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2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Dawn McGuire ◽  
Michael Bowes ◽  
Alan Brett ◽  
Neil A. Segal ◽  
Meghan Miller ◽  
...  

Abstract Background TPX-100, a promotor of osteoblast and chondroblast differentiation, is a potential osteoarthritis (OA) therapy. This retrospective study compared MRI 3D femoral bone shape changes (B-scores) after intra-articular TPX-100 or placebo and analyzed the relationship between cartilage thickness and bone shape change over 12 months. Methods One hundred and four participants with bilateral moderate to severe knee cartilage defects were randomized to receive TPX-100 (200 mg) or placebo. Each subject’s contralateral placebo-treated knee served as a paired internal control. After MRI quality control, 78/93 subjects (84%; 156 knees) were analyzed for quantitative femoral B-score and cartilage thickness. All analyses were performed centrally, blind to treatment assignment and clinical data. Results TPX-100-treated knees (n = 78) demonstrated a statistically significant decrease in pathologic bone shape change compared with placebo-treated knees at 6 and 12 months: 0.0298 (95% C.I. − 0.037, 0.097) vs 0.1246 (95% C.I. 0.067, 0.182) (P = 0.02), and 0.0856 (95% C.I. 0.013, 0.158) vs. 0.1969 (95% C.I. 0.123, 0.271) (P = 0.01), respectively. The correlation between bone shape change and medial and total tibiofemoral cartilage thickness changes at 12 months was statistically significant in TPX-100-treated knees (P < 0.01). Conclusions This is the first report of a potential therapy demonstrating a significant effect on bone shape measured by B-score in knee OA. These data, in combination with previously reported statistically significant and clinically meaningful improvements in WOMAC physical function versus placebo, support TPX-100 as a candidate for disease modification in knee OA. Trial registration NIH ClinicalTrials.gov, NCT01925261. Registered 15 August 2013


mSystems ◽  
2021 ◽  
Vol 6 (4) ◽  
Author(s):  
Christopher E. Lawson

Microbial communities (microbiomes) have been harnessed in biotechnology applications such as wastewater treatment and bioremediation for over a century. Traditionally, engineering approaches have focused on shaping the environment to steer microbiome function versus direct manipulation of the microbiome’s metabolic network.


2021 ◽  
Author(s):  
Krista M. Vincent ◽  
Alison Eaton ◽  
Vahid Reza Yassaee ◽  
Mohammad Miryounesi ◽  
Feyzollah Hashemi‐Gorji ◽  
...  

2021 ◽  
Author(s):  
Dawn McGuire ◽  
Michael Bowes ◽  
Alan Brett ◽  
Neil Segal ◽  
Meghan Miller ◽  
...  

Abstract Background: TPX-100, a promotor of osteoblast and chondroblast differentiation, is a potential osteoarthritis (OA) therapy. This retrospective study compared MRI 3D femoral bone shape changes (B-scores) after intra-articular TPX-100 or placebo and analyzed the relationship between cartilage thickness and bone shape change over 12 months.Methods: 104 participants with bilateral knee moderate to severe (ICRS 2-4) knee cartilage defects were randomized for evaluation of efficacy and safety of 200mg of TPX-100. Each subject’s contralateral placebo-treated knee served as a paired internal control. After MRI quality control, 78/93 subjects (84%; 156 knees) were analyzed for quantitative femoral B-score and cartilage thickness. All analyses were centrally performed, blind to treatment assignment and clinical data.Results: TPX-100-treated knees (n=78) demonstrated a statistically significant decrease in pathologic bone shape change compared with placebo-treated knees at 6 and 12 months: 0.0298 (95% C.I. -0.037, 0.097) vs 0.1246 (95% C.I. 0.067, 0.182) (P=0.02); and 0.0856 (95% C.I. 0.013, 0.158) vs. 0.1969 (95% C.I. 0.123, 0.271) (P = 0.01), respectively. The correlation between bone shape change and medial and total tibiofemoral cartilage thickness changes at 12 months was statistically significant in TPX-100-treated knees (P<0.01). Conclusions: This is the first report of a potential therapy demonstrating a significant effect on bone shape measured by B-score in knee OA. These data, in combination with previously reported statistically significant and clinically meaningful improvements in WOMAC function versus placebo, support TPX-100 as a candidate for disease modification in knee OA.Trial Registration: NIH clinicaltrials.gov, NCT01925261. Registered 15 August 2013, https://clinicaltrials.gov/ct2/show/NCT01925261?term=NCT01925261


2021 ◽  
Vol 44 ◽  
Author(s):  
Joshua M. Tybur ◽  
Debra Lieberman

Abstract To understand the consequences of cleansing, Lee and Schwarz favor a grounded procedures perspective over recently developed disgust theory. We believe that this position stems from three errors: (1) interpreting cleansing effects as broader than they are; (2) not detailing the proximate mechanisms underlying disgust; and (3) not detailing adaptive function versus system byproducts when developing the grounded procedures perspective.


2020 ◽  
Author(s):  
Joshua M. Tybur ◽  
Debra Lieberman

To understand the consequences of cleansing, Lee and Schwarz favor a grounded procedures perspective over recently-developed disgust theory. We believe that this position stems from three errors: (1) interpreting cleansing effects as broader than they are; (2) not detailing the proximate mechanisms underlying disgust; and (3) not detailing adaptive function versus system byproducts when developing the grounded procedures perspective.


Author(s):  
Hien H. Nguyen ◽  
Hua Zhong ◽  
Mingzhou Song

Functional dependency can lead to discoveries of new mechanisms not possible via symmetric association. Most asymmetric methods for causal direction inference are not driven by the function-versus-independence question. A recent exact functional test (EFT) was designed to detect functionally dependent patterns model-free with an exact null distribution. However, the EFT lacked a theoretical justification, had not been compared with other asymmetric methods, and was practically slow. Here, we prove the functional optimality of the EFT statistic, demonstrate its advantage in functional inference accuracy over five other methods, and develop a branch-and-bound algorithm with dynamic and quadratic programming to run at orders of magnitude faster than its previous implementation. Our results make it practical to answer the exact functional dependency question arising from discovery-driven artificial intelligence applications. Software that implements EFT is freely available in the R package 'FunChisq' (≥2.5.0) at https://cran.r-project.org/package=FunChisq


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