Feature Channels: Clinical Trials

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Cleveland: Findings from a Cleveland Clinic-led trial show that increasing the salt intake by mouth for patients who are hospitalized with heart failure undergoing aggressive diuretic therapy did not affect how much fluid they retain or their kidney function, indicating that salt intake for heart failure patients may not be as harmful as previously thought. Conversely, these new findings may challenge the common practice of salt restriction during hospital admission since that might not be as helpful.

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Researchers are working to improve outcomes for Black women with breast cancer, the most commonly diagnosed cancer and leading cause of cancer death in this population, according to the American Cancer Society. Coral Omene, MD, PhD, medical oncologist at the Stacy Goldstein Breast Cancer Center and member of the Cancer Health Equity Center of Excellence at Rutgers Cancer Institute shares more on increased participation in clinical trials, which helps find better ways to prevent, diagnose and treat cancer, diversity in breast cancer research, and what Black women need to know.

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A new study led by Cedars-Sinai investigators found using breath tests to identify gut gas profiles can potentially help lead to more personalized therapies for people diagnosed with irritable bowel syndrome (IBS). The most common gastrointestinal disorder affects 10% to15% of the world’s population.

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Um novo tipo de cardioversor desfibrilador implantável (CDI) extravascular usando um eletrodo (um fio fino) colocado atrás do esterno cumpre os objetivos de segurança e eficácia em participantes de estudo clínico global antes do lançamento no mercado. O dispositivo interrompeu com eficiência arritmias ventriculares agudas e crônicas potencialmente fatais. As descobertas foram apresentadas durante uma sessão de última hora no Congresso da Sociedade Europeia de Cardiologia e publicados no The New England Journal of Medicine simultaneamente.

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A clinical trial led by clinicians at Georgetown Lombardi Comprehensive Cancer Center showed a remarkable 20 percent advantage in the two-year overall survival rate for people with advanced melanoma who first received immunotherapy (72 percent survival rate) versus those who initially got targeted therapies (52 percent survival rate). Progression-free survival, where the cancer is stable or improving, was also trending in favor of those who started on immunotherapy.

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The University of Texas MD Anderson Cancer Center again supports World Cancer Research Day, Sept. 24, and its goals to highlight the importance of cancer research, to promote scientific collaboration and to reduce the global burden of cancer through improved prevention, early detection, treatment and survivorship strategies.

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An experimental drug to fight aggressive brain cancer has proved so successful in the first trial on humans that University of South Australia scientists will fast-track the second stage. The development provides a glimmer of hope for glioblastoma patients, who face a survival time of only 12 to 18 months after diagnosis.

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An international phase 3 clinical trial for a rare, inherited form of ALS led by Washington University School of Medicine in St. Louis, showed that an investigational drug, known as tofersen, reduced molecular signs of the fatal disease, but at six months did not improve motor control and muscle strength. However, the trial, which was sponsored by the pharmaceutical company Biogen, found evidence that longer-term use of the drug may help stabilize muscle strength and control.

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UCSF Health is recruiting patients for the only FDA-approved study of the use of single port robotic technology for colorectal surgery in the United States. UC San Francisco clinical investigators Ankit Sarin, MD, FACS, and Hueylan Chern, MD, initiated the study which will evaluate whether single port robot technology is more advantageous than the current multi-port technology used in colorectal surgery.

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Results of the first randomized controlled trial to directly compare two contemporary transcatheter edge-to-edge repair (TEER) devices for degenerative mitral regurgitation (DMR) found that the PASCAL transcatheter valve repair system was non-inferior compared with MitraClip in patients with significant symptomatic DMR who are not eligible for mitral valve surgery. Findings from the CLASP IID trial were reported today at TCT 2022, the 34th annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

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The UCLA Clinical AIDS Research and Education (CARE) Center today announced its participation in STOMP (Study of Tecovirimat for Human Monkeypox Virus), or A5418, a phase 3, randomized, placebo-controlled, double-blind trial evaluating the safety and efficacy of tecovirimat for the treatment of human monkeypox. STOMP, which is being led by the AIDS Clinical Trials Group (ACTG), has been designed to learn as much as possible in a broad population of people with monkeypox.

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Having experienced a stroke less than three hours before being admitted to the hospital, Andrea Arsimendez qualified for the Multi-arm Optimization of Stroke Thrombolysis (MOST) clinical trial at UTHealth Houston, which is investigating which blood thinner – argatroban or epitifibatide – improves recovery among acute ischemic stroke patients treated with standard-of-care thrombolysis within three hours of symptom onset.

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The highly selective RET inhibitor selpercatinib was well-tolerated and achieved durable objective responses across multiple tumor types in the Phase I/II LIBRETTO-001 trial.

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Newly released results from the Phase III ADAURA trial reveal that osimertinib yielded a 5.5-year median disease-free survival in the post-surgical treatment of patients with EGFR-mutated lung cancer, and nearly three in four patients treated with adjuvant osimertinib were disease-free at four years. The new results also indicated that the use of osimertinib reduced the risk of disease recurrence in the brain and spinal cord.

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Researchers from The University of Texas MD Anderson Cancer Center reported study results showing that the targeted therapy fruquintinib significantly improved overall survival (OS) and progression-free survival (PFS) in patients with refractory metastatic colorectal cancer. Findings from the global FRESCO-2 trial were presented today at the European Society for Medical Oncology (ESMO) Congress 2022.

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Investigadores de la Universidad de Georgia han descubierto un tratamiento potencial para la enfermedad de Chagas, marcando el primer medicamento con la promesa de atacar con éxito y seguridad la infección parasitaria en más de 50 años. Se espera que los ensayos clínicos en humanos del fármaco, un compuesto antiparasitario conocido como AN15368, pueden empezar en los próximos años.

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Researchers from the University of Georgia have discovered a potential treatment for Chagas disease, marking the first medication with promise to successfully and safely target the parasitic infection in more than 50 years. Human clinical trials of the drug, an antiparasitic compound known as AN15368, will hopefully begin in the next few years.

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A targeted kinase inhibitor added to a two-drug immunotherapy combination slowed the progression of advanced kidney cancer in previously untreated patients, according to research led by an oncologist from Dana-Farber Cancer Institute.

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With the support of a five-year, $3.5 million grant from the National Institutes of Health (NIH), researchers will study how the COVID-19 pandemic impacted opioid use disorder and how the COVID-19 response and mitigation policies impact health outcomes, especially in vulnerable populations.

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MD Anderson and Virogin Biotech today announced a strategic collaboration to accelerate the development of oncolytic virus therapies for advanced cancers.

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Ismael Seáñez will lead an interdisciplinary team of Washington University researchers and physicians to understand the changes in the neural circuits that may result in motor function improvements through using spinal cord stimulation.

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Cedars-Sinai investigators have developed an investigational therapy using support cells and a protective protein that can be delivered past the blood-brain barrier. This combined stem cell and gene therapy can potentially protect diseased motor neurons in the spinal cord of patients with amyotrophic lateral sclerosis, a fatal neurological disorder known as ALS or Lou Gehrig's disease.

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A clinical trial investigating the effects of different treatments, including light exercise and screen time restrictions, on recovery from a sport-related concussion among adolescents has opened for enrollment at UTHealth Houston.

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A small device that detects food craving-related brain activity in a key brain region, and responds by electrically stimulating that region, has shown promise in a pilot clinical trial in two patients with loss-of-control binge eating disorder (BED), according to researchers at the Perelman School of Medicine at the University of Pennsylvania.

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In a first-of-its-kind randomized clinical trial led by researchers at the Smidt Heart Institute and the Division of Artificial Intelligence in Medicine at Cedars-Sinai, artificial intelligence (AI) proved more successful in assessing and diagnosing cardiac function when compared to echocardiogram assessments made by sonographers.

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Mount Sinai researchers develop new risk stratification tool to optimize patient care and outcomes after TAVR

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A three-drug medication known as a “polypill,” developed by the Spanish National Center for Cardiovascular Research (CNIC) and Ferrer, is effective in preventing secondary adverse cardiovascular events in people who have previously had a heart attack, reducing cardiovascular mortality by 33 percent in this patient population.

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Irvine, Calif., Aug. 25, 2022 — From monitoring sandy beaches to gauge the effects of sea-level rise to holding clinical trials for potentially lifesaving cancer treatments, scholars, scientists and physicians at the University of California, Irvine are blazing new paths to help change the world. And their impact keeps growing.

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The University of Texas MD Anderson Cancer Center’s Research Highlights provides a glimpse into recent basic, translational and clinical cancer research from MD Anderson experts. Current advances include confirmation of improving response rates in Phase I trials over the last 20 years, a novel targeted therapy combination and biomarkers of response for chimeric antigen receptor (CAR) T cell therapy in B-cell lymphomas, a combination therapy for patients with melanoma brain metastases, and new treatment options for metastatic sarcomas, HPV-driven cancers and uterine cancer.

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WALTHAM, Mass., Aug. 23, 2022 – Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today that the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to conventional treatment.

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Media Briefing Schedule for ACS Fall 2022

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There’s no cure for lupus, an autoimmune disease that attacks organs. But today, scientists report they have begun phase 2 clinical trials with a pill containing a compound that, in mice, reverses organ damage and prevents death. They will present their results at ACS Fall 2022.

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UC Davis Health is recruiting people for a clinical trial, BrainGate2, with the goal of building a “neurological prosthesis” for restoring speech to people who have lost — or are losing — the ability to speak due to injuries like stroke or diseases like ALS.

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Kidney cancer encompasses a wide spectrum and can present with extensive metastases or just a handful. However, today all patients are treated the same. They all receive medication.

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Hospital is one of only five in the U.S. selected to participate in early clinical trial for the minimally invasive Impella BTR technology

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Ashish Shah, M.D., has assumed the newly created position of director of clinical trials and translational research and principal investigator in the Section of Virology and Immunotherapy at Sylvester Comprehensive Cancer Center’s Brain Tumor Initiative (BTI) at the University of Miami Miller School of Medicine. Dr. Shah, who calls himself a “quadruple ’Cane,” returns to the site of his undergraduate studies, medical school, and residency as a faculty member. This follows a year-long fellowship at the National Institutes of Health, where he focused on clinical trial design and translational neuro-oncology.

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Johns Hopkins Medicine researchers say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19.

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UT Southwestern researchers have identified a molecular pathway responsible for the spread of glioblastoma to surrounding tissue in the brain, as well as an existing drug that curbed tumor growth in animal models. The findings, published in Nature Cell Biology, have led to a clinical trial that could offer new hope to patients with glioblastoma, the most common form of brain cancer in adults that kills hundreds of thousands of people worldwide each year.

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With the support of Harrington Discovery Institute at University Hospitals (UH), an ophthalmic therapeutic dubbed KIO-301, which was initially developed by Richard Kramer, PhD, at the University of California, Berkeley (UCB), has successfully been granted approval to start a Phase 1b, first-in-human clinical trial. Currently under the stewardship of Kiora Pharmaceuticals, Inc., (NASDAQ: KPRX) via a license with UCB, Inc., the drug is intended to restore lost vision in patients with Retinitis Pigmentosa (RP)--a rare, genetic eye disease that causes severe loss of functional vision and affects an estimated 100,000 people in the U.S.

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A clinical trial is only as powerful as its participants. For years, researchers have struggled to fill clinical trials and enroll sufficiently diverse groups of patients for results to reflect the broader population, in part because of stringent guidelines on who can participate.