to intravenous (IV) opioids for the treatment of acute pain. As patients with acute pain may include those who have limited prior exposure to opioids, this phase 1, open-label, randomized, multiple ascending-dose study was conducted to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple doses of fentanyl sublingual spray in opioid-naïve participants. This article primarily reports the pharmacokinetics results.
Introduction - The prevalence of sexual dysfunctions has increased over the last decades; despite a number of available treatments for erectile dysfunction (ED), premature ejaculation (PE) and Peyronie's disease (PD), still several unmet therapeutic needs deserve to be fulfilled. The aim of this review is to detail on phase I and II clinical trials investigating novel medical treatments for ED, PE and PD. Areas covered - We conducted a systematic review of the literature including both published and on-goin...
The objective of this 6-week clinical study was to demonstrate the effectiveness of a natural ingredient-based moisturizing cream versus a colloidal oatmeal moisturizing cream in improving the hydration, barrier function, appearance, and feel of dry leg skin. Thirty-two subjects completed the study. After a 5-day washout, subjects used the natural ingredient-based moisturizing cream and oatmeal-containing cream on randomly-assigned legs twice a day for a period of three weeks. For the following two weeks su...
Time-to-event end points are the most frequent primary end points in phase III oncology trials, both in the adjuvant and advanced settings. The evaluation of these end points is important to inform clinical practice. However, although different measures can be used to describe the effect of treatment on these end points, we believe that any treatment benefit in a given trial is best reported using various absolute and relative measures. Our goal is to help clinicians understand the strengths and limitations...
In this study, we aimed to investigate the incidence, risk factors, and clinical outcomes of perianal infections during the pre-engraftment phase after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Consecutive patients who underwent non-T-cell-depleted allo-HSCT at the Peking University Institute of Hematology from January 1 to December 31, 2016 were enrolled (n = 646). Ninety-nine patients were found to have perianal infections during the pre-engraftment phase, and 80 were found to have n...
Patients with in-transit melanoma metastases frequently experience high rates of recurrence, limited overall survival and reduced quality of life. After promising results within a Phase II, multi-center study, PV-10 treatment was continued at our institution for patients with in-transit disease.
The aim of this study was to investigate the use of three treatment effect measures in the analysis of randomized trials using a time-to-event endpoint and assess their influence on the results.
Lenalidomide (LEN) is an immunomodulatory drug with significant clinical activity against relapsed and refractory multiple myeloma (r/r MM). Based on the pivotal phase 3 trials MM-009 and MM-010, LEN in combination with dexamethasone (DEX) is approved for treatment of patients with MM who have received at least one prior therapy. LEN monotherapy is also approved in first line treatment. Here, we evaluated LEN/DEX combination therapy in a non-interventional study in patients with r/r MM in routine clinical p...
Cerebral aneurysms are a major risk factor for intracranial bleeding with devastating consequences for the patient. One recently established treatment is the implantation of flow-diverters (FD). Methods to predict their treatment success before or directly after implantation are not well investigated yet. The aim of this work was to quantitatively study hemodynamic parameters in patient-specific models of treated cerebral aneurysms and its correlation with the clinical outcome. Hemodynamics were evaluated u...
Background No systemic therapies have been approved for the treatment of advanced cutaneous squamous-cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose-escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous-cell carcinoma. Methods We report the results of the phase 1 study of cem...
Background: In a phase III study, sunitinib led to a significant increase in progression- free survival (PFS) vs. placebo in patients with pancreatic neuroendocrine tumours (panNETs). This study was a post-marketing commitment to support the phase III data. Methods: In this ongoing, open-label, phase IV trial (NCT01525550), patients with progressive, advanced unresectable/metastatic, well-differentiated panNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase ...
The purpose of this study was to analyze the results of patients with ruptured aneurysms who were treated with a specific microstent in the acute phase of subarachnoid hemorrhage.
In this phase II study, we investigate clinical outcomes and tolerability of hypofractionated radiotherapy (HRT) combined with temozolomide (TMZ) to treat elderly patients with glioblastoma (GBM).