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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...
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.
Itolizumab is a humanized anti-CD6 monoclonal antibody (mAb) that has previously shown encouraging results, in terms of safety and positive clinical effects, in a 6-week monotherapy clinical trial conducted in RA patients. The current phase I study evaluated the safety and clinical response for a longer treatment of 12 itolizumab intravenous doses in subjects with active RA despite previous DMARD therapy. Twenty one subjects were enrolled in four dose groups (0.1, 0.2, 0.4 and 0.8 mg/kg). Efficacy endpoints...
Alcohol dependence remains a major health problem from both a public health and clinical perspective. Harm reduction strategies have been increasingly recognized as suitable treatment goals. Nalmefene has been recently approved for this precise therapeutic indication after completion of phase III trials. However, more data from routine practice settings are needed in order to obtain evidence with high external validity. The aim of this study was to conduct a single-arm, phase IV study with alcohol-dependent...
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...
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.
Since 2010, gemcitabine and cisplatin have been considered standard first-line treatment in patients with advanced biliary tract cancer. Many centers have replaced cisplatin with oxaliplatin, which seems to obtain similar results. While first-line treatment has been well established, there are no phase III trials supporting second-line treatment, and the phase II trials with chemotherapy do not show any clear benefit. In this study, we investigated the effect of adding bevacizumab to chemotherapy in second-...
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.
Keloids are fibrous growths that occur as a result of abnormal response to dermal injury. Keloids are cosmetically disfiguring and may impair function, often resulting in decreased patient quality-of-life. Treatment of keloids remains challenging, and rate of recurrence is high. We present a case of a 39-year-old African-American man (Fitzpatrick VI) with a 10-year history of keloid, who was successfully treated with eight sessions of fractionated carbon dioxide (CO2) laser immediately followed by laser-ass...
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...
A stability indicating high performance liquid chromatography method has been developed for the determination of triamcinolone acetonide (TCA) and its main degradation products in ointment formulations. The method, based on extensive stress testing using metal salts, azobisisobutyronitrile, acid, base and peroxide, showed that TCA undergoes oxidative degradation. All degradation products were identified using HPLC mass spectrometry. Separation and quantification was achieved using an Altima C18 RP18 HP colu...
The objective of this study is to assess the rates of infection-free achievement of hidradenitis suppurativa clinical response (HiSCR) using integrated data from 2 phase 3, placebo-controlled trials, PIONEER I and II.
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.
Human epidermal growth factor receptor 2 (HER2) is a tumor associated antigen over-expressed in 20-30% of cases of breast cancer. Passive immune therapy with HER2-directed monoclonal antibodies (mabs) has changed the natural history of this subset of breast tumors both in the localized and metastatic settings. The safety and efficacy of HER2 vaccines have been assessed in early phase clinical trials but to date clinically relevant results in late phase trials remain an elusive target. Here, we review the re...
The efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain were evaluated in a randomized, double-blind, placebo-controlled study. These data were also pooled with those from two similar phase 3 studies to explore the effects of methadone on treatment response.
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.
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...
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...
Efficacy and Safety of the α7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers.
To evaluate the efficacy and safety of the α₇-nicotinic receptor agonist ABT-126 for treatment of cognitive impairment in stable subjects with schizophrenia who smoke.
Combination pertuzumab, trastuzumab, and docetaxel (D) is considered standard first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This post hoc, exploratory analysis of CLEOPATRA study data evaluated the clinical effects of D treatment duration within this regimen. The clinical benefits of pertuzumab and trastuzumab by different durations of D treatment were also evaluated.
In this phase 2 study, we evaluated the efficacy and safety of oral gepotidacin, a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor, for the treatment of uncomplicated urogenital gonorrhea.
OBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers ra...