May 8th, 2021 - Chronic kidney disease (CKD) affects about 10% of all populations worldwide, with about 2 million people requiring dialysis. Although patients with CKD are at high risk of cardiovascular disease and events, they are often underrepresented or excluded in clinical trials, leading to important knowledge gaps about how to treat these patients. KDIGO (Kidney Disease: Improving Global Outcomes) conve...

May 30th, 2020 - A pooled analysis of clinical trial data revealed that systemic therapy with cabozantinib (Cabometyx) in advanced renal cell carcinoma (RCC) induced reliable responses for patients regardless of whether or not they had received prior immunotherapy. Patients from both the phase 3 METEOR (NCT01865747) and the phase 2 Japanese C2001 (NCT03339219) trials comprised the efficacy population whose resu...

May 30th, 2020 - Data from 2 phase 2 trials involving fam-trastuzumab deruxtecan-nxki (Enhertu) revealed the agent’s ability to induce responses in patients with HER2-positive metastatic colorectal cancer (CRC) and advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Both studies had results presented at the 2020 ASCO Virtual Scientific Program.

May 30th, 2020 - Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) lived significantly longer if they received an androgen signaling inhibitor (ASI) in addition to conventional androgen deprivation therapy (ADT), three large randomized trials of different drugs showed.

May 29th, 2020 - Although 84% of children with cancer survive 5 years or more, children with refractory, relapsed, and progressive high-risk malignancies have a poor median survival of 9.5 months. The German INFORM registry is a large prospective, noninterventional, multicenter study collecting clinical and molecular data on pediatric patients with refractory, relapsed, and progressive malignant cancers. The st...

May 29th, 2020 - Final survival results from three randomized, placebo-controlled trials, along with a safety analysis across all three, are helping to clarify the treatment landscape for nonmetastatic castration-resistant prostate cancer (nmCRPC). The results will be presented during the ASCO20 Virtual Scientific Program.

May 29th, 2020 - Participants in phase I oncology trials represent a patient population new to palliative care. These patients typically have remarkable symptoms, with a symptom burden comparable to other patients with cancer.1 Thomas J. Smith, MD, FASCO, of Johns Hopkins University, presented the results of a randomized trial evaluating a palliative care intervention (PCI) compared with usual care (UC) for pat...

May 19th, 2020 - In this meta-analysis that included 12 trials with 92 135 participants for the primary outcome measure, blood pressure lowering with antihypertensive agents, compared with control, was associated with the development of a composite dementia or cognitive impairment outcome in 7.0% vs 7.5% of patients over a mean trial follow-up of 4.1 years, a difference that was statistically significant.

Jul 30th, 2019 - Evaluate prevalence of troublesome dyskinesia and OFF through the day, assessed by 30-minute intervals, as well as the mean number and duration of troublesome dyskinesia and OFF episodes, transitions between PD states, and effects of Gocovri® (amantadine) extended release capsules on these episodes.

Increasing numbers of physicians, both within and outside academic health centers, are becoming involved in partnerships with industry to conduct biomedical and health research. As they do so, physicians must be mindful of the conflicts such engagement poses to the integrity of the research and the welfare of human participants. In addition to financial conflicts of interest created by incentiv...

As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial. This is a routine act...

The CURE Drug Repurposing Collaboratory (CDRC) is a public-private partnership initiated in June 2020 by C-Path and the U.S. Food and Drug Administration (FDA) in partnership with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). CDRC, in partnership with the FDA-NCATS CURE ID* platform, is a dedicated initiative designed to ca...

On August 23, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA)* for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.1,2 The COVID-19 Treatment Guidelines Panel (the Panel) reviewed the available evidence from published and unpublished data on convalescent plasma for the treatment for COVID-19, including the FDA analys...

Herpes zoster (HZ), also known as shingles, results from reactivation of the latent varicella-zoster virus (VZV), which commonly causes chickenpox in childhood. Greater than 90% of adults are infected with this virus, putting them at risk for reactivation. HZ presents as a painful, vesicular rash distributed in a unilateral and dermatomal pattern along dorsal root or cranial nerve ganglia. The ...

It usually takes more than a decade to develop a safe, effective anti-viral therapy. But, when it comes to coronavirus disease 2019 (COVID-19), we don’t have that kind of time. One way to speed the process may be to put some old drugs to work against this new disease threat. This is generally referred to as “drug repurposing.” NIH has been doing everything possible to encourage screens of ex...

Parkinson’s disease (PD) is a chronic neurodegenerative disorder characterized by motor symptoms such as bradykinesia, rest tremor, postural disturbances, and rigidity. PD is also characterized by non-motor symptoms such as sleep disturbances, cognitive deficits, and psychiatric disorders such as psychosis, depression, and anxiety. The pharmacological treatment for these symptoms is limited in ...

After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version of remdesivir. We will screen healthy volunteers for Phase 1 trials this week and hope to begin studies in patients with COVID-19 in August. If the trials are successful, this could represent important progress. Remdesivir, our investigational antiviral medicine, is currently give...

The US government is pouring billions into Covid-19 vaccines, and candidates from three companies are moving along quickly: Moderna, Pfizer and Novavax. Here's what you need to know about them. These are among the dozens of Covid-19 vaccines in trials around the world as researchers rush to find a way to stop the pandemic. To help speed the process, the US government's Operation Warp Speed...

The clinical presentation of Parkinson’s disease (PD) is heterogeneous and overlaps with other conditions, including the parkinsonian variant of multiple system atrophy (MSA-P), progressive supranuclear palsy (PSP) and essential tremor. Imaging of the brain in patients with parkinsonism has the ability to increase the accuracy of differential diagnosis. Magnetic resonance imaging (MRI), single ...

Acupuncture is known to have been practiced for more than 2000 years in China and then throughout East Asia. However, it only began to be studied in controlled clinical trials starting in the second half of the 20th century and in the West starting in the 1970s. Over that period of time, a pattern has emerged with trials carried out in countries such as China, Korea, and Japan tending to identi...