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Clinical Trial News

MRE and TE Show Limited Accuracy in Detecting Advanced Liver Fibrosis in Pediatric MASLD Patients

  • A new study at Children's Hospital Los Angeles reveals that magnetic resonance elastography (MRE) and transient elastography (TE) demonstrate insufficient accuracy in detecting high-grade liver fibrosis in pediatric MASLD patients.
  • Research findings show MRE performed marginally better than TE with AUROC values of 0.817 versus 0.750, though the difference was not statistically significant (P=0.4785).
  • The study, involving 77 pediatric patients with biopsy-proven MASLD, highlights the urgent need for more reliable non-invasive monitoring tools as MASLD affects up to 38% of children with obesity.

DETERMINE Trial Aims to Improve Targeted Therapy for Rare Cancers Through Genetic Understanding

  • The DETERMINE trial expands treatment options for patients with rare cancers beyond standard chemotherapy, leveraging increased knowledge of cancer genetics.
  • DETERMINE Translational aims to understand how genetic changes causing cancer are activated by conditions like mutations, inflammation, or epigenetics.
  • Researchers hope to identify ways to prevent certain cancers by interfering with triggering conditions or blocking secondary processes.
  • The combined results of DETERMINE and DETERMINE Translational could provide new treatment options and improve patient selection for effective treatments.

Technology-Assisted Health Coaching Fails to Achieve Significant Weight Loss in Primary Care Trial

  • A cluster-randomized controlled trial evaluated a technology-assisted health coaching intervention (GEM) for weight management in primary care settings.
  • The GEM intervention, involving health coaching and a software tool, did not result in clinically significant weight loss compared to enhanced usual care.
  • The study found no statistically significant differences in secondary outcomes, including weight management program attendance and dietary changes.
  • Exploratory analyses suggested a potential increase in moderate to vigorous physical activity in the GEM arm, warranting further investigation.
NCT03006328CompletedNot Applicable
NYU Langone Health
Posted 11/20/2017

LSU LCMC Health Cancer Center Spearheads Advances in Cancer Research and Equitable Care

  • The LSU LCMC Health Cancer Center is focusing on community-based research to address cancer treatment and prevention in Louisiana.
  • Clinical trials are essential for developing new cancer treatments, understanding medication toxicity, and improving patients' quality of life.
  • The Gulf South Clinical Trials Network expands access to cancer care, particularly for minority and underserved populations across multiple states.
  • LSU LCMC Health Cancer Center collaborates globally, addressing HIV-related cancer development and tailoring treatments to local community needs.

Senate Confronts Novo Nordisk Over Semaglutide Pricing, Demands U.S. Price Parity with Europe

  • Senate HELP Committee Chair Bernie Sanders challenges Novo Nordisk CEO over Ozempic and Wegovy pricing, highlighting that U.S. prices are up to nine times higher than in European countries.
  • Novo Nordisk CEO Lars Fruergaard Jorgensen defends pricing strategy, citing extensive drug development history and manufacturing investments, while pointing to PBM influence on final consumer costs.
  • The hearing revealed potential breakthrough as PBMs commit to maintaining drug access if list prices are reduced, leading to planned discussions between Novo Nordisk, PBMs, and Senate leadership.

Metformin Shows Promise in Slowing Organ Aging in Primate Study

  • A recent study on primates indicates that metformin, a common drug for type 2 diabetes, may slow the aging process in key organs.
  • The research found that monkeys treated with metformin experienced slower aging in their kidneys, lungs, skin, and brain.
  • The observed reduction in aging was significant, with some organs aging up to six years slower in the treatment group.
  • Researchers plan to conduct human trials to investigate whether metformin can replicate these anti-aging effects in people.

Psilocybin Shows Promise in Reducing Symptoms of Body Dysmorphic Disorder

  • A pilot study indicates that psilocybin significantly reduced symptoms in individuals with body dysmorphic disorder (BDD).
  • Brain scans revealed that psilocybin treatment increased connectivity between brain regions related to emotional processing and cognitive activity.
  • The improvement in BDD symptoms correlated with the strengthening of connections within brain networks, suggesting enhanced brain flexibility.
  • Further research with larger groups is necessary to confirm the effectiveness and long-term effects of psilocybin for treating BDD.

AlgoTx Completes Phase II Trial of ATX01 for Chemotherapy-Induced Peripheral Neuropathy

  • AlgoTx has announced the completion of the Last Patient Last Visit (LPLV) in its Phase II clinical trial, ACT, evaluating ATX01 for chemotherapy-induced peripheral neuropathy (CIPN).
  • The international, double-blind, placebo-controlled trial included 276 patients across more than 40 sites in multiple countries.
  • ATX01, a topical formulation of amitriptyline, targets nociceptive sodium channels to alleviate pain associated with CIPN, which currently lacks approved treatments.
  • The company anticipates sharing the ACT data in early 2025 and plans to expedite a Phase 3 trial for ATX01.

Experts Discuss Treatment Strategies and Challenges in Managing Chronic GVHD After Stem Cell Transplantation

  • Leading transplant specialists highlight the critical importance of collaboration between transplant centers and referring physicians in managing chronic graft-versus-host disease (GVHD) patients.
  • The REACH3 trial data shows ruxolitinib's effectiveness in treating steroid-refractory chronic GVHD, though complete response rates remain relatively low, emphasizing the need for managing patient expectations.
  • Multiple treatment options including ruxolitinib, belumosudil, and extracorporeal photopheresis are available for chronic GVHD, with treatment selection influenced by factors such as disease severity, patient characteristics, and insurance coverage.

Evrysdi Approved in Japan for Pre-Symptomatic SMA and Infants Under 2 Months

  • Chugai's Evrysdi (risdiplam) gains approval in Japan for treating pre-symptomatic spinal muscular atrophy (SMA) and infants under two months of age.
  • The approval is based on Phase II RAINBOWFISH study results, demonstrating Evrysdi's efficacy and safety in pre-symptomatic SMA infants.
  • Evrysdi, an oral SMN2 splicing modifier, becomes the first oral treatment option available for SMA patients of all ages after birth in Japan.
  • This approval enables earlier intervention, potentially maximizing treatment benefits for SMA patients diagnosed through genetic testing.

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