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Clinical trial participant’s autopsy and brain exam stoke Alzheimer’s drug fears | Science

A full autopsy and detailed examination of the brain of a 79-year-old Florida woman who died after receiving lecanemab, an experimental Alzheimer’s therapy, in a pivotal clinical trial has deepened some researchers’ concerns that it poses serious risks for patients who share the woman’s hard-to-diagnose, preexisting condition. The patient’s history and autopsy “strongly suggests that lecanemab infusions were a catalyst leading to the events resulting in her…

Pragmatic approach may be the way forward for clinical trials

That a new cancer trial is about to start in the US is positive but not out of the ordinary, right? Except it is. This trial will be one of the first undertaken in a real-world clinical setting and represents a new model for future clinical trials.The US’s National Cancer Institute (NCI) has helped launch a phase 3 clinical trial, the Pragmatica-Lung Study, investigating the use of a two-drug treatment for people with advanced (stage 4) non-small cell lung cancer (NSCLC). What makes this trial different is that it’s one…

Why is it so difficult to successfully get AI adopted into clinical care?

Photo by National Cancer Institute on UnsplashA look into a scientific review paper that asked that question and found answersArtificial intelligence (AI) is becoming increasingly prevalent in our daily lives. From recommendation systems in almost every webshop, to automatic translation of foreign languages on websites you visit. For some industries this transition seems to be going more smoothly than for others though. The medical field seems to be especially challenging to enter, but why? There is so much academic…

Neuralink Said to Approach US Neurosurgery Centre as Potential Human Clinical Trials Partner

Elon Musk's brain implant company Neuralink has approached one of the biggest US neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter.Neuralink has been developing brain implants since 2016 it hopes will eventually be a cure for intractable conditions such as paralysis and blindness.It suffered a blow in early 2022, when the US Food and Drug Administration rejected its application to progress…

Day procedure to slow progression of diabetes headed to clinical trial

A phase 2 clinical trial is currently exploring a new technique to slow the progression of type 2 diabetes. The simple outpatient surgery can be conducted in the early stages of diagnosis and delay the need for insulin shots.Insulin is a vital hormone that helps us process glucose in the bloodstream to produce energy, but in patients with type 2 diabetes, the body begins to lose the ability to use insulin effectively. If left untreated, prolonged elevated blood sugar levels can lead to a range of serious health…

Promising ovarian cancer drug in phase 3 clinical trials

Despite treatment, the survival rates for women with ovarian cancer remain poor, and the chance of the cancer returning is high. But there could be hope for women whose cancer has returned following chemotherapy in the form of a promising cancer-fighting drug that is currently undergoing clinical trials in the US.The drug, called upifitamab rilsodotin, is an antibody-drug conjugate, a class of drugs designed as targeted therapy for disease treatment. Upifitamab rilsodotin acts like a Trojan horse, tricking its way into…

Oral pill cuts bad cholesterol by 60% in phase 2 clinical trial

High cholesterol levels are a common and potentially deadly health problem, but a new drug could help more people manage the condition. An experimental pill has been shown to reduce levels of “bad” cholesterol by 60% in a phase 2 clinical trial.Known as MK-0616, the new drug works by inhibiting a protein called PCSK9, lower levels of which helps the liver break down low-density lipoprotein (LDL) cholesterol. PCSK9 inhibitors have been a major avenue for treatments to reduce cholesterol, but it usually involves…

Clinical Trial Demonstrates Significant Improvement for Women With Advanced or Recurrent Endometrial Cancer

Endometrial cancer is a type of cancer that starts in the lining of the uterus, called the endometrium. It is the most common type of uterine cancer. Symptoms can include abnormal vaginal bleeding, pelvic pain, and weight loss. The exact cause of endometrial cancer is not known, but certain factors such as obesity, hormonal imbalances, and a family history of cancer may increase the risk. Treatment options for endometrial cancer may include surgery, radiation therapy, and chemotherapy. Early detection and treatment can…

Clinical trial shows probiotic could prevent dangerous superbug infection

Staphylococcus aureus is a common bacteria species in humans, but it can turn nasty if it gets into the wrong part of the body. A new clinical trial has shown that a probiotic can be used to selectively cut populations of the bug in humans, reducing the risk of infection without the hazards of antibiotics.S. aureus can be found in the nose, gut and on the skin of many people, and for the most part it’s harmless there. But if it gets into a wound, the bloodstream, the lungs or anywhere else it isn’t meant to be, it can…

“Endangering Public Health” – New Investigation Reveals Startling Lack of FDA Oversight in Clinical Trials

The FDA has also been criticized for failing to notify the public or scientific journals when violations are identified, effectively hiding scientific misconduct from the medical establishment.According to a new investigation published in The BMJ, experts are raising concerns about the US Food and Drug Administration’s (FDA) insufficient monitoring of clinical trial sites for Covid-19 vaccines and drugs, which were developed at “warp speed.”The investigation reveals that out of 153 trial sites for Pfizer’s <span…