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Clinical Research

Practical Advice for Investigator-Initiated Trials
 Practical Advice for Investigator-Initiated Trials 1024 363 Lauren Dembeck
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Investigator-initiated trials play a crucial role in advancing medical research and contributing to evidence-based medicine. These trials are initiated, designed and conducted by researchers, often physicians or scientists, rather than by pharmaceutical or biotechnology companies. They allow researchers to explore specific hypotheses, novel interventions or unique patient populations that may not be addressed in industry-sponsored…

Growing Clinical Research at Nationwide Children’s With Cynthia Gerhardt, PhD
 Growing Clinical Research at Nationwide Children’s With Cynthia Gerhardt, PhD 1024 683 Cynthia Gerhardt, PhD and Natalie Wilson
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Dr. Gerhardt was appointed Chief Clinical Research Officer at Nationwide Children’s Hospital in April 2023. With integrating clinical care and research at the heart of the hospital’s strategic plan, she has big plans for ensuring our clinical research infrastructure continues to grow and evolve to support the best bench-to-bedside-and-back science for best outcomes. Learn more…

Oncolytic Virus Immunotherapy Safe and Tolerable in Children With Relapsed or Refractory Solid Tumors
 Oncolytic Virus Immunotherapy Safe and Tolerable in Children With Relapsed or Refractory Solid Tumors 1024 683 Lauren Dembeck
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The overall survival rates for children with childhood cancers is now over 80%; however, for children with relapsed and refractory tumors, the survival rates remain low. “For example, children with relapsed or refractory neuroblastoma have a five-year survival of less than ten percent,” explains Keri A. Streby, MD, director of the Neuroblastoma Program in the…

The True History of the Nuremberg Code: Leo Alexander’s Blueprint Uncovered
 The True History of the Nuremberg Code: Leo Alexander’s Blueprint Uncovered 150 150 Abbie Miller
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An investigation of Duke University’s Medical Center’s Archives boxes labeled “Alexander’s Papers” reveals a document containing six principles, which were included nearly word-for-word in the Nuremberg Code.  At the end of the famous Doctors’ Trial, the trial of Nazi doctors for their crimes and treatment of people who were identified as “research participants,” Judge Sebring…

When Every Week Matters: Advancing a Treatment to the Clinic
 When Every Week Matters: Advancing a Treatment to the Clinic 1024 491 Natalie Wilson
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Illustrations of clock faces at different times and angles

Researchers and regulatory experts bring a potential new therapy for a deadly neurodegenerative disease from IND application to clinical trial enrollment in a matter of weeks, setting a new standard in translating therapies from bench to bedside. In October 2021, the Office of Research Regulatory Affairs (ORRA) at Nationwide Children’s Hospital submitted an Investigational New…

Lubiprostone Found to be Safe, as Effective as Placebo in Children With Constipation
 Lubiprostone Found to be Safe, as Effective as Placebo in Children With Constipation 1024 680 Mary Bates, PhD
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Close up color photo of little boy holding hands on his belly

The medication, FDA-approved for adults, may benefit older pediatric patients with less of a behavioral component to their constipation. Pediatric functional constipation, though common, remains challenging to treat. Lubiprostone is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of constipation and irritable bowel syndrome with constipation in adults. In…

Long-Term Follow-up Study Shows Cannabidiol is Safe and Effective for Lennox-Gastaut Syndrome
 Long-Term Follow-up Study Shows Cannabidiol is Safe and Effective for Lennox-Gastaut Syndrome 695 473 Mary Bates, PhD
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Black and white environmental portrait of Dr. Anup Patel standing in the hospital in his lab coat with his hand in his pocket

Long-term treatment with highly purified plant-based CBD shows continued seizure reduction and no new side effects. The results of a long-term open-label extension trial of plant-derived, highly purified cannabidiol (CBD) show the treatment is effective and safe long term for patients with Lennox-Gastaut syndrome. The treatment had a similar safety profile as in the original…