A Randomized, Double-blind, Placebo-controlled, 53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Severe Tibio- Femoral Osteoarthritis of the Knee

53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the Knee

开始日期2025-05-09

申办/合作机构

OrthoTrophix, Inc.

NCT03125499

/ CompletedN/A

A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees

To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.

开始日期2017-07-27

申办/合作机构

OrthoTrophix, Inc.

NCT02837900

/ Completed临床2期

A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Safety and Efficacy of a Second Course of Intra-articular Injections of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 administered by intra-articular injection to subjects with osteoarthritis of the knee who participated in study TPX-100-1.

开始日期2016-08-01

申办/合作机构

OrthoTrophix, Inc.

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114

项与 Dentonin 相关的文献（医药）

2025-12-01·JOURNAL OF ENVIRONMENTAL MANAGEMENT

Effect of catchment characteristics and water physicochemical parameters on nitrogen and phosphorus concentrations in streams and small reservoirs

Article

作者: Chen, Long ; Jiang, Qinghu ; Tang, Bichao ; Tian, Qiuxiang ; Lu, Mengzhen ; Zhao, Xiaoxiang ; Ren, Boshen ; Liu, Feng

Water quality plays a vital role in determining the sustainability, safety, and usability of a water source. Nutrient concentrations are among the primary indicators that determine and affect water quality. Understanding the factors that influence nutrient dynamics in watershed water bodies is crucial for effective nutrient management in watersheds, but the mechanisms underlying nutrient variation in streams versus small reservoirs remain incompletely resolved for this national strategic water source area for the the Middle-Route of the South-to-North Water Diversion Project of China (hereafter "the Middle Route"). This study conducted eight seasonal sampling campaigns across 65 streams and 23 small reservoirs within the Danjiangkou Reservoir watershed, the water source area of the Middle Route. By integrating catchment characteristics and water physicochemical parameters and applying model-averaging multiple linear regression (ΔAIC <2), we investigated the key catchment-scale and in-situ drivers of dissolved total nitrogen (DTN) and total phosphorus (TP) concentrations in these waterbodies. Results revealed that DTN and TP concentrations were significantly higher in spring and summer than in autumn and winter, likely driven by the combined influence of agricultural practices and hydrological processes. Multiple regression models showed that DTN was primarily influenced by soil total nitrogen (STN, -), water pH (-), and edge density (ED, -) (adjusted R² = 0.28), with water physicochemical parameters explaining the largest portion of variance in streams (60.4 %). In reservoirs, DTN was mainly regulated by dissolved oxygen (DO, -) and STN (-) (adjusted R² = 0.27). For TP in streams, turbidity (+), slope (+), and contagion index (CONTAG, -) were the dominant drivers (adjusted R² = 0.30), whereas in reservoirs, TP concentrations were mainly associated with turbidity (+) and soil total P (STP, -) (adjusted R² = 0.37). These findings highlight distinct nutrient regulation mechanisms in lotic and lentic systems, highlighting the need for seasonally adaptive management strategies. For streams, prioritize riparian buffer restoration and higher landscape aggregation (higher CONTAG, β = -0.39, p < 0.01) to intercept nutrients, and reduce fertilizer inputs during high-flow seasons. For small reservoirs, emphasize erosion control, turbidity reduction (β = 0.34, p < 0.001), and oxygen management (β = -0.49, p < 0.001), while minimizing fertilizer inputs to limit in-reservoir accumulation.

2025-11-01·WATER RESEARCH

Hydrodynamic cavitation based advanced reduction process (ARP) for degradation of 2-nitrophenol in aqueous environment

Article

作者: Honarmandrad, Zhila ; Boczkaj, Grzegorz ; Fedorov, Kirill

Hydrodynamic cavitation (HC) along with acoustic cavitation are emerging techniques in wastewater treatment for degradation of toxic, refractory and non-biodegradable pollutants. The energy released during cavitation phenomenon has a number of applications in advanced oxidation processes (AOPs). In contrast this paper presents an effective activation of dithionite (DTN) under HC as advanced reduction process (ARP). The developed process of HC/DTN was tested for the first attempt to perform the reductive degradation of 2-nitrophenol (2-NP) in water. The complete degradation of 2-NP was achieved within 15 min at optimal conditions of C_v 0.27 with r_red 8.33, pH 11, 20 ± 2.5 °C ensuring a synergistic index (ξ) of 9.47. These results demonstrated HC as an effective tool for DTN activation. The degradation of 2-NP was primarily contributed by sulfur dioxide anion radicals (SO₂^•-) and hydrated electrons (e_aq^-), while oxidizing radicals (i.e., HO^• and SO₄^•-) played minor role. The degradation pathway of 2-NP in HC/DTN was proposed relying on the identified intermediates using gas chromatography coupled to mass spectrometry (GC-MS). The main intermediates of 2-NP degradation were aniline and hydroquinone confirming the combined ARP/AOP action of HC/DTN. The total treatment cost of 1 m³ of contaminated water by the developed HC/DTN process was estimated as 1.08 euros according to the economic feasibility analysis. Along with rapid degradation, simple instrumentation and ultra-low costs, HC/DTN offers a promising solution for industrial water treatment.

2025-10-01·International Journal of Surgery Case Reports

Distal tibial nail for complex nonunion of open distal tibial fracture with diabetes and prior pin-site infection: A case report

Article

作者: Yang, Hai ; Wang, Wei ; Wu, Wei ; Wang, Junqiu ; Zhang, Lei ; Yin, Lu

INTRODUCTION:

This study reports the successful application of distal tibial nail (DTN) for managing complex nonunions in open distal tibial fractures in patients with diabetes and a history of pin-site infection.

PRESENTATION OF CASE:

A 55-year-old diabetic female presented with an open left tibia-fibula fracture (Gustilo-Anderson Type IIIA) sustained in a car accident. She initially underwent debridement, suturing, and external fixation at a referring hospital. Postoperatively, the external fixation pin sites showed erythema, swelling, and discharge. Radiographs and CT scans revealed a tibial nonunion. Ten months post-injury, the tibial nonunion was successfully treated using the DTN, a novel technique. The distal tibia fracture achieved complete union postoperatively, allowing the patient to resume full weight-bearing and recreational activities such as running and jumping.

DISCUSSION:

To our knowledge, this is the first case report presenting the successful application of the DTN to treat nonunion following a Gustilo type IIIA open distal tibial fracture with prior pin-site infection and diabetes mellitus CONCLUSION: In this case, the DTN was effective in treating distal tibial nonunion, achieving satisfactory radiographic and functional outcomes. These findings suggest that DTN offers distinct advantages for the management of distal tibial nonunion, providing a valuable reference for clinical practice.

项与 Dentonin 相关的新闻（医药）

2022-06-01

·BioSpace

TPX-100: OrthoTrophix Presents the Latest Clinical Data at BIO 2022

FOSTER CITY, Calif., June 1, 2022 /PRNewswire/ -- OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today that the Company will present the latest clinical data and registration plan of TPX-100 in knee osteoarthritis (OA) patients at BIO 2022 (San Diego, CA for June 13 – 16). The presentation will be made by the company's CEO, Yoshi Kumagai, in Theater 2 at 1:45pm on Tuesday, June 14th. The presentation will include clinical data demonstrating the robust improvements of function, long term pain, and joint structure by TPX-100 treatment, as well as the strong associations between the clinical and structural effects. "These data are persuasive that TPX-100 affects the critical pathophysiology of knee OA and that it results in striking clinical benefits to the patients," commented Yoshi Kumagai. "I look forward to presenting the breakthrough to the pharmaceutical and investment communities at BIO." "It has been nearly four years since the FDA revised its OA therapy guidance, removing articular cartilage thickness that had been the agency's 'endorsed' OA biomarker for decades. The clinical results of TPX-100 align with the FDA's latest draft guidance for DMOAD approval," commented Dr. Dawn McGuire, OrthoTrophix' Chief Medical Officer. "We anticipate that TPX-100 will help many of the over 500 million OA patients worldwide who currently have no compelling disease modifying therapy." About OrthoTrophix, Inc. OrthoTrophix, Inc., based in the San Francisco Bay Area, California, is a privately held biopharmaceutical company focused on development and commercialization of a first-in-class Disease Modifying Osteoarthritis Drug (DMOAD). Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage and underlying bones in the knee and other joints with its novel proprietary compounds. This press release contains "forward-looking" statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix' business. Company Contact Yoshi Kumagai President and CEO Tel: (510) 488-3824 View original content to download multimedia: SOURCE OrthoTrophix, Inc.

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